Third Annual Risk Management and Drug Safety Summit

Transcription

1 Two powerhouse panels added for 2010 An exclusive summit presented by FDAnews in conjunction with United BioSource and the Center for Medicine in the Public Interest REMS Veterans Share Their Battlefront Tales Reading the Drug Safety Tea Leaves: Legal and Compliance Challenges That Lie Ahead Third Annual Risk Management and Drug Safety Summit Building an Effective Global Risk Management and Drug Safety Program Distinguished FDA Representatives Janet Woodcock M.D., Director, CDER, FDA Special Presenter John Jenkins M.D., Director, Office of New Drugs, CDER, FDA (invited) Sir Alasdair Breckenridge M.D., Chairman, Medicines and Healthcare Products Regulatory Agency Summit Faculty Mark Ammann, Pharm.D., Vice President, Regulatory Affairs, United Bob Anders, Pharm.D., Vice President, U.S. Processes & Systems, Lundbeck Carmen Bozic, M.D., Vice President, Drug Safety & Risk Management, Biogen Idec Kelly Davis, M.D., Vice President, Safety, Epidemiology & Risk Management, United Gerald Faich, M.D., M.P.H., FISPE, Senior Vice President, Safety, Epidemiology, Registries & Risk Management, United Edward Fotsch, M.D., CEO, PDR Network LLC Gary Friedman, M.D., Medical Director, Novartis Pharmaceuticals Patricia Fritz, Vice President, Government Affairs and Policy, UCB, Inc. (invited) Gordon Johnston, Vice President of Regulatory Sciences, Generic Pharmaceutical Association, former Deputy Director, Office of Generic Drugs, FDA (invited) Christopher Pitcherella, External Provider Management Team Leader, AstraZeneca Peter Pitts, Co-founder, President, Center for Medicine in the Public Interest, Partner/Director, Global Regulatory and Health Policy, Porter Novelli Juergen Schmider, M.D., Ph.D., Corporate Safety Officer and Vice President Global Pharmacovigilance & Epidemiology, Cephalon Annette Stemhagen, DrPH, FISPE, Senior Vice President, Safety, Epidemiology, Registries & Risk Management, United Josephine Torrente, J.D., Director, Hyman, Phelps & McNamara, P.C. Philippe van der Auwera, M.D., PhD., Global Head of Safety, Risk Management and European Qualified Person, F. Hoffman-La Roche AG

2 Third Annual Risk Management and Drug Safety Summit Building an Effective Global Risk Management and Drug Safety Program SUMMIT VENUE The National Press Club has been a part of Washington life for nearly 100 years. Through its doors have come all of the presidents of the U.S. since Theodore Roosevelt, as well as kings and queens, prime minister, premiers, senators, congressmen, cabinet officials, ambassadors, scholars, entertainers, business leaders and athletes. ABOUT THE CONFERENCE CO-CHAIRS Peter Pitts is co-founder and president of Center for Medicine in the Public Interest. Prior to founding CMPI, Mr. Pitts was a senior fellow for healthcare studies at the Pacific Research Institute, a San Francisco-based think tank. From 2002 to 2004, he was the FDA's associate commissioner for external relations, serving as the agency's chief messaging officer, where his challenge was to clearly define the FDA's brand image and to communicate the agency's main theme to its many constituencies. Annette Stemhagen, DrPH, FISPE, is senior vice president of safety, epidemiology, registries and risk management at United (UBS), where she provides strategic consultative services to pharmaceutical and biotechnology clients in epidemiology, safety surveillance and risk management. In addition, she assists other UBC groups in developing and implementing creative and innovative study design solutions to meet clients needs. Dr. Stemhagen has more than 25 years of public health epidemiological research experience, including 15 years in safety surveillance of pharmaceutical, biotech and vaccine products. Dr. Stemhagen received her undergraduate degree from the University of Pennsylvania, and her master's and doctoral degrees from the University of Pittsburgh Graduate School of Public Health in epidemiology. She holds adjunct faculty appointments at the University of Pennsylvania School of Medicine Center of Epidemiology and Biostatistics and the Temple University School of Pharmacy. Dr. Stemhagen is a fellow of the International Society for Pharmacoepidemiology. ABOUT THE HOST SPONSORS ABOUT Center for Medicine in the Public Interest The Center for Medicine in the Public Interest (CMPI) is a nonprofit, nonpartisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make healthcare more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, healthcare reform and comparative effectiveness. United UBC is a global pharmaceutical services organization that combines deep scientific knowledge with broad execution expertise across the life cycle continuum. UBC's focus is on generating real-world data to support the development and commercialization of medical products for emerging and established life science companies. UBC specializes in providing new and innovative ways to study drugs and devices. FDAnews publishes domestic and international regulatory, legislative and business news and information for executives in industries regulated by the U.S. Food and Drug Administration. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books, special reports and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations to get their products to market faster and boost profits. FDAnews is here to bring you the information you need, when you need it and how you need it.

