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