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8:00 am Morning Coffee or Sponsored Breakfast Presentation

(Opportunity Available. Contact Arnie Wolfson: 781.972.5431, awolfson@healthtech.com)

8:20 Chairperson’s Opening Remarks

Elizabeth E. Garrard, PharmD, RPh., Chief Safety Officer, Drug Safety Alliance, Inc.



8:30 FDAAA and REMS: What Have We Learned, What Don’t We Know

Mary PendergastMary K. Pendergast, President, Pendergast Consulting; former Deputy Commissioner and Senior Advisor to the Commissioner, U.S. Food and Drug Administration

9:00 REMS: Implications for Strategy and Marketing after the Risk Identification and Assessment

William TrombettaBill Trombetta, Ph.D., Professor of Pharmaceutical Marketing, Pharmaceutical Marketing, St. Joseph’s University

After risk identification and assessment, there are numerous strategy and marketing issues that make the drug firm vulnerable to regulatory issues. For example, how do you compensate sales reps for decreasing sales due to smaller patient populations; can REMS offer an opportunity to partner with physicians instead of just detailing the drug; and most important: what is the role of the strategy of Demarketing in minimizing regulatory exposure under REMS. This presentation addresses the practical issues that follow after the clinical and science REMS assessment. The audience will learn how to become aware of strategies and marketing tactics that can be employed to enhance REMS as an opportunity to become a strategic partner with physicians instead of just a supplier of drugs.

9:30 Preparing for Success in a New Era of Pharmacovigilance and Medical Information Auditing: A Case Study

John MclaneJohn McLane, Ph.D., Chief Operating Officer and Vice President, Clinical & Regulatory Affairs, Clinquest

It was a normal Tuesday at 9:41 am when the unrecognized visitor entered the office lobby. A brief introduction and the flash of a badge catalyzed a company-wide reaction to an unannounced FDA audit focusing on the company’s Pharmacovigilance and Medical Information systems. Five days and 280 questions and requests later, the Auditor left without issuing a 483. As the frequency of Pharmacovigilance and Medical Information regulatory audits increases, you can guarantee that the authorities will come to your door. Will you be prepared?

9:45 Networking Refreshment Break

10:30 The Benefits of REMS Planning in Pre-Approval Studies and the Transition to Post-Approval REMS

Gretchen DieckGretchen Dieck, Ph.D., Vice President, Safety, Epidemiology and Risk Management, United BioSource Corporation (UBC)

- Common misconceptions of REMS planning in pre-approval
- Opportunities for REMS development and testing in clinical development planning
- The value pre-approval REMS planning brings to post-approval REMS implementation

11:00 FDA Drug Safety Oversight Board and its Role inthe Evaluation of, and Communication About, Important Postmarket Drug Safety Issues

Steven OsborneSteve Osborne, M.D., Executive Director, Drug Safety Oversight Board, CDER, FDA

The manner in which FDA evaluates postmarket drug safety has evolved to meet greater expectations of the public and healthcare professionals. In 2005, FDA formed the Drug Safety Oversight Board to provide advice and recommendations to the Director of the Center for Drug Evaluation and Research on the management and communication of important, often emerging, drug safety issues. The Board is formed with representatives from FDA and six Federal Partner agencies and is positioned to provide key advice and recommendations on narrow and broad drug safety topics.


11:30 Break-Out Discussion Groups and Morning Session Wrap-Up:

Concurrent roundtables are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the issues presented in the morning session. Delegates will join a roundtable of interest to them and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to: share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

TABLE 1: Planning Assessments of Your REMS Program

Moderator: Kelly D. Davis, M.D., Vice President, Safety, Epidemiology, Registries & Risk Management, United BioSource Corporation (UBC)

• How to Determine Whether Patients and Healthcare Providers are getting the Message
• Developing Survey Protocols
• What to Include in REMS Assessment Reports

TABLE 2: In-licensing Opportunities: What are the Red Flags from a Safety Perspective?

Moderator: Ashraf Youssef, M.D., Ph.D., DABT, MBA, Associate Medical Director, Pharmacovigilance, Takeda Global R&D

• Weight of evidence at different stages of development: What are the main areas of concern for each stage of development?
• What are some good examples of successful in-licensing opportunity despite red flags?
• Would you in-license this product? A case study

TABLE 3: Data Quality and Compliance in ICSR Reporting

Moderator: Mick Foy, Group Manager, Signal Management Group, Vigilance and Risk Management of Medicines, Medicines & Healthcare Products Regulatory Agency (MHRA)

• What to code from the case narratives
• Creating false signals and missing important signals
• How to achieve high quality against compliance timelines

TABLE 4: Endpoint Trials as a Risk Management Tool

Moderator: Stephen Lin, M.D., Head, Diabetes Medical Safety Evaluation, Global Pharmacovigilance & Epidemiology, sanofi-aventis

• How can Endpoint Trials serve as a Risk Management Tool? And, for what aspects?
• What are the limitations of these studies as a Risk Management Tool?
• When should Endpoint Trials be conducted, if they are used as a Risk Management Tool?

