Biotechnology, Dentistry and Technology Transfer

Written by Dr. Jay H. Garlitz, D.M.D. (Consulting Editor) for "Today's FDA" May 1998

Replacement Therapy for the Prevention of Tooth Decay

Acid production by Streptococcus mutans is responsible for most human tooth decay. Can we eliminate this bacterial characteristic which leads to such human misery? Dr. Jeffrey Hillman, D.M.D., Ph.D. at the University of Florida College of Dentistry has been working to solve this important problem.

The goal of Dr. Hillman’s research and approach has been to use recombinant DNA technology to genetically modify Streptococcus mutans to produce a bacterial strain that can be used to prevent tooth decay. He has created a new strain that possesses two unique qualities: An incapability of producing caries-promoting acids (because of this it does not cause tooth decay). ; And the quality of producing an antibacterial compound which is toxic to the unmodified naturally occurring cariogenic bacterial strains that cause decay, while having no effect on itself (the modified strain). Because this resulting strain can successfully out-compete naturally occurring ones and replace them in the oral cavity, Dr. Hillman’s approach to the prevention of tooth decay is termed "replacement therapy".

With funding provided by the University of Florida Research Foundation, Dr. Hillman has tested his replacement therapy approach in animal studies. The results indicate that animals are protected against tooth decay over extended periods of time when their oral cavities are repopulated with his new strain of Streptococcus mutans. Efforts are underway to make this approach suitable for use in humans.

(Dr. Hillman has a web page which list his current research topics and published research. Please visit the site at http://www.dental.ufl.edu/Hillman.htm)

Can research such as Dr. Hillman’s be brought to market as a viable product? Human trials will need to be conducted to establish its effectiveness and potency, and the regulatory requirements of the Food and Drug Administration will have to be met before Dr. Hillman’s replacement therapy can be provided by your family dentist. The costs of these research and development activities are projected to be in the millions of dollars. While presenting a major financial challenge, these costs are similar to those incurred by companies taking pharmaceutical compounds to market. In the meantime, the clock is ticking because a U.S. patent (which will expire in 17 years) was issued on this technology in 1997. Delays in bringing a product to market can mean millions of dollars. Both the University of Florida’s Office of Technology Licensing and Dr. Hillman are seeking to identify ways to complete the transfer and bringing of his technological innovation to the commercial sector and marketplace.

Technology Transfer

The following article details Biotechnology in the Gainesville, FL area. Please write in with suggestions on this type of activity in other areas of our state, as they relate to dentistry. (Send your suggestions for additional articles to the author by E-mail using fda@floridadental.org)

Technology has made certain areas of our country very famous. Silicon Valley, the N. Carolina Research Triangle and Route 128 in the Boston area are geographic regions synonymous with technology success. Will Highway 441 North become Florida’s Biotechnology Highway? Is there Biotechnology greatness in Gainesville’s future and how will this occur?

According to Dr. John Cox of Future tech Industries of Alachua, Fl "It takes a multidisciplinary team to get a product on the fast track to market". He adds "Technology is not created by a garage based or shade tree mechanic any longer".

It is important to have all the players work as a team. The Gainesville team is evolving into a potential juggernaut that can transfer dental research into products. The challenge is for this to happen quickly, as you are in a very competitive marketplace.

Gainesville Area team members

The Major Research Institution:

From our perspective this starts with the University of Florida College of Dentistry (http://www.dental.ufl.edu). Since the school is part of a major medical complex and University there are many resources such as;

The Office of Technology Licensing at the University of Florida. There is a web site full of information about their mission and how they support and facilitate the transfer of laboratory discoveries to the marketplace (http://web.ortge.ufl.edu/dep/otl.html). Statistics about their activities and success are listed. The Office of Research, Technology, and Graduate Education’s main page is located at (http://web.ortge.ufl.edu/).

UF College of Medicine (http://www.med.ufl.edu/). A successful medical school fuels opportunities for dental research. Multidisciplinary approaches beget faculty lines which can be shared between a dental school and medical school.

The Health Science Center (http://www.health.ufl.edu/). The Health Science Center includes the Colleges of Medicine and Dentistry. The College of Pharmacy and the other affiliated entities that follow also serve as important team members.

The University of Florida Biotechnology Program (http://www.biotech.ufl.edu/). This program at the University is described on their web site.

The University of Florida Brain Institute. (http://www.ufbi.ufl.edu/). We make every attempt to make Dentistry pain-free. A major coup occurred when UF landed this institute (facility is currently under construction). Located in close proximity to the dental school, major research opportunities will exist for pain control research within our profession. Visit their Web site for more details.

The College of Veterinary Medicine. One of a small number of veterinary schools in the country, basic research into animal diseases often contributes to the solving of human diseases.

The Facilitators:

The Sid Martin Biotechnology Development Institute (http://www.biotech.ufl.org/). This arm of the Biotechnology Program at the University of Florida and is located in Alachua, Florida, approximately 18 miles from the University of Florida campus. They serve as a full service business incubator designed specifically to support biotech startup companies and to facilitate technology transfer from the State University System of Florida to the private sector.

The Gainesville Council for Economic Outreach (CEO) (http://www.gceo.com/index.htm). Serves to coordinate efforts in attracting business and industry. Formulates strategies for promoting economic development through marketing and industrial recruitment.

Enterprise Florida, the state of Florida's international trade and economic development government/business partnership. (http://www.floridabusiness.com/)

Private Industry:

Dental Products that have already come to market whose origins are in the Gainesville area include;

The Florida Probe computerized periodontal probing system (http://www.floridaprobe.com/home.htm)

USBiomaterials: Bioglass® and PerioGlas® products for dental and periodontal applications. (http://www.usbiomat.com/corp/corp.htm)

Other dental Products currently under development in the area include a digital fluoroscopy system which allows dental clinicians to view their endodontic instrumentation while the file is being used in real time (Future Tech Industries), and a digital panoramic system (Future Tech Diagnostic Partners). A saliva based HIV test and Hepatitis B test have been licensed from Future Tech and its subsidiaries as well. These diagnostic tests resulted from the research of a veterinary faculty member.

Only time will tell if Gainesville is on the verge of hi-tech and biotech greatness. If it does dentistry will be a major benefactor. The North Central Florida area may provide our profession with better tools to improve the health and welfare of our patients.

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