Physiologists & the FDA
Kevin J. Greenlees, Ph.D., DABT
Senior Advisor for Science & Policy
Office of New Animal Drug Evaluation
FDA Center for Veterinary Medicine
April, 2010
http:/www.fda.gov/default.htm
http://www.fda.gov/AboutFDA/CentersOffices/CVM/default.htm
So Where Are the Physiologists...
What Do They Actually DO at CVM...
• Evaluate data submitted by pharmaceutical sponsors to demonstrate their
veterinary drug (or additive for the animal food) is safe and effective
•Present evaluations to pharmaceutical sponsors and, when appropriate, negotiate
approaches to address Agency concerns
•Comb publications, internet, presentations, professional meetings, and more to
provide surveillance on the use of approved drugs and of unapproved drugs
•Direct regulatory legal actions (compliance) in cooperation with Federal and State
prosecuters, investigators, and others.
•National and International meeting participation
•Participate in international efforts in harmonization for veterinary products
•Research
One Physiologist’s FDA Experience
There are a number of ways I could talk about a
physiologist’s role – I am going to tell you about
some of the things I have done – since you won’t get
a more physiologist’s eye view than that
One Physiologist’s FDA Experience
Getting There
A mentor in science is important
- Dr. Alan Tucker
One Physiologist’s FDA Experience
•
BS in Biology at SUNY Cortland
•
MS in pulmonary physiology at Wright State
University
•
PhD in cardio-pulmonary physiology at Colorado
State University
One Physiologist’s FDA Experience
•
Post Doc at the University of Guelph, Canada
•
Post Doc at the Virginia-Maryland Regional
College of Veterinary Medicine at Virginia Tech
One Physiologist’s FDA Experience
•
Physiologist in the Division of Residue and Manufacturing
Chemistry
•
Responsible for review and evaluation of residue data for
new animal drugs in food producing animals
•
Toxicologist in the Division of Toxicology and
Environmental Sciences
•
Responsible for review and evaluation of toxicology
studies to support establishing an acceptable daily intake
for residues of the veterinary drug in the human diet
One Physiologist’s FDA Experience
• Work as a regulatory review scientist is stimulating and
NOT boring
• There are many more opportunities if you want more…
One Physiologist’s FDA Experience
• Project officer for contracts & grants for university research on
total residue and metabolism of selected drugs in food fish
• Reviewer for the first approval of a beta-adrenergic agonist in
food producing species
• Participated in risk assessment for clone food producing animals
• Reviewer for the first approved genetically engineered animal
(goats producing rHuman Antithrombin in milk for human
medicine)
• Co-Chair of the US Joint Subcommittee on Aquaculture Working
Group on Aquaculture Drugs, Biologics, and Pesticides.
One Physiologist’s FDA Experience
• Expert and member of the United Nations FAO/WHO Joint
Expert Committee on Food Additives in evaluation of
residues of veterinary drugs
• Current US Delegate to the United Nations Codex
Alimentarius Committee for Residues of Veterinary Drugs in
Food, setting standards for residues in international trade.
• Chair of Safety Working Group for the International
Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products
One Physiologist’s FDA Experience
• Physiology provides an exceptionally solid basis for
this work at the FDA Center for Veterinary Medicine
• In the era of the NAS New Biology for the 21st
Century, physiology critically compliments the
expertise of chemists, pharmacologists,
nutritionists,animal scientists, veterinarians, and
molecular biologists
One Physiologist’s FDA Experience
• I currently serve as a Senior Advisor for Science and Policy
in the Office of New Animal Drug Evaluation.
• I am responsible for assuring that the Office maintains the
highest standards of science, assist in solving problems in
science and help in the interaction between science, laws
and regulations (policy).
• I continue to meet and engage outstanding scientists in
CVM, across the USG, in industry and academics, and
internationally.
One Physiologist’s FDA Experience
• I draw on my training in physiology daily.
• The demands of regulatory review science are
unique - but physiology provides a valuable and
flexible scientific background to meet the mission
of the FDA
Thank you.
Kevin J. Greenlees, Ph.D., DABT
Senior Advisor for Science & Policy
Office of New Animal Drug
Evaluation
FDA Center for Veterinary Medicine
HFV-100, 7500 Standish Place
Rockville, MD USA 20855
PH 240-276-8214
FX 240-276-8114
kevin.greenlees@fda.hhs.gov