Our Executive Team
Comprehensive clinical trial management experience guided by a seasoned team.
Executive Management Experience
WCCT is a full-service CRO with an advanced executive management team with over 70 years of experience conducting clinical trials. The executive management team has extensive experience in the biopharma and CRO industries. Along with the WCCT-employed principal investigators, WCCT works closely with board-certified physicians in gynecology, pediatrics, endocrinology, pulmonology, nephrology, ophthalmology and internal medicine.
Based out of Langhorne, PA, our experienced global development services team supports our CPU clinical operations staff with in-depth project management, data management, statistical analysis, protocol writing and development, regulatory compliance and other CRO services to give you a complete end-to-end solution.
President & Chief Scientific Officer
Dr. Affrime has an extensive background in Global Clinical R&D. Following completion of his PharmD training at PCP&S in Philadelphia he completed a Clinical Pharmacology Fellowship with Marcus Reidenberg, MD at Temple University College of Medicine. He then co-founded the Clinical Pharmacology research unit at Hahnemann Hospital, Philadelphia, PA with David Lowenthal, MD, PhD in 1976. He remained on the faculty at Hahnemann until 1982 when he joined Hoechst-Roussel Pharmaceuticals as Associate Director, Clinical Pharmacology. In 1985 he joined the Schering-Plough Research Institute as Director, Clinical Pharmacology. During his 16 years at Schering he managed the early development programs for the entire Schering pipeline and was named VP, Clinical Pharmacology, Clinical Research in 1996. Mel left Schering in 2001 to Join Novartis Pharmaceuticals as Global Head of Profiling Clinical Pharmacology. He was at Novartis until 2006 when he joined ICON Development Solutions as Sr. VP and Chief Scientific Officer. He remained at ICON until 2011 where he managed the medical staff at ICON’s 3 CPUs, the Population PK software business and the R&D department. Mel joined WCCT Global in August of 2011 as the Sr. VP, Translational Medicine and has lead all Scientific and Medical Affairs initiatives. As of November, 2018 Mel is President and Chief Scientific Officer at WCCT Global.
David Charlot brings over twenty five years of international finance and business experience in various industry and corporate settings. He began his career in commercial banking and later joined General Motor’s Treasurer’s Office where he worked largely on business development including various high-tech initiatives, most notably in PEM fuel cells. David joined Tyco International’s treasury team, playing a key role in its turnaround, most notably in Tyco’s break up–its spin-offs of Covidien and Tyco Electronics. He’s worked on various transformational initiatives such as in med tech and genetic/DNA testing. In 2015, David was appointed Science 37’s first CFO, a startup CRO in the emerging distributed clinical trial space where he made lasting contributions on a variety of fronts including two strategic partnerships. In all, David’s experience spanning small startups to Fortune 50 multinationals brings a wealth of expertise across all corporate finance functions, business development, and organizational development. David earned his BS in Accounting from New York University and MBA from Columbia Business School.
Dr. Robina Smith, MD, MBA
Medical Director, Breast Surgeon
Dr. Smith is a much-lauded Physician and Surgeon and has extensive therapeutic expertise to bring to her current role as Medical Director with WCCT Global. Prior to joining WCCTG in August 2017, Dr. Smith was the Medical Director of Oncology and Medical Affairs at Ambry Genetics, a genetic laboratory company in southern California, which allowed her to apply her years of practical medical experience to the clinical trial arena. Dr. Smith is also a Fellowship-trained Breast Cancer Surgeon and a leading expert in the field of Breast Oncology specializing in hereditary cancer syndromes, high-risk screening, genetics, breast education and awareness. She has 10+ years of practical experience in taking care of cancer patients, establishing breast cancer surgery service, liaising with the Commission on Cancer for American College of Surgeons and leading multidisciplinary breast conferences and tumor boards. Additionally, Dr. Smith brings to the table a strong understanding of clinical trial design and administration, as well as managerial and leadership strengths that have been honed in her various roles in the medical field, through her volunteer work and through her pioneering of new treatment resources for patients. Not only is Dr. Smith adept at developing educational programs for medical professionals and patients alike, she is also an award-winning speaker, presenter, author and medical illustrator.
Mr. Bill Taaffe retired from ICON Clinical Research in June 2011 after 40 years’ experience within the pharmaceutical and CRO industry. He was one of the founding members of ICON, where he held the position of president and chief executive officer, North America. He was with ICON for 18 years. Prior to that, he spent two years with a generic pharma company, Circa Pharmaceuticals, two years with a preclinical research organization, Bioresearch, and 18 years with a global CRO, the Institute of Clinical Pharmacology, where he served as U.S. CEO. He holds a B.Sc. from University College Dublin, Ireland. He now lives in Tennessee.
President & CEO
Mr. Jon Rojas has over 12 years of clinical research experience and has conducted over 1500 trials in the CRO industry. Prior to joining WCCT, Mr. Rojas served as Sr. Vice President of Clinical Services & Support at OmniComm. In his role there, he managed global teams that designed, implemented and supported all of the clinical trial management (EDC) systems. In addition, part of his responsibilities included expanding global project management as Vice President of Project Management. Prior to working for OmniComm, Mr. Rojas was Executive Director of Clinical Operations at SFBC International (now PharmaNet Development Group, Inc.). Mr. Rojas was responsible for managing a 500+ bed clinical research unit with 700+ employees. Beyond clinical operations, Mr. Rojas implemented project management, clinical trial management, clinical trial monitoring, SOP and training functions. Mr. Rojas was also the clinical operations manager of a 50-bed QTc specialty unit that performed over 100 QTc trials.
