Main Meeting Program
FINAL PROGRAM NOW AVAILABLE - CLICK HERE
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Fred Falkenburg - Leiden University Medical Center
Jon Serody - University of North Carolina
John Barrett - NIH NHLBI
Steve Grupp - Children's Hospital of Philadelphia
Michael Kershaw - Peter MacCallum Cancer Centre
Marian Sturm - Cell and Tissue Therapies WA
Sarah Young - University of Otago
Patrick Hanley - Baylor College of Medicine
Xiao-Jun Huang - Peking University
Geoff Hill - Queensland Institute of Medical Research
John Koreth - Dana-Farber Cancer Institute
Chris Bredeson - University of Ottawa
James Chong - University of Washington
Bronwen Connor - University of Auckland
Derek Hart - University of Sydney
Rod Dunbar - University of Auckland
Katy Rezvani - MD Anderson Cancer Center
Dario Campana - National University of Singapore
Raewyn Broady - University of British Columbia
Juan Vera - Baylor College of Medicine
David DiGiusto - City of Hope National Medical Center
Megan Levings - University of British Columbia
Kurt Gunter - Hospira, Inc.
Adrian Gee - Baylor College of Medicine
Bruce Levine - University of Pennsylvania
Dominic Wall - Peter MacCallum Cancer Centre
Peter Flanagan - New Zealand Blood Service
Roy Jones - MD Anderson Cancer Center
Michael Kalos - University of Pennsylvania
Mickey Koh - St. George's Hospital and Health Sciences Authority
Alok Srivastava - Centre for Stem Cell Reserach
Pre-Conference Workshops (April 22, 2013)
Global Regulatory Perspectives Workshop
8:00am - 5:30pm
SKYCITY Convention Centre
for more information.
8:00am - 5:00pm
SKYCITY Convention Centre
Click Here for more information.
Flow Cytometry Workshop
9:00am - 4:30pm
Maurice Wilkins Centre - University of Auckland
Click Here for more information.
Quality and Operations Track Description
ISCT has been offering a Technical Applications Track since the 2009 meeting in San Diego. This year’s organizing committee decided to rename the track the “Quality and Operations Track” to make it clear that the broad scope would appeal to more than just “technical” professionals.
Anyone who works on HOW to get cell therapies from the preclinical stage to the patients in a safe and controlled manner that meets applicable regulations will find something in the track for them. Since that pretty much covers about everyone who attends the ISCT meeting, we hope every meeting delegate can attend at least one “Qual/Ops” session this year. There are 13 sessions in the Quality and Operations Track, with a good mixture of sessions for those working in routine stem cell processing facilities, with topics ranging from cryopreservation and post-thaw manipulations to product testing, and for those doing more advanced cell therapy manufacturing with sessions on technical aspects of immunotherapies, process development and GMP manufacturing in smaller facilities. The organizers have strived to make several sessions interactive by utilizing formats that include panel discussions, scenarios and round table debates. As such, this track offers ample opportunities for networking.
So, now in our best New Zealand-ese:
G’day (Hello). We hope you can join us and our Kiwi (New Zealander) hosts in the City of Sails (Auckland), as the organizing committee is home and hosed (has successfully completed planning), and has put together a choice (excellent) program for you. Give yourself a pressie (present) for all your hard yakka (hard work), bring some mates (friends) or rellies (family), and take some extra time before or after the meeting. From North Cape to the Bluff (one end of New Zealand to the other), there is plenty for everyone to enjoy, including your oldies (parents) and ankle-biters (small kids). Put on your jandals (flip flops) and take the tiki tour (scenic route) to one of the many whangas (harbors or bays), enjoy a footie (rugby) match, or do some tramping (hiking) in the wop-wops (middle of nowhere). So – See ya later, Take it easy and Hooroo (all Goodbye) and Ta (Thanks)!
- Vicki Antonenas and Lynn O'Donnell
Strategies for Commercialization Track Description
The clinical successes seen recently with regenerative medicines have driven market acceptance, pushed Regulatory rule-making, and have required critically important payer review of expensive cell therapies. Thus as research continues to bring more products to market, the commercialization processes are becoming increasingly well defined. But like the US tax code or a Westfield’s mall directory, definitions don’t equal simplicity. From tissue sourcing all the way to reimbursement, the 2013 Strategies for Commercialization track, under the leadership of Dr. Dawn Driscoll, will examine critical points and a few dark alleys along the road from Research to ℞.
Several of the sessions will be devoted to technical aspects of producing commercial cell therapies. Steve Oh and Guy Moeneclaey will showcase methods for practical and rapid characterization of cells during the production process for cell therapies. Knut Niss will chair a session that examines the upstream manufacturing issues related to sourcing and the importance of managing the supply chain for manufacturing. Then a session Chaired by Shirley Bartido will look at downstream manufacturing issues such as “Packaging and Delivery of Cell Therapy Products”, “Stability and Traceability of Cell Therapy Products during Shipment”, and very interestingly. “Cost and Risk with Product Delivery to Patient Bedside”. Another very pertinent session will examine the commercial challenges related to the technical demands of fussy cells. Using cord blood expansion as an example of this, Claudia Zylberberg and Robert Nordon will chair a session given by experts in the cord blood expansion field. The goal of this session is to facilitate interactions between clinical investigators, technologists and commercial players towards developing cost-effective strategies for cell manufacture.
The remainder of the sessions will examine critical aspects of product development, corporate decision making, and the stunningly dull but critically important topic of reimbursement. We’ll start with a session on late stage clinical trials, in which several companies with products in clinical development will discuss their trial designs and what approaches they are taking for collection of ancillary data (e.g. biomarkers.) Topics to be discussed include what you need to do to ensure registration and reimbursement with a focus on robust clinical trial design - patient cohorts and eligibility criteria, dosing schedules based on earlier phase trial data, statistical analysis planning, and collection of efficacy data that the regulators and payers want to see.
We will also discuss the Approvals and Post-Approvals Process with a session chaired by Tony Lee. Industry players with various categories of cell-based products approved in the market will share their experiences and insights on the approval and post-approval experiences across a number of regulatory jurisdictions. Christopher Bravery will chair a session that examines Risk in cell therapy development – from the regulatory as well as the corporate perspective.
For the second consecutive year, the Annual Meeting Planning Committee has allotted a plenary session to the Strategies for Commercialization track. The plenary session will focus on tissue engineering and regenerative medicines, with presentations by both big pharma and academic groups pushing the boundaries of cell biology, science, and medicine.
Most importantly for you, all sessions will contain an interactive portion, so that you can ask the expert presenters specific questions. We look forward to seeing you in Auckland for this very excellent and timely meeting!- Dawn Driscoll