Harold E. Bays MD, FTOS, FACC, FACE, FNLA
Medical Director / President
Louisville Metabolic and Atherosclerosis Research Center Inc. (L-MARC Research Center)
3288 Illinois Avenue
Louisville Ky. 40213
Dr. Harold Bays has served as an Investigator in over 400 Phase I - IV clinical trials for treatments for high cholesterol and other dyslipidemias, obesity, diabetes mellitus, hypertension, osteoporosis, and other metabolic and hormonal disorders. Dr. Bays has served as Medical Director of L-MARC Research Center since 1989, and has served as President of L-MARC Research Center since its independent incorporation in 1998.
1973-1974: Busboy, Dishwasher
1989-1999: National Touring Professional Stand-Up Comedian
1989-1993: Endocrine Associates PSC (Private Practice)
1993-2008: Louisville Endocrinology PSC (Private Practice)
1989-Present: Medical Director L-MARC Research Center (Research Appointment)
VA Hospital Emergency Dept.
Hardin County Memorial ER Lebanon Emergency Dept.
Flemingsburg Emergency Dept.
Hardinsburg Emergency Dept.
Jackson Emergency Dept.
Radcliff Emergency Dept.
1973-76: High School Degree = Bowling Green High School
1976-80: Bachelor of Science = Western Kentucky University
1980-84: Medical Degree = University of Louisville School of Medicine
1984-87: Internship/Residency Internal Medicine = University of Louisville School of Medicine
1987-89: Fellowship in Endocrinology and Metabolism = the University of Louisville School of Medicine
Board Certification: Internal Medicine (1987)
Board Certification: Endocrinology and Metabolism (1989)
Diplomate of the American Board of Clinical Lipidology (2011)
Diplomate of the American Board of Obesity Medicine (2013)
PROFESSIONAL MEMBERSHIPS, CHAIRMANSHIPS, BOARD OF DIRECTORS, AND TASK FORCE SERVICE
Professional Membership Fellow
- Fellow of The Obesity Society (FTOS)
- Fellow of the American College of Cardiology (FACC)
- Fellow of the American Association of Clinical Endocrinologists (FACE)
- Fellow of the National Lipid Association (FNLA)
- Member: American Society of Bariatric Physicians (ASBP)
- Member: American Society of Metabolic and Bariatric Surgery (ASMBS)
- Member: The Obesity Society (TOS)
- Member: National Lipid Association (NLA)
- Member: The Endocrine Society
- Member: American Association of Clinical Endocrinologists
- Member: American College of Cardiology (ACC)
- Member: American Diabetes Association (ADA) – Recognized Provider in the ADA’s National Committee for Quality Assurance (NCQA) from 1998 - 2010
- Member: Kentucky Medical Association (KMA)
- Member: Greater Louisville Medical Society (GLMS)
- Chairman: The Obesity Society Membership Committee (2012-2014)
- Chairman: National Lipid Association Adiposity and Dyslipidemia Consensus Conference 2012
- Chairman: American Association of Clinical Endocrinologist Adipose Tissue Pathophysiology State of the Science Conference - 2010
- Chairman: American Association of Clinical Endocrinologist Pathogenic Adipose Tissue Task Force (2006-2010)
- Chairman: "Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes" (SHIELD) (2003 – 2011)
- Chairman: Endocrine Subcommittee for Alternative Health Delivery Systems - (1996-7)
Scientific Board of Directors
- Board of Directors: National Lipid Association (2013 – Present)
- Board of Directors: South East Lipid Association (2009 – Present)
- Board of Directors: American Association of Clinical Endocrinologists (2010)
Scientific Committees, Officer, and Task Force
- President Elect: SouthEast Lipid Association (2014)
- Committee Member: The Obesity Society Education Committee (2013 – Present)
- The Obesity Society Presenter for the American Board of Obesity Medicine (ABOM) Review Course (2013 – Present)
- Contributing author of the National Lipid Association Annual Summary of Clinical Lipidology 2015
- Contributing author of the National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia 2014
- Contributing author to the American Society of Bariatric Physician Obesity Algorithm 2013 - Present
- Guest Editor and contributing author of the National Lipid Association Annual Summary of Clinical Lipidology 2015
- Associate Editor: Journal of Clinical Lipidology
"Recognized with Honor" for past participation as a physician volunteer in the Jefferson Co. Medical Society's Outreach Program for the Homeless "The Healing Place" (1990 - 2005)
Since 1989, Dr. Harold Bays has given numerous medical presentations at major scientific meetings, educational programs to physician groups, and has been a featured presenter at numerous symposia.
