David Mitchell, Phd Email & Phone Number

Broomfield, Colorado, United States

Interim Head of Clinical Pharmacology & Translational Medicine, 5/2024-10/2024

Alexandria, Va

Greater Denver Area

Nuventra, Inc. is a clinical pharmacology consulting firm specializing in pharmacokinetics (PK), pharmacodynamics (PD), and pharmacometrics (popPK). We specialize in helping biopharmaceutical companies find scalable solutions for emerging early phase drug development challenges, providing an unmatched combination of technical expertise and robust understanding of clinical pharmacology from a scientific, regulatory and clinical conduct perspective. Specialties include: pharmacokinetics (non-compartmental to Pop PK analysis), pharmacodynamics, clinical pharmacology (DDI, TQT, food effect, special population), clinical trial design, scientific and medical writing, regulatory affairs, and project management.

Broomfield, Colorado

Mitchell Pharmaceutical Consulting (MPC) was founded by David Y. Mitchell, PhD. Dr. Mitchell has over 30 years of pharmaceutical and biotechnology experience in clinical development, project leadership, and strategic drug development from candidate selection through commercialization. He has experience in big pharma and small biotech providing him the ability to find unique and individualized solutions for his clients. His services include development plans, protocol development and execution (Phase 1-4), pharmacokinetic analysis (clinical or toxicokinetic), regulatory documents (IBs, briefing documents, PSUR, EU renewal, label variations), and project management. If you would like more information regarding MPC, please contact Dr. David Mitchell at david.mitchell@mitchellpharma.com.

Arlington, Va

Boulder, Colorado

Boulder, Colorado

Leader of early and post-approval oncology research and development teams accountable for establishing project goals and developing clinical plan in alignment with corporate objectives. Ensured project delivery in a timely, cost effective and quality manner. Led, or participated as a key member of committees, to design and develop guidelines and process improvements.

Ann Arbor, Michigan

Development Team Leader of neuroscience team accountable for delivering on project goals and establishing a development plan in alignment with corporate goals. Served as single-point of accountability between project team and senior management. Collaborated with commercial team leader to develop a target product profile that integrated commercial needs with clinical and outcomes research. As a Clinical Sciences Team Leader, responsible for completion of clinical pharmacology studies for central nervous system (CNS) and oncology drug development candidates. Author/co-author of 5 peer-reviewed journal articles, 8 abstracts for international meetings, and a co-inventor on a patent.

Arlington, Va

Cincinnati, Ohio

Clinical Pharmacology Team Leader of 10-member multi-department team that was responsible for the design, conduct, analysis, and reporting of clinical pharmacokinetics studies. Completed human pharmacokinetics and bioavailability section for two NDA, pharmacokinetics section for two NDS, summary for European filings, and clinical pharmacology section of product label. Leader of clinical sub-team to design, implement, analyze and report pediatric studies that resulted in obtaining an additional 6-months exclusivity for a marketed product. Authored 6 peer-reviewed journal articles and presented 13 abstracts at international meetings describing the clinical pharmacokinetic attributes of therapeutic agents.

Groton, Connecticut

Kansas City, Kansas

Phd, Pharmaceutical Sciences

Ba, Biology - Major; Chemistry - Minor