Leadership

Dr. David Daniel provides overall scientific, clinical and strategic direction for our CNS solutions. Dr. Daniel was the founder and President of Global Learning, LLC which was acquired by United BioSource Corporation in July 2006. He formerly served as Medical Director of the NIMH Neuroscience Center at Saint Elizabeth’s, Director of Clinical Trials for the Stanley Foundation and was a founding Principal of Best Practice, LLC. For over 30 years, Dr. Daniel has supervised and trained raters in psychiatric clinical trials globally. He has published numerous scientific articles involving clinical trials and investigations of the psychopathology of mental illness. He has received patent protection for new treatment approaches in epilepsy, anxiety disorders and psychotic disorders. Dr. Daniel graduated Phi Beta Kappa and Magna Cum Laude from Emory University and obtained his medical school and psychiatry post-graduate training at Vanderbilt University, where he served as chief resident. He was a medical staff fellow and senior staff fellow within the intramural program of the National Institute of Mental Health (DIRP, NIMH) for five years.

Bill serves as Vice President of product intelligence and positioning at Signant Health, where he also serves as a principal ePRO scientist. He has worked in the Pharmaceutical industry for 30 years and is the author of over 70 publications and two industry textbooks on electronic patient-reported outcomes (ePRO). His recent scientific work includes the use of wearable technology and bring- your-own-device (BYOD) eCOA in clinical trials. Bill recently served as Vice Director of the C-PATH ePRO Consortium, and is an active member of the DIA Study Endpoints Community where he leads a cross-disciplinary group on the use of endpoints derived from wearable devices to support labelling claims and regulatory decision making. Bill provides independent eClinical commentary via LinkedIn and Twitter (@billbyrom).

Dr. Busner has over 35 years of experience as an academic clinical psychiatric researcher. She has served as the Principal Investigator for 49 industry-sponsored psychiatric clinical trials and Sub-Investigator for 35 additional clinical trials. She has served continuously on University Institutional Review Boards (IRBs) for the 20 years that preceded her move to Signant Health. Dr. Busner is an active contributor to the psychopharmacology literature and has authored or co-authored over 140 peer-reviewed articles and national or international scientific presentations. Prior to Signant, Dr. Busner directed the psychiatric clinical trials units of two major medical schools. Dr. Busner has held medical school faculty appointments since 1985 and is currently Affiliate Associate Professor of Psychiatry at Virginia Commonwealth University. She serves as Signant’s Expert Presenter and Scientific Lead for US and multinational studies of pediatrics, rare and orphan diseases, depressive disorders, anxiety disorders, attention deficit hyperactivity disorder and all child and adolescent psychiatric indications. She has trained thousands of psychiatric clinical trial investigators across the globe and lectures frequently on the application of objective rating scales in the assessment of diagnosis and efficacy in psychopharmacology, ethics in psychiatric research, the placebo effect in psychiatric research and techniques for its minimization, the role of IRBs and clinical trial methodology. Dr. Busner received her PhD in Experimental Social Psychology and her MA in General Psychology from Adelphi University. She is licensed to practice psychology in Pennsylvania, Missouri and New York.

Dr. Sachs is the Therapeutic Area Leader in bipolar disease and mood disorders at Signant. He previously co-founded Concordant Rater Systems, a specialty provider of technologies to improve CNS clinical research. Dr. Sachs is a recognized expert clinical trialist with extensive experience in rater training and the methodologies of mood and anxiety disorder research. He has been instrumental in developing technology-based solutions for randomized controlled trials that identify correlates of high placebo response, improve signal detection and reduce the risk of failed trials. Dr. Sachs is the founder and director of the Bipolar Clinic and Research Program at Massachusetts General Hospital (MGH) and is an Associate Professor of Psychiatry at Harvard Medical School. After graduating from the University of Pennsylvania and the University of Maryland Medical School, he completed his residency at MGH. His areas of academic interest include psychopharmacology, chronobiology, bipolar mood disorder and development of pragmatic measure-based practice guidelines. Dr. Sachs is Chair of the National Alliance on Mental Illness Scientific Advisory Board and serves on the Scientific Advisory Board of the Depression and Bipolar Support Alliance. He has authored over 200 articles, abstracts, books and book chapters.

Dr. Miller has over 20 years of clinical, clinical research and teaching experience, primarily in the field of geriatric psychiatry. After completing his 2-year fellowship in geriatric psychiatry at the University of Pennsylvania, he joined the faculty and served as an Assistant Professor of Psychiatry. Dr. Miller then went on to the University of Medicine and Dentistry of New Jersey, where he served as an Associate Professor of Psychiatry. Prior to joining Signant, Dr. Miller served as Chief of Geriatric Psychiatry, Medical Director of ECT, and President of the Medical Staff at Friends Hospital in Philadelphia, PA. At all of these institutions, he oversaw the education and training of medical students, residents and fellows in geriatric psychiatry, and was recognized with a departmental teaching award. Dr. Miller has served as a Principal Investigator in a number of dementia clinical trials. In addition, he has lectured locally, nationally and internationally on his dementia related research. Dr. Miller serves as the Co-Chair of the ISTAART funded Neuropsychiatric Syndromes in Dementia – Professional Interest Area (NPS-PIA), and as the Co-Chair of the ISCTM Working Group focusing on the same area. Additionally, Dr. Miller is a co-author on the updated ADCS ADAS-Cog administration and scoring manual. Since joining Signant, Dr. Miller has consulted on multiple dementia protocols and has served as the Expert Presenter at dozens of investigators’ meetings across the globe, including those addressing behavioral abnormalities and agitation in the context of dementia.

