Patrick V. Simms

Patrick V. Simms

Chief Operating Officer

Mr. Simms has participated in the development and marketing approval of many products in his 25-year career in drug development, and has contributed to over 30 drug and drug-device marketing applications in the therapeutic areas of CNS, diabetes, cancer, respiratory disease and renal disease.

Prior to joining CRC, Mr. Simms was VP of Clinical Operations for Aravive, a start-up company developing treatments for cancer and fibrosis.  Before working for Aravive, Mr. Simms served as VP of Clinical Operations for the Multiple Myeloma Research Foundation where he expanded internal clinical operations to streamline and support foundation-sponsored studies. Mr. Simms has also served as Head of Clinical Operations for a start-up pharmaceutical company, where he oversaw the analysis of the company’s legacy clinical program and the restart of its Phase II and III programs in renal disease, which contributed to the closing of a significant equity placement and a collaboration with an industry partner.

Previously, as VP of Clinical Operations and Regulatory Affairs at Biodel, Mr. Simms developed and implemented Phase I-III program execution plans and regulatory strategies. Over the course of a decade, his team completed ten Phase I PK/PD characterization studies, two Phase II studies and four Phase III studies in Type 1 and Type 2 diabetes patients, and prepared and submitted a New Drug Application.

Mr. Simms has also served as Global Director, CMC & Regulatory Affairs for an active pharmaceutical ingredient development and supply company where he oversaw the Shanghai, China and India based operations. He started his career as an Analytical Chemist and worked in formulations as well. 

Mr. Simms has served as a consultant, providing guidance on drug applications and clinical programs as well as due diligence efforts for investors.  He received his B.S. in Chemistry from Western Connecticut State University and currently serves as a Trustee on the Board of the Newtown, Connecticut Volunteer Ambulance Association.


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