3 Th Buildi SUMMIT AGENDA DAY ONE 8:00 a.m. 8:45 a.m. REGISTRATION AND CONTINENTAL BREAKFAST 8:45 a.m. 9:00 a.m. Welcome and Introduction by Chairperson Peter Pitts, Co-founder, President, Center for Medicine in the Public Interest, Partner/Director, Global Regulatory and Health Policy, Porter Novelli 9:00 a.m. 10:00 a.m. CDER s Efforts to Improve Risk Management and Drug Safety While we have a new administration and new officials in charge of the FDA, the goals of the FDA remain the same: oversight of the entire life cycle of drugs from premarket drug testing and development through drug approval, postmarket surveillance and risk management. How CDER is using additional resources and enforcement authorities to improve postmarket surveillance and drug safety What changes the agency has made in response to the globalization of the industry and international risk management concerns The FDA s efforts to strengthen the science that supports drug safety at every stage of the drug lifecycle Status report on FDAAA and how its implications are still being felt throughout the drug industry How the FDA s Sentinel Initiative will improve postmarket surveillance and safety Janet Woodcock, M.D., Director, CDER, FDA 10:00 a.m. 10:15 a.m. NETWORKING AND REFRESHMENT BREAK 10:15 a.m. 11:15 a.m. Risk Management in Drug Development A European Perspective Monitoring the long-term safety of marketed medicines is the responsibility of the regulator but of great importance to other stakeholders. Industry has failed to adhere to commitments previously given at the time of licensing, and the regulatory bodies have failed to put suitable systems in place. Politicians become engaged only after problems have arisen. Sir Alasdair Breckenridge will discuss how European risk management programs differ from REMS in the U.S. and suggest that regulators should consider asking for risk benefit assessment at regular intervals throughout the life cycle of a medicine rather than just risk assessment. The success and failures of industry, regulators and policymakers in managing drug safety The key differences between U.S. and EU regulatory schemes and enforcement What emerging standards could be used to assure all stakeholders are in agreement? How to use risk benefit assessment throughout the product lifecycle Sir Alasdair Breckenridge, Chairman, Medicines and Healthcare products Regulatory Agency, UK 11:15 a.m. 12:00 p.m. Innovative Strategies for Developing Elements to Assure Safe Use in a Classwide REMS Opioid analgesics have been used with success in pain management for de cades but have proven to carry sig nificant risks as well. What are these risks? How can they be managed? Can we preserve patient benefit while protecting public health? This pre sentation will outline considerations and challenges for the pharmaceutical industry in managing the risks associated with Class II opioid analgesics and the regulatory landscape. Implications from the FDA s recent proposal for a classwide opioid REMS Finding common ground among industry, regulators, physicians and patients Application to other therapeutic areas/ product classes Juergen Schmider, M.D., Ph.D., Corporate Safety Officer and Vice President Global Pharmacovigilance & Epidemiology, Cephalon 12:00 p.m. 1:00 p.m. LUNCH 1:00 p.m. 1:45 p.m. REMS Evaluations: What Have We Learned? A critical component of any REMS is defining how the success of the plan will be measured. This presentation will provide an overview of possible REMS evaluation methodologies, give specific examples of REMS evaluation plans that have been utilized for assessments and provide summary results from actual programs. The range of evaluation methods that can be used to assess risk management interventions The criteria used to select those methods most appropriate for the circumstances, including REMS with Medication Guides, Communication Plans, and/or Elements to Assure Safe Use The planning and timing of REMS evaluations The format for presenting findings in the REMS assessment report Kelly Davis, M.D., Vice President, Safety, Epidemiology & Risk Management, United 1:45 p.m. 2:30 p.m. Signal Detection, Triaging and Assessment Keys to Integrated Safety Management With the global focus on safety increasing, an integrated approach is necessary to assure patients are protected. Effective signal detection, triaging and assessment

