Germ Out® Hand
Antiseptic
The watermark in the background of this web site is an electron microscope
picture of MRSA (methicillin resistant Staphylococcus aureus). Germ Out®
kills MRSA on your hands in 15 to 30 seconds
Founder's Resume
JOHN S. HIBBARD, Ph.D.
PRESIDENT, CEO of
J & A COMPANIES, L.L.C.
●
Consultant - Microbiology /
Pharmaceutical Research and Development
●
Manufacturer, Packager, Distributor and
Sales of Germ Out®
4311 W. 112th Terrace
Office: 913-530-1647
Leawood, Kansas FAX: 913-661-0253
(please call before faxing)
EXPERIENCE:
● More than twenty years experience involving the clinical development and
approval of drug products and medical devices.
● More than thirteen years of graduate and postgraduate basic research in
the fields of biochemistry, immunology, microbiology, molecular biology and
pharmaceutical science.
● Developed a network of highly qualified, nationally and internationally,
respected investigators for clinical studies of drugs and medical devices.
● Fifteen years experience teaching microbiology to graduate and second year
medical school students.
SYNOPSIS OF ACHIEVEMENTS:
● Developed the following diagnostic tests and devices, Bac-T Screen®,
Strep-ID®, CDT Test® ,ChloraPrep® One Step
3.0 mL. Applicator and
Chlorascrub™ applicator.
● Wrote and obtained NDA approval for the prescription drugs Carafate®
Suspension, Rifater®, Valstar™, Chloraprep® and
Chlorascrub™,
with an estimated combined sales of more than 455 million dollars per year.
● Identified and developed a cost saving step in the CDT test which resulted
in a savings of 35 million dollars over a 5 year period.
PROFESSIONAL CAREER:
J & A Companies, L.L.C. – Leawood, Kansas 2000
to Present
PRESIDENT, CEO
● Responsibilities included consulting for Pharmaceutical companies and
Manufacture, Packaging, Distribution and Sale of the waterless hand sanitizer
Germ Out®.
BECKLOFF ASSOCIATES, INC. - Overland Park, Kansas 1997 to 2000
DIRECTOR OF CLINICAL AFFAIRS
● Responsibilities include development and implementation of all clinical
research projects from clinical operating plans to writing sections of NDAs.
STERISOURCE L.L.C. - Leawood, Kansas 1995 to 1996
V.P. RESEARCH & DEVELOPMENT /
OPERATIONS
● Responsibilities included all research, development, regulatory, labeling,
packaging, and manufacturing activities for the OTC antiseptic and
disinfectant SEP-T-BAN™.
CONSULTANT CLINICAL RESEARCH / MICOBIOLOGY 1994 to 1995
Consulting for Strategem Inc., Water-Jel Technologies, and Pharmaceutical
Formulations Inc.
MARION LABORATORIES AND MARION MERRELL DOW INC. - Kansas City, Missouri
SENIOR CLINICAL RESEARCH SCIENTIST 1992 - 1994
● Clinical Research Department, Anti-Infectives/Oncology Section, Anti-mycobacterial
Drugs
CLINICAL RESEARCH SCIENTIST 1988 - 1992
● Clinical Research Department, General Medicine Section, Gastrointestinal
Drugs
CLINICAL MICROBIOLOGIST
1986 - 1988
CLINICAL MICROBIOLOGIST II
1982 - 1986
● Marion Laboratories, Department of Diagnostic Affairs
ST. GEORGES UNIV. MED. SCHOOL - Grenada, WI 1977 to
1984
-
Part-time Faculty and Visiting Professor Department of Microbiology
UNIV. OF HEALTH SCIENCE- Kansas City, Missouri 1972 to
1982
Department of Microbiology
DEPARTMENT HEAD AND ASSOCIATE PROFESSOR 1978 - 1982
ASSISTANT PROFESSOR 1972 - 1978
OKLAHOMA STATE UNIVERSITY – Stillwater Oklahoma 1971 to 1972
Department of Parasitology and Public Health at the College of Veterinary
Medicine
ASSISTANT PROFESSOR
UNIVERSITY OF GEORGIA - Athens, Georgia 1969
to 1971
College of Veterinary Medicine
ASSISTANT PROFESSOR AND RESEARCH ASSOCIATE
EDUCATIONAL BACKGROUND:
University of Kansas - Lawrence, Kansas
University of Kansas Medical Center - Kansas City, KS
Ph.D. in Microbiology, minor Biochemistry
BA in History and Zoology
PROFESSIONAL SOCIETY MEMBERSHIPS:
American Society of Microbiology, Missouri Valley ASM, Kansas City ASM,
American Society of Parasitology, American Society of Tropical Medicine and
Hygiene, American Society for the Advancement of Science, The Lancefield
Society, Drug Information Association
PUBLICATIONS
1. Hibbard, J. S., Field,
M. F., and Mira, O. J. Fibrin Overlay Technique 64th Meeting American Society
for Microbiology, Washington, D.C., V 87, 1964.
