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

Diego Wyszynski, MD, MHS, PhD

Practice Area Focus

  • Pharmacovigilance
  • Pediatric Drug Development
  • Drug Safety in Pregnancy and Lactation
  • RMP/REMS/PBRER
  • Epidemiology

Biography

Dr. Diego Wyszynski joined NDA Partners as a Premier Expert consultant in 2015. He is the founder and Chief Executive Officer of Pregistry, LLC, an organization that maintains a registry of pregnant women and provides useful information about medications and vaccines used in pregnancy and lactation and was formerly Global Safety Medical Director and Head of Maternal & Pediatric Safety at Amgen.

Dr. Wyszynski is an experienced medical pharmaco-epidemiologist and pharmacovigilance professional with industry-leading expertise in drug safety during pregnancy, lactation, and the pediatric period. He was a member of the FDA Expert Panel on Pregnancy Registries, has developed guidelines for industry for contraception and lactation language in clinical trials, has prepared numerous safety documents for NDA submissions worldwide, and has been responsible for the design, execution and monitoring of many population-based observational studies. His main areas of therapeutic experience include oncology, cardiovascular, inflammation, respiratory and neurology.