Challenge

Provider of active pharmaceutical ingredient for mild to moderate Alzheimer’s needed a strategy for extending the useful life past patent expiration. Generic and OTC Products are currently available. Peer reviewed studies indicated the potential for re-purposing as an antidote and prophylaxis for organophosphate poisoning.   Organophosphates are the primary chemical compound in both the most widely used nerve gasses and pesticides

Solution

Develop Full Business Case and Strategic Plan for the company to successfully negotiate the Global IP, Regulatory, Sales / Marketing / Distribution / Logistics and corporate positioning activities.

Outcome

Provided Full Business Case and Strategic Plan for the company. Formed a stand-alone US company focused on the sale and distribution for this and a series of add-on products, secured the IP necessary for global distribution, developed the Regulatory Strategies for the US, EU and CFDA, secured start-up and continued program funding through the Federal Grant process.