President
Tenacia CP BIO Consulting, LLC
Dr. Heald has 37+ years working in clinical pharmacology (CP), pharmacometrics, translational science experience, strategic marketing in the pharmaceutical & biotech industries and the FDA. He was directly involved in writing or approving CP sections in 46 approved NDAs and global regulatory submissions. Prior to starting his own consulting company in 2020, Dr. Heald worked at Janssen Biotherapeutics (J&J) as Head of Discovery Translational Sciences and his group was responsible to help identify lead candidates, conduct experimental pharmacology studies and determine the FIH starting dose and prediction of an efficacious dose for biologics across all therapeutic areas. Prior to Janssen Biotherapeutics, Don served as VP and Global Head of Clinical Pharmacokinetics at J&J R&D and his group was responsible for global strategic development, design, analysis and reporting of all CP Phase 1-4 studies in all therapeutic areas and global regulatory filings. Don led the CP groups in Clinical Drug Disposition and in Medical Affairs at Rhone Poulenc Rorer and was responsible for the Bioanalytical, CP and pharmacometrics departments supporting global drug development and regulatory filings. He was a Sr. Scientist at The Upjohn Company and also served as a Clinical Pharmacologist for the Cardio/Renal Division at the FDA. While at the FDA, Don established the computer assissted NDA which began the electronic filing of NDAs. Dr. Heald earned MS (pharmacology) and PhD (pharmaceutical sciences (PK/PD)) degrees from West Virginia University. He has over 65 publications, 70 poster presentations and invited speaker over 40 times and has received numerous awards. Don has served on the Nominations and Scientific Planning Committees, Chair of the Development, Regulatory & Outcomes (DRO) Network, Strategic Planning Committee 2020-2025, mentored the ST community for the past 4 years and served on the Board of Directors and Finance Commitee for ASCPT.
Wednesday, May 28, 2025
3:00 PM - 4:00 PM East Coast USA Time