Jim Westerkamp has nearly 30 years of combined academic, diagnostic, pharmaceutical, medical device and clinical trial experience. Most recently, Jim served for 12 years at CTI Clinical Trial and Consulting Services (CTI), a global Contract Research Organization, overseeing the Consulting Operations team.
As Vice President, Jim held the responsibility for the day to day operations of the Consulting Services business unit and formulated and implemented strategic approaches to clinical trial site assessment activities to ensure the objectives of his pharmaceutical, biotechnology, medical device and medical diagnostic clients were routinely exceeded. Jim and his team were consistently faced with the challenges associated with optimal research site identification in preparation for the conduct of clinical trials in the rare disease space. Jim has developed a unique site assessment and feasibility approach with proven success. He brings an understanding and passion for the clinical development process and a commitment to delivering the highest quality service and results to our customer base.
In addition to his CRO experience, Jim has gained significant experience in the clinical development and clinical trial process over the course of his career. Prior to joining CTI, Jim served as a Senior Scientific Liaison at Astellas Pharma. At Astellas, Jim was responsible for identifying potential clinical research collaborations with global thought leaders, PIs and their support staff, with a specific focus in rare diseases. Jim started his career at The Ohio State University Medical Center, where he managed the Transplant Immunology and Human Leukocyte Antigen laboratory, under the mentorship of immunologist Charles Orosz, PhD. Jim has also served in a sales capacity for medical diagnostics and medical devices.
Jim’s passion for research, understanding of the global clinical trial landscape, desire to improve process and deliver feasibility results that exceed expectations and speed the development plans of our client base have contributed to his desire to launch Cliniceval Solutions, LLC. Jim will lead the implementation of an established clinical trial site assessment approach on behalf of our clients and is excited to further improve this process on behalf of all clinical trial stakeholders through the introduction of ClinicEval Connect™.
Chief Scientific Advisor
Dr. Irish, Research Professor and Vice Chair for Research in the Department of Surgery at East Carolina University, Greenville, NC, is an internationally recognized expert in the areas of study design and analysis. He has collaborated with clinical investigators internationally, implemented large-scale database analyses and directed analysis/programming teams.
Dr. Irish specializes in outcomes research, clinical trial methodology, statistical modeling and prediction, and large-scale database and claims analysis. He is a member of several professional organizations, including the American Society of Transplantation and the International Society of Pharmacoeconomics and Outcome Research. Dr. Irish is currently Statistical Editor for the American Journal of Transplantation and Associate Editor for Clinical Transplantation.
Dr. Irish brings more than 25 years of study design and statistical analysis expertise to our client base. Past positions include Vice President of Biostatistics and Health Outcomes Research at CTI Clinical Trial and Consulting Services (Cincinnati, OH), Vice President of Biostatistics at RTI International (Research Triangle Park, NC), Director of Biometrics at SangStat Medical Corporation (Fremont, CA) and Research Instructor of Transplantation Surgery at the University of Pittsburgh.His insight into feasibility assessment design and development ensure that Cliniceval Solutions, LLC provides comprehensive and reliable feasibility assessment results on behalf of our clients.
Chief Medical Advisor
Dr. Davis is an accomplished physician with 20 years of academic experience in a general pediatrics and nephrology setting and more than 10 years of industry experience, with a focus on pharmaceutical, biotechnology and medical devices. Dr. Davis has served in a leadership capacity throughout his career,
including roles as Division Chief of Pediatric Nephrology and Medical Director of the Pediatric Peritoneal Dialysis Center and Pediatric Renal Transplantation Program at Case Western Reserve University’s Rainbow Babies and Children’s Hospital from 1992-2007. He has held positions as Global Medical Director for Baxter International, Inc. and Hospira, providing oversight of the clinical and medical expert team of nurses and physicians providing Research and Development support for multiple dialysis products and infusion pumps and as Medical Director at CTI Clinical Trial and Consulting Services, serving as a clinical and medical expert for biopharmaceutical and medical device companies regarding clinical development plans, protocol design and providing medical oversight of Phase I-III clinical trial teams. Dr. Davis has been involved in clinical trials for 30 years and has provided medical expertise in the start-up and execution of clinical trials in the areas of hypertension, anemia, chronic kidney disease, peritoneal dialysis, hemodialysis vascular access, transplant, oncology, blood collection medical devices, and orphan drug development in the area of inherited metabolic diseases and chronic glomerular diseases.
