Safety Risk Management Company Perspective
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1 Safety Risk Management Company Perspective Akihisa Harada, MD, Ph.D VP, Development Japan Pfizer Japan Inc. R&D Head Club
2 Agenda REMS in FDAAA Safety Risk Management throughout a Drug s Lifecycle Risk Communications Conclusions cuso s
3 What is Risk Management Comprehensive and proactive science based methodologies Identify safety risk earlier Assess appropriately Communication Minimize i i risk Establish benefit risk profile
4 Risk Evaluation and Mitigation Strategies (REMS) in US PDUFA IV FDA Safety Five-year plan (draft Mar. 2008,) Required Based on FDA Benefit-Risk Assessment with $250 K - $10 MM REMS violation penalties REMS Elements: Medication Guide Risk Communication Plan Elements to Assure Safe Use Implementation System Assessment of REMAS: Timetable of Assessments Information needed for Assessment
5 Safety Risk Management throughout a Drug s Lifecycle
6 Risk management across the product lifecycle Product Life Cycle Animal studies Drug Discovery/Preclinical FIM Ph I Ph II Ph III Ph IV Clinical Development Approval Post Approval Pharmacovigilance Estimate potential benefit Understand the disease Predict potential candidates Disease Mechanism of Action Studies Studies to better understand population, risks, etc ID potential signals Promote better approval analysis Achieve appropriate label Address any new emerging safety issues Post-approval studies and epidemiology Signal detection Product defense risk management planning
7 Understanding Risk and Accumulation of Knowledge of Safety Profile Earlier Risk Management Planning is key for successful product life cycle management Clinical Studies Background Spontaneous Observational Other Epidemiology Reports Studies Activities POTENTIAL RISK IDENTIFIED FROM NON-CLINICAL STUDIES INCIDENCE OF COMMONLY OCCURRING EVENT FROM CLINICAL TRIALS INCIDENCE OF EVENT IN GENERAL POPULATION IDENTIFICATION OF RISK FACTORS 1/10,000 POTENTIAL SIGNALS OF RARE EVENTS 1/100,000 HYPOTHESIS TESTING 1/1,000,000 1/500, /1,000 1/500 1/100 1/5,000 1/1,000 1/50,000 1/10,000 1/100,000, Risk Management/Assessment Strategy
8 Risk Management Committee (RMC) Sub-team of Development Team: formed at Phase IIB Clinical i l & nonclinical i l safety stakeholders Risk Log: documents both observed and hypothetical risks Plans for signal detection, assessment, and mitigation Forum for discussion of safety issues throughout a product life cycle A forum to formalize the Safety Risk Management program for a compound
9 RMC Activities Step 1: Identify and Assess a product s benefit-risk balance Step 4: Modify risk minimization tools to further improve benefit-risk balance RMC Step 3: Evaluate tool effectiveness and reassess the benefit-risk balance Step 2: Develop and implement tools minimize risks - preserve benefits Communication of Risk Internally and Externally
10 Implementation of RMP in Japan Safety Specifications Global-RMP Pharmacovigilance Plan Japan Appendix (J-RMP) Basic Plan for Post Marketing Surveillance Basic Plan for Post Marketing Surveillance Common Technical Document J-CTD module 1
11 How effectively implement RMP in Japan? Basic PMS Plan at J-NDA effective enough? Should we wait the discussion until later stage of J-NDA review? Initiation of discussions i on RMP should be more earlier development stage Should we have new category of PMDA consultation, Risk Management Plan consultation?
12 Risk Communications
13 External Risk Communication Regulators Physicians/Investigators/Patients Telecons & F2F meetings Pre-Clinical Study Reports Clinical Study Reports License Applications Regulatory Briefing Documents Regulatory Reports Risk Management Plans Safety Investigator Reports Investigator Brochures Informed Consent Ethics Committees Web Site/ DTC (US) Dear HCP Letters Publications Reports to External Data Safety Monitoring Boards Expert Panels/ Scientific Advisory Boards Product Labels
14 Chantix: Medication Guide (US) What do you need to know? The most important information that patients should know Immediate action that patient should take if that happens Next action that t patient t should take after immediate action Common side effect Other precautions
15 Medicine Safety Web Site -Direct communication to patients and healthcare providers- In Industry First, the Web site is launched to improve understanding of how risks and benefits of medicine are determined, d monitored and communicated. A clear need to increase awareness of medicine safety among patients, healthcare providers and professionals This site delineates the role of Pharmaceutical companies The regulatory office Healthcare provider
16 Sutent: Company Web information (Japan)
17 Risk Communication Health Care Professionals Patient Regulator Company Patient s Safety First
18 Conclusions Increased focus on Safety and Risk Management is a global issue with diminishing boundaries Focus is representative of the entire lifecycle of a drug as knowledge and experience further develops and expands with drug use. Development of Global Risk Management Plan rather than individual region or country Risk Management Plans would be an important t step forward to more effectively and accurately assess the safety of pharmaceutical drug products. Earlier Risk Management Planning b/w Company, Regulator and Healthcare Professionals is key for successful u product life cycle management age e Risk Communication Plan b/w Company, Regulator, Healthcare Professionals and Patients is getting more important
19
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