David Volkin
- Ronald T. Borchardt Distinguished Professor
- Department of Pharmaceutical Chemistry
Contact Info
2030 Becker
Lawrence, KS 66047
Personal Links
Biography —
Dr. Volkin is a Distinguished Professor in the Pharmaceutical Chemistry Department at the University of Kansas (KU) and co-founder of the Vaccine Analytics and Formulation Center (VAFC). The VAFC focuses on translation of novel vaccine/biotherapeutic candidates into clinical trials and collaborates with a network of global partners including academia, biopharma companies, vaccine manufacturers, and non-profit organizations.
Dr. Volkin has collaborated on hundreds of formulation projects during his 15+ years at KU including published papers with now marketed products (e.g., a new quadrivalent HPV-VLP vaccine, a live-viral multivalent dengue vaccine, and a recombinant HA flu vaccine). Formulation development work with two novel rotavirus vaccine candidates tested in Ph3 clinical trials (recombinant t-NRRV; the live virus RV3-BB) has also been published. Recent case studies have described formulation challenges encountered with (1) various second-generation COVID-19 vaccine candidates, and (2) development of low-cost vaccine formulations targeted for use in LMICs (e.g., combination, multi-dose, adjuvanted, oral-delivery).
Dr. Volkin joined the KU faculty in 2010 after a 20-year industry career including R&D senior director positions at Merck and J&J. He led formulation and analytical groups that brought dozens of candidates into human clinical trials, including five vaccines and three monoclonal antibodies approved by regulatory agencies. He is co-author of ~220 scientific publications and co-inventor on 15 U.S. patents including work describing the formulation and stabilization of the commercial HPV (Gardasil™) and rotavirus (RotaTeq™) vaccines. Dr. Volkin graduated with B.A. in Chemistry from the UC-San Diego and earned a Ph.D. in Biochemical Engineering from MIT. He was awarded the American Association of Pharmaceutical Scientists (AAPS) Research Achievement Award in Biotechnology in 2015.
Education —
Research —
Lack of stability often limits the use of biopharmaceuticals and vaccines (e.g., recombinant proteins, mRNA, viral vectors, live and inactivated viruses) as human medicines. Loss of potency can occur during manufacturing, storage, or administration. Our research objectives are to better understand the changes in physicochemical properties that accompany the loss of biological activity, and to develop new analytical techniques to monitor structural changes at the molecular level. A detailed understanding of the causes and molecular mechanisms of instability guides the design of more potent and stable biopharmaceutical and vaccine dosage forms. As co-founder of the Vaccine Analytics and Formulation Center (VAFC) at The University of Kansas, our team collaborates with a network of global partners (academia, biopharma companies, vaccine manufacturers, and non-profit organizations) on analytical characterization and formulation development projects. Our focus is to facilitate novel candidates entering clinical trials with an emphasis on targeting their use in low- and middle-income countries (LMICs).