Dr.B. Curriculum Vitae (January 2009) PERSONAL STATEMENT There is no greater joy in life than which comes from giving of one’s self to help another RELEVANT EXPERIENCE AND SKILLS Rear Admiral (Assistant Surgeon General), United States Public Health Service Commissioned Corps (Retired August 2000) 30 years of experience in national public health policy development and implementation, and public and private practice of veterinary medicine More than 21 years of experience in complex managerial and budget administration positions 20 years of regulatory experience with the U.S. Food and Drug Administration PROFESSIONAL EXPERIENCE 2002 – present B. Consulting, L.L.C. Knoxville, Tennessee President & CEO Provides consulting services in the areas of Food and Drug Administration (FDA) regulations, public health, veterinary medicine, and organizational/HR management. With 20 years as an FDA official and more than 30 years in national public health policy development and implementation, our effective expert consultation services can help you reach your goals. 2007 – present The B.Group, L.L.C. Knoxville, Tennessee President and CEO The B. Group is a venture capital firm that provides capital, connections and strategic guidance to entrepreneurs with early-stage healthcare and information technology companies. The B. Group typically is a lead or co-lead investor in seed and early-stage financing opportunities located primarily in the Southeastern United States. The firm’s initial investment size ranges from $50,000 in a seed investment to as much as $2.5 million in a first round financing. The B. Group will invest a total of between $4 million and $8 million across multiple rounds of financing as the company matures. The firm has a balanced investment focus primarily in Life Sciences, including: Biotechnology Healthcare services Medical devices & equipment Other emerging technologies The B. Group is strategically located in Knoxville, Tennessee, allowing access to The University of Tennessee and Oak Ridge National Laboratories. This area, which has historically been underserved by other private equity groups, provides ample opportunities for investment with its focus in research & development. The B. Group has an experienced team with diverse industry and functional backgrounds. Members of the team have “hands-on” operational experience enabling them to work closely with their portfolio companies. Key impact areas include: Helping to recruit and assemble management teams Leveraging industry contacts to help secure customers and strategic partners Introductions to service providers such as commercial bankers, investment bankers, attorneys and accountants Introductions to other venture capital firms for co-investment purposes Leveraging industry knowledge to provide guidance on business strategy 2000 – 2008 University of Tennessee College of Veterinary Medicine Knoxville, Tennessee Dean Served as chief executive officer of the college, managing an annual operating budget of more than $35 million and over 350 personnel and 300 students. Served as the chief fundraiser, working with private and public donors to help ensure financial health of the College. Developed academic policies and programs for the College. Directed and coordinated activities of associate deans, department heads, and directors. Advised on personnel matters. Determined scheduling of courses and recommended implementation of additional courses. Coordinated activities of student advisors. Participated in activities of faculty committees, and in development of academic budget. Advised the university president, vice-presidents, and chancellor on academic matters. Served as liaison officer with accrediting agencies that evaluate academic programs. 1999 – 2000 Dept. of Health and Human Services Office of the Surgeon General Rockville, Maryland Chief of Staff Responsible for the day-to-day operations of the U.S. Office of the Surgeon General (OSG) as it provides leadership and direction for the more than 5,800 active duty commissioned corps personnel. The OSG directs the selection process and coordinates the activities of eleven chief professional officers to identify and resolve policy issues, 2 and ensures that the Public Health Service policies are implemented uniformly. The OSG provides the necessary interface with other government entities including the Federal Emergency Management Agency, Environmental Protection Agency, Departments of Defense, Justice, Commerce, Transportation, and State to ensure national security. It also directs a wide rage of special initiatives to include, but not limited to, reports, workshops, and conferences as directed by the President, Congress, or the Department of Health and Human Services, and serves as the focal point for dialogue with health professional societies. 