Xtalks On Demand Archives - Life Sciences |
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Synopsis |
Webinar Title |
Date |
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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 |
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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 |
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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
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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
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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
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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
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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 |
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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
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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 |
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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 |
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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
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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 |
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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
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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 |
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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
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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 |
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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
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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 |
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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 |
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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 |
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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 |
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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 |
Dec 13/12 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 - 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 |
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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 |
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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 |
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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 |
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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 |
|
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 |
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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 |
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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 |
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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 |
|
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 |
|
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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 - 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 |
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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 |
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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 |
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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 |
|
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 |
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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 |
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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 - 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 - 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 |
|
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 |
|
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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 - 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 - 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 - 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 |
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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 - 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 - 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 |
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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 - 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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
 |
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 |
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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 |
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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 - 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 |
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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 |
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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 |
|
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 - 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/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 - 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 |
|
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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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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Click here for more information about our Life Sciences sector
Click here for a list of upcoming Web Conferences | |
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