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Xtalks On Demand Webinars - Life Sciences

  Synopsis Webinar Title Date
LifeSciences - The presenters will share lessons learned, critical partnerships, permitting, tax and VAT implications, local labor considerations and other pertinent topics associated with execution of a successful project in a new environment
Speakers: Doug Tom Hendricks, Vice President, Fluor Industrial Services
Rob Bollenback, Project Director, Fluor Industrial Services
Stuart Mosby, Project Director, Fluor Industrial Services
Maximizing Production Capacity for Growth
Part 4: Designing and Building Production Facilities in New Markets
Nov 24/14
LifeSciences - Hear TransCelerate and Medidata discuss the results of a data-driven analysis on the relative effectiveness of SDV—which will be published in the November 2014 issue of Therapeutic Innovation & Regulatory Science (TIRS), the official journal of DIA—as well as learn how to turn the findings into real-world practice
Speakers: Stephen Young, Principal Engagement Consultant, Medidata
Andy Lawton, Global Head of Clinical Data Management, Boehringer Ingelheim
Mark Travers, Vice President, Head of Clinical Study Units, Sanofi
TransCelerate and Medidata Discuss SDV ​Findings and Application to Risk-Based Monitoring Nov 17/14
LifeSciences - Hear industry experts offering key insights which will help you gain a better understanding of the opportunities and challenges when conducting vaccines studies within Latin America
Speakers: Valeria Staffolani, Associate Medical Director, Quintiles Pediatric Center of Excellence
Mauro Martinelli, DEmerging Markets Specialist, Quintiles
Vaccine Trials in Latin America – Insight and Opportunities Nov 13/14
LifeSciences - The speakers will present a novel targeted RNA sequencing method and elaborate on experiences with targeted RNA sequencing that overcomes many of the standard RNA-Seq limitations and achieves unprecedented read coverage, sensitivity and resolution.
Speakers: Timothy R. Mercer, PhD, Lab Head - Transcriptomic Research, The Garvan Institute of Medical Research, Australia
John Tan, PhD., Senior Scientist – Sequence Capture, Roche NimbleGen
Discover More in Transcriptome Research with the Unprecedented Read Coverage, Sensitivity and Resolution of Targeted RNA Sequencing Nov 12/14
LifeSciences - The presenters will discuss ways to improve site engagement and cost management by leveraging the industry’s latest developments and technologies
Speakers: Frank J. Cattie, Vice President, Trial Planning Solutions (TPS), Medidata
Marcus Thornton,Senior Director, CTMS, Medidata
Streamlining the Site Budgeting and Payment Process Nov 11/14
LifeSciences - This webinar will outline the background and evolution of the role. It will show how the role of MSL both complements and exceeds that of traditional sales representatives – demonstrating the key differences between these two roles
Speakers: James Cornwall, PhD, Regional Head, New Business Ventures, Quintiles AA
Jill Morjaria, MSc B Pharm, Regional Lead, Quintiles AA
Evolving Role of the Medical Field-force in Asia-Pacific Nov 11/14 (APAC live broadcast)
LifeSciences - Learn how optimized study design dramatically decreases excessive cost, waste and subject burden, the positive effect of streamlined protocols on downstream operational execution, and the benefits of a facilitated design and review process
Speaker: Jason Attanucci, Global Director, Study and Protocol Design, Medidata
Focusing Resources on the Science of Study Design Nov 6/14
LifeSciences - The presenter will discuss definitions for bound residues and NER, explanations for their formation, regulatory approaches and guidance, and review case studies of experimental approaches and analytical techniques employed to answer both scientific and regulatory questions
Speaker: James Schmidt, Senior Scientific Advisor, ABC Laboratories
Strategies for Bound and Non-Extractable Residues in Laboratory Environmental Fate Studies Nov 6/14
LifeSciences - The presenter will examine the growth of pre-filled syringes, the factors contributing to this growth, and the key role technological advances in syringe assembly and labeling are playing in this expanding area
Speaker: Pamela Osborne, Senior Clinical Supply Chain Manager, Fisher Clinical Services
Pre-Filled Syringes in Clinical Trials Nov 6/14
LifeSciences - As R&D expenditures in Asia-Pac continue to increase, Dr. Gries’ presentation will examine the five ways to maximize molecule value and will provide practical advice on reaching your proof-of-concept milestones
Speaker: Jean-Michel Gries, PharmD PhD MBA FCP, VP & GM, Early Clinical Development, Covance
Insights on Improving Global Drug Development from Bench to Commercialization
Part 4: Strategies and Operations for Early Clinical Development
Nov 4/14
LifeSciences - qPCR experts describe their experience overcoming challenges to assay design for diverse applications. The BHQplus® probe format presents a compact oligo design offering enhanced specificity for the detection of challenging target sequences and discrimination of sequence variations.
Speakers: James C. Willey George Isaac Professor for Cancer Research, University of Toledo Health Sciences Campus, Consultant for Accugenomics, Inc.
Cassie Keppel Laboratory Operations Manager, Douglas Scientific
Probe-based qPCR Approaches for Detection of SNPs and Validation of Molecular Diagnostics Oct 30/14
LifeSciences - This webinar will examine three key benefits of electronic clinical outcome assessments: reduced data variance, increased patient compliance and reduced site monitoring costs
Speakers: Elisabeth Kurkimilis, Senior Manager of Clinical Operations, Celgene Corporation
Valdo Arnera, MD, General Manager Europe, PHT Corporation
Benefits and ROI of eCOA Data Collection in Clinical Trials Oct 30/14
LifeSciences - As biopharmaceutical companies increasingly seek to achieve global patient access, there is a need to develop PV procedures and systems that go beyond the strict confines of safety signal detection to provide for proactive benefit/risk management and optimized oversight
Speakers: Brian Guza , VP of Infosario Safety, Quintiles
Annette Williams , Senior Director, Pharmacovigilance Services, Lifecycle Safety , Quintiles
Patient-Centric Pharmacovigilance: Building Better Outcomes through Integrated Technology Oct 29/14
LifeSciences - Recent Standardization and harmonization of methodologies across multicenter allergy and respiratory trials with induced sputum biomarkers as a primary outcome
Speakers: Graham Clarke, PhD, Senior Director and Head of Respiratory & Inflammation, Quintiles Early Clinical Development
Neil Alexis, Professor, Department of Pediatrics, Division of Immunology and Infectious Disease, University of North Carolina at Chapel Hill
Improving the Quality of Allergy and Respiratory Clinical Research Using Induced Sputum Biomarkers Oct 29/14
LifeSciences - The speakers will present data and lessons drawn from risk based monitoring of 12 global schizophrenia trials involving over 80000 visits
Speakers: Alan Kott, MUDr, Senior Manager Data Analytics, Bracket
David G. Daniel, M.D., Senior Vice President and Chief Medical Officer, Bracket
Risk-Based Monitoring in Global Schizophrenia Trials: A 360 Degree View Oct 28/14
Pharma/Healthcare SupplyChain - The presenters will follow an imaginary high-value, temperature-sensitive healthcare shipment from the moment the products are loaded into your trucks for delivery
Speakers: Douglas Braund, Manager, Security, FedEx Custom Critical
Chris Swearingen, Marketing Manager, SenseAware, powered by FedEx
Identifying and Preventing Security Vulnerabilities and Temperatrue Excursions in Your Clinical Supply Chain Oct 23/14
LifeSciences - There is great excitement in the pharmaceutical and oncology fields as drugs targeting immune checkpoint proteins promise to truly restore immune anti-tumor activity to broad patient populations across many indications
Speakers: Chris Learn PhD, PMP, Senior Clinical Project Manager , Quintiles
Brad Smith, PhD, VP of Translational Medicine, Quintiles
Eric Groves, MD, PhD, VP, Center for Integrated Drug Development, Quintiles
Seizing the Future in Oncology: Improving the Clinical Development of Immunotherapies Oct 23/14
LifeSciences - This webinar will review the technical advantages of extrusion and spheronization, xxcipient selection for the extrusion process, examples of process equipment available in the industry, specifically at Xcelience, and dosage form examples
Speaker: Jeff Williamson, Manager, Pre-Formulation and Formulation Development, Xcelience
Exploring the Extrusion and Spheronization Process Oct 21/14
LifeSciences - Presentation will include a case study where a sponsor found sites in a highly competitive therapeutic area, with a number of competing ongoing studies, and successfully rescued their study
Speakers: William Turnbull, Local Study Leader, AstraZeneca
Kirsty Kwiatkowski, Director, Feasibility and Site Identification, DrugDev
Jim DiCesare, Vice President, Contract & Regulatory Services, DrugDev
S.O.S. – Best Practices for Finding, Engaging and Activating Investigators on a Rescue Study Oct 21/14
LifeSciences - The presenters will explore and showcase how Cambrex can manage your API life cycle through innovation, process and cost improvements, to meet you API development needs and help you move your products quickly to market
Speakers: Jonathan Knight, VP of New Product Development, Cambrex
Margus Eek, Head of R&D, Cambrex Tallinn
Lars Eklund, Technical Lead, Cambrex
Managing the API Life Cycle: Cambrex Innovation, Process and Cost Improvement Oct 16/14
LifeSciences - Knowledge created from holistic clinical trial insights are improving efficiency in clinical development through timely, integrated data, enabling the identification of potential issues faster than previously possible – but changes are required in how we integrate processes and change roles
Speakers: Crona O’Conallain, Director, Global Data and Safety Monitoring, Quintiles
Rajneesh Patil, Director, Clinical Development Productivity and Quality, Quintiles
The Evolving Role of Data Management in Risk-Based Monitoring Oct 16/14
LifeSciences - This webinar attempts to highlight the last development of REACH including testing strategy and tips and tricks to more efficiently and successfully use QSAR and read across in REACH registrations
Speakers: Erwin Annys, Director REACH/Chemicals Policy, CEFIC
Marie-Elène Boivin, Head of Regulatory Affairs, WIL Research
Tatiana Netzeva, Senior Scientific Officer, Computational Assessment and Dissemination Unit, ECHA
REACH: Suggestions, Tips and Tricks for Effective Testing Strategies Oct 15/14
LifeSciences - This discussion will focus on the primary CMC requirements for a biopharmaceutical IND submission
Speaker: Glenn E. Petrie, Ph.D., Senior Scientific Advisor, ABC Laboratories
The Critical Role of CMC in Your IND Submission Oct 15/14
LifeSciences - The session will include a hands-on workshop using a simple ITC tool requiring no technical experience
Speaker: Marie Maxime Hubert, M.Sc., Health Economics and Outcomes Research Manager, JSS Medical Research
Indirect Treatment Comparisons and Network Meta-analyses for Managers and Directors: Concept & Application Using a Non-technical, User-friendly Tool Oct 14/14
LifeSciences - Topics include clinical data challenges when outsourcing trials to CROs, capturing data from EDC, CTMS, Electronic patient reported outcomes, Electronic health records, and actionable analytics that are possible once the data is captured and aggregated
Speakers: Greg Caressi, Senior Vice President, Healthcare & Life Sciences, Frost & Sullivan
Hunter Walker, Chief Technology Officer, Atlantic Research Group
Ben McGraw, Senior Vice President, Strategy & Marketing, Comprehend Systems
Partnering with the Right CRO to Complement Clinical Data Analytics Oct 10/14
LifeSciences - This interactive webinar will review how to manage various working relationships while being aware of the challenges with co employment
Speakers: Wendy Wolf, Senior VP, Commercial & Clinical Operations, Ashfield Healthcare
Vicki Alston, Director, Human Resources, Ashfield Healthcare
Co-employment: Get the Best of a Flexible Partnership with the Strategic Benefits of Outsourcing Oct 7/14
LifeSciences - This webinar will focus on newer patient recruitment techniques that can be implemented much earlier in the process
Speakers: Chris Frega, Sr. Director & Head of Global Feasibility and Patient Recruitment, Quintiles
Julie Parmelee, Director, Patient Recruitment, Quintiles
Bernadette Tosti, Director Business Development, Health Engagement and Communications, Quintiles
The Right Start: Optimizing Trial Recruitment Through Earlier Planning and Patient Identification Oct 2/14
LifeSciences - In today’s monitoring environment which has been enabled by recent guidance and reflection papers by regulators on clinical risk-based approaches to monitoring clinical study quality, monitoring activities should now be designed to track two types of risks identified in the clinical risk assessment
Speakers: Michael Macri, Director, Strategic Services, inVentiv Health Clinical
Jeffrey Fetterman, President, ParagonRx, an inVentiv Health company
Using a Clinical Quality Risk Management (QRM) Process to Implement Risk-Based Monitoring: Concepts and Case Study Oct 1/14
LifeSciences - Discussion of the current clinical trial regulatory scenario in India and the many aspects involved in conducting clinical trials in this region
Speaker: Dr. Renu Razdan, Chief Operating Officer, Max Neeman International
Clinical Trials in India: Approval Process Sep 26/14
LifeSciences - The webinar will discuss eBR as a key functionality for MES in the pharmaceutical Industry
Speaker: Andrew Whytock, Business Development Manager MES & Life Sciences, Siemens AG - Industry Sector
Discover Paperless Manufacturing with Electronic Batch Records (eBR) Sep 26/14
LifeSciences - This session will provide latest information concerning mAb placental transfer and put into perspective the relevance of using these animal models during the development of antibody-like biotherapeutics
Speakers: Edward Marsden, Associate Director and Head of Reproductive and Developmental Toxicology, WIL Research
Eddie Sloter, Associate Director of Developmental and Reproductive Toxicology, WIL Research
John DeSesso, Principal Scientist and Office Director in Exponent’s Center for Toxicology and Mechanistic Biology, Exponent
Don Stump, Vice President, Nonclinical Safety Science, WIL Research
Comparative Placental Transfer of Biologics: Preclinical Alternatives to the Nonhuman Primate Sep 24/14
LifeSciences - Using real-world examples, the presenter will provide an overview of Tissue Phenomics™ and how the platform supports improved biomarker discovery on through to clinical diagnostic assay commercialization
Speakers: Thomas Nifong, MD, Executive Vice President, Diagnostic Tests, Definiens
Tissue Phenomics™: From Biomarker Discovery to Clinical Diagnostic Assay Commercialization Sep 23/14
LifeSciences - The presenters will discuss ways to improve site engagement and cost management by leveraging the industry’s latest developments and technologies
Speakers: Frank J. Cattie, Vice President, Trial Planning Solutions (TPS), Medidata Solutions
Marcus Thornton, Senior Director, CTMS, Medidata Solutions
Streamlining the Site Budgeting and Payment Process Sep 23/14
LifeSciences - This webinar will provide best practice approaches fo decision making regarding the identification and mitigation of operational risk, and optimization of positive opportunities
Speakers: Coleen Glessner, Vice President, Clinical Trials Process & Quality Pfizer Inc.
Brian W. Hagen, Ph.D., Managing Director, Decision Empowerment Institute
Ann Meeker O'Connell, Senior Director, Clinical Strategy Strategic Development QA, Janssen Research & Development LLC
Steve Whitaker, Executive Director, The Avoca Quality Consortium The Avoca Group
Clinical Trial Risk Management Using Decision Analytics Sep 23/14
LifeSciences - This webinar will benefit agriculture or model organism researchers, as well as scientists working on any genomes less well-annotated than human or mouse
Speaker: Mick Watson, Head of Bioinformatics, Edinburgh Genomics, University of Edinburgh
Efficient Identification of Protein-Coding Variants in a Model Organism through Exome Sequencing Sep 17/14
LifeSciences - Join the presenter for insight on the current German requirements, recent trends in price negotiations, and future direction for the AMNOG assessment
Speaker: Thomas Mittendorf, MBA, PhD, Vice President and Managing Director, Herescon GmbH, an AmerisourceBergen company
AMNOG – German Regulation in the Past, Present and Future Sep 17/14
LifeSciences - Join experts from Covance in a five-part webinar series that explores critical aspects of pharmaceutical development to help you accelerate your drug development success
Speaker: James Yan, PhD, MD, DABT, Executive Director, Early Development, Covance
Insights on Improving Global Drug Development from Bench to Commercialization
Part 3: Transitioning from Bench into Clinical Phase
Sep 17/14
LifeSciences - This presentation will visit current guidelines and also discuss subjects such as when should I study forced degradation
Speaker: Harley Everett Wilcox, Senior Scientific Advisor, ABC Laboratories
Analytical Methods: What Makes Them “Suitable” Can Be Subtle Sep 16/14
LifeSciences - The process of signal detection (Signal Generation, Signal Strengthening, Signal Assessment and Signal Follow-Up) can generate more signals than true signals. Consequently, methods for ranking signals for further evaluation are required.
Speaker: Declan O’Rourke, MVB DipM MBA FRCVS, Ortec Consultancy, UK
Signal Detection & Trending in Veterinary Pharmacovigilance Sep 15/14
LifeSciences - Now that both regulators and the industry alike have had almost two years of experience evolving the expectations of how PBRERs should be written and assessed, biopharmaceutical companies must create streamlined processes that will allow them to develop consistent standards for meaningful benefit-risk assessments
Speakers: Dominique Coleman, Director, Safety Aggregate Reporting and Analytics (SARA), Quintiles
Carrie Messina, Safety Aggregate Reporting Manager for the SARA group, Quintiles
Top Five Best Practices for Developing Your Periodic Benefit Risk Evaluation Report (PBRER) Sep 11/14
LifeSciences - This webinar will delve into patient self-reporting, examining the use of paper and ePRO by phase and therapeutic area, and examining the projected use of patient-direct data
Speaker: Anne Zielinski, Global Lead for the Patient Engagement, Medidata Solutions
The Voice of the Patient in Clinical Trials: Hearing It, Understanding It Sep 10/14
LifeSciences - During this webinar, the presenter will discuss the opportunities and challenges and provide tips on how to achieve success in running clinical trials in China
Speaker: Ianne Loh, General Manager, Fisher Clinical Services, China
China – Land of Opportunities & Challenges for the Clinical Research Industry Sep 10/14
LifeSciences - This presentation will address regulatory trends and how to design a phase-appropriate E&L program
Speaker: Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories
Are Extractable and Leachables Going Phase-Appropriate? Sep 4/14
LifeSciences - This webinar will explore the benefits, challenges and methodologies for using POD and Protocol Pooling philosophies
Speaker: Joseph G. Iacobucci,Vice-President, Clinical Supplies, Xcelience
Protocol Pooling & Point of Distribution (POD) Clinical Labeling Sep 3/14
LifeSciences - The speakers will provide an examination of the Conceptual Design process and Cost Evaluation of capacity, single-use vs. multi-use operations, redundancy, planned expansion and modularity
Speakers: Carrier Li, Director in Global Asset Planning, Amgen
Bob Allen, Senior Director, Facilities Integration, Fluor Industrial Services
Craig Sandstrom, PhD, Director of Process Engineering, Fluor Industrial Services
Maximizing Production Capacity for Growth
Part 3: Defining Low Cost in Your Solution for Future Facilities
Aug 26/14
LifeSciences - Through this webinar viewers will have a much more comprehensive understanding of the types of biological questions and problems RNA-Seq can address fully or be a key aid in addressing, and those it cannot
Speaker: Wendell Jones, PhD, Global Head, Genomic Bioinformatics, EA | Quintiles
Genomic Know-How® Webinar Series
Part 5: The Evolution of RNA-Sequencing
Aug 22/14
LifeSciences - The objective of this webinar is to review types of datasets commonly used in this field, discuss potential pros & cons of each type depending on research question, and identify other key considerations
Speaker: Pamela Landsman-Blumberg, MPH, DrPH, Director, Xcenda
Leveraging ‘Big Data’ - Methodological Considerations in Health Services Research Aug 21/14
LifeSciences - Gain an understanding of ways to make the most of your early clinical development -- from efficiently conducting studies to providing dependable model predictions to optimize the overall process
Speakers: N. Seth Berry, PharmD, Director, Clinical PK/PD Modeling & Simulation, & Center for Statistics in Drug Development, Quintiles
Professor Tim Mant, FRCP FFPM, Vice President, Medical Research and Principal Investigator, Quintiles
Best Practices for Optimizing Dose Escalation in First in Human Studies Aug 6/14
LifeSciences - The presenters will share examples of delivering effective programs that achieved greater resource efficiencies and improved data quality nearly twofold better than industry benchmarks
Speakers: Teresa Lamantia, Vice President, Strategic Operations Quintiles
Alexandra Massoud, Director of Clinical Operations, Quintiles
Implementing Risk-based Monitoring, Using Oncology Examples Jul 31/14
LifeSciences - This program will benefit Discovery and Development Scientists from large pharmaceutical and small-midsize biotechnology companies
Speaker: Kim Robasky, PhD, Associate Director, Bioinformatics, EA | Quintiles
Genomic Know-How® Webinar Series
Part 4: Sources of Error and the Role of Replicates in Next Generation Sequencing (NGS)
Jul 25/14
LifeSciences - The presenters will discuss time response modeling for Rheumatoid Arthritis (RA) and similar indications based on a number of biologic agents that they have studied
Speakers: Russell Reeve, PhD, Senior Biostatistics Director, Center for Statistics in Drug Development, Quintiles
Niti Goel, MD, Senior Medical Director & Global Head, Rheumatology Center of Excellence, Quintiles
Time Response Modeling in Rheumatoid Arthritis and Other Autoimmune Indications Jul 23/14
LifeSciences - This In this webinar, learn about a novel mass spectrometer-based approach that can speed detection and quantitation while achieving the required specificity and sensitivity—and how multiple reaction monitoring (MRM) techniques can be effectively applied to CMC-related development activities
Speakers: John Anders, Ph.D., Senior Scientific Advisor, ABC Laboratories
Rowel Tobias, Ph.D., Senior Scientist, Protein Chemistry ABC Laboratories
Novel MS Techniques Speed Detection of Biopharmaceutical Product and Process Impurities Jul 22/14
LifeSciences - The increase in adoption of rapid sepsis diagnostic tests has been driven, in large part, by clinical studies that have captured the clinical and economic impact of these tests. This webinar will look at a few of these studies and discuss the design, execution and clinical and/or economic outcomes achieved in each.
Speakers: Michael Saubolle, Ph.D., D(ABMM), F(AAM), F(IDSA), Medical Director, Infectious Diseases Division Laboratory Sciences of Arizona/Banner Health, Clinical Associate Professor of Medicine, University of Arizona College of Medicine
Bert Lopansri, M.D, Associate Professor of Medicine, Division of Infectious Diseases , Intermountain Medical Center
Each Hour Counts: The Clinical and Economic Case for Rapid Sepsis Diagnostics Jul 17/14
LifeSciences - This A case-study approach will be used to demonstrate how quickly evolving data can affect timelines and impact HEOR initiatives
Speakers: Jay Jackson, PharmD, MPH ,Vice-President, GHEOR Xcenda
Kasia Puto, PharmD, MBA, BCOP, BCPS, Associate Director, Xcenda
Breakthrough Therapy Designation: Oncology Lessons Jul 16/14
LifeSciences - The aim of this webinar is to enable the end-user to select the best model and study design for their research
Speaker: Dr. James Wilson, Principal Scientist, Epistem
Pre-clinical Inflammatory Bowel Disease (IBD) Models July 10/14
LifeSciences - This webinar will examine strategies, processes, and technology to help maximize productivity and reduce cycle times
Speakers: Wendy Stewart, Vice President, Integrated Site Start Up, Quintiles
Sam Searcy, Associate Contracts Services Director, Global Regulatory Start Up, Quintiles
Accelerated Start-Up: The Right Start to Trial Success July 10/14
LifeSciences - This webinar will describe the Translational Pharmaceutics™ platform and present Enabled-First-in-Human case studies to illustrate how it has been applied in early stage drug development programs
Speakers: Alyson Connor, Director, Exploratory Clinical Pharmacology, Quotient Clinical
Phil Collis, VP, Clinical Development, Biocryst Pharmaceuticals
Enabled-First-in-Human™ – Accelerating Your Programs into Clinic and Through to Proof of Concept (PoC) July 9/14
LifeSciences - This webinar will examine strategies, processes, and technology to help maximize productivity and reduce cycle times
Speakers: Mark Thomson, MBA, NA Sales & Marketing Manager, Arazy Group Consultants Inc.
John Iannone, Program Manager – Extractables/Leachables & Special Studies, Toxikon Corporation
Colorants in Devices: Integrated Strategies Toward Regulatory Approval July 8/14
LifeSciences - Join ACM Global Central Lab and Pharm-Olam to learn the key considerations in working with outsourced partners in minimizing study start-up times, processing times and in optimizing work efficiencies
Speakers: Mark Engelhart, Chief Commercial Officer, ACM Global Central Laboratory
Jerry Boxall, Managing Director, ACM Europe and Asia ACM Global Central Laboratory
Dr. Yamin “Mo” Khan, Executive VP of Global Clinical Development Pharm-Olam International
Successful Management of Global Studies in Emerging Markets – Key Considerations from the CRO and Central Laboratory Perspective Jun 30/14
LifeSciences - Join experts from Covance in a five-part webinar series that explores critical aspects of pharmaceutical development to help you accelerate your drug development success
Speaker: William Hanlon, PhD, VP, Head of Global Regulatory Affairs, Covance
Insights on Improving Global Drug Development from Bench to Commercialization
Part 2: Starting with the End in Mind: Regulatory Strategy from the Beginning
Jun 27/14
LifeSciences - During this presentation, you will discover how the Target Product Profile (TPP) process can provide your company with a clear advantage in early clinical development, leading to the greatest possibility of approval and successful product launch
Speaker: Kimberly Hunsicker, MSN, CRNP, MBA, Vice President, Medical Device and Diagnostics, Premier Research
Target Product Profile Guiding Cross-functional Strategies for Medical Device and Diagnostic Organizations Jun 26/14
LifeSciences - This program will benefit Discovery and Development Scientists from large pharmaceutical and small-midsize biotechnology companies
Speaker: Vic Weigman, PhD, Associate Director of Translational Genomics, EA | Quintiles
Genomic Know-How® Webinar Series
Part 3: Exome Sequencing and Analysis: Considerations for Sample Input, Capture Techniques and Pipelines related to Variant Detection
Jun 25/14
LifeSciences - This webinar focuses on the relationship between Infinity Pharmaceuticals and INC Research as a case study in how Pharma and CROs can successfully make this transition
Speakers: Maria Makarovskaya, Clinical Outsourcing Lead, Infinity Pharmaceuticals
David Burnham, Vice President, Strategic Alliances INC Research
Innovation in Strategic Alliances: Moving from Transactional Outsourcing to a Partnership Jun 25/14
LifeSciences - This webinar will focus on translating current business drivers and challenges within the global drug product labeling domain into a set of opportunities and next-generation operating models that support scale, efficiency, quality and compliance
Speakers: Bindu Narang, Director of Scientific Writing and Regulatory Affairs, Sciformix
Boris Jankowski, Director of Solutions Architecture, Sciformix
Craig Trautman, CEO, Intagras
Trends & Best Practices in Global Drug Product Labeling Management: Taking Control of the End-to-End Labeling Process June 24/14
LifeSciences - This webinar will describe the applications and benefits of Translational Pharmaceutics and RapidFACT™, illustrated by case studies and metrics from industry experts and users of RapidFACT™
Speakers: John McDermott, Director, Drug Product Optimization, Quotient Clinical
Magnus Ronn, VP, CMC, Tetraphase Pharmaceuticals
Rapid Formulation Development and Clinical Testing (RapidFACT™) – Expediting Development of Optimal Drug Products June 24/14
LifeSciences - This webinar will explore the impact of clinical labels design and execution on the patient and site experience
Speaker: Kevin Shea, Label Program Director, Clintrak Clinical Labeling LLC., Part of Thermo Fisher Scientific
Clinical Labels: Keeping the Patient & Site in Mind Jun 17/14
LifeSciences - The presentation will provide a discussion of operational challenges that are of key importance in adaptive trials with illlustrations using an actual phase I trial in oncology
Speakers: Marc Buyse, Sc.D., Founder and Chairman, IDDI
Linda Danielson, Chief Operating Officer, IDDI
Implementing Adaptive Trials: Operational Considerations June 12/14
LifeSciences - Viewers will learn Industry-wide monitoring trends from the annual monitorforhire.com survey, how monitors spend their time on-site to support activities like recruitment and training, and a methodology for triggered monitoring visit schedules
Speakers: Scott Freedman, President, Founder, monitorforhire.com
Marcus Thornton, Senior Director, CTMS, Medidata Solutions
The Role of the Monitor in a Risk-Based Monitoring Program June 12/14
LifeSciences - In this webinar, the speakers will examine how Cambrex works with large, mid-size, emerging and niche pharmaceutical companies to meet their changing small molecule needs and bring their products to market quickly
Speakers: Joe Nettleton, VP of Operations and Site Director, Cambrex Charles City
Bjarne Sandberg, Managing Director, Cambrex Karlskoga
Quality, Speed, Flexibility and Customer Focus in API Manufacturing: An Introduction of Cambrex through Customer Case Studies June 11/14
LifeSciences - Learn how OmniComm’s enterprise class cloud technology, when combined with an innovative electronic data capture application, can create the platform for an integrated and optimized clinical enterprise
Speaker: Keith Howells, SVP Development, OmniComm Systems, Inc.
Ken Light, EVP Transformation and Professional Services, OmniComm Systems, Inc.
Kuno van der Post, Ph.D, SVP Business Development, OmniComm Systems, Inc.
Integrating the Clinical Enterprise with Innovative Cloud Technology June 11/14
LifeSciences - Topics address include the neuropsychiatric tests required for demonstrating safety and tolerability in neuropsychiatric clinical trials, cognitive and functional endpoints that are relevant clinically and for regulatory purposes, and options that are available and affordable in the marketplace
Speakers: Thomas Laage, MD, MPH, Director, Product Development Consulting and Regulatory Medical Writing Support, Premier Research
Matthew T. Healy, Senior Manager, Clinical Management, Premier Research
Measuring How Well Subjects Know and Do in Neuropsychiatric Clinical Trials Jun 10/14
LifeSciences - This webinar will examine the evolving payer and health technology assessment (HTA) landscape
Speakers: Trent McLaughlin, BSc (Pharm), PhD, Vice-President, Xcenda
Marie-Josee Martel, PhD, Director, Xcenda
Current and Future Access Challenges for Specialty and Biotechnology Products Jun 9/14
LifeSciences - This webinar focuses on tips and best practices for navigating through the complex regulatory landscape of cosmetic adverse event reporting
Speaker: Sharon Donatucci, Vice President of Pharmacovigilance Operations, Drug Safety Alliance, Inc.
Cosmetovigilance – Vignette for the First Regulatory Year of EU Regulations – Impact on North America and Europe Jun 5/14
LifeSciences - This webinar will demonstrate how image analysis technology, such as Definiens, is particularly well suited to objectively characterize the tumor microenvironment and show how Definiens is being used by the Society for Immunotherapy of Cancer (SITC)-led global immunoscore initiative, that seeks to validate the immunoscore as a prognostic biomarker for patients with colon cancer
Speakers: Bernard A. Fox, Ph.D., Endowed Chair and Chief, Laboratory of Molecular and Tumor Immunology, at the Robert W. Franz Cancer Research Center, Earle A. Chiles Research Institute, Providence Cancer Center
Carlo B. Bifulco, M.D., Director of Molecular Pathology and Pathology Informatics at the Providence Regional Laboratory and Director of Translational Molecular Pathology at the Earle A. Chiles Research Institute
The Immunoscore and Immunoprofile: Assessing Anti-Cancer Immunity as a Biomarker to Stratify Patients for Clinical Trials May 29/14
LifeSciences - This program will benefit Discovery and Development Scientists from large pharmaceutical and small-midsize biotechnology companies
Speakers: Sarah Bacus, PhD, Senior VP and Chief Scientific Officer, Translational R&D Oncology, Quintiles
Jeff Fitzgerald, Director, Personalized Medicine Integration, EA | Quintiles
Genomic Know-How® Webinar Series
Part 2: Targeted Oncology Biomarker Solutions in the Elucidation of Inflammatory Breast Cancer Mechanisms
May 28/14
LifeSciences - Hear from Sanofi Aventis how intelligent Central Statistical Monitoring techniques have been harnessed to improve data quality and oversight
Speakers: Eric Genevois-Marlin, Vice-President of Biostatistics and Programming, Sanofi
Francois Torche, CEO, CluePoints
Karen FANOUILLERE, Biostatistics Project Leader, Sanofi - Biostatistics & Programming
Risk-Based Monitoring – What we’ve learnt in a year, a Large Pharma Perspective from Sanofi May 28/14
LifeSciences - This webinar will explore the relationship between dry powder inhalers and hard capsules, how to match them together to give good powder aerosolization and delivery of the active ingredient deep into the lungs
Speakers: Brian E. Jones, Scientific Advisor, Qualicaps Europe S.A., Alcobendas (Madrid), Spain
Mauro Citterio, Director of R&D and Industrialization, Plastiape S.p.A.
Pulmonary Drug Delivery, Hard Capsules and Dry Powder Inhalers: Solving Development Challenges May 22/14
LifeSciences - This talk will focus on lessons learned and applied to the standardization of global clinical trials and reducing variability in Anatomic Pathology and Histology (APH) services supporting global clinical trials
Speakers: Paul Kirchgraber, MD, MBA, FCAP, Vice President, Global Testing Services, Medical & Technical Affairs, General Manager of the Americas, Covance Central Laboratory
Steven G. Brodie, PhD, FACMG, Director of Molecular Genetics and Cytogenetics, NeoGenomics Laboratories
Harmonization of Anatomic Pathology and Histology services in Support of Global Oncology Clinical Trials May 21/14
LifeSciences - This webinar will provide insight into Evotec’s approach to phenotypic screening for hit ID in the context of complex & novel biological systems
Speakers: Mark Slack, PhD, Vice President, In Vitro Pharmacology, Evotec
Stefan Müller, PhD, Head of Chemical Biology, Evotec
Integrated Phenotypic Screening and Target Deconvolution for Accelerated Drug Discovery May 21/14
LifeSciences - This webinar focuses on the importance of consistent quality practices for management of veterinary pharmacovigilance, particularly, adverse event data
Speaker: Renee Helms, DVM, Director, PV Operations, Drug Safety Alliance, Inc.
Minimizing Negative Impact of Dirty Data in Veterinary Pharmacovigilance May 15/14
LifeSciences - Viewers Join experts from Covance in a five-part webinar series that explores critical aspects of pharmaceutical development to help you accelerate your drug development success
Speaker: Eric Lang, MD, VP, Molecule Development Group, Covance
Insights on Improving Global Drug Development from Bench to Commercialization
Part 1: Integrated Approach for Successful Drug Development
May 14/14
LifeSciences - Viewers will learn about the advantages of continuous glucose monitoring and the new possibilities DSI’s solution enables for diabetes and metabolic disease research
Speaker: Bob Brockway, Director of Advanced Market Research, Data Science International (DSI)
Continuous Glucose Monitoring Applications in Rodents May 13/14
LifeSciences - This session includes a regulatory overview of rare diseases and orphan drug status as well as practical considerations for varying stages of the development process
Speaker: Angi Robinson, Executive Director, Pediatrics and Rare Diseases, Premier Research
Rare Disease Trials: The Beginning, the Middle and the End May 12/14
LifeSciences - In this presentation the challenge of timely reporting of SUSARs to Investigators in global and large-scale clinical trials with a high number of SUSARs will be addressed
Speaker: Dr. Max Horneck, CEO, maxclinical GmbH Germany
Informing the Investigator: Implementation of an Automated SUSAR System May 8/14
LifeSciences - This webinar is intended to provide a better understanding of Rheumatoid Arthritis (RA) and new targets and pathways for developing new and potentially more effective RA, from more personalized approaches to RA drug development in the near-term future, to the critical next steps that could improve your company’s probability of successfully developing and commercializing new RA treatments
Speakers: Prof. Iain B. McInnes, Muirhead Professor of Medicine, Director of the Institute of Infection, Immunity and Inflammation, University of Glasgow, UK
Mary Katherine (MK) Farmer, MD, Senior Medical Director & Rheumatology Therapeutic Strategy Lead, Quintiles
Rheumatoid Arthritis – Biomarkers and Other New Advances in Drug Development May 7/14
LifeSciences - This webinar will provide insight on how PhosphoScout® technology utilizes quantitative mass spectrometry and bioinformatics to investigate and signaling pathways and mechanisms on a global scale
Speaker: Henrik Daub, PhD, Senior Vice President, Science & Technology, Evotec
Quantitative Phosphoproteomics to Support the Discovery and Development of Kinase-selective Drugs May 7/14
LifeSciences - This webinar will include a discussion of the current missing data landscape, how missing data can be prevented, the framework for handling missing data known as multiple imputation, and examples of how multiple imputation can provide reasonable approaches to analysing missing data
Speakers: Michael O’Kelly, Ph.D, Senior Director, Centre for Statistics in Drug Development (CSDD), Innovation, Quintiles
Jessica Cooper, Clinical Project Manager, Quintiles
Ilya Lipkovich, Ph.D., Senior Director, Center for Statistics in Drug Development (CSDD), Innovation, Quintiles
Handling & Preventing Missing Data: Improving Clinical Trial Data Credibility May 2/14
LifeSciences - The key to successful implementation starts with identifying what type of strategy your study needs
Speaker: Donna Hanson, Director, Global Feasibility and Patient Recruitment, Advanced Clinical
How to Determine and Build an Effective Patient Recruitment and Retention Strategy Apr 30/14
LifeSciences - This presentation reviews some of the elements that go into decision making for outsourcing pharmacovigilance work especially for off shore projects
Speaker: Angela Pitwood, Vice President, IPM Safety Services
Cracking the Code…
To Successfully Outsourcing Pharmacovigilance Activites
Apr 30/14
LifeSciences - The presenters will share the rationale behind the development of this flexible targeted bisulfite sequencing tool and how it has been applied in methylation research
Speakers:Daniel Burgess, PhD, Group Leader – Sequence Capture, Roche NimbleGen
Nathan Springer, PhD, Professor, University of Minnesota
Discover Epigenomic Variation with a Flexible Targeted Bisulfite Sequencing Method Apr 29/14
LifeSciences - This webinar is intended to help genomic researchers better understand technical hurdles in the analysis of FFPE-derived RNA
Speaker: Patrick Hurban, PhD, Global Head of Genomic Research and Development, EA | Quintiles
Genomic Know-How® Webinar Series Part 1: Best Practices for Obtaining RNA Sequencing Data from Formalin-fixed Paraffin-embedded (FFPE) Samples Apr 25/14
LifeSciences/SupplyChain - The presenter will provide insights on how to address these challenges, updates on regulatory requirements and examples of new technology that can assist with monitoring and compliance
Speaker: Euan Douglas, Global Project Director, Fisher Clinical Services
Extreme Transportation Challenges Apr 23/14
LifeSciences - This webinar will focus on an introduction and overview of Antibody Drug Conjugates, and the development of a mechanistic PK/PD model for preclinical-to-clinical translation of ADCs
Speaker: Dhaval Shah, PhD, MS Pharmaceutics, Assistant Professor, Department of Pharmaceutical Sciences, University at Buffalo, The State University of New York
Using PK/PD Modeling for Antibody Drug Conjugate Translation Apr 23/14
LifeSciences - This webinar will explore the current state of eCOA and the future offered by BYOD, while highlighting some of the issues that need to be addressed to move the industry forward
Speaker: Paul O’Donohoe, Director of Health Outcomes, CRF Health
What's Next in eCOA? Psychometric Validation and BYOD Apr 17/14
LifeSciences - The focus of the presentation will be on introducing an emerging process-development methodology that is based on applying novel and existing bioreactor monitoring technologies to existing bioreactor processes, coupled with applied mathematics and data-integration techniques across disciplines
Speakers: Jeff Breitm Ph.D., Director, Bend Research Inc.
Brandon Downey, Technical Group Leader, Bend Research Inc.
A Multi-Disciplinary Approach to Optimize and Redefine Bioreactor Operations: Leveraging Coupled Bioreactor Analytics, Automated Sampling, and Applied Mathematics to Improve Productivity & Product Quality Apr 16/14
LifeSciences - The speaker will share his experience gathered during several projects related to mobile medical applications
Speaker: Frederic Ehrler, R & D Developer, Division of Medical Information Sciences HUG , Geneva University Hospitals,Switzerland
Mobile Medical Applications - Optimizing the User Interface on a Mobile Device Apr 16/14
LifeSciences - The presentation will discuss when a HAL study will likely be required and how a HAL study is conducted
Speaker: Dr. Lynn Webster, Vice President of Scientific Affairs, PRA, and President, American Academy of Pain Medicine

