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Mark Monane Biosketch

Mark Monane is Chief Medical Officer at Monane Group Clinical Consulting LLC since September 2018. 

Most recently, he joined CardioDx in 2011 and served as Chief Medical Officer from 2011-2018. At CardioDx, he led Clinical/Medical Affairs and serves as Clinical Consultant for the CLIA Laboratory. In this role, Mark focused on molecular diagnostics, clinical utility and economic utility, and payor support. He also directed the publications/presentations strategy and field-based regional medical director programs. Dr. Monane also serves as the Clinical Consultant for the CardioDx CLIA lab. 

Prior to joining CardioDx, he served 11 years as managing director of equity research for Needham & Company, where he focused on emerging biotechnology companies in cancer and cardiovascular disease areas. In this role, he wrote more than 2,500 research summaries including company pipeline reviews, industry overviews, and financial models with a focus on small-mid cap biotechnology stocks in cardiovascular and oncological therapeutics as well as supervised a team of five analysts and associates. Prior to Needham & Company, Mark served as Senior Director of Medical Policy and Practices at Medco Health, where he helped direct pharmaceutical benefit manager strategies and programs for the elderly. Before joining Medco, Dr. Monane was an Assistant Professor at Harvard Medical School and the Harvard School of Public Health, where he completed fellowship training in geriatrics, clinical pharmacology, and clinical effectiveness and centered his research work on optimizing medication use in the elderly around cardiovascular disease and other chronic disorders. His clinical work centered on the care of geriatric patients in the inpatient and outpatient settings at Beth Israel Hospital and Brigham and Women’s Hospital. Mark has more than 50 publications in peer-reviewed and professional journals, focusing on pharmacoepidemiology, pharmacoeconomics and improving physician prescribing patterns as well as clinical validity, clinical utility, economic utility of diagnostic tests. 

Mark holds an A.B. and an M.B.A. from Columbia University, an M.S. degree in health policy and management from Harvard University, and an M.D. from New York University. He is board certified in Internal Medicine and is a Fellow of the American College of Physicians, Fellow of the American Heart Association, American Geriatrics Society Fellow, and Fellow of the American Board of Medical Quality. He serves as Adjunct Associate Professor at the Ernest Mario School of Pharmacy at Rutgers University.

Susan Monane Biosketch

Susan Monane is Principal at Monane Group Clinical Consulting LLC since September 2015. 

She has a Master of Science in Nursing degree with an active Certified Clinical Research Coordinator (CCRC) certification as well as more than 25 years of work in research and clinical care, including extensive day-to-day experience with clinical trials functions such as clinical operations and safety monitoring in the areas of oncology, cardiology, and women’s health. Susan has been part of research teams responsible for three successful FDA submissions and approvals.

With respect to her work in research, Susan has been involved in several phases of clinical drug development in both the academic and industry settings. Her first research job was a nurse researcher role in the Systolic Hypertension in Elderly People Project (SHEP) at Albert Einstein College of Medicine, Bronx, NY. In this role, Susan was involved in the development and execution of subject recruitment plans as well as ongoing communication with the other trial sites as part of the SHEP study. More recently, at Sanofi, Susan served as a Medical Reviewer prior to a Phase III database lock and was responsible for verifying appropriate reporting and documentation of adverse safety events for a diabetes study. At Roche, Susan was part of a Phase III team evaluating Actemra for rheumatoid arthritis and coordinated data management and queries of over 12,000 case report forms for the Actemra studies at Roche. At Innovative Clinical Solutions, Hackensack Medical Center, and the Hebrew Rehabilitation Center/Brigham and Women’s Hospital/Harvard Medical School, her work included Phase I-IV multisite trials including audits and oversight of outpatient research sites. With respect to her work in clinical care, Susan has a strong background in a variety of care arenas, including outpatient and inpatient geriatric and adult patient clinical care settings as well as long-term care settings.

Susan holds a B.S.N degree from Boston University School of Nursing, Boston, MA and a M.S.N degree with added focus on Geriatrics and Education from Hunter-Bellevue School of Nursing. She has been a Certified Clinical Research Coordinator since 2001. Susan has active nursing licenses in New York, New Jersey, and Massachusetts.

Monane Group Clinical Consulting, LLC

The Monane Group Clinical Consulting, LLC is a firm devoted to delivering deep and ethical professional advice and consultative services to the biotechnology, diagnostics, and pharmaceutical industry. Our mission is to provide strategic advice and content to help clients tell their stories. Such activities include medical affairs and medical strategy work such as publications/presentations, medical oversight, key opinion leader relationships, clinical advisory boards, and field-based regional medical director efforts. Such activities also include medical and scientific communications work addressing the patient, physician, payer, and financial communities.

Our group has extensive experience in a wide range of healthcare arenas, including medical affairs and clinical research in the academic and industry settings as well as nursing and medical care in the outpatient and long-term care settings. Our team members have added interest and expertise in the areas of cardiology, oncology, geriatrics, clinical pharmacology, and precision medicine as well as Wall Street equity research, managed care, clinical utility, and cost-effectiveness analyses.

Recent projects supporting our clients and partners have focused in the areas of

  • Medical strategy and late-stage clinical research

  • Communications and product messaging

  • Patient/physician/payor support and engagement

Biosketches: Project
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