TABLE 5: Design and Execute a Proactive Risk Management Plan to Achieve the Best Benefit-Risk Ratio

Moderator: John McLane, Ph.D., COO & Vice President, Clinical and Regulatory, Clinquest, Inc.

• Anticipate early if a drug will likely to be put into a REMS program and at what level
• Evaluate if diagnosis, testing or follow-up will improve your assessment of benefit risk ratio (even if not at REMS level)
• Test your RMP at Ph II and III

TABLE 6:  Collaborative Research and Surveillance: Can Anyone Really Afford to “Go it Alone”?
Moderator: Daniel Foltz, Director, Health Informatics, Computer Sciences Corporation 
•  Influential stakeholders are creating collaborative networks to leverage the growing body of real world data for both research and surveillance purposes.
•  Which collaborative networks appear to be ones that will shape the future?  Why?
•  What are the common attributes of successful collaborative networks?
•  What opportunities and barriers exist for biopharmaceutical companies as these research and surveillance networks continue to emerge and evolve?


12:15 pm Sponsored Luncheon Presentation (Opportunity Available. Contact Arnie Wolfson: 781.972.5431, awolfson@healthtech.com) or Lunch on your Own



1:40 Chairperson’s Opening Remarks

Kelly D. Davis, M.D., Vice President, Safety, Epidemiology, Registries & Risk Management, United BioSource Corporation (UBC)

1:45 Case Study: Stratifying Risk among Populations

Carmen BozicCarmen Bozic, M.D., Senior Vice President and Global Head, Drug Safety and Risk Management, Biogen Idec, Inc.

2:15 Registries and Observational Studies: Analyzing and Incorporating Drug/Condition Information for Overall Population and Subgroups to Demonstrate your Product’s True Value and Risk/Benefit and Improve Decision Making

Susan Eaton, MSPH MT (ASCP), Research Manager, North America, General Practice Research Database, Medicines and Healthcare Product Regulatory Agency

2:45 Optimizing Electronic Health Records for Pro-Active Pharmacovigilance

Mick FoyMick Foy, Group Manager, Signal Management Group, Vigilance and Risk Management of Medicines, Medicines & Healthcare Products Regulatory Agency (MHRA)

This presentation will reflect on recent developments with the EHR and how these can aid ADR reporting, signal detection and risk management planning. The speaker aims to stimulate debate on the new capabilities offered by electronic health records. Audience will learn about up to date information on new UK initiatives and some of the pitfalls of e-transmission of such data.

3:15 Drug Safety on a Budget: Cost/Benefit Analyses and Budgeting for the Drug Safety Function

Barton CobertBarton Cobert, M.D., BLCMD Associates LLC; former Global Head, Pharmacovigilance, Schering-Plough Research Institute

Drug safety is a critical and vital function necessary to protect the public health. Although much is talked about and written regarding what is needed, how to minimize risk and how to do it, little is available on the cost/benefit analyses and budgeting for the drug safety function. This session will examine how to approach the issue and how to prepare a plan to perform excellent drug safety within a reasonable cost structure. The aim is to understand what functions are necessary and what functions are “nice to have”. We will examine which functions must remain in-house and which ones can feasibly and appropriately be out-sourced from the costing point of view. Finally, we will propose a strategy for companies, vendors and providers to develop the appropriate models for their situations realizing that small, mid-size and large companies all have different needs and interests.


3:45 What is the Best Method to Fulfill Post-Marketing Commitments and REMS Required Studies in the Current Regulatory Environment?


Sean Zhao Sean Zhao, M.D., Ph.D., Vice President, Global Safety, Amylin Pharmaceuticals, Inc.

John SeegerJohn Seeger, Pharm.D., DrPH, Adjunct Assistant Professor, Department of Epidemiology, Harvard School of Public Health

Paul CoplanPaul Coplan, D.Sc., MBA, Executive Director, Risk Management and Epidemiology, Purdue Pharma L.P.

Mary PendergastMary K. Pendergast, President, Pendergast Consulting; former Deputy Commissioner and Senior Advisor to the Commissioner, U.S. Food and Drug Administration

4:15 Closing Comments

4:30 End of Conference

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