Daniel Shelly, PhD, MBA- Dr. Shelly is the Director of Business Development, R&D Externalization, andClinical Development at Albumedix a developer of novel recombinant albumin enabled therapeutics andimmunotherapies. Dr. Shelly is responsible for business development and out-licensing of Albumedix’score technologies. Dr. Shelly also serves on the R&D Externalization team responsible for formingcollaborations with Industry and Academia to exemplify novel applications for Albumedix technologies.In this role, Dr. Shelly has been responsible for inventing/developing novel applications for modifiedalbumin including the use of albumin in immunomodulation/ immuno-oncology and for oral or nasaldelivery of proteins and peptides. Dr. Shelly is also the commercial lead on the Clinical Developmentteam responsible for Albumedix’s clinical portfolio.

Prior to Albumedix, he spent 8 years in the vaccine and gene therapy business where he focused onclinical development, regulation and manufacturing of Biopharmaceuticals (protein therapeutics,vaccines, gene therapies and VLPs) and prior to that, 2 years in clinical research and development. He isthe author of several peer reviewed articles and book chapters. He is also an adjunct professor at theUniversity of Cincinnati and actively teaches Drug and Biologics Discovery and Biotechnology BusinessManagement courses each year in the UC College of Pharmacy’s Masters in Clinical Drug Developmentprogram.

Dr. Shelly has a BA in biology from Lehigh University, an MA in Biology from the College of William andMary, and a PhD (Molecular Physiology) at the Florida State University. He was a postdoctoral fellow inthe U. of Cincinnati Department of Molecular and Cellular Physiology from 1997 to 2001 where he wonthe prestigious APS Fellowship in Physiological Genomics (one of two awards given annually) and a NRSAfrom the NIH. He obtained his MBA in Innovation Management from the U. of Cincinnati Lindner Schoolof Management in 2002.

Areas of Expertise for Capstone Considerations:
Biologic therapeutics (vaccines, gene therapies, RNAi, cell therapies, recombinant proteins),immunotherapies and immuno-oncology, biotech business models, regulatory aspects of biologics,Biopharma industry (patent cliff, productivity challenges, etc.), biosimilar.

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