TOXICOLOGIST / DRUG DEVELOPER
- 30+ years in global pharmaceutical and biotechnology drug discovery and development
Pharmacology / Safety; Drug Metabolism / Pharmacokinetics (DMPK); Toxicology; Good LaboratoryPractices (GLPs); INDs; Clinical Trial Applications (CTAs); NDAs; MAAs; Internal Reports and InternationalRegulatory Filings and Interactions (IBs, CTAs, PIP); Safety Evaluation Program Operations; QA Audits /Technical Assessments; Predictive Computer Models; Presentations; Leading Cross-functional Teams;Excellent Oral and Written Communications. Therapeutic areas include pulmonary and neuromuscular diseases, oncology, and anti-infectives. Earned a BS in Biology at Purdue University and Master of Science and PhD (toxicology/pharmacology) at NC State University. Has more than 50 publications, 19 seminars and invited presentations, and 10 posters and presentations. Lifelong learner: 40 CE courses/symposia and 32 management/GLP trainings.
- Completed two successful new drug applications (NDAs) / marketing authorization applications (MAAs) for rare diseases: Kalydeco (ivacaftor) for cystic fibrosis and Exondys 51 (eteplirsen) for Duchenne muscular dystrophy (DMD).
- Designed and completed over 150 GLP and non-GLP toxicology and DMPK studies at contract research organizations (CROs) in the US, Europe, and Japan.
- Capably interacts with international regulatory agencies: US Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada, Therapeutic Goods Administration (Australia), etc.
- Filed dozens of regulatory submissions.
Owner, MPC Nonclinical Consulting Services LLC
Provide consulting services to biotechnology and pharmaceutical companies covering all aspects of nonclinical drug discovery and development.
Associate Director, Preclinical Development, Sarepta Therapeutics (Cambridge, MA)
Lead toxicologist for DMD franchise (Duchenne muscular dystrophy). Responsible for two successful IND filings for phosphorodiamidate morpholino oligomer (PMO) class of exon skipping antisense therapies: golodirsen(SRP-4053) and casimersen(SRP-4045). Authored the nonclinical sections of Module 2 for a successful NDA/MAA to treat DMD, Exondys51 (eteplirsen). Completed 15 GLP and 4 non-GLP toxicology/DMPK studies in 4+ years.
Senior Staff Scientist, then Director, Drug Safety Evaluation, Vertex Pharmaceuticals (Cambridge, MA)
Therapeutic area head for cystic fibrosis (CF) franchise. Responsible for successful NDA filing for Kalydeco (ivacaftor) and oversaw nonclinical development of other CF therapies in Phases 0-3. Completed 70 GLP toxicology and safety pharmacology studies, plus 33 non-GLP studies in 9+ years.
Senior, then Principal Research Scientist I, Exploratory Drug Safety Dept., Drug Safety and MetabolismDivision, Wyeth Research (Andover, MA)
Led Molecular Toxicology Group to conduct mechanistic toxicology studies to support selection of IND-track candidates across broad range of therapeutic areas. Helped organize industrial research consortium of drug companies to develop mechanistically based, higher-throughput toxicology screens for use in drug discovery (Affymetrix GeneChip® technology, TaqMan™ assays, and mass-spectrometry based proteomics methods for predictive toxicology).