Continuous Manufacturing: Product Control Strategy from Industry and Regulatory Perspectives
AAPS CMC Community
DATE: 1 December 2023
TIME: 1:00 pm to 2:30 pm EST
PARTICIPANT NUMBER LIMITED TO 250
Please join us for an engaging panel discussion titled: Continuous Manufacturing: Product Control Strategy from Industry and Regulatory Perspectives.
Continuous drug product manufacturing is becoming more common in the pharmaceutical industry. The control strategy ensures a robust process and quality product. The focus is to elaborate on control strategy for products manufactured by continuous manufacturing (CM) or by a hybrid approach involving both conventional batch manufacturing and CM. Salient discussion points are definition of a batch, considerations for the development of a control strategy and release testing of products manufactured by CM. The panelists will discuss the challenges in developing a control strategy, incorporation and maintenance of modeling in the regulatory filing and other pertinent topics.
These and audience questions will make for an interesting discussion on December 1st – please join us.
The following experts will share their experiences and views on this topic:
· Thomas Roper (Virginia Commonwealth University)
· Justin Pritchard (Vertex)
· Mohan Sapru (FDA/CDER/OPQ)
Panelists
Thomas Roper, Ph.D.
Dr. Thomas Roper is a professor of Chemical Engineering and Director of the Pharmaceutical Engineering program for the School of Engineering at Virginia Commonwealth University. He is the principal investigator for the Pharmaceuticals on Demand project at VCU, and collaborator on the Medicines for All initiative. His research interests are in the miniaturization of manufacturing footprints, including continuous chemistry and formulation technologies. Bringing science, technology, medicine and education close to the point of use is a major theme for his research efforts. Roper was previously with GSK Pharmaceuticals for 22 years where his past positions included "Head of API Chemistry and Analysis US" and "Global Head of Exploratory Development Sciences.
Justin Pritchard, Ph.D.
Justin Pritchard is a Senior Director in Biopharmaceutical Sciences at Vertex Pharmaceuticals
Incorporated working on the Formulation Development Leadership Team and leading two groups in the
department, the Process Analytics and Control Team and the Dissolution Team. Vertex has the first
automated continuous drug product manufacturing process with multiple approved products
manufactured continuously. Justin and the PAC team are responsible for the development,
implementation, and validation of PAT methods and for the implementation of an automated control
strategy for continuous drug product manufacturing at Vertex. The dissolution team is responsible for
dissolution method development and justification for all clinical products and initial submissions. Justin
also provides CMC leadership on clinical development programs as necessary. Justin has spent his career
innovating in Pharmaceutical Development, the last 15 years at Vertex and, prior to that, working at
Alkermes and Aphios. Justin also currently serves on the IFPAC Scientific Board.
Mohan Sapru, Ph.D.
Mohan Sapru, M.S., Ph.D., is a Branch Chief in the Office of Pharmaceutical Quality (OPQ), FDA. With about 15-year regulatory experience at FDA, he is primarily involved with providing technical, organizational and management leadership to CMC review staff, including the CMC Leads, for quality assessment of new drug products. As a member of the Emerging Technology Team (ETT), Dr. Sapru serves as ETT Project Lead for evaluating emerging technology-based sponsor proposals aimed to promote pharmaceutical product innovation and modernization. Besides serving as a session chair, he has made several key presentations on CMC regulatory aspects for various national and international conferences. Prior to joining the FDA, he served as a faculty member at Northwestern University, Chicago, where his research focus was in the area of innovative technologies, including RNAi-based allele-specific gene therapy.
Moderators
Sigita Zibas, Ph.D. is a Principal, R3LS, LLC, consulting on Regulatory CMC and Quality Assurance. She previously worked at Celgene Corporation (Bristol Myers Squibb) for almost 20 years in various positions in Global Regulatory CMC and Quality. Prior to that, Sigita was in Analytical Development at Schering Plough (Merck) for several years. She held various leadership positions in Regulatory CMC and Quality and served as a technical expert in analytical development. As CMC submission lead, she was responsible for IND/CTA/NDA/BLA/MAAs for small molecule and cell therapy products. Dr. Zibas holds a MS and PhD in chemistry. Within AAPS, she is an active volunteer in the CMC and Regulatory Sciences and Cell and Gene Therapy Communities.
Scott Eaton, M.S. is a retired Senior Director CMC from Pfizer, Inc. He possesses broad, extensive experience in pharmaceutical regulatory compliance, leadership and project management including full life cycle of products - development CMC (IND/CTA and amendments) to product registrations (NDA/MAA) and post-approval CMC (sNDA and variations) including query responses for most global markets. Prior to his role in regulatory CMC, his experiences involved chemical process development and research medicinal chemistry. His formal education includes a B.S. in Biochemistry from Indiana University and a M.S. in Organic Chemistry from Purdue University.
Organizing Team:
Andrea Schirmer (Boehringer Ingelheim), Kin Tang (Genentech), Lindsey Saunders Gorka (Pfizer), Sigita Zibas (R3LS, LLC), Scott Eaton
DISCLAIMER
The views and opinions expressed in this discussion are the participants' own and do not necessarily reflect the views or policies of their respective employers.
PLEASE READ THESE NOTES CAREFULLY:
1. No Registration is necessary – log in will be accepted on first come first served basis. The number of participants is limited to 250.
(Please make sure you have a reliable internet connection as there is no warranty if you can reconnect once logged out.)
2. The link will be available 10 min before the discussion start for attendees to sign on. The discussion will begin promptly at 1:00 pm EST.
Link to connect: See below
3. You will be in listening only mode. Questions for the panel during the discussion can be entered in the chat area and will be addressed as time allows.
Link for Joining Continuous Virtual Panel Discussion
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Kin Tang Ph.D.
Senior Director, Regulatory
Genentech
South San Francisco CA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.Senior Director, Regulatory
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