Quantitative Systems Pharmacology in pharma and biotech, a few case studies

An introduction to Quantitative Systems Pharmacology (QSP) applications in pharma and biotech with some case studies. The case studies should be accessible to mathematicians, biologists, and engineers interested in using engineering and mathematical modeling, simulation and analysis approaches to de risk and better inform decisions in pharma and biotech in Discovery, Preclinical Development, and Clinical Development. Case studies include, time permitting, (1) performing an early feasibility assessment for multiple bispecific biologics in Discovery, (2) providing mechanistic translation for first in human dose predictions of a T Cell engager multispecific biologic to inform an IND in Preclinical Development, and (3) Clinical Development support of a biologic for patients with Alzheimer's Disease.

Bio
https://www.linkedin.com/in/johnmburkephd/

Since June 2024, John Burke has served as VP QSP Consultancy at Certara, a company that accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. He was previously a Co-Founder and the President and CEO of Applied BioMath, LLC. He has over 25 years of mathematical modeling, analysis, and simulation experience in life sciences and mathematical biology, and over 18 years experience assisting pharmaceutical and biotechnology research, development, and clinical trial support.

Prior to co-founding Applied BioMath, Burke served as the head of Systems Biology at Boehringer Ingelheim, where he was responsible for starting, implementing, scaling, and managing the strategy, portfolio, and efforts of Boehringer Ingelheim’s systems pharmacology initiative. Burke also worked at Merrimack Pharmaceuticals, where he supported multiple biologics projects.

He received his PhD in Mathematics from Arizona State University (ASU) in 2003. He received his BS and MS in Applied Mathematics from University of Massachusetts Lowell, where he is presently an Adjunct Professor at the Mathematics Department. Following his graduate work, Burke joined Douglas Lauffenberger’s lab, in the Biological Engineering Dept, at the Massachusetts Institute of Technology as a Postdoctoral Fellow, and later as a Sr Fellow. After MIT, he joined Peter Sorger’s lab, in the Systems Biology Department, at Harvard Medical School, as Co-scientific Director of the Cell Decision Process, an NIH Center of Excellence. While at MIT and HMS, he provided systems math modeling and simulation consulting and advice for numerous biotechs and pharma, including AstraZeneca, Pfizer, Momenta, and other companies.