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 combining for over 80 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 ophthalmology, nephrology, gastroenterology, gynecology, cardiology, rheumatology, pulmonology, allergy/asthma, family practice, and internal medicine.
Mel Affrime, PharmD
President & Chief Scientific Officer
Mel Affrime has an extensive background in Global Clinical R&D. Following completion 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 2011 as Sr. VP, Translational Medicine and was promoted to President & CSO by the Board of Directors in October 2019.
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.
Gregory P. Hanson CMA, MBA
Executive Chairman of the Board
Mr. Hanson has been a member of the Board of Directors for WCCT Global, Inc. since November 2016. Mr. Hanson has over 30 years of experience as CFO, investment banker, and executive business strategist, having successfully listed companies on the Nasdaq Stock Market and the NYSE MKT LLC, and completing two merger/acquisition transactions. Mr. Hanson is the former CFO and current member of the board for MabVax Therapeutics Holdings, Inc., a former Nasdaq-listed company (MBVX) that sold substantially all its assets in May 2019. Mr. Hanson is also managing director of a management advisory service he founded in 2008. Executive experience includes CFO at Avanir Pharmaceuticals (sold to Otsuka Holdings Co., Ltd.), and two other life sciences and tech companies; Senior Vice President and Life Sciences Advisory Board Member of Brinson Patrick Securities, a boutique investment bank; and earlier in his career in management positions at Ford Motor Company and a Caterpillar Inc. subsidiary.
Mr. Hanson is Past-President and 12-year Member of the Board of Directors of San Diego Financial Executives International; a founding and 6-year former member of the FASB Small Business Advisory Committee and has twice spoken before the U.S. Securities and Exchange Commission’s Committee on Improvements to Financial Reporting.
Hanson has a Bachelor of Science from Kansas State University and also earned an MBA with distinction from the University of Michigan. He has passed the examination for Certified Public Accountants and is a Certified Management Accountant. He maintained Series 7 & Series 63 securities licenses in the U.S. from 2008 to 2016.
Dr. Robina Smith, MD, MBA
Medical Director & Clinical Investigator
Dr. Robina 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 WCCT 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.
David Nguyen, MD, MBA
Medical Director & Clinical Investigator
Dr. David Nguyen is an anesthesiology-trained principal investigator. He has provided anesthesia for all major inpatient surgical specialties including neurosurgery, cardiothoracic, and obstetrics, as well as outpatient procedures and GI services. He is intimately familiar with transfusion medicine, fluid management, infusion reactions, and emergency anaphylactic airway response. He has also treated chronic pain patients, which gave him a first-hand account of both the opioid crisis as well as the frustrations and poor quality of life for a patient suffering from chronic pain. This impetus drove Dr. Nguyen to research the burgeoning medical cannabis field for patients, and has since become a patient advocate for responsible medical cannabis use. He has given a number of “TED”-like talks outlining the medical benefits of cannabis, as well as panel discussions with community leaders about the endocannabinoid system and its effects on improving quality of life. He joined WCCT with the goal of pushing forward more high-quality pharmaceutical therapies for patients, and leverages his diverse training and experience to ensure subject safety on all trials.
Dr. Nguyen received his MBA with an emphasis on healthcare. Prior to joining WCCT, he founded his medical aesthetic practice “Dr. Dave’s Dermal Institute”, where he functioned as both medical director and primary practitioner. His clinical knowledge expanded to include dermatology and regenerative medicine. He brings the same customer-focused approach from this practice to volunteers in his clinical trials, ensuring subject satisfaction at all levels.
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 14 years’ experience performing Business Development, Financial, and Operational Services. Joining WCCT Global in 2013 with a strong background in the Pharmaceutical and Clinical Research industries, Josh also brings to the table a thorough knowledge of corporate finances, which includes a deft understanding of market dynamics. Josh began his career with WCCT through supervisory roles in the Contracts and Analysis Departments, which allowed him to lend his knowledge of financial forecasting, contract negotiation and budget analysis to help the Business Development team achieve their goals for growth, new partnerships, and strategic planning. Along the way to his current position, Josh has also helped streamline operational processes across the organization. In Josh’s current role as Vice President of Business Operations, his exemplary leadership skills are apparent as he oversees a diverse team spanning multiple departments in order to provide effective, cross-functional solutions to individual projects and to the strategic goals of WCCT.
Vice President, Clinical Research Services
Maria Apkarian brings over 20 years of clinical research experience to her role as VP of Clinical Research Services for WCCT Global. Maria has been working in the clinical research industry since 1999, starting her career as a Phlebotomist for a Phase I unit and grew to manage two departments providing unparalleled support and insight to everything pertaining to Clinical Operations and Clinical Development at WCCT. Within the span of her profession, Maria has held many responsibilities including everything from being a Project Manager to the Director of Clinical Operations. These experiences give her the perfect balance of leadership expertise, practical clinical skills, and insight into the CRO experience. Maria is one of WCCT’s most trusted resources by proving time and again that her knowledge and insight bring efficiency and proper planning to the execution of our trials, and ultimately, exemplary service to our clients. Maria is well-versed in all aspects of a CRO and clinical research site including coordinating, developing source documents, preparing and submitting regulatory documents, project management, staffing, training, clinical monitoring, business development, partner relations, medical consulting, contract review and budgeting. Not only this, but Maria is a hands-on and an insightful leader that acts as a skilled liaison between all pertinent teams in the planning and execution of new studies. As a specialist in early Phase studies, Maria also has significant knowledge in specialty therapeutic areas such as Pediatrics, Gynecology, and Viral Challenge.
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 16 years of experience in the drug development industry, Talia has amassed a wide range of knowledge extending across general management, business development, marketing, finance and operations. Talia started as a clinical research coordinator at WCCT, and then moved into a variety of management roles as the company grew from 15 employees to 200+ employees. 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.