North America 2013 Regional Meeting Presentations
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Please note: Only those presentations where permission has been received for posting are available to meeting delegates. A large number of speakers are in the process of providing ISCT with revised slides and as a result, these presentations will be gradually uploaded to the website as they are received.

Reference to these materials will be useful but not comprehensive in developing appropriate standards of care. Their use does not confer any professional qualification or standard. Publication of these materials does not constitute an endorsement of ISCT. ISCT has not reviewed these materials to ensure consistency with acceptable practices. The views expressed in these materials represent the opinion of the authors. ISCT expressly disclaims any liability arising from any inaccuracy or misstatement. Each facility and/or individual referring to these materials should analyze the information, practices and procedures outlined therein to determine their acceptability for use in the context of their own obligations and within their own facility's standards and procedures.

Speakers for the following presentations have given authorization to post their materials.

Presentations are continually being added. Please check back regularly.

 

Sunday, September 8th

 

 

Workshop 1 - Point-of-Care Cell Processing

Chair: Janice Davis-Sproul

Speakers:

Lee Buckler
Yong Fan
Brian Barnes

 

 

Workshop 2 - Upgrading to Closed, Large Scale Productions-Requirements for Equipment and Training

Chair: Shirley Bartido

Speakers:

Steven Roberts
Clive Glover
Shirley Bartido

 

 

Quality Tool Box Session 1 - Risk Assessment and Mitigation

Chair: Olive Sturtevant
Speakers:
Karen Snow
Angela Ondo

 

 

Workshop 3 - Raw Materials, Ancillary Products, Qualification

Chair: Claudia Zylberberg

Speakers:

Fouad Atouf
Lynn Csontos and Jennifer Solomon
Kim Nguyen

 

 

Workshop 4 - Working With Biotech Companies - Management's Perspective

Co-Chairs: Janice Davis-Sproul, and Lynn O'Donnell

Speakers:

Olive Sturtevant
Paul Griggs

Panelists

Lynn O'Donnell
Janice Davis-Sproul
Doug Padley

 

 

Quality Tool Box Session 2 - Managing Deviations

Chair and Presenter: William Janssen

 

 

Workshop 5 - MSC Biology

Co-Chairs: Allan Dietz

Presenters:

Allan Dietz
Satoru Otsuru
Robert Deans

 

 

Workshop 6 - Optimizing Bench to Bedside Translation of Research - An Update from PACT

Chair: Deborah Wood

Speakers:

David H. McKenna Jr.
Frits van Rhee

 

 

Quality Tool Box Session 3 - Technical Writing Led by the Co-Editors of the Telegraft

Co-Chairs and Presenters: Deborah Griffin and Lynn O'Donnell

 

 

Monday, September 9th

 

 

Technical Session 1 - The Who, What, Where, Why and How of FDA Deviation Reporting

Chair: Karen Snow

Speakers:

Fran Rabe
Sharon O'Callaghan

 

 

Technical Session 2 - Transportation Logistics for Cell Therapy Products

Chair: Janice Davis-Sproul

Speakers:

Doug Padley
Daniel O'Donnell

 

 

Technical Session 3 - Movin' On Up: Designing, Commissioning, & Qualifying Your Piece of the Pie

Chair: Lynn O'Donnell

Speakers:

Lynn O'Donnell
Kurt Last

 

 

Plenary Session 1
Cord Blood Expansion

Chair: Colleen Delaney

Speakers:

Colleen Delaney
William Reed
Mitch Horwitz

 

 

Workshop 7 - Cell Therapy Medical Tourism and Unproven Stem Cell Therapies

Chair: Linda Miller

Speakers/Panelists:

Leigh Turner
Kurt Gunter
Lee Buckler
Michael Lill

 

 

Workshop 8 - Cryopreservation Biology

Chair: Lizette Caballero

Speakers:

Allison Hubel
Utkan Demirci
Michael H. Creer

 

 

Workshop 9 - Manufacturing Comparability

Chair: David Williams

Speakers:

Nick Medcalf
Robert Deans
David Williams

 

 

Plenary Session 2
MSC Topic: Translational Development of Universal Donor MSC-Like Cellular Pharmaceuticals

Chairs: Jacques Galipeau

Speakers:

Jacques Galipeau
Ohad Karnieli
John McMannis

 

 

Workshop 10 - Cord Blood: Distinguishing the Good, the Bad, and the Unacceptable

Chair: Karen Snow

Speakers:

Fran Rabe
Karen Ballen

 

 

Workshop 11 - Regulatory Challenges

Chair: Lynn O'Donnell

Speakers:

Lizette Caballero
Sharon Miller

 

 

Oral Abstract Session 1

Chair: Paul Eldridge

Presenters:

Richard Maziarz
Catherine Bollard
Raghavan Chinnadurai
Daniel Powell Jr.
Aaron Levine (please contact the presenter directly to obtain these slides: aaron.levine@pubpolicy.gatech.edu)

 

 

Tuesday, September 10th

 

 

Technical Session 4 - Novel Published Guidelines from ISCT MSC Committee

Chair: Donald Phinney
Speakers:
Jacques Galipeau
Donald Phinney

 

 

Technical Session 5 - Reimbursement 101

Chair:Richard Maziarz

Speakers:

Joel Brill
Robert Wanerman

 

 

Technical Session 6 - FACT Accreditation of Minimal and More Than Minimal Manipulation of Research Products

Chair: Linda Miller

Speakers:

Deborah Griffin

 

 

Plenary Session 3
Redirecting Immunity Through Chimeric Antigen Receptor T Cells

Chair: Bruce Levine

Speakers:

Mark Dudley
Isabelle Riviere
Bruce Levine

 

 

Workshop 12 - Product Labeling - Updates, Perspectives and ISBT 128

Chair: Paul Eldridge

Speakers:

Leigh Sims Poston
Lizette Caballero
William Janssen

 

 

Workshop 13 - Preclinical Assessment of Investigational Cellular and Gene Therapy Projects

Chair: Doug Padley

Speakers:

Doug Padley
Christopher Breuer

 

 

Workshop 14 - Commercialization Case Study: Cell Therapy From Concept to Market

Chair: Robert Deans

Speakers:

Robert Preti
Dolores Baksh

 

 

Lunchtime Session - Regulatory Updates from the Japanese PMDA (Pharmaceuticals and Medical Devices Agency)

Chair: Akihiro Shimosaka

Speakers:

Akihiro Shimosaka
Daiju Okuda

 

 

Plenary Session 4
Tissue Engineering & Organ Recellularization

Chair: Allan Dietz

Speakers:

Allan Dietz
Jeffrey Ross
Christopher Breuer

 

 

Workshop 15 - Harmonizing Manufacturing Across Multiple Sites and Regions

Chair: Karen Edward

Speakers:

Byron McAllister
Erin Lowry
EJ Read

 

 

Workshop 16 - The Perspectives of Academia and Industry in Cellular Therapy Research

Chair: Linda Miller

Speakers:

Ian McNiece

 

 

Oral Abstract Session 2

Chair: Lizette Caballero

Presenters:

Mark McCall
Sophie Derniame
Joseph Frank
Gregory Cooksey
Eric Ahrens

 

 

 

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