1. Food and Drug Administration Center for Biologics Evaluation and Research The Office of Cellular, Tissue, and Gene Therapies Web Seminar Series presents: The Office of Cellular, Tissue, and Gene Therapies Web Seminar Series presents: Introduction and Scope of OCTGT Webinar Series Patrick Riggins, Ph.D. Branch Chief Regulatory Management Staff

2. Scope and Disclaimer The associated Webinars are intended to refer to submissions to OCTGT General information to assist in the preparation of IND submissions –IND Basics –Administrative Information/Meetings –Product/CMC Information –Preclinical Considerations – Information regarding HCT/Ps

3. Future Topics/Improvements Evaluations –Each web seminar has an associated evaluation –Please comment in order to potentially improve the existing web seminars and to enhance any future topics Suggested Topics –Please suggest additional topics which you feel will be helpful to you

4. Products Under OCTGT Cellular Therapy Products Gene Therapy Products –Including gene modified cells Therapeutic Vaccines –Peptides –Dendritic Cells Xenogeneic Products Tissues/Tissue-based products Some Combination Products Devices

5. Devices Regulated in OCTGT Cell selection devices Point of Care Devices –PRP Cord Blood Processing Devices For more detail see: –See CDRH Device Advice http://www.fda.gov/MedicalDevices/DeviceRegulationand Guidance/default.htm –CDRH Learn http://www.fda.gov/Training/CDRHLearn/default.htm

6. Contact Information All Submissions to: FDA/CBER Attn: Office of Cellular, Tissue, and Gene Therapies Document Control Center/HFM-99/Suite 200N 1401 Rockville Pike Rockville, MD 20852 Fax Number: 1-301-827-9796 Phone Number: 1-301-827-5102 Email: CBEROCTGTRMS@fda.hhs.gov

7. Questions? Please refer to the Web Seminars –Email: CBEROCTGTRMS@fda.hhs.gov or –Email: patrick.riggins@fda.hhs.gov –Phone: 301-827-5366 Please do not forget the Evaluations