David Wurtman, MD, MBA
President & CEO, Co-Founder
David is an experienced pharmaceutical executive who has held leadership roles in corporate development, business development and licensing, marketing, product development, and, medical affairs. Prior to co-founding Lyric, he was most recently Vice President of Medical Affairs & Product Development at Kineta and maintained a successful practice as an independent corporate & product development consultant. David has held senior positions at Protein Design Labs, Eos Biotechnology and Genzyme, and worked at S.G. Cowen in the Pharmaceutical Analyst practice. He has executed numerous licensing and partnering transactions and has raised funds from both U.S. government and from venture capital sources. David received his B.A. from Harvard College, M.D. from Harvard Medical School, and M.B.A. from the MIT Sloan School of Management. He completed a primary care internal medicine residency at Mt. Auburn Hospital, a Harvard teaching hospital, and practiced Primary Care at Harvard Community Health Plan. He has been board-certified in Internal Medicine.
M. Scott Harris, MD
Scott is a gastroenterologist whose experience in drug development spans two decades. He has served as Chief Medical Officer of Avaxia Biologics, Ocera Therapeutics and Napo Pharmaceuticals, as well as Interim Chief Medical Officer of Tranzyme Pharmaceuticals. At Napo, he authored the Phase 3 program that in 2012 resulted in the approval of Fulyzaq® (crofelemer) for HIV-associated diarrhea. He has also been Principal of Middleburg Consultants, a pharmaceutical consulting firm. Scott has led clinical programs in gastrointestinal disease indications in North America, Europe, Australia, and Asia. He is currently Professor of Clinical Pharmacology and Physiology at Georgetown University School of Medicine, where he leads the masters level course in drug development. Scott is a magna cum laude graduate of Harvard College and Harvard Medical School. He undertook his post-graduate medical training at Johns Hopkins Hospital and Yale University School of Medicine. Scott holds an M.S. in Population Health and Administrative Medicine from the University of Wisconsin Schools of Medicine and is a Fellow of the American College of Physicians and the American Gastroenterological Association.
Joyce James, PhD
VP, Clinical Pharmacology & Early Development
Joyce has 20 years of industry experience, dedicated in large part to the discovery and development of small molecules. Prior to joining Lyric, she served as Senior Director and Head of Drug Metabolism and Pharmacokinetics (DMPK) and Analytical Chemistry at Cytokinetics, supporting numerous research and clinical stage programs as they progressed through development. From 2005 to 2012, Joyce held senior positions at Ambit Biosciences, where she played a key role in the discovery and development of quizartinib, now in Phase 3 for treatment of acute myelogenous leukemia. She provided critical support for the successful filing of multiple INDs and early phase clinical development. She also has deep experience in Phase 1 study design. Joyce has also consulted to a number of startup biotech companies on DMPK and clinical pharmacology. She began her pharmaceutical career as a Research Fellow at Merck Research Labs, devoting her time to NMR spectroscopy and DMPK. Joyce received her B.S. from The College of Charleston, graduating summa cum laude, and her Ph.D. from The University of California, Berkeley, Department of Biophysical Chemistry.
VP, Clinical Operations
Randy is a seasoned pharmaceutical executive with over 20 years of drug development experience in clinical operations and program management. He has led clinical trial programs in over 35 countries resulting in numerous approvals. Randy has served in leadership roles within the pharmaceutical and biotechnology sectors, most recently as Chief of Operations for Spherix and lead of clinical research programs at DaVita Labs. He played a key role in the Xigris approval for Eli Lilly and Company. He also served as the project director for the Remicade ulcerative colitis program at Centocor (now Janssen). Randy holds a BS and MS in Clinical Research Administration from George Washington University.
Meredith Brown-Tuttle, RAC, FRAPS
VP, Regulatory & Quality
Meredith has 25 years of industry experience from bench to clinic to approval of both drugs and devices. Prior to joining Lyric, Meredith was founder and principal of Regulatorium, a full service regulatory consulting agency, and served as Director of Regulatory Affairs at Intermune, APT Therapeutics and Clinimetrics. Meredith has written, managed and led over 30 successful domestic and international IND and NDA submissions. She is a founding instructor at UC Santa Cruz Regulatory Certificate Program and author of two books: “IND Submissions: A Primer” and “Regulatory Intelligence 101.” Meredith graduated with a BA in biological psychology (neuroscience) from San Jose State University.
David Klein, MD, MBA
David is staff physician in critical care medicine at St. Michael’s Hospital at the University of Toronto. His practice is focused on medical/surgical and cardiovascular intensive care. His experience in the development and commercialization of novel diagnostics and therapeutics for the intensive care unit includes medical leadership for Spectral Medical Inc. in the development of the Endotoxin Activity Assay and Polymyxin B Hemoperfusion. Prior to his joining the faculty of the University of Toronto, David was a consultant at McKinsey and Company where founded the Canadian Healthcare Practice and served as a member of the North American Pharmaceutical Practice. He holds an MD from the University of Toronto, where he was the Cody Medalist, and an MBA from Kellogg School of Management. He is board certified in internal medicine, critical care medicine, and sleep medicine in Canada and the United States. He is the author of over 50 papers and abstracts.
Scott Chadwick, PhD, MBA
Randy is a seasoned pharmaceutical executive with 25 years of drug development experience in clinical operations and program management. He has led several clinical trial programs in over 35 countries resulting in numerous approvals. Randy has served in leadership roles within the pharmaceutical and biotechnology sectors, most recently as Chief of Operations for Spherix and Director of Program Management at DaVita. He played a key role in the Xigris approval for Eli Lilly and Company where he was responsible for the execution of the initial proof of concept trial. He also served as the project director for the Remicade ulcerative colitis program for Centocor (now Janssen). Randy holds a BS and MS in Clinical Research Administration from George Washington University.
Kevin Kaster, JD
VP, Intellectual Property
Kevin has over 20 years of experience in developing effective patent and licensing strategies for important technologies and products in the pharmaceutical and biotechnology industries. Kevin most recently served as Vice President, Corporate Development for Threshold Pharmaceuticals, a public company focused on developing anti-cancer agents. Previously, he was Vice President, Intellectual Property for Kosan Biosciences, a public company developing the anti-cancer drugs epothilone D and geldanamycin, acquired by BMS in 2008. Kevin has managed Geron’s telomerase and human embryonic stem cell technology patent portfolios, Affymax/Affymetrix’s combinatorial chemistry and DNA chip technology portfolios, and Cetus’ PCR technology portfolio. He began his career at Eli Lilly and Company as a research scientist and then patent technician. Kevin received his J.D. from Indiana University School of Law and B.S. in Chemistry and Molecular Biology from Vanderbilt University.
Dana S. McGowan
Chief Financial Officer
Dana has served as CFO of public and private biotechnology, healthcare technology and internet companies including Ocera Therapeutics, Inc., DepoTech Corporation (acquired by Skyepharma), MedVantx, Inc., and Kinzan, Inc. She has extensive experience in public, venture, and debt financing, mergers and acquisitions, investor relations, financial strategy, and financial operations and maintains an active consulting practice. Dana consulted to Auspex Pharmaceuticals, Inc. on their IPO and their secondary offerings and to Tobira Therapeutics, Inc. on their reverse merger. She previously held various financial positions with Cytel Corporation, a public biotechnology company, and at SAIC, a Fortune 500 technical services company. She has a B.S. in Business Administration from San Diego State and is a certified public accountant.