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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