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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA/CVM & NRSP-7 International Workshop Speaker Biographies

Dr. Stephen Sundlof

Dr. Sundlof is Director of the Center for Veterinary Medicine, Food and Drug Administration. He received both his Doctorate in Veterinary Medicine and Ph.D. in toxicology from the University of Illinois , and is a diplomate of the American Board of Veterinary Toxicology. He served on the faculty of the University of Florida , College of Veterinary Medicine from 1980 through 1994 where he held the rank of professor.

Dr. Sundlof has published numerous articles in scientific journals on drug residues and food safety. He has presented more than 100 invited lectures at national and international meetings.

He presently serves as chairman of the WHO/FAO Codex Alimentarius Committee on Residues of Veterinary Drugs in Foods and is past president of the American Academy of Veterinary Pharmacology and Therapeutics.

Dr. Murray Lumpkin

Dr. Lumpkin is the Acting Deputy Commissioner for International and Special Programs of the United States Food and Drug Administration. His duties include overseeing the Office of International Programs, the Office of Pediatric Therapeutics, the Office of Combination Products, and coordinating the FDA responses to national public health issues that cut across programmatic centers at FDA.

He received his baccalaureate degree from Davidson College in 1975 and his medical doctorate degree from Wake Forest University in 1979. He then completed a three-year residency in pediatrics and a two-year fellowship in pediatric infectious diseases at the Mayo Clinic in Rochester , MN . In 1984, he attended the London School of Hygiene and Tropical Medicine as a Fulbright Fellow and received an M.Sc. in Medical Parasitology from the University of London . His professional certifications include pediatrics and tropical medicine.

He served as Director of the Division of Anti-Infective Drug Products (DAIDP) in the FDA from 1989 until 1994. For the next six and one-half years, he served as Deputy Center Director for the Center for Drug Evaluation and Research.

He has also represented FDA on various international working groups and commissions. He was one of the initial members of FDA's representatives to the International Conference on Harmonization (a position he maintained for 10 years); and he was FDA's representative for 9 years to the World Health Organization's CIOMS working groups on drug safety issues. He has represented FDA in numerous bilateral initiatives with other governments. In 2000 he spent 3 months working at the European Agency for the Evaluation of Medicinal Products (“EMEA”) in London on a special initiative to encourage bilateral exchanges of senior level leaders from both regulatory organizations.

Prior to his present appointment at the FDA, his professional experience included time as a medical student as a clinical worker in a refugee camp in Bangladesh; a three year appointment as head of pediatric infectious diseases at East Tennessee Children's Hospital in Knoxville; and a two year appointment as a Medical Director at Abbott Laboratories in Chicago where he was in a senior leadership position on the multi-disciplinary, global team responsible for the world-wide development of a new antimicrobial.

Dr. Andrew Beaulieu

Dr. Beaulieu is the (Acting) Director of the Office of Minor Use and Minor Species Animal Drug Development in the Center for Veterinary Medicine, Food & Drug Administration. Prior to assuming this position, he was an Associate Director in the Office of the Center Director and significantly contributed to the Minor Use and Minor Species Animal Health Act of 2004. Prior to his service in the Office of the Center Director, Dr. Beaulieu worked in CVM's Office of New Animal Drug Evaluation for about 8 years as a Division Director for food animal therapeutics and as a Deputy Director of the Office. He was directly involved in most of the significant changes in policy and procedures that affected new animal drug review over that period, including participating in drafting and implementing the Animal Drug Availability Act of 1996.

Dr. Beaulieu joined the Center in June, 1972. Most of his time prior to 1991 was spent in the Office of Surveillance and Compliance in the Division of Surveillance where he was responsible for the review of Drug Experience Reports and supporting compliance actions against marketers of unapproved new animal drugs. Dr. Beaulieu received his DVM degree from The Ohio State University in 1972 and B.S. and B.A. degrees (in biology and chemistry respectively) from the University of Miami in 1967.

Dr. Peter Jones

Dr Peter Jones graduated from the Faculty of Veterinary Science at Liverpool University in July 1971. After several years in general veterinary practice in the United Kingdom and Canada he joined the pharmaceutical industry in the animal health sector.