BRIEF BIOGRAPHY - MEDICAL / RESEARCH
Harold Bays, MD, FTOS, FACC, FACE, FNLA is Medical Director and President of Louisville Metabolic and Atherosclerosis Research Center (L-MARC). Dr. Bays received his medical degree, completed his Internship and Residency in Internal Medicine, and received his Fellowship in Endocrinology and Metabolism all at the University of Louisville, School of Medicine. He is Board Certified in both Internal Medicine and Endocrinology and Metabolism. He is a Diplomate in the American Board of Lipidology, as well as Obesity Medicine.
Dr. Bays has served as a Principal Investigator for over 400 clinical trials including investigational pharmacotherapies for dyslipidemia, obesity, diabetes mellitus, hypertension, osteoporosis, osteoarthritis, and other metabolic disorders. He has written, or served as a contributing author to over 200 scientific manuscripts and book chapters, and authored/presented over 100 scientific abstracts.
Dr. Bays has published in journals such as the New England Journal of Medicine, Archives of Internal Medicine, Obesity/Obesity Research, Journal of Clinical Endocrinology and Metabolism, Cell Metabolism, Diabetes Care, Journal of American College of Cardiology, Circulation, Atherosclerosis, Metabolism, The American Journal of Medicine, Journal of Clinical Lipidology, Medical Clinics of North America, Lipids in Health & Disease, Current Atherosclerosis Reports, Drug Development & Research, Expert Opinion on Investigational Drugs, Journal of Cardiovascular Therapy, Endocrine Practice, Diabetes Obesity and Metabolism, Expert Opinion on Pharmacotherapy, Progress in Drug Research, Journal of Clinical Pharmacology, Mayo Clinic Proceedings, Current Opinion in Lipidology, Nutrition Metabolism, Nutrition Journal, Journal of Cardiovascular Pharmacology, American Journal of Cardiology, Drug Safety, Clinical Therapeutics, Journal of Clinical Investigations in Arteriosclerosis, American Journal of Kidney Disease, American Journal of Cardiovascular Drugs, American Journal of Therapeutics, Clinical Therapeutics, Metabolic Syndrome and Related Disorders, Preventive Cardiology, Expert Review of Cardiovascular Therapy, US Endocrine Diseases, Current Medical Research and Opinion, Current Treatment Options in Cardiovascular Medicine, Evidence-based Cardiovascular Medicine, European Heart Journal, Therapy, Clinical Cardiology, Future Cardiology, Future Lipidology, International Journal of Clinical Practice, Drugs in Research and Development, Coronary Artery Disease, European Journal of Neurology, Hospital Pharmacy Europe, Nature Clinical Practice Cardiovascular Medicine, BMC Public Health, Management Strategies in Diabetes, Vascular Health and Risk Management, Nutrition Metabolism & Cardiovascular Disease, Archives of Gynecology and Obstetrics, Today in Cardiology, Managed Care Supplement, California Journal of Health Promotion, Journal of Women’s Health, and has been a scientific contributor to www.lipidsonline.org.
Other Academic Activities
Dr. Bays originated the term "adiposopathy" ("sick fat"), defined as pathogenic adipose tissue promoted by positive caloric balance and sedentary lifestyle in genetically and environmentally susceptible patients. Adiposopathy may be anatomically manifested by adipocyte hypertrophy, visceral adiposity, adipose tissue expansion beyond vascular supply, and ectopic fat deposition. Physiologically, adiposopathy results in adverse metabolic and immune consequences resulting in clinical metabolic disease. Dr. Bays has published numerous manuscripts, and given numerous scientific presentations on the adipocentric paradigm wherein pathogenic adipose tissue represents a rational, unifying cause of excessive adipose tissue-related metabolic diseases. He has also explored this correlation as a
- Contributing author to the American Society of Bariatric Physician Obesity Algorithm (2013 – Present)
- Guest Editor and contributing author of the National Lipid Association Annual Summary of Clinical Lipidology 2015
- Chairman of the National Lipid Association Adiposity and Dyslipidemia Consensus Conference 2012
- Chairman of the American Association of Clinical Endocrinologist Adipose Tissue Pathophysiology State of the Science Conference 2010
- Chairman of the American Association of Clinical Endocrinologist Pathogenic Adipose Tissue Task Force 2010.
