Kristi Olson Smedley

Resumè

Education:

Doctorate of Philosophy--Virginia Polytechnic Institute and State University (Animal Nutrition and Forage Science)--1986

Masters of Science--Virginia Polytechnic Institute and State University (Animal Nutrition)--1982

Bachelor of Science--The Pennsylvania State University (Biology)--1980

Present Position:

Consultant, Center for Regulatory Services (1996-present). I provide consulting services to pharmaceutical, food, and pesticide firms with a primary emphasis on product development and regulatory compliance. I have a broad understanding of FDA-related regulations, current guidance, and extensive experience in clinical study development and conduct in animal research.

Experience:

Chief, Petitions and Regulations Staff, Division of Compliance, Center for Veterinary Medicine, Food and Drug Administration (1993-1996). I supervised a staff whose varied duties included, drafting new animal drug approval regulations, procedural regulations, and policy documents, interpreting of the Federal Food Drug and Cosmetic Act and other related laws, regulations, and guidances, and overseeing policy development. Examples of regulations or guidances that I developed or supervised the development of, include: the implementing regulations for the Animal Medicinal Drug Use Clarification Act of 1994, the agency's regulations regarding the use of animal-derived feed products to reduce the risk of TSE's in the United States, and guidances regarding debarment, the application integrity policy, and clinical studies. I was also responsible for the coordination of the clearance of all CVM-generated FEDERAL REGISTER documents (rules and notices). In addition, I was the team leader for many other CVM projects that were not related to regulation or policy development.

Consumer Safety Officer, Petitions and Regulations Staff, Center for Veterinary Medicine, Food and Drug Administration (1990-1993). My duties were as described above, excluding supervision of personnel. Examples of specific projects conducted during this time include: implementation of the agency's Application Integrity Policy as it relates to animal drug applications, drafting guidance related to the monitoring and conduct of clinical investigator studies, oversight of the audits of applications administered under the application integrity policy, drafting procedural regulations, and drafting notices of opportunity of hearings.

Animal Scientist, Petitions Review & Medicated Feeds Branch, Center for Veterinary Medicine, Food and Drug Administration (1987-1990). My duties were to review and respond to food additive petitions, generally recognized as safe petitions, and informal advisory petitions related to animal products. During this time, I formulated the Center's position on biotechnologically-derived animal foods and food additives. In addition, I coordinated the agency's response to challenges related to the use of selenium in animal feeds.

Private Contractor for the United States Department of Agriculture (1985-
1986). I provided statistical and laboratory analyses related to animal and forage studies.

Honors and Awards:

FDA Awards:

May, 1997-Group Recognition Award-Animal Medicinal Drug Use Clarification Act Implementation.

May, 1996-Group Recognition Award-Strategic Planning Group

May, 1995-Group Recognition Award-Bovine Spongiform Encephalopathy Working Group

May, 1994-Group Recognition Award-Selenium Evaluation Team

May, 1994-Group Recognition Award-Financial Disclosure group

May, 1993-Commendable Service Award-Outstanding and exceptional contributions to the Center for Veterinary Medicine

May, 1993-Group Recognition Award-Pen-Strep Desi Finalization Group

Outstanding Evaluations-1987, 1989, 1991, 1992, 1993, 1994, and 1995

Other:

John Lee Pratt Fellowship for Outstanding Animal Nutrition Students-1981-1985 (full graduate scholarship)

Professional Memberships:

Member, American Society of Animal Science

Member, American Registry of Professional Animal Scientists (past-treasurer)

References: Available upon request