4 ird Annual Risk Management and Drug Safety Summ ng an Effective Global Risk Management and Drug Safety Pro are the keys to building a safety system that assures product safety and meets regulatory expectations. Each requires an open-minded approach that draws on multiple variables and internal and external resources to assure the highest quality program. How to use iterative data mining processes including literature, clinical, safety and epidemiology databases for signal detection Strategies for dealing with the real surprises, often with no biological plausibility Developing a strong disciplined benefit/ risk framework as a basis for an integrated safety management system Seeing REMS as a product of the integrated safety management process Philippe van der Auwera, M.D., Ph.D., Global Head of Safety, Risk Management and European Qualified Person, F. Hoffman- La Roche AG 2:30 p.m. 3:15 p.m. REMS: Beyond the Rhetoric Post-healthcare reform and PDUFA reauthorization how is the FDA using its new REMS authority to both protect and advance the public health? How has the agency's draft guidance, actions and requests for additional authority helped (or hindered) the use of REMS as a progressive regulatory tool? How has the FDA been implementing REMS since FDAAA? Will the FDA be granted greater authority for REMS under PDUFA? How have FDA actions impacted non-u.s. drug regulation? How has industry adapted to the new REMS environment? Peter Pitts, Co-founder, President, Center for Medicine in the Public Interest, Partner/ Director, Global Regulatory and Health Policy, Porter Novelli 3:15 p.m. 3:45 p.m. NETWORKING AND REFRESHMENT BREAK 3:45 p.m. 4:30 p.m. FDA s Office of New Drugs Perspective on Risk-Benefit Considerations Regulatory risk/benefit (R/B) decisionmaking is a qualitative science grounded in quantitative data. Professional judgment is required in making regulatory R/B decisions and those judgments are influenced by many factors, both extrinsic and intrinsic. The FDA's Office of New Drugs works hard to clearly outline the available data and explain how decisions (judgments) are made to improve the safety and efficacy of drugs. How the FDA is working to improve predictability and consistency through a standardized structure Balancing regulators population R/B view with the doctors and patients individual R/B view Understanding how the OND interprets statutory standards that do not require new therapeutics be superior to available choices, only that it be safe and effective for the intended use Dr. John Jenkins, Director, Office of New Drugs, CDER, FDA (invited) 4:30 p.m. 5:30 p.m. Incorporating Risk Management Strategies Throughout the Product Life Cycle The regulatory and corporate emphasis put on PMR and REMS is a formidable incentive to manage in a much more robust way the benefit-risk perspective of medicines whether in development or approved and in use. The impact of REMS when developing and marketing new medicines is important and affects the organizational structure, human resources, key cross-functional processes, methods for running clinical studies as well as analyzing, reporting and governance. This presentation will detail Novartis significant experience in PMR and REMS programs. Important gaps and how to address them understanding the benefit-risk decisionmaking by manufacturers, prescribers and patients Best practices for developing REMS strategies and implementation programs throughout drug development Gary Friedman, M.D., Medical Director, Novartis Pharmaceuticals 5:30 p.m. 6:30 p.m. ADJOURNMENT AND NETWORKING RECEPTION DAY TWO 8:00 a.m. 8:45 a.m. CONTINENTAL BREAKFAST 8:45 a.m. 9:00 a.m. Welcome and Introduction by Chairperson Annette Stemhagen, DrPH, FISPE, Senior Vice President, Safety, Epidemiology, Registries & Risk Management, United 9:00 a.m. 10:00 a.m. Panel Discussion: Reading the Drug Safety Tea Leaves Top Legal and Compliance Challenges That Lie Ahead This panel discussion will feature some of the nation s top legal and regulatory experts who will discuss and analyze what the future might hold for REMS and drug safety initiatives and their implementation. Additionally, they will spotlight product classes that might be next in line for REMS. Moderator: Mark Ammann, Pharm.D., Vice President, Regulatory Affairs, United BioSource Corporation Panelists: Gordon Johnston, Vice President of Regulatory Sciences, Generic Pharmaceutical Association, former Deputy Director, Office of Generic Drugs, FDA (invited)