2. Hibbard, J. S., Field,
F. F., and Mira, O. J. Studies of a Fibrinolytic Enzyme from Primary Rhesus
Monkey-Kidney Cells 66th Annual Meeting of the American Society for
Microbiology, 54, V. 73, 1966.
3. Hibbard, J. S. and Dusanic, D. G. Glucose and Endogenous Metabolism of Culture and Bloodstream
Forms of Trypanosoma lewisi Proc 43rd Annual Meeting of the American Society of
Parasitology, No. 40, p. 34, 1968.
4. Hibbard, J. S. and Dusanic, D. G. Comparative Studies of Bloodstream and Culture Forms of
Trypanosoma lewisi I. Oxygen Utilization, Carbon Dioxide Production and Glucose
Uptake Comp. Biochem. and Physiol., 29, 621, 1969.
5. Hibbard, J. S. and Dusanic, D. G. Comparative Studies of Bloodstream and Culture Forms of
Trypanosoma lewisi II. Biochemical Composition Comp. Biochem. and Physiol., 32:
529-541, 1970.
6. Hibbard, J. S. and
Thompson, P. E. Chemotherapy of Filariasis Parasitic Diseases Panel - U.S. -
Japan Cooperative Medical Science Program. Johns Hopkins School of Hygiene and
Public Health, Baltimore, Maryland, 1970. Invited Participant.
7. Hibbard, J. S., Arnold,
J. D. and Thompson, P. E. Scanning Electron Micrographs of the Filariid
Litomosoides carinii Southern Society of Parasitologist Meeting, No. 16, Auburn
University, March 18, 1971.
8. Hibbard, J. S., Norred,
C. J. and Thompson, P. E. Immunizing Agents of the Filarial Parasite
Litomosoides carinii Southern Society of Parasitology Meetings, No. 25, Auburn
University, March 18, 1971.
9. Hibbard, J. S., Norred,
C. J. and Thompson, P. E. Artificially Acquired Immunity to Litomosoides carinii
Microfilaria in the Mongolian Jird Joint Conference on Filariasis and
Schistosomiasis. U. S. - Japan Cooperative Medical Science Program, Geographic
Medicine Branch, NIAID, NIH, July 26-28, 1971. Invited Participant.
10. Hibbard, J. S., Zeigler,
J. B. and Thompson, P. E. Chemotherapy of Litomosoides carinii Joint conference
of Filariasis and Schistosomiasis. U. S. - Japan Cooperative Medical Science
Program Geographic Medicine Branch, NIAID, NIH, July 26-28, 1971. Invited
Participant.
11. Pezzlo, M. T., Hibbard,
J. S. and Matsen, J. M. Monograph: Screening for Urinary Tract Infections
Marion Scientific, A Division of Marion Laboratories Inc. Kansas City, Missouri
64114. February 1984.
12. Hibbard, J. S.
Clostridium difficile - Associated Colitis and Pseudomembranous Colitis
Am.J.Clin.Prod.Rev., Feb: 18-23, 1986.
13. Hibbard, J. S. Carafate
Suspension New Drug Application (NDA) - Clinical Section (8), Overall Summary of
Controlled and Uncontrolled Studies, Integrated Summaries of Effectiveness,
Safety, and Benefits and Risks, Labeling and Application Summary. NDA submitted
to the FDA in 1989 and approved in 1993.
14. Hibbard, J. S. Rifater
New Drug Application (NDA) Created a database and listings for one of the
controlled studies in the NDA, wrote the entire Clinical Section (8) including
the clinical study reports, the Overall Summary of Controlled and Uncontrolled
Studies, the Integrated Summaries of Effectiveness, Safety and the Benefits and
Risks, Labeling and Application Summary. NDA submitted to the FDA on May 19,
1993 and approved on June 2, 1994.
15. Hibbard, J.S. Rifapentine
New Drug Application Directed strategy for drug development and approval
in the U.S. Wrote protocols and initiated phase II clinical trials for Rifapentine in South Africa and the United States. Rifapentine NDA was filed in
1997 and approved in 1998.