He has held a number of appointments in research and regulatory affairs in multinational companies, working both in Europe and in the United States in his last appointment being as Senior Director of International Regulatory Affairs for Animal Health Products for Merck Sharp and Dohme in New Jersey , USA . He served as chairman of the UK Association of Veterinarians in Industry from 1981-1983.

He has published reports of his work on antimicrobials and anthelmintics in veterinary medicine and on critical aspects of registration of veterinary medicinal products. He joined the European Agency for the Evaluation of Medicinal Products in June 1995, and was appointed Head of the Veterinary Unit in December of the same year. Dr Jones has assumed the additional responsibility for the IT sector at the EMEA until recently and now also leads the Inspections group at EMEA in charge of GMP, GCP and GLP for both human and veterinary medicines.

Dr. Flurina Stucki

After her thesis in the field of animal protection, which demonstrated the relationship between the distinguishing characteristics of various domestic animal breeds and their diseases, Flurina Stucki completed a three-year residency in anaesthesiology in the department of Clinical Veterinary Sciences at the University of Bern . She then worked as a practicing veterinarian for two years, in a private clinic for farm and pet animals.

For the last two years, Flurina Stucki has been working at the Swiss Agency of Therapeutic products as a veterinary reviewer. Her special subject area concerns the simplified procedures for marketing authorizations for veterinary medicinal products, mainly for minor species and minor uses. Besides the regulatory work, she took part in developing the new act for veterinary drugs and is now involved in implementing it. The new ordinance deals with the delivery and the application of veterinary drugs, especially in food-producing animals, and is aimed at guaranteeing a high level of food safety.

Dr. Eric Mitema

Dr. Mitema received his veterinary degree in 1976 from the University of Nairobi . This was followed by an M.S. degree from the University of Kansas in 1978 and a Ph.D. from the University of Nairobi in 1984. He speaks Swahili and English.

Since 1976, Dr. Mitema has been part of the faculty at the University of Nairobi teaching Pharmacology and Toxicology in the Department of Public Health, Pharmacology and Toxicology. He is currently a full professor of Veterinary Pharmacology and Toxicology.

In 1986 - 1987, Dr. Mitema was Visiting Associate Professor of Toxicology and Pharmacology at the College of Veterinary Medicine , Oklahoma State University , USA . In 2002 – 2003, he held a visiting scientist position at the Centre for Veterinary Medicine (CVM) at the United States , Food and Drug Administration (FDA). He worked with the Epidemiology division in the Office of Surveillance and Compliance.

Dr. Tatsuro Sekiya

Dr. Sekiya received his degree in Veterinary Medicine from Tokyo University of Agriculture and Technology , Japan in 1992.

Since 1993, he has been working as a technical official with the Ministry of Agriculture, Forestry, and Fisheries of Japan involved in various matters concerning veterinary drugs such as residues in food-producing animals, examination for the approvals of new drugs, quality testing of drugs, GMP, GLP, GCP , etc..

His current position is Senior Officer of Veterinary Drugs at the National Veterinary Assay Laboratory.

Dr. Jorge Errecalde

Dr. Errecalde received his Bachelor's degree, with honors, in Veterinary Science in Pretoria , South Africa . He then earned both Veterinary and Medical doctorates in La Plata , Argentina . He also has a Master's Degree in Pharmacology and Toxicology , South Africa .

He is a Fellow, American Academy of Veterinary Pharmacology and Therapeutics and an Invited Honorary Member of the European College of Veterinary Pharmacology and Toxicology. He has also served as a member of the Editorial Board of the Journal of Veterinary Pharmacology and Therapeutics (1992-2002) and as an FAO consultant, 2003-2004.

Currently, he is Professor of Pharmacology, Fac. Veterinary Science University of La Plata, Argentina, teaching and doing research in the areas of antibacterials and antiparasitics.

He also serves as President of INCAM S.A., a company conducting contract research.

Dr. Philip Reeves

Dr Reeves holds a Bachelor of Veterinary Science (Honors) degree from the University of Queensland and a Doctor of Philosophy from the University of Western Australia . He is a Fellow of the Australian College of Veterinary Scientists by examination in veterinary pharmacology and a registered specialist in veterinary pharmacology.

Dr Reeves is currently an FAO Consultant to the Joint FAO/WHO Expert Committee on Food Additives (Veterinary Drugs). He is a member of the Board of Examiners of the Australian College of Veterinary Scientists, sits on two Editorial Boards and is an external lecturer at Monash University in Melbourne and The University of Sydney.

