Marcus Hompesch, M.D.

President and Chief Executive Officer

Dr. Marcus Hompesch is an expert in the field of metabolic diseases, a licensed physician and entrepreneur.  Dr. Hompesch established Profil Institute for Clinical Research in San Diego, CA in 2004.  Under Dr. Hompesch’s leadership, Profil Institute has become a leading provider for early phase clinical development of new diabetes and obesity treatments; and since the company’s inception, Profil Institute has been involved with almost every clinically promising drug and device development in diabetes and in more than 140 clinical studies.  Dr. Hompesch spent eight years as a practicing physician receiving his training in internal medicine and diabetology at the Klinikum Wuppertal Medical Center, University Witten-Herdecke in Germany.  Since then he has actively been involved in designing, performing and publishing many clinical studies in metabolic diseases, in particular early phase diabetes studies. Dr. Hompesch also spent time as a scientific associate at the department of Biostatistics and Medical Informatics at the Ruhr University in Bochum, Germany. Dr. Hompesch received his M.D. from the University of Duesseldorf, Germany.

Prior to establishing the Profil Institute for Clinical Research in San Diego, Dr. Hompesch also held various management roles, including CFO and COO, at Profil Institute for Metabolic Research, GmbH in Neuss, Germany. Dr. Hompesch was the founder of Med.IQ, a company that developed electronic patient records and disease management tools for patients with diabetes, which he led as CEO until completing the sale of the company in 2000.

Linda Morrow, M.D.

Chief Operating Officer

Dr. Morrow has over 15 years of experience in clinical research and experimental studies in carbohydrate metabolism, insulin resistance, and diabetes mellitus. Dr. Morrow joined Profil Institute in 2007 as Medical Director and in 2009 became the company’s COO.  Prior to joining Profil Institute, Dr. Morrow performed clinical trials and was a practicing physician at Northern California Cardiology Associates in Sacramento, and prior to that served as Medical Director of the Senior Health Connection at Carolinas Medical Center in Charlotte, North Carolina.  Dr. Morrow received her M.D. from the Medical College of Pennsylvania, and subsequent training at the University of Michigan.   She was a faculty member at the University of Michigan and subsequently Harvard's Division on Aging.  She spent 10 years conducting clinical trials in metabolic diseases, carbohydrate metabolism and aging at the two institutions.  She is Board Certified in Internal Medicine and Geriatric Medicine.

Claus Hakenesch

Chief Financial Officer and Corporate Secretary

Mr. Hakenesch joined Profil Institute in 2007 as the company’s CFO and has since that time overseen year over year company revenue grow over 50%. Mr. Hakenesch has over 15 years of experience helping to build the financial systems and securing funding for companies in healthcare-related fields. Previously, Mr. Hakenesch served as Director of Finance at Cyntellect, Inc. and prior to that was Finance Manager at Sequenom, Inc.  Before emigrating from Germany to San Diego in 1999, Mr. Hakenesch worked as a Project Manager for BaaN implementing ERP systems across Europe, and he was an auditor for Deloitte & Touche in Hannover, Germany. Mr. Hakenesch received his M.B.A. from the University of Goettingen. 

Prof. Andrew J Krentz, MB, ChB, MD, FRCP

Senior Director of Scientific Services

Prof. Krentz oversees the scientific aspects of Profil Institute’s integrated approach from protocol design to publication. He has three decades of clinical academic experience in diabetes and endocrinology; he is also accredited as a clinical specialist in hypertension. He joined Profil in 2011 from the Postgraduate Medical School at the University of Bedfordshire, UK where he is visiting Professor of Medicine. Other previous positions held include:  University of New Mexico School of Medicine, USA; University of Southampton, UK; University of California San Diego, USA, where he holds a faculty position. Prof. Krentz’s publications include several textbooks, among them “Insulin Resistance” (2001) and “The Metabolic Syndrome & Cardiovascular Disease” (2007). In 2012 he will launch a new international journal – Cardiovascular Endocrinology – as Editor-in-Chief.

Prof. Lutz Heinemann, Ph.D.

Senior Scientific Consultant 

Prof. Dr. Heinemann oversees the scientific aspects of Profil Institute’s integrated approach from clinical trial protocol design to the publication of study results. He also plays a leading role in coordinating the EU-supported project AP@home. Prof. Dr. Heinemann has acted as scientific advisor for Profil Institute since the company’s inception in 2004. He is also co-founder of Profil Institute for Metabolic Research in Neuss, Germany and led the company as CEO for 10 years until 2009. Prior to that, Prof. Dr. Heinemann spent 17 years performing diabetes-related clinical and experimental research at the Department of Metabolic Diseases and Nutrition, a World Health Organization Collaborating Center of Diabetes, at Heinrich-Heine University of Düsseldorf in Germany.  Prof. Dr. Heinemann has published more than 180 scientific papers and is author of the book “Time-Action Profiles of Insulin Preparations.” He is the recipient of the award “Leadership in Diabetes Technology” from the Diabetes Technology Society in 2007 and is a member of the editorial board of a number of diabetes-related publications. Dr. Heinemann received his Ph.D. from the Heinrich-Heine University of Duesseldorf, Germany.

Robert J. Schott, MD, MPH, FACC

Medical Director &
Director of Cardiometabolic Research. 