16. Hibbard J.S. Valstar (valrubicin)
New Drug Application Wrote the Human Pharmacokinetic and Bioavailability section
of the NDA including the summary section 2.6, all of section 6.0, and the PK
section of the labeling. Valstar NDA was filed and approved in 1999.
17. Hibbard J.S. 2%
Chloraprep New Drug Application. Project Director for drug development in the
U.S. Wrote protocols for two pivotal clinical studies. Monitored both studies
from prestudy site visits to closing site visits. Reviewed and commented on the
Clinical Statistical Reports. The Clinical Statistical reports were filed as an
amendment to the NDA on January 13, 2000 and the NDA was approved in July of
2000.
18. John S. Hibbard, Gayle K. Mulberry,
and Ann R. Brady. ChloraPrep Compared with Isopropyl Alcohol or Aqueous
Chlorhexidine for Skin Antisepsis. At Poster Presentation No. 9 on Tuesday May
1, 2001 and at Oral Presentation No. 4 on Wednesday May 2, 2001 at the 2001
Intravenous Nurses Society Annual Meeting and Industrial Exhibit in
Indianapolis, Indiana.
19. Robert Garcia, John S. Hibbard.
Antimicrobial Activity of a Recently Approved Chlorhexidine-Isopropyl Alcohol
Antiseptic vs 70% Isopropyl Alcohol: A Randomized, Blinded Trial. An Oral
Presentation at the 28th Annual Educational Conference and
International Meeting of the Association for Professionals in Infection Control
and Epidemiology. June 12, 2001 at 2:30 PM in Seattle, Washington.
20. John S. Hibbard. Administration of 2% Chlorhexidine Gluconate in 70% Isopropyl Alcohol Is Effective in 30 Seconds.
Letter to the Editor. Infection Control and Hospital Epidemiology, May, 23 No.5:
233, 2002
21. John S. Hibbard, Gayle K. Mulberry,
Ann R. Brady. A Clinical Study Comparing the Skin Antisepsis and Safety of ChloraPrep, 70% Isopropyl Alcohol, and 2% Aqueous Chlorhexidine. Journal of
Infusion Nursing, July-August, 25 No.4: 244-249, 2002
22. Robert Garcia, Gayle Mulberry, Ann
Brady, and John S. Hibbard. Comparison of ChloraPrep and Betadine as
Preoperative Skin Preparation Antiseptics. A Poster Presentation at the 40th
Annual Meeting of the Infectious Disease Society of America, October 25, 2002.
23. Hibbard, J.S.
3.15% Chlorascrub New Drug Application (NDA). Project consultant for drug development in the
U.S. Reviewed and commented on protocols for two pivotal clinical studies.
Consulted on both studies
from pre-study site visits to closing site visits. Reviewed and commented on the
Clinical Statistical Reports. Wrote and prepared sections 7, 8, 9, 10, 11, and
12 and reviewed and commented on sections 2, 3, 5 and 6 of the NDA. The NDA was
filed in 2004 and approved by the FDA in 2005.
24. John S. Hibbard.
Comparative Analysis of the Antimicrobial Activity and Safety of Current
Antiseptic Agents. An Oral Presentation at the Infusion Nurses Society, National
Academy of Infusion Therapy meeting, Session Code 001, May 1, 2004, Salt Lake
City, Utah.
25. John S. Hibbard. Analyses Comparing the Antimicrobial Activity and Safety
of Current Antiseptic Agents: A Review. Journal of Infusion Nursing, May-June, 28
No.3: 194-207, 2005
26. John S. Hibbard. Initial Treatment of Infectious Diseases: One or Two
Antimicrobials. Microbe, Vol. 1 No. 5: 209, 2006.
27. John S. Hibbard. Combined Antimicrobial Treatment of Infectious Diseases.
Microbe, Vol. 1 No. 12: 549, 2006.
28. John S. Hibbard. Combined Antimicrobial Therapy - Can We Outsmart the Microbes?
Microbe, Vol. 2 No. 6: 271, 2007.
29. John S. Hibbard. Combination Antimicrobial Treatment – Benefits and Risks.
Microbe, Vol. 3 No. 1: 2, 2008.
Mailing Address:4311 W. 112th Terrace,
Leawood, Kansas 66211
E-Mail Address: johnshibbard@att.net
Telephone 913-530-1647, Facsimile
913-661-0253 (please call before faxing)
Copyright © 2005 J & A
Companies, L.L.C.