PDA West Coast Chapter: ATMP Dinner Meeting

Featured Presenters

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  Patrick Chen

  VP of CMC/Technical Operations, Senti Bio

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  Patrick Chen

  Senti Bio

  Patrick Chen joined Senti Bio in 2023 and leads the CMC / Technical Operations department and is responsible for the process development, analytical development, and manufacturing activities.  He brings over 30 years of experience in the biopharma industry in the development and manufacturing of proteins, enzymes, monoclonal antibodies, gene and cell therapy products.  Prior to Senti Bio, Patrick was Vice President of Manufacturing at Grace Science and led the CMC activities for the development and manufacturing of a gene therapy for an ultra rare disease indication. Prior to that, he was the head of External Manufacturing at Sangamo Therapeutics and was responsible for GMP manufacturing and supply of plasmids, mRNA, viral vectors and cell therapy products including stem cells and Treg cells. He has had increasing roles of responsibility and has been in involved in the initial process development and manufacturing of Humira®, the design of a large-scale biologics manufacturing facility for Amgen Rhode Island to manufacture Enbrel®, led the CMC project management department at Chiron and was the CMC and tech transfer leader at Genentech for various products including Activase®, Rituxan® and Perjeta®.

  Patrick Chen received his Chemical Engineering degree from UCLA and his MBA from the Babson FW Olin Graduate School of Business.

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  Ines Mende

  Senior Director of Process Science, Arsenal Bio

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  Ines Mende

  Arsenal Bio

  Ines Mende, Ph.D., is the Vice President of Process Sciences at Arsenal Biosciences. She has more than a decade of experience in cell therapy process and analytical development, technology transfer and contributed to multiple successful CMC regulatory filings. Prior to joining Arsenal Bio, she held roles of increasing responsibility at PACT Pharma and Hitachi Chemical Advanced Therapeutics Solutions (now Minaris). She received her PhD in Immunology from the Technical University in Munich and completed her postdoctoral studies at Stanford University.
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  Katie Miller

  VP, Global Head of Biologics Development Analytics and Quality, Bayer

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  Katie Miller

  Bayer

  Katharine (“Katie”) Miller, Ph.D. is a biotechnology/biopharmaceutical executive with 30+ years of industry experience leading multiple CMC functions (Analytical and Product Development, Quality Control, Quality Assurance) in the development and commercialization of advanced therapeutics including cell and gene therapies, inhalation and parenteral formulations, multi-active solid oral dosage forms, in vitro diagnostics, and device/combination products.

  She has a successful track record of supporting multiple programs from pre-IND/IMPD through marketing authorizations (BLA, MAA, NDA, NDS), commercial launches, and product lifecycle management in diverse geographies (US/CAN/EU/AUS/Asia/ME/SA). Katie is an experienced and effective lead based on a broad foundation of technical expertise, a demonstrated ability to manage multiple projects to tight timelines and evolving regulatory requirements, and active cross-functional collaboration and long-view strategic planning. Katie has a particular focus on building forward-looking and holistic product characterization plans, demonstration of potency/mechanism of action, and comparability for advanced therapeutics.

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  Steve Rabin

  Senior Director, CMC Regulatory Affairs, Iovance Biotherapeutics

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  Steve Rabin

  Iovance Biotherapeutics

  Steve has more than 25 years experience in the pharmaceutical industry, starting with the drug delivery company ALZA Corporation in Palo Alto and Mountain View. When ALZA was acquired by Johnson and Johnson, he remained with J&J, ultimately serving in product development of a drug/device combination product. He then transitioned to CMC Regulatory Affairs at J&J for 5 years, leading the submission and approval of prostate cancer drug in 120 countries. He then moved to Iovance, a cell therapy company where he started the CMC Regulatory Affairs group 7 years ago. Iovance recently had its first product approved, Amtagvi, the first cell therapy product using the patient’s own natural tumor fighting T-cells, for metastatic melanoma. A portion of the patient’s tumor is harvested, the T-cells extracted and grown out in vitro, and then returned to the patient Comparability has proven to be an important topic for cell and gene therapies. Analytical comparability is often insufficient to demonstrate changes in the manufacturing process, which may force companies to perform additional clinical trials. Many discussions have taken place between industrial representatives and the FDA, however, it is still a topic in its infancy.