Size matters: ensuring donor pool sustainability and cell therapy supply chain success when scaling up and outPublished: June 30, 2020
Thursday, 6 August 2020. 08:00 PDT; 11:00 EDT; 16:00 BST; 17:00 CEST
As cell and gene therapies progress through clinical trials and prepare for commercialization, it becomes increasingly critical for sponsors to pursue scalable solutions to overcome the imminent increase in risk. How can cell and gene therapy developers effectively prepare for a commercial environment that exists in an industry still in its infancy?
To increase potential for long-term success in both allogeneic and autologous programs, choosing partners with proven experience is essential. Leveraging service providers with specialized expertise, established global relationships and expansive infrastructure in place to collect, manufacture, deliver and provide required reporting for large quantities of therapies will ensure a smoother, faster transition to market, and ultimately, more patients.
Attendees will learn:
- What to expect when transitioning from small trial sizes to large volumes and how to effectively manage imminent disruptions
- Global partnerships and critical strategies to best orchestrate scalable cell therapy logistics in a highly variable environment
- The importance of a broad, diverse starting donor pool impacts scalable sourcing of quality starting material for downstream activities
- How specialized and diverse knowledge of apheresis processes can be transformed into highly productive site onboarding and training
Chris Learn, PhD, Senior Director, Therapeutic Science & Strategy Unit, IQVIA
Dr. Learn is a Senior Therapeutics Strategy Director, Cell and Gene Therapy at IQVIA. He is the Senior Director of both the Cell and Gene Therapy Center of Excellence (CAGT COE) and the Cardiovascular Center of Excellence (CV COE). As a clinical research professional with 19+ years of trial execution and team management experience, Chris is enthusiastic and passionate about translational science. With focused interests in strategic development of novel therapeutics, Chris has been a team leader in the registrational development, agency submission and regulatory approval of three separate and unique oncology products (YONDELIS®, IMBRUVICA® and KEYTRUDA®), and oversaw the outsourced global trialing operations for the clinical development of lisocabtagene maraleucel (liso-cel) and idecabtagene vicleucel (ide-cel).
As a former project leader with the Duke University Brain Tumor Center, Chris has been an author on three separate investigator-initiated clinical trials, including design, implementation and execution. His current interests and commitments lie in cell and gene therapy clinical trial strategy and development.
Amit Agarwal, Managing Director, Life Sciences, Deloitte Consulting
Amit is a Managing Director in Deloitte Consulting’s Life Sciences practice. Amit has more than 25 years of management consulting experience and has led multiple projects in both strategy and operations. Amit co-leads the Next Generation Therapies practice. The practice focuses on advising clients on taking advantage of and/or developing strategic responses to new disruptive technologies in cell and gene therapies space. Amit has worked with Life Science clients in the U.S. Europe and Asia on high-impact projects.
Amit also has experience as Vice President at Leerink Swann & Co., a boutique investment bank focused on the life sciences. He helped innovative life science companies raise capital, identify merger and acquisition targets and negotiate strategic partnerships and alliances. He helped his clients generate nearly $1 billion of market value through the deals he helped broker.
Amit publishes extensively in the business press and in peer reviewed academic journals on personalized medicine. Amit has presented at multiple conferences in North America, South America and Europe and worked with industry associations on value-based care and risk sharing contracts in light of new technology paradigms. Amit holds an MBA in finance and technological innovation from the MIT Sloan School of Management and a bachelor’s degree in history and pre-med from Occidental College. Prior to business school, Amit conducted research in neurobiology at the California Institute of Technology and was an American diplomat posted in China and the Middle East.
Ray Hornung, MBA, MBCI, CEM, CBCP, Senior Manager, Logistics and Emergency Preparedness, Be The Match BioTherapies® and National Marrow Donor Program® (NMDP)/Be The Match®
Ray manages the Logistics and Emergency Preparedness team for Be The Match BioTherapies and its parent company, the NMDP/Be The Match. He and his team are responsible for managing the logistics for more than 36,000 time-sensitive cell and blood shipments per year. The NMDP/Be The Match has more than 30 years of supply chain and logistics experience shown through the successful delivery of more than 100,000 life-saving therapies to patients in need. Prior to joining the NMDP/Be The Match and Be The Match BioTherapies, Ray spent 23 years on active duty in the Army performing operations and logistics.