2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges Thursday, May 9 Registration Open Continental Breakfast

Transcription

1 2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges End-to-End Product Development Manufacturing, Supply, and Quality May 9-10, 2019 Hilton Long Beach Long Beach, CA As of March 15, 2019 Thursday, May 9 7:00 a.m. 6:30 p.m. Registration Open 7:00 a.m. 8:15 a.m. Continental Breakfast 8:15 a.m. 8:30 a.m. Welcome and Opening Remarks from Conference Co-Chair Peter Makowenskyj, Director of Sales Engineering, G-CON Manufacturing 8:30 a.m. 10:00 a.m. P1: Evaluating Comparability and Demonstrating Similarity Moderator: Peter Makowenskyj, Director of Sales Engineering, G-CON Manufacturing Throughout a products lifecycle, various changes will take place that could potentially impact product quality attributes and therefore the product safety and efficacy. Demonstrating product similarity with robust techniques is crucial to ensuring patient safety. This session will discuss best practices in biosimilars and vaccines, so attendees can not only hear about the latest trends in their field but also how this is viewed through a slightly different lens by the other modality. 8:30 a.m. 9:15 a.m. Evaluating Comparability and Demonstrating Similarity of Vaccines and Biosimilars Hillel Cohen, Executive Director, Scientific Affairs, Sandoz 9:15 a.m. 10:00 a.m. with Additional Panelists Maria T. Gutierrez Lugo, Supervisory Chemist, CDER, FDA Patrick J. Lynch, PhD, Lead Biologist, CDER, FDA 9:45 a.m. 6:30 p.m. Exhibit Area Open 10:00 a.m. 10:45 a.m. Refreshment Break and Poster Presentations in Exhibit Area Poster Presentations The following posters will be presented during refreshment breaks on Thursday and Friday 1. Cleaning Cycle Development for Parts Washer Richard Chai, Technical Service Manager, STERIS Corporation 10:45 a.m. 12:15 p.m. A1: Management of Lifecycle Similarities in Biosimilars Moderator: Jennifer L. Liu, PhD, Director of Process Development, Biosimilars, Amgen Inc. Lifecycle management is a systematic approach to managing the product evolution from initial design and development through approval, to commercialization. Biosimilar products must demonstrate similarity at approval but become standalone products after approval. Hence the opportunity arises to introduce changes, even innovations outside the comparison to the reference product. This session will explore the B1: Current Topics in Vaccine Modernization: Comparability Strategies and Other Approaches This session will cover the challenges and strategies used to manage consistency as changes are introduced into a vaccine product. Both during development and post approval, manufacturing and testing procedures can be modified in response to improved technologies, supplier-driven changes and evolving regulatory requirements. Many vaccines are marketed for a number of years and manufacturers must 1

2 development approaches that can be employed and consider the role regulators play in increasing confidence in biosimilars by establishing regulatory oversight throughout their lifecycle, from development to post-licensing. Regulatory Perspective on the Management of Lifecycle Similarities in Biosimilars Monitoring Post-Approval Process Changes of Biosimilars Hillel Cohen, Executive Director, Scientific Affairs, Sandoz develop strategies to ensure that modifications do not affect the purity, safety or potency of a vaccine. The diverse nature of vaccines and complexity of vaccines leads to unique challenges when developing strategies to modernize older products and develop comparability programs. 3Rs in Quality Control of Human Vaccines: Opportunities and Challenges Sue C. Nelson, PhD, Global Analytical Expert, 3Rs and Immunology, Sanofi Pasteur Regulatory Perspective on the Current Topics in Vaccine Modernization: Comparability Strategies and Other Approaches 12:15 p.m. 1:45 p.m. Lunch on Your Own. Exhibit Area Closed. A listing of local restaurants is available at the PDA Registration Desk. 1:45 p.m. 3:15 p.m. A2: Comparability and Similarity in Biosimilars Moderator: Maria T. Gutierrez Lugo, Supervisory Chemist, CDER, FDA The demonstration of analytical similarity between biosimilar and reference product is based on the well-established scientific principle of comparability. Since the term comparability first appeared describing head-to-head product comparisons in the FDA 1996 guidance, the concept has been extensively used to support an array of changes, during all stages of product lifecycle. Both comparability and similarity are data-driven, with the burden placed with the developer to generate appropriate data to satisfy the expectations of Regulators. This session will discuss practical challenges and resulting strategies for the evaluating analytical comparability and similarity. A Streamlined Bioanalytical Approach to Select a Compatible Primary Container System for Biosimilars Early in the Drug Development Program Ranjana Singh, PhD, Senior Scientist, West Pharmaceuticals, Inc. Regulatory Perspective on the Comparability and Similarity in Biosimilars B2: Vaccines Lifecycle Management in the 21st Century Moderator: Sabrina Restrepo, PhD, Director, Sterile & Validation CoE, Merck & Co., Inc. This session will provide perspective around the challenge s vaccines face from a lifecycle management perspective. Although ICH Q12 is seeking to address some of challenges, the question is still there for legacy vaccines and the increased complexity of a more diverse regulatory environment worldwide. A case study will be presented seeking to illustrate the challenges this complexity brings in terms of supply and potential enablers to allow vaccines reach patients worldwide. Case Study: Complexity of Vaccine Lifecycle Management, Associated Supply Challenges, and Potential Enablers Kimberly Duffy, Executive Director, Global Regulatory Affairs Vaccines CMC, Merck & Co., Inc. Optimizing Critical Reagent Manufacture for Consistency: Understanding the Impact of Production Parameters and Bioassay Performance Jodi A. Pegg, Principal Scientist, Pfizer Biotherapeutics Pharmaceutical Analytical Research and Development 3:15 p.m. 4:00 p.m. 2

