'Hct ps' presentation slideshows

Cell, Tissue, and Gene Therapies

Cell, Tissue, and Gene Therapies. Elizabeth Read, MD Adjunct Professor, Lab Medicine, UCSF May 13, 2010. My background. MD, Internal Medicine with Hematology/Oncology subspecialties Immediately after fellowship, worked at NCI managing extramural cancer cooperative group clinical trials

805 views • 45 slides

Cell, Tissue, and Gene Therapies

Cell, Tissue, and Gene Therapies. Elizabeth Read, MD Adjunct Professor, Lab Medicine, UCSF May 13, 2010. My background. MD, Internal Medicine with Hematology/Oncology subspecialties Immediately after fellowship, worked at NCI managing extramural cancer cooperative group clinical trials

570 views • 45 slides

Development Considerations for Cell & Tissue Therapies and Gene Therapies

Development Considerations for Cell & Tissue Therapies and Gene Therapies. Elizabeth Read, MD Epi 260 UCSF May 9, 2012. Cell & Tissue Therapies. Development pathway for 351 HCT/Ps (same as drugs & conventional biologics). How HCT/Ps differ as a product class. Extremely heterogeneous

620 views • 37 slides

Melissa A. Greenwald, M.D. Office of Cellular, Tissue and Gene Therapies (OCTGT); CBER

Issues Related to the Potential Transmission of Trypanosoma cruzi by Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps). Melissa A. Greenwald, M.D. Office of Cellular, Tissue and Gene Therapies (OCTGT); CBER Blood Products Advisory Committee 26 April 2007. Overview.

441 views • 30 slides

Regulation of Blood & Blood Products and Cell, Tissue & Gene Therapies

Regulation of Blood & Blood Products and Cell, Tissue & Gene Therapies. Elizabeth Read, MD Epi 260 UCSF May 9, 2012. Biologics Review at FDA. C D ER Monoclonal antibodies Therapeutic proteins (cytokines, enzymes, etc.) Immunomodulators

495 views • 25 slides

Behavioral Deferrals for HCT/Ps are often Less Stringent than for Blood: Rationale (Ruth Solomon)

FDA Workshop on Behavior-Based Donor Deferrals in the NAT Era Lister Hill Auditorium, NIH Bethesda, Maryland March 8, 2006 Summary of the Workshop Andrew I. Dayton, M.D., Ph.D., CBER. Behavioral Deferrals for HCT/Ps are often Less Stringent than for Blood: Rationale (Ruth Solomon).

353 views • 22 slides

Ana Kolin, Ph.D. DHT, OCTGT email: ana.kolin@fda.hhs.gov CTGTAC Meeting, May 14, 2009

620 views • 21 slides

FDA Good Guidance Practices (GGP)

Development of Guidance Documents Jennifer Scharpf, M.P.H. Associate Director for Policy and Communication Office of Blood Research and Review, CBER September 15, 2009. FDA Good Guidance Practices (GGP).

358 views • 17 slides

The Practicalities of Biospecimen Storage & Good Storage Practice

312 views • 14 slides

The Practicalities of Biospecimen Storage & Good Storage Practice

267 views • 14 slides

HCT/P Contamination Prevention and Biologic Product Sterility Regulations Applicable to PBSCs

HCT/P Contamination Prevention and Biologic Product Sterility Regulations Applicable to PBSCs. Cell Therapy Liaison Meeting June 16, 2006 Ellen F. Lazarus, M.D. Division of Human Tissues Office of Cellular, Tissue, and Gene Therapies. C. B. E. R.

194 views • 8 slides

HCT/P Contamination Prevention and Biologic Product Sterility Regulations Applicable to PBSCs

HCT/P Contamination Prevention and Biologic Product Sterility Regulations Applicable to PBSCs. Cell Therapy Liaison Meeting June 16, 2006 Ellen F. Lazarus, M.D. Division of Human Tissues Office of Cellular, Tissue, and Gene Therapies. C. B. E. R.

81 views • 8 slides

HCT/P Contamination Prevention and Biologic Product Sterility Regulations Applicable to PBSCs

HCT/P Contamination Prevention and Biologic Product Sterility Regulations Applicable to PBSCs. Cell Therapy Liaison Meeting June 16, 2006 Ellen F. Lazarus, M.D. Division of Human Tissues Office of Cellular, Tissue, and Gene Therapies. C. B. E. R.

81 views • 8 slides