Human Abuse Liability Role in NDAs
Apr 15/14
LifeSciences/SupplyChain: Find out how sponsors, CMOs and their integral partners are successfully using active units to support global clinical and commercial supply chain with industry best practices.
Speakers: James Klingelhoefer, Business Development Manager, World Courier
Tony Mistretta, Distribution Manager, Almac Clinical Services
Global Clinical and Commercial Supply Chain: Protecting Bulk Product with Active Temperature Controlled Systems Apr 8/14
LifeSciences - Learn about the complexities and challenges in producing SDTM datasets, as well as groundbreaking new technology that allows SDTM datasets to be generated directly from an EDC system
Speakers: Keith Howells, SVP Development, OmniComm Systems, Inc.
Albert Chau, CStat CSci, Senior Director, Data Science, SCRI Development Innovations
Automating the Production of SDTM Datasets Apr 2/14
LifeSciences - Five considerations are discussed to optimize the budget impact analysis’ methodology
Speaker: Marie Maxime Hubert, M.Sc., Manager, Health Economics and Outcomes Research, JSS Medical Research Inc.
Pharmacoeconomics: Five Simple and Effective Ways to Optimize Budget Impact Analyses and Obtain Drug Reimbursement Apr 1/14
LifeSciences - This is part two of a four-part series that presents the tools and methods used to identify and quantify Production Capacity at a Facility/Site/Enterprise level
Speakers: Jim Robertson, Senior Director, Facilities Integration, Fluor Industrial Services
Craig Sandstrom, PhD, Director of Process Engineering, Fluor Industrial Services
Tim McNeill, Director of Technology, Fluor Industrial Services
Maximizing Production Capacity for Growth
Part 2: Unlocking High Volumes of Production Capacity & Increasing Enterprise Level Output
Mar 27/14
LifeSciences - This webinar will examine how an eISF can improve site performance and audit readiness, as well as enable a remote monitoring strategy that significantly reduces the amount of on-site monitoring visits
Speaker: Kevin McNulty, Product Marketing Director, Intralinks
Leveraging a Single Source of Truth to Improve Site-Sponsor Collaboration from Site Activation to Study Close Out Mar 27/14
LifeSciences - Through case examples the speakers will discuss ways to accelerate enrollment across the continuum of protocol development to activation
Speakers: Martin Lee, M.D., Vice President, Investigator Relations, PRA
Gretchen Goller, MSW , Sr. Director, Patient Access and Retention Services, PRA

A Comprehensive Approach to Accelerating Clinical Trial Enrollment
Mar 26/14
LifeSciences - This webinar will provide a regulatory perspective on what is expected from an independent and objective assessment of clinical data
Speakers: Marc Buyse, Founder, IDDI and CluePoints
Francois Torche, CEO, CluePoints

Risk-Based Monitoring & Central Statistical Monitoring
Mar 25/14
LifeSciences - The aim of this webinar will be to convey the importance of considering differing ages/ stages of development of children when designing and conducting clinical trials, and how doing so can contribute to successful well-designed pediatric studies
Speakers: Susan P. Tansey, MD, Medical Director, Paediatrics, Premier Research
Susanne Schmidt, MD, PhD, Director Medical Affairs, Premier Research

The Aspects of Clinical Development Related to the ICH E11 Categories of Children: Preterm Neonates, Term Neonates, Infants and Toddlers, Children and Adolescents
Mar 24/14
LifeSciences - Speaking from years of experience, the presenters will share insights they have gained through years of deploying risk-based monitoring principals and procedures from a variety of therapeutic studies on a global scale
Speakers: Martin Giblin, Vice President, Clinical Data Management, Quintiles
Teresa Lamantia, Vice President, Strategic Operations, Quintiles
Risk-based Monitoring: Using Centralized Data Surveillance to Evolve Data Review and Site Engagement Mar 20/14
LifeSciences - Dr. Moulis will discuss how Merrimack Pharmaceutical has devised a method of IHC assay design that increases the chance of finding the optimal cutpoint of biomarker expression and maximizing the chance of success for companion diagnostic use
Speaker: Sharon Moulis, Ph.D., Principal Scientist and Director of the Human Tissues Laboratory, Merrimack Pharmaceuticals
IHC Assays for Companion Diagnostic Use: Standardization Methods that Maximize Success Mar 18/14
LifeSciences - This webinar will focus on APAC, including a review of the new GVP guideline by EMA & its impact, the challenges of complying with changing country regulations for patient data collection, and an overview of the major achievements of PvPI
Speaker: Michal Borawski, International Pharmacovigilance Officer for the Asia-Pacific Region Affairs, Sanofi Pasteur
Pharmacovigilance in APAC: An Update and Focus on India (PvPI) Mar 13/14
LifeSciences - In this webinar, you will learn what an employer can do with baseline testing
Speaker: MaryRose Cusimano-Reaston, Ph.D., Founder and Chief Science Officer, Emerge Diagnostics
The Sunshine Act: CMS Mandatory Reporting Requirements and Baseline Testing Mar 12/14
LifeSciences - The presenters will discuss scientific and ethical imperatives associated with the use of animals in experiments and testing, and examine burgeoning alternatives to animal research
Speakers: Aysha Akhtar, Fellow, Oxford Centre for Animal Ethics, and Medical Officer, Food and Drug Administration
Dr. Toby Gill, Independent Nanotechnology Professional, UK
Alternatives to Animal Testing Methods Feb 27/14
LifeSciences - The presenters have used whole-genome bisulfite sequencing (WGBS) to profile dozens of primary tumors from The Cancer Genome Atlas (TCGA) project, and found that DNA methylation changes occur within lineage-specific and cancer-specific chromatin states
Speakers: Ben Berman, Ph.D., Assistant Professor, Division of Bioinformatics, Department of Preventive Medicine, University of Southern California
Ramesh Vaidyanathan, Ph.D., Associate Director of Research and Development, Epicentre
Using Whole-genome Bisulfite Sequencing to Understand Chromatin State Changes in Cancer Feb 26/14
LifeSciences - This webinar will focus on EMA and FDA regulatory perspectives on nonclinical and clinical safety assessment in biosimilars
Speaker: Joerg Bluemel, Director Toxicology within Biologics Safety Assessment / Translational Sciences, MedImmune, Gaithersburg MD

Nonclinical and Clinical Safety Assessment of Biosimilars
Part 2 : Regulatory Perspective

