Join the PDA West Coast Chapter for a dinner and discussion on Advanced Therapeutic Medicinal Products (ATMP) and Comparability Studies.

Our expert industry panelists will provide insight on the challenges and strategies for comparability studies for these new and complex products.

Moderator:

• Kathy Francissen (Global Head of Regulatory PT Cell & Gene Therapies at Genentech)

Panelists:

• Patrick Chen (VP of CMC/Tech Ops at Senti Bio)
• Ines Mende (Senior Director of Process Science at Arsenal Bio)
• Katie Miller (VP, Global Head of Biologics Development Analytics and Quality at Bayer)
• Steve Rabin (Senior Director of Regulatory Affairs at Iovance)

Agenda:

Registration Opens | 5:00 PM

Appetizers & Networking | 5:00 PM - 6:00 PM

Dinner & Announcements | 6:00 PM - 6:45 PM

ATMP Panel Discussion | 6:45 PM - 7:50 PM

Q&A | 7:50 PM - 8:20 PM

Closing Remarks | 8:20 PM - 8:30 PM

Dessert Reception & Networking (Optional) | 8:30 PM - 9:00 PM

Speakers:

Kathleen Francissen, Ph.D. 

Global Head, PT Cell & Gene Therapy Regulatory at Roche-Genentech

Moderator

Dr. Francissen has been dedicated to the development of advanced therapy medicinal products (ATMP) for the past several years, thus leveraging >25 years of experience in biopharmaceutical development.  She has extensive experience assessing comparability of a range of biotherapeutics.  Kathy currently leads a team of regulatory professionals responsible for developing and implementing regulatory strategies for ATMP programs in the Roche-Genentech portfolio.  She also serves as the Rapporteur of the ICH Cell and Gene Therapy Discussion Group (ICH CGT DG), representing the Biotechnology Innovation Organization (BIO).  In addition, she is the chair of the CASSS 2024 Cell & Gene Therapy Products (CGTP) Symposium.

Patrick Chen, MBA

VP of CMC/Technical Operations at Senti Bio

Panelist

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.

Ines Mende, Ph.D.

Vice President of Process Sciences

Panelist

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.

Katie Miller, Ph.D.

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

Panelist

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.

Steve Rabin, Ph.D.

Senior Director, CMC Regulatory Affairs at Iovance Biotherapeutics

Panelist

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.

Sponsors:

more information at www.basciences.com/

more info at www.bayer.com

more info at www.biomerieux-usa.com

more info at www.boehringer-ingelheim.com

more info at https://www.criticalmass-consulting.com

more info at www.element.com

more info at www.globalcompliancepartners.com

more info at https://www.gene.com

more info at www.gilead.com

more info at www.halolabs.com

more info at www.kitepharma.com

more info at https://ntint.com

more info at www.thermofisher.com

more info at https://sterile.com/

FAQs

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Tickets are not reimbursable, however you can transfer your ticket by 13MAY24 to whomever would like to attend on your behalf.

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Yes, our WCC PDA Sponsorship Program offers a unique opportunity for companies that want to strengthen brand image, increase visibility, and gain access to leaders of the San Francisco Bay Life Science Community.

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