Session Abstract – PMWC 2022 Silicon Valley

 Session Chair Profile

Ph.D., Chief Business Development Officer, Adaptive Biotechnologies

Biography
Dr. Sharon Benzeno is the Chief Business Development Officer and leads the Drug Discovery group at Adaptive. Sharon oversees the use of the company’s immune medicine platform for novel drug discovery, including TCR discovery to inform next-generation cellular therapy, antibody discovery, and vaccines. Before joining Adaptive in 2014, Sharon was Senior Director at Elsevier Inc., a healthcare informatics company. Prior to Elsevier, Sharon co-led the oncology business unit at Capgemini SE, a consulting and technology services company. Sharon came to Elsevier from Capgemini, where she held a variety of management roles at AstraZeneca plc. Sharon holds a PhD in Biomedical Sciences from New York University School of Medicine, an MBA in Finance and Leadership from New York University Stern School of Business and a BA in Biochemistry from New York University. Sharon completed a postdoctoral fellowship in cancer biology at the University of Pennsylvania Abramson Cancer Center.

Talk
Next-generation Supply Chain For Cell & Gene Therapies
For truly personalized cell and gene therapies to become standard of care, we must continue to leverage and successfully implement advances in science, technology, automation and digitization to scale the process and shorten the time it takes to get lifesaving medicines to patients in need.


 Speaker Profile

M.D., Senior VP, Head of Clinical Development, PACT Pharma

Biography
Dr. Arati Rao is dual fellowship trained Geriatric-Oncologist and a former Associate Professor of Medicine at the Duke University School of Medicine who is passionate about cell therapy development. She has worked both in the heme malignancies CAR T space at Kite-Gilead and now in the solid tumor neoantigen TCR space at PACT. She has in depth knowledge on cell therapy/immunology programs and has worked closely with regulatory agencies including the FDA and EMA. As the global lead and Medical Monitor for ZUMA-2, she was responsible for successfully filing a BLA and received accelerated approval for Tecartus™ (brexucabtagene autoleucel) in relapsed/refractory mantle cell lymphoma with the FDA. During her academic career, she led the myeloid leukemia efforts at Duke and served as a PI/Co-PI on several trials. She was also an NIH funded clinical researcher. She has served as a faculty on the NCCN-Acute Lymphoblastic Lymphoma guidelines (v1.0) and on several ASCO and ASH committees including the ASH- scientific committee for myeloid biology.

Talk
Challenges in Cell Therapy Development
Cell therapy development globally has continued to increase. CAR T therapies have led the way but TCR, TIL, neoantigen and other therapies are also being evaluated. The development of cell therapies brings several challenges: type of study and biometrics, regulatory, operations, manufacturing, cost and reimbursement and most importantly patient related and toxicity issues.


 Speaker Profile

M.D., Ph.D., CEO, bit.bio

Biography
Mark is a doctor, scientist, and entrepreneur. As a neurosurgeon, he treats patients with spinal cord injury. Mark is best known for discovering the importance of macrophages for brain regeneration, which led to the first regenerative medicine trial for degenerative cervical myelopathy, and for developing opti-ox, a gene targeting approach that enables faithful execution of genetic information in cells. Applied to cellular reprogramming, opti-ox demonstrated that robust activation of a new cell type program (encoded in transcription factors) is necessary and sufficient to deterministically induce a new cellular identity. These findings challenge the theory that cell reprogramming depends on stochastically determined permissive states and enable the production of any human cell within days at purities approaching 100%. He is the founder of bit.bio, co-founder of cultured meat startup Meatable, and co-founder and trustee of Myelopathy.org, the first charity dedicated to a common yet overseen condition causing a 'slow motion spinal cord injury'.


 Speaker Profile

M.D., President, R&D, Century Therapeutics

Biography
Hy Levitsky is President of Research and Development. He was previously EVP and CSO at Juno Therapeutics, and before that, Head of Cancer Immunotherapy Experimental Medicine at Roche Pharma Research and Early Development. He received an MD from Johns Hopkins School of Medicine in 1984, followed by training in internal medicine and medical oncology. He joined the Johns Hopkins faculty in 1991, rising to Professor of Oncology, Medicine and Urology in 2001 while working at the Sidney Kimmel Comprehensive Cancer Center where he served as Scientific Director of the George Santos Bone Marrow Transplant Program. Upon joining industry, he has held an adjunct professorship since 2011. His research has focused on tumor immunology, cancer vaccines, and adoptive T cell therapy. He is a Leukemia and Lymphoma Society Stohlman Scholar, a Member of the American Society for Clinical Investigation, and is a founding member of the Cancer Immunotherapy Consortium of the Cancer Research Institute.