Feb 20/14

LifeSciences - This webinar will review the benefits of leveraging a secure collaboration platform to ensure distribution of patient safety documents to sites and other parties across the globe, while reducing notification time from days to hours
Speaker: Martin K. Grant, Senior Program Manager Life Sciences, Intralinks
Informing the Investigator: Reduce Liability Risk and Improve Patient Safety through Automated SUSAR Processing Feb 20/14
LifeSciences - The presenters will share data demonstrating how our workflow will help you achieve greater molecular complexity with minimal DNA sample input or with FFPE DNA, hence maximizing variant discovery with your precious samples
Speakers: Maryke Appel, PhD, Technical Director Kapa Biosystems
Daniel Burgess, PhD, Group Leader Sequence Capture, Roche NimbleGen
Unleash the Potential of your DNA Samples with an Optimized Target Enrichment Workflow for Next-Generation Sequencing Feb 5/14
LifeSciences - During this webinar, the speakers discuss preclinical and clinical perspectives on how to use increasingly intricate and sophisticated procedures for intravenous injection or infusion, and new ideas on attending to animal welfare
Speakers: Stéphane Milano, Chief Scientific Officer, WIL Research – Europe
Edward Marsden, Associate Director, WIL Research – Europe
Tim Vanderveen, Vice President, Center for Safety and Clinical Excellence
Intravenous Infusion: From Preclinical Challenge to Clinical Reality Feb 5/14
LifeSciences - The Sunshine Act compliance requirements in the context of the present regulatory environment, enforcement, penalties for failure to comply, and potential unintended consequences, both good and bad, will be discussed
Speakers: Gary Yingling, BS, MS, JD., Partner, Morgan Lewis, Washington DC
The Sunshine Act: Necessary Regulation or Unnecessary Dysregulation? Jan 29/14
LifeSciences - This webinar will discuss adaptive designs for phase I, phase II and phase III clinical trials in oncology
Speakers: Marc Buyse, Sc.D, Founder and Chairman, IDDI
Tomasz Burzykowski, PhD, VP of Research, IDDI
Everardo Saad, MD, Scientific Director and Chairman, Dendrix, Senior Oncology Consultant, IDDI
Pros and Cons of Adaptive Designs: A Leisurely Conversation Between a Clinician and Two Statisticians Jan 14/14
LifeSciences - This webinar will focus on cardiovascular pressure sensing and relevant performance specifications to ensure integrity of your data
Speaker: R. Dustan (Dusty) Sarazan DVM, PhD, Vice President & Chief Scientific Officer, Data Science International (DSI)
A Review of Cardiovascular Pressure Sensing and Relevant Performance Specifications to Ensure Data Integrity Jan 8/14
LifeSciences - The presenters will discuss the theory and application of quality systems and their foundations with measurable outcomes to achieve successful design and implementation of meaningful QMS
Speakers: Pierre Deschamps, C.M., Ad. E., Adjunct Professor, Faculty of Law, McGill University
Marianne Vanderwel, MEng, MSc, Director, Human Research Protection Program, IRB Services
Quality Management in Clinical Research: A Matter of Human Rights Dec 18/13
LifeSciences - During this webinar, the presenters will explore how mHealth technology can be used to reduce overall clinical development cost, while increasing subject and investigator satisfaction, retention, and engagement
Speakers: Andy Lee, Deputy Head of Clinical Sciences and Operations, Sanofi
Glen De Vries, President, Medidata Solutions
Randy Spaulding, Founder and President, Spaulding Clinical Research, LLC
Patient-Centric Technology for Better Trial Outcomes Dec 13/13
LifeSciences - This webinar will provide insight into key genomic concepts and technologies that have shaped our contemporary understanding of the biology, treatment, and drug development opportunities in oncology
Speakers: Philip Breitfeld, MD, Vice President, Therapeutic Strategy, Oncology, Quintiles
Jeff Fitzgerald, Product Specialist Director, Global Laboratory Solutions, Quintiles
Catching Up with the Genomic Era in Oncology: Key Considerations for Incorporating Genomics into Oncology Drug Development Dec 13/13
LifeSciences - The presenters will discuss the design and function of the UVivatec instrument, its effectiveness, how to integrate this technology into a manufacturing process, plus the results from a case study detailing the use of UVC as a solution to viral inactivation when other techniques failed for a virus-like-particle vaccine
Speakers: Katherine Bergmann, Ph.D., Manager, Viral Safety and Viral Clearance Services, Eurofins Lancaster Laboratories
Dr. Todd Talarico, Vice President of Manufacturing, Medicago
Sherri Dolan, Field Marketing Manager, Virus Clearance Technologies, Sartorius Stedim North America
UV-C Treatment—a New Procedure for Viral Inactivation Dec 11/13
LifeSciences - In this webinar, you will learn how Metamark Genetics developed a new prognostic test using image analysis for early stage prostate cancer based on tissue samples: ProMark
Speakers: Thomas Nifong, M.D., Senior Vice President of Clinical Labs, Metamark Genetics
Thomas Colarusso, Vice President, Business Development Tissue Diagnostics, Definiens
ProMark: Lessons Learned in Launching a Prognostic Test Based on Tissue Image Analysis Dec 10/13
LifeSciences - Learn about the details of the candidate identification, assay development, testing and results, beginning with the derivation of the initial list of candidates, to the identification of the five blood-based proteins, which together constitute the biomarker panel used in the commercial protein expression test, developed by Caprion Proteomics in collaboration with Integrated Diagnostics (InDi)
Speaker: Daniel Chelsky, Chief Scientific Officer, Caprion Proteomics
A Blood-Based Proteomic Classifier for the Molecular Characterization of Pulmonary Nodules:
A Case Study in the Discovery and Validation of a Molecular Diagnostic Using Caprion’s Technology Platform
Dec 9/13
LifeSciences - This webinar will outline the methodology and conduct of safety benefit-risk assessments for post-marketed products
Speaker: Mary Mease, RPH, MPH, Senior Director, Risk Management, Quintiles
Pharmacovigilance Benefit-Risk Assessments: Requirements, Transparency, and Implications Dec 6/13
LifeSciences - The presenters will examine MCIDs and different types of PROs that are available for respiratory diseases and review case studies of successful demonstrations of product value in respiratory programs
Speakers: Dr. Chad Gwaltney , Senior Director, Consulting Services, ERT
Dr. Kai-Michael Beeh , Founder and Medical Director, insaf Respiratory Research Institute Wiesbaden
Respiratory Update: Interpreting Minimal Clinically Important Differences in COPD and Demonstrating Product Value with Patient-Reported Outcomes (PROs) Dec 4/13
LifeSciences - A discussion of current trends and insights by the presenters
Speakers: Dr. Marcin Marciniak, Director Drug Safety & Pharmacovigilance, PregLem SA, and member of Gedeon Richter Group
Dr. Philip Jones, BMBS, MA, MSc, PhD, Associate Director & Deputy QPPV, Symogen Limited

Pharmacovigilance: ADR Management and Reporting & Outsourcing Trends

Dec 4/13

LifeSciences -  The presenters will discuss the primary drivers of site costs, the correlation and impact of study complexity, plus case studies highlighting the benefits of better study planning
Speakers: Stella Stergiopoulos, Project Manager, Tufts Center of the Study of Drug Developtment (CSDD)
Vic DeSario, Director, Trial Planning Solutions, Medidata Solutions
Data-driven Site Negotiations: Fast Track to Fair Market Value (FMV) Nov 25/13
LifeSciences -  In this short, 40 minute webinar viewers will learn about how the Archimedes Model was applied by Eli Lilly and Company to prioritize early stage compounds for development
Speaker: Badri Rengarajan, MD, Medical Director, Archimedes, Inc.
Market Access and Pipeline Development – How Healthcare Modeling Can Make a Difference Nov 22/13
LifeSciences -  In this webinar, Dr. Eisinger will describe the development and validation of a multiplex panel of biomarkers for quantifying the commitment, onset, and induction of apoptosis by the intrinsic pathway in tumor tissue samples
Speaker: Dominic Eisinger, PhD, Director of Strategic Development, Myriad RBM
Quantitative Profiling of the Intrinsic Pathway of Apoptosis in Tumor Tissue using Myriad RBM’s Multiplex ApoptosisMAP™ Nov 22/13
LifeSciences -  This webinar will discuss the latest advances in AD research and explain how central laboratories can contribute to the progress in the battle against this disease by supporting clinical trials through quality testing
Speaker: Tatiana Souslova, M.Sc., Ph.D., Principal Scientist, ACM Global Central Laboratory
Past, Present and Future: The Role of Central Laboratories in Alzheimer’s Disease Research Nov 21/13
LifeSciences -  This webinar will highlight a solutions-based approach to filling large panels for complex trials, while incorporating special populations in a high volume environment
Speakers: Ingrid Holmes, Senior Director, Clinical Operations, Algorithme Pharma
Petra Hillebrand, Vice President, Integrated Services, Altasciences
Early Stage Recruitment Strategies for Complex Trials & Special Populations: How to Deliver Full Panels On-Time Nov 21/13
LifeSciences -  The seminar will address the tools used to define and examine facility critical path production, methods of identification of high value/low impact bottlenecks and the tools used to evaluate and present multi-year variable production volumes with hierarchically organized production improvement solutions
Speakers: Craig Sandstrom, PhD, Director of Process Engineering, Fluor Corporation
Tim McNeill, Director of Technology, Fluor Industrial Services
Jim Humphries, Vice President, Performance Technology, Fluor Corporation
Maximizing Production Capacity for Growth
Part 1: Finding 5% through Facility Optimization
Nov 21/13
LifeSciences - This third webinar of the series will focus on the data analysis questions related to clinical outcome assessment in multinational clinical trials
Speaker: Antoine Regnault, PhD, MSc, MA , Research Director, Mapi HEOR & Strategic Market Access - France
Managing Cultural Variability in PRO Measurement in Global Clinical Research
Part 3: Quantitative Approaches for Clinical Outcome Assessment in a Cross-cultural Context
Nov 20/13
LifeSciences/Manufacturing -  The presenter shares his experience and recommendations for optimizing clinical programs through a flexible approach
Speaker: Michael McNear, RPh, Global Head, Clinical Supply Optimization Services, Fisher Clinical Services
Why Flexibility Matters in Your Clinical Supply Chain Nov 20/13
LifeSciences -  This webinar provides an overview of the key benefits of hard capsules liquid-fill encapsulation with a focus on practical applications, case studies and coating technologies
Speakers: Jakob Mettler, Marketing Manager, Tillotts Pharma AG
Brian E. Jones, Scientific Advisor, Qualicaps Europe S.A., Alcobendas (Madrid), Spain
Claudio Scialdone, Contract Services & Business Development Senior Manager, Tillotts Pharma AG
Discovering the Power of Capsules and Liquid Filling Technology Nov 19/13
LifeSciences -  In this webinar, the presenters will discuss ways to develop targeted strategies with the potential to increase enrollment rates and reduce lost to follow-up
Speakers: Tracy Stewart, MBA, Associate Director, Patient Recruitment, Quintiles
Scott Oakes, PhD, Associate Clinical Project Management Director, Cardiovascular and Metabolic Therapeutic Area, Quintiles
Erica Caveney, MD, Senior Medical Director & Therapeutic Strategy Head, Diabetes, Quintiles
Bernadette Tosti, Manager, Market Development, Quintiles Communications, Quintiles
Best Practices in Patient Recruitment and Retention for Diabetes Trials Nov 18/13
LifeSciences -  Designing and implementing an extractables and leachables program can save significant time/cost in development and potentially avoid pitfalls, which may increase time to market
Speaker: Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories
Understanding and Implementing Effective Extractable and Leachable Programs Nov 15/13
LifeSciences -  An open dialog explaining the changes occurring now, and what the future looks like, for clinical product development
Speaker: Dan White, Vice President, Global Operations, Quintiles
The Next-Generation of Risk-based Monitoring Nov 15/13
LifeSciences -  This program will present a systematic approach to the risk assessment of clinical trials, using methodologies that have been accepted by regulatory authorities as the basis for approvals in other healthcare categories and in other industries
Speakers: Michael Macri, Director, Strategic Services, inVentiv Health Clinical
Jeffrey Fetterman, President, ParagonRx International, an inVentiv Health Business
Risk Assessment: Laying the Foundation for RBM Nov 14/13
LifeSciences -  Learn about the importance of early and careful planning of all activities related to the generation and submission of DSURs, which includes resource planning
Speaker: Sabine Richter, PhD, M.Sc, Vice President Safety and Risk Management PRA
Challenges with Planning and Generation of Development Safety Update Reports (DSURs) and How to Overcome Them Nov 13/13
LifeSciences -  This webinar will address in more detail the advantages of globalization as well as the best practices for overcoming the challenges
Speakers: Garth Tierney, Executive Vice President, Asia/Pacific, INC Research
Silvia Zieher, President, Clinical Development and Latin America Operations, INC Research
Globalizing Clinical Trials to Include Emerging Markets Nov 12/13
LifeSciences -  In this webinar, an overview of the market environment along with the key operational, logistical, and regulatory aspects of conducting clinical trials in China and other Asian countries will be discussed
Speakers: Li Yan, MD, PhD, Executive Director of Clinical Development for Infectious Diseases, Oncology, Respiratory & Immunology, and Vaccines in Emerging Markets, Merck
Patrice Hugo, PhD, Chief Scientist, LabCorp Clinical Trials
Current Trends for Conducting Clinical Trials in China Nov 12/13
LifeSciences -  This webinar will discuss factors critical to success in the design and execution of pediatric clinical trials
Speaker: Alison Sampson, Senior Project Director, Premier Research
Successful Pediatric Studies: Key Study Design and Operational Considerations Nov 11/13
LifeSciences -  This presentation will focus on the use of RNA aptamers for developing cancer diagnostics and treatments
Speakers: Paolo Serafini, Ph.D., Assistant Professor of Microbiology & Immunology, University of Miami, Miller School of Medicine
Samir Iqbal, Ph.D., Assistant Professor Electrical Engineering and Bioengineering (Courtesy), Nanotechnology Research and Education Center, University of Texas at Arlington
Justin Dassie, Ph.D., Post-Doctoral Research Fellow, University of Iowa
RNA Aptamers: A New Paradigm in Cancer Diagnosis and Treatment Nov 7/13
LifeSciences - This webinar focuses on Covance's experience with in vitro assays to demonstrate pharmacological similarity between biologics and biosimilars
Speaker: Sinnathamby Gomathinayagam, PhD, Senior Scientist, Biomarker Center of Excellence, Covance
Biomarker Challenges in Biosimilar Drug Development Nov 6/13
LifeSciences -  This presentation reviews the background and drivers for making the decision - when to outsource pharmacovigilance work. There are several schools of thought on how best to handle safety data as well
Speaker: Angela Pitwood, Vice President, IPM Safety Services, a division of IndiPharm, Inc.
Outsourcing in Pharmacovigilance Nov 5/13
LifeSciences -  Join our speakers for an in-depth look at challenges and proven strategies to develop and implement post-approval risk management procedures
Speakers: Mazhar Thakur, MD, MBA, MAMM, Senior Director, Safety and Risk Management, PRA
Agnes Rivaille, Scientific Affairs Director, Late Phase Services, PRA
Risk Minimization/Mitigation in the Post-Marketing Arena: Regulatory Landscape, Strategy and Effectiveness Nov 4/13
LifeSciences - The presenter will share his thoughts and discuss the importance of having an independent Medical Affairs Strategy that is aligned with business objectives
Speaker: Ramin Farhood, PharmD, MBA, Senior Director, Global Head Medical Affairs Operations, Baxter BioScience

The Evolving Role of Global Medical Affairs

Nov 1/13

LifeSciences -  The talk will outline the steps taken to transform a complex natural product with poor ‘druggability’ features into an orally available agent suitable for clinical investigations
Speakers: Mike Peel, Ph.D., Executive Director Discovery Research, SCYNEXIS, Inc.
James Balkovec, Ph.D., Principal and Owner, ChemTract LLC
Drug Discovery using Natural Products – Optimization Studies of Inhibitors of Glucan Synthesis as Anti-Fungal Agents Oct 31/13
LifeSciences - This presentation will focus on the rationale for selecting varioius technologies enabling the progression of compounds that require bioavailability enhancement to achieve target absorption
Speaker: David Vodak, Ph.D, Vice President of Chemistry, Bend Research Inc.
Technology Selection for Enhancing Bioavailability Oct 30/13
LifeSciences - This webinar will focus on Covance's experience in standardization of methods for microparticle isolation from preclinical and clinical samples, as well as recent findings from microparticle analyses in disease models of Oncology and Cardiovascular/Metabolic Disease
Speaker: Katherine T. Landschulz , PhD, Manager, Biomarker Center of Excellence, Covance
Microparticles and Applications in Assays and Endpoints Oct 29/13
LifeSciences -  In this presentation the challenge of timely reporting of SUSARs to Investigators in global and large-scale clinical trials with a high number of SUSARs will be addressed
Speaker: Dr. Max Horneck, CEO, maxclinical GmbH Germany
Informing the Investigator: Implementing an Automated SUSAR Reporting System Oct 24/13
LifeSciences -  This webinar will cover the concepts involved in using metadata to improve the efficiency of data transformation programming. We will also see a case study of a large portfolio of work that has implemented these concepts to great success
Speaker: Keith Hibbetts, Manager, Statistical Programming, inVentiv Health Clinical
Using Metadata for Data Transformation: How Your Specifications Can Serve You Oct 24/13
LifeSciences -  This diabetes webinar will provide an overview of advanced data mining and software applications that can be used to understand the implications of various protocol entrance criteria
Speakers: Claudia de Oliveira, MD, PhD, MPH, Associate Medical Director, Cardiovascular and Metabolic Therapeutic Delivery Unit , Quintiles
Denise Messer, MA, Senior Project Manager, Clinical Analytics and Simulations, Quintiles
Erica Caveney, MD, MD, Senior Medical Director & Therapeutic Strategy Head, Diabetes, Cardiovascular & Metabolic Therapeutic Delivery Unit, Quintiles
Bruce Basson, MS, Associate Director, Clinical Planning & Design, Quintiles
Improve Protocol Designs for Diabetes Trials Using Predictive Techniques Oct 23/13
LifeSciences -  Discover the flexibility and efficiencies offered through an FSP partnership
Speaker: Bryan Haas, Pharm.D., Vice President, Functional Service Partnerships, PPD
FSP Answered: How New Partnership Models are Shaping Client-Provider Relationships Oct 22/13
LifeSciences -  The need for leaner, faster and cost effective clinical trials demands more attention on where to target enrollment and Latin America can  play a key role this regard
Speakers: Mauro Martinelli, Emerging Markets Specialist, Quintiles
Jose Emilio, Associate Director, Clinical Operations, Quintiles
The Clinical Research Landscape in Latin America Oct 21/13
LifeSciences - In this presentation, the advantages and challenges of applying NMR in these new areas will be discussed
Speakers: Darryl LeBlanc, Ph.D., NMR Spectroscopist, Manager - Analytical Services, SCYNEXIS, Inc.
Allan R. Moorman , Ph.D., Founder, Alta Vetta Pharmaceutical Consulting
Determining Relative Response Factors of Impurities by NMR & Developing GMP NMR Methods – Expanding the Role of NMR beyond Structure Identification Oct 18/13
LifeSciences/Manufacturing -  Learn how RFID enabled smart rooms can eliminate shrinkage, automate reordering processes, simplify inventory reconciliation and financial accounting, and eliminate manual inventory checkouts to return researchers and lab tech’s back to their bench more quickly
Speaker: Keith Hoffman, Director of Marketing, Terso Solutions, Inc.
Improving Efficiency in Research and Clinical Labs with RFID Smart Rooms Oct 18/13
LifeSciences - Learn how to customize a cost-effective communications mix that is continually monitored and updated across multiple channels, including sales reps, so that you can drive prescription growth at any point in your commercial lifecycle – from launch to loss of exclusivity
Speaker: Peter Dussias, Executive Director, Integrated Channel Management Services, Quintiles
Maximize your Physician Reach and Optimize your Spend with Integrated Channel Management Oct 17/13
LifeSciences/Manufacturing -  The webinar will examine the automation of NGS library preparation using different chemistries and its applications
Speakers: Dr. Oleg V Evgrafov, Associate Professor, University of Southern California
Susan Lee, Senior Application Specialist, Hamilton Robotics
Automation Solutions for NGS Sample Preparation Oct 16/13
LifeSciences -  During this webinar leaders in agricultural research will share their research using Roche’s sequence capture technology for genotyping by sequencing in wheat, barley and maize
Speakers: Patrick Schnable, PhD, Distinguished Professor and Director, Center for Plant Genomics, Iowa State University
Eduard Akhunov, PhD, Associate Professor – Department of Plant Pathology, Kansas State University
Nils Stein, PhD, Group Leader Research, Leibniz Institute of Plant Genetics and Crop Plant Research (IPK), Gatersleben, Germany
Efficient SNP Discovery for Crop Genomes through Exome Sequencing Oct 16/13
LifeSciences - During this presentation, you will learn how to establish the best and most cost-effective approach to a cleaning, disinfection and monitoring program
Speakers: Harolyn M. Clow, M.S., SM (NRCM), Manager, Pharmaceutical Microbiology, Eurofins Lancaster Laboratories
Anthony J. Langione, Senior Chemist, Method Development & Validation, Eurofins Lancaster Laboratories
Chemistry and Microbiology Perspectives on Cleaning Validations and Disinfectant Efficacy Studies Oct 10/13
LifeSciences - During the past two decades, the number and complexity of clinical trials have grown dramatically. These changes create new challenges to clinical trial oversight, particularly increased variability in clinical investigator experience, site infrastructure, treatment choices, and standards of health care.
Speaker: Mark Travers, VP, Head of Clinical Study Units, Sanofi-Aventis

Risk-Based Monitoring

Oct 10/13

LifeSciences - The speaker will discuss the emerging field of companion diagnostics with focus on its importance in clinical trial design and how drug / companion diagnostic co-development is rapidly changing the drug development process
Speaker: Mark Roberts, PhD, Director, Diagnostics Development, Covance
Accelerating Drug Development through Drug & Companion Diagnostic Co-Development Oct 9/13
LifeSciences -  A discussion of the issues from Health Canada’s perspective as the regulatory agency with the most recent and perhaps progressive guidance in the world on the inclusion of women in clinical trials, plus insights into the practical barriers to overcome, and some strategies that can be successfully employed by sponsors and sites to encourage better engagement and improved recruitment and retention of women in clinical trials, a legal, moral and pragmatic imperative
Speaker: Dr. Agnes Klein, MD, MPH, Director, Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutic Products in the Biologics and Genetic Therapies Directorate, Health Canada
Mr. Zach Halinan, Director of Patient Communication and Engagement Programs, Center for Information and Study on Clinical Research Participation
Gender Issues in Clinical Trials: Ethical, Regulatory and Practical Considerations Oct 7/13
LifeSciences - This presentation will discuss how the LCMS Biomarkers and Biologics Services business at Quintiles has partnered with a sponsor to develop methods that compare the surrogate matrix and surrogate analyte approaches for the analysis of five amino acids in human plasma: alanine, valine, methionine, leucine and isoleucine
Speaker: Barry R. Jones, Ph.D., Assistant Research Investigator, LCMS Biomarkers and Biologics, Quintiles Bioanalytical and ADME Labs
Better Methods for Novel Biomarkers Series:
LC/MS Biomarker Assay Validation Strategies Using Surrogate Matrix and Surrogate Analyte Approaches
Oct 3/13
LifeSciences - In this webinar, the speakers will focus on the use and quality of COA translations, the importance of linguistic validation and how to assess the reliability of its process
Speakers: Axelle Nadjar, Key Account Director – Linguistic Validation, Mapi
Caroline Anfray, Business Development Director – Linguistic Validation, Mapi
Managing Cultural Variability in PRO Measurement in Global Clinical Research
Part 2: Maximizing Cross-cultural Equivalence of PRO Measures: The Linguistic Validation Methodology
Oct 3/13
LifeSciences - Discussion includes how to develop a distribution plan that takes into account the temperature zones and whether to use a regional versus centralized hub strategy
Speaker: Des Charlery, EMEA Logistics Operations Manager, Fisher Clinical Services
Managing Cold Chain Shipments from Door to Door Oct 1/13
LifeSciences - The speaker will present a unique cooperation between IMS GrantPlan and Greenphire’s eClinical GPS that delivers powerful reporting and analytics on costs throughout a clinical trial, allowing you to stay informed as never before
Speakers: Sam Whitaker, CEO, Greenphire
John Humphreys, Senior Product Manager, IMS Health
Investigator Payments: Handling the Entire Process from Initial Budget to Payment Reconciliation Sep 30/13
LifeSciences - The presenters will share their views of the most recent FDA guidance and explain its impact on clinical development
Speakers: Dan White, Vice President, Global Operations, Quintiles
Dan Ballard, Senior Director, Data Quality, Quintiles
FDA Guidance on Risk-based Monitoring while Improving Data Quality Sep 30/13
LifeSciences - During this webinar you will learn how planning can help avoid costly delays and quality issues, ultimately saving you time and setting you off on the right path to a successful dossier filing and registration
Speakers: Terry Weber Sosa, Vice President, NAMR Biostatistics, Quintiles
Laurie Henricks, Senior Director, Head of North America Regulatory Affairs, Quintiles
Planning for Success: Early Opportunities to Set the Course for Successful Global Marketing Authorization Sep 26/13
LifeSciences - During this webinar, Cubist Pharmaceuticals and CluePoints will explore how sponsors are harnessing the power of Central Statistical Monitoring (CSM) to improve data quality and de-risk their studies
Speakers: Marc Buyse, Sc.D, Founder, CluePoints
Kostia Franklin, Senior Manager, Clinical Data Management, Cubist Pharmaceuticals
Risk-Based Monitoring Improves Data Quality – It’s A Fact! Sep 25/13
LifeSciences -  The implementation of innovative technology tools that make INC Researcg's SDM approach a viable option for improving efficiency in clinical trials will be discussed, as well as how life science companies can use technology to implement a strategic monitoring program
Speakers: Jill Collins, Senior Director, Clinical Innovation, INC Research
Stephen Young, Senior Product Director, Medidata Solutions
Reduce Site Monitoring Costs with a Strategic Approach Sep 25/13
LifeSciences - The case-reports presented will include a discussion of the tools used to comprehensively monitor antigen-specific T cells and evaluation of the immunostimulatory and suppressive compartments
Speaker: Yoav Peretz, Ph.D, Senior Principal Scientist, Caprion/IMMUNECARTA Services
Revealing Relationships Between the Clinical and Immunological Response in Vaccination Trials Sep 24/13
LifeSciences - This webinar will demonstrate how selecting the right EDC can help ensure project success and return on investment
Speaker: Toby Odenheim, MBA, Director, Clinical Technology Services, SynteractHCR, United States
Selecting the Right Electronic Data Capture (EDC) Platform Sep 23/13
LifeSciences - The presentation will include valid examples for using SIPAT in Biologics and API; going from batch production on a single unit operation to complete batch production lines, including continuous manufacturing
Speakers: Jan Verelst, M.Sc. Chemical Engineering, International Business Development Manager for Life Sciences, Siemens
Kjell Francois, Ph.D., Sr. SIPAT Consultant, Business Area Manager, Siemens IS IT
PAT/QbD – Keeping an Eye on Your Quality Sep 18/13
LifeSciences - In vitro pharmacological profiling, testing compounds in select panels of assays like SafetyScreen, play an increasingly important role in reducing drug related safety attrition
Speaker: Gonzalo Castillo, Ph.D., Technical Director, Eurofins Panlabs
In Vitro Safety Screening for Clinical Liabilities Sep 17/13
LifeSciences - This webinar will explore the role of life cycle management and our observations and experiences as they relate to “what’s worked” and “what hasn’t"
Speakers: Keith Ruark, Vice President, AVOS Consulting (an INC Research business)
Bridget Martell, President, BAM Consulting
Life Cycle Management of Biopharmaceuticals: An Approach and Lessons Learned for an Imperative Business Practice Sep 17/13
LifeSciences - This webinar and panel discussion focuses on new ways to design biomarker driven trials and access the right patients, as well as demonstrate the power of the Total Cancer Care data warehouse, featuring participation from Millennium Pharmaceuticals
Speakers: Kyle Kuvalanka, MBA, VP, Strategy and Business Development, Millennium Pharmaceuticals
William (Bill) Trepicchio, PhD, Senior Director, Translational Medicine, Millennium Pharmaceuticals
William Dalton, PhD, MD, CEO, M2Gen and Director, Personalized Medicine Institute at Moffitt Cancer Center
Frank Makosiej, PharmD, Executive Director, Operations, Strategy and Planning, Covance
Enhanced Strategies for Design and Execution of Biomarker-driven Oncology Trials Sep 12/13
LifeSciences - During this webinar the presenters will discuss the wide array of scalable dosage form technologies available, matching technology strengths with API properties, and bringing all of the choices together through biological modeling
Speakers: Chris Craig, Director, Dosage Form Product Development, Bend Research Inc.
Brett Caldwell, Ph.D., Director, Formulation Science, Bend Research Inc.
Rational Design Of Modified Release Dosage Forms: From Pharmacokinetic Targets Through Technology Selection Sep 12/13
LifeSciences - This second webinar in the series will examine market access related issues in Japan, South Korea and Taiwan including the ongoing healthcare reform and its implication on access
Speaker: Chia Wen Lee, Head of Emerging Markets Access, Biogen Idec

