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Principals

Howard Golub, MD, PhD
Principal

Dr. Golub received his Ph.D. in BioElectrical Engineering from M.I.T. in 1979, and medical degree from Harvard Medical School (M.I.T.-Harvard Joint Program: H.S.T) in 1983.

In 1980, Dr. Golub was the CEO and founder of PDS Inc., a medical computer based diagnostic device company, which was sold to Tokos Medical Corp. in 1990. Also in 1980, he was one of the founders of Venturcom Inc. (a computer software company) and had served on its board of directors which was acquired in 1998. Since 1990, Dr. Golub served as the President and founder of Cry Research Inc. a company formed to determine the clinical usefulness of infant cry analysis (a technology he developed as part of his Ph.D. work), and he is one of the founders, the patent holder of the central IP and CEO of DxTek Inc. a medical device company (that developed a continuous, cuffless non-invasive blood pressure device).

In 1995, Dr. Golub was founder and CEO of MSO-NY, a Management Service Organization setup as a partnership of physicians and managed care experts to provide all necessary managed care services (especially data outcomes and information systems management) to one of the first fully integrated physician networks that was able to accept full-risk payer contracts in the New York City area.

Also in 1995, Dr. Golub was founder, president and one of the medical monitors of CareStat Inc. CareStat, based in Boston, was a full service Clinical Research Organization (CRO) specializing in FDA based registration trials for pharmaceuticals, biotech and medical devices. CareStat was acquired by Battelle Memorial Institute in 2005, where he served as the president of their clinical trials subsidiary until 2008.

In 2009, Dr. Golub served as Senior Consultant/Head of New Ventures for Transform Pharmaceuticals (a Johnson & Johnson company) where he led internal (to J&J) and external strategic business relationships for drug form and formulation and high throughput experimentation projects.

In addition, Dr. Golub has been the Principal Investigator on 2 large N.I.H. sponsored trials.

Dr. Golub currently holds an appointment as Senior Lecturer in the M.I.T.-Harvard Joint Program (H.S.T.) and as a Distinguished Fellow at the Center for Biomedical Innovation also at M.I.T. In addition, he has an adjunct appointment at the Boston University School of Public Health in Biostatistics and Epidemiology.



Michael Corwin, MD
Principal

Dr. Corwin has had a long and varied career as both an academic and an entrepreneur with extensive experience performing both government and industry sponsored clinical research. He was a founder of a medical device company where he led their successful FDA studies as well as a Principal Investigator of a large NIH-sponsored data coordinating center. Dr. Corwin’s research has been focused on the epidemiology and physiology of the sudden infant death syndrome. He has been PI of the Collaborative Home Infant Monitoring Evaluation (CHIME), and the National Infant Sleep Position (NISP) surveys. Dr. Corwin also has been Co-Director of the Massachusetts Center for SIDS, Medical Director of the MCHB Program to Enhance Performance of SIDS/OID Initiatives and has participated in the SIDS Global Strategy Working group and NICHD 5-Year SIDS Research Plan Committee.

Dr. Corwin was one of the founding partners of CareStat/BattelleCRO where he provided leadership in Medical Affairs, including medical monitoring, safety and medical writing. He also led a team of senior scientists and provided general oversight in Project Management.

Dr. Corwin is currently an Associate Professor of Pediatrics and Epidemiology at the Boston University Schools of Medicine and Public Health, and Senior Epidemiologist at the Slone Epidemiology Center at Boston University and is board-certified in Neonatal-Perinatal Medicine. He is the author of over 50 publications.



Cheryl Hamer Lou
Principal

Ms. Lou has over 20 years of experience in the clinical research area. She has held management positions in both pharmaceutical and medical device companies, most recently as Vice President of Clinical Operations at Flexion Therapeutics in Woburn, MA. She was Director of Clinical Research for a large medical device and telemetric healthcare company, now Matria Healthcare of Marietta, GA.

She was a founder of CareStat/BattelleCRO where she provided management oversight to project management, clinical site monitoring, regulatory and quality assurance departments. In this role, she developed and implemented a large number of employee training programs in many areas of clinical research, various therapeutic areas and in ICH GCP and FDA regulations.

Ms. Lou has extensive experience in the design and conduct of clinical trials for drugs, biologics and medical devices. She also has a strong background in IT system specification, testing and validation for clinical trial management systems. She has also developed the quality systems infrastructure within a number of organizations.



Mark Peucker
Principal

Mr. Peucker has over 20 year’s experience designing and maintaining enterprise computer networks, data analysis (including SAS) and database management systems.

He has been a co-founder and served as Vice President of IT of a full service CRO, that has since been sold. The systems he designed were fully GCP (Good Clinical Practice) compliant, including the creation of appropriate SOP’s and the implementation of computer system validation protocols. These data systems also typically contained very large clinical data sets. Mr Peucker also was primarily responsible for designing, and implementing systems for all clinical data repository tasks. These tasks were required by clients who needed to harmonize relatively disparate databases holding data from all their clinical trials.

In addition, as part of his role at the Data Coordinating Center at the Boston University School of Public Health, he served as the head of IT for a large, multiyear NIH project containing terabytes of patient and electronic bio-signals information.



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