Chief Scientific Advisor
James D. Carlson, Pharm.D provides over 35 years of experience in the clinical research industry. Dr. Carlson co-founded the PRACS Institute, LTD in Fargo in 1983 and assumed ownership and principal investigator status in 1990. He directed the growth of PRACS, which included adding e-DC, scientific affairs, regulatory affairs, bioanalytical sample analysis, data management, business development and dermatology studies. Dr. Carlson later served as President/CEO of Algorithme Pharma USA LLC in Fargo. Dr. Carlson received his Bachelors and Doctor of Pharmacy degrees from the Universities of Iowa and Michigan, respectively, and as a Clinical Pharmacy Residency from Buffalo General, NY. At AXIS Clinicals, Dr. Carlson aids in enhancing our clinical and bioanalytical services to support various studies while facilitating study designs and project execution of these programs. He is a member of the American Association of Pharmaceutical Scientists and the North Dakota Pharmaceutical Association.
Michael Willett , Pharm. D. RAC
Senior Advisor, Clinical & Scientific Affairs
Michael S. Willett, PharmD, RAC provides more than 30 years of experience in clinical research. Dr. Willett started his career in a progressive hospital providing critical care, cardiology, infectious disease, nutritional team support and therapeutic drug monitoring. He transitioned into the industry and was involved in all phases of clinical research and multiple product launches at Marion Laboratories and Bristol-Myers Squibb. He moved to the CRO side of the industry in 1992 and founded Advanced Biomedical Research, Inc. (ABR) in 1994. ABR was a full-service Phase I-IV CRO and 72-bed Phase I-II clinical pharmacology unit focused on innovator compounds and complex studies. With an outstanding team of people, he built ABR into a medium-sized CRO and sold it to Frontage Laboratories in 2008. He then established Ready Clinical, LLC in 2009 as a clinical and regulatory consultancy. Dr. Willett received his Bachelor and Doctor of Pharmacy degrees from University of Illinois and completed an adult internal medicine residency at Truman Medical Center in Kansas City. He has maintained a regulatory affairs certification from Regulatory Affairs Professional Society (RAPS) since 2010. At AXIS Clinicals, Dr. Willett provides senior scientific input into the design and execution of early phase clinical trials. He is a member of RAPS and the Drug Information Association.
Chief Executive Officer
Mr. Dinkar brings experience from over 20 years in building and developing organizations. With that, he has developed business and organizational design plans, and has executed these in all phases of organizational maturity. Dinkar has held many leadership positions in the CRO, Pharmaceutical, Engineering, and Railroad industries. He has led teams in International Commercial Operations, Business Development, and General Management. Dinkar holds a Masters Degree in Business Administration and a Bachelors Degree in Engineering.
Senior Vice President, Bioanalytical Operations
With over 25 years of experience in the Bioanalytical field, Mr. Khadang provides overall direction of the Bioanalytical Division, offering hands-on leadership in the areas of method development, analytical method validation, and sample analysis. Mr. Khadang has held numerous leadership positions at major global CRO’s by leading teams in the bioanalytical techniques including mass spectrometry, chromatography, and automation. Over the last two decades, he has developed and/or overseen hundreds of LC/MS-MS methods and authored several publications. Mr. Khadang received his B.S. in Analytical Chemistry from Concordia University in Montreal, Quebec. He is a member of the American Society for Mass Spectrometry and the American Association of Pharmaceutical Scientists.
Vice President, Clinical Operations
Pete Boldingh, Pharm.D. has over 12 years in the clinical research industry. He has held past management positions with PRACS Institute, Ltd., Webber and Judd Pharmacies, and Vibra Hospital Pharmacy. Currently, Dr. Boldingh oversees clinical study scheduling and management. His oversight includes pharmacy operations, training, SOP’s and strategic planning for clinical operations. He has served as principle or sub-investigator on clinical projects for over 20 years. Dr. Boldingh is a registered pharmacist in Minnesota and North Dakota. He received his Doctor of Pharmacy degree from North Dakota State University, Fargo. He is a member of the Minnesota Pharmaceutical Association, North Dakota Pharmaceutical Association and the Association of Clinical Research Professionals.
Senior Vice President, Business Development
As a collaborative business development executive, John Pottier has over 25 years of leadership experience within the contact research industry. Identifying and implementing sales and marketing strategies, John has built business models to serve the pharmaceutical markets’ research and development requirements of bioequivalence, 505(b)(2), and pharmacology programs. Facilitating business development initiatives, John addressed clinical research markets within areas of dermatology, cardiac safety, diabetes, and neurology/psychology for ANDA and NDA regulatory filings. John earned a Bachelor of Science Business degree with a major in Marketing and is a member of American Association of Pharmaceutical Scientist, Drug Information Association, and Associates for Affordable Medicines.
Director, Quality Assurance
Amy Karels brings with her a rich experience of 16 years in clinical research with 11 of those years as a Senior Clinical Coordinator. As a Senior Clinical Coordinator, she worked on a multitude of clinical projects and gained in-depth working perspective on clinical studies. Amy was also involved in many sponsor visits and responded to questions raised during these visits. In addition, she has worked with many disciplines to assure timelines were met and a quality product delivered. For the past year, Amy has been with the Quality Assurance Department with AXIS Clinicals.