Strategies for Commercialization (SFC) Track
Hear from industry leaders developing solutions to the most prominent challenges facing the cell and gene therapy industry. The 2020 Strategies for Commercialization track theme, moving from commercialization to industrialization, will share critical strategies required to tackle scale up and optimization challenges as more cell and gene therapy products reach the market. Learn how to optimize your manufacturing process, overcome logistics challenges, leverage fast track regulations in your commercialization plan, evaluate and improve your business model, raise capital, and ultimately contribute to the goal of delivering more cell and gene therapies to patients.
- Session 1: Innovating Process Development for Sustainable Manufacturing
- Session 2: Can we Industrialize CAR T Therapies?
- Session 3: Raising capital for CGT industrialization
- Plenary Satellite A: Industrializing Clinical Delivery
- Plenary 4: Is Big Pharma Ready for Industrial Scale Cell and Gene Therapy?
- Plenary Satellite B: Industrializing the administration setting
- Session 4: Best practices for funding CGT startups from academia
- Session 5: Providing effective cellular therapies in the face of commercialization – meeting the patients’ needs and expectations
- Session 6: Clinical experience in regenerative medicine and tissue engineering, the next wave of advanced therapies
- Session 7: Fast Track Regulations
SFC Session 1: Innovating Process Development for Sustainable Manufacturing
Optimizing a product through process development is a natural step in translating the therapeutic to the clinic. While this is a critical milestone, many of the processes have not been optimized for larger-scale industrialization. This session will evaluate how industry innovators are implementing new processing platforms and strategies to position future products for sustainable industrialization
Dominic Clarke, PhD, HemaCare Corporation, United States
Denis Bedoret, PhD, MaSTherCell Global, Belgium
Stuart Curbishley, PhD, University of Birmingham Medical School, United Kingdom
Ricardo Batista, PhD, Cellectis, France
SFC Session 2: Can we industrialize CAR T therapies? The practical challenges in achieving wide-spread patient access
Today the first two autologous CAR T therapies are commercialized in multiple developed countries, through dozens of health care facilities, and many hundreds of patients are benefiting from treatment! Now “industrializing” CAR T therapy to gain world-wide, broad patient access to this new standard of care, means not only extensive scale-up of manufacturing capacity but also transforming hundreds of health care centers into CAR T competent treatment sites using either autologous or “off-the-shelf” products in treating patients. What are some key considerations for how academia, industry and healthcare centers can meet this challenge? Today we’ll explore autologous, allogeneic, and stakeholder partnering perspectives from three experts active in pursuing this CAR T industrialization vision.
Bill Milligan, Steminent Biotherapies, Canada/Taiwan
Gunther Busam, RPh, PhD, Celgene, Switzerland
Elizabeth Hexner, MD, Penn Medicine, United States
Wen Bo Wang, PhD, Fate Therapeutics, United States
SFC Session 3: Raising capital for CGT industrialization
In this session we will discuss the current landscape of cell and gene therapies from the investor’s perspective. As these therapies reach more advanced stages of development and eventually commercialization the capital requirements will continue to increase – and along with this the need to expand the scope of the investor base. We aim to address the following questions:
- How do investors characterize opportunities for CGT companies relative to more traditional drug modalities?
- What role does pharma need to play to support the CGT ecosystem?
- Will investor appetite for CGT continue to increase, or have we hit a local maximum?
Patrick Rivers, MBA, Aquilo Capital, United States
Jak Knowles, MD, Century Therapeutics, United States
Plenary Satellite A – Industrializing Clinical Delivery
Life changing therapies are being created and manufacturing systems are constantly evolving. However there also needs to be innovation within the logistically delivery of advanced therapies within the clinical setting. This session will highlight some key challenges that developers need to be aware of, and present solutions that are being developed.
