Implementing Cell Therapy/ Vector Product Changeover in a GMP suite

When:  Jan 14, 2022 from 13:00 to 14:30 (ET)
Friday, Jan 14 - 10:00 PST / 13:00 EST
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Implementing Cell Therapy/Vector Product Changeover in a GMP suite
Facility and Product Sponsor Perspectives


Webinar Description:
This webinar will focus on the considerations for the changeover process at three different GMP multiuse facilities. A controlled changeover process is essential to avoid contamination of previous or other ancillary material into the new product when sequential processing occurs. Even more stringent control processes are required when multiple products are manufactured in the same suite. The risks and challenges are increased when using viral vectors and other sources of materials that could linger in the environment. In this webinar, you will learn how controls and risk of cross-contamination change as one moves from manual and open systems to closed automated systems, but the need for control and monitoring remains.

Chaired By: 

Patrick Bedford, RAC, MBHL
VP of Regulatory Strategy, Artisan Biotechnologies, and Managing Director, weCANreg Consulting Group, Inc. (Toronto, Ontario, Canada) 

Patrick Bedford is an experienced and certified regulatory professional who is focused on facilitating global regenerative medicine developments. He is a VP of Regulatory Strategy at a CRISPR-enabled multiplex cell engineering company supporting cell therapy applications, and he leads an emerging Canadian regulatory consulting company that provides regulatory planning, interaction, and submission services. Patrick also provides commercialization tools and advice to start-ups through organizations such as CellCAN, Stem Cell Network, and Creative Destruction Labs. He is an active educator and contributor to regulatory policy development in Canada.

Patrick previously developed regulatory consulting services for a regenerative medicine Network Centre of Excellence; planned 2 Canadian CAR-T New Drug Submissions; and led teams at Health Canada responsible for developing guidance for biosimilars, transplant material, and cell and gene therapies. While leading these policy initiatives at Health Canada, Patrick also supported their Therapeutic Products Classification Committee; chaired the Cells, Tissues, and Organs Classification Committee; and championed international harmonization initiatives.

Patrick completed an Honours Bachelor of Health Sciences degree at the University of Western Ontario, a Master’s degree in Bioethics and Health Law at the University of Otago, and obtained a Regulatory Affairs Certificate from the Regulatory Affairs Professional Society.


Venkatesh Ponemone, PhD, MBA
Director, Manufacturing Science & Technology (MSAT), CCRM (Toronto, Ontario, Canada)

Venkatesh has 15 plus years of Biopharmaceutical manufacturing and clinical development experience with extensive technical and strategic leadership for end-to-end manufacturing for early phase to commercial-scale manufacturing.
Currently, serving as Director, Manufacturing Science and Technology (MSAT) at CCRM where the primary focus is to oversee and manage CDMO technical operations, including technology transfer, process design and validation, and Scale-up of autologous and allogeneic cell therapy products, including drug substance and drug product. Efficiently managed technical manufacturing operations and Compliance program to improve CDMO capacity, i.e., autologous multi-patient batch production utilizing semi or fully functional closed systems.
Prior to joining CCRM, Venkatesh served as Senior Director of Cell Processing Facility and Clinical development at TotipotentRX-Cesca Therapeutics, where he led and managed processing of hematopoietic stem cell transplant program, haploidentical stem cells, established MCB/WCB, led and managed cord blood processing and banking, served as study director of 7 cell-based therapy Clinical trials including IND/IDE submissions.
Venkatesh has MSc in medical microbiology and holds a PhD in Cancer and Radiation Biology from Manipal University, followed by a post-doctoral fellowship in Gastrointestinal Inflammation at the University of Illinois, Chicago. Venkatesh has co-authored 50 plus publications, several book chapters, and four patents related to stem cells, regenerative medicine, and cancer biology. Venkatesh is actively involved in several professional organizations like FACT, ISCT, and AABB and serves as an editorial member and reviewer on several journals.


Olive J Sturtevant, MHP, MT (ASCP) SBB, SLS, CQA(ASQ)
Senior Administrative Director of Connell & O'Reilly Families Cell Manipulation Core Facility, Dana Farber Cancer Institute (Boston, Massachusetts, US)

Olive is the Administrative Director of the Connell & O'Reilly Families, Cell Manipulation Core Facility (CMCF) at Dana Farber Cancer Institute (DFCI) in Boston Massachusetts. CMCF is a busy cellular product manufacturing facility that specializes in developing and manufacturing human cell and tissue-based products for research and clinical trials within the Harvard-affiliated programs in Boston, with industry sponsors as well as the Bone Marrow Transplant programs at DFCI, Brigham and Women’s Hospital, and Boston Children’s Hospital. In this role, she is directly responsible for Financial and Administrative oversight, Quality Control and Quality Assurance, Materials Management, and Information Systems. In addition, Olive works with investigators and facilitates the technology transfer of projects administratively by maintaining project timelines, tracking progress against goals, coordinating with Quality Assurance and technical experts, and fulfilling reporting obligations under existing program contracts. In this role, she works collaboratively with Brigham & Women’s Kraft’s Families Blood Donor Apheresis Center and the Boston Children’s Apheresis Center to activate both clinical trials (currently 40+) and commercial collections and shipments of MOS (Manufactured Off-Site) products.

Olive is actively involved in several professional organizations; FACT, ISCT, MABB and AABB, and serves on a variety of quality and regulatory committees and boards. She also serves as a regulatory consultant for both clinical laboratories and other cellular therapy and tissue-related programs.

Emily Hopewell, PhD
Assistant Professor of Clinical Medical and Molecular Genetics
Director of Cell and Gene Therapy Manufacturing, Indiana University (Indianapolis, Indiana, US)

Emily is an Assistant Professor of Clinical Medical and Molecular Genetics and the Director of Cell and Gene Therapy Manufacturing (CGTM) at the Indiana University School of Medicine. The CGTM provides translational process development services, viral vector manufacturing, and cellular product manipulation and manufacturing for investigators for Phase I and Phase I/II clinical trials. She oversees development efforts through clinical production of cell and gene therapies provides leadership, strategic direction, and input on education, research, and clinical missions within the Cell and Gene Therapy GMP Facilities.

Emily began her career at the Moffitt Cancer Center as a technologist in the Cell Therapy Facility in 2003. She received her PhD in Cancer Biology from the University of South Florida and returned to the Cell Therapy Facility as a Development Specialist and then Assistant Technical Director, prior to moving to IU in 2018. She is active in several cell and gene therapy societies (ISCT, AABB, SITC), with a focus on educating professionals, providing career development opportunities, and improving regulations.