1994 – 1999 Food and Drug Administration Center for Veterinary Medicine Rockville, Maryland Deputy Director Formulated and recommended to the center director management philosophy and operating policies in consonance with the Food and Drug Administration. Shared with the center director the responsibility for: (1) developing and implementing veterinary medical policy of the Food and Drug Administration with respect to safety and effectiveness of animal drugs, feed additives, and devices, and; (2) providing scientific and regulatory expertise for regulatory surveillance and compliance activity in the veterinary area which is conducted by the Food and Drug Administration field office personnel. Directly managed a budget of $41.6 million involving a center of 270 professional and clerical staff members. 1994 - 1998 U.S. Public Health Service Commissioned Corps Rockville, Maryland Chief Veterinarian Represented the surgeon general and the United States Public Health Service in contacts with public and professional groups associated with veterinary medicine, and provided continuing liaison to such groups on matters of common interest as directed by the surgeon general. Advised the United States Public Health Service agencies in areas of manpower development, recruitment, training, and career counseling as the agencies developed recommendations for consideration by the surgeon general, assistant secretary for health, secretary of health and human services, the president and the congress. Represented veterinarians as the Chief Professional Officer, and as ex officio member of the Veterinary Professional Advisory Committee. Accepted invitations for speeches, meetings, and ceremonial duties directly in relation to the function of representing the surgeon general and the United States Public Health Service veterinarians. 1994 - 1994 3 Food and Drug Administration Rockville, Maryland Center for Devices and Radiological Health Division of General and Restorative Devices Deputy Director Assisted the Director in planning, organizing, directing, staffing, coordinating, and evaluating division activities to achieve its mission of pre-approval evaluation of medical devices used for surgical and rehabilitation purposes. This assignment was made by Center management in response to a congressional mandate to correct a serious backlog of applications. I was selected as deputy director to bring strong management experience. We successfully eliminated the backlog ahead of schedule. 1992 - 1994 Food and Drug Administration Rockville, Maryland Center for Devices and Radiological Health Program Operations Staff Chief, Investigational Device Exemptions Coordinated the scientific and regulatory review process, including the approval and disapproval decisions of all Investigational Device Exemptions applications for a 260member multi disciplinary scientific professional and technical workforce. Duties included ensuring the effective and efficient receipt, processing, and review of approximately 4,100 original, amendment, and supplement submissions each year. Quality assurance and quality control procedures were applied in order to verify that the 28 reviewing Branches were adhering to the regulations and policies. Additionally, designed, developed, and implemented training programs for the device evaluation divisions to ensure uniform and consistent interpretation and application of the law and regulations with respect to the administrative review functions pertaining to Investigational Device Exemptions. Served as the focal point for interactions between the application sponsors and the Food and Drug Administration. Implemented policies necessary to improve the regulation of clinical investigations of medical devices for human use. Training and experience in medicine and epidemiology, as well as experience with the U.S. Public Health Service, provided great insight into the design and conduct of these diverse clinical studies. 1988 - 1992 Food and Drug Administration Rockville, Maryland Center for Devices and Radiological Health Restorative Devices Branch Branch Chief Supervised a staff which included engineers, physicians, a veterinarian, physical therapist, and other scientists engaged in the review and evaluation of all rehabilitation and physical medicine devices for human use, including some orthopedic implants for knee reconstruction as well as bone healing devices. Provided technical guidance to the staff members on precedent setting and controversial device issues involving complex 4 questions of opinion and policy. The staff reviewed Premarket Notification, Premarket Approval, and Investigational Device Exemptions applications to either market or conduct clinical investigations with these devices. Made recommendations to management regarding the approvability of the applications. 