Evolving Market Access in the APAC Region: The Pharmaceutical Market in Japan, South Korea and Taiwan

Sep 6/13

LifeSciences - A discussion of platforms, platform selection and migration, optimising tests for FFPE tissue, clinical delivery for trial enrichment, and development routes for companion diagnostics
Speaker: Dr. Austin Tanney, Scientific Liaison Manager, Almac
Optimizing Assays from FFPE for Biomarker Strategies Sep 4/13
Healthcare/Life Sciences - Learn how technology can assist VAMC’s & Hospital’s to not only meet regulatory requirements, but also provide savings and patient safety
Speakers: Alan J. Brander, RN BSN BSW MBA CHE HACP, Vice President of National Sales & Clinical Services, LPIT Solutions
Alisa Riebe, Terso Solutions, Inc.
Using RFID Technology to Compliantly Track Tissue and Implants Aug 22/13
LifeSciences - Improving Development of antibacterial and antifungal agents remains an important priority in the pharmaceutical research industry
Speaker: Lynn Miesel, Ph. D., Global Technical Director, Infectious Disease and Microbiology, Eurofins Panlabs
Anti-Infective Services for Drug Discovery and Development Aug 15/13
LifeSciences - Improving management of CRE’s and other antibiotic-resistant BSI’s with rapid molecular diagnostics
Speakers: Karen C. Carroll, M.D., Professor of Pathology and Medicine, Johns Hopkins University School of Medicine
Blake W. Buchan, PhD, Assistant Professor of Pathology, Medical College of Wisconsin, Associate Director, Clinical Microbiology Dynacare Laboratory
Debra A. Goff, PharmD, FFCP, Clinical Associate Professor, The Ohio State University College of Pharmacy, Infectious Diseases Specialist, The Ohio State Medical Center
Each Hour Counts: Improving Management of CRE’s and Other Antibiotic-Resistant BSI’s with Rapid Molecular Diagnostics Aug 14/13
LifeSciences - An overview of clinically relevant assays for ultrasensitive endocrine clinical trial testing services will be discussed
Speakers: Walt Chandler, PhD, Executive Director of Endocrine Sciences, LabCorp
Patrice Hugo, PhD, Chief Scientist, LabCorp Clinical Trials
Advancements in Endocrine Testing – Case Studies and Solutions for Clinical Trials Aug 7/13
LifeSciences - This webinar will explain the similarities and differences that exist for device and drug studies in the US and EU and the nuances of study conduct
Speakers: Kimberly D. Hunsicker, MSN, CRNP, MBA, Vice President, Global Medical Devices & Diagnostics, Premier Research
Victoria Cavendish, BSc(Hons), MPhil, PhD, PGDipPH, MICR, CSci, Senior Director, Devices, Premier Research
Medical Device and Drug Research: Similarities and Differences Jul 30/13
LifeSciences - This webinar will focus on the regulatory requirements and expectancies for the conduct of studies to support the scheduling of new chemical entities
Speaker: Mary Jeanne Kallman, Ph.D., Director of Nonclinical Neuroscience, Covance
Addressing Scientific and Regulatory Challenges for Abuse Liability Studies Jul 26/13
LifeSciences - The webinar will review the current regulatory landscape and guidance for nonclinical and clinical development of biosimilars with a focus on safety-related aspects and discuss the current challenges and future perspectives in this area
Speaker: Joerg Bluemel, Director Toxicology within Biologics Safety Assessment / Translational Sciences, MedImmune, Gaithersburg MD

Nonclinical and Clinical Safety Assessment of Biosimilars: Status and Perspective

Jul 25/13

LifeSciences - The presentation will include valid examples for using SIPAT in Biologics and API; going from batch production on a single unit operation to complete batch production lines, including continuous manufacturing
Speakers: Pamela Bruen, Life Sciences Industry Manager, USA, Siemens
John Klaas, Corporate Account Manager, Siemens
Dr. Kjell Francois, Sr. SIPAT Consultant, Business Area Manager, Siemens IS IT
PAT/QbD – Keeping an Eye on Your Quality Jul 23/13
LifeSciences - The best practices for applying quantitative and qualitative information to develop study strategies, from feasibility through patient recruitment will be discussed
Speakers: Michelle Archibald, Senor Director, Site & Patient Strategies, Quintiles
Nicole Turner, Associate Director, Global Feasibility, Quintiles
Julie Parmelee, Director, Patient Recruitment, Quintiles
Mark Brown, Vice President of Strategic Site Intelligence and Feasibility, Quintiles
DOs and DON’Ts of Study Start-Up: Best Practices to Improve Efficiency and Meet/Exceed Timelines Jul 23/13
LifeSciences - The panel will explain how safety and therapeutic medics, biostatisticians, data management experts and operations gurus apply risk-based thinking before a trial begins
Speakers: Rick Sax, M.D., Senior Vice President, Integrated Clinical Services, Quintiles
Dan White, Vice President, Global Operations, Quintiles
Risk-based Thinking: The Success of Risk-based Monitoring Begins with Risk-based Thinking Jul 19/13
LifeSciences - This webinar will explore the roles of DSMBs and IRBs in particular and examine how they are involved in ensuring patient safety in pediatric trials, the unique considerations in developing DSMBs for pediatric populations, how regulatory guidance is driving change for DSMBs and IRBs and how to best work with each other and sponsors to ensure the highest degree of safety for patients and the best quality of research and data
Speakers: Jeffrey Cooper: Vice President Global Consulting at WIRB Copernicus Group IRB
Amy Professor Philip Walson, MD Board Certified in Paediatrics, Clinical Pharmacology and Medical Toxicology; Visiting Professor, Department of Laboratory Medicine at Georg-August-University Medical School, Germany
Moderator: Kathy Bohannon, Principal Strategist, Pediatrics, INC Research
Pediatric Safety Monitoring: Role of IRBs and DSMBs Jul 18/13
LifeSciences - Learn about the hurdles to overcome when studying rare diseases and find out how to skillfully navigate the clinical and regulatory challenges on the path to successful orphan drug development
Speakers: Angi Robinson, Executive Director, Scientific Account Leader, Premier Research
Charlene Sanders, Vice President, Global Regulatory Affairs & Pediatric Strategic Consulting, Premier Research
Strategies for Rare Disease Studies and Orphan Drug Development in the US Jul 16/13
LifeSciences - This webinar will feature a case study on Heparin-induced thrombocytopenia (HIT) antibodies developed in response to heparin, and its low molecular weight analogues using the SQI Diagnostics’ platform
Speakers: Jaymie R. Sawyer, Ph.D., Vice-President, Research and Development, SQI Diagnostics
Robert Massé, Ph.D., Vice-President, Large Molecule Bioanalysis, Algorithme Pharma
A Multiplexed Approach for Immunogenicity Assessment Using the New SQiDlite™ System: Case Study Analysis Jul 11/13
LifeSciences - This webinar will cover mapping SDTM specifications during study design, describe the benefits of having an SDTM database available during study conduct and the final datasets within 24 hours of database lock, and provide a brief overview of the technology that provides these capabilities
Speakers: Keith Howells, SVP Development, OmniComm Systems, Inc.
Prashanthi Vunnava, Senior SAS Programmer, Alkermes, Plc.
SDTM in Real Time – A Case Study: Initial Datasets by First Patient In; Final Datasets Within 24 Hours of Study Lock Jul 11/13
LifeSciences - This webinar will discuss approaches used at Bend Research to design, assay, and manufacture spray-dried powder formulations containing proteins and nucleic acids
Speakers: Jeff Breit, Ph.D., Director of Inhalation Technology, Bend Research Inc.
Devon DuBose, Senior Research Engineer, Bend Research Inc.
Vaccine and Biotherapeutic Formulation Development and Manufacture Using Spray-Drying Jul 10/13
LifeSciences - This webinar will encompass the three key steps that maximize cross-cultural equivalence of scales assessing patient benefit and safety in international research
Speakers: Benoit Arnould, PhD, Senior Director, Mapi
Nicola Germain, MA, Senior Research Associate, Mapi
Managing Cultural Variability in PRO Measurement in Global Clinical Research
Part 1: Cross-cultural Qualitative Research for Simultaneous Scale Development
Jul 2/13
LifeSciences - This presentation will examine recent changes in Indian clinical trial regulations, iImmediate and long term impacts, an foreseeable opportunities
Speaker: Dr. Josemund Menezes, MBBS, Regional Director, Clinical Development (Asia-Pacific), Sanofi Pasteur

Adhering Navigating the Dynamic Indian Clinical Trial Landscape

Jun 28/13

LifeSciences - This presentation will discuss how the LCMS Biomarkers and Biologics Services business at Quintiles has partnered with our sponsors to develop quantitative methods for biomarkers and biotherapeutics by adapting the immunoprecipitation methodologies of ELISA with the specificity and robustness of LCMS to achieve sensitivity that is comparable to ELISA but with the specificity of LCMS
Speaker: Gary Schultz Ph.D., Director, LCMS Biomarkers and Biologics, Quintiles Bioanalytical and ADME Labs
Quantitative Analysis of Biomarkers with the Specificity and Robustness of Liquid Chromatography/Mass Spectrometry (LC/MS) and the Sensitivity of ELISA Jun 27/13
LifeSciences - This presentation will explore optimization and validation strategies for flow cytometry assays, as well as highlight assays used at MPI Research on GLP toxicology and drug discovery studies
Speaker: Brandon Zeigler, PhD, research scientist, MPI Research
Practical Uses for Flow Cytometry in Toxicology Studies Within a GLP Environment Jun 25/13
LifeSciences - This webinar will examine the need for more oversight in pharmaceutical advertising and promotion, and review the basic regulations and guiding principles
Speaker: Moulakshi (Mou) Roychowdhury, PharmD, JD, Director of Regulatory Affairs – Global Advertising & Labeling, Forest Laboratories

Drug Advertising and Promotion Labeling: FDA Regulations

Jun 21/13

LifeSciences - Learn how to optimize your product launch by first understanding and addressing the needs of all your key stakeholders and then organizing all the launch activities
Speaker: Troy Hampton, MBA, Senior Director, Global Market Access and Commercialization, Quintiles
Optimize Your Product Launch in a Multi-Stakeholder Environment Jun 20/13
LifeSciences - In this webinar, animal models of pain to explore the efficacy of novel new drug candidates will be summarized to include acute, inflammatory and chronic pain conditions
Speakers: Linda Hedley, Global CNS Technical Director, Eurofins Panlabs
Tamara King, Ph.D., Assistant Professor, College of Osteopathic Medicine and Center for Excellence in the Neurosciences, University of New England
Translational Animal Models of Pain Jun 19/13
LifeSciences This webinar will provide an overview of clinical outsourcing in the MENA (Middle East and North Africa) and APAC (Asia-Pacific) regions and will provide considerations for programs of development
Speaker: Larry Ajuwon, (former) Senior Outsourcing Manager, Genzyme Europe, the Netherlands

Clinical Development, Contracts and Outsourcing in MENA & APAC

Jun 19/13

LifeSciences This webinar will explore the direction clinical research is headed and the role innovation plays in its new course
Speakers: Jamie Macdonald, Chief Executive Officer, INC Research
Amy Kissam, Executive Director, Integrated Clinical Processes, INC Research
John Whitaker, Ph.D., Senior Vice President, Clinical Innovation, INC Research
Clinical Process Innovation: Driving Predictability in Clinical Development through Innovation Jun 18/13
LifeSciences In this webinar the issue of adherence to asthma medication in both clinical trials and the real world will be explored, including measurement of adherence, data interpretation, regulatory implications, and the challenges of generalizing study data to routine clinical practice
Speakers: Liam Heaney, Clinical Professor and Consultant, Queen's University. Belfast, UK
Peter Summerfield, VP, Global TAH Respiratory, Global Product Development, PPD
Rav Seeruthun, MRCGP, MFPM, Senior Director, Global Late Stage Research, PPD
Adherence in Asthma: Comparing Clinical Trials to the "Real-World" Jun 14/13
LifeSciences - This webinar will discuss the new European Union (EU) Pharmacovigilance legislation to ensure compliance and evaluate the optimal risk management plan (RMP) and Risk Evaluation and Risk Evaluation and Mitigation Strategies (REMS) for EU and US submissions
Speaker: Amy Sun MD, Ph.D., FACP, Director of Clinical Risk Management, Merck

Drug Safety & Risk Management

Jun 14/13

LifeSciences This webinar will discuss the benefits of partnering with an academic medical center and will feature case studies for successful biomarker discovery, biomarker development and companion diagnostics co-development
Speakers: Steve Groshong, MD, PhD, Pathology Division Chief, National Jewish Health
Preveen Ramamoorthy, PhD, Molecular Diagnostics Laboratory Director, National Jewish Health
Leveraging an Academic-Industry Partnership for Commercial Success Jun 13/13
LifeSciences - A discussion of the core principles, best practices and steps that must be taken in order to optimize the selection of the diagnostic testing to support the trial protocol
Speaker panel from ACM Global Central Laboratory: Mark Engelhart, Chief Commercial Officer
Kathleen Murray, Executive Director, Scientific Affairs
Suzanne Dale, PhD, D(ABMM), Director of Microbiology and Molecular Diagnostics
Endpoint Based Protocol Development: A Central Laboratory Perspective + Microbiology Case Study Jun 12/13
LifeSciences This webinar will discuss ways in which we can ensure “distribution readiness” by having a real understanding of the pre-FPI planning and preparation as well as country rollout post approval
Speaker: Elizabeth Gallagher, Director Global Logistics, Fisher Clinical Services
Ensuring Distribution Readiness Before FPI: A Simple Guide to De-Risking Jun 12/13
LifeSciences This session will give an in-depth examination of Central Statistical Monitoring (CSM)
Speakers: Marc Buyse, Sc.D, Founder, CluePoints
Brian Nugent, Associate Director, Clinical Operations, Gilead Sciences, Inc.
Removing the Risk in Risk-Based Monitoring – A Practical and Proven Approach to Implementing Central Statistical Monitoring Jun 10/13
LifeSciences This webinar will explore how biopharma can use information technology to bring drugs to market faster, better, and cheaper
Speaker: Thomas Grundstrom, Vice President & Global Head, Integrated Processes and Technologies, Quintiles Infosario
Mark Gorton, Senior Director of Information Technology, Quintiles
Accelerating Drug Development by Harnessing Technology Jun 7/13
LifeSciences/Business Strategy - A discussion of the clinical research scenario in S.E. Asia including market opportunity, registration, new regulatory and safety guidelines
Speakers: Dr. Shariq Anwar, Head of Operations, Max Neeman International
Donald Swankie, MBA, Vice President, USA, Max Neeman International
S.E. Asia Drug/Device Update: Market Potential and Regulatory Environment Jun 6/13
LifeSciences - The webinar will examine the objectives of PMOS and Phase IV studies, possible designs, benefits, disadvantages and challenges
Speaker: John S. Sampalis, B.Sc., B.A. (Hon.), M.Sc., Ph.D., F.A.C.E., Founder, CEO and Chief Scientific Officer, JSS Medical Research Inc.
Post-Marketing Observation Studies (PMOS) and Phase IV Studies Jun 5/13
LifeSciences The speakers will discuss the disposition challenges required to guide lead optimization, predict in vivo activity in animal models, and identify any species-dependent variables that may impact the likely human clinical dose
Speakers: Steve Wring, Ph.D., Director of Drug Metabolism and Pharmacokinetics, SCYNEXIS, Inc.
Tom von Geldern, Ph.D., Pharma/Biotech Consultant, Embedded Consulting
DMPK for Targeted Tissue Delivery: Solutions for the Most Challenging Part of Outsourcing Jun 4/13
LifeSciences - Understand the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP) and additional regulations for the conduction of clinical trials
Speaker: Jeremy Lim, Pharm.D., Fellow, Clinical Development, Novartis Pharmaceuticals Corporation

Adhering to Good Clinical Practice: An Overview of Clinical Trials

May 31/13

LifeSciences LifeSciences - The presentation will include a discussion of a suite of techniques developed at UCSF/HHMI based on ribosome profiling (deep sequencing of ribosome protected fragments) that dramatically expand our ability to follow translation in vivo
Speakers: Jonathan Weissman, Ph.D., HHMI Investigator, UCSF/HHMI Nicholas Ingolia, Ph.D., Principal Investigator, Carnegie Institution for Science
Scott Kuersten, Ph.D., Staff Scientist, Epicentre, an Illumina Company
Monitoring Protein Synthesis One Codon at a Time Through Ribosome Profiling May 30/13
LifeSciences LifeSciences - In this webinar, the presenter will review how an effective collaboration between client and service provider can be achieved in outsourcing pharmaceutical development
Speakers: Torkel Gren, PhD, Director, Recipharm
Development of an Innovative Microtablet Dosage Form May 30/13
LifeSciences LifeSciences - This talk will discuss the use of computational biology tools to ensure high-quality genomics when used as part of the QC process
Speaker: Sergey Stepaniants, Ph.D., Head of Computational Biology, Genomics Laboratory, Covance
Impacting Clinical and Preclinical Decisions: Computational Analysis of Complex Genomics Data Sets May 29/13
LifeSciences LifeSciences - In this webinar the presenter will discuss best practices for optimizing design to improve success rates and deliver more cost effective and timely clinical programs
Speaker: Dan Frederic L. Sax, M.D., Global Head, Center for Integrated Drug Development, Quintiles
Optimizing Trial Outcomes through Computer Assisted Design May 28/13
LifeSciences Healthcare/SupplyChain - An examination of recent advances in medical device technology, surgical procedures and tissue preservation that are revolutionizing the health care industry
Speakers: Peter Casady, CEO & President, Champion Medical Technologies
Joe Pleshek, CEO & President,Terso Solutions, Inc.
Best Practices for Tracking Tissue in the Healthcare Supply Chain May 23/13
LifeSciences LifeSciences - An in depth look at release of a draft revision by the European Commission in 2012 that will impact medical device and medical diagnostic manufacturers in the EU and abroad
Speakers: Janette Benaddi, RGN, BSc, MICR, CSci, CDir, MIOD, CEO, Medvance
Marcus Thornton, Senior Director, CTMS, Medidata Solutions
How the Medical Device Industry Can Prepare for the EU Regulatory Changes Ahead May 23/13
LifeSciences LifeSciences - This webinar focuses on OncoPanelTM,, a collection of 240 genomically and histologically diverse cancer cell lines, that providesmultiplexed high-content imaging analysis of therapeutics in oncology
Speakers: O. Jameel Shah, Ph.D, Principal Scientist and Group Leader, Oncology, Eurofins Panlabs
Jonathan Crane, Ph.D., Senior Scientist, Oncology and Cell Biology, Eurofins Panlabs
Predictive Biomarker Discovery for Oncology Small-Molecules and Biologics May 22/13
LifeSciences LifeSciences - Learn strategies for establishing an extractables study design, allowing for a detailed risk assessment
Speakers: Thomas C. Lehman, Ph.D., Manager, Method Development and Validation, Eurofins Lancaster Laboratories, Inc.
Erica J. Tullo, Ph.D., Senior Chemist, Method Development and Validation, Eurofins Lancaster Laboratories, Inc.
Paolo Pescio, Medical Devices & Toxicology Manager, Eurofins Biolab
Best Practices for Conducting Extractable and Leachable Studies May 22/13
LifeSciences LifeSciences - Learn how Caprion applies its label-free mass spectrometry-based proteomics platform to successfully identify tissue-specific protein biomarkers that can be used to follow disease progression in human blood
Speaker: Eustache Paramithiotis, Ph.D., Senior Director, Molecular and Cell Biology, Caprion
Discovery of Circulating Protein Biomarkers by Analysis of the Tissue Secretome May 21/13
LifeSciences LifeSciences - An in-depth look at the challenges and solutions in conducting biosimilar trials
Speaker: Rodeina Challand B.Sc., Executive Director, Biosimilars Development, Scientific Affairs, PRA
Challenges and Solutions in Conducting Biosimilar Trials May 15/13
LifeSciences LifeSciences - Learn about the hurdles to overcome when studying rare diseases and find out how to skillfully navigate the clinical and regulatory challenges on the path to successful orphan drug development
Speakers: Susan Tansey, MD, Medical Director, Paediatrics, Premier Research
Susan Bhatti, PhD, Executive Director European Regulatory Affairs and Medical Writing, Premier Research
Strategies for Rare Disease Studies and Orphan Drug Development in Europe May 14/13
LifeSciences - A discussion of the latest developments in nanotechnology including a case study of a targeted therapeutic developed with the use of nanotechnology
Speakers: Dr. Toby Gill, Independent Nanotechnology Professional, UK
Dr. Jeff Hrkach, Senior Vice President of Technology, Research and Development, BIND Biosciences

Nanotechnologies in Bioscience: Targeted Therapeutics & Drug Development

May 10/13

LifeSciences LifeSciences - Translating the Preclinical Pharmacology of the Select TLR8 Agonist VTX-2337, into Clinical Activity using the Myriad RBM MAP Inflammation Panel
Speaker: Dr. Gregory N Dietsch, Ph.D., DABT, Vice President of Research, VentiRx Pharmaceuticals
Translating Preclinical Pharmacology to Clinical Activity May 2/13
LifeSciences LifeSciences - In this webinar, Quintiles will share recent research insights and real experiences using a modernized approach to risk-based monitoring
Speakers: Dan White, Quintiles, Vice President, Global Operations, Quintiles
Amanda Sax, Senior Director, Integrated Processes and Technologies, Quintiles
Risk-based Approach to Monitoring: Deployment Insights and Lessons Learned Apr 30/13
LifeSciences LifeSciences - An in-depth look at strategies to implement risk minimization procedures in Clinical Pharmacology Units at PRA
Speaker: Thijs van Iersel, M.D., Senior Director of Scientific Affairs, PRA, Early Development Services, The Netherlands
Risk Assessment and Risk Mitigation in Phase I Trials in High Risk Compounds: A Continuously Developing Process Apr 25/13
LifeSciences LifeSciences - This webinar will break down the issues related to the implementation and tracking of a risk-based monitoring program through the utilization of site quality management as well as the process and organizational challenges of adopting site quality management and centralized monitoring
Speakers: Steve Young, Senior Product Director, Medidata Solutions
Laurie Halloran, President, Halloran Consulting Group
Site Quality Management to Optimize Risk-Based and Centralized Monitoring Apr 23/13
LifeSciences LifeSciences/SupplyChain - Forward-thinking companies are now looking to the cutting edge in supply chain technology: sensor-based logistics (SBL). During this webinar, you will be provided with five questions to get ahead of the SBL trend and things to consider when getting a program off the ground
Speakers: Richard W. Horan, Vice President, Support Operations, med fusion
Chris Swearingen, Marketing Manager, FedEx
Sensor-Based Logistics for Life Science Supply Chains Apr 22/13
LifeSciences LifeSciences - This webinar will provide insight into current approaches and issues in co-developing novel oncology therapeutics and diagnostics
Speakers: Brad Smith, Ph.D., Vice President, Translational Medicine, Center for Integrated Drug Development, Quintiles
Eric Faulkner, MPH, Director, Global Market Access – Diagnostics / Personalized Medicine, Quintiles
Drug-Diagnostic Co-Development Strategies for Oncology: Critical Aspects of Development and Launching an Oncology Companion Diagnostic Apr 19/13
LifeSciences - This first webinar in the series will examine market access related issues in China, including the ongoing healthcare reform in China and its implication on access
Speaker: Chia Wen Lee, Head of Emerging Markets Access, Biogen Idec

