NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Anthony R. DiSanto, PhD

Practice Area Focus

  • Phase 1 Development
  • Biopharmaceutics/ Formulation Development
  • Pharmacokinetics/ Clinical Pharmacology
  • Bioequivalence

Biography

Dr DiSanto has most recently been involved assessing and implementing to final report the bioavailability/pharmacokinetic studies to meet the Biopharmaceutic-required studies for 505(b)(2) to the development of NCE's from IND onward. His scope of involvement in the drug development process has included early interaction with marketing research to implementing the manufacture of the bulk drug for preclinical pharmacology, toxicology, formulation development, up to the contracting of phase I/II clinical studies. His prior experience has been as Vice President, Worldwide Drug Delivery Research & Development for the Upjohn Company; Vice President Research and Development for Somerset Pharmaceuticals, Inc.; and Vice President, Drug Development for Alamo Pharmaceuticals, LLC. He holds 15 patents and has authored or co-authored numerous articles on clinical pharmacology, pharmacokinetics, and bioavailability.