Karin A. Kook, Ph.D.

Expertise

Primary areas of technical expertise are in the clinical and regulatory aspects of product develtopment, gained over the past 23 years working in the FDA, the pharmaceutical industry and consulting.

Professional Experience

Feb 1996 - Present

Principal and Managing Director
Salamandra, LLC, Bethesda, MD

Providing scientific, regulatory and strategic support to the pharmaceutical industry.
Consulting the client on all facets of product development, from the early stages of screening and evaluation, to formulation of strategic business plans, and the preparation, production, and follow-up of a wide range of regulatory submissions.

1991-
1996

Managing Associate
The Weinberg Group Inc.

Responsible for providing scientific, regulatory and strategic support to the pharmaceutical industry, the investment community, and technical support to counsel in product liability litigation.
. Supervised a staff of consultants, research associates and support personnel, as well as numerous technical experts serving as subcontractors.
Responsible for business development and financial management of drug practice.

1990-
1991

Clinical Scientist
FIDIA Pharmaceutical Corporation

Project management of Phase 1 and Phase 2 clinical R&D of neuropharmacological drugs.
Responsible for the design and implementation of the clinical pharmacokinetic development program at FIDIA.
Key advisor for FDA and international regulatory strategy.

1985-
1990

Medical Reviewer, Division of Neuropharmacological Division
U.S. Food and Drug Administration

Primarily responsible for the clinical review and evaluation of applications for psychopharmacologic drug products.
Review duties included the evaluation of trials submitted to NDAs and INDs, evaluation of protocols to conduct tests and clinical trials of new psychopharmacologic drugs in humans, and review of treatment INDs.
Responsible for the integration of reviews from other disciplines, including pharmacology, biopharmaceutics, and biostatistics into complete medical summaries.
Frequently consulted on special projects including citizen petitions and congressional inquiries.

1984-
1985

Clinical Pharmacologist, Division of Biopharmaceutics
U.S. Food and Drug Administration

Evaluated bioavailability and pharmacokinetic clinical protocols and data in INDs and NDAs.
Responsible for the review and evaluation of the biopharmaceutic portion of NDAs submitted to the Division of Neuropharmacological Drug Products.
Supervised summer interns from the National Institutes of Health.

Education

Ph.D. Clinical Pharmacology (Pharmacokinetics), University of Southern California, Los Angeles, CA (1982)
B.S. Biology, University of California, Los Angeles, CA (1976)

Professional Activities

Member, Data Monitoring Board, Veteran’s Administration Medical Center, Perry Point, 1997
Member, Technical Review Committee to the National Institute on Drug Abuse, 1993
Recorder, Chesapeake Chapter of the American College of Clinical Pharmacology, 1991-1994
Chair, Open Communications Session, New Clinical Drug Evaluation Unit, Annual Meeting, Key Biscayne, Florida, May 1990, June 1989
Member, Contracts and Grants Review Committee, Center for Drug Evaluation and Research, Food and Drug Administration, 1987-1989
Guest Researcher, Clinical Neurosciences Division, National Institutes of Mental Health. Laboratory projects with Steven Paul, M.D. have included in vitro and in vivo receptor-binding experiments to study the effects of corticosterone and stress on the benzodiazepine receptor complex, 1985-1990
Volunteer, Mental Health Liaison, Project for the Homeless, Washington, DC 1985

Honors, Awards, and Certifications

Postdoctoral Psychopharmacology Fellow, University of Southern California, Los Angeles, CA
(1982-1984) .

Publications

International Experience and Foreign Languages

Estonian; French
Diplôme Superieure, Cours de Civilisation Française, Université de Paris à la Sorbonne, Paris France (1973)