Glen D. Park, PharmD, MSJ

Glen Park has 35+ years of experience in the pharmaceutical/biotech/medical device industry in clinical development and regulatory affairs. Prior to that he had 9 years of experience in clinical pharmacy practice and academia. He has had oversight and management of clinical teams based in the US, Europe and Japan through all phases of development with a focus on motivating teams to meet aggressive timelines. He also brings that focus to managing regulatory programs that achieve regulatory approvals in an efficient and timely manner.

He has had primary responsibility for the global clinical development of a long-acting insulin analogue, a novel agent for prevention of progression of diabetic nephropathy, an agent for chronic treatment of diabetic neuropathy, and a non-absorbable agent for blood glucose lowering.

As a consultant, he has experience with early stage clinical development and/or regulatory strategy for a nanoparticle-based diagnostic, treatment of bladder cancer (DNA plasmid), treatment of ovarian and hepatocellular carcinoma (Aurora kinase inhibitor), treatment of lymphoma (antibody-drug conjugate), a soy-derived phytoestrogen for menopause, a nanoparticle formulation of paclitaxel, and a prodrug formulation of cytarabine.

Glen has managed and submitted multiple INDs (diabetes, renal disease, schizophrenia, Gaucher disease, Fabry disease, head lice, hepatocellular carcinoma, pancreatic cancer, bladder cancer, fungal infections); multiple successful medical device submissions including 510(k), PMA and de novo; had key roles in designing and managing clinical programs and primary authorship responsibility for the clinical section of four NDAs leading to marketing authorization (diabetes, hypertension, head lice, Gaucher disease); managed 100+ FDA meetings across multiple Divisions in CDER, CBER and CDRH from pre-IND/IDE to Advisory Committee; and created and managed a Promotional Review Committee.

He regularly serves as a chair and member of review panels that support all aspects of the clinical development efforts of the National Institutes of Allergy and Infectious Diseases.

Glen has a Bachelor of Science and Doctor of Pharmacy degrees from the University of Missouri-Kansas City and completed a Clinical Pharmacy Residency at Truman Medical Center in Kansas City. He also has a Masters of Science in Jurisprudence from Seton Hall Law School.