Mr. Rojas has delivered a multitude of educational presentations at key industry meetings such as DIA, EDC & Beyond and ACRP.
Vice President, Business Operations
Josh Trenton has over 13 years’ experience within the biotech/pharmaceutical space. He possesses substantial knowledge of the pharmaceutical and clinical research industries, which includes a thorough understanding of market dynamics. Mr. Trenton provides leadership in program development, utilization management, process improvement, implementation and measurement to support the overall strategic initiatives of the Global Clinical Development business unit.
Vice President, Clinical Research Services
Ms. Maria Apkarian has over 18 years of clinical research experience focusing in early phase trials. She is a clinical operations specialist with site and project management expertise. Prior to WCCT, Ms. Apkarian has worked in all functional areas of a Clinical Pharmacology Unit, including but not limited to, administration and finance, business development, volunteer recruitment, regulatory, clinical laboratory, data entry, staffing, QA/QC, monitoring, and project management. Outside of phase 1 studies, Maria also has clinical trial experience in academia, pediatrics, and women’s health.
Vice President, Clinical Operations, Global Clinical Development
Ruth has over 20 years of clinical research within CRO and Pharmaceutical companies responsible for direct management of the operational teams from small Phase I studies to management of a global Phase III cardiovascular megatrial. Ruth has currently is responsible for the Project Management, Clinical Monitoring, Data Management and Site Management departments. Ruth has experience across multiple therapeutic areas as well as with multiple EDC Platforms and other analytical tools.
Kenneth T. Kim, MD
Chief Medical Officer
Dr. Kenneth Kim, a summa cum laude graduate of Harvard College, received his MD from Harvard Medical School. Following a fellowship at the MIT Sloan School of Management, he completed his internal medicine and allergy/immunology training at UCLA. He is the founder and CEO of WCCT, an early-phase drug development clinical CRO, based in the U.S. with two 180-bed CPUs and three research site locations.
Dr. Kim has served as a medical monitor, consultant, or investigator on over 500 clinical trials, having published over 30 research articles and 50 abstracts in peer-reviewed journals. He has presented to the FDA on challenges and strategies of dose selection and study design for pediatric trials and met key decision makers at the PMDA, SFDA and KFDA. He has spoken at multiple national and international meetings and is a well-recognized expert in the areas of clinical pharmacology, ethnobridging, and respiratory and allergic diseases.
MBA/MHA, PMP: Vice President, Clinical Operations
Seventeen years of clinical research experience working for big pharma, CROs and specialty research providers has given Mr. Lee Barsky a balanced perspective. Mr. Barsky is responsible for the successful design and implementation of 1,000+ clinical trials across multiple therapeutic areas. He is an expert in global project management, clinical operations/clinical development and data management.
Vice President, Global Clinical Development
Ms. Joanne Hollenbach has 25 years of drug development experience within both pharma and CROs. She served as Chief Operating Officer, U.S., for Cmed from 2010 to 2015. Prior to that she held the roles of Head of Operations and Head of Clinical Operations at Cmed from 2005 to 2010. From 1995 to 2005, Ms. Hollenbach held operational positions of increasing responsibility within clinical operations and project management at ICON and PRA. Prior to joining the CRO sector, Ms. Hollenbach worked in clinical operations within Rorer and Johnson & Johnson Merck from 1990 to 1994. Ms. Hollenbach received a B.S. from Chestnut Hill College and a master’s in biology from Temple University.
Talia Nikolao Hight, MBA
Vice President, Commercial Operations
With 15 years of experience in the drug development industry, Talia has worked in Project Management, Business Development, Proposals & Contracts, and Clinical Operations. Prior to working with WCCT Global, Talia spent two years managing Phase 3 trials through to NDA submission at Allergan, Inc. Her areas of therapeutic expertise include ophthalmology, respiratory, infectious disease, immunology, cardiovascular, women’s health, and CNS. Talia brings a balanced perspective from both the CRO and Sponsor viewpoints, as well as across the clinical drug development spectrum from early phase to late phase clinical trials.
Vice President, Biostatistics
Kalyan Ghosh, PhD, has over 20 years’ experience in biostatistics supporting clinical research, 17 of which were spent at Merck and Bristol-Myers Squibb Co., as well as 3 years in a CRO that he founded with Merck Capital Ventures’ help. He has also worked at INC Research, one of the major CROs, as Head of Statistical Consulting. Kalyan has been in charge of operational as well as strategic function of the biostatistics groups in both early and late stage trials. He has represented companies at multiple regulatory agencies – the FDA, EMA, PMDA, and the rest of the world. Kalyan has participated in a number of industry-wide groups (e.g. PhRMA) formulating opinion on statistical and drug development issues. He has served as a reviewer for multiple statistical journals, and is an expert statistical reviewer for The Lancet.