3 Refreshment Break and Poster Presentations in Exhibit Area 4:00 p.m. 5:30 p.m. P2: Biosimilars and Vaccines Lifecycle Management in the Digital Era Moderator: Sabrina Restrepo, PhD, Director, Sterile & Validation CoE, Merck & Co., Inc. More biosimilars and vaccines are becoming available to people in conjunction with an increased demand for existing and new products which is driving more complexity around product lifecycle management. We are in the digital era and in several instances, we manufacture products developed prior to many of today s technologies being available to process developers. Also, new products are in development which are seeking to bring innovation. There is a possibility to bring elements of the digital era into lifecycle management that could enable a leaner approach in the near future. This session will create a forum to discuss challenges and opportunities for lifecycle management and the evolution needed to align with the demands of the current public health landscape. 4:00 p.m. 4:30 p.m. Industry Perspective on Biosimilars and Vaccines Lifecycle Management in the Digital Era 4:30 p.m. 5:30 p.m. Panel Discussion 5:30 p.m. 6:30 p.m. Networking Reception in Exhibit Area Friday, May 10 7:00 a.m. 5:30 p.m. Registration Open 7:00 a.m. 8:45 a.m. Continental Breakfast 7:30 a.m. 8:30 a.m. Concurrent Breakfast Sessions Biosimilars IG Biosimilars Interest Group Breakfast Session Moderator: Stephan O. Krause, PhD, Head of Product Quality Group, AstraZeneca Biologics Bev Ingram, PhD, Senior Director, Portfolio Lead Biosimilars Regulatory Affairs, Pfizer Inc. This session will review and discuss the highlights from the recent PDA Biosimilars Workshop, co-chaired by Emanuela Lacana, PhD, CDER, FDA. The workshop was set up to capture lessons learned and well-working practices. The Workshop covered expectations for data quality, the creation of a final control strategy, and practical alternative solutions to current statistical approaches. Experiences from regulatory agencies outside the U.S. were discussed with the intent to consider complementing some of the content in the U.S. FDA Draft Guidance. Attendees will have the opportunity to ask questions and/or provide their experience. Vaccines IG Vaccines Interest Group Breakfast Session Sabrina Restrepo, PhD, Director, Sterile & Validation CoE, Merck & Co., Inc. The session will present to the participants the status of the ongoing activities within the Vaccines Interest Group which are mainly focused around the development of technical report(s) or key deliverables regarding vaccines lifecycle management, vaccines specifications and new technologies. Participants will have the opportunity to listen case study or studies that frame the relevance of these topics and share their perspective as well. 8:45 a.m. 10:15 a.m. P3: Lessons Learned: Applying QbD Principles to Vaccines and Biosimilars The development of new biologic products, their launch, and ensuring their supply, present multiple challenges across technical, regulatory, and market concerns. Setting a successful strategy and leveraging previous experiences are essential for this process. Quality by design is a systematic approach to development and manufacturing that emphasizes product understanding and process control and can minimize the impact of challenges that arise during product development and commercial manufacturing. The presentations in this session will address how quality by design principles are being used to address challenges in both vaccine and biosimilar development and/or manufacturing and how they are addressed. 8:45 a.m. 9:15 a.m. 3

