Dr. Christopher Burcham is a Senior Engineering Advisor at Eli Lilly and Company, in the Small Molecule Design and Development department within Product Research and Development. He currently is the scientific integrator for lasmiditan, an investigational new selective serotonin 5-HT1F agonist, under evaluation for treatment of acute migraines in adults. The New Drug Application (NDA) for lasmiditan was made in October of 2018. In this role he is responsible for the technical oversight of all aspects of API and product development, including registration and technology transfer into Lilly Manufacturing Operations.
Chris received his PhD from Princeton University in 1998, and his BS from the University of Illinois in 1992, both in Chemical Engineering. His career started in Corporate R&D at The Dow Chemical Company transferring later to the Formulation Development group at Dow AgroSciences. There he was responsible for the development of controlled release formulations through various batch and continuous encapsulations processes of nano- and micro-particles.
In 2002, Chris joined Eli Lilly. Initially he led the development of chemical processes for a number of late stage molecules, of which, one is currently on the market. In 2009, Chris formed the Particle Design Laboratory. The group’s responsibilities include:
1. The design and development of batch and continuous crystallization processes for all small molecule drug substances in development,
2. The transfer of the process through scale-up into commercial manufacturing.
3. The development of spray drying process development for the production of solid dispersions.
Crystallization is used to control particle size to the needs of the downstream operations (filtration and drying), patient performance (bio-availability) and to ensure control of dose uniformity (content uniformity) in the final dosage form. Dr. Burcham has integrated modeling tools, online analytical tools and automatic lab reactors into the development process to supplement and speed commercialization.
Utilization and application of modeling tools has been a common denominator through-out his career. He is a strong advocate and primary initiator of the Systems Based Pharmaceutical Alliance; being able to model the impact of processing conditions from API synthesis through crystallization, and formulation to product performance and the impact of process changes on fraction of dose absorbed as well as dissolution and tablet disintegration.
Chris currently serves on a number of academic Industrial Advisory Boards. He is very active in AIChE, serving regularly as session chair at the annual meeting since 2004, and currently the Area Chair for Section 2B, Crystallization and Evaporation. He is also a member of the planning committee for the Association of Crystallization Technology and is the Technical Community Leader with CMAC.