Led the full development teams at Pfizer and Acorda in designing, planning, implementing and executing registrational clinical trials for a rare form of epilepsy known as Acute Repetitive Seizures or Cluster Seizures.
Acute Repetitive Seizures: Intranasal Delivery of Diazepam at Acorda*
Executed clinical strategies for a novel CNS clinical program with Orphan designation and led cGCP Phase 3 clinical trials and Human Factors studies with accelerated timelines. Program terminated due to safety and efficacy signals from safety arm of trials.
Provide medical expertise to Commercial and Legal functions on marketed products and drugs. Coordinate with legal and regulatory counsel as lead Medical reviewer in Review Councils of promotional materials ensuring medical/scientific accuracy and fair and balanced presentation.
Experienced in building and maintaining professional relationships with key medical experts, researchers and academic institutions within medical/scientific community. Identified and led advisors and the planning, facilitation and conduct of scientific Advisory Boards.
Direct and oversee clinical programs, including clinical strategy, trial, design, protocol writing, Institutional Review Board (IRB) applications, site training, monitoring, documentation and data analysis. Develop, design and implement clinical protocols, data collection systems and reports.
Manage clinical studies, efficacy of clinical protocols with alignment to cGCP and ICH guidelines incorporating new BIMO ethics guidelines. Accelerated enrollment with active recruitment strategies leveraging I/E training and novel study materials.
Provide site level safety surveillance guidance, coordinate with medical monitors, and assure adherence to cGCP requirements and all applicable regulatory references and guidelines.
- Clinical Development
- Managed critical design and analytical aspects of clinical protocols and statistical analysis plans (SAPs):
- Direct and oversee clinical programs, including clinical strategy, trial, design, protocol writing, Institutional Review Board (IRB) applications, site training, monitoring, documentation and data analysis. Develop, design and implement clinical protocols, SAP development, data collection systems and reports.
- Study director for ongoing clinical programs in neurology – Acute Repetitive Seizures in epilepsy; manage clinical studies, efficacy of clinical protocols with alignment to cGCP and ICH guidelines. Accelerated enrollment with active recruitment strategies leveraging I/E training and novel study materials.
- Clinical Operations
- Led strategy and support operational aspects of clinical trial execution, data management and data analysis in partnership with program operations managers.
- Provide site level safety surveillance guidance, coordinate with medical monitors, and assure adherence to cGCP requirements and all applicable regulatory references and guidelines.
- Led conduct of two Cluster Seizure trials:
- A Study to Determine the Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel and An Open-Label, Safety and
- Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray in Adolescents and Adults With Cluster Seizures
- Medical Affairs
- Built and maintained relationships with Key Opinion Leaders and recognized thought leaders.
- Provide medical expertise to Commercial and Legal functions on marketed products and drugs. Coordinate with legal and regulatory counsel as Medical lead in Review Councils of promotional materials ensuring medical/scientific accuracy and fair and balanced presentation.
- Experienced in building and maintaining professional relationships with key medical experts, researchers and academic institutions within medical/scientific community. Identified and led advisors and the planning, facilitation and conduct of scientific Advisory Boards.
- *An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray: https://clinicaltrials.gov/study/NCT02316847
Acute Repetitive Seizures: Autoinjector Delivery of Diazepam at Pfizer: Vanquix
- 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.
- Coordinated NDA submission strategy, market research, and positioning to enable out-licensed value in the high $100sMM.
- 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.
- Led US and Canadian CNS, Oncology, Asthma, Anaphylaxis, 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.
- Represented Division at FDA for preIND, EOPII, preNDA meetings.
- Published ARS trial results:
- A double-blind, randomized, placebo-controlled trial of a diazepam auto-injector administered by caregivers to patients with epilepsy who require intermittent intervention for acute repetitive seizures: https://onlinelibrary.wiley.com/doi/abs/10.1111/epi.12373
- Safety and effectiveness of long-term treatment with diazepam auto-injector administered by caregivers in an outpatient setting for the treatment of acute repetitive seizures: https://pubmed.ncbi.nlm.nih.gov/24964913/