5 it gram Edward Fotsch, M.D., CEO, PDR Network LLC Josephine Torrente, J.D., Director, Hyman, Phelps & McNamara, P.C. Peter Pitts, Co-founder, President, Center for Medicine in the Public Interest, Partner/Director Global Regulatory and Health Policy, Porter Novelli, former Associate Commissioner for External Relations, FDA Gerald Faich, M.D., M.P.H., FISPE, Senior Vice President, Safety, Epidemiology, Registries & Risk Management, United 10:00 a.m. 11:00 a.m. Panel Discussion: REMS Veterans Share Their Battlefront Tales Negotiating a REMS with the FDA is tough. Working with the agency to balance the safety and efficacy characteristics and concerns requires medical, regulatory, legal, compliance and commercial experience and expertise. This panel is comprised of REMS veterans each panelist has already been through the REMS approval process. Panelists will share their unique experiences, along with tips, tricks and a few secrets to REMS approval success. Moderator: Patricia Fritz, Vice President, Government Affairs and Policy, UCB, Inc. (invited) Panelists: Gerald Faich, M.D., M.P.H., FISPE, Senior Vice President, Safety, Epidemiology, Registries & Risk Management, United Carmen Bozic, M.D., Vice President, Drug Safety & Risk Management, Biogen Idec Gary Friedman, M.D., Medical Director, Novartis Pharmaceuticals Bob Anders, Pharm.D., Vice President, U.S. Processes & Systems, Lundbeck Christopher Pitcherella, External Provider Management Team Leader, AstraZeneca WHO SHOULD ATTEND Executive Management Regulatory Affairs Risk Management Professionals Clinical Safety/ Pharmcovigilance Medical Affairs/ Medical Safety Research and Development Commercial Affairs/ Business Development Clinical Trial Directors COMPANIES THAT ATTENDED THE 2009 RISK MANAGEMENT AND DRUG SAFETY SUMMIT Abbott Abraxis BioScience AcelRx Pharmaceuticals Adolor Allergan Alpharma Pharmaceuticals Amgen ApoPharma Aris Global Baxter Healthcare Becton Dickinson BioMarin Bristol-Myers Squibb Campbell University Cangene Celgene Centocor Ortho Biotech Clinquest Covidien Daiichi Sankyo Dendreon Drug Safety Alliance Eli Lilly Endo Pharmaceuticals EPI-Q EpiSource FDA Forest Laboratories Genentech Genzyme Greg A Burkhart LLC Helsinn Healthcare Hoffmann-La Roche InterMune Intrexon Janssen-Ortho Javeline Pharmaceuticals Johnson & Johnson KV Pharmaceutical Lundbeck Mannkind MAPI USA McKesson Medscape CME Medtronic Millennium MJM Signature Group Novo Nordisk Otsuka Pharmaceuticals Palio Pfizer Portola Pharmaceuticals PPD Medical Communications PRA International Promethus Laboratories Purdue Pharma Quintiles Reckitt Benckiser Pharmaceuticals Registrat-Mapi Rienzi & Rienzi Communications Roche RTI Health Solutions Sanofi-Aventis Sanofi Pasteur Schering-Plough Sermo Sheppard Mullin Solvay Pharmaceuticals Summit Takeda Pharmaceuticals Teva Pharmaceutical The CementWorks TheraCom Unigene Laboratories Unither Vertex Pharmaceuticals ViroPharma

6 Third Annual Risk Management and Drug Safety Summit Building An Effective Global Risk Management and Drug Safety Program LOCATION AND HOTEL ACCOMODATIONS Hotel rooms have not been designated for this event. For your convenience, please refer to a list of the nearest hotels to the National Press Club on the conference website at Conference Venue: National Press Club th Street, NW Washington, DC (202) CANCELLATIONS AND SUBSTITUTIONS Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund less a $200 administration fee. No cancellations will be accepted nor refunds issued within 21 calendar days of the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice. TEAM DISCOUNTS Significant tuition discounts are available for teams of three or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount. Call (888) for details. TUITION Tuition includes all summit sessions, summit written materials, two breakfasts, one luncheon, cocktail reception and daily refreshments. FOUR EASY WAYS TO REGISTER Online: Fax: +1 (703) Phone: Toll free (888) (inside the U.S.) or +1 (703) Mail: FDAnews, 300 N. Washington St., Suite 200 Falls Church, VA U.S.A. EXHIBIT AND SPONSORSHIP OPPORTUNITIES For exhibit and sponsorship opportunities at this event, please contact: Matt Salt +1 (703) Fax: +1 (703) msalt@fdanews.com z YES! I want to attend the Third Annual Risk Management and Drug Safety Summit on Oct , Sign me up for the options I've selected below. Early Bird Fee before Sept. 17, 2010 No. of Attendees Regular Fee Sept. 18 Oct. 19, 2010 Complete Summit $1,967 $2,297 TOTAL PAYMENT $ $ No. of Attendees 300 N. Washington St., Suite 200 Falls Church, VA Attendee 1: Name Title Attendee 2: Name Title address (so you can receive order acknowledgements, updated news, product information and special offers) Company Information Organization Address City State Zip Country Phone Fax Payment Options Check enclosed, payable in U.S. funds to FDAnews Charge to: Visa MasterCard American Express Credit card no. Expiration date Total amount $ Signature (Signature required on credit card and bill-me orders.) Print name Bill me/my company $ Purchase order # (Payment is required by the date of the conference.) Copyright 2010 by FDAnews