Regulatory Toxicology Drug Development Strategy and ImplementationChemical classes of compounds include small molecules, natural products, oligonucleotides, and recombinant proteins IND and NDA Document Preparation Contact Laboratory Selection and Monitoring GLP Compliance Due Diligence
Experience
Over 20 years of pharmaceutical experience with demonstrated ability to lead, mentor, and manage in both small and large organizations. Directed and/or supervised the management of FDA interactions for preclinical, CMC, and clinical activities in Phase 1 through 3 development programs. These responsibilities applied to as many 40 INDs at a given time and across a variety of therapeutic areas including Oncology, Neuropharmacology, Cardio-Renal, Dermatology, Anti-Infective, Anti-Viral, Gastrointestinal, Metabolic and Endocrine, Anesthesia and Rheumatology, and Therapeutic Vaccines. Chmical classess of compounds include small molecules, natural products, oligonucleotides, and recombinant proteins.
