Academic Partnerships Reduce Costs, Integrate Scientific Know-How
One of the most effective ways for a small firm to create a new drug is to collaborate with university-based researchers. The NIH gives out over $28 billion in grants each year for medical research, while universities and research institutes, collectively, spend billions more to support scientific research.
Small pharmaceutical companies focused on commercializing drugs should tap this enormous resource of brains and capital. Of course, strong management, a sound business strategy, and effective execution will increase the odds of success.
By collaborating with a scientific consortium, we are able to activate the scientific research and know-how made possible by decades of funding from the government and universities.
Licensing science from universities is not unique—it has been done for decades. By focusing on a group of compounds or a specific disease, companies can create an open-system of knowledge-sharing. Such a system that invites contribution and participation from many scientists offers one way of accelerating drug discovery and selection. While researchers focus on drug discovery work, a commercial partner can propel the compound toward commercialization.
For smaller firms, the business development model should be best kept simple. Immtech Pharmaceuticals (www.immtechpharma.com) chose infectious diseases because while the potential market is enormous and the needs are great for new drugs, the trials are relatively short in duration and the endpoints generally easily measurable. A trial that targets a measurable event such as the absence of infection can usually be completed in days or weeks instead of months or years.
Targeting a treatment for an underserved market can also position the development effort for FDA fast-track status or orphan drug status. Fast-track status reduces the development timetable, while orphan drug status can position a company to take advantage of certain tax credits, bypass NDA filing fees, and have market exclusivity for seven years following approval.