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

Charles Grudzinskas, PhD

Practice Area Focus

  • Regulatory and Development Strategy
  • FDA Interactions and Meetings
  • Clinical Study Design
  • Drugs & Biologics
  • Pain Treatments
  • Abuse Liability
  • Tobacco Products
  • Combination Products
  • Animal Rule Pathway
  • Intellectual Property Evaluations & Litigations
  • Due Diligence

Biography

Charles Grudzinskas, PhD is a founder and Partner in NDA Partners. He has provided expert consulting to numerous biotechnology companies and organizations including the Center for Drug Development Science (CDDS) located at UCSF, and MdBio, an organization dedicated to promoting the success of bioscience companies in Maryland. His drug development career includes positions as Vice President, Medications Development and Project Management at GD Searle and Company (now Pfizer), and Director, New Product Management at Lederle Laboratories (now Pfizer). While at Lederle, he was the Project Director for three drug approvals: Pipracil, Novantrone and oral calcium leucovorin. Prior to joining Searle, Dr. Grudzinskas was the first Director of the Medications Development Division of the National Institute on Drug Abuse (NIDA) at the US National Institutes of Health (NIH). Dr. Grudzinskas is the Chair of the Curriculum Committee and a faculty member of the American Course of Drug Development and regulatory Science (ACDRS). Dr. Grudzinskas was a faculty member of the NIH courses "Principles of Clinical Pharmacology" and "Principles of Clinical Research," was the course director for the PERI Drug Development Course, and was a founding faculty member of PERI courses in Project Management and "The NDA Simulation," as well as a PERI faculty member for R&D Finance, Clinical Trials, and Primer for New Physicians and Scientists. Dr. Grudzinskas is a registered US Patent Agent.