Evolving Market Access in the APAC Region: The Pharmaceutical Market in China

Apr 18/13

LifeSciences - The speaker will examine the move in the pharma/biotech industry to the adoption and implementation of Lean Six Sigma
Speaker: Rodrigo Crispim, Hub Unit Manager, Regional Clinical Operations Office, Bristol-Myers Squibb

Serialization Best Practices for Lean Six Sigma in Clinical Development and R&D

Apr 17/13

LifeSciences Life Sciences - This webinar will focus on lead optimization pharmacology and toxicology and a fail fast strategy that many companies are using
Speaker: Shawn Heidel, D.V.M., Ph.D., Executive Director, Global Discovery Pharmacology & Toxicology, Covance
A “Fail Fast” Strategy for Lead Optimization Pharmacology and Toxicology Apr 16/13
LifeSciences LifeSciences/Business Strategy - This fourth webinar in our series will focus on the regulatory aspects of conducting clinical trials in Russia
Speakers: Yuri Afonchikov, MD, PhD, Vice President, Regulatory Affairs, Synergy Research Group
Igor Stefanov, Director, General Manager, Synergy Research Group
WEBINAR SERIES: Conducting Clinical Trials in Emerging Markets
Part 4 - Regulatory Affairs: The Key to Russia
Apr 10/13
LifeSciences LifeSciences/Manufacturing - During this webinar, the speakers will discuss how Fujifilm Diosynth Biotechnologies has provided manufacturing flexibility under accelerated timelines on a cost-effective basis and how they compared process and product quality data for single use systems vs. stainless steel reactors, critical factors to consider when selecting the elements of the final (1000L) manufacturing train

Speakers: Stewart McNaull, Section Leader, Upstream Process Development, Fujifilm Diosynth Biotechnologies, RTP, NC, USA
Bo Kara, Director of Science & Technology, Fujifilm Diosynth Biotechnologies, Billingham, UK

Achieving Optimal Performance From Single Use Platforms: Elegant Process Design To Achieve Efficient and Economic Operational Flexibility in Multi-product GMP Facilities Mar 27
LifeSciences Life Sciences/Business Strategy - The speakers will evaluate the quality of clinical trials being conducted in Russia / Ukraine compared to Western Europe, Eastern Europe and other Emerging Markets based on the results of recent FDA inspections conducted at clinical trial sites in these regions
Speakers: David Passov, MBA Senior Vice President, Eastern Europe, ClinStar, A PRA Company
Stanislav Gneushev, MD, MRQA, Director, Quality Assurance, ClinStar, A PRA Company
An Evaluation of Clinical Trial Quality in Russia / Ukraine Compared to Western Europe, Eastern Europe and Other Emerging Markets Mar 22/13
LifeSciences Life Sciences/Healthcare - Viewers will learn how organizations, such the ONC sponsored Colorado Beacon Consortium (CBC), are using IndiGO, a clinical decision support tool, to optimize the cost and quality objectives in their population-based programs
Speakers: David Eddy, MD, PhD, Founder and CMO Emeritus, Archimedes Inc.
Patrick Gordon MPA, Associate Vice President , Rocky Mountain Health Plans
David Kendrick, MD, MPH, CEO , MyHealth Access Network
Succeed in a World of Shared Savings and Capitation Mar 21/13
LifeSciences LifeSciences - During this presentation, you will learn current strategies and best practices for comparator product testing
Speakers: Nathan T. Whitford, M.B.A., Manager, Chemistry and Site Operations, Eurofins Lancaster Laboratories, Inc.
Jutta Wagner, Head of Project Management Manufacturing, Fisher Clinical Services
Chrissy Leslie, Manager, Pharmaceutical Product Testing, Eurofins Lancaster Laboratories, Inc.
Effective Strategies for Managing Comparator Product Testing Mar 20/13
LifeSciences LifeSciences - The speaker will present an overview of LabCorp's HCV capabilities, and discuss ongoing and future HCV assay development activities, such as the implementation of next generation sequencing platforms for minor variant detection
Speaker: Christos Petropoulos, PhD, Chief Scientific Officer, Monogram Biosciences, a LabCorp Company
Comprehensive Global Testing Solutions for HCV Novel Therapeutics in Clinical Development Mar 13/13
LifeSciences LifeSciences - This webinar will examine highlights of the draft guidance issued in late 2011 by the FDA entitled: “A Risk-based Approach to Monitoring” and will provide examples of potential cost savings and increased efficiencies gained by implementing a risk-based monitoring approach
Speakers: Keith Howells, SVP Development, OmniComm Systems, Inc.
Becky (Causey) Carpenter, VP of Operations, ResearchPoint Global
Challenges and Opportunities in Risk-based Approach to Monitoring Mar 12/13
LifeSciences LifeSciences - This webinar will provide an overview of the basics of model based drug development and its practical applications in selecting the right dose and population, optimizing trial, program, and portfolio design, and quantitative decision making through computer modeling and simulation
Speakers: N. Seth Berry, PharmD, Director, Clinical PK/PD and Modeling & Simulation, Quintiles
Russell Reeve, PhD, Senior Strategic Biostatistics Director, Quintiles
Model-Based Drug Development (MBDD) 101: A Primer on MBDD and Its Benefits Feb 28/13
LifeSciences/SupplyChain - Join our speaker from Bristol-Myers Squibb, one of the first companies to understand the multiple benefits of item level serialization, as he examines serialization and its use in fighting counterfeit drugs
Speaker: Daljeet Sahni, AD EDO Engineering, Global Supply Chain, Bristol-Myers Squibb

Serialization in Pharmaceuticals

Feb 27/13

LifeSciences LifeSciences/Business Strategy - This third webinar in our series will focus on how conducting clinical trials in Russia can help cut the cost of clinical research
Speakers: Sergei Varshavsky, MD, PhD, Sr. VP, Global Strategy, Synergy Research Group
Igor Stefanov, Director, General Manager, Synergy Research Group
WEBINAR SERIES: Conducting Clinical Trials in Emerging Markets
Part 3 - Cutting the Cost of Clinical Research: The Solution Comes from Russia
Feb 25/13
LifeSciences In this webinar, Dr. Speers will describe the AAHRPP accreditation process, the value of accreditation and why sites and IRBs should seek accreditation, and demonstrate that research protection and quality are responsibilities of those at the highest level at the site
Speaker: Marjorie A. Speers, Ph.D., President and CEO, AAHRPP

Human Research Protection and Understanding the Landscape of AAHRPP Accreditation

Feb 20/13

LifeSciences LifeSciences - In this webinar, our expert shares a case study for a biological drug product that required re-development of both the bioassay method for potency, as well as an improved process for extracting the drug product from a carrier so that the potency of the final drug product could be reproducibly measured
Speaker: Peter Wunderli, Ph.D., associate director, biopharmaceutical services, PPD, cGMP laboratory
Developing Robust Potency Assays for Validation: A Case Study Feb 19/13
LifeSciences LifeSciences/BusinessStrategy - In this webinar we will discuss best practices for using data to objectively assess the best fit countries and associated sites for particular trials
Speakers: Chris Frega, Sr. Director and Head of Global Feasibility, Quintiles
Tom Larrichio, Senior Director, Strategic Site Intelligence, Quintiles
Country and Site Selection: Optimizing Protocol Planning Decisions by Leveraging Data Through Custom Algorithms Feb 13/13
LifeSciences This presentation will discuss the number of new and diverse items that will be included in the new directive (eg. validation, quality management and risk management). More guidance will be offered for topics such as temperature management and transportation.
Speaker: Riekert Bruinink, Senior GMP/GDP Inspector, Dutch Health Care Inspectorate, The Netherlands

EU Good Distribution Practice Guidelines 2013

Feb 8/13

LifeSciences LifeSciences - A strategy to achieve a better assessment of QT liability early in the drug development cycle, at lower cost, will be discussed by the experts in this webinar
Speakers: Dr. Jay Mason, Chief Medical Officer, Spaulding Clinical Research
Dr. Charles Benson, Eli Lilly and Company and E14 Implementation Working Group Member
Moderator: Daniel Selness, Sr. VP and GM of Clinical Research, Spaulding Clinical Research
Farewell to TQT Studies? Feb 7/13
LifeSciences This webinar will focus on ensuring compliance with international and local country specific PV Requirements from an Asia-Pacific perspective
Speaker: Michal Borawski, International Pharmacovigilance Officer for the Asia-Pacific Region Affairs, Sanofi Pasteur

How to Ensure Pharmacovigilance Practices are Compliant with Global Safety Requirements: Challenges in Asia-Pacific

Jan 30/13

LifeSciences LifeSciences/Healthcare -  The webinar will provide an overview of healthcare administrative data and registries analysis, including objectives, challenges, examples, and a comparison to to other post-approval studies designs
Speaker: John S. Sampalis, B.Sc., B.A. (Hon.), M.Sc., Ph.D., F.A.C.E., Founder, CEO and Chief Scientific Officer, JSS Medical Research Inc.
Healthcare Administrative Databases Analysis Jan 29/13
LifeSciences In this presentation, a detailed description of the requirements for registration and post-marketing, as well as a Pharmacovigilance plan will be discussed
Speaker: Vijay Tammara, VP Global Regulatory Affairs, Nuron Biotech, AAPS Member

Biosimilar Regulatory Guidelines in Emerging Markets – India

Jan 24/13

LifeSciences LifeSciences - Dr. Klein will discuss Health Canada’s approach and stringent infectious disease requirements for Phase 1 clincal trials. Dr. Larouche will discuss the practical dimensions of the problem, and what must be done at the clinic level, over and above regulatory requirements.
Speakers: Dr. Agnes Klein, MD, MPH, Director, Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutic Products in the Biologics and Genetic Therapies Directorate, Health Canada
Dr. Richard Larouche, BPharm, MD, Director, Medical Affairs, Early Stage Development, Pharmanet/i3
Protection of Phase 1 Research Volunteers in an Age of Pandemics and Re-emergence of Contagious Diseases Long Thought Conquered Jan 18/13
LifeSciences The goal of this presentation is to provide an understanding of the current regulations and continued challenges, future directions by the regulatory authorities and provide insight into the regulatory pathway for biosimilar and biobetter registration
Speaker: Dr. Steven Engel, MS, PharmD, Senior Principal Scientist, Worldwide Regulatory Affairs, Merck & Co., Inc.

FDA New Guidelines for Biosimilars and Biobetters: An Outlook for 2013

Jan 16/13

LifeSciences LifeSciences - This webinar will address the various clinical, regulatory (US & EU) and commercialization strategies that may be implemented in the development of products to treat rare diseases and orphan indications
Speaker: William C. Maier, PhD, Chief Scientific Officer, REGISTRAT-MAPI
Clinical, Regulatory and Commercialization Strategies for Rare Diseases Jan 15/13
LifeSciences Life Sciences/Supply Chain - Learn how to dramatically enhance the value derived from outsourcing, without additional expense
Speakers: Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories
Thomas J. Wilson, Vice President of Quality, Synta Pharmaceuticals Corp.
Best Practices for Outsourcing Drug Development: The Human Elements of a Successful Relationship Jan 14/13
LifeSciences Life Sciences - This webinar is part of a series about innovative approaches and specialized techniques to bioanalytical studies
Speaker: Clark Williard, Executive Director, Mass Spectrometry Operations, PharmaNet/i3
Application of GC/MS/MS in Monitoring Steriods as a Pharmacokinetic and Pharmacological Biomarker Dec 17/12
LifeSciences Life Sciences - This webinar will provide insight into some of the current issues in progressing oncology compounds from the pre-clinical arena through early clinical development in humans, with specific focus on three areas of early oncology research that can make or break these critical first-in-man studies
Speakers: Philip Breitfeld, MD, Vice President, Therapeutic Strategy, Oncology Therapeutic Area, Quintiles
Eric Groves, MD, PhD, Vice President, Center for Integrated Drug Development, Quintiles
Chris Learn, PhD, PMP, Senior Clinical Project Manager, Quintiles
Maximizing Quality and Efficiency of Go/No Go Decisions in Early Oncology Development Dec 14/12
LifeSciences Life Sciences - Understand the role of Next Generation Sequencing in personalized medicine, how to identify various genomic alterations in rapid time, and how Next Generation Sequencing can help stratify patient populations
Speaker: Anup Madan, Ph.D., Director of Sequencing, Covance
Personalized Medicine Through Integrated Next Generation Sequencing Dec 12/12
LifeSciences LifeSciences - In this webinar we will discuss how evidence generated for regulatory purposes can be useful for CER
Speakers: Jeroen Jansen, PhD, Vice President, Health Economics & Outcomes Research, MAPI Consultancy
Carl de Moor, PhD, Vice President Epidemiology, REGISTRAT-MAPI, North America
Comparative Effectiveness Research – The Role of Evidence Synthesis and Non-randomized Real World Studies Dec 11/12
LifeSciences LifeSciences - During this session we will explore ways to minimize the variability in pain studies and methods for increasing the chances of showing a therapeutic effect for the study medication being tested
Speaker: Michael Kuss, Vice President, Analgesia, Premier Research
Managing Variability in Pain Studies Dec 10/12
LifeSciences LifeSciences - This presentation will explore requisite study designs and detail the procedures routinely employed in support of scientific and regulatory best practices in assessing auditory safety
Speakers: Matthew Abernathy, MS, Associate Scientist, MPI Research
Rachel Tapp, BS, LATG, Study Director, MPI Research
What’d You Say? Understanding Nonclinical Auditory Safety Evaluations Dec 7/12
LifeSciences LifeSciences - This presentation will review the potential clinical applications of Vectra DA in the management of RA, with a specific focus on findings from recent studies presented at the Annual Rheumatology Meeting held in DC
Speaker: Eric Sasso, MD, Vice President Medical and Scientific Affairs Crescendo Bioscience
Clinical Applications of Vectra™ DA: Review of Recent Study Findings Dec 4/12
LifeSciences Life Sciences This webinar will explore the current regulatory and scientific challenges facing industry engaged in developing biosimilars with emphasis on EU and US regulatory framework.
Speakers: Carolyn Finkle, Vice President, Global Regulatory Consulting, Catalent Pharma Solutions
Vincy Abraham, Senior Manager, Bioanalytics Catalent Pharma Solutions
Biosimilars: Creating Workable Solutions to Global Regulatory and Analytical Challenges Nov 30/12
LifeSciences Healthcare/Life Sciences - Optimizing patient flow through the hospital is a key strategic initiative being implemented across many hospitals in an effort to add value and eliminate waste. However, the availability of macro-level analytic tools to guide these key strategic decisions is lacking. Carilion Clinic developed a discrete-event computer simulation (DES) model to replicate patient flow from hospital admission to discharge.
Speaker: Jim Montgomery, MHA, FACHE, CSSBB, Carilion Clinic
Carilion Clinic: Hospital Patient Flow Optimization Decision Support Tool Nov 29/12
LifeSciences LifeSciences - This presentation will provide an overview of cell based potency assays, including current regulatory expectations as well as trends within the industry
Speakers: Weihong Wang, Ph.D., manager of Molecular and Cell Biology Services, Eurofins Lancaster Laboratories
Darren Kamikura, Ph.D., Research Scientist, Eli Lilly and Co
Outsourcing Cell Based Potency Assays: Perspectives from a Sponsor and a Contract Testing Laboratory Nov 15/12
LifeSciences LifeSciences/SupplyChain - The purpose of this webinar is to discuss recent changes in regulatory requirements and their impact on the clinical supply chain, including the QP release process, considerations when using comparators, and cold chain/temperature sensitive materials
Speaker: Ronnie Constable, Director of Quality, Fisher Clinical Services
The Changing Role of the QP and Regulatory Challenges That Impact the Clinical Supply Chain Nov 14/12
LifeSciences LifeSciences This webinar discusses evolution and the current landscape of pediatric clinical research networks, selecting and engaging with the right network for your pediatric trial, and enhancing your pediatric clinical research process while fostering high-quality, ethical research on medicines for use in children
Speakers: Brian Smith, MD, MPH, MHS, Associate Professor of Pediatrics, Duke University Medical Center, Duke Clinical Research Institute
Peter Clayton, BSc, MB, ChB, MD, MRCP, FRCPCH, Professor of Child Health, Director NIHR Greater Manchester, Lancashire & South Cumbria (GMLC) Medicines for Children Local Research Network, Associate Director, Greater Manchester Comprehensive Local Research Network
Moderator: Kathy Bohannon, Principal Strategist, Pediatrics, INC Research
The Role of Research Networks in Pediatric Clinical Trials Nov 13/12
LifeSciences LifeSciences - In this webinar we will present and discuss some tools that Emerald Bio uses for the expression and crystallization of membrane proteins
Speaker: James Fairman, Ph.D., Group Leader, Membrane Protein Crystallography, Emerald Bio
Tools for the Expression and Crystallization of Membrane Proteins Nov 12/12
LifeSciences LifeSciences - Post Ap­proval Clinical and Epidemio­logical Studies (PACES) that in­clude Phase IV and Post Mar­keting Observational Studies (PMOS) have evolved into an integral and essential phase of the drug develop­ment life cycle with implications that have comparable weight to that of the Phase II and III registrational studies. Join Dr. John Sampalis for a live discussion.
Speaker: John S. Sampalis, B.Sc., B.A. (Hon.), M.Sc., Ph.D., F.A.C.E., Founder, CEO and Chief Scientific Officer, JSS Medical Research Inc.
Post Approval Clinical Epidemiological Studies (PACES) Nov 12/12
LifeSciences Life Sciences - In this final webinar of our series, we will look at (i) when we should start preparing for database lock, (ii) what can/will go wrong, (iii) how we can minimize/correct issues and (iv) what checklists everyone should have in their repertoire to ensure success.
Speakers: St. Clare Chung, Director - Biostatistics & CDM, SCiAN Services Inc.
Ann Neale, VP Clinical Operations, Biotie Therapies, Inc.
Advanced EDC Trials: The Homestretch – Don’t Let the Timelines Slip Nov 9/12
LifeSciences Life Sciences/Business Straregy - Our speaker will discuss the enormous value and practical considerations of including Russia in your global clinical study planning from the outset, and at a minimum, in your risk management and contingency planning
Speakers: Richard Koenig, Vice President of Operations, ClinStar,
Alina Tatarenko, MD, Senior Project Manager, ClinStar
Including Russia and Ukraine in Your Risk Management and Rescue Study Plans Nov 8/12
LifeSciences Life Sciences/Supply Chain - During this webinar, you’ll get practical guidance from CMC experts on a stepwise approach to determining if, what type, and how much extractables/leachables data may be required to address the regulatory concerns
Speakers: Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories
Ken M. Wong, M.Sc., Senior Scientist, Center for Extractables and Leachables, Merck & Co.
Supply Chain Changes in Phase III/Post-Commercialization: Regulatory Considerations for Container/Closure Systems Nov 6/12
LifeSciences Life Sciences - This webinar will focus on the key aspects of monitoring for the development of renal toxicities and the issues in conducting clinical trials in patients with both recognized and unrecognized kidney disease
Speaker: Lynda Szczech, MD, MSCE, FASN, FNKF, Medical Director, Pharmacovigilance, PPD, LLC
Kidney Safety in Clinical Trial Design: Recognizing the Complexities and Avoiding the Pitfalls Nov 2/12
LifeSciences Life Sciences - Our speakers will discuss how to develop and implement a true partnership through an FSP outsourcing model – characterized by long term goals, integration of operations and leadership and optimized delivery based on portfolio transparency, dedicated resourcing, INC’s Trusted Process and innovation in process and technology.
Speakers: Andrew S. Townshend, Vice President of Alliance Development, INC Research
Peter Carberry, Senior VP, Global Development Operations, Astellas Pharma Global Development Inc.
Strategic Alliance Partnerships: Development of a Successful FSP Relationship Oct 24/12
LifeSciences Life Sciences - This webinar will discuss a number of methodologies to facilitate the assessment of potential development risks including safety and immunogenicity, stability, aggregation and low productivity
Speaker: Noel Smith, Ph.D., Senior Scientist, Lonza Applied Protein Services, Lonza Biologics plc
Developability: Reducing the Risk of Failure of Biotherapeutic Candidates Oct 23/12
LifeSciences Life Sciences - This webinar will provide insight into the various regulations which direct pediatric diabetes drug development for registration globally
Speakers: Cynthia Jackson, DO, Leader, Pediatric Center of Excellence, Quintiles
Paul Strumph, MD, Leader, Diabetes Center of Excellence, Quintiles
Robin Huff, PhD, Sr. Director, Global Pediatric Regulatory Strategy Lead, Quintiles
Moderator: Rick Turner, PhD, Sr. Scientific Director, Corporate Communications, Quintiles
DIABETES DRUG DEVELOPMENT: A Perspective on Pediatric Indication Planning Oct 19/12
LifeSciences Life Sciences - This webinar presents an overview of some of the key components involved in developing products related to the application of biomarkers earlier in the drug development pipeline
Speakers: Tim Davison , B. Math, Ph.D., VP, Bioinformatics and Biostatistics, Almac Diagnostics
Susan Farragher, Operations Manager, Almac Diagnostics
Developing and Applying Biomarkers in Early Phase Clinical Trials

Oct 18/12

LifeSciences LifeSciences - The webinar will examine operational and analytical considerations for early detection of potential organ toxicity
Speakers from ACM Global Central Laboratory:
Mark Engelhart, Chief Commercial Officer
Andrew Botham, PhD, Research & Development Manager
Maria-Magdalena Patru, MD, PhD, Scientific Affairs Medical Liaison
Drug-Induced Organ Toxicity (DIOT): The Early Detection and Management of Elevated Biomarkers to Ensure Patient Safety Oct 17/12
LifeSciences Life Sciences - The speakers will provide a definition of RBM, insight into the regulatory landscape, and a perspective on executing RBM leveraging the three elements of people, process and technology
Speakers: Thomas Grundstrom, Vice President, Integrated Processes and Technologies and Global Head, Quintiles Infosario®
Amanda Sax, Senior Director, Integrated Processes and Technologies, Quintiles
Risk-based Approach to Monitoring: The Future Roles of People, Process & Technology Oct 15/12
LifeSciences Life Sciences - This webinar is part of a series about innovative approaches and specialized techniques to bioanalytical studies
Speaker: Brigitte Pellerin, Senior Bioanalytical Project Manager, PharmaNet/i3
Reduce Filing Time - Fast Turnaround of Innovator and BE First-to-File Analysis Oct 15/12
LifeSciences LifeSciences/Business Strategy - This second webinar in the series will examine the the advantages and disadvantages of conducting clinical trials in Russia and Kazakhstan, and the upcoming trends in this market
Speakers: Igor Stefanov, Director, General Manager, Synergy Research Group
Anna Ravdel, Director of Business Development, Synergy Research Group
Evgeny (Eugene) Rogov, MD, PhD, JD, Deputy Head of Clinical Trials State Control Department (ROSZDRAVNADZOR)
WEBINAR SERIES: Conducting Clinical Trials in Emerging Markets
Part 2 - Conducting Cinical Trials in Russia and Kazakhstan
Oct 12/12
LifeSciences Life Sciences/Supply Chain - During this webinar, you’ll get practical guidance from CMC experts on how to avoid the most common development hiccups and E&L pitfalls related to container/closure selection and regulatory requirements
Speakers: Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories
Allan R. Moorman, Ph.D., President and Chief Operating Officer, Alta Vetta Pharmaceutical Consulting
You Have Received Extractables Information From Your Container/Closure Manufacturer. Now What? Oct 10/12
LifeSciences Life Sciences - This webinar will present rationale for a dedicated study start-up process which lends to a decrease in cycle times, higher quality pre-study site assessments, and improved study start up metrics
Speakers: Brett Barber, Senior Director, Strategic Sourcing, PharmaNet/i3
Nicole Baker, Director, Strategic Resourcing, PharmaNet/i3
Lisa Rhiner, Clinical Study Lead, PharmaNet/i3
Innovative Solutions Designed to Improve Operational Capacity, Efficiency, and Effectiveness in Clinical Monitoring Oct 4/12
LifeSciences LifeSciences - This webinar will provide a review of current adnexal mass management practices, including improvements in patient care with the addition of recently cleared blood tests, and the criteria necessary for utility of blood tests when used to identify potential ovarian malignancy
Speaker: Michael D. Randell, MD, FACOG, Department of Obstetrics and Gynecology, Northside Hospital, Atlanta, Georgia
OVA1 & Managing Adnexal Masses Oct 2/12
LifeSciences Life Sciences - Our speakers will provide insight into primary cost drivers and explore key activities that can help make the biggest impact to improving profitability, as well as discuss strategies for outsourcing, as well as example process and technology approaches to improve efficiency and governance
Speaker Panel from Quintiles: Geoff Garabedian, VP and Managing Director - Regulatory & Quality and Horizontal Capabilities
Peter Lassoff, Pharm.D., Vice President and Head, Global Regulatory Affairs
Uwe Maennl, MD, Ph.D., MBA, Vice President and Global Head of Lifecycle Safety
Regulatory & Safety Operations: Unlocking Additional Value of Your Marketed Products Sep 28/12
LifeSciences Life Sciences/Business Strategy - An examination of why Asia-Pac excels as a region for strategic clinical data management / medical writing base in which to achieve savings in cost and time investment
Speakers: Koteshwar Govind, Head of Data Management, Max Neeman International
Donald Swankie, MBA, Vice President, USA, Max Neeman International
Global Data Management & Medical Writing: The Asia-Pac Advantage

