Hyman Phelps and McNamara
Joseph W. Cormier
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J.D., Georgetown University Law Center,
Ph.D., Pharmacology, Columbia University
A.B., Genetics, Cell, and Developmental Biology modified with Computer Science, Dartmouth College

Bar Admissions
District of Columbia
New York

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Joseph "Jay" Cormier, Ph.D., brings a highly technical perspective to his work helping clients with regulatory strategy, compliance, and regulatory policy. With a doctorate in Pharmacology and experience as a scientist and reviewer at FDA, he understands the technical and regulatory nuances of drugs, biologics, medical devices, and veterinary medicine. He advises companies on the FDA approval process, current Good Manufacturing Practice (cGMP) as well as compliance with FDA rules and regulations governing product advertising and promotion and advanced biotechnology.

Mr. Cormier has worked with companies of all sizes on early stage products, particularly drugs, medical devices, and biologics. He has extensive knowledge of genetic engineering, drug and medical device manufacturing and drug and medical device product promotion.

Before joining the firm, Mr. Cormier worked in private practice, and as a pharmacologist in the Animal Biotechnology Interdisciplinary Group in FDA's Center for Veterinary Medicine from 2005 to 2011. While at FDA, Mr. Cormier was actively involved in developing policies on the regulation of genetically engineered animals, and evaluated the manufacturing of new animal drugs. He was a recipient of several FDA awards, including the Scientific Achievement Award and the Commissioner's Special Citation, and was a nominee for the New Reviewer Award.

Related Experience
Prescription Drugs & Biologics
• Advises on matters involving general FDA product development, regulatory compliance policies, and FDA submission strategies.
• Provides counsel on drug development matters, including early stage clinical trials.
• Advises on strategies for interacting with FDA before and during the IND/NDA/BLA process.
• Assists clients with issues related to cGMPs, facility inspections, and responses to related FDA actions.

Medical Devices
• Assists medical device clients on determining whether and to what extent a product is regulated by FDA.
• Advises on strategies for interacting with FDA before and during the IDE/PMA and 510(k) processes.

Advertising & Promotion
• Reviews and advises clients regarding advertising and promotional materials for prescription drugs and medical devices.
• Participates in review committees, assisting with new product launches as well as ongoing brand management.

Veterinary Drugs
• Works with animal drug companies to develop strategies with respect to their interactions with FDA and/or USDA.

Awards & Recognition
Center for Biologics Evaluation and Research's Scientific Achievement Award, 2009
FDA Scientific Achievement Award, 2009
FDA Commissioner's Special Citation, 2007
FDA New Reviewer Award, nominee, 2007

Professional Affiliations
Food and Drug Law Institute
American Bar Association
D.C. Bar Association, Health Law Section

Articles / Publications   
•  Ready or Not, CRISPR and Gene Editing Have Arrived and Are Here to Stay,  September 2016

Speaking Engagements   
•  Genetic Engineering: The Future of Agriculture and Public Health, July 12, 2017
•  ACI Legal, Regulatory and Compliance Forum on Animal Health, Veterinary Medicines and Therapeutics, Panel Chair: "From Glofish to Frankenfish: Understanding How the Approval of Transgenic Animals May Impact Animal and Human Food and Drugs", September 13-15, 2016
•  Legal, Regulatory and Compliance Forum on Animal Health, JWC 9/11 Workshop Co-Presenter: “Mastering Protocols for Successfully Working With FDA, USDA, and EPA from the Pre to Post Commercialization Stages of Your Animal Drug Product, September 10-11, 2015
•  Livestock Biotech Summit, Biomedical Regulatory Pathway, September 16-18, 2014

Blog Posts    -    see more blog entries
•  Forum Shopping for Agency Deliberative Documents? San Francisco is the Place to Be (For Now),  April 23, 2017
•  Comment Period Extended for GE Animal Draft Revised Guidance,  April 13, 2017
•  In Last Gasps of the Obama Administration, FDA Attempts to Clarify Role of Government in Regulation of Genome Editing,  February 7, 2017
•  FDA Issues Final Quality Agreement Guidance,  November 27, 2016
•  While NIH Argues with Congress for Zika Funding, FDA Gives Green-Light to Investigational Release of Genetically Engineered Mosquitos,  August 9, 2016