The Medical Officer Function in the
University Start Up Company
Peter C. Johnson, MD and Gerald L. Klein, MD
A substantial cultural shift occurred in federally funded non-profit research institutions such as universities with the passage of the Bayh-Dole Act (37 CFR Part 401). The Act requires them to form a contractual relationship with faculty regarding intellectual property rights and prompted the formation of Technology Transfer Offices to manage the external flow of such property. Small companies must be the preferred recipients of such intellectual property. This has led to an explosion of entrepreneurship among faculty members who, as a result, can participate in the commercialization of their ideas under circumstances favorable to both them and to their Universities
In many cases, faculty members having no commercial experience have formed companies, often leading to a failure of commercialization of the product of interest. To combat this tendency, non-profit Incubators both within and external to Universities have blossomed and in many cases, they are able to successfully provide the continuum of business support that early commercialization requires. They function especially well in areas of technology (Information Technology and Industrial Goods, for example) that are not highly regulated. Where the University start up commercialization system remains weak, however is in the development of regulated products, particularly medical products such as drugs, diagnostics and devices.
The commercialization of medical products requires a different skill set than the commercialization of non-regulated products, notably a deep understanding of both the practice of Medicine/Surgery, Regulatory Affairs, Pharmacovigilance, GMP Manufacturing, Reimbursement, and Pharmaceutical, Device or Diagnostic Marketing/Sales. Importantly, these skills need to be infused into product commercialization at the very earliest stages of product development, arguably even within the University itself. Rich awareness of medical practice systems provide the judgment needed to determine whether a product is likely to be clinically developable, able to be cleared by regulatory bodies and to be accepted by health care providers and reimbursed in the marketplace of medicine. Unfortunately, all too often, this knowledge and experience is not brought into the medical product development stream early enough in the development cycle, either through lack of funding, naïveté regarding medical practices or a lack of awareness by students and professors of regulatory science requirements.
The criticality of early involvement of a “medical officer function” has recently been recognized more commonly amongst University start up companies. The coordination of such involvement is generally begun by the Technology Transfer Officer, who recognizes the enhanced potential for success of medical product spinouts that the incorporation of early medical product development judgment can bring. Since in the early stages of spinout life, levels of funding generally do not allow for the hiring of a full time Chief Medical Officer, this function is perhaps better provided by medical consultants who have had significant medical and commercial experience. Often, medical officer consultants are retained by the Technology Transfer Office or by Incubators to more readily provide access to the companies they are forming or supporting. Many of the functions that are provided by such consultants are listed in Table I.
Consulting Medical Officer Functions
a. Determination of the potential for the medical product idea to fill a gap in medical practice.
b. Assist the intellectual property attorney with assessment of the uniqueness of the proposed product.
c. Provide an initial assessment of the competition to be faced in the medical marketplace and ongoing competitive intelligence
d. Identification and recruitment of medical and surgical Key Opinion Leaders to provide a broad-based assessment of the product’s potential.
e. Provide medical communication skills to enhance the success of grant submissions, business plans, and investor presentations
f. Coordinate interaction with domestic and international regulatory authorities to determine regulatory pathways
g. Assistance with the development of clinical trial protocols and their successful implementation, including Contract Research Organization recruitment and oversight.
h. Provision of the medical “presence” that can assist with fundraising.
i. Provide safety and pharmacovigilance oversight for adverse reactions.
j. Assist in the design of a reimbursement strategy including pharmacoeconomic parameters in the clinical trials.
k. Aid in the development of a publication strategy to include presentations, posters, and peer reviewed papers
Fortunately, in the start up environment, the amount of time needed for the successful utilization of the medical officer function is not great. For optimal involvement by the Technology Transfer Office, the consulting medical officer should be available to review the value of proposed intellectual property, assist with start up planning from the medical perspective and be available for interaction with faculty entrepreneurs to guide them in the earliest stages of product development, sometimes even at the onset of IP generation. An experienced medical officer is invaluable to the start-up. Mistakes at this stage can doom the entire venture. Using a part time or full time virtual medical officer is a cost effective way to obtain this key member of the team.
For optimal involvement by the spinout company, the consulting medical officer should attend product planning meetings, assist with the activities in Table I as required and be “on call” for ad hoc medically-related questions.
As experience grows in interaction with the consulting medical officer, both the Technology Transfer Office/Incubator and their spinout companies should see substantial value added to the product development and commercialization processes. This will enhance the potential for spinout company success and most importantly, increase the probability that needed technology reaches the patient’s bedside.
1. Johnson, P, Bertram, T, Hellman, K, Tawil, B, Van Dyke, M, Carty, N, Awareness of the Role of Science in the FDA Regulatory Submission Process: A Survey of the TERMIS-Americas Membership, Tissue Engineering, Part A, 2014, Jun 20(11-12):1565-82.