Todd Everhart, MD, FACP, is the internal medicine leader at Signant. Dr. Everhart is board-certified in internal medicine and a fellow of the American College of Physicians with over 23 years of experience in the practice of medicine and over 12 years of experience in clinical development. Prior to joining Signant, Dr. Everhart held positions of Vice President, Medical Affairs and Vice President, Medical Informatics at Chiltern and Covance, and consulted independently in the areas of medical monitoring, medical data review, data analytics, and physician adoption of technology. He has worked in all phases of clinical development in numerous therapeutic areas including allergy & immunology, cardiovascular, hematology & oncology, infectious disease & HIV, neurology, ophthalmology, psychiatry, respiratory, and rheumatology.

As Clinical Vice President, Dr. Fredane will serve as the Therapeutic Area Leader for neurology and will oversee Signant’s eCOA, Rater Training, and Quality Assurance work in this important therapeutic area. Prior to joining Bracket, Dr. Fredane served as a practicing neurologist and clinical assistant professor of Neurology at Drexel University College of Medicine in Philadelphia, Pennsylvania. He has worked in pharmaceutical drug development at several companies including at Sanofi/Genzyme Pharmaceuticals, Meda Pharmaceuticals and with CRO Omnicare Clinical Research. He also maintains extensive experience in medical affairs and has published research on multiple sclerosis, pain management and transplantation. Dr. Fredane received his medical degree from Albert Einstein College of Medicine and completed his training with a residency in Neurology at Duke University. He completed fellowships in Clinical Immunology at St. Luke’s-Roosevelt Hospital Center in New York and in Immunology at Yale University School of Medicine in New Haven, Connecticut through a research fellowship with the National MS Society.

Dr. Frakes is an executive physician based in San Diego, California, with over 30 years of leadership experience in the biotech and pharma industries. Specializing in psychiatry and central nervous system clinical drug development, he has provided strategic guidance to numerous clients in areas such as Alzheimer’s, multiple sclerosis, and mental health disorders. With over 15 years of experience in general medicine, he has led large clinical trials across various specialties including rheumatology and gastroenterology. Dr. Frakes holds a Bachelor of Science in biology and psychology from the University of British Columbia and a medical degree from the University of Calgary. He is board-certified in psychiatry and holds fellowships with the Royal College of Physicians and Surgeons of Canada and the American Psychiatric Association.

Dr. Alan Kott is a Practice Leader for Data Analytics at Signant Health. He has both academic and industry experience in clinical trials. Having led the development of the Data Analytics Program for Signant, he has overseen the design and implementation of data analytics across indication in over 200 clinical trials. Prior to Signant Health, Dr. Kott worked as an Assistant Professor at Charles University, 1st Medical Faculty – Department of Psychiatry and a house officer in Psychiatry at General Teaching Hospital, Department of Psychiatry, both in Prague, Czech Republic. Dr. Kott has a Medicinae Universae Doctor (MUDr.) from Charles University.

Dr. Elias Ketiar serves as the Clinical Vice President, Science & Medicine, at Signant Health. Dr. Ketiar draws on his wealth of more than 20 years of academic and clinical experience to advise on clinical trial design, execution, and governance.

He has extensive experience in General Internal Medicine and Cardiology and is a Member of Royal College of Physicians (London), UK. Dr Ketiar has been engaged in academic research and was involved in a pioneering project investigating genetic causes of congenital heart disease, which culminated in a Medical Doctorate with St George’s University of London, UK.

He also has peer reviewed papers published. He has always been involved in all phases of clinical development and interested in global clinical trial solutions.

Dr. Frakes is an executive physician based in San Diego, California, with over 30 years of leadership experience in the biotech and pharma industries. Specializing in psychiatry and central nervous system clinical drug development, he has provided strategic guidance to numerous clients in areas such as Alzheimer’s, multiple sclerosis, and mental health disorders. With over 15 years of experience in general medicine, he has led large clinical trials across various specialties including rheumatology and gastroenterology. Dr. Frakes holds a Bachelor of Science in biology and psychology from the University of British Columbia and a medical degree from the University of Calgary. He is board-certified in psychiatry and holds fellowships with the Royal College of Physicians and Surgeons of Canada and the American Psychiatric Association.

