President
Tenacia CP BIO Consulting, LLC
Dr. Heald has over 37 years of clinical pharmacology (CP), translational science experience, strategic marketing in the pharmaceutical & biotech industries and the FDA. He was directly responsible for the 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 was responsible for global strategic development, design and analysis of all CP Phase 1-4 studies in all therapeutic areas and global regulatory filings. Don led the CP groups in Medical Affairs at and Clinical Drug Disposition groups at Rhone Poulenc Rorer (RPR) and was responsible for the Bioanalytical, CP and pharmacometrics departments supporting global drug development and global regulatory filings. He was a Sr. Scientist at The Upjohn Company and served as a Clinical Pharmacologist for the Cardio/Renal Division at the FDA. 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 served on the Nominations and Scientific Planning Committees, Chair of the Development, Regulatory & Outcomes (DRO) Network, Strategic Planning Committee 2020-2025 and is currently serving on the Board of Directors for ASCPT. In addition, he has served in leadership positions in the IQ Clinical Pharmacology Technical Group, Society of Nuclear Imaging in Drug Development (Founding Father) and was an active member in AAPS and the International Society of Pharmacometrics (ISoP).
Disclosure information not submitted.
Tuesday, January 11, 2022
5:05 PM – 5:35 PM ET
Thursday, January 13, 2022
10:00 AM – 11:00 AM ET
Thursday, January 13, 2022
8:30 PM – 9:00 PM ET
Wednesday, March 16, 2022
6:00 PM – 6:15 PM ET
Friday, March 18, 2022
12:30 PM – 1:00 PM ET
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