1986 - 1988 Maryland Food and Drug Administration Silver Spring, Center for Devices and Radiological Health Restorative Devices Branch Scientific Reviewer Served as a consulting reviewer on device applications submitted to the Branch, with primary focus on clinical trials and pre-clinical animal studies. Effectively used post doctorate training in epidemiology to evaluate the data from clinical investigations of the devices the Restorative Devices Branch was responsible for evaluating. Helped to determine if a restorative medical device was sufficiently safe and effective to meet the requirements of the Federal Food, Drug, and Cosmetic Act for use in a clinical investigation or as a marketed device. 1980 - 1986 Food and Drug Administration Center for Veterinary Medicine Rockville, Maryland Epidemiologist Served as the primary epidemiologist for the Center for Veterinary Medicine and principle epidemiologist advisor to the Center Director. Analyzed over 31,000 medical records in the Veterinary Drug Experience Reporting Program database. This database was the most comprehensive database available to the Food and Drug Administration that gave insights into adverse veterinary drug experiences. Wrote over 30 internal reports regarding the results of using the targeted marketed drugs in the database. Developed the United States position on international cooperation in the exchange of veterinary drug use information. Participated in emergency response activities, most notably the investigation of the 1985 Listeriosis epidemic in California. 1978 - 1980 Maryland Centers for Disease Control and Prevention Rockville, National Institute for Occupational Safety and Health Toxicologist Reviewed published and unpublished information on toxic substances in the occupational setting in order to assess the need for regulatory action by the Occupational Safety and Health Administration. Wrote Current Intelligence Bulletins 5 which were documents sent throughout the United States to the occupational health community to alert workers and health care providers of new hazards, or new information about known hazards in the work place. Served as the agency's alternate representative to the interagency committee on the Toxic Substances Control Act. Provided expertise to assist the other members of the Branch regarding occupational hazards they were assessing. 1977 - 1978 Food and Drug Administration Center for Veterinary Medicine Rockville, Maryland Veterinary Medical Officer Reviewed applications to determine if the proposed drug was safe and effective for their intended use in food animals. Made recommendations to Center management regarding the approvability of drugs for the United States market. 1975 - 1997 Veterinary Home Care B. Animal Hospital Silver Spring, Maryland Idabel, Oklahoma Private Practitioner and Owner Has owned two practices of general veterinary medicine and surgery. In addition, provided contract services as a Relief Veterinarian for several practices in the Washington DC metro area. PUBLICATIONS "Adverse Health Effects of Smoking and the Occupational Environment." Am Ind Hyg Assoc J. July 1997, 40(7):A38-A47 "Arsine (Arsenic Hydride) Poisoning in the Workplace." Am Ind Hyg Assoc J. October 1979, 40(10):A56- A61 "Formaldehyde: Evidence of Carcinogenicity." Am Ind Hyg Assoc J. July 1981, 42:A34A46 "Controlling Exposure to Formaldehyde in the Veterinary Anatomy Laboratory." Zentralbladtt fur Veterinarmedizin, Reihe C. 1982 "Evolution of Veterinary Adverse Drug Reaction/Experience Reporting.” Proceedings American Academy of Veterinary Preventive Medicine. Nashville, Tennessee, November 1982 6 "RABIES: The Only Cure is Prevention." Consumer Information Bulletin. DHHS, Food and Drug Administration, October 1984 "Computerized Adverse Drug Reaction Profiles." J Vet Med Ed. January 1984, 11(1):12-15 "Population Description of the Veterinary Drug Experience Reporting Program." Proceedings of the Third Symposium on Computer Applications in Veterinary Medicine. The American Veterinary Computer Society, October 1985 "Micro to Mainframe: Link to Flexible Data Analysis?" Proceedings of the Third Symposium on Computer Applications in Veterinary Medicine. The American Veterinary Computer Society, October 1985 "Beyond Philosophical Differences: The Future Training of Veterinarians." J Vet Med Ed. December 2001 “Global Public Health Issues.” Global Veterinary Opportunities and Responsibilities Workshop, J Vet Med Ed., 2004 (Accepted) PRESENTATIONS AND PUBLIC APPEARANCES Various (Too numerous to list) PROFESSIONAL