Dr. Kott is based in Signant’s Prague office and until recently was Senior Clinical Manager for Europe. Having led the development of the Data Analytics Program for Bracket, he has overseen the design and reporting of data analytics in multiple large schizophrenia studies. For the past seven years, he has also provided training to investigators as an Expert Trainer. Dr. Kott has been responsible for the design and implementation of multiple in-study data quality programs and served as a Product Business Owner for Rater Reliability Statistical Measures Application. Prior to Bracket, Dr. Kott worked as a house officer in Psychiatry at General Teaching Hospital, Department of Psychiatry, and as an Assistant Professor at Charles University, 1st Medical Faculty – Department of Psychiatry, in Prague. Dr. Kott has a Medicinae Universae Doctor (MUDr.) from Charles University.

John brings more than 30 years of leadership experience in the biopharmaceutical industry to guide Signant Health on its mission to transform the clinical trial process by providing simple, intuitive technologies that accelerate the clinical trial process, improve clinical data quality and enhance the lives of patients around the world.

Most recently, he was President and CEO of Bioclinica, a leading provider of medical imaging and clinical technologies.  Prior to Bioclinica, he was Senior Vice President and Worldwide Head of Development Operations at Pfizer.  He was responsible for global drug development of more than 450 clinical trials. Before joining Pfizer, he was Group President of ICON plc’s Global Clinical Research Division and also held executive positions at Parexel International Corporation and Sanofi Pharmaceuticals (formerly Hoechst Marion Roussel).

John was a founding member of the Board of Directors of TransCelerate Biopharma, Inc., is an Executive Committee Member Emeritus on the Clinical Trials Transformation Initiative (CTTI).  He is on the board of Agile Therapeutics (NASDAQ: AGRX), Life Sciences Pennsylvania, and was former Chairman of the Board of the Association of Clinical Research Organizations (ACRO).  As part of his role as a Healthcare Strategic Advisory Board Member to Genstar Capital, John advises the firm on healthcare investments and serves as a board member on portfolio companies (Signant Health and Advara). He was recognized by Pharma Voice as one of the 100 Most Inspirational People of 2016.

John’s Ph.D., is in cardiovascular physiology and he is a Fellow in the American College of Clinical Pharmacology.  His hobby is martial arts and holds a 4^th Degree Black Belt and is a Master Instructor in Kung Jung Mu Sul.  John and his wife have been married 40 years, enjoy traveling globally and reside in Doylestown, Pennsylvania.

Jean-Pierre Conte is the Chairman and Managing Director of Genstar Capital, responsible for acquisitions, divestitures and oversight of portfolio companies in a number of industries including healthcare and industrials. He joined Genstar Capital in 1995. Prior to leading Genstar Capital, J-P was a principal at The NTC Group, Inc., a private-equity firm focused on industrial technology companies. He began his career at Chase Manhattan Bank in 1985.

Ms. Baddour is currently serving on the board of directors of Advarra, Signant Health and Waters Corporation (“Waters”). Waters is the world’s leading specialty measurement company focused on improving human health and well-being through the application of advanced analytical science technologies. With approximately 7,000 employees worldwide, Waters operates directly in 31 countries, including 15 manufacturing facilities, and with products available in more than 100 countries.

Ms. Baddour has over twenty years of experience in the Life Sciences industry. From June 2007 to October 2018, Ms. Baddour served as Executive Vice President and CFO of PRA Health Sciences (“PRA”). PRA is a global contract research organization and data science company serving the pharmaceutical and biotech industry for more than 40 years. PRA, formerly a Genstar portfolio company, grew from approximately 3000 employees to over 17,000 during her tenure with the company.

In addition to her eleven years at PRA, Ms. Baddour worked at Pharmaceutical Product Development, Inc (“PPD”) from November 1995 to May 2007. She served as CFO at PPD from 2002 until her departure to join PRA. At PPD, she also managed the company’s M&A and information technology strategies. Prior to being named CFO at PPD, she was Treasurer and Chief Accounting Officer.

Ms. Baddour is also a certified public accountant.

Bob Conway served as the Chief Executive Officer and member of the Board of Directors of Array BioPharma (NASDAQ: ARRY) from 1999 to 2012. Array is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer and inflammatory diseases.  Array was acquired by Pfizer in 2019.

Prior to joining Array, Bob Conway was the Chief Operating Officer and Executive Vice President of Hill Top Research, Inc., a clinical research services company, from 1996 to 1999. He also held various executive positions for Corning Inc . (NYSE: GLW) including Corporate Vice President and General Manager of Corning Hazleton, Inc., a contract research organization, from 1979 to 1996.

Bob Conway serves as Chairman of ARCA biopharma, Inc. (NASDAQ:ABIO) a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases. He is on the Board of Directors of Alpine Immune Sciences, an oncology-focused biotech (NASDAQ:ALPN). Previously he was Chairman of Wall Family Enterprise, a leading library and education supplies company. He served as a Director of eResearch Technology and PRA International, Inc. prior Genstar companies and currently serves as a Director of Advarra and Signant Health, two of Genstar’s portfolio companies.