Special Events*

Wednesday August 14, 10:45Am – 12:45pm

Translating Science to Medicine: How Cell Therapy Developers Must Overcome Challenges to Plan for Commercial Success – An ISCT PPD Townhall Discussion

The ISCT Process and Product Development (PPD) Subcommittee strives to be the leading source of educational content for overcoming global challenges in translating cell and gene therapeutics from the bench to the bedside. Developing a cell and gene therapy process and translating that process to a scalable manufacturing platform for clinical and commercial success requires a multifaceted approach. Through industry feedback, the members of the PPD have been actively collaborating and addressing translational requirements to drive the industry forward.

This session will highlight critical considerations for overcoming challenges from an end to end development perspective. A sequence of short presentations will be followed by an open and interactive discussion.

10:45-10:55  Welcome and Introduction

Session and ISCT PPD Subcommittee Co-Chairs:

Dominic Clarke, PhD, Global Head of Cell Therapy, HemaCare, USA

10:55-11:05  ISCT Cost of Goods Survey – Learnings

Dominic Clarke, PhD, Global Head of Cell Therapy, HemaCare, USA

11:05-11:15  End to End:  A Manufacturing Overview

David Smith, PhD, Head of Innovation and Engineering, Hitachi Advanced Therapeutics Solutions, USA

11:15-11:25  Cell Culture Scalability and Flexibility

Shannon Eaker, PhD, Cell Therapy Enterprise Technical Leader, GE Healthcare, USA

11:25-11:35  Freezing, Storage and Transit – Biopreservation Best Practices

Alireza Abazari, PhD, Senior Sceintist, Process Development, Lyell Immunoparma

11:35-11:45  Automation – What, When, How

Ohad Karnieli, PhD, MBA, CEO & Co-Founder, Atvio Biotech, Israel

11:45-11:55  A Developer’s Perspective

Yonatan Lipsitz, PhD, Team Lead, Cell Therapy Process Development, Technical Operations, Sana Biotechnology

For Speaker biographies, please visit https://www.bioprocessingsummit.com/Speaker-Biographies#SE-ISCT

EVENTS SCHEDULE

10:45 - 12:45pm  Special Events

12:45 - 1:45          Session Break

1:45 - 3:50            Special Events

3:50 - 4:45            Networking Refreshment Break in the Exhibit Hall with Poster Viewing

4:45 - 6:00            Plenary Keynote Session

6:00 - 7:00            A Taste of New England Reception in the Exhibit Hall with Poster Viewing

* Requires a Main Conference or Exhibit Hall Visitor Pass to attend. Pre-registration encouraged due to limited spaces available.

Established in 1992, ISCT, the International Society for Cell & Gene Therapy is a growing global organization of clinicians, regulators, researchers, technologists and industry partners with a shared vision to translate cell and gene therapies into safe and effective therapies to improve patients’ lives worldwide.

ISCT is the global leader focused on translational aspects of developing cell-based therapeutics, thereby advancing scientific research into innovative treatments for patients. ISCT provides a unique collaborative environment that addresses three key areas of clinical translation: Academia, Regulatory and Commercialization. Through long term strategic relationships with global regulatory agencies, academic institutions and industry partners, ISCT leads the advancement of research into clinical adoption and standard of care.

Comprised of over 1500 cell therapy experts across five geographic regions and representation from over 60 countries, ISCT members are part of a global community of peers, thought leaders and organizations invested in cell therapy translation. For more information about the organization, key initiatives and upcoming meetings, please visit: www.celltherapysociety.org, @ISCTglobal.