Xtalks On Demand Archives - Life Sciences |
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Synopsis |
Webinar Title |
Date |
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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 |
Include 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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
 |
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 |
 |
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 |
 |
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 |
 |
Life Sciences/Supply Chain - A panel discussion of a flexible, cost effective approach for today's R&D and clinical supply leaders that accounts for the complexity of the global distribution of the clinical trial supplies Speakers: Dr. Michael N. Eakins, Principal Consultant, Eakins & Associates Martin Page, General Manager, Catalent Pharma Solutions Andrew Willis, VP of Regulatory Affairs, Catalent Pharma Solutions Phil Wilson, Director of Global Trade Operations, Supply Chain and Corp. Security, Catalent Pharma Solutions |
Meeting the Challenges of Global Clinical Supply Chain Management |
Jan 27/09 |
 |
Healthcare/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 |
 |
Life Sciences - This workshop is intended to highlight the key problems at a program level with existing performance improvement systems and to demonstrate solid solutions to those problems using a Lean Sigma framework Speaker: Dr. Richard H. (Rick) Allen, Healthcare Practice Leader, Sigma Breakthrough Technologies, Inc. |
SBTI Healthcare Webinar Series Part 3: Creating the Infrastructure for Successful Lean Sigma Integration |
Jan 13/09 |
 |
Healthcare/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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
Life Sciences - Learn how to design adaptive trials; and explore the challenges in the implementations of adaptive designs Speakers: Mark Chang, Director of Biostatistics, Millennium Pharmaceuticals Ken Light, Senior Vice President Professional Services, OmniComm Systems, Inc. |
Designing Adaptive Clinical Trials - Part 2 |
Sep 14/07 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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 |
 |
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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