Challenge
A start-up company was planning to license an immunomodulatory product from a European pharmaceutical company. The therapy had been unsuccessfully tried in allergic disorders, but the client saw an opportunity to exploit the drug in an oncology setting, particularly in combination with immuno-oncology compounds such as the PD-1 and PD-L1 inhibitors. Owing to its unique mechanism of action, the drug could stimulate or suppress the immune system, depending on the biological context. The client company was in its infancy, and needed a Chief Medical Officer with substantial experience to lay the groundwork for the clinical side of the operation.
Solution
Bill Slichenmyer, an experienced oncology development consultant, stepped in as the Chief Medical Officer to develop and implement a clinical plan for the development of the drug. Bill has many years’ experience of oncology drug development and was able to rapidly contribute to the project. He began with due diligence, investigating the existing data on the safety and pharmacology of the compound. He summarized and repackaged the data from over a dozen clinical studies for a meeting with the FDA to discuss an Investigational New Drug (IND) application, and worked with them to get the Phase 1 study approved and on track. He then helped the client select an oncology-focussed contract research organization (CRO) and together they identified study sites and set up the Phase 1 trial.
In parallel, he helped to build a team that could support development of the compound, including the recruitment of a regulatory professional and a clinical operations specialist, and generated a network of consultants with subject-specific knowledge (such as a biostatistician and medical writers) that would be required through the initial stages of drug development. He also contributed to the licensing negotiations with the originator company. As the compound progressed he interacted with the new company’s board of directors, which included two investors, and the company secured $20million in series A funding. Finally, Bill helped to recruit and transition his work to a new full-time Chief Medical Officer, who is now working on setting up additional clinical trials for the investigational agent.