On-Demand Webinar - Streamlining Cell Therapy IND Submission: Leveraging Raw Material Supplier Partnerships


Available On-Demand (Recorded October 29th, 2019)
Streamlining Cell Therapy IND Filing by Partnering with Raw Material Suppliers Webinar


Bringing a cell or gene therapy from discovery to the clinic cannot be done in isolation. Partnerships with regulatory agencies like the U.S Food and Drug Administration (FDA) or contract manufacturing organization (CMOs) are required. However, less obvious partnerships with raw material providers can be equally as important and impactful in helping emerging cell therapies navigate the path through IND submission and clinical scale-up. In this webinar, Dr. Derek Hei from BlueRock Therapeutics and Dr. Dan Fowler from Rapa Therapeutics will discuss how their partnerships with Bio-Techne is helping them build robust and scalable manufacturing platforms and facilitate their IND submissions.

Please join us to learn how partnerships can better prepare you for translating your cell and gene therapies to the clinic.


Webinar Topics:

  • IND submission insights from BlueRock’s iPSC-derived cell therapy
  • Resolving FDA raw material testing and documentation requests
  • Insights from Rapa Therapeutics on collaborations for RAPA T cell manufacturing
  • Process development optimization using novel reagents and custom packaging
  • Pioneering technologies and partnership opportunities with Bio-Techne

Rapa Therapeutics Webinar Topic Description

Working in collaboration with Bio-Techne, Rapa has developed manufacturing processes that are cost-effective (no gene manipulation), feasible (6-day duration), and effective for generation of a reproducible T cell phenotype. In this talk, Dr. Fowler will focus on efforts in collaboration with Bio-Techne for cytokine supplementation of cultures, the use of novel co-stimulatory reagents, and analytical testing of the manufactured T cell products.   

BlueRock Therapeutics Webinar Topic Description

BlueRock is using its unique manufacturing platforms that direct cellular differentiation and genetically engineer cells to create an entirely new generation of cellular medicines in the areas of neurology, cardiology, and immunology. In this talk, Dr. Hei will discuss how Bio-Techne partnered with BlueRock on qualifying raw material and providing documentation to facilitate IND submission.



SPEAKERS

Dan Fowler, MD

Dan Fowler, MD
Chief Medical Officer
Rapa Therapeutics


Dr. Daniel Fowler, is the Chief Medical Officer at Rapa Therapeutics. Dr. Fowler worked at the National Cancer Institute of NIH for 27 years and treated 200+ patients developing various prior forms of cancer therapy using novel adoptive T cell therapy approaches. His current venture, Rapa Therapeutics, is a clinical stage biotechnology company, spun out of NIH in September 2017. Rapa is focused on the development and commercialization of innovative adoptive T cell immunotherapy products that reprogram, modulate and harness the power of the immune system. Rapa has developed a next-generation cell therapy platform, including stimulatory “RAPA-T” therapy for cancer and regulatory “RAPA-TREG” therapy for neurodegenerative and autoimmune diseases.



Derek Hei, Ph.D.

Derek Hei, Ph.D.
Chief Manufacturing and technical Operations Officer
BlueRock Therapeutics


Derek Hei is the Chief Manufacturing and Technical Operations Officer at BlueRock Therapeutics. Dr. Hei joined BlueRock in September 2017 to oversee their entire manufacturing function, which includes developing and producing BlueRock’s induced pluripotent stem cell platform, maintaining its state-of-the-art cleanroom facility under cGMP, and leading the CMC regulatory efforts for the submission of investigational new drug applications. Prior to joining BlueRock, Dr. Hei served as vice president of clinical manufacture, quality and regulatory at Cellular Dynamics International, where he oversaw the development and production of its cell therapy products. Dr. Hei obtained his Bachelor of Science in chemical engineering from the University of Wisconsin-Madison, and his Ph.D. in biochemical engineering from the University of California, Berkeley.
Scott Schachtele, Ph.D.
Scott Schachtele, Ph.D.
Product Manager, Cell and Gene Therapy
Bio-Techne


Scott Schachtele is a Product Manager for the Cell and Gene Therapy portfolio at Bio-Techne. Scott works closely with the research teams at Bio-Techne and with industry partners to develop and offer innovative solutions that support cell, gene, and regenerative therapy manufacturing. Scott received his Ph.D. in Neuroscience and joined Bio-Techne in 2014.