AFFILIATIONS American Veterinary Medical Association Tennessee Veterinary Medical Association Tennessee Public Health Association Commissioned Officers Association Reserved Officers Association Association of Military Surgeons of the United States Tuskegee University School of Veterinary Medicine Alumni Association EDUCATION Bachelor of Science, Agricultural Sciences, 1973 Tuskegee Institute, Tuskegee, Alabama Student Representative, Board of Trustees, 1970-71 President, Agricultural Sciences Club, 1970-71 Doctor of Veterinary Medicine, 1975 7 Tuskegee Institute, Tuskegee, Alabama School of Veterinary Medicine Representative, Student Congress, 1974-75 Chairman, Executive Board, Student Chapter of the American Veterinary Medical Association, 1974-75 President, Student Chapter of the American Veterinary Medical Assoc, 1973-74 President, Junior Class, 1973-74 Vice-President, Sophomore Class, 1972-73 Freshman Class Representative, Faculty/Student Advisory Committee, 1971-72 Master of Public Health, Epidemiology, 1981 Loma Linda University, Loma Linda, California ADDITIONAL TRAINING Building a High Performance Organization for the 21st Century, CCHPO, 1997 Leadership for a Democratic Society, Federal Executive Institute, 1995 Medical Device Law, Food and Drug Law Institute, 1986 Basic Food and Drug Law, Food and Drug Administration, 1985 Feed Ingredient Institute, National Feed Ingredients Association, 1985 Fundamentals of Microcomputers and Lotus 1,2,3, Parklawn Training Center, 1984 Applied Statistics, Food and Drug Administration, 1984 LAB I, Effective Communication Through Skilled Listening, Staunton, VA, 1984 Project Officer’s Course, Food and Drug Administration, 1983 Epidemiology Training Program, U.S. Public Health Service, 1980-83 Intro. to Epidemiology and Environmental Health, George Washington Univ., 1978 Numerous continuing education courses in medicine and surgery, 1975-1997 Numerous management and leadership short courses, 1981-present HONORS AND AWARDS Distinguished Alumni Award, Food and Drug Administration, 2007 Hall of Fame, University of Tennessee, Commission on Blacks, 2005 Distinguished Service Medal, U.S. Public Health Service, 2000 Distinguished Alumnus, Tuskegee University, 2000 Veterinarian of the Year, U.S. Public Health Service, 1999 Surgeon General's Exemplary Service Medal, Surgeon General of the U.S., 1999 Unit Commendation, Food and Drug Administration, 1999 Meritorious Service Medal, U.S. Public Health Service, 1998 Unit Commendation, Food and Drug Administration, 1998 Deputy Commissioner Special Recognition, Food and Drug Administration, 1997 Unit Commendation, Food and Drug Administration, 1997 Unit Commendation, Food and Drug Administration, 1996 Surgeon General's Exemplary Service Medal, Surgeon General of the U.S., 1995 Commissioner's Special Citation, Food and Drug Administration, 1995 8 Exceptional Capability Promotion Nomination, Food and Drug Administration, 1991 Plaque of Appreciation, Commissioned Officers Association, 1992 Certificate of Appreciation, Surgeon General of the U.S., 1991 Exceptional Capability Promotion Nomination, Food and Drug Administration, 1990 Unit Commendation, U.S. Public Health Service, 1990 Public Health Service Citation, U.S. Public Health Service, 1990. Exceptional Capability Promotion Nomination, Food and Drug Administration, 1989 Unit Commendation, U.S. Public Health Service, 1989 Outstanding Unit Citation, U.S. Public Health Service, 1988 Certificate of Appreciation, Food and Drug Administration, 1988 Certificate of Appreciation, Food and Drug Administration, 1988 Regular Corps of the U.S. Commissioned Corps, 1987 Commendation Medal, U.S. Public Health Service, 1986 Certificate of Appreciation, Food and Drug Administration, 1986 Honorary Diploma, American Veterinary Epidemiology Society, 1997 Delta Omega, Public Health Honor Society, Loma Linda University Chapter, 1981 Outstanding Young Men of America, 1978 Who's Who Among Students in American Universities and Colleges, 1975 Outstanding Veterinary Student, Women's Auxiliary to the Student Chapter of the American Veterinary Medical Association, 1975 Outstanding Senior Veterinary Student, Diamond Laboratories, 1975 President's Essay Contest, Third Place, Tuskegee Institute, 1971 Numerous other awards and recognitions not mentioned. SPECIAL ACTIVITIES One Health Taskforce, American Veterinary Medical Association, 2007 National Commission on Industrial Farm Animal Production, PEW Charitable Trusts and Johns Hopkins Bloomberg School of Public Health, 2006-2009 Secretary’s Advisory Committee on Foreign Animal and Poultry Diseases, USDA 2006-2008 Board of Trustees, USPHS Commissioned Officers Foundation, 2005-2008 Board of Directors, University Health System, Inc., 