(Research Triangle Park, N.C.) Fast becoming the pharmaceutical industry’s go-to resource for pharmacokinetics (PK), ClinPharm Consulting, LLC is pleased to announce the addition of David Y. Mitchell, Ph.D. to its experienced team of drug development professionals. Currently serving as President of the American Association of Pharmaceutical Scientists (AAPS), Dr. Mitchell strengthens ClinPharm’s core competencies in PK and clinical pharmacology, with regulatory affairs, medical writing, protocol development, and strategic planning services to help navigate client companies down the complex path to marketing approval. “Dr. Mitchell is an accomplished pharmacokinetic and drug development consultant and we are very pleased to have him bring his professional and scientific talents to ClinPharm,” said Geoffrey Banks, Ph.D., ClinPharm President and CEO. Over the past 20 years Dr. Mitchell has guided projects at Array BioPharma, OSI Pharmaceuticals, and Pfizer, and has directed clinical pharmacology programs at Pfizer and Procter & Gamble Pharmaceuticals in the areas of oncology, neuroscience, and bone disease. He has published over 60 manuscripts, chapters, and abstracts in the areas of pharmacokinetics, metabolism, toxicology, and epidemiology.
“As ClinPharm’s Vice President and Executive Consultant of Clinical Pharmacology and PK, Dr. Mitchell will enable clients to conduct more effective human clinical trials by taking complex pharmacokinetic principals and making them understandable and usable for common sense drug development,” Dr. Banks explained.
ClinPharm services include traditional (rich sampling) non-compartmental and compartmental PK analysis using WinNonlin (i.e., characterization of PK parameters) in addition to population pharmacokinetics (sparse sampling). ClinPharm also provides services related to clinical protocol/study design development, authoring clinical/PK/PD study reports and standalone PK/PD reports, brainstorming clinical pharmacology strategic plans, and engaging in a wide array of regulatory writing associated with clinical pharmacology aspects of regulatory submissions (briefing documents, INDs, NDAs etc.).
Drawing from his background working with large pharma and small biotech firms, Dr. Mitchell’s clinical pharmacology knowledge and strategic drug development vision will provide significant value to ClinPharm’s clients.
“I look forward to working with ClinPharm Consulting. Geoff Banks and Alex Shaw have assembled an excellent staff and leadership team. The consultants at ClinPharm strive to meet or exceed their Client’s expectations, and they take pride in providing the very best Clinical Pharmacology services at a reasonable cost,” Dr. Mitchell said. “In addition, I like their ability to meet the specific needs of the client, tailoring their project proposals with options for the client, and ensuring that not only is the project completed in a timely manner, but that the final product fits well into the scope of the overall drug development program.”
By organically growing its team of veteran consultants with proven industry professionals like Dr. Mitchell, ClinPharm is able to expand its breadth of experience and offerings to clients.
Receiving his bachelor’s in biological sciences from the University of Northern Colorado and his doctorate in pharmaceutical sciences from the University of Colorado, Dr. Mitchell completed a postdoctoral fellowship in metabolism and toxicology at the University of Kansas Medical Center. He began in the pharmaceutical industry in 1990 at Pfizer Inc. as a research scientist in the Drug Metabolism Department, joining Procter & Gamble Pharmaceuticals in 1992 as a pharmacokineticist in the Clinical Pharmacology and Pharmacokinetics Department, then moving to Parke-Davis (now Pfizer Inc.) as a senior research associate in the Clinical Pharmacokinetics and Pharmacodynamics Department in 1999. Dr. Mitchell was promoted to senior director in the Medical and Development Sciences Department in 2003 and led research and development lines of a CNS project team. In 2005, he became a director at OSI Pharmaceuticals, leading the development lines of an oncology project team, and in 2007 he became a director and department head in Project Planning & Management at Array BioPharma. Mitchell opened his own consulting firm in early 2009, with his primary focus on clinical pharmacology.
Prior to serving as AAPS President, Dr. Mitchell has served as President-Elect and Member at Large on the Executive Council, the co-chair and chair of the AAPS Annual Meeting, and chair of the Program Coordination Committee. Additionally, he has served as vice-chair, chair-elect, chair, and past chair for the Pharmacokinetics, Pharmacodynamics and Drug Metabolism Scientific Section. A professional, scientific association of approximately 12,000 members employed in industry, academia, government, and other research institutes worldwide, AAPS is the premier organization of all scientists dedicated to the discovery, development, and manufacture of pharmaceutical products and therapies through advances in science and technology. In addition to leading AAPS, Dr. Mitchell is also active in the American Society of Clinical Pharmacology & Therapeutics as well as the American Society of Clinical Oncology.
To learn more about the ClinPharm team of clinical pharmacology and PK professionals visit www.clinpharmconsulting.com.
About ClinPharm Consulting
ClinPharm Consulting, LLC is a clinical pharmacology consulting firm specializing in pharmacokinetics (PK). Fast becoming the pharmaceutical industry’s go-to resource for PK, ClinPharm gives pharmaceutical companies and CROs rare access to a hands-on team of leading clinical pharmacology and PK professionals experienced in a multitude of therapeutic areas. We embrace the notion that simplicity and clarity lead to good decisions by taking complex PK principals and making them understandable and usable for common sense drug development. ClinPharm’s flexible business structure enables us to integrate with our clients and help them maximize the potential of clinical pharmacology studies and PK analyses to pave the way toward marketing approval. For more information visit www.clinpharmconsulting.com.