4 Statistical Approaches and Considerations for QbD in Bioassay Development Ryan T. Yamagata, MS, US Function Head, CMC Statistical Sciences, GSK Vacines 9:15 a.m. 9:45 a.m. QbD Considerations for Biosimilar Drug Development Stanley Speaker, Technical Product Leader, Pfizer Inc. 9:45 a.m. 10:15 a.m. 10:15 a.m. 10:45 a.m. Refreshment Break and Poster Presentations 10:45 a.m. 12:15 p.m. A3: Challenges in Biosimilars Moderator: Stephan O. Krause, PhD, Head of Product Quality Group, AstraZeneca Biologics This session will address technical challenges with the intent to avoid pitfalls often encountered during biosimilar candidate development. Continued from the Breakfast Interest Group session, the following topics will be covered: Data quality expectations, fit for purpose analytical methods, inspectional expectations, the intersection of the analytical similarity assessment with the final control strategy, and critical strategic decisions necessary in a biosimilar development program. Regulatory Perspective on Challenges in Biosimilars Patrick J. Lynch, PhD, Lead Biologist, CDER, FDA Industry Perspective on Challenges in Biosimilars B3: New Technologies, New Platforms Moderator: Jody A. Gould, PhD, Senior Director, Head, Regulatory Policy & Intelligence, GSK Vaccines Advances in technology have resulted in a wide array of new platforms and new adjuvants that potentially can improve the clinical performance of existing vaccines and lead to efficacious vaccines for diseases for which no vaccine is currently available. This session will include talks on new technologies that are being use for investigational vaccines and how unique regulatory, manufacturing, and quality concerns could be addressed. Novel Self-Amplifying mrna (SAM) Technology Kunal Aggarwal, Director, Head of Technical R&D Programs, US Vaccines R&D Center, GlaxoSmithKline Adjuvant Formulations: Manufacturing and Control Erik Laursen, Director, GMP Operations, Infectious Disease Research Institute 12:15 p.m. 1:45 p.m. Lunch on Your Own. Exhibit Area Closed. A listing of local restaurants is available at the PDA Registration Desk. 1:45 p.m. 3:15 p.m. A4: Maximizing Global Development Moderator: Bev Ingram, PhD, Senior Director, Portfolio Lead Biosimilars Regulatory Affairs, Pfizer Inc. The regulatory science for biosimilars is well established, however expectations globally does differ. For example, most regulators require a biosimilar to be similar to their source originator product. As a result, creating a global biosimilar product requires conducting multiple 3-way studies (a sourcelicensed product, a non-source licensed product, and biosimilar). Such requirements create an increased complexity during development, additional testing burdens, and delay the registration of biosimilar products globally. This session will B4: Challenges in Vaccines Moderator: Christopher M. Bussineau, PhD, Senior Consultant Biologics Consulting Group, Inc. With so many medical needs where vaccines are an option, innovation and reliable supply are becoming more relevant. Innovative approaches are important for addressing existing regulatory requirements and for introducing new technologies into manufacturing processes. This session will share some of the experiences and opportunities vaccine developers and manufacturers have faced and are seeking to pursue to overcome these challenges. 4

5 explore global development approaches and innovations that can help reduce the burden of additional studies and address delays in the global registration of biosimilar products. Biosimilar Global Submissions: Challenges and Opportunities Janett Mugaburu-Richards, Global regulatory strategist, Biosimilars, Pfizer Inc. Regulatory Perspective on Maximizing Global Development 3:15 p.m. 3:45 p.m. Refreshment Break and Poster Presentations Novel Low-Cost, High Intensity Viral Vaccine Manufacturing Platform Alfred Luitjens, Global Technical Sales Director, Batavia Biosciences B.V., The Netherlands Challenges in Novel Therapeutic Vaccines: New Generation Biologics Indu Colenly, Department Manager, Process Engineering, DPS Group 3:45 p.m. 5:15 p.m. P4: Continuous Manufacturing and its Future in Biosimilars and Vaccines Moderator: Peter Makowenskyj, Director of Sales Engineering, G-CON Manufacturing Continuous Manufacturing is at the cusp of being a viable platform for large molecule therapies. Continuous manufacturing has been demonstrated to show many benefits, primary among them the ability to drive down costs and decrease time to market. We will look at the efforts taking place in the field of biosimilars and vaccines as it relates to continuous manufacturing and how this manufacturing concept is shaping our industries future. 3:45 p.m. 4:15 p.m. End-to-End Modular Manufacturing for Distributed Production of Biopharmaceuticals Chris Love, Professor of Chemical Engineering, MIT 4:15 p.m. 4:45 p.m. Industry Perspective on Continuous Manufacturing and its Future in Biosimilars and Vaccines 4:45 p.m. 5:15 p.m. 5:15 p.m. Closing Remarks from Conference Co-Chair Peter Makowenskyj, Director of Sales Engineering, G-CON Manufacturing 5