Vice President, Translational Research And Early Development
Current
Sep 2021 - Present
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Patrick Au Email & Phone Number
Vice President, Translational Research and Early Development
at
Ensoma
LinkedIn matched
✓ Verified May 2026
3 data sources
Profile completeness 86%
Current company
Role
Vice President, Translational Research and Early Development
Location
Greater Boston, United States, United States
Who is Patrick Au? Overview
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Quick answer
Patrick Au is listed as Vice President, Translational Research and Early Development at Ensoma, based in Greater Boston, United States, United States. AeroLeads shows a matched LinkedIn profile for Patrick Au.
Patrick Au previously worked as Head of Nonclinical Development and Regulatory at Ensoma and Senior Director of Regulatory, Pharmacology and Toxicology at Casebia Therapeutics. Patrick Au holds Phd, Medical Engineering from Massachusetts Institute Of Technology.
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Email format at Ensoma
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Ensoma
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Profile bio
About Patrick Au
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 medicineFDA/CBER Master Reviewer in the review of advanced therapies including complex cell therapy, gene therapy, and tissue-engineered products for diverse clinical indicationsDiplomate 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
Current workplace
Patrick Au's current company
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12 roles
Patrick Au work experience
A career timeline built from the work history available for this profile.
Head Of Nonclinical Development And Regulatory
Oct 2019 - Aug 2021
Senior Director Of Regulatory, Pharmacology And Toxicology
Jan 2019 - Sep 2019
Director Of Regulatory, Pharmacology & Toxicology
Sep 2017 - Dec 2018
Pharmacology-Toxicology Lead
Design and manage IND-enabling pharmacology and toxicology studies (non-GLP/GLP) to support all phases of global development
Feb 2016 - Aug 2017
Project Team Leader, Huntington'S Disease
Led cross-functional project team to develop novel, first-in-class gene therapy for the treatment of Huntington’s Disease
Apr 2016 - Jun 2017
Director Of Regulatory Affairs
Avalanche Biotechnologies, Inc.
Provide regulatory guidance to cross-functional product development teams on nonclinical, clinical and CMC strategy
Oct 2014 - Dec 2015
Pharmacology/Toxicology Reviewer
Center for Drug Evaluation and Research (CDER)Office of Drug Evaluation (ODE III)Division of Gastroenterology and Inborn Errors Products (DGIEP)
Jul 2014 - Sep 2014
Acting Team Leader, Pharmacology/Toxicology
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.
Dec 2013 - May 2014
Pharmacology/Toxicology Reviewer
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.
Jun 2009 - Nov 2013
Research Fellow
- 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
Jun 2008 - Jun 2009
Research Intern, Vaccine Bioproces Engineer
Merck
- Assisted in assay development for an adenovirus-based HIV vaccine and conducted study to reduce assay cost
Jun 2000 - Sep 2000
3 education records
Patrick Au education
Phd, Medical Engineering
Massachusetts Institute Of Technology
Education record
Harvard Medical School
Bs, Chemical Engineering
The Johns Hopkins University
FAQ
Frequently asked questions about Patrick Au
Quick answers generated from the profile data available on this page.
What company does Patrick Au work for?
Patrick Au works for Ensoma.
What is Patrick Au's role at Ensoma?
Patrick Au is listed as Vice President, Translational Research and Early Development at Ensoma.
Where is Patrick Au based?
Patrick Au is based in Greater Boston, United States, United States while working with Ensoma.
What companies has Patrick Au worked for?
Patrick Au has worked for Ensoma, Casebia Therapeutics, Spark Therapeutics, Inc., Avalanche Biotechnologies, Inc., and Fda.
How can I contact Patrick Au?
You can use AeroLeads to view verified contact signals for Patrick Au at Ensoma, including work email, phone, and LinkedIn data when available.
What schools did Patrick Au attend?
Patrick Au holds Phd, Medical Engineering from Massachusetts Institute Of Technology.
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