Dr. Bays was also Chairman of the study group overseeing the "Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes" (SHIELD), which is was largest survey of its kind. SHIELD was designed as a cross-sectional and subsequent longitudinal study of various parameters relevant to metabolic diseases, including diabetes mellitus, overweight, and obesity.
Dr. Bays has served as an expert manuscript reviewer for over 60 scientific medical journals including: New England Journal of Medicine, Journal of the American Medical Association (JAMA), The Lancet, Archives of Internal Medicine, Obesity Research/Obesity, International Journal of Obesity, Annals of Internal Medicine, Journal of the American College of Cardiology (JACC), Diabetes, Diabetes Care, Journal of Clinical Endocrinology and Metabolism (JCEM), The American Journal of Medicine (AJM), American Journal of Cardiology (AJC), Endocrine Practice, The American Heart Journal, European Heart Journal, The Journal of Internal Medicine, Regulatory Peptides, Methods and Findings in Experimental and Clinical Pharmacology, Diabetic Medicine, Opinion in Molecular Therapeutics, Mayo Clinic Proceedings, Environmental Science & Technology, Journal of Diabetes, Archives of Medical Research, Physician and Sports Medicine, Diabetes Obesity and Metabolism, Current Pharmaceutical Design, Annuals of Nutrition and Metabolism, Biomarkers in Medicine, Current Medical Literature - Cardiology, Biochemical Pharmacology, Vascular Health and Risk Management, Drug Discovery Today, Investigational Drug Database, Trends in Pharmacological Sciences, Expert Opinion on Biologic Therapy, Drugs, Journal of the American College of Nutrition, Journal of Clinical Lipidology, American Journal of Cardiovascular Drugs, Expert Opinion on Pharmacotherapy, Expert Opinion on Investigational Drugs, International Journal of Clinical Practice, Pharmacological Research, Expert Opinion on Drug Safety, Life Sciences, Drug News and Perspectives, Consultant, Future Lipidology, Nature Clinical Practice Cardiovascular Medicine, Expert Opinion on Therapeutic Targets, Expert Opinion on Emerging Drugs, Public Library of Science, Metabolic Syndrome and Obesity: Targets and Therapy, Treatments in Endocrinology, Indian Journal of Medical Research, Journal of Clinical Outcomes Management, Advances in Preventive Medicine, Vascular Health and Risk Management, Aging Health, Agro Food Industry Hi-Tech, Clinical Pharmacology in Drug Development, Pharmacy and Therapeutics, Metabolic Syndrome and Related Disorders, Mount Sinai Journal of Medicine, Diabetes/Metabolism Research and Reviews, Cardiovascular Drugs and Therapy, Combination Products in Therapy and Journal of Cardiovascular Drugs.
Integral to his duties as Medical Director of a metabolic research facility, Dr. Bays routinely serves as a national and international advisor and consultant to pharmaceutical companies in drug development. His expertise involves the practical aspects of protocol design, for the ultimate purpose of obtaining scientifically valid results and fulfillment of regulatory requirements. As importantly, because of his vast experience as a clinical trials Investigator and advisor to numerous prior protocols, Dr. Bays often provides unique insights into practical study design issues that affect recruitment and retention, which are critical for timely clinical trial start-up, timely completion, and clinical validity when interpreting study results.
Dr. Bays has served as the sole Investigator of single-site "proof of concept" and other studies conducted at L-MARC Research Center wherein timeliness, quality, and cost-effectiveness are premium considerations. At the end of studies, Dr. Bays is often asked to conduct the tedious, yet thorough review of Clinical Study Reports, and assist with scientific abstract submission and eventual publication of study results.
In addition to his extensive research relationships with "big pharma" for decades, Dr. Bays has also has advised smaller pharmaceutical companies in their development programs, and has spoken on their behalf to investors or others involved in potential collaborations and partnerships. He also advises larger capitalized pharmaceutical companies in helping determine the relative advantages and disadvantages of potential acquisitions or other collaborations with smaller, upstart drug companies developing promising novel therapeutic agents.
