Post-Approval Drug Safety Strategies - Day 2



8:15 am Morning Coffee (Breakfast Workshop Sponsorship Available)


8:40 Chairperson’s Opening Remarks
Sean Darcy, Director, Product Safety, MedImmune, Inc.

8:45 Effectively Working with Data and Safety Monitoring Boards (DSMBs) to Ensure Patient Safety and Study Integrity
Sean Darcy Sean Darcy, Director, Product Safety, MedImmune, Inc.
Planning for a DMC during clinical development requires careful planning, design, implementation and evaluation. Various factors impact the function and operation of a DMC including member experience with DMCs, length and size of trial, therapeutic expertise and ethics of the trial. It is imperative that a sponsor understand the role and responsibility of a DMC and effectively manage the sharing of data on a periodic and/or ad-hoc basis.



  • Determine eligibility of DMC membership
  • Strategies for overcoming shortage of DMC members
  • Criteria for effective DMC Chair
  • Balancing expertise and personality
  • Effective Charter
  • DMC Data Review

9:30 Participating as a DSMB Member: Challenges and Responsibilities
Yola Moride Yola Moride, Ph.D., FISPE, Associate Professor of Pharmacy, Université de Montréal; President, International Society for Pharmacoepidemiology (ISPE)





  • What is being done well/what is not being done well to ensure patient safety and study integrity: A Board Member's perspective
  • Where DSMBs should be in the future, next steps
  • DSMBs as a part of a pro-active risk communication strategy

10:00 Networking Coffee Break


10:45 Proactive Risk Communication as Key to Public Health and Pharmaceutical Risk Benefit Management Strategy
Cherif Benattia Cherif Benattia, M.D., Vice President, Pharmacovigilance & Public Health, Vertex Pharmaceuticals, Inc.
The objective of good communication is to compel Health Care Professionals (HCP) and patients to use drugs in the most appropriate and safest ways. If (HCP) and patients understand the drug information better they can change their behavior and act on it. Despite advances in information and communication technologies, communicating risks from any source to any audiences is still a challenge. Risk communication remains one of the key challenges in Risk Management. We recommend that Risk Communication strategies should be developed during drug development as a key component in Risk Management.


  • Identify the key factors for risk perception
  • Develop a risk communication plan as part of the risk management strategy
  • Implement the basics of good risk communication practices

 11:15 CASE STUDY of TYSABRI: RiskMAP Development and Implementation
Carmen Bozic Carmen Bozic, M.D., Vice President and Global Head, Drug Safety and Risk Management, Biogen Idec, Inc.
Natalizumab is the first 4-integrin antagonist approved for the treatment of relapsing MS. Natalizumab monotherapy significantly reduced annualized relapse rate by 68%, and 12- and 24-week sustained disability progression by 42-54%, respectively, compared with placebo in a pivotal Phase 3 study. Due to the rare risk of progressive multifocal leukoencephalopathy (PML) associated with natalizumab, there is an ongoing risk management program to further evaluate the safety of natalizumab: the TYSABRI Outreach: Unified Commitment to Health (TOUCH™) Prescribing Program. The TOUCH Prescribing Program is a mandatory prescribing program in the United States into which all patients, physicians, and infusion centers must enroll prior to initiating natalizumab treatment. This program ensures appropriate and informed use of natalizumab. Physicians monitor patients for signs and symptoms of PML and report on serious opportunistic infections, including PML, deaths, and natalizumab discontinuations. This presentation will provide an update on the status of the program.


11:45 Sponsored Luncheon Workshop (Sponsorships available, please contact Arnie Wolfson +1.781.972.5431, or Lunch on Your Own


1:30 Chairperson’s Remarks
Jan Willem van der Velden, M.D., Senior Vice President, Global Safety and Pharmacovigilance, PharmaNet

 1:45 Data Mining and Beyond: The Integration of Qualitative and Quantitative Pharmacovigilance Methods
Michael Blum Michael D. Blum, M.D., M.P.H., Vice President, Global Safety Surveillance and Epidemiology, Wyeth Research
While pharmacovigilance has traditionally integrated qualitative and quantitative methods, the sophistication of quantitative methods has markedly increased with advances in computer systems. Available data mining methods for application to spontaneous reporting databases now permit the combination of millions of two-by-two tables using Bayesian algorithms to determine if an adverse event has been disproportionately reported. This presentation will discuss the challenges faced when routinely implementing these methods as an adjunct to traditional pharmacovigilance.



 2:15 Improving Pharmacovigilance through Active Surveillance: Opportunities and Challenges
Robert Reynolds Robert F. Reynolds, Sc.D., Executive Director, Epidemiology Safety and Risk Management, Pfizer, Inc.
Active, continuous safety monitoring of new medicines, vaccines and devices using large, electronic healthcare databases holds promise for enhancing our pharmacovigilance capabilities. These approaches complement passive surveillance systems and may increase the likelihood of identifying adverse events difficult to detect in voluntary systems. To advance the use of these data it is critical to develop and standardize operational guidance; introduce, test and validate methods for identifying signals of suspected and unsuspected adverse events; and improve data access and integration capabilities. It is also necessary to clarify the strengths and limitations of using these data for active surveillance, since these data are not sufficient to monitor all safety concerns. This talk will review general approaches to active surveillance and provide an industry perspective on areas for further development.


