Planning for CGT commercialization: It starts sooner than you think

Every decision throughout cell and gene therapy preclinical development is an opportunity to ensure future commercial success. From anticipating supply needs to planning ahead for commercial scale-up, what are the major factors that influence commercial readiness for these therapies at every stage?

  • Which practical strategies enable a seamless, adaptive manufacturing plan from preclinical development to commercialization
  • How integrated scale-down platforms can inform future scale-up decisions
  • Where the industry is headed next with data analytics, automation and technology
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Rashmi Kshirsagar

Rashmi Kshirsagar

Vice President, Technical Development, Rubius Therapeutics

Rashmi Kshirsagar joined Rubius as Vice President, Technical Development in October 2019 and is responsible for leading the teams within Technical Operations that focus on process, product and analytical innovation to advance the RED PLATFORM®. She also oversees Chemistry, Manufacturing and Controls (CMC) development for Rubius’ Red Cell Therapeutic™ product candidates that transition from the discovery phase through clinical development.

Rashmi brings to Rubius more than 20 years of experience in Manufacturing and CMC Product Development. Prior to her role at Rubius, Rashmi spent 16 years at Biogen, most recently serving as Senior Director of Protein Development in Pharmaceutical Operations & Technology, where she was responsible for developing and supporting preclinical to post-commercialization manufacturing processes for internal and partnered biopharmaceutical programs. She has experience in CMC project management, led cell culture process development activities for biologics, influenced scientific endeavors for fundamental process understanding and led cross-functional teams in technical development. Rashmi began her career at Millennium Pharmaceuticals in Process Development Technology.

Rashmi has been active for more than 20 years in the scientific community by presenting at conferences, publishing scientific papers and book chapters as well as planning conferences, conference sessions and workshops, and participating in industrial forums and consortia. She holds a Bachelor of Chemical Engineering from the University Department of Chemical Technology, University of Bombay, Mumbai, India, and a Ph.D. from the University of Minnesota.

Stephen Hill

Stephen Hill

COO, Lyell Immunopharma

Stephen joined Lyell in 2019 as Chief Technical Operations Officer and became the company's Chief Operating Officer in 2021. Prior to joining Lyell, Stephen held several senior positions at AstraZeneca including Senior Vice-President, Head of Global Biologics Operations and Vice-President, Site Head. Stephen also held multiple positions at Amgen, including Vice President, Bulk Manufacturing, Executive Director, Plant Manager and Executive Director, Manufacturing Technologies. He received an MBA and a B.S. in Microbiology and B.A. in Political Science from the University of Washington.

Dan Kirby

Dan Kirby

CCO, Orca Bio

Dan leads Orca Bio’s commercial strategy for its cell therapy platform products. His areas of focus include market engagement, reimbursement landscape evaluation, value story creation, key opinion leader outreach, and communications. Previously, Dan was Chief Commercial Officer at Omeros Corporation where he oversaw the market access, medical affairs, advocacy, marketing, sales and operation functions. This includes overseeing all launch preparations for the company’s lectin pathway inhibitor, narsoplimab for HSCT-TMA and all P&L responsibilities for their marketed product, OMIDRIA. Prior to joining Omeros, Dan was Vice President of US Commercial Cell and Gene Therapy at Celgene, overseeing all market access, reimbursement and marketing efforts for their CAR T products. Dan joined Celgene as part of the Juno Therapeutics acquisition where he was Vice President of Marketing and Market Access, responsible for building these functions at Juno. Prior to Juno, Dan was Head of Marketing for Medivation, and spent more than 14 years at Amgen in various commercial roles.

Arsalan Arif

Arsalan Arif

Founder & publisher, endpoints news

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.