The team at Target Health LLC is comprised of over 100 talented individuals with decades of experience in the pharmaceutical industry, both in the US and worldwide.
Dr. Jules T. Mitchel is CEO of Target Health LLC, a New York City based CRO with expertise in Regulatory Affairs, including FDA interactions and all submissions, Strategic Planning, Clinical Research Management, Biostatistics and Data Management, Medical Writing, Good Manufacturing Practices (GMP) and other support services to the pharmaceutical industry. Dr. Mitchel has broad base pharmaceutical experience in drugs, biologics, devices and diagnostics including three NDA submission, many FDA meetings and IND/IDE submissions, study reports, manuscripts and strategic planning. Areas of expertise include but are not limited to, Women's Health, Dermatology, Antimicrobials, Pharmacokinetics, Rheumatology, Ophthalmology, Natural Products, Oral Care, Oncology and Regulatory Affairs. Dr. Mitchel has held industry positions at American Home Products, Pfizer Laboratories and Pfizer Consumer Health Care and academic positions at New York Medical College, Cornell University School of Medicine and NYU School of Medicine.
Bill Duval is COO of Target Health and brings over 30 years of drug development experience to the team. Bill has served in a wide range of roles on a global basis, starting as European project manager for Procter & Gamble Pharmaceuticals’ largest clinical development program, where he was initially exposed to the CRO world. From there, he has held functional leadership and executive roles in a number of organizations with a focus on global operations and business management. Bill has also served as a consultant to sponsors, CROs and the financial community and has worked in a broad range of therapeutic areas. Bill holds a B.E. in Information Systems from the University of South Florida and has taken multiple continuing education and graduate courses at Harvard University and The University of North Carolina.
Executive Director, Biostatistics and Statistical Programming
Luis Rojas has spent more than 30 years in the pharmaceutical, medical device, CRO, and academia industries and has a robust managerial and technical background. Luis is a subject matter expert in protocol development, study design, adaptive design, master protocols, bioequivalence, DMCs, the estimand, modeling and simulations, advanced analytics, ISS/ISE, RWD/RWE, interactions with regulatory agencies, and recognized thought leadership with multiple presentations world-wide.
Luis has a solid grip in multiple therapeutic areas including but not limited to cardiovascular, oncology, Systemic Lupus Erythematosus, central nervous system, gastrointestinal, dermatology, rare and ultra-rare diseases, immunology, diabetes, stem cell, and bone marrow transplantation.
Vice President, Business Development
Kathleen Kane Tremmel is Vice President of Business Development and brings over 25 years of global experience to Target Health. Throughout Kathleen’s career, she has also supported clinical functions such as study start-up, co-monitoring visits and data management activities. Most recently Kathleen spent over 15 years with a global full-service CRO followed by a global site network with a special focus on patient engagement. Kathleen holds a Bachelor’s degree from Villanova University and has been enrolled in St. Joseph University’s MBA program in Philadelphia
Senior Director, Clinical Operations
Clinical research was a natural evolution for Ron after over 15 years as an RN/NP in trauma, cardiology, and infectious disease with a specialty in HIV/AIDS. As Senior Director of Clinical Research at Target Health, Ron works with a diverse and multi-talented team of Project Managers, Clinical Research Associates and Clinical Operations Specialists who collectively bring to the table over 100 years of expertise in clinical trial management, clinical monitoring, expedited study start-up, patient recruitment and study feasibility assessment. This team also specializes in innovation. They are pioneers in ground-breaking technology using Direct Data Entry to conduct paperless clinical trials to actualizing risk-based monitoring strategies.
Executive Director, Data Management
Yong Joong Kim joined the Data Management team at Target Health in 1999. He designed and developed the EDC system shortly after joining and has been part of the continued growth of the company. He oversees Data Management operations and is involved in development and enhancement of the clinical trials software and strategic directions for the company.
Yong Joong holds a master’s degree in Computer Science. Before joining Target Health, he held a position at the Rockefeller University as a System Analyst/SAS Programmer working on NIH funded clinical trials for 10 years.
Director, Project Management
Marcelo Roschel is the Director of Project Management and brings over 17 years of experience in global drug development and clinical research. Prior to joining Target Health, Marcelo has served in various global positions in large Pharma and CROs, where he helped bring many new drugs to market in the fields of immunology, oncology, hematology, and neurology.
Marcelo holds a BS in pharmacy and biochemistry from University of Sao Paulo and a Master of Business and Administration from UNC Kenan-Flagler Business School. In addition, Marcelo is also Project Management Professional (PMP) certified.
Senior Director, Regulatory Affairs
Mary Shatzoff is a Regulatory Affairs executive and has been working in the pharmaceutical industry in clinical drug development for over 20 years. She has been Senior Director of Regulatory Affairs at Target Health since 2006. Before joining Target Health, she worked as a Manager of Regulatory Affairs at Sanofi Aventis and a Quality Control Microbiologist at Pfizer. She is an active member of The Regulatory Affairs Professional Society (RAPS) as well as the Drug Information Association (DIA). Two of her articles have been published in Applied Clinical Trials Magazine and RAPS Focus Magazine. Mary received a Bachelor of Science in Biology from Northeastern University, a Master of Science in Regulatory Affairs from Long Island University, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, and is currently working on a Master of Science degree in Molecular Biology from Lehigh University. Mary maintains The Regulatory Affairs Certification (RAC-US) and is a Certified Quality Auditor (CQA).
Director, Regulatory Affairs
Adam Harris currently leads drug, device, and combination regulatory programs at Target Health. Adam started his career in brand drugs at Sanofi-Aventis in post approval drug regulatory affairs and CMC, and then moved to generic drug regulatory affairs at IVAX Pharmaceuticals, which was later acquired by TEVA Pharmaceuticals. Next, at Siemens Healthcare in-vitro diagnostics, Adam began his involvement in the medical device regulatory world. In 2010, he brought his device expertise to Target Health and works closely with sponsors to interact with FDA to obtain critical feedback in a multifaceted regulatory sphere. Adam also manages regulatory staff at Target to meet a demanding and diverse submission schedule on behalf of clients.
Adam has authored regulatory strategies for numerous drug, device, and combination programs while at Target, shepherding a number of investigational programs throughout the dynamic and highly interactive pre-submission process. Adam has achieved more than 10 FDA approvals in devices alone and has led more than 17 in-person FDA meetings. In addition to holding both a bachelor’s and a master’s degree, Adam maintains the Regulatory Affairs Certification (RAC) from RAPS and is currently working on a Master of Science in Jurisprudence degree at Seton Hall University.
Senior Director, Software Development & IT
Joonhyuk Choi is Senior Director, Software Development & IT at Target Health. With over 15 years of experience specializing in clinical trial software solutions and technology-driven processes, he is responsible for creating software platform and strategic enhancement of products and operations. Prior to Target Health, Joonhyuk worked as an ERP System developer at Samsung Electronic Service.
Joonhyuk graduated with a B.S. in Electrical Engineering from Rutgers University.