Dr. Davis will provide medical and clinical insight to all Cliniceval Solutions projects and will be instrumental in upholding our corporate mission of “Connecting clinical trial stakeholders to expedite the development of novel therapies to patients in need”.
Clinical Development Advisor
Ken Canter fully understands the challenges of clinical research. He began his career in research over 20 years ago, working at a large Contract Research Organization (CRO) as a Regulatory Affairs and Clinical Research Associate. He moved to a large Site Management Organization (SMO), eventually serving as Vice President
of Compliance. In 1995, Ken co-founded a CRO that specialized in study monitoring and quality assurance. It was during this time that Ken developed an expertise in clinical quality assurance auditing. Given his deep knowledge of the industry, Ken worked as a Clinical Research Scientist for a large consumer products company, where he specialized in developing and conducting claims support studies.
Ken founded C3 Clinical Sciences, Inc. in 1999, where he has served as the President and the company’s Senior Consultant. Under Ken’s leadership, C3 has become an industry leader in senior level consulting services, establishing preferred partnerships with numerous pharmaceutical and consumer products companies.
Ken has held pivotal roles at large CROs, SMOs, pharmaceutical, biotechnology and consumer product companies. Through these invaluable experiences, Ken has become intimately familiar with all facets of the clinical research industry. Ken has the ability to effectively manage challenging projects with a professional and steadfast approach. Ken brings a comprehensive understanding of clinical research, trial design, quality assurance auditing and operational expertise to our client base. His contributions to our clients and their projects ensure that Cliniceval Solutions, LLC provides comprehensive and reliable feasibility assessment results, saving our clients development time and cost, while expediting the delivery of novel therapies to patients in need.
C3 Clinical Sciences, Inc.
Expert Clinical Research Consulting
Health Economics Advisor
Dr. Peter Mallow is the Director of Health Economics and Clinical Outcomes Research and Assistant Professor at Xavier University, in Cincinnati, OH. He has collaborated with sponsors on numerous studies to ensure patient outcomes and economic endpoints are optimally collected during the development process
in order to ensure and establish value to reimbursement and Health Technology Assessment (HTA)bodies. His research interests include decision making within complex organizations with respect to uncertainty, value, efficiency, and equity. His methodological expertise is in conducting economic evaluations and outcomes research to make explicit the trade-offs involved in these complex decisions.
Pete has previously served as a Program Director, Health Economics, Market Access and Reimbursement for a Fortune 500 global healthcare services and products company, and as Associate Director of Health Economics for a global Contract Research Organization with a focus in rare and orphan diseases. His understanding of the complexities associated with health economics, as related to protocol design and site selection criteria, are critical to ensuring the developmental program successes of our client base. Pete’s contributions to our clients and their projects ensure that Cliniceval Solutions, LLC provides the highest quality health economic analytical insight when it matters most- in advance of trial conduct at the feasibility assessment phase.
Master of Science in Health Economics and Clinical Outcomes Research (HECOR) Program
Vice President, Market Strategy
Dr. Tanya Bradford is Vice President, Market Strategy for Cliniceval Solutions. She brings more than 20 years of experience in marketing and communications in the global healthcare industry, and is responsible for strategic marketing and market research initiatives in support of our client base.
Formally trained as a journalist, Tanya worked in radio and print media and was the News and Features Editor for the Australian Health and Aged Journal. Following various communications roles within the Australian government, she founded her own agency which provided specialist marketing services to public, private, and not-for-profit organizations.
Tanya earned a PhD in Synthetic Organic Chemistry from the prestigious Research School of Chemistry at Australian National University and has held various scientific and pharmaceutical industry positions of increasing responsibility. In her role as Product Manager at Baxter Healthcare (Australia and New Zealand) she led a number of projects for key markets including the USA, Canada, UK, and the Asia Pacific region in anesthesia and critical care.
Dr. Bradford’s role at Cliniceval Solutions will include the support of both academic and industry-based healthcare company market research efforts. Her focus will include global expansion of strategic marketing initiatives, market research projects, educational program development, and commercial and academic grant application strategy.
Tanya is well positioned to assist clients throughout the clinical and commercial pathways due to her exceptional analytical skills and ability to transform complex technical information into a marketing edge.
“Cliniceval Solutions, LLC delivers on the promise to develop successful, long-standing partnerships with all healthcare stakeholders, connecting clinical trial stakeholders to expedite the development of novel therapies for patients in need.“