Over the last two decades, the University Research sector has witnessed an explosion in drug discovery activities that before have been the domain of the traditional pharmaceutical companies. This shift has been fueled by the changing landscape of the pharmaceutical industry. As pressure mounts on these companies to increase the return on publicly traded investments, hard-line decisions are being made about which therapies to pursue. Unfortunately for the patient, more therapies are being left behind that don’t have large or immediate promise.

Public and private research institutions have, to some extent, filled the gap through traditional grant funded research. The more savvy institutions have leveraged those research efforts into increased royalty and patent income streams, but at best, have produced mixed revenue levels. Public or private research universities find it daunting to navigate through the treacherous waters of drug development and delivery. The barriers to entry are high, and in many cases nearly impossible to surmount due to factors ranging from insufficient funding to lack of training in the intricacies of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). Our goal here is to provide a means by which new therapeutic discoveries can be delivered effectively and safely to the market.

The Challenges

Each potential therapy discovered will meet the same long series of problems that it must surmount --- including safety testing, formulation, clinical trials and a New Drug Application (NDA). However, in the case of University based efforts, the hurdles can be more basic but have far reaching impacts as several questions are considered:

How do we transition to a more entrepreneurial culture where decisions concerning what to research and how to go about the research will maximize patent income?
Should cGMP activities take place on the campus and how are they implemented? What are the best out-sourcing alternatives for my situation?
Cultural and ethical questions - is the research being driven more by profit motive or is the institution staying true to its public mission? How is this balanced against the trend to more entrepreneurial research efforts?
How to manage change - both technically and culturally? Is this really a change I want and what are the impacts? Do I need a public relations plan?
How is funding obtained and from where? What strings are attached? What impact do the various funding sources have on the entrepreneurial model?
How are start-up companies managed and is their maximum potential realized? At what point do I need to construct a facility and how much will it cost in the life cycle?
How do I know that my IP protection is as good as it can be? Will I be taken advantage of by more savvy players in the industry when we are ready for commercialization?
Can a business plan be developed that takes other institutions into account and so everyone benefits? This is particularly true for state-funded institutions where the opportunity exists to create a homegrown pharma or biotech industry.


	Copyright 2011 The Pivotal Point Group, LLC