SEATTLE--(BUSINESS WIRE)--Lumen Bioscience, a clinical-stage biopharmaceutical company developing biologic drugs for highly prevalent diseases, today announced the appointment of Mike Spigarelli, MD, PhD, MBA as Chief Medical Officer.
Dr. Spigarelli brings more than 30 years of industry-related experience in clinical product development, including trial design, implementation, data analysis, and oversight, as well as decades of experience in medical research and development, scientific research, and clinical leadership and education.
“Mike’s extensive experience across all facets of clinical drug, device, and diagnostic test development, including oversight of a vast array of FDA approvals and successful clinical trials, will be invaluable to Lumen as we look to advance and expand our clinical pipeline,” said Brian Finrow, Lumen’s co-founder and CEO. “We found our way to Mike after an exhaustive, nationwide search, and his unique background of high-impact product developed experience in industry and deep theoretical founding from his time in academia stood out prominently.”
Dr. Spigarelli most recently served as Vice President, Medical Affairs for Immucor, Inc., a leading provider of transfusion and transplantation diagnostic products worldwide. There, he helped develop and obtain FDA as well as global regulatory approval for numerous assays and reagents, including monoclonal and polyclonal antibodies, and led the company’s global clinical affairs team which implemented over 40 clinical trials. He also led the global assay development team, working in both the US and EU. Prior to Immucor, he advised drug development companies at all stages on clinical trial design, site selection, and regulatory strategy. Dr. Spigarelli previously served in the academic environment, reaching the rank of Professor of Pediatrics, Internal Medicine and Pharmaceutics & Therapeutics and developing clinical trials offices to improve clinical research at several major universities. Dr. Spigarelli received his MBA from the University of Utah, PhD in Medicinal Chemistry, and MD with Distinction in Research from the University of Michigan in Ann Arbor.
“Lumen’s unique approach to drug development offers the potential to impact the treatment landscape for many diseases that currently lack effective treatments,” said Dr. Spigarelli. “I am overjoyed to build Lumen’s clinical development team and guide the development of these potential products into clinical trials, through the regulatory pathway, and on to the world market where they can start to positively impact patients’ lives.”
Lumen’s clinical pipeline includes investigational biologics for traveler’s diarrhea, norovirus, and C. difficile infection. Earlier this year Lumen completed a Phase 1 safety and dose-escalation trial of LMN-101 for treatment of travelers’ diarrhea (NCT04098263), and plans to initiate Phase 2 studies in early 2021.
About Lumen
Lumen Bioscience discovers, develops and manufactures biologic drugs and vaccine candidates for several prevalent, worldwide diseases—many of which currently lack any effective treatments. The company’s unique drug development and manufacturing platform offers the potential to transform the biologics industry through increased speed, mass-market scale and exponentially lower costs than current approaches. For more information, visit: www.lumen.bio.
