Plenary Keynote Sessions

MONDAY, AUGUST 16

Solving Today’s Challenges

4:20 pm Plenary Keynote Introduction
john-sterlingJohn Sterling, MA, Editor in Chief, Genetic Engineering & Biotechnology News, Mary Ann Liebert, Inc. Publishers


4:30 mRNA Vaccines: A Paradigm Shift in Pandemic Preparedness
Sudha Chivukula, PhDSudha Chivukula, PhD, Head, mRNA Technology, Sanofi Pasteur Biologics Co.
The rapid development for clinical proof-of-concept and bioprocess scale-up leading to commercial manufacturing and approval under emergency use authorization of COVID mRNA vaccines highlights the potential for an mRNA platform to address future pandemics as well as other unmet public health needs. The framework for optimizing novel mRNA vaccines and formulations, which could include adaptation to monovalent and multivalent vaccines, delivery and balanced immune responses to address emerging viral pathogens such as SARS-COV-2 and pandemic Influenza, will be discussed.

5:00 Lessons Learned from the Pandemic
Darrin CowleyDarrin Cowley, PhD, Vice President & Head, Developmental Quality Biologics, Quality Lead COVID Vaccine, AstraZeneca
During the pandemic, there had to be focus in several areas. Primarily, the safety of the workforce and allowing front line operators to function unhindered. Management needed to change its ways of working, prioritize and create the environment for optimal working. Decision-making and digital tools were implemented and an altered culture was created. Ways of dealing with virtual inspections were also developed.

5:30 Bioprocessing Summit Connects

 

WEDNESDAY, AUGUST 18

Leading to Tomorrow’s Advances

3:50 pm Plenary Keynote Introduction
Clarke_DominicDominic Clarke, PhD, ISCT Process & Product Committee Co-Chair & Global Head, Cell Therapy, HemaCare Corp.


4:00 Manufacturing Next-Generation Therapies
Martha RookMartha Rook, PhD, Chief Technology Officer, Sigilon Therapeutics, Inc.
Cell and gene therapies have shown dramatic clinical progress in recent years. Driven by this clinical success and the needs of commercialization, manufacturing strategies are progressing. Nevertheless, a standard manufacturing template for these therapies has not evolved and with novel modalities continuing to emerge we may be in a post-template manufacturing landscape. CMC strategies must be developed to avoid manufacturing becoming a roadblock to therapeutic success.

4:30 Sustainability and the Future of Bioprocessing
Budzinski_KristiKristi Budzinski, PhD, Principal Product Stewardship & Green BioPharma Manager, Genentech, Inc.
The future of bioprocessing demands flexible, scalable solutions that can accommodate the rapidly evolving landscape of biopharmaceutical products while also minimizing impact on the environment. This talk will highlight some of the major opportunities for reducing the environmental impact of bioprocessing through the application of metrics such as process mass intensity and lifecycle assessment methodology. Results will be presented from both a Genentech perspective and industry-wide perspective.

5:00 Bioprocessing Summit Connects

 

PLENARY KEYNOTE BIOGRAPHIES

John Sterling, MA, Editor in Chief, Genetic Engineering & Biotechnology News, Mary Ann Liebert, Inc. Publishers
John Sterling has been editor in chief of Genetic Engineering & Biotechnology News since 1985. He holds a BS in biology from CCNY and a Master’s in journalism from the University of Minnesota.

Sudha Chivukula, PhD, Head, mRNA Technology, Sanofi Pasteur Biologics Co.
Dr. Sudha Chivukula is a PhD in Biochemistry and a management graduate, with several years of vaccine R&D experience, in-depth scientific expertise and business acumen. Sudha has held scientific and managerial positions in translational research and taking vaccine candidates from conceptual phase through pharmaceutical and clinical development phases. She is involved in developing strategy, design and process development for new vaccines with an objective to meet the medical need and regulatory requirements for vaccines. Sudha is currently leading the RNA Vaccine Technology at Sanofi Pasteur with a mission to build and integrate strategy to develop a robust mRNA vaccine platform.

Darrin Cowley, PhD, Vice President & Head, Developmental Quality Biologics, Quality Lead COVID Vaccine, AstraZeneca
Darrin Cowley, PhD, is currently Head of Developmental Quality, Biologics & COVID Vaccine at AstraZeneca. He was previously Executive Director Product Quality at Amgen, Inc. He trained in Molecular and Cell Biology and has a PhD in Biochemistry and NIH Post-doctoral work in cell signaling and sorting. Darrin has extensive experience in the development, filing and commercialization of a wide range of synthetic and biological molecules including biosimilars and COVID vaccine. Darrin has experience with the development and approval of several types of combination products such as auto-injectors and on body injectors. Most recently, Darrin has served as quality lead supporting the global development and approval of AstraZeneca’s COVID vaccine.

Dominic Clarke, PhD, ISCT Process & Product Committee Co-Chair & Global Head, Cell Therapy, HemaCare Corp.
Dr. Clarke has over 15 years of experience developing enabling solutions to support cell and gene therapies. He is the Global Head of Cell Therapy at HemaCare, a leading provider of source material for clinical development and commercial manufacturing of cell-based therapies. His previous roles include Global Product Manager for Charter Medical's cell therapy and bioprocessing single-use systems portfolio and Director of Research and Development for BioLife Solutions. Dominic currently serves as the Co-chair for the International Society for Cell and Gene Therapies' Process and Product Development Committee with efforts directed towards translating research and process development from bench to clinic.

Martha Rook, PhD, Chief Technology Officer, Sigilon Therapeutics, Inc.
Martha Rook, PhD, is the Senior Vice President & Head of CMC and Analytics for Sigilon Therapeutics. She has more than 20 years of experience in analytics and bioprocessing including more than 10 years in the development of cell and gene therapy manufacturing processes. Prior to joining Sigilon, Dr. Rook was VP and Head of the Gene Editing & Novel Modalities Business of MilliporeSigma. There she led a team developing and providing tools and services for cell and gene therapies from discovery to GMP manufacturing. Dr. Rook received her PhD in biochemistry from MIT and holds a BS in chemistry from Texas A&M University. She pursued post-doctoral studies in neuroscience as a Lefler Fellow at Harvard Medical School’s Center for Neurologic Diseases.

Kristi Budzinski, PhD, Principal Product Stewardship & Green BioPharma Manager, Genentech, Inc.
Kristi Budzinski joined Genentech’s Environment Health and Safety department in 2011 to help create and launch the Green BioPharma program with the mission of integrating and adapting Green Chemistry principles in Research and Development. She has created Green Lab assessment tools for researchers to identify opportunities to reduce their environmental impact, developed supplier collaborations for take-back and recycling initiatives and advanced environmental metrics for drug development and manufacturing. She is a founding member of the biopharma focus group, a part of the American Chemical Society Green Chemistry Institute Pharmaceutical Roundtable. Through this industry consortium, she participated in the development of Process Mass Intensity and Cleaning Mass Intensity metrics for biologics which measures the environmental impact of biologics production. She also serves as a Board member for BioLink Equipment Depot, a bay area non-profit empowering educators and researchers through donated scientific equipment and supplies. Kristi received her undergraduate degrees in Biochemistry and Mathematics from the University of Southern Mississippi and her PhD in chemistry from the University of Washington.



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