Workshop Goals and Objectives
The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), is announcing a public workshop entitled “Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products.” The purpose of the public workshop is to bring together a broad range of stakeholders to discuss current and future standards development activities involving cellular therapies and regenerative medicine products.
Standardization efforts concerning the clinical development of cellular therapies and regenerative medicine products have generated a great deal of interest. These efforts include standards development, expert opinion position papers, and professional practice guidelines. However, relatively little is done to coordinate the various existing efforts. In the public workshop, FDA hopes to bring together a broad range of stakeholders of cellular therapies and regenerative medicine products in order to:
8:30am Introductory remarks
8:40 am Government Overview (Session Chair: Judy Arcidiacono)
Chris Joneckis (CBER/FDA)
David Kaplan (CDRH/FDA)
Traci Mondoro (NHLBI/NIH)
Carl Simon (NIST)
9:40 am Standards Development Organizations (Session Chair: Jiyoung Dang)
Frank Simione (ATCC)
Liisa Kuhn (representing ASTM)
David Kaplan (representing ISO)
10:40 am Break
11:00 am Standards Related Organizations (Session Chair: Malcolm Moos)
Eduardo Nunes (AABB)
Carolyn Keever-Taylor (FACT)
Fouad Atouf (USP)
Erwin Cabana (ICCBBA)
12:00 pm Lunch
1:00 pm Professional Societies and Industry Groups (Session Chair: Allen Wensky)
Robert Deans (representing ARM)
Paul Eldridge (representing ISCT)
Deepak Jain (representing TERMIS)
1:45 pm Case studies for regenerative medicine standards development and use (Session Chair: Diana Yoon)
George Muschler (Cleveland Clinic)
Hany Demian (CDRH/FDA)
Anthony Ratcliffe (Synthasome)
2:45 pm Break
3:00 pm Panel Discussion on opportunities for synergizing standards activities (Session Chair: Keith Wonnacott)
4:20 pm Wrap-up and Concluding remarks
The public workshop will be held at the following location:
FDA White Oak Campus
The Great Room, Bldg. 31, Room 1503A
10903 New Hampshire Ave
Silver Spring, MD 20993
Please visit the following Website for location, parking, security, and travel information:
The public workshop will also be available to be viewed online via webcast.
Streaming Webcast of the Public Workshop: For those unable to attend in person, FDA will Webcast the public workshop. To join the Webcast of the public workshop, please go to:https://collaboration.fda.gov/sesdctrmpworkshop/.
If you have never attended an Adobe Connect meeting before, test your connection athttps://collaboration.fda.gov/common/help/en/support/meeting_test.htm. Get a quick overview:http://www.adobe.com/go/connectpro_overview.
Registration is not required for those attending via Adobe Connect.
Mail or fax your registration information (including name, title, firm name, address, telephone, and fax numbers) to Sherri Revell (see Contact Person) or email to CBERPublicEvents@fda.hhs.gov (Subject line: SESDCTRMP Workshop Registration) by March 24, 2014. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 7:30 a.m.
Office of Communication, Outreach, and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, Suite 200N, HFM-49
Rockville, MD 20852-1448
e-mail: CBERPublicEvents@fda.hhs.gov (Subject Line: SESDCTRMP Workshop)