Simon Ellison, MBA, World Courier, United Kingdom
Jacqueline Barry, PhD, Cell and Gene Therapy Catapult , United Kingdom
Plenary Session – Is Big Pharma ready for industrial scale Cell and Gene Therapy?
Recent successes in the market authorization of cell and gene therapy products has generated tremendous excitement. However. to be successful, the industry now needs to move into a phase of industrialization, where like the car industry it needs the “eureka” moment of standardization that allows the efficient flow from product to patient. To realize this, we need to overcome the barriers between all the silos in the system (e.g. hospital, manufacture, testing, etc.) so that patients are efficiently treated.
Anthony Ting, PhD, Athersys, United States
Angela Krackhardt, MD, Technical University of Munich, Germany
Alberto Santagostino, MBA, Lonza, Switzerland
Emanuele Ostuni, PhD, Novartis Oncology, Switzerland
Plenary Satellite B – Industrializing the administration setting
The supply chain is working now but how will it cope when there are tens of therapies and thousands of patients, globally? The “hidden challenge” is the last 100m within the clinical setting. Here, we will describe ways the infrastructure, equipment, staffing, training, and systems need to be designed to operate efficiently to treat the patients.
Julie Murrell, PhD, MilliporeSigma, United States
Chris Herbert, PhD, Leeds Teaching Hospitals NHS Trust, United Kingdom
Anne Black, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, United Kingdom
Christoph Demmerle, Novartis, Germany
SFC Session 4: Best practices for funding CGT startups from academia
The path to taking a great platform or therapeutic program that has been incubated at an academic center and turning it into a biotech company is fraught with peril and cautionary tales. We want to explore the lessons learned by academic founders of successfully funded academic spin-outs and provide a better blueprint for others who are wondering how to pursue the creation of a company around their novel science.
Patrick Rivers, MBA, Aquilo Capital, United States
Mike Milone, MD, PhD, Cabaletta Bio, United States
Colleen Delaney, MD, MSc, Nohla Therapeutics, United States
SFC Session 5: Providing effective cellular therapies in the face of commercialization – meeting patients’ needs and expectations
Commercialization of cellular and gene therapies is irrelevant if the patients do not receive the therapy they require. As we industrialize the manufacturing of such products, assuming equivalent efficacy, the therapy that is the easiest to adopt, depending on process and cost, and is the least difficult for the patient to tolerate will be the most widely adopted. To arrive at this endpoint, we need to understand the patient’s needs and expectations when they consider cell and gene therapy options. In this context, it is important to discriminate between legitimate, safe and effective therapies versus alternative treatments that are offered to patients who are desperate. Cell and gene therapies, and particularly stem cell therapies need be placed into the category of highly advanced and often life saving therapies, if chosen and administered in a responsible and ethical way.
Gerhard Bauer, PhD, University of California, Davis Institute for Regenerative Cures, United States
Kathryn Rodden, NHS University Hospitals of Birmingham, United Kingdom
Mohamed Abou-El-Enein, MD, PhD, Charité – Universitätsmedizin Berlin, Germany
Mark Yarborough, PhD, University of California, Davis, United States
SFC Session 6: Clinical experience in regenerative medicine and tissue engineering, the next wave of advanced therapies
Julie Allickson, PhD, Wake Forest Institute for Regenerative Medicine, United States
Petter Björquist, PhD, VERIGRAFT AB, Sweden
Martin Birchall, MD, University College London, United Kingdom
Heather Prichard, PhD, Humacyte, United States
SFC Session 7: Fast Track Regulations
Recent years have seen an increase in the number of fast track regulatory pathways available to developers, many of which are intended to accelerate commercialisation of promising cell and gene therapies. As these pathways begin to be tested and products are commercialised through them, this session will focus on both the opportunities and challenges that they present. Key differences between geographies will be discussed and how these novel pathways affect global product development plans.
Siofradh McMahon, MSc, CCRM, Canada
Katy Spink, PhD, Dark Horse Consulting, United States