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

So Where Are the Physiologists...

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 What Do They Actually DO at CVM...

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

A mentor in science is important - Dr. Alan Tucker One Physiologist’s FDA Experience Getting There

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 21 st 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 One Physiologist’s FDA Experience

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 PH FX Thank you.