The Office of Pharmaceutical Quality: An Update on Team-Based Review and One Quality Voice

Transcription

1 The Office of Pharmaceutical Quality: An Update on Team-Based Review and One Quality Voice DIA Annual Meeting 2015/Washington DC June 16, 2015 Sarah Pope Miksinski, Ph.D. Giuseppe Randazzo, M.S.

2 Objectives of OPQ A single unit in CDER dedicated to drug product quality Across all drug product areas new drugs, generic drugs, biotechnology products, and over-the-counter drugs Across all sites of manufacture domestic and foreign 2

3 Objectives of OPQ The creation of one quality voice streamlining quality oversight throughout the lifecycle of a drug product Aligns review, inspection, and research functional areas Spans pre- and post-approval for brand and generic drugs Strengthens surveillance and inspections of facilities globally 3

4 Objectives of OPQ Encourages use of modern, more efficient manufacturing technologies Establishes consistent quality standards and clear expectations for industry Balances potential quality risks with the risk of a patient not getting a drug 4

5 Objectives of OPQ Anticipates quality problems before they develop to help prevent drug shortages Emphasizes quality metrics and surveillance techniques to help monitor quality across facilities 5

6 OPQ Immediate Office Acting Director: Janet Woodcock Deputy Director: Lawrence Yu Office of Program and Regulatory Operations Acting Director: Giuseppe Randazzo Office of Policy for Pharmaceutical Quality Acting Director: Ashley Boam Office of Biotech Products Director: Steven Kozlowski Office of New Drug Products Acting Director: Sarah Pope Miksinski Office of Lifecycle Drug Products Acting Director: Susan Rosencrance Office of Testing and Research Director: Lucinda Buhse Office of Surveillance Acting Director: Russ Wesdyk Office of Process and Facilities Acting Director: Christine Moore 6

7 Seamless Integration of Review, Inspection, Surveillance, Policy and Research Performing team based quality assessments of applications inclusive of drug substance, drug product, manufacturing, and facilities Drug Substance Product Experts Experts One Quality Voice Technical Advisors OTR OPPQ OS Others as needed Process Experts Facility Experts 7 7

8 What is One Quality Voice? One Quality Voice is: Patient-centric Clear and Unified Efficient Transparent Collaborative Concise One Quality Voice is not: Just a saying Confrontational Polarized Territorial Siloed Slow 8

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10 Expectations for Quality Patients and caregivers assume that their drugs: Are safe, efficacious, and have the correct identity Deliver the same performance as described in the label Perform consistently over their shelf life Are made in a manner that ensures quality Will be available when needed 10

11 The Link to the Patient - Considerations Why does it matter to the patient? or What is the impact on overall quality? Effective discussions are timely, transparent, and robust Multiple collaborators involved (e.g., clinical review division, Applicants, other offices) Can be framed by any review discipline Occurs within the appropriate regulatory framework (e.g program deliverables, application urgency) End result using sound science and technical expertise to identify/discuss major risks to quality, with effective communication to stakeholders regarding risk and the resulting impact to the patient 11

12 One Quality Voice Where We Are OPQ review process Integrated Quality Assessment Builds on previous adaptations of team review Team touchpoints based on program deliverables Exploration into additional review paradigms Flexible use of teams Expertise-based Strategic/case-specific Cross-office Stakeholder input Continuous improvement/learning 12

13 Team-based Integrated Quality Assessment (IQA) 13 13

14 Team-based IQA (OPQ) Team-based Integrated Quality Assessment Maximizes team expertise Provides aligned patient-focused and risk-based quality recommendations An IQA team/original NDAs Application technical lead (ATL) Responsible for overseeing the scientific content of the assessment Regulatory business process manager (RBPM) Responsible for process and timeline Discipline reviewers Drug substance, drug product, process, facility, microbiology, biopharmaceutics, and Office of Regulatory Affairs (ORA) investigators. Other members (as needed) FDA laboratories (e.g., Office of Testing and Research), policy, surveillance, and other offices 14

