Friday, November 6, 2009
7:45am Morning Coffee or Sponsored Breakfast Presentation (Opportunity Available)
8:30 Chairperson’s Opening Remarks
John McLane, Ph.D., Vice President Clinical and Regulatory Affairs, Clinquest
8:45 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
9:15 Optimizing the Allocation of an Organization’s Product Safety and Risk Management
Jill Robinson, R.Ph., M.B.A., Vice President, Global Safety Surveillance & Epidemiology, Wyeth
The product safety landscape is changing quickly. Regulators around the world are responding to legislative and public pressure. Therapies continue to increase in their complexity. Payers, consumers and other stakeholders in the healthcare market segment are more sophisticated about weighing drug benefits and safety risk.
Become familiar with new sourcing language and definitions
Different ways to think about how they can allocate and utilize their resources to ensure they are meeting all the needs of the regulators, company, HCPs and patients
Internal and external considerations that should be asked to make the right decision for the product
9:45 The Intersection of REMS in Driving Reimbursement & Access Strategy
Heather Morel, Vice President and General Manager, Reimbursement & Access Services, McKesson Specialty Care Solutions
With the growing presence of REMS in the industry, understanding what role REMS may play in the reimbursement and access environment is becoming a core element in launch planning. REMS programs are changing market access dynamics and reshaping reimbursement strategies, which are crucial to commercialization success. Organizations need to prepare themselves by developing and executing strategies that result in long-term product success, while ensuring safe use no matter what path the FDA may take the manufacturer. Leveraging recent REMS experiences, this session provides a view from the trenches that will put the manufacturer back in the driver seat for reimbursement and access success. Topics of discussion include:
Integrating REMS program development with reimbursement and commercialization strategies for optimal product access
Understanding how REMS drives reimbursement strategy and how unintended consequences of reimbursement challenges can impact REMS program operations
Examining how REMS drives a payer’s decision-making process and affects coverage and payment
Getting expert insights on designing, implementing, and operating successful REMS programs from the team who has been actively implementing REMS and reimbursement strategies
10:15 Networking Coffee Break
11:00 Are You Ready for a Crisis?
Cherif Benattia, M.D., former Vice President, Pharmacovigilance & Public Health, Vertex Pharmaceuticals, Inc.; CEO, Patient Safety 1st, APhaRC
Do you know where to start if something bad happens and you have to communicate to media, Health Authorities, HCP and patients? This communication will cover the basics of Crisis Management, how to build a crisis team and how to prepare a Risk-Crisis Communication Plan.
11:30 Drug Safety in Pregnant Women
Sonia Hernández-Díaz, M.D., Ph.D., Associate Professor, Epidemiology, Director, Pharmacoepidemiology Program, Harvard School of Public Health
Using a case-based study format, this session will acquaint participants with practical issues relevant or unique to the evaluation of drug safety in pregnant women. In the context of the Thalidomide and Bendectin drug safety debacles, facts ranging from scientific evidence to policy implications will be discussed by the participants. Important methodological aspects will be emphasized by the speaker.
Recognize the role of Thalidomide on FDA regulatory power.
Identify the main sources of data on drug safety during pregnancy.
Review the value and limitations of case reports.
Specify the main challenges of studying the teratogenicity of drugs.
12:00 Suicidality and Drug Safety in CNS and Beyond: What Do We Really Know and Where Are We Going?
Kelly Posner, Ph.D., Principal Investigator, Columbia/FDA Classification Project for Drug Safety Analyses, Director of the Center for Suicide Risk Assessment, Columbia University, Child Psychiatry, New York State Psychiatric Institute/Columbia University
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Hosted by
12:30 The Cooperative Roles of Safety Science, Clinical Safety and Marketing in Risk Management Program
Facilitator: Jack A. Reynolds, former-Senior Vice President of Research and Development and Worldwide Head of Safety Sciences and Comparative Medicine, Pfizer; Chairman, Drug Safety Executive Council (DSEC)
The increasing expectations and challenges in pharmaceutical safety and risk management cry out for the innovative and transformational changes. An important component to meet these objectives is to increase the opportunities for communication and timely dialogue around solutions and relevant topics. The Drug Safety Executive Council (DSEC) is emerging as an important enabler of these activities amongst the safety and regulatory community. In that spirit, this open discussion on what has been presented in the preceding session and capture key learnings that can be identified and reduced to practice in order to shape our future in drug safety and risk management. In this open discussion with the audience, Jack will lead a discussion focused on:
Current issues facing the safety community The Compelling case for cross-discipline, cross-department and cross-company collaboration How can an online safety community such as DSEC be beneficial? What are the limitations to data and best practice sharing amongst the industry What are the opportunities to improve our model and ensure success
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1:15 Closing Comments
1:30 End of Conference
Day 1 | Day 2
For questions or suggestions about the meeting, please contact:
Micah Lieberman
Executive Director, Conferences
Pharmaceutical Strategy Series
Cambridge Healthtech Institute (CHI)
T: (+1) 541.482.4709
E: mlieberman@pharmaseries.com
For exhibit, partnering and sponsorship information, please contact:
Arnold Wolfson
Business Development Manager
Pharmaceutical Strategy Series
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5431
E: awolfson@healthtech.com
For media and association partnerships, please contact:
James Prudhomme
Marketing Manager
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5486
E: jprudhomme@healthtech.com