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Risk Management Legislation,
Guidance, and Best Practices
October 22, 2008

Post-Approval Drug Safety Strategies - Day 1

WEDNESDAY, NOVEMBER 12, 2008

7:30 am Registration and Morning Coffee

8:15 Organizer’s Welcome and Chairperson’s Opening Remarks
Micah Lieberman, Executive Director, Conferences, Pharmaceutical Strategy Series, CHI
John Ferguson, M.D., Ph.D., Vice President & Global Head, Pharmacovigilance & Medical Safety, Novartis Vaccines & Diagnostics

INCLUSIVE OPENING WORKSHOP LED BY
United BioSource Corporation

IN-DEPTH CO-PRESENTATION ON
DEVELOPING AND IMPLEMENTING A RISK MANAGEMENT PLAN

8:20-10:15 am

Identifying and Minimizing Product Risk: A Program Example from Safety Signal Identification through Implementation and Evaluation of a REMS Program

This interactive workshop will present you with facts and challenges about a safety issue from early identification of the signal to design and implementation of a Risk Evaluation and Mitigation Strategy (REMS), through evaluation of the REMS. Experts will guide you through a timeline for key decision points in risk management, strategies your company can use to minimize risk, “tool” creation, implementation of a minimization program and evaluation of the REMS.

Key Lessons Learned:

Identifying key decision points for risk management during product development
Designing and evaluating risk management “tools”
Establishing an infrastructure for risk minimization
Understanding the results of a risk management program evaluation and designing a solution to address any identified problem areas
Reporting effectiveness of risk management programs to regulatory agencies

Your Workshop Leaders:
Your workshop leaders are experts in safety signaling, risk assessment and risk minimization, having been involved in 25 regulatory mandated studies for risk assessment; signal detection and evaluation for more than 40 products and over 30 risk management programs.

Chad Clark, Senior Vice President Operations, Epidemiology Risk Management, United BioSource Corporation
Abbe Steel, Executive Director, Trial Enhancement Services, United BioSource Corporation
John Clark, MD, MSPH, Vice President, Epidemiology Risk Management, United BioSource Corporation
Gwyneth Moya, M.P.H., Epidemiology Risk Management, United BioSource Corporation
Bob Sharrar, M.D., MSc, BA, Executive Director, Epidemiology and Risk Management, United BioSource Corporation

10:20 Networking Coffee Break

PROACTIVE APPROACHES TO SAFETY AND RISK MANAGEMENT

10:55 Chairperson’s Remarks
John Ferguson, M.D., Ph.D., Vice President & Global Head, Pharmacovigilance & Medical Safety, Novartis Vaccines & Diagnostics

11:00 Problem Oriented Safety Evaluation through the Life Cycle
Joanna Haas Joanna F. Haas, M.D., M.Sc., Vice President, Pharmacovigilance, Genzyme
Drug safety risks require integrated life cycle management. Over the course of the product life cycle, enormous quantities of data are generated from different sources. The meaning of certain observations can only be interpreted over time and in the context of new information. Meaningful organization of these data requires a problem oriented approach. Potential safety concerns are identified at each stage of development and previously identified concerns are reevaluated in an iterative fashion as new information becomes available, regardless of source. This approach has implications for all aspects of drug development and post-approval safety management.

A problem oriented approach to safety issues increases transparency and facilitates decision making.
Information from diverse sources is integrated into a matrix of known or potential safety concerns.
Safety concerns are evaluated in an iterative fashion throughout the product life cycle.
Longitudinal issue tracking is essential but challenging

11:30 Genomics Role in Safety: Moving from Observation to Prediction & Leveraging New Tools and Thinking
Dan Burns Dan Burns, Ph.D., Sr. Vice President, Pharmacogenetics,GlaxoSmithKline

12:00 pm Sponsored Luncheon Workshop (Sponsorships available, please contact Arnie Wolfson +1.781.972.5431, awolfson@healthtech.com)
or Lunch on Your Own

ORGANIZATIONAL AND CULTURAL CONSIDERATIONS AND CHALLENGES

1:45 Challenging Organizational Structure and Current Thinking in Drug Safety: Taking a Holistic Approach to Data and Departments
Milbhor D'Silva Milbhor D'Silva, M.D., Vice President, Product Safety & Pharmacovigilance, Astellas Pharmaceuticals
Safety departments in small, mid-sized, and large Pharma companies are under increasing regulatory scrutiny and pressure to rethink their ‘safety mindset and culture’ and move from a reactive and defensive position to a proactive and more forward looking mindset. Implicit in that messaging is the expectation that by implementing a more holistic approach towards safety risk ascertainment and management within their organization, any drug development enterprise will exercise more responsibility and accountability towards public health, the welfare of which should be an integral part of any drug development initiative from the outset. Our safety organizational structures and strategies are laden with legacies that obviously do not meet our needs today and tomorrow. Instead of tinkering with legacy systems and practices, it may benefit us to re-engineer and re-invent the much needed safety leadership that meets or exceeds the challenges we are already facing. This presentation will allow one to deepen one’s understanding on at least three fronts: how we got here, the need for an audacious safety/risk culture mindset change, and how best to re-organize our departments with adequate doses of leverage, objectivity, and decision authority thrown in. The presentation will touch on a few thought-provoking themes:

Creating a New Paradigm for Safety
Moving beyond guideances and risk man plans, get off of auto-pilot
Cultural Considerations
Organizational Considerations (How to build safety surveillance and risk management groups while still doing the day-to-day work of safety)
Strategic Considerations
Tactical Considerations when Initiating Change
A Holistic Approach to Safety

2:15 Optimizing the Allocation of an Organization's Drug Safety Assessment Resources
Jill Robinson Jill Robinson, R.Ph., M.B.A., Vice President, Global Safety Surveillance & Epidemiology, Wyeth

2:45 Networking Refreshment Break

3:45 Risk Management as Prerequisite for Commercial Success: It's Time for a Chief Safety Officer
Nayan Nanavati Nayan T. Nanavati, Vice President and GM, Peri and Post Approval Research (PACE), Americas, PAREXEL International

4:15 Global Product Risk Management Planning: Organizational Process, Structure and Governance for Getting ‘All Hands on Board’
Susan Rosen Susan Rosen, M.D., Senior Vice President, Global Pharmacovigilance & Risk Management, Shire Pharmaceuticals
Developing global risk management planning strategies in an evolving regulatory environment requires bringing all company stakeholders together in an integrated approach. Regardless of organizational structure or size, basic principles relative to process, structure, and governance need to be considered to successfully support benefit/risk assessment and global risk management planning throughout product development and commercialization.

Understanding the goals and objectives of pharma risk management planning and the process and activities in different phases of drug development and commercialization
Implementing the forums, roles and responsibilities, and governance for benefit/risk assessment and risk management in highly matrixed multidisciplinary R&D organizations
Developing SOPs, tools and templates for risk management activities
Transitioning clinical data and internal risk management plans into health authority pharmacovigilance and risk management plan submissions
Lessons learned from implementation of US and EMEA Risk Management Guidances

OPEN DISCUSSION:

4:45 The Cooperative Roles of Safety Science, Clinical Safety and Marketing in Risk Management Program
Jack Reynolds 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 could 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

5:30 Networking Cocktail Reception

6:30 Close of Day One

DAY 2 >