Positioning early cell therapy programs for clinical success: insights to mitigate risk and ensure GMP readiness
Mar
7
2024
Upcoming webinar

Positioning early cell therapy programs for clinical success: insights to mitigate risk and ensure GMP readiness

Thursday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET
Sponsor
Positioning early cell therapy programs for clinical success: insights to mitigate risk and ensure GMP readiness

The promise of cell therapies is often tempered by the many complexities of transitioning these innovations from R&D to the clinic. For early-phase programs, there are many aspects to consider, from understanding evolving regulatory guidelines and review pathway options to addressing common manufacturing-related issues such as scalability, high cost of goods, and workforce retention. Additionally, organizing and executing a successful cell therapy clinical trial can be challenged by a limited number of qualified clinical sites with experience in conducting advanced therapy studies, access to desired patient populations, and managing the complex supply chain required to deliver therapies to patients in a timely fashion.

Through a series of brief presentations on three key topic areas, this webinar will help early-phase cell therapy developers identify insights to mitigate risk and ensure clinical readiness to position their programs for success. Specific topic areas of focus include:

  • Ensuring patient-centricity in the complex cell therapy ecosystem and leveraging a unique, comprehensive operating model for your product
  • Navigating an evolving cell therapy regulatory landscape
  • How to assess GMP-readiness and prepare your cell therapy workflow for clinical and commercial manufacturing

Attend this webinar to learn about

  • Opportunities for a more streamlined, patient-centric approach to cell therapy clinical trials
  • Strategies to navigate regulatory hurdles and maximize impact of meetings with regulators
  • Best practices to address common challenges in cell therapy process development and manufacturing
  • Benefits of working with an integrated CRO/CDMO partner to simplify the cell therapy value chain and improve patient-centricity
Kim Watanabe
Kim Watanabe
Executive Director, Cell and Gene Therapy Pillar Head at Thermo Fisher Scientific

Dr. Kim Watanabe recently joined PPD, part of Thermo Fisher Scientific, as Executive Director, Cell and Gene Therapy Pillar Head where she leads business and operational strategy development and deployment in hematology and oncology clinical development services. She has 20 years of experience in R&D, business, and operations, of which the last 14 years have been focused on cell and gene therapies. Prior to her current role, she served as General Manager and Site Head for the Patheon Translational Services, part of pharma services contract development and manufacturing organization of Thermo Fisher Scientific. She also held multiple positions with increasing responsibility in Product Management at her current company where she was responsible for viral and non-viral therapeutic gene delivery tools portfolio. From 2012- 2016, she was at Irvine Scientific, now FUJIFILM Irvine Scientific, in Product Management and led the commercialization of cell culture reagents for regenerative medicine and cell therapy applications. She was a postdoctoral scholar at University of California, San Diego, School of Medicine and received her Ph.D. in Microbiology from University of Virginia, School of Medicine. She holds a BSc in Cell and Structural Biology from University of Illinois at Urbana-Champaign.

Mindy Sadik
Mindy Sadik
Director, Cell Therapy Sciences at Thermo Fisher Scientifc

Dr. Mindy Sadik joined Thermo Fisher Scientific in 2021 as the Director, Cell Therapy Sciences and oversees the Process Development and Analytical Development teams for the Cell Therapy Business unit for Advanced Therapies. Mindy’s teams work closely with partners to provide development and clinical scale services, which include gene and non-gene modified cell processing for autologous and allogeneic cell therapies. This work includes technology transfer from the client to Thermo Fisher’s site, process optimization, and workflow readiness for transition into GMP manufacturing. In her previous roles, Mindy has led teams of scientists and engineers and the associated R&D and pilot facilities in both large and small organizations concentrating on medical devices, biologics, and tissue products. Her expertise is in process and product development specializing in regenerative medicine, tissue engineering, biomaterials, and stem cells. Prior to joining Thermo Fisher, Mindy was the Associate Director for the Process Development Engineering and Operations teams at Humacyte where she was responsible for the development of a portfolio of tissue-engineered vascular products. She completed a postdoctoral fellowship at University of Pennsylvania in Neurosurgery and received her Ph.D. in Biomedical Engineering from Rutgers University. She also holds a MSc from Columbia University and a BSc from Tulane University, both in Biomedical Engineering.

Michele Duggan
Michele Duggan
Sr. Manager, Regulatory Affairs at Thermo Fisher Scientific

Michele Duggan joined Thermo Fisher Scientific in 2021 as Sr. Manager Regulatory Affairs supporting the development and delivery of regulatory solutions for customers within the biologics and advanced therapies pharma services manufacturing network. Prior to joining Thermo Fisher Scientific, Michele spent over 17 years in CMC regulatory consulting, providing regulatory strategy, dossier authoring and review expertise for biologics and cell therapy products across all stages of the product life cycle. Michele holds a BSc in Pharmacology and Toxicology from the University of Western Ontario.