Sep 26/12

LifeSciences Life Sciences - This presentation addresses the challenges of analytical method development that is required for physicochemical characterization
Speakers: Robert J. Duff, Ph.D., manager, Biopharmaceutical Services, Lancaster Laboratories
Lieza M. Danan-Leon, Ph.D., principal scientist, Biochemistry, Lancaster Laboratories
Critical Aspects of Antibody-Drug Conjugates: Structural Characterization and Analysis Sep 25/12
LifeSciences Life Sciences - This webinar will provide best practice insights into dose selection for First in Human (FIH) dose escalation studies to mitigate risk and optimize the value of your early clinical data
Speaker Panel from Quintiles: Eleanor A. Lisbon MD, MPH, CPI, Senior Medical Research Director, Early Clinical Development
Professor Tim Mant, Vice President, Medical Research and Principal Investigator
Steve Lowes, PhD, Vice President, Scientific, Advion Bioanalytical Labs
N. Seth Berry, PharmD, Director, Clinical PK/PD and Modeling & Simulation
EARLY CLINICAL INSIGHTS: Best Practices for Optimizing Dose Escalation in FIH Studies Sep 24/12
LifeSciences Life Sciences - In this webinar, case studies will be presented to demonstrate how advanced immune monitoring tools have been used to gain insight on the proportion of major lymphocyte subsets, their response to various stimuli and their activation versus exhaustion status.
Speaker: Yoav Peretz Ph.D., Principal Scientist, Caprion/IMMUNECARTA Services
PD-1 and the Immune Exhaustion Paradigm: Immune Profiling tools for Drug Discovery and Clinical Monitoring Sep 20/12
LifeSciences Life Sciences - This webinar will encompass key spray-dried dispersion (SDD) aspects that enhance and sustain in vivo drug solubility, and how these attributes are preserved during downstream solid dosage form formulation and process development
Speakers: Randy Wald, R.Ph., Senior Research Fellow, Bend Research Inc.
Chris Craig, Research Fellow, Bend Research Inc.
Using Amorphous Spray-Dried Dispersions to Develop Oral Solid Dosage Forms Sep 19/12
LifeSciences Life Sciences - This webinar is part of a series about innovative approaches and specialized techniques to bioanalytical studies
Speaker: Chris Beaver, Director, Immunochemistry and Cell Biology Operations, PharmaNet/i3
Immunogenicity Testing Considerations for Biosimilar Drug Development Sep 17/12
LifeSciences Life Sciences/BusinessStrategy - The presentation give an overview of the advantages of conducting clinical trials in emerging markets, an analysis of the importance of start-up timelines in the decision-making process when selecting geographies for a global clinical trial, and a review of the regulatory challenges that can be anticipated when starting up a trial in Russia
Speakers: Leon Dzivinsky, Senior Vice President & General Counsel, ClinStar, LLC / IMP Logistics
Richard Koenig, Vice President of Operations, ClinStar
Study Start-up: A Comparison Across Emerging Markets Sep 13/12
LifeSciences LifeSciences - A discussion of the  fundamental principles of preclinical modeling in cancer and the specific roles that imaging can play in improving the predictive power for clinical success, formulating a new standard for drug development, with particular reference to gliomas as case studies
Speakers: Jim Dougherty, MD, General Partner, Arcus Ventures, and former Deputy Physician-in Chief for Clinical Affairs a Memorial Sloan-Kettering Cancer Center (MSKCC)
Dick Leopold, PhD, VP, R&D, Molecular Imaging Inc.
John L. Chunta, PhD, Senior Imaging Scientist, Molecular Imaging Inc.
Driving Translational Imaging to a Drug Industry Standard: Case Studies in Glioblastoma and Other Clinically Predictive Cancer Models Sep 12/12
LifeSciences LifeSciences - The session will address key regulatory expectations and the role of ethics committees in pediatric development
Speakers: Daniel Brasseur, MD, PhD, Chairman of the EU Paediatric Committee (PDCO)
Petra B. Knupfer, MD, MBA, Managing Director of the Ethics Committee, Medical Association of Baden-Württemberg, Germany
Moderator: Kathy Bohannon, Principal Strategist, Pediatrics, INC Research
Regulatory Authorities and Ethics Committees: Perspectives from Europe for Pediatric Drug Development Sep 11/12
LifeSciences Life Sciences - In this 3rd of 4 webinars, we look at the impact of one or more protocol amendment(s) on the study database and the EDC team and how changes can be implemented smoothly and with minimal effect on the ongoing study
Speaker: St. Clare Chung, Director - Biostatistics & CDM, SCiAN Services Inc.
Advanced EDC Trials: The Team is Working Together, Now Get Ready for Change Sep 10/12
LifeSciences Life Sciences - Although the Guidance remains in draft form, it is clear that the key elements of the Final Guidance will likely be retained. Some sponsors and CROs have already begun to adopt a risk-based approach, but the key questions around operationalizing the Guidance and its implications to all drug development stakeholders remain. The discussion will include perceptions from the legal and regulatory perspective, recent initiatives at the highest levels to integrate a risk-based approach to clinical trial monitoring, and practical implementation aspects of risk based monitoring.
Speakers: - Mr. Gary Yingling, BS, MS, JD, Partner, K&L Gates, Washington DC
- Nicholas Alp, PhD, BM BCh, FRCP, DM, Vice President, Scientific Council, ICON plc, and Hon. Consultant Cardiologist, Oxford University Hospitals NHS Trust
- Anick Duchesne, BSc, DSA, Senior Director, CRA Management - North America, ICON plc
A Risk-Based Approach to Monitoring - Implications for Sponsors, CROs, Investigators and IRBs — AN UPDATE Sep 6/12
LifeSciences Life Sciences - Learn about a new transformative proteomic biomarker discovery technology that measures over 1129 human proteins in small sample volumes with a sensitive, specific and semi-automated assay
Speakers: Steve Williams, M.D., Chief Medical Officer, SomaLogic
Nick Saccomano, Ph.D., Chief Technology Officer, SomaLogic
Unlocking Protein Biomarker Discovery for Pharma, Biotech and Academia Aug 23/12
Healthcare Healthcare/Supply Chain/RFID - This presentation will discuss best practices in laboratory automation and the benefits of RFID for laboratory inventory management
Speaker: Tim Sheehy, Global Director of Genomics, Promega Corporation
Best Practices in Laboratory Automation Aug 16/12
LifeSciences Life Sciences - This presentation will focus on Orbis Biosciences’ patented Precision Particle Fabrication technology and its ability to develop novel oral formulations of both new and existing drugs
Speaker: Cory Berkland, PhD, Chief Scientific Officer, Orbis Biosciences, Inc.
Improving Oral Dosage Formulations: Microencapsulation for Controlled and Immediate Release Jul 24/12
LifeSciences Life Sciences - This webinar will discuss the Covance LC-MS based in vivo target occupancy capabilities and discuss the advantages of using this approach in a preclinical drug discovery arena
Speakers: Patrick L. Love, B.S., Staff Scientist and Supervisor, Receptor Occupancy/In Vivo Pharmacology, Discovery and Translational Services, Covance
Sally Old, Ph.D., Site Leader, Alnwick, Covance
John Batchelor, M.Sc., Head of Toxicology, Alnwick, Covance
Determining Target Occupancy using LC-MS: Advantages and Application to a Preclinical Drug Discovery Paradigm Jun 28/12
LifeSciences Life Sciences - No single strain or vector is capable of being the best expression option for all types of biopharmaceuticals. Case studies will be presented on use of the XS tool box to address common problems such as low productivity, product-related impurities, insolubility, plasmid and host instability.
Speaker: Dr. Joachim Klein, Group Leader, Microbial R&D, Lonza Biopharmaceuticals, Switzerland
Using the XS Toolbox to Optimize Strain Design and Development for Efficient Microbial GMP Production Jun 27/12
LifeSciences Life Sciences - This webinar will review models available for assessing anti-inflammatory activity in vivo then focus on imaging technologies, for discovery screening and for translatable biomarkers as applied in inflammation models
Speakers: James Mobley, Ph.D., Founder and CSO, Sunapten Therapeutics, Inc.
Patrick McConville, Ph.D., COO, CSO and Co-founder, Molecular Imaging Inc.
Advances in Inflammation Models and Associated Drug Evaluation: Improved Assessment Using Imaging Biomarkers Jun 26/12
LifeSciences Life Sciences - In this 2nd of 4 webinars, the speakers highlight the typical problems associated with the initial stage and present several tips and solutions to addressing them at the start, while showing how technology can play an integral part in coordination, control and communication
Speakers: St. Clare Chung, Director - Biostatistics & CDM, SCiAN Services Inc.
Ann Neale, VP Clinical Operations, Biotie Therapies, Inc.
Advanced EDC Trials: Bringing the Team Together Jun 8/12
LifeSciences Life Sciences - This webinar will discuss compounding at the clinic’s pharmacy as a means to accelerate development and minimize CMC development resources
Speakers: William Schachtner, associate director, small molecule and inhalation product testing services, cGMP laboratory, PPD
Eugene McNally, Ph.D., executive director, global CM&C, global regulatory affairs, PPD
Webinar Series: Innovative Analytical Approaches to Expedite Product Development
Part 4: Accelerating to Phase I Clinical Trials for All Dosage Forms
Jun 7/12
LifeSciences Life Sciences - Learn how Caprion accelerates validation of biomarkers, diagnostics, and toxicology profiles using MRM technology. A variety of sample types and applications will be covered, including plasma proteins, immune response, toxicology, and tissue-specific panels
Speaker: Daniel Chelsky, Chief Scientific Officer, Caprion Proteomics
New Solutions for Highly Multiplexed Protein Assays via MRM Jun 4/12
LifeSciences Life Sciences - In this 1st of 4 webinars, the speakers will provide insight into the unique needs of Biotech/Biopharma companies from both the Sponsor and Technology/Services providers (CROs) perspectives. Subsequent webinars will focus on case studies, specific challenges and solutions.
Speakers: St. Clare Chung, Director - Biostatistics & CDM, SCiAN Services Inc.
Ann Neale, VP Clinical Operations, Biotie Therapies, Inc.
Advanced EDC Trials: The Unique Needs of Biotech/Biopharma May 30/12
LifeSciences Life Sciences - This presentation will discuss a unique system called Isolation Liquid Chromatography with Mass Spectrometry (Iso-LCMS), a two-dimensional HPLC system coupled to MS that allows for one-step mass analysis of peaks in MS-incompatible mobile phases
Speaker: David J. Sherlock, Senior Research Scientist, cGMP Laboratory, PPD
Webinar Series: Innovative Analytical Approaches to Expedite Product Development
Part 3: Impurity Identification Using Two Dimensional LCMS
May 24/12
LifeSciences Life Sciences - This webinar will further explore the challenges that we face in the industry today due to the globalization of clinical trials and the increased penetration of less developed countries
Speaker: Rognvald Lamb, Distribution & Logistics, Fisher Clinical Services
Evaluating Challenges with Clinical Trial Supply Logistics in the Less Developed World May 22/12
LifeSciences LifeSciences/BusinessStrategy - The speakers will discuss the benefits of conducting clinical trials in Russia and parts of Eastern Europe compared to other emerging markets, address many of the questions and concerns Sponsors have about logistics, and introduce five keys to successfully managing clinical trial logistics in this region
Speakers: David Passov, CEO, ClinStar
Leon Dzivinsky, Senior Vice President & General Counsel, ClinStar, LLC / IMP Logistics
5 Keys to Successful Clinical Trial Logistics in Russia, Ukraine and Belarus May 17/12
LifeSciences LifeSciences - This presentation will include a brief background on the development & validation of Vectra DA delivered by Dr. David Chernoff, followed by a patient case study discussion led by Dr. Alvin Wells highlighting the application of Vectra DA in clinical practice
Speakers: Alvin Wells, MD, PhD, Director, Rheumatology and Immunotherapy Center
David Chernoff, MD, Chief Medical Officer, Crescendo Bioscience®, Inc.
Clinical Applications of Vectra™ DA, a Multi-Biomarker Blood Test for Rheumatoid Arthritis Disease Activity May 15/12
LifeSciences LifeSciences - Learn types of analytical methods requiring verification, what is required to demonstrate that methods can be run successfully in a laboratory, actions to take when method is found not suitable for intended purpose, approaches for qualification for non-compendial products, and how to track performance of execution of standard compendia methods with the laboratory
Speakers: Pauline McGregor, Ph.D., CChem, MRSC, PMcG Consulting
Travis Emig, Director, Pharmaceutical Chemistry, Lancaster Laboratories
Kimberly Rhoades, Manager, Pharmaceutical Raw Materials, Lancaster Laboratories
Terry Schuck, Principal Chemist/Group Leader, Pharmaceutical Raw Materials, Lancaster Laboratories
Efficient and Effective Approaches to Managing Raw Material Methods May 15/12
LifeSciences

Life Sciences - This presentation will address: the importance of E&L for patient and product safety, a well-planned and thorough E&L study design for the entire drug development and manufacturing process, and the types of E&L evaluations that are being performed for dosage forms other than just orally-inhaled and nasal products and which will help prevent delays in regulatory approvals
Speakers: Derek Wood, laboratory manager, cGMP laboratory, PPD
Istvan Kovac, Ph.D., senior research scientist, cGMP laboratory, PPD
Contributor: Xiaochun Yu, Ph.D., principal scientist, cGMP laboratory, PPD

Webinar Series: Innovative Analytical Approaches to Expedite Product Development
Part 2: Timely and Thorough Extractables/Leachables Evaluations to Expedite Regulatory Approval
May 10/12
BusinessStrategy Life Sciences/Business Strategy - This program will analyze the basis of India’s Regulatory environment, the regulations [both current and future] of clinical trials in India, and the challenges faced in the present scenario
Speakers from Max Neeman International: Renu Razdan, PhD, Chief Operating Officer
Vandana Pandey, Manager Regulatory Affairs
Clinical Research in India – Regulatory Environment May 9/12
LifeSciences

Life Sciences - This presentation will outline important aspects of the spray-drying process and highlight formulation and process parameters that dictate a scalable, stable, and efficacious inhalable drug product
Speakers: Jeff Breit, Ph.D., Director of Inhalation Technologies, Bend Research Inc.
Devon DuBose, Senior Research Engineer, Bend Research Inc.

Engineered Particles for Inhaled Biotherapeutics: Considerations in Process and Formulation May 3/12
LifeSciences

Life Sciences - The panel, representing both big pharma, and small biotech, and will speak from deep experience about the likely intended and unintended consequences of the new guidance
Speakers: Jack Corman, President, IRB SERVICES
Nestor Nituch, Director Clinical Research, Bristol-Myers Squibb Canada (retired)
Terri Hinkley, RN, BScN, MBA, CCRC, Director, Clinical Operations, Helix BioPharma
Ronald Fehst, President, Ronald Fehst Research Consultants

New FDA Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring - Implications for Sponsors, CROs, Investigators and IRBs May 1/12
LifeSciences

Life Sciences - This presentation will address strategies and the analytical testing considerations that help speed the process for getting a follow-on biological product to market
Speakers: William Bakewell, Ph.D., associate director, biopharmaceutical services PPD, cGMP laboratory
Steven Becht, Ph.D., research and development senior research scientist PPD, cGMP laboratory

Webinar Series: Innovative Analytical Approaches to Expedite Product Development
Part 1: Strategies to Speed Follow-on Biologicals to Market
Apr 26/12
LifeSciences LifeSciences - This webinar will address advances in the development of drugs to treat respiratory diseases with a focus on new technologies that enrich data collected early in clinical research
Speakers: J. Fred Pritchard, PhD, Vice President, Global Drug Development, Celerion
Professor J. Stuart Elborn, MD, FRCP, Professor of Respiratory Medicine, Queen's University of Belfast
Stephen Smith, MB BCh BAO, MRCGP, Diploma Pharmaceutical Medicine, Principal Investigator, Celerion
Discerning Early Clinical Signals of Efficacy for Treating Respiratory Diseases Apr 24/12
LifeSciences LifeSciences - The presentation will focus on how sponsors evaluate bids from CROs and provide you with some practical tips on how to improve your proposals
Speaker: Leif Kjetil Skjæveland, Partner, Xait
CROs/CMOs – How Does a Sponsor Evaluate Your Bid? Apr 17/12
LifeSciences LifeSciences - Case studies will be presented to illustrate the unique benefits of Tandem Labs targeted proteomics service, as well as the unique challenges associated with the technique, the role of bioinformatics, and optimization of sample preparation
Speaker: Bob Xiong, Ph.D., Associate Lab Director, Tandem Labs
Targeted Bioanalytical Proteomics by LC-MS/MS Apr 11/12
LifeSciences

Life Sciences - This webinar will provide insight into the latest scientific and regulatory thinking around the use of early-phase QT data and concentration QT modeling as a predictor of cardiac risk, ultimately improving decisions about further development and future study design
Speakers: Dhiraj Narula, MD, MRCP UK, DM Card, FACC, FISE, Medical Director, Quintiles Cardiac Safety Services
J. Rick Turner, PhD, Senior Director, Quintiles Integrated & Translational Cardiovascular Safety
Jared Schettler, MS, Associate Director, Quintiles Phase I Biostatistics

EARLY CLINICAL INSIGHTS: The Case for Early Cardiac Safety Data & Modeling Apr 10/12
LifeSciences Life Sciences - This webinar will examine the new EU legislation and its impact on the pharmacovigilance practice of regulators and the pharmaceutical industry in years 2012-2016
Speaker: Jan Petracek, MD, MSc, DIC, Partner, CEO, PharmInvent
EU Pharmacovigilance Change Readiness 2012 Apr 4/12
BusinessStrategy Life Sciences/Business Strategy - This program will analyze the basis of India’s Regulatory environment, the regulations [both current and future] of clinical trials in India, and the challenges faced in the present scenario
Speakers from Max Neeman International: Renu Razdan, PhD, Chief Operating Officer
Vandana Pandey, Manager Regulatory Affairs
Donald Swankie, MBA, Vice President, USA
Asia-Pac Clinical Research – Regulatory Environment Mar 28/12
LifeSciences LifeSciences - This in-depth webinar will focus on current global trends in sample management
Moderator: Pinar Gencturk, Managing Editor, 20/20 Pharma
Speakers: Steve Sweeney, Head of Clinical Technologies, Southern Infinity Pharmaceuticals, Inc.
Cathy Michael, Senior Director - Comprehensive Solutions, Biostorage Technologies, Inc.
Comprehensive Sample Management: Leveraging an Onsite Model to Maximize Research and Minimize Costs Mar 22/12
LifeSciences LifeSciences - This presentation will address current strategies for evaluating and mitigating the risk of contamination by adventitious agents
Speakers: Jeri Ann Boose, Ph.D., Director, Biopharmaceutical Services, Lancaster Laboratories
Hans Katherine Bergmann, Ph.D., Manager, Viral Safety and Viral Clearance Services, Lancaster Laboratories
Yuling Li, Ph.D., fellow, BioPharmaceutical Development, MedImmune
Risk Management of Adventitious Agent Contamination in Biopharmaceutical Products Mar 21/12
LifeSciences Life Sciences/Healthcare - This webinar will provide an overview of simulation modeling and how it can be used to improve clinical development efforts, including enhancing choice of target population, powering, and operational feasibility, as well as understanding performance in real-world settings
Speaker: Badri Rengarajan, MD, Medical Director, Archimedes Inc.
Simulation Modeling for Optimizing Design of Clinical Trials and Registries Mar 20/12
LifeSciences LifeSciences - This webinar will address the key elements of early biosimilar development that provide the bridge between the manufactured product and the larger clinical studies needed to prove comparable efficacy and safety
Speakers: J. Fred Pritchard, PhD, Vice President, Global Drug Development, Celerion
Raymond Farmen, PhD, Vice President, Global Bioanalytical Services, Celerion
Michael E. Placke, PhD, DABT, Senior Vice President and General Manager, Ricerca Biosciences

