Board certified adult neurologist MD
17+ years of clinical and academic practice experience

21+ years of biopharmaceutical experience in medical affairs, clinical development and business development

Approved Products: RELPAX (migraine), LUNESTA (insomnia), TYSABRI (multiple sclerosis), BELVIQ (obesity/weight management), RYTARY and NUMIENT (Parkinson's disease), ZOMIG NASAL SPRAY (pediatric migraine)

Clinical Development Product Candidates: JZP441 (hypersomnias), JZP150 (PTSD, ASD), TAK-341 (synucleinopathies), TAK-925 (hypersomnias), TAK-994 (hypersomnias), IPX066 (RYTARY & NUMIENT), IPX229 (ZOMIG NS for pediatric migraine), IPX159 (RLS & neuropathic pain), IPX218 (epilepsy/ARS), IPX203 (advanced Parkinson's disease), IPX231 (Parkinson's disease - abortive treatment of "off" episodes), IPX233 (ADHD), IPX234 (migraine), IPX239 (neuropathic pain), IPX240 (PD psychosis)

Clinical Development experience:

  • Development of Target Product Profile (collaboration with commercial team)

  • Phases I, II, III, IIIb, and IV studies: strategy, synopsis/protocol design, study execution as medical monitor

  • Clinical Regulatory Strategy for Development Programs

  • Study Planning and Design

  • Phases 1, 2, 3, 3b, and 4 Study Synopsis and Protocol development: extensive literature review, study design, primary and key secondary endpoints (for inclusion in package label), entry criteria,

  • Preparation of Regulatory Documents (clinical sections): IND applications, Study Protocols, Investigator Brochures (IBs), Clinical Study Reports (CSRs), FDA meeting briefing packages, New Drug Application (NDAs) preparation, Risk Evaluation Mitigation Strategies (REMS) preparation, Statistical Analysis Plans (SAPs) (editor only), MAA applications and response to clinical questions;

  • Clinical lead in face to face meetings with regulators

  • Study start-up activities: CRO selection, site selection, CRO and site training, investigator meetings (protocol training)

  • Study execution: primary medical safety monitor, data monitoring, expedited reporting of SAEs,

  • Data management and analysis (clinical lead)

  • Publication planning and development

  • Clinical data presentations at scientific meetings (AAN, MDS, AASM)

Medical Affairs experience:

  • Medical review and adjudication of promotional materials

  • Publications planning, writing, and editing (abstracts, posters, oral presentations, manuscripts)

  • Medical Information: development and editing of standard response letters (SRLs)

  • Clinical data live presentations at scientific meetings (abstract publications), advisory boards, managed care providers/payers

  • Sales force training modules development

  • Sales force training

  • Development of managed markets Dossier

  • Design and execution of large, randomized, double-blind, controlled, Phase 3B,4 Studies

  • Selection and approval of Investigator Initiated Trials (IITs)

  • Oversee, train, and manage activities of Medical Science Liaisons (MSLs)

Business Development Experience:

  • Clinical review and evaluation of several hundred product/company in-licensing opportunities

  • Due diligence visits to potential in-licensing opportunities

  • Summary reports and presentations to senior management

  • Out-licensing presentations to prospective interested customers