Lonza Discussion Panel

Bringing It All Together – From Early Technology Evaluations to Commercial Approval

In partnership with

(PRNewsfoto/Lonza)

There is more than meets the eye with cell therapy manufacturing than just scalability. Please listen to our discussion on the lessons learned from early technology evaluations to the commercial approval of immunotherapies.

Cellular immunotherapies (cell therapies) have opened new curative options for patients fighting various forms of cancer. The FDA approvals of Kymriah (Novartis) and Yescarta (Gilead) indicate a maturity in the development of commercial oncology therapeutics. This view was further bolstered by the recent FDA approval of Kite’s Tecartus and approvals will likely be granted for multiple cell therapies targeting multiple myeloma. Concurrently, cell therapy development targeting solid tumors has exploded.

 

Worldwide the number of companies focused on cell therapy development and commercialization for oncology continue to grow as does the number of programs entering the clinic. Academic clinical centers continue to hone their knowledge from developing first generation cell therapies and dosing the first cell therapy patients.

 

Notwithstanding these tailwinds, significant challenges remain including where to manufacture cell therapies, centralized or decentralized, and how to efficiently scale manufacturing to meet clinical and/or commercial program needs. The key to maintaining cell therapy’s evolution is to implement innovative solutions which serve to streamline manufacturing workflows, lower cell therapy cost to increase patient adoption, while improving product quality and process robustness.

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Dr. Laurence Cooper PhD, M.D.
Chief Executive Officer
Ziopharm Oncology

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Dr. Eytan Abraham PhD
Head of Personalized Medicine
Lonza

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Dr. Steven Feldman PhD
Director of Manufacturing and Process Development
Stanford Center for Cancer Cell Therapy

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Dr. Isabelle Rivière PhD
Director, Michael G. Harries Cell Therapy and Cell Engineering Facility
Memorial Sloan-Kettering Cancer Center

Listen to our panel discussion with Lonza, ZIOPHARM, MSKCC and Stanford Center for Cancer Cell Therapy where we discussed and debated:

 

  • Implementing innovative platform and solutions suitable for cGMP with an aim to streamline manufacturing workflows

 

  • Avenues to reduce costs when developing clinical-grade CAR-T therapy

 

  • Product quality and manufacturing process robustness

 

  • Scale-up and Scale-out challenges associated with late-stage clinical and commercial manufacturing

 

  • Facilitating cell therapy manufacturing which meets and passed clinical release testing utilizing serum-free media

 

  • How to discuss and ultimately gain regulatory support regarding novel cell therapy attributes and cell therapy manufacturing innovations

 

This expert roundtable includes leading cell therapy scientists from academic clinical centers and industry. They offered insights and experiences on advancing cell therapies from bench to bedside (clinical trials), the challenges they face, and wherein their view the fast-evolving cell therapy field is heading

Panel Members:

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Dr. Laurence Cooper M.D., PhD

Dr. Laurence Cooper joined Ziopharm Oncology as the Chief Executive Officer in 2015 after the Company licensed technology for a non-viral approach for genetically modifying T cells from MD Anderson Cancer and the University of Minnesota. Before joining Ziopharm, Laurence was a tenured Professor at MD Anderson where he served as Section Chief of Cell Therapy at the Children’s Cancer Hospital and helped lead scientific and clinical efforts to develop new treatment approaches which pair genetic engineering with immunotherapies. He is a leader in the development and implementation of T-cell therapies for cancer.

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Dr. Steven A. Feldman

Dr. Steven A. Feldman left Surgery Branch, NCI to join Stanford in 2018. As a Staff Scientist and Director of the Vector Production Facility at Surgery Branch, NCI for the past twelve years, Dr. Feldman’s group was responsible for the development, characterization, and manufacturing of the viral vectors used in gene therapy clinical trials at the Surgery Branch. Additionally, Dr. Feldman oversaw the Cell Therapy Process Development Group within the Surgery Branch. Recently, Dr. Feldman joined the Stanford Center for Cancer Cell Therapy (CCCT) as Director of Manufacturing and Process Development where he will take a lead role in the development and manufacture of viral vectors and novel cell therapies for the treatment of cancer. Dr. Feldman is also a member of the Correlative Science Group within the CCCT in an effort to better understand biomarkers of our manufactured CAR T cell products and how those markers can inform us on patient response and how to manufacture more efficacious CAR T cell products.

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Dr. Isabelle Rivière PhD

Dr. Rivière received her Ph.D. in Cellular and Molecular Biology from the University of Paris. She initiated her graduate studies at the Institut Curie in Paris and completed her thesis in thelaboratory of Richard Mulligan at the Whitehead Institute in Cambridge, MA. During this time,she developed novel retroviral vectors for in vivo long-term expression of transgenes in hematopoietic cellsusingMFG/SFG-based retroviral vectors that are widely used in clinical studies. After completing her postdoctoral workwith Dan Littman at NYU, Dr. Rivière joined the faculty of Memorial Sloan-Kettering Cancer Center in 1999 whereshe focuses on developing novel strategies for cell therapies and immunotherapies. Her laboratory investigatesgenetic approaches to enhance various cell types including T lymphocytes and stem cells for the treatment of cancerand genetic blood disorders. Over the past 20 years, she has developed cell manufacturing processes for severalPhase I/II clinical trials under current Good Manufacturing Practices in the academic setting. Her lab currentlysupports multiple CAR-T cell based clinical trials for the treatment of hematological malignancies and solid tumors.She also investigates immunological functions of CAR T cells in clinical trials and animal models.She is a memberof the Board of Directors of the American Society of Gene and Cell Therapy (ASGCT), the Alliance forRegenerative Medicine (ARM) and the Center for Commercialization of Cancer Immunotherapy C3i (Canada).Shealso serves on the Scientific Advisory Board of the National Science Foundation (NSF) Engineering ResearchCenter (ERC) for Cell Manufacturing Technologies (CMaT).

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Moderator: Dr. Eytan Abraham PhD

Dr. Eytan Abraham heads Lonza Personalized Medicine, which focuses on developing and bringing to market solutions that enable research and development, scale out, and commercialization of patient scale cell therapies, with an emphasis on decentralized and point of care manufacturing. 

Prior to this Eytan led Lonza’s Cell and Viral Therapy R&D for five years, focusing on developing manufacturing solutions for the Cell and Gene therapy continuum. 

Prior to Lonza, Dr. Abraham was head of therapeutic pipeline development at Pluristem Therapeutics, developing stem cell therapies for cardiovascular indications. 

Dr. Abraham holds a Ph.D. in developmental and molecular biology from the University of Maryland Biotechnology Institute, and a post-doctorate in cell therapy and tissue engineering from the Harvard-MIT Biomedical Engineering Center and Harvard Medical School.