Finally, Dr. Bays is one of the most requested advisors for money managers whose interests are investments in in biotech and pharmaceutical companies involved with anti-obesity, lipid-altering/cholesterol, and diabetes mellitus drug therapies.
Regulatory and Patent Assistance
Dr. Bays has provided assistance in various regulatory matters, such as input in pharmaceutical company interactions with the FDA Center for Drug Evaluation and Research (CDER). Specifically, Dr. Bays has helped provide input towards effective and successful Special Protocol Assessment (SPA) submissions, with a focus on crafting the most appropriate regulatory questions regarding the protocol, protocol design (including proposed size), study conduct, study goals, and/or data analysis for the proposed investigation. Dr. Bays has also represented pharmaceutical companies in direct discussions with regulatory agencies regarding issues that naturally arise during the submission and development process. Such representation includes being a presenter regarding metabolic pharmaceuticals at FDA Endocrine and Metabolism Drug Advisory Committee (EMDAC) meetings in Washington DC (White Oak / Silver Spring MD).
Finally, beyond regulatory matters regarding the FDA, Dr. Bays has also served as an advisor and expert in working with the US Patent Office, as it applies to pharmaceutical declaration statements, and responses to federal patent examiners.
Dr. Bays has presented at international symposia, university conferences (e.g. Grand Rounds), and invited educational presentations, including Continuing Educational Education (CME) programs. To the extent that Dr. Bays receives payment for his consultant and advisory activity, and speaking, these research activities help offset and fund other unpaid research endeavors, such as the numerous scientific publications previously discussed, abstract poster and oral/podium creation and presentations conducted at scientific meetings (listed under "Academia" on the L-MARC Home Page), and expert scientific reviews of journal articles.
Disclosures: In over two decades of clinical research: Dr. Harold Bays has served as a Clinical Investigator for (and has received research grants from) pharmaceutical companies such as Abbott, Aegerion, Akros, Alere, Amarin, Amgen, Amylin, Alteon, Arena, Ardea, Arete, AstraZeneca, Aventis, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, California Raisin Board, Cargill, Catabasis, Ciba Geigy, Daiichi Sankyo, Eisai, Elcelyx, Eli Lilly, Esperion, Essentialis, Forest, Fujisawa, GelTex, Genentech, Gilead, Given, GlaxoSmithKline, High Point, Hoechst Roussel, Hoffman LaRoche, Home Access, InterMune, Intekrin, Ironwood Pharmaceuticals, ISIS, Janssen, Johnson & Johnson, KGK Micropharma, KOS, Kowa, Kyorin, Lederle, Marion Merrell Dow, Merck, Merck Schering Plough, Metabolex, Miles, Microbia, Nektar, Neuromed, Nicox, Novartis, NovoNordisk, Obecure, Omthera, Orexigen, Parke Davis, Pfizer, Pliva, Pozen, Procter and Gamble, Pronova, Purdue, Pronova, Reliant, Roche, Rorer, Regeneron, Sandoz, Sanofi, Sciele, Searle, Shionogi, Schering Plough, SmithKline Beacham, Stratum Nutrition, Surface Logix, Takeda, TAP, Transtech, Trygg, TransTech, TWI Bio, UpJohn, Upsher Smith, Warner Lambert, WPU, Vivus, Wyeth-Ayerst, WPU, Xoma, and Zeomedex. Dr. Harold Bays has served as a consultant, advisor, and/or speaker, for pharmaceutical companies such as Abbott, Aegerion, Amarin, Amgen, Arena, AstraZeneca, Aventis, Bayer, Bristol Myers Squibb, Catabasis, Cerenis, Daiichi Sankyo, DSM Nutritional Products, Inc. Eisai, Essentialis Therapeutics, GlaxoSmithKline, Ironwood Pharmaceuticals, Johnson and Johnson, KOS, Merck, Merck Schering Plough, Metabasis Therapeutics, Microbia, Novartis, Nicox, Novartis, Omthera, Ortho-McNeil, Parke Davis, Pfizer, Reliant, Roche, Regeneron, Sandoz, Sanofi Aventis, Schering Plough, SmithKline Beacham, Stratum Nutrition, Surface Logix, Takeda, Trygg, UpJohn, Vivus, Warner Lambert, WPU, and Zeomedex. Dr. Harold Bays serves as an investor consultant for GLG, Guidepoint, and MEDACorp.
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