Michael Jerome Blackwell

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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,
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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
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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
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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
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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
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"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
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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
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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
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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
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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
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