PHARMACOLOGY, NONCLINICAL SAFETY, NONCLINICAL DRUG,
- Pharmacologist / safety scientist / director with 24+ years in pharma drug development.
Pharmacology/Safety (toxicology), Nonclinical Drug Discovery / Development, Management / Leadership, Regulatory Filings (IND / NDA), Nonclinical Support of Clinical Trials (Phases 1-2), Post-marketing, In-licensing, Business Development, Grant Applications, Collaborations, and Budgets. Therapeutic and Technical Specialties: Cardiovascular, CNS, Oncology, Renal, Diabetes / Endocrine, Immunology.
Has over 40 peer-reviewed publications and over 50 abstracts, 19 invited presentations and seminars; worked on 4 approved product programs, 9 in-licensing / business development products, and holds nine patents.
Founder and Principal, Skyline Biopharma, LLC
Support clients’ nonclinical development study design, placement, and monitoring. Provide business strategy, target product profile development, project management, biomarker identification and development, business development, SBIR / STTR grant-writing, pre-IND / IND section writing, translational medicine, biomarkers, clinical pharmacology, and PK/PD analysis.
Senior Director, Pharmacology and Safety, Acorda Therapeutics
Directed nonclinical pharmacology / safety assessment studies in heart failure and neurologic disease. Assessed primary and secondary pharmacology, ADME, PK and dose-ranging toxicology including post-marketing studies. Designed and monitored non-GLP and GLP studies: CRO selection and monitoring, dose ranging, single- and multi-dose toxicology (including toxicokinetics), safety pharmacology, abuse potential, and reproductive and juvenile toxicology. Managed vivarium facility design, SOP development, AAALAC-I accreditation, animal care staff, and IACUC activities support. Member of senior management team managing multiple BS, MS, MD, and PhD research staff. Prepared nonclinical elements for regulatory submissions (INDs, NDAs, annual reports, meeting packages, fast track applications, study reports, etc.). Advanced cimaglermin, rHIgM22, intranasally administered diazepam, dalfampridine (stroke), AC-105 (PEG-magnesium) and inhaled zolmitriptan development programs. Prepared nonclinical sections and/or post-filing activities for cimaglermin, rHIgM22,
AC-105 (PEG-magnesium), intranasally administered diazepam, inhaled L-DOPA and zolmitriptan products, and post-marketing activities (reporting of required nonclinical studies to FDA) for Ampyra (dalfampridine-MS) and Zanaflex (tizanidine). Identified, reviewed (due diligence), and prioritized in-licensing candidate therapeutics.
Principal Scientist, Vascular Research and Metabolic Diseases Drug Discovery, Johnson & Johnson
Planned and executed primary pharmacodynamic and safety studies in metabolic and cardiovascular diseases. Developed animal models, characterization, and validation. Worked on nonclinical program supporting joint rivaroxaban (Xarelto) development program with Bayer. Supervised in vivo pharmacology BS/MS/MD staff. Drafted preclinical reports for regulatory submissions. Performed preclinical drug discovery and formulation support for restenosis, vulnerable plaque, and other vascular indications, and evaluated new technologies and mechanistic studies for sirolimus-eluting stent platform (Cordis). Responsible for preclinical animal model development and cell culture studies supporting drug coated-stent therapeutics. Submitted intellectual property claims and patent applications (Cordis).
Senior Scientist, Preclinical Development / Antibody Development, Human Genome Sciences
Preclinical discovery and development in oncology, inflammation, autoimmunity, endocrinology and cardiovascular disease. Conducted preclinical pharmacology studies supporting target discovery, target validation efforts, and identification of new indications for therapeutic proteins. Drove nonclinical and GLP preclinical toxicology program for repifermin (keratinocyte growth factor-2) through Phase 2.