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

Stephanie Greene, PhD

Practice Area Focus

  • Drugs
  • Biologics
  • Devices
  • Drug Safety
  • Toxicology
  • Regulatory Submissions
  • Development Strategy
  • PKPD
  • Project Management

Biography

Dr. Stephanie Greene joined NDA Partners in 2017 as a nonclinical drug development expert with a specialty in small molecules, biologics and devices.

Dr. Greene was formerly Senior Director, Pharmacology and Toxicology at MannKind Corporation, where she was responsible for nonclinical sections of NDAs, CTAs and INDs for oncology and metabolic disorders, and served as study director for in-house GLP toxicology studies. As Associate Director, Toxicology at Amgen she filed the first eCTD along with multiple INDs for oncology and diabetes indications, and was the PharmTox representative on metabolic disorders, cardiovascular disease, and oncology licensing teams. At Pharmacia (formerly Miravant Pharmaceuticals), she was Senior Scientist, New Drug Screening, where she developed animal models of disease and xenograft models.

Dr. Greene has 20-years’ experience in preclinical drug development, safety assessment, study directing and monitoring, regulatory support, and portfolio licensing. Over her career, she directed and monitored several hundred GLP toxicology studies, authored the nonclinical sections of more than 25 INDs/CTAs, filed 5 NDA/eCTDs for oncology and metabolic disorder therapeutics, and authored nonclinical sections of investigator brochures, package inserts, annual reports (DSURs), safety assessments and white papers.