Key ISCT Projects - Update

Catherine Bollard, MBChB, MD ISCT President 2016-2018

Firstly- Thank you to Head Office!!

Queenie Jang (Executive Director)

Audrey Le (Association Manager)

Brian Poole (Association Project Manager)

Madeline St. Onge (Association Coordinator)

John Wheeler (Association Coordinator)

Justine Ho (Association Coordinator)

Overview of Key ISCT Projects Q3-Q4 2016

Public Relations and Media Strategy

Regional Education Initiatives

Regulatory Leadership

Inaugural Commercialization Signature Series

2017 ISCT-ASBMT Cell Therapy Training Course Launch

ISCT 2017 Annual Meeting

ISCT 25th Anniversary Celebration Planning

Public Relations and Media Strategy

Official PR Agency: Image Box Ltd. (based in London, UK)

ISCT released 2 press releases in August 2016: 1. “ISCT awards London as city venue to host silver jubilee year

cell therapy conference” • Announced ISCT 2017 Annual Meeting in London and new ISCT President

Catherine Bollard.

2. “ISCT calls for changes to proposed US REGROW Act on cell therapies” • ISCT’s reasons for opposition, and recommendations to draft US REGROW Act.

Public Relations and Media Strategy

Press Releases distributed to over 4000 global media contacts

ISCT Officer interviews with journalists from key tier one life science industry publications produced or are in progress:

• BioWorld (US)

• BioPharm Insight (US/UK)

• BioPharma Reporter, Outsourcing Pharma and In-Pharma Technologist (US/UK/FR)

• Translational Scientist (UK)

• Life Science Leader (US)

• Science Magazine (US)

Regional Educational Initiatives

2016 SBTMO and ABTCEL Meeting August 24-27 in Fortaleza, Brazil

• Presentations by ISCT Officers: • Massimo Dominici, MD, Immediate Past President

• Dan Weiss, MD, PhD, Chief Scientific Officer

• Maroun Khoury, PhD, South & Central America, Regional Vice-President Elect

7th ACTO Meeting November 11-13 in Beijing, China • Presentations by ISCT Officers:

• Massimo Dominici, MD, Immediate Past President

• Steve Oh, PhD, Asia Regional Co-Regional Vice-President

ISCT Australia and New Zealand 2016 Regional Meeting November 12 in Parkville, Victoria, Australia

Regulatory Leadership

September 8th FDA Public Workshop: Scientific Evidence in Development of Human Cells, Tissues, and Cellular and Tissue-based Products Subject to Premarket Approval

• “Dissecting Unproven Cellular Therapies: The International Society for Cellular Therapy (ISCT) Position”

• Presented by Massimo Dominici, MD ISCT Past President and Chair of the Presidential Task Force on Unproven Cellular Therapy

• Attended by Daniel J. Weiss, MD, PhD, ISCT Chief Scientific Officer

• Also speaking and in attendance Jacques Galipeau, MD, FRCP(C), ISCT MSC Committee Chair

Regulatory Leadership

September 12-13th FDA Public Hearing: Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-based Products

• Formal presentation by ISCT • Presented by Karen Nichols, Esq., ISCT Chief Regulatory Officer

• Also in attendance Deborah Griffin, MSc, ASQ CPGP, ISCT North America Legal and Regulatory Affairs Committee Chair

Relaunch of ISCT-Led FDA Cell Therapy Liaison Meeting (CTLM) • Meeting scheduled for October 19, 2016 in Bethesda

• Involving 15 Stakeholder Organizations

Inaugural Commercialization Signature Series

First ISCT Commercialization Signature Series Event Launched on September 29, 2016

• “Delivering Value in Cell Therapy: A Patient Focussed Approach”

• Held at the Marlo Thomas Center for Global Education and Collaboration (St. Jude Campus)

• A Think Tank of Industry Leaders

2017 ISCT-ASBMT Cell Therapy Training Course

October 23-27, 2017 – A partnership between ISCT and ASBMT

Fred Hutchinson Cancer Research Centre in Seattle, WA, USA

Co-Chairs: David DiGiusto, PhD and John Barrett, MD

12 Full Scholarships to be awarded • 6 North America

• 6 International

Up to 3 Host Institutional Scholars

12 Scholarships Available!

Check Back for Application Details at

www.celltherapysociety.org

ISCT Celebrates 25 Years