2:45 Networking Refreshment Break

 3:30 CASE STUDY: Disease Management Programs as a Tool for Risk Management
Yola Moride Yola Moride, Ph.D., FISPE, Associate Professor of Pharmacy, Université de Montréal; President, International Society for Pharmacoepidemiology (ISPE)
Disease management (DM) programs have traditionally been designed to optimize health care resources. Central to the success of these programs is the presence of communication activities that aim at empowering the patient and, consequently, the care process. The application of disease management programs as part of the risk management toolbox will be discussed.



  • Efficacy of DM programs to optimize the benefit-risk of medicines using antidepressants as a demonstration case-
  • Assessment of efficacy on the following outcomes: retention rate in program, treatment persistence, qualitative assessment of acceptability by all stakeholders
  • Barriers of implementation in general practice
  • Return on investment for large organizations through departments of human resources

 4:00 Transforming Health Plan Assets into an Environment for Clinical Evidence Generation: The Wellpoint Safety Sentinel System
Marcus Wilson Marcus D. Wilson, Pharm.D., President, HealthCore, a unit of WellPoint
WellPoint's Safety Sentinel System, being developed in collaboration with leading academic institutions and as an interoperable component of the national system under development by US health regulators, is focused on delivering more rapid and granular assessments of potential health risks of drugs as they are utilized in the general population. This presentation will outline the strengths and limitations of active surveillance using claims data and will cover strategies to improve the accuracy, speed and cost-effectiveness of large-scale post-marketing assessments.



4:30 Roundtable Discussions:
Concurrent round tables are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. 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. Evaluation of Risk Minimization Interventions
Yola Moride Yola Moride, Ph.D., FISPE, Associate Professor of Pharmacy, Université de Montréal; President, International Society for Pharmacoepidemiology (ISPE)
This is the last section of the EU risk management template, and often is problematic for the industry. What are the methods of evaluation and what are people in drug safety risk management doing?



 Table 2. Outsourcing Post Approval-Drug Safety
Jill Robinson Jill Robinson, R.Ph., M.B.A., Vice President, Global Safety Surveillance & Epidemiology, Wyeth




Table 3. Managing DMC Processes for Maximal Independence
Cathy Tyner Catherine A. Tyner, M.A., M.F.A., A.B.D., Global Director, CEVA, Safety Services, Drug Safety & Medical Affairs, Quintiles, Inc.
Jill Edwards, Associate Director, CEVA, Drug Safety & Medical Affairs, Quintiles, Inc.



 Table 4. Choice of Databases for Safety Surveillance
Michael Blum Michael D. Blum, M.D., M.P.H., Vice President, Global Safety Surveillance and Epidemiology, Wyeth Research
With increasing availability of spontaneous report, claims, and large-linked databases that can conceivably be used for prospective safety surveillance, the choice of databases by industry is by no means simple and has significant resource implications.



Table 5. Marketing and Drug Safety: Enemies or Allies
Jan Willem Jan Willem van der Velden, M.D., Senior Vice President, Global Safety and Pharmacovigilance, PharmaNet




Table 6. Costs and Opportunities of Phase IV Risk Management Programs
Nayan Nanavati Nayan T. Nanavati, Vice President and General Manager, Peri and Post Approval Research (PACE), Americas, PAREXEL International
Utility of Post Marketing Clinical Trials, specifically registries, in Risk Identification and Risk Management is a well established concept. However, we can expend and optimize the role of post marketing studies to better manage safety risks associated with a marketed product. We will evaluate current practices, evolving roles and cost implications of late phase studies in Risk Management programs


 Table 7. Expanded Access Programs
Joanna Haas Joanna F. Haas, M.D., M.Sc., Vice President, Pharmacovigilance, Genzyme
With the prospect of approval of an effective new agent come demands to make it available quickly. There are a variety of ways that can be done, each with its advantages and limitations. This is an opportunity to share experiences and consider options that are available



Table 8. Drug Interaction Programs
Facilitator to be Announced

 Table 9. Identifying and Managing Pharmacovigilance Risk with Alliance Partners
Ashraf Youssef Ashraf Youssef, M.D., Ph.D., M.B.A., Associate Medical Director, Pharmcovigilance, Takeda Pharmaceuticals




  • Models of safety management among partners/alliances
  • Examples of challenging issues in safety management among partners/alliance
  • Best practices in managing safety issues among partners/alliances

Table 10. Organizational Structure (Operations) in Pharmaceutical Companies for Drug Safety and Risk Management
Cathy Sigler, Ph.D., M.P.H., Senior Director, Epidemiology Risk Management, United BioSource Corporation
Gwyneth Moya, M.P.H., Epidemiology Risk Management, United BioSource Corporation

Table 11. The Use of Post Marketing Surveillance Data (e.g., spontaneous reports) to Fulfill Risk Management Obligations
Robert BaderRobert Bader, Pharm.D., Director of Drug Safety Services, Covance Periapproval Services
This discussion will include the pros and cons of utilizing post marketing data to address safety questions posed by regulatory authorities. Considerations for global safety departments will be highlighted, as well as data quality and cost efficiencies.

5:30 Close of Day Two

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