Patrick Au
Vice President, Translational Research and Early Development @ Ensoma
About
Accomplished translational scientist with a combination of scientific and drug development expertise and extensive regulatory experience (5+ years of US FDA experience) in the development of drugs, biologics and combinational products across therapeutic areas including inborn errors of metabolism, rare/orphan diseases, hematology, immuno-oncology, inflammation and immunology, ophthalmology, neurology and regenerative medicine FDA/CBER Master Reviewer in the review of advanced therapies including complex cell therapy, gene therapy, and tissue-engineered products for diverse clinical indications Diplomate of the American Board of Toxicology (DABT) and Regulatory Affairs Certification (RAC) Specialties: Regulatory strategy to expedite development of drugs and biologics; US FDA laws, regulation, policies and submissions (BLA, IND, IDE); drug development; translational research
United States
Greater Boston
Biotechnology
Drug Development, Toxicology, Gene Therapy, Cell Therapy, Pharmacology, Cancer Immunotherapy, Biotechnology, Clinical Development, Medical Devices, Regulatory Affairs, Tissue Engineering, Biomedical Engineering, Molecular Biology, Regulatory Analysis, Lifesciences, Clinical Research, Rare Diseases, Cancer, Vaccines, Animal Models
Experience
Vice President, Translational Research and Early Development
Ensoma
Boston, Massachusetts, United States
Head of Nonclinical Development and Regulatory
Ensoma
Greater Boston
Senior Director of Regulatory, Pharmacology and Toxicology
Casebia Therapeutics
Cambridge, Massachusetts
Director of Regulatory, Pharmacology & Toxicology
Casebia Therapeutics
Greater Boston Area
Pharmacology-Toxicology Lead
Spark Therapeutics, Inc.
Greater Philadelphia Area
Design and manage IND-enabling pharmacology and toxicology studies (non-GLP/GLP) to support all phases of global development
Project Team Leader, Huntington's Disease
Spark Therapeutics, Inc.
Greater Philadelphia Area
Led cross-functional project team to develop novel, first-in-class gene therapy for the treatment of Huntington’s Disease
Director of Regulatory Affairs
Avalanche Biotechnologies, Inc.
Menlo Park, CA
Provide regulatory guidance to cross-functional product development teams on nonclinical, clinical and CMC strategy
Pharmacology/Toxicology Reviewer
FDA
Center for Drug Evaluation and Research (CDER) Office of Drug Evaluation (ODE III) Division of Gastroenterology and Inborn Errors Products (DGIEP)
Acting Team Leader, Pharmacology/Toxicology
FDA
Washington D.C. Metro Area
Center for Biologics Evaluation and Research (CBER) Office of Cellular, Tissue and Gene Therapies (OCTGT) Pharmacology Toxicology Branch (PTB) - Lead and oversee the day-to-day operation of a team of Pharmacology/Toxicology reviewers - Provide scientific and regulatory oversight on regulatory submissions (preIND, IND, IDE) - Preceptor in the FDA Commissioner's Fellowship Program, CBER-CDRH fellowship in Regenerative Medicine (2013-2015)
Pharmacology/Toxicology Reviewer
FDA
Washington D.C. Metro Area
Center for Biologics Evaluation and Research (CBER) Office of Cellular, Tissue and Gene Therapies (OCTGT) Pharmacology Toxicology Branch - Perform regulatory review of biologics, medical devices and combination products (IND, IDE, and BLA submissions) to the Office of Cellular, Tissue and Gene Therapies - Leverage technical expertise as well as knowledge of FDA laws, regulations, and policies to provide scientific and regulatory guidance on pharmacology and toxicology study designs, as well as product development and preclinical testing strategies Key Accomplishments: * Primary Pharmacology/Toxicology reviewer for the first cell-device combination product and first allogeneic cell-based therapy licensed by CBER (Gintuit, March 2012) * Co-chair FDA planning committee for FDA Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) on cellular and gene therapy products for the treatment of retinal disorders. June 29, 2011 * FDA Lead in organizing NIH-FDA Workshop: Pluripotent Stem Cells in Translation: Preclinical Considerations. July 11-12, 2012 * Delivered 10 external presentations to stakeholders regarding US regulatory considerations in the preclinical development of cell and gene therapy products
Research Fellow
Massachusetts General Hospital
Boston, MA
- Developed a novel technique to quantitatively and non-invasively monitor tumor cell proliferation and metastasis in animals - Conducted research on the combined use of gene and cell therapy approaches to generate functional blood vessels in vivo
Research Intern, Vaccine Bioproces Engineer
Merck
West Point, PA
- Assisted in assay development for an adenovirus-based HIV vaccine and conducted study to reduce assay cost
Education
Massachusetts Institute of Technology
Medical Engineering
Advisor: Rakesh K. Jain, PhD - Conducted research in isolating and characterizing vascular progenitor cells from peripheral blood and bone marrow. - Utilized intravital microscopy for the study of angiogenesis and vasculogenesis in various animal models - Differentiated vascular progenitor cells from human embryonic stem cells and demonstrated their clinical utility in vivo
Harvard Medical School
- Completed the first two years of courses at Harvard Medical School - Spent 3 months in hospital ward in learning to interview patients and perform physical exam
The Johns Hopkins University
Chemical Engineering
Patrick Au's Contact Information
Phone
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