Bret A. Wittmer, DVM, MD
240 East Ayr Parkway
Madisonville, KY 42431
Phone (270)825-8345
Fax (270) 825-2975
E-mail dr@cwbr1.com

Clinical investigator/consultant adept at: developing, implementing, and directing study protocols for animal and human clinical studies; designing case report forms; reviewing and analyzing data; clinical trial and CRO monitoring; medical monitoring; writing final study reports; manuscripts; investigator brochure; and training manual development.

Experienced in working with FDA regarding clinical research plans for marketed pharmaceuticals and Prescription to OTC switch requirements.

Have effectively initiated and completed challenging projects, conducting myself in a manner responsive to the needs of medical, regulatory, marketing, and legal.

Am a competent, organized, outgoing, humanly-oriented medical professional who thinks on his feet with a broad knowledge base and diversity of experience.

• Doctor of Medicine; May 1998 - Indiana University School of Medicine, Indianapolis, Indiana.
• Attended Indiana School of Medicine; August 1994 - May 1998. Major areas of interest: Research, Family Practice, and Acupuncture.
• Trover Foundation Family Practice Residency; July 1998 - June 2001.
• UCLA Acupuncture Course for physicians; completed April 2000, 300 CME
• Acupuncture Training, 250 additional hours under board certified acupuncturists
• Clinical training during residency for three years in acupuncture
• Multiple clinical research trials coordinated during residency and private practice.
• Privileges to admit patients to Regional Medical Center, Madisonville, KY
• Private Family Practice, July 2001-Present, Madisonville, KY
• Board Certified Family Physician, July 2001, Madisonville, KY
• Certified Clinical Investigator, March 2004 DIA

 

I joined Toxicology and Pathology Services, Inc., in November 1988, bringing to the company more than seven years of experience in the area of animal health care. I served as protocol developer, study director, attending veterinarian, and necropsy and colony supervisor of the facility. My responsibilities at T.P.S., Inc., included the day-to-day management of the animal facilities and general health maintenance of in-house colonies including physical and ophthalmic examinations, reviewing all EKG's and clinical pathology data, and adhering to all GLP, FDA, and USDA Guidelines. My responsibilities in various support areas of the facility included methods development, writing standard operating procedures, inspecting animal vendors, and maintaining the facility in a clean and operable state to assure the studies performed were of the best possible quality. I have been involved in acute, subacute, pharmacokinetic, dermal, and chronic studies involving mice, rats, guinea pigs, hamsters, dogs, rabbits, pigs, chickens, and monkeys. I was the instructor of classes for the laboratory associates in order to prepare them for the AALAS certification examination and taught them how to appropriately handle and dose the study animals. During my tenure at T.P.S., Inc., I worked on over 250 projects and was directly responsible for many of these, including six pivotal studies for NDA submissions. These projects were being conducted for over 35 pharmaceutical companies worldwide.

I joined Bristol-Myers Squibb in August 1990. From August 1990 to August 1991 I served as medical study director for oncology clinical studies in the Department of Medical Affairs, Oncology. My responsibilities included developing, overseeing, and/or directing the following: protocols, case report forms, final study reports, publications, toxicology data, investigators' budgets, letters of agreement, site visits, monitoring, GCP compliance, clinical research organization selection, and over 110 Scientific Relation Grafts.

In August 1991 I became the first full-time medical study director for the Department of Medical Affairs, Mead Johnson Laboratories. I had direct responsibility for strategic clinical research plans for five product brands - Estrace, Ovcon, Vagistat-1, Natalins Rx, and Stadol Nasal Spray. These responsibilities included developing, overseeing, and/or directing the following: clinical marketing plans, protocols, case report forms, final study reports, publications, the entire MJL Clinical Studies budget, investigators' budgets, letters of agreement, initial site visits, monitoring, GCP compliance, clinical research organization selection, toxicology data review, two full-time employees, four BMS consultants, and 10 Scientific Relation Grants. This position involved working directly with the marketing group to develop marketing strategies and clinical research plans for support of the product brands.

In January 1993 I became a full-time medical consultant to the pharmaceutical and device industry. I have worked for a variety of companies and have managed and completed a variety of different projects. I have worked in several therapeutic areas, including the following: hormonal products, anti-fungals, anti-infectives, oncology, OTC, dermatological products, pain medications, herbal medications, veterinary drug products, anti-virals, and device products. Other areas of involvement include adverse drug reactions, alternative health care, analgesics, asthma, hypertensive medications, cancer, Candidiasis, headache pain, post-surgical pain, medicolegal issues, nutrition, osteoporosis, parasitic diseases, and womens health. I have interacted with the Food and Drug Administration in the development of clinical study programs for various pharmaceutical products and had direct FDA contact regarding drug approval.

I have had direct responsibilities in the development of several drugs at Bristol-Myers Squibb and other drug companies. Most of this developmental information is proprietary. However, I can tell you about the roles I played regarding the following marketed products. I worked on Megace for the treatment of weight loss in AIDS patients; Estrace for the prevention of osteoporosis; coronary stents and their use in the treatment of coronary artery collapse; and Vagistat-1 as both a prescription product and its switch to the over-the-counter marketplace.

Chemical Research Experience – In 1994, Commonwealth Biomedical Research, LLC was founded to provide medical consulting services to the pharmaceutical industry. In 1998, I became a principal investigator conducting trials for the pharmaceutical industry.

The experiences gained as Medical Director at Commonwealth Biomedical Research, LLC, Bristol-Myers Squibb, and as a pharmaceutical consultant are immeasurable and will allow me to branch out and work as a team member in many capacities.

Photography; cooking; aquaculture; investments; First Baptist Daycare Advisory Board