Prior to joining the APVMA, Dr Reeves held various positions including Postdoctoral Research Fellow at the University of Western Australia where his research focused on molecular pharmacology and toxicology. Prior to embarking on his career in research, he spent 10 years in veterinary clinical practice.

Dr Reeves joined the APVMA in 1993 where he has held senior positions within the Veterinary Medicines Program and the Chemistry and Residues Program. In his current position as Principal Scientist, Residues and Veterinary Medicines, he is responsible for leading the provision of scientific advice in relation to residues and veterinary medicines across the APVMA.

Dr. Stephen Groft

Stephen Groft, Pharm.D. is the Director, Office of Rare Diseases at the National Institutes of Health. He started his career as a commissioned officer in the United States Public Health Service as a pharmacist in the Indian Health Service with assignments in South Dakota and Oklahoma . From 1982-1986, he served in the Office of Orphan Products Development at the Food and Drug Administration and from 1986-1989 with the Department of Health and Human Services as the Executive Director of the National Commission on Orphan Diseases.

As the Director of NIH's Office of Rare Diseases, he has devoted particular attention to working with patient advocacy groups in their efforts to stimulate research for their diseases. The Office has co-sponsored over 465 rare diseases-related scientific workshops and conferences with the NIH research Institutes and Centers. The NIH recently completed the first phase of developing the Rare Diseases Clinical Research Network by providing support to 10 research consortia and a Data and Technology Coordinating Center . In 1991, Dr. Groft, as the first Acting Director, established the Office of Alternative Medicine at the NIH and in 2002 completed an assignment as the Executive Director of the White House Commission on Complementary and Alternative Medicine Policy. Dr. Groft received both his Bachelor of Science (1968) and Doctor of Pharmacy (1979) degrees from Duquesne University .

Dr. Elaine Jette'

Dr. Jette' received her baccalaureate degree with honors in sciences and mathematics in 1971 from Montreal University . This was followed by a Doctor of Veterinary Medicine degree in 1975. She then received a Master's degree in Tropical Veterinary Medicine from James Cook University of North Queensland, Australia in 1978, an Advanced Diploma in immunology from the University of Alfort in Paris in 1983, and a Diploma on Specialized Topics in Veterinary Medicine from the University of Saskatoon in 1998. These topics included the recent developments in food-borne zoonosis, toxicology, epidemiology, risk assessment and biotechnology. At Carleton University in Ottawa , Canada , between 1999 and 2001, Dr. Jette' wrote a wide variety of dissertations on topics such as risk communication, biotechnology, International Politics, microeconomics and macroeconomics.

Dr. Jette' has worked as veterinarian for the Canadian Food Inspection Agency. She also served as Special Projects Officer, Regional Animal Health Director in Atlantic Canada; Assistant-Director Issue Management; and Animal Health Staff Veterinarian. She was seconded to the Canadian International Development Agency for an animal health project in Indonesia .

She spent 2 years as Staff veterinarian, Veterinary Drugs Directorate, Health Products and Food Branch at Health Canada (HC). She was Executive Assistant to the Deputy Minister (HC) in 2002. She provided information on public health to HC's stakeholders and partners and managed issues such as emergency drug releases and smart regulations for drug submission reviews.

In 2003, while serving as Special Projects Officer, Veterinary Drugs Directorate (VDD), Health Products and Food Branch, HC, she reviewed and translated VDD texts for publication and distribution e.g., antimicrobial resistance, MLR, food safety standards and VICH guidelines. Last December, she joined the Veterinary Drug Directorate of Health Canada as a policy analyst.

Dr. Rick Clayton

In 1982 Dr. Clayton graduated from Brunel University (Uxbridge, West London ) with a degree in Applied Biology, and in 1994 he obtained a diploma in Marketing. He has many years experience in product development and registration, and product management.

He joined IFAH-Europe (then known as FEDESA) in 1997 to be the Technical Coordinator, and is now the Technical Project Manager. Prior to joining IFAH-Europe he spent 3 years as Product Development and Registration Manager for Sorex Ltd (UK) for ectoparasiticides. Previously he has worked for Cambridge Veterinary Sciences on antibiotic detection methods and Unilever Research in the area of clinical diagnostics. During this time he was also part-time editor of “Focus on Diagnostics” (a monthly publication from the RSC).