Challenges in Early Comparability Assessment of Biosimilars
Mar 20/12
LifeSciences LifeSciences/Business Straregy - This first webinar in the series will examine the the advantages and disadvantages of conducting clinical trials in Russia, the clinical studies cycle, regulatory environment, and impact of the new Drug Law in Russia on the clinical trials
Speakers: Igor Stefanov, Director, General Manager, Synergy Research Group
Anna Ravdel, Director of Business Development, Synergy Research Group
Evgeny (Eugene) Rogov, MD, PhD, JD, Deputy Head of Clinical Trials State Control Department (ROSZDRAVNADZOR)
WEBINAR SERIES: Conducting Clinical Trials in Emerging Markets
Part 1 - Russia: Understanding the Regulatory Environment, Challenges & Benefits
Mar 13/12
LifeSciences LifeSciences - Our speakers will discuss interventional observational studies, including different types of data that can be collected, different country regulations and approval processes, and setting up and running international real-world observational studies
Speakers: Dr. William Maier, Chief Scientific Offier & VP Epidemiology, Drug Safety and Risk Management, Registrat-Mapi
Dr. Carl de Moor, Vice President Epidemiology, North America, Registrat-Mapi
Sarah Rosen, Global Project Director, Registrat-Mapi
International Real World Post-marketing Studies that Involve Patient Intervention Mar 12/12
LifeSciences LifeSciences - The purpose of this presentation is to discuss how DART capabilities have been introduced into an established toxicology laboratory at Southern Research, in compliance with Good Laboratory Practices (GLP)
Speakers: Stephen B. Harris, Ph.D., Fellow, ATS, President, Stephen B. Harris Group
Eve Mylchreest, Ph.D., Program Leader, Developmental and Reproductive Toxicology (DART), Southern Research
Kellye K. Daniels, Ph.D., D.A.B.T., Director, Toxicology and Pathology Services Department, Southern Research
Successful Introduction of GLP-compliant Reproductive Toxicology Programs Feb 28/12
LifeSciences LifeSciences - The speaker panel will discuss key elements for clinical research in pediatric patients from the point of view of the research site and the investigator
Speakers: Ginger Steinhilber RN.MS. CCRC, Clinical Research Manager, Children’s Hospital of Michigan and Wayne State University
John van den Anker, MD, Vice Chair of Pediatrics for Experimental Therapeutics and Director of Pediatric Clinical Pharmacology at Children’s National Medical Center (Washington, DC)
Moderator: Kathy Bohannon, Principal Strategist, Pediatrics, INC Research
Perspectives on Pediatric Trials from Investigative Sites Feb 14/12
LifeSciences LifeSciences - In this presentation, the principles of applying the melt extrusion technology in the development of high-energy materials and solid dispersion systems will be discussed, along with some of the issues in the successful development of melt-extruded products. Strategies to overcome such issues will be presented by using case histories.
Speakers: Abu T. M. Serajuddin, Ph.D., Professor, Dept of Pharmaceutical Sciences, College of Pharmacy & Allied Health Professions, St. John's University
Hans Maeir, Head Formulation Scientist, Catalent Pharma Solutions
Michael Valazza, Catalent Pharma Solutions
Irena McGuffy, Manager, Softgel Formulation, Catalent Pharma Solutions
Applied Drug Delivery: Hot Melt Extrusion and Optidose Technology Feb 8/12
LifeSciences LifeSciences - The presentation will include an overview of the FDA’s Animal Rule followed by an example end-user case study
Speakers: Peter Silvera, Ph.D., Program Leader for the Animal Models and Vaccine Program, Southern Research
Michael G. Murray, Ph.D., Director, Department of Infectious Disease, Southern Research
The FDA Animal Rule – Successful Submission of Animal Efficacy Studies Feb 7/12
LifeSciences LifeSciences - Topics include a discussion of different models available to commercialisation, IVD and Regulated Laboratory Developed Test (LDT), scalable commercialization pathways, and strategies to reduce CDx development timelines by up to 12 months. Recent case studies with FDA submissions will also be cited to demonstrate a different approach.
Speaker: Alan Wookey, Executive Director, Companion Diagnostics, LabCorp
Companion Diagnostics (CDx): Accelerating the Path to Commercialization Feb 1/12
LifeSciences LifeSciences - This webinar will explore the challenges in clinical supply chain strategy and discuss how to develop the appropriate risk profile
Speaker: Jim Benkendorf, General Manager, Fisher Clinical Services
Optimizing Clinical Supplies When Facing Drug and Resource Constraints Jan 30/12
LifeSciences LifeSciences/Business Strategy - Learn how to effectively navigate the challenges of conducting clinical trials in Russia and parts of Eastern Europe (EE) and successfully include these emerging markets in rescue trials and as an integral part of your initial study plans
Speaker: David Passov, CEO, ClinStar
Include Russia and Eastern Europe for Successful Clinical Trials Jan 24/12
LifeSciences LifeSciences - An examination of the complex process of translating biomarkers into clinically applicable tests and their use in clinical trials
Speakers: Dr. Peter Kerr, Product Development Team Manager, Almac
Dr. Stephen Moore, Product Development Team Manager, Almac
Translating Pre-clinical Markers to Validated Assays and Their Application to Clinical Trials for the Pharma Industry Jan 19/12
LifeSciences LifeSciences - The aim of this webinar is to present an overview of molecular imaging technologies, including the multiple imaging modalities and radiotracers available. Examples of preclinical imaging studies will be applied to illustrate how molecular imaging can advance preclinical drug discovery and development.
Speakers: Stephen Lokitz, Ph.D., Medical Physicist, PET Imaging Center, Biomedical Research Foundation of Northwest Louisiana
J. Michael Mathis, Ph.D., Professor and Director, Small Animal Imaging Facility, LSU Health Sciences Center
Novel Uses of In Vivo Molecular Imaging in Pre-clinical Drug Development Dec 13/11
LifeSciences LifeSciences - This presentation will, through the use of actual illustrations, demonstrate some of the pitfalls encountered in early phase pediatric clinical pharmacology studies and by doing so, provide direction on how they might be avoided in the design and conduct of future studies
Speakers: Gregory L. Kearns, PharmD, PhD, Marion Merrell Dow/ Missouri Chair in Pediatric Medial Research
Dr. Alexander Cvetkovich Muntañola, Senior Director Clinical Development, INC Research
Pediatric Clinical Trials - Lessons Learned the Hard Way Dec 13/11
LifeSciences LifeSciences - This webinar will consider recent proposed changes to the regulatory and legislative environment and efforts to better define the roles of the IRB and the investigator in effectively carrying out their responsibilities
Speakers: Greg Koski, PhD, MD, Senior Scientist, James Mongan Institute for Health Policy, Associate Professor of Anesthesia, Harvard Medical School, Associate Editor, Journal for Empirical Research on Human Research Ethics
Jack Corman, B.Sc, B.Ed, President and Founder, Institutional Review Board Services
Human Research Subject Protection: A Time of Reflection, Renewal and Reform? No--It's Time to Redesign! Dec 12/11
LifeSciences LifeSciences - A discussion of how an integrated drug development perspective will allow biopharmaceutical developers to bring biosimilars to market quickly
Speakers: Tom Fritz, Managing Partner, Swiftwater Group LLC
Tom Stover, Ph.D., Associate Principal, Swiftwater Group LLC
Developing Biosimilars in the US – The Dawn of a New Era? Nov 16/11
LifeSciences LifeSciences/Manufacturing - Topics include evaluating CTCs as prognostic and predictive tools, obtaining extensive biomarker data without invasive procedures, and personalized therapy based upon CTC molecular pathology
Speaker: Ken Pennline, PhD, Vice President and Global Head, Cytometry Services, Esoterix Clinical Trials Services, a Division of LabCorp
Circulating Tumor Cells as a Biomarker Approach in Oncology Nov 9/11
LifeSciences LifeSciences - Advice on how to create insightful and innovative pediatric strategies that meet the stringent regulatory requirements from the FDA and EMA of pediatric plans for new active ingredients, dosage forms, dosing regimens or routes of administration
Speakers: Dr. med. Klaus Rose, MD, MS, Managing Director, klausrose Consulting
William Sietsema, PhD, Vice President, Regulatory Consulting & Submissions, INC Research
Navigating Pediatric Regulations in the United States and European Union Nov 8/11
LifeSciences LifeSciences - The goals of this presentation are to provide clarity on the rationale for this proposed change to the federal regulations; to discuss the potential impact on sponsors, CROs, and academic institutions; to dispel some of the myths regarding the independent review board model and to provide a case study of the collaborative relationship between the Duke University and Copernicus Group IRB in the review and conduct of clinical trials
Speakers: Barry Mangum, Pharm.D., FCP, Director Clinical Pharmacology, Duke Clinical Research Unit
Yvonne Higgins, A.B., CIP, Director Quality Management, Copernicus Group IRB
Reducing the Barriers to the Conduct and Oversight of Clinical Trials: A Case Study Oct 18/11
LifeSciences LifeSciences/Business Strategy - This program will provide overview and key lessons in leveraging India as a strategic venue for research, as well as post market approval in a growing economy whose in-country population is 1.3 Billion
Speakers: Ajoy Kumar, MD, Chief Executive Officer, Max Neeman International
Donald Swankie, MBA, Vice President, USA, Max Neeman International
Increase Firm Value thru Commercialization of Cardio Drug & Device in India Oct 12/11
LifeSciences LifeSciences - This webinar will address scientific and practical aspects of formulation selection and process design relative to early- and late-stage pharmaceutical development
Speakers: Dana Settell, Director of Engineering, Late Stage Programs, Bend Research Inc.
Corey Bloom, Director, Formulation Science, Bend Research Inc.
Spray Dried Dispersions: Robust Formulation and Science of Scale from Preclinical to Launch Sep 29/11
LifeSciences LifeSciences - A look at the current status and future of oral Vitamin D3 analogs; main biopharmaceutical, physico-chemical and industrial hurdles to the development of appropriate drug delivery systems; and preferred drug delivery systems for Vit D3 analogs
Speakers: Hector F. DeLuca, Professor Emeritus, Department of Biochemistry, University of Wisconsin-Madison
Julien Meissonnier, Director, Research and Development, Catalent Pharma Solutions
Applied Drug Delivery: Options for Vitamin D Analogs Sep 27/11
LifeSciences LifeSciences - This webinar will discuss the new US REMS guidance and EU-RMP legislation, and what companies need to do in order to prepare for submissions
Speakers: Dr. William Maier, Vice-President, Epidemiology, Drug Safety and Risk Management, Registrat-Mapi
Dr. Carl de Moor, Vice President Epidemiology, North America, Registrat-Mapi
Dr. Paula Thompson, Senior Epidemiologist, Registrat-Mapi
Risk Management of Drug Safety: Pre-Approval Planning and Research will Ensure Success Sep 23/11
SupplyChain Manufacturing/Supply Chain - This session will help you understand supply chain issues surrounding consignment inventory, and offer real world examples of how RFID solutions have helped many organizations take control of their consignment inventory
Speakers:Jason Rosemurgy, Global Sales Director, Terso Solutions, Inc.
Patrick C. McCarthy, Esq., CEO, Validiti LLC
RFID: Removing the Complexity of Managing Consignment Inventory Sep 22/11
LifeSciences LifeSciences - The presentation will focus on how sponsors evaluate bids from CROs and provide you with some practical tips on how to improve your proposals
Speaker: Leif Kjetil Skjæveland, Partner, Xait
CROs/CMOs – How Does a Sponsor Evaluate Your Bid? Sep 19/11
LifeSciences LifeSciences/Manufacturing - This webinar for Clinical Trial Supply professionals,  will help you plan ahead in order to reduce the risk involved in Cold Chain management practices
Speakers: Brian S. Hilton, Product Manager, Almac Clinical Services
Anthony Mistretta, Distribution Manager, Almac Clinical Services
Cold Chain Capabilities – Packaging, Labeling and Distribution Solutions for Your Organization Sep 8/11
LifeSciences LifeSciences - This webinar will discuss dry granulation/roller compaction technologies, including the advantages/disadvantages of dry granulation over wet granulation
Speaker: Theodore S. Koontz, Director Operations, Xcelience
Introduction and Technical Notes for Dry Granulation – Roller Compaction Jun 22/11
LifeSciences LifeSciences/Business Strategy - This program will provide an overview and key lessons in leveraging India as a strategic venue for research as well as post market approval in a country of 1.3 Billion
Speaker panel from Max Neeman International: Ajoy Kumar, MD, CEO, Renu Razdan, COO, and Donald Swankie, MBA, VP, USA
Clinical Research in India – Potential & Challenges Jun 15/11
LifeSciences LifeSciences - The presentation will focus on how sponsors evaluate bids from CROs and provide you with some practical tips on how to improve your proposals
Speaker: Leif Kjetil Skjæveland, Partner, Xait
CROs – How Does a Sponsor Evaluate Your Bid? Jun 9/11
LifeSciences Life Sciences -  This webinar will review the requirements and practical considerations around preparation and parametric release of drug in a pharmacy clean room to be administered intravenously. In addition, the regulatory requirements around validation and quality control of AMS assays will be reviewed.
Speakers: Staci McDonald, PharmD, Senior Director, Scientific Clinical Operations, Celerion
Stuart Best, PhD, Senior Director of Operations, Xceleron
Optimizing Early Clinical Research to Accelerate Drug Development Timelines: Microtracer Studies Jun 8/11
LifeSciences LifeSciences - During this webinar, the speaker will introduce a unique web-based solution for gaining rapid insight into temperature-sensitive shipments in clinical trials
Speaker: Shirley Attryde, Product Manager, STEMS, Almac
Improving Insight and Increasing Control of Temperature-Sensitive Supplies in Clinical Trial Jun 1/11
Healthcare Healthcare/Life Sciences - In this webinar David Eddy, MD. PhD. will demonstrate ARCHeS Innovator, a software as a service (SaaS) that enables researchers and decision makers to use many of the capabilities of the Archimedes Model over the web
Speaker: David M. Eddy, MD, PhD, Founder and Chief Medical Officer Emeritus, Archimedes
DEMO: ARCHeS Innovator May 31/11
LifeSciences LifeSciences - Our speaker panel from Swiftwater Group LLC will discuss what works and what doesn’t in dealing with vendors, whether the vendors are CROs, CMOs, Quality Assurance/Control Consultants, or Bioanalytical vendors
Speakers: Tom Fritz, Managing Partner / Chris Seifarth, Associate Partner / Agnes Cobbum, Associate Principal /William J. Miller, Ph.D., Senior Manager
Managing Vendors: Tips and Tricks for Pharma and Biotech Companies to Get What You Need While Cutting Costs May 18/11
LifeSciences Life Sciences -  Celerion's clinical pharmacology scientists will describe recent trends in adaptive designs, highlight areas where innovative approaches resulted in more robust clinical study results and discuss the challenges sometimes faced with these designs
Speakers: Michelle L. Combs, PhD, Vice President, Clinical Pharmacology Sciences
Elliot Offman, BSc Pharm, MSc, Director, Clinical Pharmacology Sciences
Optimizing Early Clinical Research to Accelerate Drug Development Timelines: Adaptive Study Design May 17/11
Healthcare Healthcare/Life Sciences - In this webinar, David Eddy MD. PhD will provide an detailed overview of Individualized Guidelines, how they compare to traditional population based guidelines, and how their use can improve outcomes and reduce healthcare costs
Speaker: David M. Eddy, MD, PhD, Founder and Chief Medical Officer Emeritus, Archimedes
Individualized Guidelines: The Potential for Increasing Quality and Reducing Costs May 16/11
BusinessStrategy Business Strategy/Life Sciences - Learn why Madrid is the perfect value-adding location for life science companies to face today’s challenges
Speakers: Vicente Hernández, Pharmaceutical Technical Director and Institutional Relations Manager, Lilly S.A.
Cátia Rabaça, Business Development Unit, Parque Científico de Madrid (Madrid Science Park)
Irene Herrera, Life Sciences Manager, Inward Investment Department, PromoMadrid
Partnering with Madrid’s Life Sciences Industry: Investing in Europe May 11/11
LifeSciences LifeSciences - Reduce the reporting burden on sites, sponsors, CROs and review boards while raising the bar on providing real protection of the subjects participating in clinical trials
Speaker: Glenn Veit, JD, CIP, Chairperson, Copernicus Group IRB
Safety Reporting to the Institutional Review Board (IRB): Understanding Recent Guidance May 4/11
LifeSciences Life Sciences -  Panel discussion with Celerion’s experienced physicians describing their approaches and experience in making the early assessments of safety and tolerability of new drug candidates. Through brief case studies, the audience will learn about changing tools, approaches and considerations for identifying hepatic, renal, pulmonary, neuropsychiatric, ophthalmologic and cardiovascular adverse effects as well as assessing risk for ocular toxicity in humans.
Key Presenter: William Wheeler, M.D., Therapeutic Area Lead-Cardiovascular (Chair)
Optimizing Early Clinical Research to Accelerate Drug Development Timelines: Value of Early Safety Assessments Apr 28/11
LifeSciences Life Sciences - This webinar will discuss using amorphous dispersions as a platform technology to rapidly formulate compounds as respirable dry powders for preclinical evaluation
Speakers: Dan Dobry, Vice President Engineering, Bend Research Inc.
Dr. David T. Vodak, Vice President Chemistry, Bend Research Inc.
Dana M. Settell, Director of Business Development, Bend Research Inc.
Dextran-Based Amorphous Dispersions as a Platform Technology in Preclinical Screening for Inhaled Dry Powders Apr 27/11
LifeSciences Life Sciences - The role of the Clinical Logistics Leader will be explained as well as the contributions to study performance that such a role can provide
Speakers: Rico Berger, Ph.D., Manager Central Laboratory Services, PAREXEL International
Alain Eudaric, Director Clinical Logistics, North America and Asia Pacific, PAREXEL International
Leveraging Your Clinical Supply Chain Talent For A Well-Run Global Clinical Trial Apr 21/11
LifeSciences LifeSciences - Join this webinar and learn how some of the major challenges of biomarker discovery can be addressed in an integrated manner, how to discover and select the biomarker models most suitable for independent validation, and the importance of functional analysis as an essential component of biomarker discovery
Speakers: Max Bylesjo, Ph.D., Bioinformatics Team Leader, Almac
Nicolas Goffard, Ph.D, Bioinformatics Scientist, Almac
An Integrated Approach to Biomarker Discovery Mar 28/11
LifeSciences LifeSciences - This webinar will address strategies for expediting small molecule oral dosage formulations to Phase I studies, strategies to overcome challenges associated with poorly soluble compounds, technical considerations for liquid in capsule formulations, and controlled release formulations
Speaker: Paul F. Skultety, PhD, Director, Pharmaceutical Development Services, Xcelience, LLC
Formulation Development Strategies for Expediting Small Molecule Oral Dosage Formulations to Phase I Studies Mar 23/11
Legal LifeSciences - This webinar will explore the utilization of fit-for-purpose strategies in the discovery and development of solid-state forms of drug substances and highlight how these strategies impact cost, speed, and risk
Speakers: Joanna Bis, Principal Scientist, Catalent Pharma Solutions
Pingyun (PY) Chen, Manager, Optiform™ Technologies, Catalent Pharma Solutions
David Igo, Director, Optiform™ Technologies, Catalent Pharma Solutions
Fit-for-Purpose Strategies for Solid-form Discovery and Development Jan 26/11
SupplyChain Manufacturing/Supply Chain - Learn the basics of a hosted RFID Inventory Management solution, how to integrate with existing systems to significantly reduce costs, and how to reduce the risks usually associated with RFID Inventory Management projects
Speakers:Joe Pleshek, President and CEO, Terso Solutions, Inc.
Nathan Cowan, General Manager of Global Sales, HubSpan
Tracy Hillstrom, Sr. Product Line Manager, Impinj, Inc.
Understanding RFID in the “Cloud”: A Look at the Future of RFID Software Dec 9/10
LifeSciences Life Sciences/IT - Learn how innovative approaches to Records Management can improve adherence to protocols, instill best practices, ensure regulatory compliance, and most importantly increase business efficiency and decrease TCO
Speakers:  Ron Fitzmartin, PhD, MBA, Managing Partner, Decision Analytics
Dr. Ganesh Swaminathan, Practice Leader Life Sciences, Syntel
Business Aligned Records Management for Life Sciences - Unlock the "Efficiency-Code" in your Content Management Strategy Dec 8/10
Healthcare Healthcare/Life Sciences - Archimedes has created a web application which enables anyone to analyze and share simulation datasets produced by the Archimedes Model. During this webinar Dr. David Eddy will show why the Outcomes Analyzer is essential for anyone interested in understanding future health and cost issues and especially recommended for those interested in cardiovascular risk, obesity, and diabetes complications.
Speaker: David M. Eddy, MD, PhD, Founder and Chief Medical Officer Emeritus, Archimedes
DEMO: The Archimedes Outcomes Analyzer Oct 28/10
LifeSciences Life Sciences - This webinar discusses some of the most pertinent changes to regulations regarding compounds coming to approval since the implementation of ICH E14 by the FDA in 2005.
Speakers:  Joy Olbertz, Ph.D., PharmD., Clinical Site Director, Celerion
William Wheeler, M.D., Therapeutic Area Lead Cardiovascular, Celerion
The Need for Speed: Science and Innovation Driving Efficient, Cost Effective QT Assessment Oct 26/10
LifeSciences Life Sciences - In this webinar, Celerion partners with Xceleron to discuss how Accelerator Mass Spectrometry (AMS), through measurement of ultra low levels of drug-associated radioactivity, can enrich the information gathered from early clinical studies
Speakers:  J. Fred Pritchard, Ph.D.,Vice President, Drug Development Services, Celerion
Jeremy Hague, BSc, Senior Director, Strategic Development, Xceleron Ltd.
The Need for Speed: Enriching Early Clinical Studies for Better Data, Faster Oct 7/10
Healthcare Healthcare/Life Sciences - In this webinar Dr. Eddy will describe and illustrate data sources and methods for deriving equations for physiological pathways and the occurrence of diseases, as well as methods for validating the equations
Speaker:David M. Eddy, MD, PhD, Founder and Chief Medical Officer Emeritus, Archimedes
Healthcare Modeling Part 5: How the Archimedes Model Works – Derivation of Equations Oct 6/10
LifeSciences Life Sciences - QbD extends beyond formulation and process development. On-going monitoring of the manufacturing process, a vigorous continuous improvement program and commitment to quality are critical to maintain the success of a QbD program.
Speaker: Dr. Tahir Nazir, Manager, Formulation Development, Pharmaceutical Development Services, Patheon UK Limited
Effective Application of Quality-by-Design in Pharmaceutical Development and Product Manufacture Oct 1/10
LifeSciences Life Sciences - Our speaker panel from Almac will utilise their experience in the industry to explore the various mechanisms and techniques currently available in the marketplace to promote successful clinical trial supply capsule manufacture and over-encapsulation. They will also discuss key GMP challenges that need to be overcome in order to ensure product quality and study result integrity.
Speakers: Dr. Colin Lorimer, Senior Formulation Scientist
James Hurst, Analytical Support Manager
Michael Rainey, Production Manager
Richard Shannon, Head of Business Development (Europe)
Evaluating Capsule Manufacturing & Comparator Blinding Techniques for Clinical Trials Sept 24/10
LifeSciences Life Sciences - A discussion of the potential of biopharmaceutical products including differentiating the risk associated with internal attributes of the drug from the risk derived from external factors, a guideline to selecting the best methods to analyze and characterize antibodies, and recommendations on a risk-based sampling strategy and representative clinical case studies describing the importance of immunogenicity testing not only during clinical trials but also after the drug is commercialized
Speaker: Ana T. Menendez, Ph.D., Senior Director of Biotechnology, Catalent Pharma Solutions
Strategic Considerations For A Successful Immunogenicity Program Sept 17/10
LifeSciences Life Sciences - This webinar will explore what clinical delivery alliances are and the value alliance partnership models bring to the drug development process from both the sponsor and CRO perspective
Speakers: Tim Dietlin, Vice President of Alliance Development, INC Research
David Gillogly, Global Head, Clinical Contracting and Category Management, Novartis
The Value of Strategic Alliances vs. Transactional CRO-Sponsor Relationships Sept 15/10
LifeSciences Life Sciences - The role of the Clinical Logistics Leader will be explained as well as the contributions to study performance that such a role can provide
Speakers: Rico Berger, Ph.D., Manager Central Laboratory Services, PAREXEL International
Alain Eudaric, Director Clinical Logistics, North America and Asia Pacific, PAREXEL International
Leveraging Your Clinical Supply Chain Talent For A Well-Run Global Clinical Trial Sept 9/10
BusinessStrategy Media & Marketing/Manufacturing - This free webinar will guide you through the creative process of using video, the fastest growing media online, supply ideas for promotion and provide tips for working with agencies such as Outlier Solutions
Speaker: Ben Friedle, Principal, Outlier Solutions
360 Degrees of Video Marketing Online July 13/10
LifeSciences Life Sciences - QbD extends beyond formulation and process development. On-going monitoring of the manufacturing process, a vigorous continuous improvement program and commitment to quality are critical to maintain the success of a QbD program.
Speaker: Kwok Chow, Ph.D., Senior Director Global Pharmaceutical Development Technology and Alliances, Patheon
Effective Application of Quality-by-Design in Pharmaceutical Development and Product Manufacture June 17/10
LifeSciences Life Sciences - This talk will explore how steps in the generation of mammalian cell lines were optimized to make a process more efficient and outline certain risks that were taken to improve timelines and throughput
