J. Michael Morgan, Ph.D., DABT

J. Michael Morgan,Ph.D., DABT

Expertise

Over 20 years experience in operational management and technical aspects of regulatory toxicology from within pharmaceutical companies and CROs.
Over 10 years experience in designing and/or implementing preclinical development plans for several pharmaceutical companies.
Extensive experience in the conduct and reporting of nonclinical toxicology studies for registration of products with the FDA and European regulatory authorities.
Writing the Preclinical Sections and Environmental Assessment Sections for such submissions as NDAs, INDs, Investigator's Brochures and Pre-IND information packages as well as international dossiers and FDA submissions in CTD format for pharmaceutical companies worldwide.
Successfully managed several contract toxicology laboratory facilities to include renovations, building, and acquisitions of facilities, and recruitment of scientific staff, validation of data acquisition systems, and handling FDA inspections.
Placing and monitoring several hundred toxicology, pharmacology, and pharmacokinetic studies and/or audited such studies in every major contract laboratory in the United States, Canada, Scotland, England and France.
In-licensing consultation, scientific support and presentations to potential investors in pharmaceutical development ventures and due diligence support for potential investors.

Professional Experience

Feb 2004 - Present

Senior Consultant - Toxicologist
Salamandra, LLC, Bethesda, MD

Authoring nonclinical sections of pre-IND Packages, INDs, NDAs (in standard, electronic and CTD format), Investigator’s Brochures, electronic filings, and international dossiers.
Serving as Project Manager for numerous regulatory submissions.
Evaluating data and authored environmental assessment sections of NDAs.
Providing nonclinical support as part of development teams for numerous pharmaceutical companies.
Directing and evaluating searches of the worldwide literature for position papers, Annual Reports and other submissions.
Participating in Pre-IND, End-of-Phase-2, and pre-NDA meetings at the FDA.
Designing nonclinical protocols, obtaining quotes for, placing and monitoring studies in contract toxicology laboratories.

Mar. 1995-
Jan. 2003

President
Morgan Consulting, Germantown, MD

Designed nonclinical development plans for numerous pharmaceutical companies (large molecule, nanoparticles and gene-therapy).
Placed and monitored nonclinical studies in contract laboratories worldwide.
Performed GLP inspections of final reports as well as GLP facilities.
Supported clients in meetings with the FDA to discuss plans, protocols and review results during review phase.
Served on the Board of Directors of a large contract laboratory, a small biotechnology company and on the Scientific Advisory Board of two drug development companies.
Served as Vice-President of Preclinical Development of Canadian pharmaceutical company.
Directed preclinical development program for U.S. firm up to NDA approval.

Apr. 1997-
Mar. 2000

Senior Vice-President
TherImmune Research Corporation/ R.O.W. Sciences, Rockville, MD

Responsible for the Life Sciences Group, which included two divisions, one a contract toxicology laboratory.
Responsibilities included supervising over 200 staff operating in sites at 15 government facilities for N.I.H., F.D.A., N.I.E.H.S, N.I.O.S.H., and the Department of Defense.
Responsible for adding new operational divisions, assurance of contract compliance, communication with clients, new business development, effective management of group resources, recruiting senior staff, and the assurance of profitability .

Nov. 1991-
Mar. 1995

Vice-President/ General Manager, Director of Toxicology
Pharmakon Research Intl, Inc., Clarks Summit, PA

Responsible for managing all aspects of a 42,000 sq. ft. contract laboratory facility.
Responsibilities included recruiting director level staff, developing and maintaining U.S. operational budget, promoting marketing and business development opportunities and managing the overall operation of the facility.
Responsible for a staff of approximately 100 employees.
Grew revenues from $3 MM to $7 MM in two years.
Designed and oversaw the construction of a $3.5 MM toxicology facility and the acquisition of a large European laboratory (Hazleton France).
Developed complete preclinical toxicology plans for several biotechnology clients including protocol design, setting dose levels, dosage forms, stability, etc.

Mar. 1998-
Nov. 1991

Research Manager, Drug Safety
Immunobiology Research Institute, Annandale, NJ (a Johnson & Johnson Co.)

Responsible for pharmacokinetics and toxicology studies submitted to regulatory agencies in support of all compounds developed by the company.
Wrote the preclinical sections of international dossiers for European submissions of pharmaceuticals.

Oct. 1984-
Mar. 1988

Associate Director, General Toxicology Services
Bio-Research Laboratories LTD., Montreal, Canada

Responsible for one of two general toxicology divisions and the pharmacy during the growth years of this large Canadian laboratory .
Responsible for the proper conduct and GLP compliance of hundreds of nonclinical studies performed for major US pharmaceutical companies.
Responsible for technical and management training of a staff of 45.

Jan. 1980-
Mar. 1984

Director, Toxicology,
Inhausen Research Institute, Fort Collins, CO
Director, Inhalation Toxicology; Manager Acute Toxicology
Toxigenics, Inc., Decatur, IL.

Responsible for the proper conduct and GLP compliance of hundreds of nonclinical studies performed for numerous pharmaceutical companies.

Professional Activities

Education

Ph.D. Toxicology, University of Mississippi, University, MS (1980)
M.S. Pharmacognosy, (Natural Products Chemistry), University of Mississippi (1975)
B.Sc. Chemistry, Murray State University, Murray, KY (1973)

Honors, Awards, and Certifications

Board Certification: American Board of Toxicology 1986, 1992, 1997
Rho Chi, Pharmaceutical Honor Society 1979

Publications

Click here for a list of publications.

International Experience and Foreign Languages

Served almost 4 years in senior scientific and management roles at the largest Canadian contract laboratory.
Convinced the Board of Directors of DNX to consider the acquisition of a large European laboraoty (Hazelton France); performed the due diligence in Lyon; helped with the technical and legal aspects of the acquisition; renamed the lab Pharmakon Europe; served on the Board of Directors.