EBE s Approach to Development of Concept, Position & Reflection Papers. Saroj Ramdas, GSK on behalf of EBE Biomanufacturing Working Group

Transcription

1 EBE s Approach to Development of Concept, Position & Reflection Papers Saroj Ramdas, GSK on behalf of EBE Biomanufacturing Working Group

2 Overview Definitions of EBE papers How do we develop papers? Published and in progress papers Survey results Conclusion: Value proposition 2

3 Definition of Papers EBE Concept Paper - Paper providing practical guidance by leveraging current industry practice and experience regarding a biomanufacturing topic. EBE Position Paper - Paper summarizing a consensus industry position regarding a key topic/concern related to biomanufacturing. It includes an industry proposal on how to address the key topic/concern and encourages discussion between industry and regulatory agencies. EBE Reflection Paper - Similar to a position paper, however, this approach addresses potential future regulatory requirements regarding a key biomanufacturing topic/concern. It proposes approaches industry can utilize to address the topic and encourages discussion between industry and regulatory agencies. Joint EFPIA/EBE Paper - Joint effort between EFPIA/EBE which is relevant to multiple modalities (i.e. small molecule & large molecule) and broader topics. 3

4 How Do We Develop Papers (1 of 2) Presented at Biomanufacturing WG meeting Topic of interest problem statement Team interest Request for sub team representation from member companies Build consensus on position within team regarding problem statement Sub team establishment Draft & review paper Member companies of the WG will review 4

5 How Do We Develop Papers (2 of 2) Finalized paper endorsed for approval Finalize & approval Industry Feedback For ex: Via EBE Satellite session at CASSS Share key papers with regulators Regulatory Feedback Publication EBE Website Industry publications EBE Forum (visible particles): Further collaboration across industry to discuss best practices, enhance understanding, training opportunities 5

6 Published Papers Concept Papers Considerations in Setting Specifications Mar 2013 Platform Manufacturing of Biopharmaceuticals: Putting Accumulated Data and Experience Feb 2013 to Work Forced Degradation Studies Mar 2015 Management and Control of Raw Materials Used in the Manufacture of Biological Medicinal Products Nov 2017 Position Papers Visible Particle Inspection - Practices for Biotechnology Derived Drug Products including Monoclonal Antibodies EBE Reflection & Joint EFPIA/EBE Papers Jun 2015 A Risk-based Approach to Setting Sterile Filtration Bioburden Limits Oct 2016 EFPIA-EBE White Paper on Expedited CMC Development: Accelerated Access for Medicines of Unmet Medical Need CMC Challenges and Opportunities Dec 2017 EBE Reflection paper on a Medicinal product incorporating a drug delivery device component: An Industry Perspective on the EU marketing application technical requirements, regulatory review process and post-approval device related change assessment 6 Jan 2018

7 In Progress Papers Position Papers Currently Under Development Link to Published Papers on EBE Website 7

8 Survey Results Biomanufacturing Working Group survey participants: 10 company responses - 6 Large Companies (> 10,000) - 3 Mid size Companies (200-10,000) - 1 Small Company (< 200) Advantages of being part of the team - Benchmarking with industry peers of different size companies - Opportunity to influence direction of paper - Allows larger companies to leverage experience and knowledge - Opportunity for smaller companies to learn from others experience and utilize knowledge shared - Driving industry to a consensus position Challenges - Time commitment - Achieving industry consensus 8

9 Survey Results (continued) Strategic use of papers within companies - Support Subject Matter Experts within companies to understand industry best practices/positions - Improve internal Ways of Working such as updating SOPs, implementing best practices, framework for in house discussions - Used in deviation documentation as reference Key papers identified by members (top 4) Visible Particle Inspection - Practices for Biotechnology Derived Drug Products including Monoclonal Antibodies EFPIA-EBE White Paper on Expedited CMC Development: Accelerated Access for Medicines of Unmet Medical Need CMC Challenges and Opportunities A Risk-based Approach to Setting Sterile Filtration Bioburden Limits EBE Reflection paper on a Medicinal product incorporating a drug delivery device component: An Industry Perspective on the EU marketing application technical requirements, regulatory review process and post-approval device related change assessment Example Paper (1): Support specification discussion with agency 9 Example Paper (2): Referred to paper during PRIME kick-off meeting with EMA

10 Conclusion Value Proposition: Papers used to progress risk based approaches within industry Address evolving best practices in industry and used in communication with regulators Referenced in regulatory submissions and to support industry responses to regulatory queries Process to leverage and document prior/platform knowledge across industry Link to Published Papers on EBE Website 10

11 Acknowledgement Thanks to the members of the Biomanufacturing Working Group and EBE paper team leads for their dedicated efforts 11