A pharmaceutical drug development expert witness and consultant with more than 20 years of experience, this expert specializes in drug discovery and development, with additional expertise in clinical pharmacology, DMPK/ADME, pharmacokinetics and pharmacodynamics, pharmaceutical regulatory affairs, and FDA compliance. Experience spans small molecules, biologics, oligonucleotides, peptides, antibody-drug conjugates, and long-acting injectables across discovery, nonclinical development, clinical development, and regulatory review. Technical expertise includes bioanalysis, bioavailability and bioequivalence, formulation development and drug delivery, in vitro release testing, nonclinical development and GLP compliance, clinical trials and GCP compliance, translational medicine, and drug safety and pharmacovigilance.

In pharmaceutical litigation, the expert provides expert witness and scientific consulting support, with documented engagements involving antitrust litigation, patent litigation, complex pharmaceutical formulation technology, and civil litigation. Current litigation consulting has included scientific expertise in dissolution and stability testing, bioavailability and bioequivalence, pharmaceutical formulation, facility inspections, and regulatory matters. Broader litigation-related capabilities encompass scientific data interpretation, product liability claim evaluation, new and generic drug development, intellectual property and patent-related analysis, DMF-related issues, drug safety assessment, clinical trial conduct, ANDA litigation and generic drug-development issues, and report writing and deposition preparation.

Drawing on more than seven years as an FDA clinical pharmacologist and inspector, the expert has substantial regulatory review and inspection experience. Responsibilities included reviewing clinical and nonclinical pharmacology data supporting INDs, NDAs, BLAs, biosimilars, amendments, and supplements, as well as conducting premarket inspections of clinical and bioanalytical sites in the United States and internationally. Regulatory review and inspection experience encompasses bioavailability and bioequivalence, pharmacokinetics and pharmacodynamics, safety and efficacy, immunogenicity, and data integrity, along with supporting cGMP inspections. The expert also contributed to revision of the FDA Bioanalytical Method Validation Guidance for Industry and has experience with FDA and EMA requirements and GCP, GLP, USP, ICH, and applicable federal regulations.

Leadership across pharmaceutical research and development includes current service as a Principal Consultant and prior responsibility as Director of Clinical Pharmacology and DMPK, leading and supporting drug development programs from clinical pharmacology and DMPK perspectives. Responsibilities have included dose and dosing-regimen assessments, design and oversight of nonclinical and clinical pharmacology studies, evaluation of pharmacokinetic and safety/efficacy relationships, and preparation of regulatory documentation and submissions. Earlier experience includes leadership of scientific teams conducting pharmacology, bioanalytical, PK/PD, formulation, and drug-development work, as well as service as a Study Director for GLP toxicokinetic and toxicology studies. Drug-development experience encompasses oncology, type 2 diabetes, CNS and Parkinson's disease, pain and inflammation, COPD, inflammatory bowel disease, tuberculosis, and ocular diseases.

Professional qualifications include a Ph.D. in Pharmaceutical Sciences, Master of Science in Pharmacology and Bioassay, and Bachelor of Science in Pharmaceutical Sciences, supplemented by postdoctoral training in pharmacology and pharmacokinetics and a Regulatory Affairs Certificate. The expert is also pursuing graduate study in pharmacometrics. Additional scientific credentials include status as a patent holder, authorship and coauthorship of peer-reviewed scientific publications, service as a scientific peer reviewer for multiple journals, and membership on several scientific editorial and advisory boards. Professional affiliations include the American Association of Pharmaceutical Scientists (AAPS), International Society of Pharmacovigilance (ISOP), and International Pharmaceutical Federation (FIP).