This opportunity at a pulmonary drug delivery startup focused on CNS and Clinical Immunology targets using a novel piezoelectric driven dry powder inhaler. Leveraging prior expertise in pharmaceutical development, CMC, engineering skills, I built out the clinical trial infrastructure starting with the company’s first IND filing and tripled company size and attracting over $120MM in clinical development funding from Merck and US-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
- Authored clinical protocols 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.
- Spearheaded novel RSV antiviral NME (ViroPharma) evaluation for acquisition strategy by providing IP due diligence, competitor analysis, NME developability, Phase I clinical trial data review, IND filing analysis, FDA commentary review, acquisition to IND/NDA filing budgeting and clinical trial strategy through NDA. Identified QT prolongation in human subjects as a key concern in further development of in-licensed agents.
- 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.
- Led analytical methods development, formulation development, clinical supply operations, CRO and CMO management for two parallel Merck clinical trials titled ‘Randomized, Placebo-Controlled Clinical Trials (Phase I and II) to Study the Safety and Bronchodilatory Effect of MK-0476 and Mometasone in Patients with Chronic Asthma’.
- Improved internal and external operations with CRO/CMO’s including, clinical supply operations, external cGLP/cGMP labs and cGMP device manufacturer’s clinical trials. Led resource management of cGMP clinical supply operations and drug product supply chain to clinical trial sites. Proactive coordination of clinical supply operations, rigorous oversight of CRO/CMO operations led to successful CSO and clinical trial execution.
- Responsible for clinical product release for all commercial and military programs in Phase I through Phase III.
- Managed clinical research monitoring companies, assured cGCP compliance with clinical monitors, clinical research assistants, clinical site pharmacies, and provide oversight of clinical trial management.
Research and Development
- Grew R&D from $3MM/year budget with half at risk of termination to $18MM/year guaranteed drug development funding through 2015.
- Led Pharmaceutical Development Group (PDG) with Analytical Chemistry, Formulation Development and Aerosol Device Optimization departments with financial, line, program management and laboratory infrastructure responsibility of 25 experienced pharmaceutical scientists and senior R&D managers with three directors and two managers.
- Originated novel dry powder formulations for pulmonary drug delivery of proprietary and generic API. Instituted state-of-the-art approaches in solid state chemistry to enhance dry powder inhalation formulation design. Initiated technology innovation in device design and optimization, high throughput impactor methods to reduce drug/device development cycle time, Cohesive/Adhesion Balance Theory approaches for novel inhalation dry powder formulation development and novel blister filling methods for metered dose electronic pulmonary inhalers.
Regulatory Affairs
- Acquired previously filed NDAs from FDA through Freedom of Information Act to harness regulatory guidance, garner future development insight, build risk management base and generate risk mitigation plans. Critical review of prior filed NDAs led to FDA concerns of long-term API instability and propensity to microbial contamination.
- Compiled pre-IND Briefing Package for combination of enalapril and metformin to treat co-morbidity in hypertension and diabetes. Led pre-IND meeting focus to limited design of the pharmaco-dynamic study with defined clinical endpoints for Diastolic blood pressure and Glucose (HBA1C). Acquired three-year exclusivity with no toxicology/pharmacology studies and 505(b)(2) submission.
- Wrote, compiled and submitted entire INDs, Investigational Brochures, CRF’s, Clinical Protocols, CMC, 510(K), device GMP with expertise in oncology, metabolic, antiviral, neurological and respiratory diseases.
- Authored ADPI IND within two (2) months and submitted filing within 3 months including clinical site and funding agency review. Attained ‘Safe to Proceed’ letter within 20 days of filing from FDA program manager.
- Headed FDA-clinical site interaction, strategy, trial progress and communications. Coordinated clinical monitoring CRO’s to optimize R&D trials throughput and to provide time critical program deliverables for startup companies and fully integrated pharmaceutical companies from molecular concept through NDA.