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Cell therapies represent an exciting new treatment paradigm for patients, with multiple global approvals expected in the coming years. As with any new and emerging therapy, patient challenges and operating model complexities still require further optimization to improve accessibility. Some specific obstacles for cell therapy clinical trials include a limited number of qualified sites, meeting patient recruitment targets, complex care needs and potential adverse events, logistics/travel requirements, and more. Manufacturing also continues to be one of the major bottlenecks to more widespread adoption of cell therapies globally and a major contribution to high treatment costs. Difficulties achieving commercial scale, labor-intensive processes due to lack of standardization/automation, and complex supply chain needs are all examples of current challenges that have yet to be fully addressed.
Patient journey mapping is a critical strategy to better understand the key touchpoints that provide opportunities for improvements, many of which can be influenced by CRO and CDMO organizations. Working with a single integrated partner can help ease industry challenges and provide an accelerated path from development to manufacturing, as well as the benefits that come from unified teams and infrastructure.
In this webinar, we will provide insights on the cell therapy patient experience and the role of a CRO/CDMO partner in optimizing that journey through effective collaboration and end-to-end integrated solutions for development, manufacturing, and distribution.
- Overview of patient mapping approach to better understand the patient journey and identify areas for enhanced efficiencies
- Insights into complexities of the cell therapy ecosystem and specific challenges that must be overcome to successfully move therapies from bench to bedside
- Opportunities to leverage an integrated partner to streamline cell therapy development and mitigate risks related to manufacturing, regulatory compliance, and commercialization
- Real-world case study demonstrating improvement of patient experience
Panteli Theocharous
Global Vice President, Cell and Gene Therapy Strategy Lead, Thermo Fisher Scientific
Dr. Panteli Theocharous is Global Vice President, Cell and Gene Therapy Strategy Lead at PPD/Thermo Fisher Scientific. In this role, he is the global business leader and single point of accountability for building partnerships with a broad range of clients in the advanced therapies field across all phases of development. As a senior-level industry executive in prior CMO roles and a cancer immunotherapy expert, Dr. Theocharous has led multiple hematology/oncology assets in clinical development including innovative immuno-oncology technologies (1st generation clinical CAR-T cell applications in hematologic malignancies, and AAV gene-directed therapies in benign disorders) and successful life cycle management, MAA/NDA and HTA submissions. His background comprises a M.S. in applied clinical hematology from the University of London, and cancer medicine related higher degrees from the Royal Free and University College Medical School at the University of London where he was clinical director for stem cell transplantation and cell and gene therapies. He is also formally trained as a JACIE – The Joint Accreditation Committee of the International Society for Cellular Therapy (ISCT) and the European Group for Blood and Marrow Transplantation (EBMT) Inspector. Dr. Theocharous has a successful track record of significant executive-level client consultation and strategic advisement including leadership and influence at CEO and biotech board level.
Rupa Pike
Senior Director, Technical Affairs, Advanced Therapies, Thermo Fisher Scientific
Dr. Rupa Pike is the Sr. Director of Technical Affairs for Advanced Therapies at Thermo Fisher Scientific. The Office of Technical Affairs comprises scientific experts that serve as strategic, innovative and educational leaders in the area of cell-based therapies, plasmids and mRNA therapeutics. In her prior role as the Director of Enterprise Science and Innovation Partnerships, she developed and managed strategic partnerships with global bioPharma, biotech and healthcare customers in the area of cell and gene therapy. Prior to this, she was the Head of Technical Operations (Patheon/Thermo Fisher Scientific) where she worked closely with customers to conduct technology transfer and process optimization activities related to GMP manufacturing of cell-based therapies. She has over 15 years of expertise in GMP manufacturing and has successfully led GMP operations, Process Development and MSAT activities, infrastructure buildout, customer relations and business development. In her past roles, she has been the Director of Cell Manufacturing for Program for Advanced Cell Therapy- UW Hospitals and Clinics. At Ligand Pharmaceuticals, she was part of the team that designed novel hematopoietic screening assays for erythropoietin and thrombopoietin in partnership with GlaxoSmithKline, a part of the program that led to development of Promacta®. Rupa holds a master’s degree in Biology from Loyola University and a doctorate from Harvard University with focus on Immunology and Hematology.