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IND-Enabling Studies: Preclinical Perspective Mercedes A. Serabian, M.S., DABT FDA/CBER/OCTGT/DCEPT/PTB 11th Annual Gene Therapy Symposium for Heart, Lung, and Blood Diseases
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Document Date: 2012-12-03 16:57:55


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IndustryTerm

manufacturing / /

Organization

Regulatory Management Staff Division / Division of Clinical Evaluation and Pharmacology/Toxicology / Division of Human Tissue Products / FDA / CBER Office / /

Person

Allen Wensky / Yongjie Zhou / Celia M. Witten / Wei Liang / Ellen Lazarus / Mercedes A. Serabian / Rachael Anatol / Wilson Bryan / Alex Bailey / Stephanie Simek / Basel Assaf / Theresa Chen / Patrick Riggins / Pakwai (Patrick) Au / Richard McFarland / Raj Puri / Jinhua (Jim) Lu / Kimberly Benton / Ying Huang / /

Position

Investigator / individual An IND sponsor-investigator / The IND Review Process Team Concept Regulatory project manager / Biomedical Engineer / Director 3 Pharmacology/Toxicology Staff / Pharmacologist / Deputy Director / Director / Commissioner / Associate Director for Policy / Biologist / Chemist / Toxicologist / Supervisory Toxicologist / /

Product

Sonoma / /

Technology

Gene Therapy / /

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