Working with FDA: Biological Products and Clinical Development

**Speaker Information**

**Donna L. Bialozor**

Technology Transfer Assistant

Technology Transfer Branch

Office of the Director

National Cancer Institute

Phone: 301-846-5465

Email: bialozod@mail.nih.gov

**Eda T. Bloom, Ph.D.\
**Chief

Gene Transfer and Immunogenicity Branch\
Division of Cellular and Gene Therapies\
Office of Cellular, Tissue and Gene Therapies\
Center for Biologics Evaluation and Research\
U.S. Food and Drug Administration\
Phone: 301-827-0452\
Email: eda.bloom@fda.hhs.gov

**Jerry M. Collins, Ph.D.**

Associate Director

Developmental Therapeutics Program

Division of Cancer Treatment and Diagnosis

National Cancer Institute

Phone: 301-496-8720

Email: jc181p@nih.gov

**Stephen Creekmore, M.D., Ph.D.**

Chief

Biological Resources Branch

Developmental Therapeutics Program

Division of Cancer Treatment and Diagnosis

National Cancer Institute

Phone: 301-846-1100

Email: creekmor@ncifcrf.gov

**Ying Huang, Ph.D.**

Pharmacologist

Pharmacology/Toxicology Branch

Division of Clinical Evaluation and Pharmacology/Toxicology

Office of Cellular, Tissue and Gene Therapies

Center for Biologics Evaluation and Research

U.S. Food and Drug Administration

Phone: 301-827-5346

Email: ying.huang@fda.hhs.gov

**Karen D. Jones**

Chief

Project Management Staff

Division of Biologic Oncology Products

Office of Oncology Drug Products

Office of New Drugs

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

Phone: 301-796-2320

Email: karen.jones@fda.hhs.gov

**Patricia Keegan, M.D.**

Director

Division of Biologic Oncology Products

Office of Oncology Drug Products

Office of New Drugs

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

Phone: 301-796-2320

Email: patricia.keegan@fda.hhs.gov

**Deborah Lavoie, J.D., RAC**

Branch Chief

Regulatory Management Staff

Office of Cellular, Tissue and Gene Therapies

Center for Biologics Evaluation and Research

U.S. Food and Drug Administration

Phone: 301-827-5102

Email: deborah.lavoie@fda.hhs.gov

**Ke Liu, M.D., Ph.D.**

Medical Officer and Clinical Reviewer

Division of Clinical Evaluation and Pharmacology/Toxicology

Office of Cellular, Tissue and Gene Therapies

Center for Biologics Evaluation and Research

U.S. Food and Drug Administration

Phone: 301-827-6536

Email: ke.liu@fda.hhs.gov

**Ingrid Markovic, Ph.D.**

Biologist

Laboratory of Biochemistry

Division of Therapeutic Proteins

Office of Biotechnology Products

Office of Pharmaceutical Science

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

Phone: 301-827-1730

Email: ingrid.markovic@fda.hhs.gov

**Anne M. Pilaro, Ph.D.**

Supervisory Toxicologist (Acting)

Division of Biologic Oncology Products

Office of Oncology Drug Products

Office of New Drugs

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

Phone: 301-796-2320

Email: anne.pilaro@fda.hhs.gov

**Raj K. Puri, M.D., Ph.D.\
**Director\
Division of Cellular and Gene Therapies\
Office of Cellular, Tissue and Gene Therapies\
Center for Biologics Evaluation and Research\
U.S. Food and Drug Administration\
Phone: 301-827-0471\
Email: raj.puri@fda.hhs.gov

**Dan Takefman, Ph.D.**

Chief

Gene Therapy Branch

Division of Cellular and Gene Therapies

Office of Cellular, Tissue and Gene Therapies

Center for Biologics Evaluation and Research

U.S. Food and Drug Administration

Phone: 301-827-5102

Email: daniel.takefman@fda.hhs.gov

**Keith Wonnacott, Ph.D.\
**Chief

Cellular Therapies Branch\
Division of Cellular and Gene Therapies\
Office of Cellular, Tissue and Gene Therapies\
Center for Biologics Evaluation and Research\
U. S. Food and Drug Administration\
Phone: 301-827-5102\
Email: keith.wonnacott@fda.hhs.gov

**Hong Zhao, Ph.D.**

Team Leader, Biologics

Division of Clinical Pharmacology V

Office of Clinical Pharmacology

Office of Translational Science

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

Phone: 301-796-1636

Email: hong.zhao@fda.hhs.gov