Speaker: Gregory T. Bleck, Ph.D., Senior Director of Cell Line Engineering, Catalent Pharma Solutions
Characteristics of an Effective Mammalian Cell Line Generation Process for Bio-Pharmaceutical Production May 25/10
LifeSciences Life Sciences - This talk will introduce 3 new technologies which could revolutionize the formulation world and how you approach your product's development and life-cycle management
Speakers: Emma Mickley, Ph.D., Director of Business Development, R5 Pharmaceuticals
Richard Johnson, Ph.D., Managing Director, Upperton Limited
Marcel de Matas, Ph.D., Scientific Manager, Lena Nanoceutics
Steffen Mittwich, Dipl. Wi.-Ing., CEO, Atacama Labs
Rob Lammens, Ph.D., CTO, Atacama Labs
Innovative but Practical Technologies to Tame Difficult APIs for Formulation Development & GMP Manufacture May 12/10
LifeSciences Life Sciences/Manufacturing - Supplier Management, Improving Supplier Oversight and Product Quality Outcomes
Speakers: John C. (Jack) Garvey, Principal, Compliance Architects ®
Peter Miller, Senior Partner, Dynamic Compliance Solutions, Inc.
Enforcement Risk Reduction Approaches for FDA-Regulated Manufacturers Apr 28/10
LifeSciences Life Sciences - This webinar will cover 3 key topics: Beyond 30 Parameters in Single Cells with Mass Cytometry, Mass Cytometry (Equipment and Reagents - how does it work?), and Mass Cytometry Methods
Speakers: Scott D. Tanner, President - Dmitry R. Bandura, Director - Olga I. Ornatsky, Director - DVS Sciences, Inc.
Massively Multi-parameter Single Cell Analysis by Mass Cytometry Apr 15/10
LifeSciences Life Sciences - This presentation provides an introduction to the regulatory documents surrounding leachables and extractables testing requirements for pharmaceutical products intended for US submission
Speaker: Alan D. Hendricker, Ph.D., Principal Scientist, Catalent Pharma Solutions
Leachables and Extractables: Regulatory Context Mar 18/10
LifeSciences Life Sciences - Discussion will include using Firmex Document Room for Licensing Agreements, Joint Ventures, Corporate Finance, Corporate Audits, Acquisitions and Divestitures
Speaker: Joel Lessem, Chief Executive Officer, Firmex
How Life Sciences Firms Use the Web to Manage Corporate Transactions Mar 9/10
LifeSciences Life Sciences - This webinar will introduce the utility of SharePoint for clinical trial operations and will present the application of SharePoint to two specific areas: clinical trial management and investigator portals. Viewers will learn how they can use technology to manage their clinical operational data to collect more timely information and to make more informed decisions.
Speakers: Les Jordan, CTO, Life Sciences Industry Unit, Microsoft
Bob Webber, President & CEO, TranSenda
Greg Cohee, Director, eClinical Services, Pharmica Consulting
Perspectives on Utilizing Microsoft SharePoint to Improve Clinical Trial Operations Mar 4/10
Healthcare Healthcare/Life Sciences - In this webinar Dr Eddy will explain how the Archimedes Model is formulated, how physiology is modeled, how patient behavior is modeled, sources and methods for deriving equations, how utilization and costs are calculated, and how the Model is validated
Speaker:David M. Eddy, MD, PhD, Founder and Chief Medical Officer Emeritus, Archimedes
Healthcare Modeling Part 4: How the Archimedes Model Works and is Validated Feb 11/10
LifeSciences Life Sciences/Manufacturing/Media&Marketing - This webinar will present ideas for creating, promoting and optimizing online videos for training, sales, and technical support of products
Speakers: Vinnie Martorano, VP of Sales, Sheldon MFG
Ben Friedle, Principal, Outlier Solutions
Online Video Training and Promotion in the Scientific and Industrial Markets Jan 28/10
LifeSciences Life Sciences/Supply Chain - This webinar will examine the current market and industry trends and discuss the latest innovative and automated technologies in clinical packaging and how they help improve time and cost efficiencies. You will also learn how companies are leveraging automation and innovation to achieve a more effective, efficient supply chain.
Speakers: Jim Miller, President, PharmSource
William Zeigler, Manager of Project Planning, Catalent Pharma Solutions
Peter Brun, Director, Clinical Supply Services, Catalent Pharma Solutions
Clinical Packaging: Driving Efficiencies Through Automation and Innovation Jan 26/10
LifeSciences Life Sciences - This webinar will address considerations for prototype formulation development, formulation options for phase I studies, a prototype formulation approach, strategies to overcome poorly soluble compounds, liquid in capsule, and controlled release formulations
Speaker: Paul F. Skultety, PhD, Director, Pharmaceutical Development Services, Xcelience, LLC
Formulation Development Options for Speed to Phase I Studies Jan 21/10
Healthcare Healthcare/Supply Chain - RFID - Driving Collaboration With Suppliers and Providers: The presentations in this web seminar will highlight the emerging trends, business cases and application of RFID technologies that are driving a holistic collaboration between all healthcare supply chain stakeholders
Speakers: Joe Pleshek, President and CEO, Terso Solutions
Reik Read, Managing Director and Senior Supply Chain Analyst, Robert W. Baird & Co.
Hanns-Christian L. Hanebeck, Vice President, Professional Services, Venture Research Inc.
Michael McCartney, Managing Principal, QLM Consulting
Real Time Visibility for Healthcare Supply Chains Dec 9/09
LifeSciences Life Sciences/Sales&Marketing - Real Life Examples and Solutions for Dissemination of Promotional Content
Speakers: Elsa Chi Abruzzo, RAC, President and CEO, ARAC, LLC
Benjamin S. Martin, Associate, Epstein Becker and Green, P.C.
Promotional Content Dissemination by your Sales Force Dec 7/09
LifeSciences Life Sciences - This webinar will address the principles and practices of stability studies in the drug development process, discuss the framework of the FDA cGMP guidelines as expressed in 21CFR 211 which will help pharmaceutical analysts to understand the process, and provide a comprehensive review of the ICH and WHO stability guidelines and discuss the strategy used in stability protocols design to support global registration
Speakers: Wei Pan, Ph.D. RAC, Senior Manager, Catalent Pharma Solutions
Kathy Waddle, Director, Stability QC Biology, Catalent Pharma Solutions
Stability Studies in Pharmaceutical Development Nov 20/09
LifeSciences Life Sciences - An in-depth look at the most effective strategies for planning and implementing this new breed of trials.
Speaker: Judith Quinlan, Vice President, Adaptive Trials, Cytel Inc.
Real-time Clinical Trial Decision Making: Reaching the correct decisions - at the earliest time point - in the most efficient way Nov 18/09
LifeSciences Life Sciences - Learn how to organize, analyze, and visualize chemical and biological data quickly and efficiently, enhancing efficiency and productivity
Speaker: Brian Masek, Ph.D., Product Manager and Lead Scientist, Tripos International
Strategies for Merging and Analyzing Chemical and Biological Data for Effective Compound Prioritization Decisions Nov 16/09
LifeSciences Life Sciences - Join our webcast as we discuss paperless clinical trials, covering the initiatives, the progress and what we have learned along the way
Speakers: Gail M. Farfel, Ph.D., President, Pharmaceutical & Regulatory Strategy, GM Group Consulting
Alison Shurell, Vice President, Life Sciences Product Marketing, IntraLinks
The Journey Toward Paperless Clinical Trials Nov 5/09
LifeSciences Life Sciences - This webinar will focus on the importance of self-emulsification (dispersion) and lipolysis (digestion) properties for achieving acceptable “in-vivo” performance of lipid-based formulations
Speakers: Dr. Jean Cuiné, Fellow Project Leader, Novartis Pharma AG
Julien Meissonnier, Director, R&D and Technical Services, Catalent Pharma Solutions
Sarah Dr. Jeffrey Browne, Technical Director, Pharmaceutical Softgel Business Development, Catalent Pharma Solutions
Norman Stroud, Director, Technology Development, Catalent Pharma Solutions
Unlocking the Therapeutic Potential of BCS Type II & IV Compounds: Oral Lipid-based Drug Delivery Sep 23/09
Healthcare Healthcare/Life Sciences - Healthcare Modeling is explained using the Archimedes Model, including its importance in defining inclusion and exclusion criteria to lower the risk of failure in clinical trials
Speaker: Peter Alperin, M.D., Medical Director, Archimedes
Healthcare Modeling Part 3: Cost Effectiveness of Personalized Medicine Sep 22/09
BusinessStrategy Business Strategy/Life Sciences - This seminar will present the biotech and pharmaceutical sector in Spain and the investment opportunities that it offers.
Speakers: Bárbara López Gómez, Investor Services Manager, INVEST IN SPAIN
Jorge Arenas-Vidal, Director, BIOSERENTIA
Dr. Javier Arias-Diaz, Deputy Director for Cell Therapy and Regenerative Medicine, CARLOS III Health Institute
Eduardo Bravo, CEO, CELLERIX
Dr. Agustin Ruiz, Research & Development Director, NEOCODEX
Invest in Spain: Business Opportunities in the Biotechnology, Pharma and Life Sciences Sector July 14/09
LifeSciences Life Sciences - The webinar will focus on improving preclinical studies by combining MDS Pharma Services' 40 years of experience and insight in safety pharmacology and toxicology, with innovative technology and processes that improve study data and provide greater animal welfare. Presentations will highlight key challenges, best practices and methodologies.
Speakers: Dr. Stéphane Milano, Vice President, Drug Safety Assessment, MDS Pharma Services
Paul Barrow, Director of Toxicology, MDS Pharma Services
Sarah Merrett, Lean Sigma Black Belt, MDS Pharma Services
Advances Insight and Innovation: Novel Approaches to Safety Pharmacology and Toxicology in the 21st Century June 23/09
LifeSciences Life Sciences - Learn about how drug development strategies are changing to keep pace with these discoveries
Speakers: Jeffrey Settleman, Ph.D., Laurel Schwartz Professor of Oncology, Scientific Director, Massachusetts General Hospital Cancer Center
Christine O’Day, Ph.D., Technical Director, In Vitro Pharmacology, MDS Pharma Services
Dan Rhodes, Ph.D., CEO, Compendia Bioscience
Advances in Oncology Drug Development: Linking Drug Response Phenotypes to Multiplex Molecular Signatures June 18/09
LifeSciences Life Sciences - This web-based training class is geared to clinical program managers, clinical trial managers and directors of clinical trials to expand their understanding and to learn the intricacies involved in managing the Central Lab component of clinical trials through the APOLLO:RDA™
Speaker: Jennifer Trudel, Training Manager, MDS Pharma Services
Quality On Time™ results with APOLLO:RDA™ (Remote Data Access) Apr 23/09
LifeSciences Life Sciences - Through case studies this webinar will introduce integrated approaches for data management, PK/PD analysis, reporting technology and automation to optimize drug development
Speakers: JF Marier, Ph.D., FCP, Vice President and Lead Scientist, Reporting and Analysis Services, Pharsight Corporation
Mark LJ Reimer, Ph.D., Senior Director, Reporting and Analysis Services, Pharsight Corporation
Combining Technology and PK/PD Expertise to Optimize Drug Development: A New Era for Collaborative Environments in Translational Medicine Apr 22/09
LifeSciences Life Sciences - This program is intended for clinical research and regulatory affairs professionals who are responsible for or impact their organizations’ efforts applied to clinical trial patient recruitment and retention and/or study site performance
Speaker: Tony L. Hursey, MPH, Vice President, Cardiology & Endocrinology, MMG
Perspectives on Patient Recruitment: Site and Patient Awareness Items and Participant Insurance Coverage Apr 21/09
LifeSciences Life Sciences - This webinar will feature an examination of the current status of the hemagglutination inhibition assay (HAI) as a surrogate test for evaluating serological status to influenza, both vaccines and natural infection
Speaker: Keith A. Gottlieb, PhD, Principal Scientist, Clinical Trials Department, Focus Diagnostics, Inc.
Influenza Options: HAI and Beyond Apr 14/09
LifeSciences Life Sciences - How should manufacturers retool to navigate reimbursement planning in this brave new world?
Speakers: DrEric Faulkner, MPH, Senior Director, Market Access and Reimbursement, RTI Health Solutions, and Executive Director, Genomics Biotech Institute, National Association of Managed Care Physicians
Allan Jay Kogan, MD, Vice President and Regional Medical Director, CIGNA
Jayson S. Slotnick, Associate, Hogan & Hartson LLP
Reimbursement Planning: Reverse Engineering Drug Development to Meet Changing Payer Requirements Mar 10/09
LifeSciences Life Sciences/Supply Chain - A panel discussion of a flexible, cost effective approach for today's R&D and clinical supply leaders that accounts for the complexity of the global distribution of the clinical trial supplies
Speakers: Dr. Michael N. Eakins, Principal Consultant, Eakins & Associates
Martin Page, General Manager, Catalent Pharma Solutions
Andrew Willis, VP of Regulatory Affairs, Catalent Pharma Solutions
Phil Wilson, Director of Global Trade Operations, Supply Chain and Corp. Security, Catalent Pharma Solutions
Meeting the Challenges of Global Clinical Supply Chain Management Jan 27/09
Healthcare Healthcare/Life Sciences - Healthcare Modeling is explained using the Archimedes Model, including its importance in defining inclusion and exclusion criteria to lower the risk of failure in clinical trials
Speaker: Peter Alperin, M.D., Medical Director, Archimedes
Healthcare Modeling Part 2: Simulation Modeling in Clinical Trial Design Jan 21/09
LifeSciences Life Sciences - This workshop is intended to highlight the key problems at a program level with existing performance improvement systems and to demonstrate solid solutions to those problems using a Lean Sigma framework
Speaker: Dr. Richard H. (Rick) Allen, Healthcare Practice Leader, Sigma Breakthrough Technologies, Inc.
SBTI Healthcare Webinar Series Part 3: Creating the Infrastructure for Successful Lean Sigma Integration Jan 13/09
Healthcare Healthcare/Life Sciences - Healthcare Modeling is explained using the Archimedes Model, a rigorously validated, mathematical model of human physiology, diseases, interventions, and healthcare systems
Speaker: Peter Alperin, M.D., Medical Director, Archimedes
Healthcare Modeling Part 1: What If Patients Listened to Their Doctors? Nov 19/08
BusinessStrategy Business Strategy/Life Sciences - Find out why innovative biotech and pharma companies are moving into Minnesota
Speakers: Dale Wahlstrom, CEO, BioBusiness Alliance of Minnesota, with co-presenters from Mayo Clinic Genomics Research Center, University of Minnesota, Upsher-Smith Laboratories Inc.
Minnesota: Join Our Culture of Innovators Nov 14/08
LifeSciences Life Sciences - This presentation will follow actual case examples from award winning Columbus Regional Hospital, including multiple hospital functions, such as imaging, laboratory and pharmacy
Speaker: Dr. Richard H. (Rick) Allen, Healthcare Practice Leader, Sigma Breakthrough Technologies, Inc.
SBTI Healthcare Webinar Series Part 2: Using Lean Sigma to Improve Patient Flow and Increase Capacity Nov 11/08
LifeSciences Life Sciences - This presentation will address the recent regulatory initiatives in the U.S. and Europe and how safety registries can effectively be used as part of a risk management, riskMAP, or REMS program strategy
Speaker: Richard Gliklich, MD, President, Outcome
From Registries to REMS, Measuring Safety, Minimizing Risk, and Meeting New Regulatory Requirements Nov 6/08
LifeSciences Life Sciences - Leveraging a Multiphase QT Strategy to Expedite Development and Reduce Investment Risk: Cost Effective Design, Execution and Analysis
Speakers: William Wheeler, MD, FACC, Global Medical Director, Centralized Cardiac Services, MDS Pharma Services
Michelle L. Combs, PhD, Vice President, Global Clinical Pharmacology, MDS Pharma Services
Nathan S. Teuscher, PhD, Director, PK/PD, MDS Pharma Services
Joy Olbertz, PharmD, PhD, Director, Cardiac Safety Services, MDS Pharma Services
Leveraging a Multiphase QT Strategy to Expedite Development and Reduce Investment Risk: Cost Effective Design, Execution and Analysis Nov 5/08
LifeSciences Life Sciences - Find out in an exclusive webcast that brings together CROs and investigative sites to share their experiences managing study start-ups online
Speakers: Lee Ferrell, Director, Site Start Up, Quintiles, Inc.
Adam McFarland, ECMP, Business Systems Specialist, Copernicus Group IRB
Dave Espenshade, Vice President of Life Sciences, IntraLinks, Inc.
Site Activation: How to Reduce Costs and Shorten Study Start-up Time Oct 29/08
LifeSciences Life Sciences - Learn about science-driven strategies for a successful First-in-Human trial
Speakers: Todd Johnson, MD, Senior Vice President, Early Stage Development, MDS Pharma Services
Robert F. Butz, PhD, Vice President, Medical & Scientific Affairs, Biovail
Michelle L. Combs, PhD, Vice President, Global Clinical Pharmacology, MDS Pharma Services
Gaetano Morelli, MD, Senior Director, Global Medical Affairs, MDS Pharma Services
First- In-Human Studies: Science-Driven Strategies Oct 23/08
LifeSciences Life Sciences - Using the framework of a common hospital process problem and following a case example, learn how Lean and Six Sigma methods can be successfully applied in a healthcare environment to gain unprecedented results
Speaker: Dr. Ian Wedgwood, Executive Director, Sigma Breakthrough Technologies, Inc.
SBTI Healthcare Webinar Series Part 1: Introducing Lean Sigma to Drive Performance Improvements in Healthcare Aug 19/08
LifeSciences Life Sciences - Collaboration, Harmonization and KPI with Blue Mountain Regulatory Asset Manager
Speaker: Bryce Johannes, Director of Marketing, Blue Mountain Quality Resources, Inc.
Improving Productivity in Asset Management for Life Sciences May 8/08
LifeSciences Life Sciences/IT - A guide through current multi-site and web marketing trends in the pharmacy space and the steps you need to map out your future WCM success
Speakers: Kevin Adkisson, Director of Software Sales, Crown Partners LLC
Rob Alfieri, Strategic Consultant, Crown Partners LLC
Andrew Zupfer, Senior WCM Product Manager, Crown Partners LLC
Web Content Management for Pharma Marketing -- Leveraging the Present, Mapping the Future Feb 21/08
LifeSciences Life Sciences/Supply Chain - The key challenge areas associated with serializing distribution processes and best practices learned from the front line with early adopters
Speakers: Ann Grackin, Mangaging Director, Supply Chain Risk (RISC) Consulting, Marsh Advisors
John DiPalo, Senior Vice President, Product Development, Acsis
Mike Lipton, Director of Strategy for RIFD/Supply Chain Management, SAP Labs
James Dowden, Director, Distribution Services, Hoffman La-Roche
Best Practices for Serialized Distribution in Support of ePedigree Compliance Jan 31/08
IT Healthcare/Life Sciences - Preventing Medical ID Theft
Speakers: John C. Wade, Vice President, former CIO, Saint Luke’s Health System
Richard J. Carroll, Senior Director, Healthcare IT Infrastructure, ARINC, Inc.
Identity Management for the Healthcare Enterprise Oct 18/07
LifeSciences Life Sciences - Harmonizing calibration, maintenance and validation with the new Blue Mountain Regulatory Asset Manager enterprise solution
Speakers: James Erickson, President and CEO, Blue Mountain Quality Resources, Inc.
Bill Taliaferro, Director of Global Sales, Blue Mountain Quality Resources, Inc.
Implementing Asset Management Best Practices for Life Sciences Oct 9/07
LifeSciences Life Sciences/Marketing - A panel dicussion of the ethical marketing practices in the Pharmaceutical and Biotech industries
Speaker: Wesley Wheeler, President, Valeant Pharmaceuticals
Dr. John F. Kamp, Executive Director, Coalition for Healthcare Communication
Denis Arnold, Director of the Center for Applied and Professional Ethics, The University of Tennessee
Gene Guselli, Co-founder, President, CEO, InfoMedics, Inc.
Ethical Marketing to Improve the Public’s Perception of the Pharmaceutical and Biotech Industry Sep 24/07
LifeSciences Life Sciences - Benefits of the Clinical Investigator Management Process System (CIMPS)
Speaker panel from CTMG, Inc. led by Anton Usala, M.D., CEO & Medical Director
CIMPS—A GMP Approach to Physician Site Management Enabling Clinical Trial Success (Regardless of PI Experience) Sep 19/07
LifeSciences Life Sciences - Learn how to get better visibility into your data and improve your understanding of industry trends and drivers to improve overall company ROI
Speakers: George Foldes, Senior Business Analyst, Aspreva Pharmaceuticals
Christopher-Paul Milne, D.V.M., M.P.H., J.D., Associate Director, Tufts Center For The Study Of Drug Development
Tim Knutson, Area Manager, Applix
Better Understanding Industry Trends and Drivers in the Pharma and Biotech Industries through the use of Performance Management (PM) Technology Aug 22/07
LifeSciences Life Sciences - This Adaptive Dose-Ranging Studies: an Evaluation with Recommendations from the PhRMA Working Group
Speaker: Dr. Jose Pinheiro, Director Biostatistics, Senior Modeler, Pharmacology Modeling and Simulation, Novartis Pharmaceutical
Adaptive Clinical Trials: Improving the Efficacy of Dose Finding Trials June 28/07
LifeSciences Life Sciences - This The team from CRG will present three simple solutions to accelerating trial completion
Speakers: Lynn. S. Bachrach, President and CEO, CRG
Harry Bachrach, Principal and CFO, CRG
Vicky Rochford, Senior Vice President, CRG
Three Simple Solutions to Accelerating Trial Completion June 19/07
LifeSciences Life Sciences - An examination of Electronic Data Capture (EDC), including the differences between EDC and eClinical, why the industry is shifting from EDC to eClinical, and the key benefits of implementing an eClinical platform
Speaker:David J. Laky, Vice-President & General Manager Clinical Data Applications, eResearchTechnology, Inc.
eClinical Delivers Solutions June 14/07
LifeSciences Life Sciences - A case study that will include a discussion of site selection and recruitment strategies, the importance of patient advocacy support, regional differences and participant expectations, acknowledge and address barriers to participation & moral concerns, and retention strategies
Speakers: Lisa A. Ward, MPH Clinical Research Manager, Genzyme Corporation
Gail Adinamis, President, CEO, Clinical Resource Network, Inc.
Patient Retention in Orphan Drug Studies June 8/07
LifeSciences Life Sciences - Current insights into the differences between Phase I versus Phases II-III and Phase IV cardiac safety testing. Discussion will also include common ECG collection practices at sites versus best practices, the impact of the TQT on Phase III programs, ECG data considerations beyond QTc, and how implementation of best practices ensures data quality and consistency and reduces data evaluation time.
Speaker: Jeffrey S. Litwin, M.D., F.A.C.C., Executive Vice -President, Chief Medical Officer, eResearchTechnology, Inc
Best Practices in Cardiac Safety Data Collection Before and After the Thorough QT Trial June 7/07
LifeSciences Life Sciences - The collaboration of pharmaceutical, medical devices, and diagnostic testing companies in order to create innovative ways to administer drugs and increase patent lengths
Speaker: Wesley Wheeler, President, Valeant Pharmaceuticals
Alternative Methods of Drug Delivery June 4/07
LifeSciences Life Sciences - Our speakers will explore the opportunities and perspectives of personalized medicine and discuss what is required on the pharmaceutical and diagnostics part to make this model successful and practical for the society
Speakers: Dr. Raymond Woosley, MD, PhD, President and CEO, The Critical Path Institute
Mara G. Aspinall, President, Genzyme Genetics
Wayne Rosenkrans, Business Strategy Director External Scientific Affairs, Co-Chair Personalized Medicine Coalition, AstraZeneca Pharmaceuticals
Dr. Elaine Weidenhammer, Associate Director, Strategic Market Development, Nanogen
Annette K. Taylor, M.S., Ph.D., President and CEO, Kimball Genetics
Personalized Medicine: Realizing the Full Potential May 30/07
LifeSciences Life Sciences - Current insights into the ICH guidance and practical implications for implementation of the TQT
Speaker: Joel Morganroth, M.D., F.A.C.C., Chairman, Chief Scientist, eResearchTechnology, Inc.
ICH-E14 Two Years Later - Trends in Design & Conduct of a Thorough ECG Trial (TET) May 31/07
LifeSciences Life Sciences/Marketing - This webinar will explore best practices in linking online e-detailing to rep-based tablet PC detailing, thus transforming traditional pharmaceutical marketing practice
Speakers: Henry B. Slotnick, Ph.D.Ph.D., Professor Emeritus, University of North Dakota
Dr. Jens Härtel, Managing Director, BSMO Business Solutions Medicine Online
Richie A. Bavasso, President, Exploria SPS
Multi- Channel Marketing: A Tablet PC Driven E-Detailing Success Phenomenon May 24/07
LifeSciences Life Sciences/Supply Chain - Exploring cost- effective ways of maintaining integrity of biological and pharmaceutical products during transportation
Speaker: Clifford H. Harze, Consultant, C H Harze Pharmaceutical Distribution Consultant LLC
Distribution of Biopharma Products Feb 28/07
LifeSciences Life Sciences/Supply Chain - Exploring the first stage implementation results of Pfizer’s RFID Pilot Program
Speaker: Peggy Staver, Director of Trade Product Integrity, Pfizer
RFID for Pharma Feb 2/07
LifeSciences Life Sciences/Healthcare - Strategies for accelerating patient recruitment
Speaker: Jim Kremidas, Global Enrollment Optimization, Eli Lilly
Peter DiBiaso, MHA, Director, Worldwide Development Operations, Pfizer Global Research & Development
Kenneth J. Tomaszewski, PhD, MS, SVP, Healthcare Research, Harris Interactive
Gail Adinamis, President, CEO, Clinical Resource Network, Inc.
Taking Clinical Trials and Patient Recruitment Global Nov 14/06
LifeSciences Life Sciences - Ensuring quality and efficiency in technology transfer (featuring a case study with Dowpharma)
Speaker: Jeff Dudley, Business Operations Director, Dowpharma and Dow Ventures
Implementing Technology Transfer for a New Product Using a CMO Aug 10/06
LifeSciences Life Sciences/Supply Chain - Anti- Counterfeiting Drug Strategies
Speakers: Mr. Eshetu Wondemagegnehu Technical Officer & Focal Person for Counterfeit Drugs, Quality Assurance & Safety Medicines Essential Drugs and Medicines Policy World Health Organization
Dr. Peter Rost, VP, Marketing, Endocrine Care, Pfizer. (Dr. Rost speaks as a private citizen and does not represent Pfizer in his talk.)
Anti-Counterfeiting Drug Strategies Dec 10/04

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