Dr. Christopher Scull has more than 15 years of experience leading teams through regulatory interactions, First-in-Human trial submissions, and marketing applications. As a nonclinical and regulatory consultant, he has directly supported more than 40 successful IND applications to the FDA for all types of biologics. He has helped define the ‘pathway to the clinic’ in several programs with unclear regulatory requirements, such as engineered or edited cell therapies and novel cell/drug/device combinations.

Prior to full time consulting, Dr. Scull led the regulatory and R&D functions at a biotech startup and also held positions in drug development functions at Memorial Sloan Kettering Cancer Center. He also serves as a member of the review team for preclinical development grants at the California Institute for Regenerative Medicine (CIRM).

In 2024 Dr. Scull founded his own consulting firm focused on the development of complex biologics. He holds a B.S. in Chemistry and Ph.D. in Pathology from UNC Chapel Hill.