Our Executive Team – WCCT, a Full-service CRO
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.
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.
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.
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.
Senior Vice President, Translational Medicine
Mr. Mel Affrime has 30+ years of clinical research experience in the CRO industry. He co-founded an Academic Clinical Pharmacology Unit and served as Chief Scientific Officer for a major global CRO and VP and Global Head of Early Development for two major pharma companies. He has designed and successfully implemented early development programs for more than 15 successfully marketed products.
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.
Vice President, Business Development
David Fox has a broad range of clinical research experience ranging from clinical pharmacology through Phase IV Registration studies. With over 30 years of healthcare and CRO experience, David was co-founder of Praxis, a leading patient recruitment company located in Nashville, TN. He served as President and Chief Executive Officer until it was sold in 2010.
Prior to forming Praxis, David was Vice President of the Clinical Services Group at West Pharmaceutical Services. This group consisted of an 80-bed clinical pharmacology unit, a CRO, SMO and Patient Recruitment Group. This allowed for a comprehensive view of projects from the perspective of the sites, the patients as well as the CRO and sponsor companies.
In addition to a nursing degree from the University of Tennessee, David holds a BS, Biology degree from Lipscomb University.
David operates out of Medelis’ clinical operations office in Nashville, TN.
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.