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JAMES A TAYLOR, Ph.D.
12022-A Royal Birkdale Row
2105 Redbud Lane
San Diego, CA 92128
Furlong, PA 18925
Merchant-Taylor International Inc.
Partner MTI, Inc. was formed to assist clients who require a broad spectrum of services extending from facilities design, validation and operational activities through design and evaluation of clinical trials. Strategic planning for new product development and all aspects of product regulatory affairs support continue to be a major focus of activity. Special emphasis is provided in the area of emerging biological therapies.
Service to clients in all areas of drugs and biologics product development. This has included advisory and hands-on regulatory and broad product development support. Emphasis has largely been in the area of new products including classical small drug molecules as well as peptides and recombinant proteins. Efforts have included active preparation and/or support for more than 50 new INDs in addition to ongoing advice and support for many investigational and marketed drug and biological products.
ImmunoGen Inc., Cambridge, MA
Corporate Officer with primary responsibility for all local, state, federal and international
regulatory matters as well as GMP Compliance, Quality Control, Quality Assurance and
Health & Safety issues reporting to the Chairman/CEO. Provided cohesive influence and
central communication function through establishment of group product planning,
teams and product development timelines. Served as chief liaison to major
international licensees as well as primary vendors (monoclonal antibody, etc.), trade organizations (PhRMA, BIO and Massachusetts Biotech Council) and contract organizations for aseptic
product fills, preclinical, QC and clinical testing.
Brought extensive drug development experience to start-up biotech company establishing pre-clinical toxicity and initiating clinical trials (Phase I/II) for new cancer therapeutics. Successfully initiated five U.S. and two Canadian INDs for monoclonal antibody immunotoxins without clinical hold. Processed INDs to Phase III pivotal trials during
time when company grew from <5 to >170 employees. Obtained Orphan Drug Designation for five U.S. INDs and received $100,000 Orphan Drug Grant, one of only two commercial sponsors given such an award.
Carter-Wallace, Inc., Cranbury, NJ
Primary corporate regulatory position responsible for several Divisions including Wallace Labs (Ethical Pharmaceuticals), Wampole Labs (Devices and Diagnostics), Carter Products (Consumer Products) and Lambert-Kay (Veterinary Products). Maintained responsibility for 30-person Department to handle all regulatory aspects for investigational and marketed products as well as responsibility for Product Complaints and Clinical Packaging and Supplies.
Filed first new product NDAs (2) in several years (First NDA subsequently approved).
Additional new product INDs processed to NDA stage (NDAs subsequently filed for all
products). Several diagnostic products (monoclonal antibody-based) also filed as 510(k)
submissions, approved and introduced for commercial sale.
Zeneca Pharmaceuticals ,Wilmington,DE
Primary North American drug regulatory position including responsible for GMP
compliance and QA (GLP and GCP oversight). Several major INDs and NDAs
including NDAs filed and approved for Tenormin and Tenoretic. Interaction with
FDA Drug Divisions. Extensive travel and international liaison with UK-based
Primary responsibility for interaction with FDA and HPB (Canada) for all investigational
products and new marketing applications.
Pfizer Central Research, Groton, CT 1967-1979
Responsible for processing all Pfizer Research INDs and NDAs, including NDA filed
major NSAI commercial product, Feldene. Reported to Director.
Responsible for pharmacokinetic and metabolism studies with investigational drug
Argonne National Laboratories, Argonne,IL
Conducted research studies concerning toxicity and metabolism of radionuclides and
effects of x-irradiation on thyroid glands of beagle dogs.
Ph.D. in Biochemistry, Purdue University
M. S. in Biochemistry, Purdue University
Alpha Chi Sigma (National Chemical Fraternity)
Sigma Xi (National Scientific Honor Society)
American Society of Pharmacology & Experimental Therapeutics Drug
Regulatory Affairs Professional Society (Charter Member-1975) American Society for Gene Therapy
Bio-Imaging Technologies, Inc., West Trenton, NJ
Drug Information Association 2001 Annual Meeting
Presentation: Regulatory Development in a Virtual Environment
Presentation: Regulatory Considerations in Support of an Aggressive Product Development Strategy
Presentation: Implementation of a Phase I Gene Therapy Program in a GLP/GMP Continuum
Regulatory Affairs Professional Society Meeting:
Presentation: Regulatory Interactions and Negotiation Skills
Presentation: Optimizing Regulatory Success for Accelerated Product Development
Presentation: Viral Safety Concerns with Xenotransplantation
Presentation: Contract Manufacturing Session
Manufacturer’s Perspective with a Regulatory Twist
Session Chair: Regulatory Strategies for Manufacturing Changes
Presentation: Regulatory Strategies for Accelerated Approval
University of Connecticut H.G. Hewitt Symposium
Keynote Address: Introduction to Pharmaceutical Biotechnology: The Risks and Successes of Biotechnology Development
Society of Toxicology, Southern California Chapter
Toxicology of New Biotechnology-Based Pharmaceuticals
Presentation: Historical Perspectives on the Growth of the Biopharmaceutical Industry
Presentation: Regulatory Aspects of Biotechnology
FDA/NCI/NIAID Workshop: Preclinical Safety Testing Of Monoclonal Antibodies
Session Co-Chair with CBER Div. Director
Presentation: Antibody-Toxin Conjugates: Structural and Functional Profiles
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