Faculty Feature: Tom Colonna

Posted in Bioinformatics, Biotechnology, Biotechnology Education, Biotechnology Enterprise, Biotechnology Enterprise and Entrepreneurship, Center for Biotechnology Education, Food Safety Regulation, Post Master’s Certificate in Sequence Analysis and Genomics, Regulatory Science

Food Safety RegulationDr. Thomas Colonna, JD, PhD is the associate program director for our Regulatory and Food Safety Regulation programs. He has published in several areas and has extensive regulatory affairs experience. We asked him a few questions about his background, his career, and his thoughts about our new Food Safety Regulation program:

Can you tell us a little bit about your education? What led you to such a wide range of expertise?

I earned a Bachelor of Science in Microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science) in 1990, a Ph.D. in molecular biology from the Johns Hopkins University in 1996, and a law degree from the Georgetown University Law Center in 1999. I was originally on track to enter a career in basic research but became interested in the biomedical entrepreneurial enterprises launched in the mid-1990’s (when I was finishing my doctoral thesis work). Several doctoral students and I decided to form a biotech start-up, and during the formation process, it became apparent that we needed legal knowledge of intellectual property, business structures, and regulatory compliance. However, we didn’t have the money to employ lawyers so it eventually occurred to me that I could be more useful to my colleagues if I studied law rather than go onto the post-doc treadmill. I enrolled at Georgetown University Law Center (GULC) soon after I was awarded my Ph.D. In order to minimize the amount of debt I was going to incur, I decided that I should leverage my Ph.D. and find a job while going to law school.  I sent my CV to many law firms in Washington, DC with a cover letter asking for a job in intellectual property. I received a phone call from Jonathan Kahn, a partner at Hogan & Hartson LLP (now Hogan Lovells) asking me to come in for an interview. My interview was originally scheduled in January 1996- the day a big snowstorm hit the region which shut down DC for nearly a week. When I finally arrived for an interview a month later, Jon explained to me that while he did not practice intellectual property law, he practiced FDA regulatory affairs with a specialization in medical device regulation. Jon suggested that I consider a career in FDA regulatory affairs and offered me a job as a medical device specialist. What started out as a part-time job eventually turned into a full-time job while I was also attending law school full-time. Consequently, the years 1997 to 1999 went by quickly as I learned about FDA regulatory affairs while on the job and general law with a focus on intellectual property law at GULC.

What kinds of things have you published?

Initially I published several peer review papers based upon my doctoral thesis work at JHU, then I published a few legal articles based upon some legal research projects I worked on while in law school and at Hogan. Eventually I was teaching regulatory courses at JHU and published a couple of textbooks (Promotion of Biomedical Products: Regulatory Considerations and Biomedical Software Regulation) specifically for courses I was teaching because there were no viable textbook options at the time.

What have some of your experiences in regulatory affairs been?

I worked on many FDA regulatory submissions at Hogan & Hartson LLP and later I founded Biotech Consultant LLC in 2003, as an independent regulatory consultant. I have worked on regulatory submissions for a wide range of products regulated by FDA – pharmaceuticals, biologics, medical devices, combination products, dietary supplements. My consulting clients range from Fortune 500 companies to small start-up companies located throughout the U.S., as well as in Canada, India, the E.U., and Russia. Most recently, my wife Dr. Desencia E. Thomas (B.A. 1994) and I purchased a 115 acre farm in 2009, so I have now branched into food regulation. I have learned a great deal of food regulation through my experiences establishing and growing our farm. I also use my scientific and legal training to build our agricultural interests (Organian Farms LLC, Organian Livestock LLC, and Organian’s Bounty LLC).

Can you talk about the new Food Safety Regulation program you’re launching with Dr. Langer?

With pleasure. The JHU-AAP Center for Biotechnology Education (CBE) was approached a couple of years ago by separate international organizations (National Taiwan University and the Chinese Ministry of Health) and the FDA about offering training in food safety regulation. Consequently, Dr. Langer and I drafted a proposal for a new Master of Science in Food Safety Regulation which was approved by JHU in April 2014 and eventually the Maryland Higher Education Council (MHEC) in October 2014.

The new Master of Science in Food Safety Regulation is designed to provide students with an understanding of the legal and regulatory complexities of food production, labeling, and distribution. The program provides students with the knowledge required for companies and organizations that grow, process, distribute, or sell foods and beverages while complying with federal and state regulatory statutes for the production, distribution, and commercialization of food products. The new program in Food Safety Regulation will advance the mission of the university and JHU-AAP by offering life-long learning for those developing new skills, exploring new careers, or expanding their professional knowledge. The program will cultivate knowledge and specific skills intended to prepare graduates to deal with the complex and pressing issues discussed above. For example, a risk-based approach is necessary to prevent the spread of foodborne illnesses and preserve the public’s trust in the food safety system. Training and hiring personnel with various expertise, such as risk management and analysis, is critical to implementing a risk-based system. Developing a comprehensive strategic plan that identifies public health goals and metrics to measure success is essential. Risk communication is an integral part of food safety management, especially during an emergency, when information needs to be conveyed clearly and in a timely fashion. The risk-based system will require integrating effective risk communication and food safety education.

The new program consists of ten graduate level courses—seven required courses and three elective courses – all of which are taken online. Students will need to complete the courses within a five year timeframe. The landscape of food safety regulation is currently undergoing extensive changes. As the field continues to change, the proposed program is designed to change with it. While the seven required courses will remain constant, the content will adapt to changes in discoveries in and understanding of the covered topics. Similarly, the approved list of elective courses will be a living document that will include newly created courses as appropriate. Furthermore, new courses will be considered based on student feedback and changes in the industry. The first MS in Food Safety Regulation students began their studies in the Spring 2015 term.