2005-2008 Chairman of the Board, Young-Williams Animal Center, Knoxville, Tennessee, 2005present Instructor/Mentor, IMPACT Youth Entrepreneur and Job Training, Knoxville, Tennessee, 2004-2006 Board of Directors, Knoxville Zoological Gardens, 2000-2008 9 Board of Directors, National Exploring Health Careers, 1998-2008 Alternate Delegate for the Uniformed Services of the United States Served four year term in the House of Delegates, American Veterinary Medical Association, representing the U. S. Public Health Service Commissioned Corps, U. S. Air Force, and U. S. Army veterinarians Chairman, U.S. Public Health Service Mentoring Committee The Surgeon General tasked this committee to review existing professional category specific mentoring programs and submit recommendations that would be used to develop a mentorship program for the entire Public Health Service Commissioned Corps. The mentorship program was to assist and advise junior officers in their professional growth in keeping with the mission of the Commissioned Corps. Attending Veterinarian Institutional Animal Care and Use Committee, Center for Devices and Radiological Health, Food and Drug Administration. Responsible for assuring that uses of animals in the research programs met standards of care and welfare that are mandated by Public Law 99-158, "Health Research Extension Act of 1985" and subsequent policies, and Public Law 99-158, "The Improved Standards for Laboratory Animals Act" and its implementing regulations. Internal Control Area Manager Responsible for the financial integrity of the Investigational Device Exemptions program of the Center for Devices and Radiological Health, Food and Drug Administration. During early 1993, successfully completed the Federal Managers Financial Integrity Act internal control review. National Board of Directors, Commissioned Officers Association Represented veterinarians, physical therapists, and dieticians in the U.S. Public Health Service Commissioned Corps. Served as liaison for several Branches in several states of the U.S. Provided input regarding outstanding issues confronting Commissioned Officers. Chairman, Veterinary Professional Advisory Committee Advised Surgeon General C. Everett Koop and assisted the Chief Veterinarian on issues regarding all U.S. Public Health Service veterinarians. Implemented the Surgeon General's Revitalization Action Plan of 1988. Served two full terms as a member of the Committee from February 1985 to 1991. Epidemiologist, USNS Mercy (T-AH 19) This hospital ship was on its "scrub-down" voyage, which included a detachment to the Republic of Vanuatu to investigate a suspected typhoid fever outbreak. In 1987, the U.S. Navy requested several U.S. Public Health Service specialists to serve in the South 10 Pacific aboard the USNS Mercy. I conducted a typhoid fever outbreak investigation on several islands. This was a very politically sensitive mission because the people of Vanuatu, being a neutral nation, did not want outside political influences, yet the Soviet Union was attempting to make some inroads. Therefore, President Ronald Reagan offered U.S. humanitarian assistance. Isolated a pathogen in a water reservoir that had been responsible for the death of a tribal chief and one of his family members, as well causing nonfatal illnesses among other tribal members. Did not find typhoid fever. Chairman, Committee on Epidemiology Represented the Center for Veterinary Medicine on the Food and Drug Administration Epidemiology Committee. The committee was charged with: (1) integrating the discipline of epidemiology into the framework of the Center, and (2) developing liaison and cooperative programs with other epidemiology units in the Food and Drug Administration. Chairman, General Training Committee Directed and coordinated the development of the Training and Orientation Program System (TOPS), which was an orientation plan for new employees of the Center for Veterinary Medicine, Food and Drug Administration. This effort involved coordination of work from individuals from all of the Center's programs. Produced the first training video to be used for new employee orientation. Contract Reviewer Intramural and Administrative Support Contract Review Committee, National Cancer Institute, National Institutes of Health. Instructor, Smoking cessation classes, Washington DC metro area, 1982-1996 Instructor, Focus on Health, Jessup Prison Pre-Release Unit, Jessup, Maryland 1984-86 Vice-President, Board of Directors, Kiamichi Alcoholism Treatment Center, Idabel, Oklahoma 1977 Member, Board of Advisors to CETA On-The-Job-Training for Minority Women, Idabel, Oklahoma 1976-77 Chairman, Education Committee, NAACP, Idabel, Oklahoma 1976-77 Numerous committees 11