Emerging global trends and regulatory opportunities in cell therapies for cancer

Wednesday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET

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Emerging global trends and regulatory opportunities in cell therapies for cancer

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

Cell-based I-O therapies are a significantly active area of clinical development, representing nearly 60% of clinical trials in cancer treatment. Despite the approval of several autologous cell therapies, the overall number of approved cell therapy treatments are few. One key reasons for this is the high commercialization hurdles.

Commercialization of cell therapies needs to begin several years prior to the expected approval. Preparing the market requires innovative approaches to raising awareness and educating cancer centers, hospitals, and community healthcare providers in order to ensure patients have access to these specialized therapies. It further requires the regulatory planning early in the process.

In this webinar, we will review the current trends in the development of cell therapies for oncology as well as the regulatory opportunities and actions needed to increase patient access to these therapies.

Attend this webinar to:

Understand the emerging trends in cell therapy development in oncology
Gain an understanding of key hurdles in the development of cell therapies
Discover the regulatory opportunities and actions needed to increase patient access to cell therapies and trials

Kim Watanabe

Executive Director, Cell and Gene Therapy Pillar Head, Hematology/Oncology, Project Delivery at Thermo Fisher Scientific

Dr. Kim Watanabe is an Executive Director and the Cell and Gene Therapy Pillar Head at PPD, part of Thermo Fisher Scientific. She leads business and operational strategy development and deployment in hematology and oncology clinical development services. She has 15 years of experience in R&D, business, and operations in 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 B.Sc. in Cell and Structural Biology from University of Illinois at Urbana-Champaign.

Sushama Sankpal

Associate Medical Director at Thermo Fisher Scientific

I am a Hemato-oncologist with 25 years of clinical experience. I am based in London. At PPD, and I lead cell and gene therapy studies for various indication.

Kasey Kime

Director, Regulatory Affairs at Thermo Fisher Scientific

Kasey Kime has 15 years of experience in global quality and regulatory affairs within the Life Sciences sector. She currently serves as the Director of Regulatory Affairs at Thermo Fisher Scientific, focusing on technology and tools essential for cell and gene therapy manufacturing. Her educational background includes a bachelor’s degree in medical laboratory science, along with post-graduate degrees in Medical Microbiology, Quality Systems Management, and Business Administration. In addition to her role at Thermo Fisher Scientific, Kasey is actively involved in the industry through her participation in the Australia and New Zealand ISCT Regulatory Committee and the Alliance for Regenerative Medicine (ARM) CMC Advisory Group.

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