Don’t Give Away Control Of The Regulatory Submission Process
One of this company’s competitors had been dealing exclusively with the military. Apparently, this military branch was responsible for running all of this company’s clinical programs, interacting with the regulatory authorities, and paying for everything. In return, the company which had pioneered the drug being developed, would get back all of the data being generated. “Imagine, a public company having its research being fully funded by the military,” this person exclaims. “All they had to do was manufacture and sell under a supply agreement. It seemed like a beautiful deal, and we were all sort of envious at the time. However, what we observed was that the company lost control of the drug approval process.” Upon this realization, they immediately called a group meeting of the people responsible for lobbying the military on behalf of the company. From the due diligence conducted, the decision was made to take a different approach – one of increased collaboration and joint responsibility for following the FDA drug approval process. This executive was glad to have learned this lesson prior to signing a collaborative agreement with the military.
Why Do You Want A Military Collaborative Agreement
Another thing to keep in mind is the reason for pursuing a military collaborative agreement for drug development. Commercialization of a product for battlefield injuries is not a big enough market to sustain a company. The benefit of a collaborative agreement with the military is in gaining access to top government scientists and clinicians, as well as provide you with significant credibility factor. This person advises to take this approach as well as considering it your patriotic duty - as military drug commercialization is not a viable strategy.
Another lesson this person learned was that getting this type of agreement in place can take several iterations and a long period of time. “While you are waiting for approval, you are still burning cash waiting for responses,” they state. So, be sure you have the financial resources to play the waiting game. Another tip when pursuing a military collaboration — stick with one branch. The military is not a single entity. Each branch will have different requirements for what they want. For drug development companies, the benefit of working with the military is gaining access to top government scientists and clinicians providing you with significant credibility factor. Developing and selling drugs just for the military is not a big enough market to sustain a pharmaceutical company.