Dr. Schott joined Profil Institute in 2010 and oversees the design and execution of cardiometabolic and cardiac safety studies for the company’s biopharmaceutical clients.   Before joining Profil Institute, Dr. Schott was Chairman of the Cardiology Department at Deborah Heart and Lung Center in Browns Mills, NJ.  Prior to that, he was Chief of the Cardiovascular Disease Section at Sutter Medical Center in Sacramento, CA, where he also served as Vice President for Medical Affairs.  Dr. Schott was previously the Associate Medical Director of the Lipid Institute Medical Clinic, associated with Berkeley Heart Labs.  Dr. Schott has participated in the Speaker’s Bureau for Pfizer, Merck, Abbot and GlaxoSmithKline.  
A graduate of the University of Michigan Medical School, he was a Burgher fellow at the Harvard Medical School, conducting post-doctoral research in cardiac molecular biology at Children’s Hospital in Boston with subsequent training in clinical cardiology at the Massachusetts General Hospital.

Dr. Donald Hill (Pharm.D.)

Director of Pharmaceutical Services

Dr. Hill joined Profil Institute in 2007 where he oversees the pharmaceutical services. Dr Hill also supports study protocol development, data review, and contributes to scientific publications. Previously, Dr. Hill was a practicing pharmacist at San Diego Hospice, and prior to that he served as Director of Research Pharmacy at the VA Hospital in Bay Pines, FL. There Dr. Hill helped establish the Institute of Tissue Regeneration, Repair and Rehabilitation (ITR3), dedicated to preclinical and clinical wound healing research. While at ITR3, Dr. Hill acted as principal and sub-investigator for various NIH and industry sponsored studies. Dr. Hill is also responsible for establishing pharmacy-based research services at both the University of Texas Medical Branch in Galveston and the VA Hospital in Bay Pines, FL. Dr. Hill is a licensed pharmacist in California, earned a Doctorate in Pharmacy at UC San Francisco and completed a Fellowship in Clinical Pharmacology at the Dallas VA with an emphasis on pharmacokinetics and clinical research. 

Laura McManus

Director of Clinical Project Management

Ms. McManus has over 20 years of experience coordinating clinical trials in the areas of diabetes, obesity, osteoporosis, lipid disorders and women’s health and has coordinated studies during the investigational phase of many of the market’s largest blockbuster drugs.  Since joining Profil Institute at the company’s inception in 2004, Ms. McManus has directed over 130 clinical studies.  Previously, she was a Clinical Research Coordinator at Radiant Research/ The San Diego Endocrine and Medical Clinic and prior to that a medical assistant at Diabetes and Endocrine Associates.  Ms. McManus is certified as a Clinical Research Coordinator with the Association of Clinical Research Professionals and is certified in Human Subject Protection from the National Institute for Health.

Khin Win, M.B.B.S.

Director of Clinical Operations

Dr. Win joined Profil Institute in 2005 and now oversees operational aspects of the company’s clinical trials from study logistics to direct patient care.  Dr. Win also oversees the company’s use of automated glucose clamps, one of the key methods for many of Profil Institute’s clinical trials.  He received an M.B.A. from National University in San Diego and an M.B.B.S. from the Medical University of Burma and is certified as a Clinical Research Coordinator with the Association of Clinical Research Professionals.

Dennis DeRosia

Director of Business Development

Mr. DeRosia has over 30 years experience in the medical and clinical research industry with a focus on clinical operations and strategic business development.  Before joining Profil Institute in 2004, Mr. DeRosia was Senior Director of Strategic Development at Research Pharmaceutical Services in Fort Washington, PA.  Prior to that, he was Managing Director of Strategic Accounts at Kendle International in Cincinnati, OH, and Vice President of Strategic Development in Paragon Biomedical in Irvine, CA, respectively. He has also held various leadership roles, including President and Chairman of the Association Board of Trustees, for the Association of Clinical Research Professionals (ACRP).  Mr. DeRosia holds an M.A. in Management from Claremont Graduate School, CA and a M.A. in Educational Leadership from Western Michigan University.

Susan Penn

Director of Human Resources

Ms. Penn joined Profil Institute in November 2009 and during her tenure has overseen a 20% increase in employees.  Since joining Profil Institute, she has designed and executed a company-wide employee engagement survey, implemented employee and supervisor training and staffing processes and created a set of management performance tools. Ms. Penn has spent 15 years working in human resources management, most recently as Vice President of Human Resources at Charlotte Russe Holding Company, and prior to that as Director of Human Resources at Lawrence Merchandising.  Ms. Penn earned her MA in Psychology at Sierra University in CA.  Ms. Penn has also earned Certification in Leadership Development. 

Mary Byrne-Halaszi

Director of Quality Assurance

Ms. Byrne-Halaszi joined Profil in 2011 as the director, quality assurance. Her expertise includes managing complex business process improvement projects, development of compliance driven GxP quality assurance, development and delivery of quality training strategies and; developing and implementing electronic document management systems.
She is a Registered Nurse and has over 20 years’ experience in the CRO, pharmaceutical and biotechnology industries, specifically in the areas of phase I and IIa clinical research, GxP auditing, Quality training and documentation practices. She has a degree in adult education and an MBA in business administration.