[vc_row][vc_column][vc_column_text]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.[/vc_column_text][vc_empty_space][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]

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SFC Session 1: Innovating Process Development for Sustainable Manufacturing

[/vc_column_text][vc_empty_space][vc_column_text]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[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_column_text el_id=”SFC3″]

SFC Session 2: Raising capital for CGT industrialization

[/vc_column_text][vc_empty_space][vc_column_text]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?

[/vc_column_text][vc_empty_space height=”15″][vc_column_text]Chair:
Patrick Rivers, MBA, Aquilo Capital, United States

Jak Knowles, MD, Leaps by Bayer, United States[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_column_text el_id=”SFC2″]

SFC Session 3: Can we industrialize CAR T therapies? The practical challenges in achieving wide-spread patient access

[/vc_column_text][vc_empty_space][vc_column_text]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, University of Pennsylvania, United States

Wen Bo Wang, PhD, Fate Therapeutics, United States

Suma Roa, PhD, Allogene Therapeutics, United States[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_column_text el_id=”SFC4″]

Plenary Satellite A – Industrializing Clinical Delivery

[/vc_column_text][vc_empty_space][vc_column_text]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[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_column_text el_id=”SFC5″]

Plenary Session – Is Big Pharma ready for industrial scale Cell and Gene Therapy?

[/vc_column_text][vc_empty_space][vc_column_text]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[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_column_text el_id=”SFC6″]

Plenary Satellite B – Industrializing the administration setting

[/vc_column_text][vc_empty_space][vc_column_text]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

Christopher 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[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_column_text el_id=”SFC7″]

SFC Session 4: Best practices for funding CGT startups from academia

[/vc_column_text][vc_empty_space][vc_column_text]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

Patrick Hanley, PhD, Children’s National Medical Center, USA[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_column_text el_id=”SFC8″]

SFC Session 5: Providing effective cellular therapies in the face of commercialization – meeting patients’ needs and expectations

[/vc_column_text][vc_empty_space][vc_column_text]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

Kathie 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[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_column_text el_id=”SFC9″]

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,

Martin Birchall, MD, University College London, United Kingdom

Heather Prichard, PhD, Humacyte, United States
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SFC Session 7: Fast Track Regulations

[/vc_column_text][vc_empty_space][vc_column_text]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 Group, United States[/vc_column_text][/vc_column][/vc_row]