15 How is IQA different from previous process? OPQ process uses: expert teams concurrent assessment single review template Predictable, scheduled team meetings Pre-OPQ process uses: one application, one reviewer independent assessment separate templates Inconsistent communication between disciplines 15

16 IQA Team Roles Role / Task Scientific Content / Initial Risk Assessment Process and Timeline IQA Executive Summary Assessment of Drug Substance Assessment of Drug Product Assessment of the Manufacturing Process Assessment of Facilities Assessment of Biopharmaceutics Assessment of Microbiology Assessment of Environmental Analysis Labeling & Package Insert Facility Inspections FDA Labs Others as needed Lifecycle Knowledge Management Responsible* ATL RBPM ATL / IQA Team DS/DP Reviewer DP Reviewer Process Reviewer Facility Reviewer Biopharm Reviewer Micro Reviewer EA reviewer DP Reviewer ORA Leads / SMEs participate OTR and/or OBP OS, OPPQ, etc ATL/ IQA Team * Represents General Cases 16

17 Team Review (OPQ) - Observations Proactive meeting framework essential to alignment and communication (CMC pilot) Meeting timeframes most effective when aligned with PDUFA deliverables (filing, midcycle, etc) Various review templates considered Effective team leadership essential to outcomes and progress One Quality Voice (technical, regulatory) Risk-based conversations (technical) PDUFA deliverables (regulatory) 17 17

18 IQA Template (OPQ) - Highlights Structured in CTD format Uses guiding questions & reviewer guide Clear delineation of roles / responsibilities Executive Summary Initial and Final Risk Assessment Lifecycle Communication Consolidated Comments 18

19 IQA Continuous improvement Integrated Product Process/Facility Review Committee Meets weekly to assess current process and make interim improvements Representatives from all OPQ sub-offices Continuous feedback from end users Retreats for ATL/Secondary reviewers Retreat for reviewers and RBPMs Additional feedback vehicles (e.g. end of cycle surveys) IQA document to be evaluated on a predictable cycle with new version rolled out periodically IT enhancement to facilitate review process, collaboration and knowledge management 19 19

20 IQA can be broken down into modules for authoring by owners Quality Review Data Sheet and Executive Summary Owner: Application Technical Lead Assessment of the Drug Substance Owner: Drug Substance Reviewer Assessment of the Drug Product Owner: Drug Product Reviewer Integrated Quality Assessment (IQA) Assessment of the Facilities Owner: Facility Reviewer Assessment of the Biopharmaceutics Owner: Biopharm Reviewer Assessment of Microbiology Owner: Microbiology Reviewer Assessment of the Process Owner: Drug Process Reviewer Appendices Owner: All Reviewers Read access for all other parties involved and IT solution to consolidate

21 Formal Risk Assessment Provides a consistent understanding of the inherent risk of different types of products Establishes a common platform for risk communication and knowledge retention Enables a more efficient review processes Focus on the most critical aspects Supports more efficient and targeted inspections Focus on the most critical processes and facilities 21 21

22 Risk Communication - Considerations How do we intentionally and explicitly link the risks identified in our quality assessment to patient outcomes? How do we communicate our findings and recommendations to our stakeholders outside of OPQ? Internal: OND, OGD External: e.g., industry, patients 22 22

23 Quality information Technical Assessment How does it link to the patient?

24 Additional Review Considerations Are we having the right conversation at the right time? Determining communication gaps and clarification needs from actual scientific disagreements Generating One Quality Voice within the appropriate regulatory framework Embracing a culture of curiosity Utilizing resources effectively (e.g. consolidated IRs) Building proactive communication into review process Building formalized risk assessments into review process and team staffing decisions Integrating review and inspection Improving overall risk communication to stakeholders 24

25 Conclusions Patient/caregiver expectations of quality Safe, effective, high quality, correct identity, perform as labelled, available Multiple OPQ drivers/values based on risk benefit balance Team based IQA currently in use within OPQ Based on historical team review experience Incorporates risk-based elements in review process Continuously improving based on internal and external feedback Evolving IQA template Additional ongoing initiatives Risk communication Knowledge transfer All on behalf of the ultimate stakeholder the patient 25