He is author of a patent in clinical diagnostics and numerous articles covering veterinary regulatory affairs. He is on the editorial board of the Regulatory Affairs Journal, and author of Chapter 17 – Veterinary Medicinal products in the RAPS publication “Fundamentals of EU Regulatory Affairs”.

Dr. Richard Carnevale

Dr. Carnevale obtained a doctorate in veterinary medicine from the University of Pennsylvania in Philadelphia in 1973 and a bachelor's of science degree from the University of Arizona in Tucson in 1969. After graduating from veterinary school, he practiced veterinary medicine in Pennsylvania . He then joined the Food and Drug Administration and spent five years as a veterinary medical review officer in the Center for Veterinary Medicine's Office of New Animal Drug Evaluation (NADE), engaged in the evaluation of both food animal and companion animal drugs. He then was promoted to branch chief in one of the review divisions, and eventually to Deputy Director for NADE. During this time he also served in an acting capacity as Director for NADE.

In 1988 he joined U.S. Department of Agriculture, Food Safety and Inspection Service as the Assistant Deputy Administrator in the Science and Technology Program. He was responsible for nearly 100 scientists engaged in the residue, microbiology, pathology, and analytical laboratory programs that supported the FSIS meat and poultry inspection programs. During his tenure he helped to develop the microbial testing programs to support the meat and poultry Hazard Analysis and Critical Control Point (HACCP) programs now mandatory in all meat and poultry plants under federal inspection.

In 1995 he joined the Animal Health Institute as the Vice President for Regulatory, Scientific, and International Affairs. AHI represents the manufacturers of animal drugs and veterinary biologicals before federal agencies, Congress, and international health and food safety organizations.

Dr. John Babish

Dr. Babish, formerly NE Regional Coordinator and currently the NRSP-7 National Coordinator, has served in the program the since its inception in 1982.

His academic career included 17 years as professor of toxicology and pharmacology at Cornell University 's College of Veterinary Medicine . His research areas of expertise included drug metabolism and epidemiology.

Since 1996 he has worked as a consultant in the development and application of bioinformatic technology for the pharmaceutical and food industries. He has spoken at 38 national conferences on such topics as cytochrome P-450 mediated drug metabolism, epidemiology and molecular biology of cancer, AIDS drug development, nutrition in HIV, and environmental risk assessment. Dr. Babish has published over 100 peer-reviewed scientific papers and is inventor on 14 US and 3 foreign patents.

Dr. Ronald Baynes

Dr. Baynes is currently an Associate Professor of Pharmacology at the North Carolina State University College of Veterinary Medicine and is Assistant Director of FARAD (Food Animal Residue Avoidance Databank) Eastern Region Access Center at NCSU.

The main focus of his drug/chemical food safety research involves development of strategies for extrapolating drug residue withdrawal intervals for extra-label drug use in food animals. More specifically, the research concerns utilizing algorithms for estimating safe levels for drug residues that are consistent with US food safety standards and those internationally . His other research efforts are focused on modeling transport of chemical mixtures (e.g., drug and pesticides formulations and petroleum products) across the skin of humans as well as livestock species. He is also involved in teaching pharmacokinetics to veterinary and graduate students at NCSU.

Dr. Kornelia Grein

Dr. Grein is a qualified chemist and pharmacist. She holds a PhD in chemistry from the Free University of Berlin.

From 1976 to 1981, Dr Grein held a position at the Free University of Berlin in Germany teaching and conducting research. This was followed by positions as a pharmacist. In 1987, she joined the German Environmental Agency as scientific administrator involved in risk assessment of industrial chemicals. Seconded to the European Commission in 1992, she was involved in the implementation of the EU legislation on existing chemicals, and coordinated the development of the EU approach on risk assessment for chemicals. She was also involved in international harmonization activities on this subject.

She joined the EMEA in April 1996, where she holds the position as Head of Sector for safety of veterinary medicines. In this function, she is responsible for the EMEA activities in relation to the establishment of maximum residue limits, pharmacovigilance for veterinary medicinal products, other safety issues such as antimicrobial resistance and environmental risk assessment, and availability of medicines. Since April 2002 she has served as the EU regulatory authorities coordinator for VICH.