Positioning Early Cell Therapy for Clinical Success: Mitigating Risk & Ensuring GMP Readiness
October 22 @ 12:00 pm – 1:00 pm
Positioning Early Cell Therapy for Clinical Success: Mitigating Risk & Ensuring GMP Readiness
Tuesday, October 22, 2024 | 12:00 p.m.-1:00 p.m. | Virtual
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 reviewimg 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:
- Navigating an evolving cell therapy regulatory landscape
- How to assess GMP-readiness and prepare your cell therapy workflow for clinical and commercial manufacturing
- Ensuring patient-centricity in the complex cell therapy ecosystem and leveraging a unique, comprehensive operating model for your product
Learning objectives:
- 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
- Opportunities for a more streamlined, Patient-centric approach to cell therapy clinical trials
- Benefits of working with an integrated CRO/CDMO partner to simplify the cell therapy value chain and improve Patient-centricity
Presenters:
Michele Duggan
Sr. Manager, Regulatory Affairs
Thermo Fisher Scientific
Ms. 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, she 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.
Mindy Sadik, Ph.D.
Director, Cell Therapy Sciences
Thermo Fisher Scientific
Dr. Sadik oversees the Process Development and Analytical Development teams for the Cell Therapy Business unit for Advanced Therapies. Dr. Sadik’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.
Kim Watanabe, Ph.D.
Executive Director, Cell and Gene Therapy Pillar Head
Thermo Fisher Scientific
Dr. Watanabe recently joined PPD, part of Thermo Fisher Scientific, 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, Dr. Watanabe served as General Manager and Site Head for the Patheon Translational Services. Prior to her current role, she served as GM/ Site Head for the Patheon Translational Services, part of the contract development and manufacturing organization of Thermo Fisher Scientific.
Register today and join us on October 22 for this FREE educational webinar.
Come ready to learn and ask questions!
