Monoclonal Antibodies:
Challenges in the Development of the Control Strategy
AAPS CMC Community
DATE: 20 October 2023
TIME: 11:30 am to 1 pm EDT (11:30 – 1:00 PM EDT)
PARTICIPANT NUMBER LIMITED TO 250
Please join us for an engaging panel discussion titled: "Monoclonal Antibodies: Challenges in the Development of the Control Strategy".
The control strategy for monoclonal antibodies (mAb) from pre-clinical through pivotal clinical studies must fit several challenging criteria: fit for purpose at various phases of clinical development, sufficient to guarantee human safety and satisfy regulatory authorities, and forward-looking towards rapid filing of a Biological License Application (BLA). The use of technology platform-based controls early in development accompanied by a shift towards increased product-specific controls provides one basis for the development of the control strategy for those sponsors with sufficient product background to provide platform-based controls. The use of binding assays, while popular, may not always encompass the attributes specific to a given mode of action or other critical quality attributes related to efficacy. The increased fraction of development programs seeking an expedited status (e.g. Breakthrough designation) also contributes to the challenges for both sponsors and regulators. These and audience questions will make for an interesting discussion on October 20th – please join us.
The following experts will share their experiences and views on this topic:
· Tura Camilli (Genentech)
· Joey Studts (Boehringer-Ingelheim)
· Rachel Novak (FDA/CDER/OPQ)
· Jennifer Swisher (FDA/CDER/OPQ)
Panelists
Tura Camilli, Ph.D.
Tura Camilli is a Sr. Group leader in Pharma Technical Regulatory at Genentech, a member of the Roche group.
Prior to joining Genentech, a year ago, she worked at Amgen, where she led the regulatory CMC group for early development programs and contributed to development of strategies for acceleration into the clinic and to commercialization. In addition to her regulatory experience in Industry, Tura spent several years at FDA, as a CMC reviewer in the Office of Biotechnology Products/OPQ/CDER. She received a Ph.D. in Molecular and Cellular Oncology from The George Washington University, followed by a postdoc at the National Institute on Ageing, NIH.
Joey Studts, Ph.D.
Dr. Joey Studts is currently Director of Downstream Development in the Innovation Unit of Boehringer Ingelheim Pharma GmbH in Biberach Germany. In this role, he is responsible for the development of purification processes for the production of therapeutic proteins for pre-clinical, clinical, and market supply. Dr. Studts has a strong focus on late-stage process development with experience in bringing innovative drugs to the market from a CMC perspective as well as implementing novel technologies in the field of modeling, digital control strategies and PAT. Dr. Studts did a post-doctoral fellowship in the Department of Immunology at Washington University in St. Louis with Professor Daved Fremont, Ph.D. Joey received his Ph.D. under the guidance of Professor Brian G. Fox, Ph.D., at the Institute for Enzyme Research in the Department of Biochemistry at the University of Wisconsin at Madison after completing a B.S. in Chemistry at Loras College in Dubuque, IA, USA.
Rachel Novak, Ph.D.
Dr. Rachel Novak is a Review Chief in the Office of Biotechnology Products (OBP) at the FDA. OBP is responsible for the assessment of product quality information submitted in regulatory applications for therapeutic proteins, including new molecular entities and biosimilars. Dr. Novak received her bachelor's degree in Chemistry and Biology from Middle Tennessee State University and obtained her Ph.D. at the Institute of Molecular Medicine and Genetics at the Medical College of Georgia, followed by a postdoc at the National Cancer Institute (NCI), NIH working on mouse models of hematopoietic malignancies. Dr. Novak came to OBP as an Interagency Oncology Task Force (IOTF) Fellow followed by tenure as a product quality assessor, Team Lead, and Review Chief. Dr. Novak has over 10 years experience in the regulation of biotechnology products, including but not limited to, monoclonal antibodies.
Jennifer Swisher, Ph.D.
Jennifer Swisher is a Review Chief in the Division of Biotechnology Review and Research IV (DBRR4) of the Office of Biotechnology Products (OBP), in the Office of Pharmaceutical Quality (OPQ), CDER, FDA. OBP is responsible for the assessment of product quality information submitted in regulatory applications for therapeutic proteins, including new molecular entities and biosimilars. She received her bachelor's degree in Molecular Biology from Princeton University and obtained her Ph.D. in the department of Biochemistry and Molecular Biophysics at Columbia University, followed by a postdoc in the Cellular Immunology Section of NIDCR, NIH. During her time at the FDA, she has been a researcher-reviewer, Team Lead, and Review Chief and has served extensively on internal and external working groups and committees, with particular focus on antibody effector function as well as the conduct of compatibility/in-use stability studies to support the safe administration of highly potent products.
Moderators
Twinkle Christian, M.S. is a Principal Scientist and team lead in Process Development at Amgen. Prior to joining Amgen, Twinkle worked at VaxGen and Alza where she focused on vaccine product development and alternate drug delivery of biologics, respectively. Twinkle has 20 years of experience in drug product development across diverse modalities and has led the advancement of multiple programs from early discovery to clinical trials and commercialization. Twinkle's expertise encompasses high concentration and ultra-high concentration product development, alternate drug delivery of biologics, investigating protein-protein interactions, and macromolecular crystallography for structure and formulation. Twinkle is a recognized SME in biologics formulation and drug delivery with peer reviewed publications, multiple granted US patents and patent applications and invited speaker at national and international conferences.
James Bernstein, Ph.D. founded the Live Oak Pharmaceutical Consulting group in 2007, providing services and consultant teams across all CMC functions. Prior to Live Oak, he worked at GSK and heritage companies for 24 years in drug substance and drug product roles. He served as Chief Scientific Officer for Marius Pharmaceuticals from 2017 to 2022, concluding with an approved NDA. His contributions to consulting projects include CMC strategy, regulatory support and authoring, and physical science. His formal education includes a B.S. in Chemistry and Physics from Centenary College of Louisiana and a Ph.D. in Physical Chemistry from the University of North Carolina at Chapel Hill.
Organizing Team:
Andrea Schirmer (Boehringer Ingelheim), James Bernstein (Live Oak Pharmaceutical Consulting Group), Cheenu Murti (Takeda), Kin Tang (Genentech), Tom Oliver (FDA), Twinkle Christian (Amgen), Lindsey Saunders Gorka (Pfizer).
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 1pm EST.
Link to connect: See below
3. You will be in a 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 mAb Control Strategy Virtual Panel Discussion
Please join my meeting from your computer, tablet or smartphone.
https://www.gotomeet.me/AAPS-CMC_Community
You can also dial in using your phone.
Access Code:
510-150-997
United States:
+1 (872) 240-3311
Join from a video-conferencing room or system.
Meeting ID:
510-150-997
Dial in or type:
67.217.95.2 or inroomlink.goto.com
Or dial directly:
[email protected] or 67.217.95.2##510150997
Get the app now and be ready when your first meeting starts:
https://meet.goto.com/install
------------------------------
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
------------------------------