Experience in design and conduct of clinical trials targeting Status Epilepticus stems from pulmonary drug delivery and autoinjector delivery of agents that rapidly reach targeted Tmax and Cmax in the CNS. For a pulmonary drug delivery startup focused on CNS targets. I tripled company size and attracted over $120MM in clinical development funding from Merck and DoD. Direct reports included pulmonologists, R&D personnel, regulatory affairs, engineering and PM colleagues conducting preclinical, non-clinical, cGCP Phase 1-2 trials in neurology and clinical immunology. Company underwent bankruptcy and acquired by Teva.
Clinical Development: Epilepsy
- Authored clinical protocols for status epilepticus to evaluate the safety and tolerability of atropine dry powder inhalation (Clinical Labs testing, Pulse, Pulse Oximetry, Temperature, Heart Rate, Pulmonary Function Tests, Respiratory Rate, Near Point of Accommodation, Pupil Size for the development of a chemical weapons mediation inhaler.
- Authored clinical protocols to characterize pharmacokinetic endpoints for atropine dry powder inhalation (Cmax, Tmax, AUC) and comparison to intramuscular pharmacokinetics integrating sampling intervals, sampling duration, bioanalytical methods development, transfer and implementation at clinical sites.
- Study director for Atropine Dry Powder Inhaler (ADPI) clinical trials and lead investigator signatory for clinical protocol, IB and CMC sections.
- Performed data review and analysis of clinical data, authoring and editing of clinical study reports.
- Proactively managed interagency interactions and communications (NCI, Military HSRRB, FDA) to regulate impact on FDA decision processes.
Clinical Operations
- Coordinated CRAs, Research Investigators and physician roles in clinical trials. Acquired IRB approvals from clinical sites. Secured HSRRB approvals and coordinated IRB-HSRRB interactions for updating clinical protocols, investigational brochures, consent forms, CRFs, AE forms, ClinicalTrial.gov registration and post-trial follow up.
- Managed clinical research monitoring companies, assured cGCP compliance with clinical monitors, clinical research assistants, clinical site pharmacies, and provide oversight of clinical trial management.
Pfizer: Midazolam Autoinjector for Status Epilepticus (RAMPART)
Led collaborative clinical research between Pfizer, BARDA, DoD, academic centers resulting in registrational approval of Seizalam.
- Clinical Affairs
- Accelerated enrollment for GABAA receptor clinical phase asset at key sites to complete Phase III clinical trial within one year and transformed asset value from $50MM/yr to $160MM/yr. Published clinical results within one year of trial completion. Drove regulatory strategy to acquire Orphan Designation. Coordinated NDA submission strategy, market research, and positioning to enable out-licensed value in the high $100sMM.
- Transformed high potency GABAA receptor anticonvulsant program leading Pfizer clinical, regulatory, and legal to align with academic centers and build coalitions (NIH, BARDA, DoD).
- Championed, led, and delivered novel approaches for the treatment of refractory epilepsies. Spearheaded the benzodiazepine clinical development and regulatory strategies.
- Medical Affairs
- Led US and Canadian CNS and Epilepsy National Advisory Boards to provide R&D guidance from preclinical through clinical drug development, market development and communication strategies for emergent and chronic disease areas.
- Provided medical and clinical due diligence on business development initiatives, M&A (Innopharma), out-licensing, and divestitures.
- Managed medical reviewers with legal and regulatory counsel for Review Councils of promotional materials, ensuring medical/scientific accuracy and fair and balanced presentation.
- Research & Development
- Advanced collaborative translational, non-clinical, preclinical, and clinical research through late-stage NDA programs with direct and indirect management of neurologists, clinicians, clinical scientists, and engineers in CNS, Clinical Immunology, Endocrinology, and Oncology. Total clinical development asset base exceeded $400MM in annual revenue within five years.
- Coordinated R&D initiatives with internal and external IP counsel for prosecution and litigation strategies, technical assessments on interference, educating litigation counsel on clinical, medical and scientific concepts, market dynamics, and competitor activity.
- Delivered on P&L for R&D with compliance oversight (Sarbanes-Oxley). Acquired Government R&D and clinical funding for CNS programs (>$80MM).
- Transcended limits to incorporate nationwide community Informed Consent 3rd party trial data and hospital data into anticonvulsant NDA with a $60MM clinical development contract from BARDA.
- Clinical and Medical Affairs
- Trained across Pfizer R&D, legal, clinical, medical and regulatory affairs SOPs.
- Represented Division at FDA for preIND, EOPII, preNDA meetings.
- Led Orphan Drug strategy and acquired Orphan designations for Acute Repetitive Seizure and Status Epilepticus clinical programs including development of epidemiologic data in OOPD applications.
- Compiled Pfizer position on FDA draft guidance expanding use of Animal Rule from countermeasure clinical development to all therapeutic areas.
- Developed HFE formative and summative trial strategies to meet new DMEPA/CDRH requirements for both civilian and DoD programs.
- Guide corporate counsel on contractual agreements including those for vendors, University collaborations, Alliance partners, regulatory CROs, clinical CROs and academic consultants.