Friday, November 14

 7:45 am Morning Coffee (Breakfast Workshop Sponsorship Available)

BENEFIT-RISK

 8:15 Chairperson’s Opening Remarks and Roundtable Report Outs
Jill Robinson, R.Ph., M.B.A., Vice President, Global Safety Surveillance & Epidemiology, Wyeth

 9:00 Plotting a Strategy for the Best Benefit-Risk Ratio
John Ferguson, M.D., Ph.D., Vice President & Global Head, Pharmacovigilance & Medical Safety, Novartis Vaccines & Diagnostics

9:30 Endpoint Trials as a Risk Management Tool
Peggy Schrammel, Vice President, Clinical Research, Phase IV Development, PharmaNet
More and more sponsors are turning to large-scale, global endpoint trials as a means of early detection of any untoward safety events associated with a product in various phases of clinical development. Establishing processes for managing endpoint definition, adjudication and reporting is not found in the execution of typical clinical trials. This session will explore how a dedicated approach to this, run in tandem with the trial, can result in expedient reporting and decision-making.

 10:00 Establishing Best Practices in Evaluating, Planning and Executing “Fit-for-Purpose” Benefit/Risk Management Programs for the 21st Century
Axel Olsen, Ph.D., Executive Director, Drug Safety and Medical Affairs, Quintiles, Inc.
The increasing complexity of medical practice, together with the rapid increase in human exposure to new medications and complex medical procedures, has uncovered serious weaknesses in the management of benefit and risk by sponsors and regulators alike. While regulatory agencies strive to bring control to the approval and post-approval period by monitoring medication safety and risk communication, manufacturers are challenged to provide timely, clearly understood safety and benefit information to support applications for marketing authorization and post-approval product support. It is this evolving framework that provides serious challenges for pharmaceutical product development and marketing teams. Each compound in development, potentially at any stage of the life cycle, requires unique assessment and program evaluation, planning and execution. No longer will the status quo be acceptable. The full gamut of stakeholders from regulators to providers to patients expects full transparency, accurate communication and unfettered access to critical information for evidence-based decision-making.

• This presentation provides a unique perspective and set of solutions for the Pharmaceutical Industry.
• Innovative solutions that are consistent with the spirit of the “Culture of Safety” are a must in the current environment.
• All elements of the life sciences sector must be diligent in assuring they fulfill their responsibilities to this end.
• The Pharmaceutical Industry must be presented with creative solutions to meet these evolving requirements to be continually successful.

10:30 Networking Coffee Break

 11:00 Drug Benefit-Risk Evidence, Assessment and Decision-Making Across Life-Cycle: Health Canada Perspective and Proposal
Robyn Lim, Ph.D., Science Advisor, Progressive Licensing Project, Therapeutic Products Directorate, Health Products and Food Branch, Health Canada
Health Canada, Canada’s federal drug regulatory authority, is in the process of modernising the Canadian drug (pharmaceuticals and biologics) regulatory framework through the Progressive Licensing Project. Measurement of drug performance on the basis of benefits and risks is a central concept of the proposals for the new legal evidence standard and authorisation mechanisms. The new framework is thus intended to establish the federal regulator as a catalyst for the development of benefit-risk science (absent cost components), mandating the collection, assessment and communication of benefit and risk evidence across drug life-cycle. A regulator’s contemporary interpretation of drug evidence and a description of current regulatory benefit-risk assessment practices will be provided. Proposed new legal and operational structures that support best practices will then be described. Parting thoughts include some of the potential scientific, legal and social implications of the proposals.

 11:30 Challenges in Benefit-Risk Evaluations during Global Development and in Partnerships and Alliances
Ashraf Youssef, M.D., Ph.D., M.B.A., Associate Medical Director, Pharmcovigilance, Takeda Pharmaceuticals
Alliances through mergers, accusations and/or in-licensing aim to achieve successful business partnerships. Decisions on agreements on safety issues had to be achieved over differences on perceptions and evaluations of the safety signals across departments within the same company or between regions within global companies. The presence of a co-partner in development will additionally complicate such decisions. The differences in regulations, reporting requirements, marketing practices and business focus, in addition to perceptions of the benefits and risks are some of the factors that pose additional challenges. There are multiple processes, agreements and models which had to be considered among alliances to achieve the closest agreement on safety messages and risk management plans. The focus of this presentation will be on the rationale and differences in approaches that affect this process, mainly in presence of a partnership or during co-development.

• Describe some of the challenges in coordination of safety activities during alliances and partnerships
• Provide practical lessons learned to facilitate solutions of some of the challenges within alliances
• Review best practices from business models, approaches, and paradigms from alliances as applicable to safety issues

 12:00 pm Sponsored Luncheon Workshop (Sponsorships available, please contact Arnie Wolfson +1.781.972.5431, awolfson@healthtech.com)or Lunch on Your Own

FUTURE OF SAFETY -- MOVING FROM OBSERVATION TO PREDICTION,
NEW MODELS & COLLABORATION

1:25 Chairperson’s Opening Remarks
Federico Goodsaid, Ph.D., Associate Director for Operations in Genomics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration

 1:30 Safety Sciences - How Far Have We Come and Where are We Heading?
Dr. Rebecca P. Emmons, Board Certified Clinical Immunologist, Ph.D., Drug Safety Committee Strategy and Coordination, F. Hoffmann La Roche, Basel, Switzerland

co-developed with Kasia Petchel, M.D., Vice President, Global Head, Safety Risk Management, Roche

• Business drivers in making us change
• What are key ingredients in Safety Science in pre-market and post-market arenas
• How can Safety Science be incorporated into everyday work
• What are the value factors in adopting safety science principles
• Forecasting the future, or looking into Safety Science’s crystal ball

 2:00 An Industry Update: The Impact of the FDAAA and Recent Updates on Risk Management Practices Objectives:
Annette Stemhagen, DrPH, FISPE, Vice President, Epidemiology and Risk Management, United BioSource Corporation

• To gain a better understanding of how FDAAA will affect industry practices around risk management
• To analyze the guidances, discussions, and FAQs that FDA has given to the public since the passing of the law on September 21, 2007
• To understand strategies for responding to FDA requests for further post-marketing information under FDAAA

 2:30 Translational Safety Biomarkers and the Path to Phase-1 Studies
Federico Goodsaid, Ph.D., Associate Director for Operations in Genomics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration
Novel translational safety biomarkers are used internally within pharmaceutical companies as tools integrated with drug development. This information is often only used in the early stages of development because these biomarkers have not been qualified in the application contexts for which data are available. The FDA has developed a Pilot Process for Biomarker Qualification to provide a comprehensive biomarker qualification process for drug development and regulatory review. This biomarker qualification process provides a focus for an accurate management of risk.

4:00 Closing Comments

4:30 End of Conference

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