RMDS 2010 Agenda

Untitled Document

DAY ONE

8:00 a.m. – 8:45 a.m.

Registration/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.

Attendees will learn:

  • How CDER is using additional resources and enforcement authorities to improve post market 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 life-cycle
  • Status report on FDAAA and how its implications are still being felt throughout the drug industry
  • How the FDA’s Sentinel Initiative
    will improve post market 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 will discuss how European risk management programs differ from REMS in the US 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. He’ll also discuss using agreed upon frameworks so that different stakeholders can become involved in the debate.

Attendees will learn:

  • The success — and failures — of industry, regulators and policymakers in managing drug safety
  • The key differences between US 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.

Beyond REMS – The Strategic Advantage
New regulatory demands and controls, specifically the new REMS legislation appear to encroach deep into the profit margin while simultaneously the blockbuster era is coming to an end. However, this new environment also offers opportunities for product differentiation and long term strategic positioning. During this session, the speaker analyzes societal expectations and customer demands on drug treatment specifically in relation to pharmacovigilance and safety risk management. He will address the consequences of failure to adapt and explore emerging opportunities for companies adapting early, as well as strategies to transform into a state of the art benefit/risk focused pharma company.

Attendees will learn:

  • The dynamics and demands of the healthcare environment in the REMS dominated regulatory environment
  • How to utilize recent developments in regulatory risk management regulations to build a strategic advantage

Juergen Schmider M.D., Ph.D., Corporate Safety Officer and Vice President Global Pharmacovigilance & Epidemiology, Cephalon

12:00 p.m. – 12:45 p.m.

Lunch Break

12:45 p.m. – 1:00 p.m.

Morning Recap and Introduction by Chairperson

Annette Stemhagen, DrPH, FISPE, Senior Vice President, Safety, Epidemiology, Registries & Risk Management, United BioSource Corporation

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.

Attendees will learn:

  • 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 BioSource Corporation

1:45 p.m. – 2:30 p.m.

Practical Approaches to Lifecycle Signal Detection — Case Studies Where Data Mining Provided Valuable Insight Into Potential Signals
Proactive pharmacovigilance has become of paramount importance to facilitate risk management activities. In this session, attendees will be shown practical approaches to lifecycle signal detection. The presentation will provide an analysis of the methods used in signal detection from basic sorting and imputation screening methods to disproportionally methods and will identify some of the available data mining tools currently in use. This presentation will provide case studies where data mining provided valuable insight into potential signals. In addition, the presentation will show examples of recent FDA actions precipitated by product risk identification and show how proactive signal programs together with innovative technology solutions can identify and mitigate risk earlier in the product life cycle.

Attendees will learn:

  • Practical signal management program principles
  • What data sources for suitable and available for signaling?
  • What is the process for signaling? Specifically describing detection, prioritization, assessment and evaluation?
  • What methods are used in signal detection?
  • What types of questions can be answered by using data mining methods?

Elizabeth Garrard, Pharm.D., Chief Safety Officer, Drug Safety Alliance

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?

Attendees will learn:

  • How has the FDA been implementing REMS since FDAA?
  • Will the FDA be granted greater authority for REMS under PDUFA?
  • How have FDA actions impacted non-US 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

Rob Dhoble, President, Diversified Agency Services Healthcare, Omnicom Group, and Founder, Adherent Health, LLC

3:15 p.m. – 3:30 p.m.

Networking and Refreshment Break

3:30 p.m. – 4:15 p.m.

Safety Risk Management and Benefit/Risk Assessment: Considerations and Challenges in Oncology
Effective safety risk management and assessments of benefit/risk relationships are essential for all marketed products. This is particularly important in the field of oncology where disease-related morbidity and mortality rates are often high, and treatments frequently involve significant risks. This presentation will provide examples to illustrate some of the issues faced by innovators, regulators, and prescribers in managing safety risk and assuring positive benefit-risk relationships in the treatment of malignancies.

Attendees will learn:

  • How REMS are affecting safety risk management in cancer
  • How the assessment of benefit-risk relationships in oncology may be confounded by disease- and treatment-related factors
  • Examples of how new agents are being developed and novel personalized healthcare approaches are being used to improve the balance of benefit and risk in cancer treatment

Joseph Hoffman, M.D., F.C.C.P., Global Head, Safety Science, Oncology Safety Risk Management, Roche Pharmaceuticals and Genentech, a Member of the Roche Group

4:15 p.m. – 5:00 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.

Attendees will learn:

  • Important gaps and how to address them — understanding the benefit-risk decision making by manufacturers, prescribers and patients
  • Best practices for developing REMS strategies and implementation programs throughout drug development

Gary Appio, Pharm.D., US Safety Risk Director, Novartis Pharmaceuticals

5:00 p.m. – 6:15 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

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

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:

  • Christine Côté, M.D., Chief Medical Officer, PDR Network
  • Josephine Torrente, J.D., Director, Hyman, Phelps & McNamara
  • 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 BioSource Corporation

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:
Gerald Faich, M.D., M.P.H., FISPE
, Senior Vice President, Safety, Epidemiology, Registries & Risk Management, United BioSource Corporation

Panelists:

  • Carmen Bozic, M.D., Senior Vice President and Global Head of Drug Safety and Risk Management, Biogen Idec
  • Gary Appio, Pharm.D., US Safety Risk Director, Novartis Pharmaceuticals
  • Bob Anders, Pharm.D., Vice President, US Processes & Systems, Lundbeck
  • Christopher Pitcherella, External Provider Management Team Leader, AstraZeneca