PHARMACOLOGY, DRUG DISCOVERY, DRUG INFUSION DEVICES & NONCLINICAL DRUG DEVELOPMENT 
PERSONAL PROFILE
- Pharmacologist / implantable device scientist / consultant with 25+ years in pharma drug discovery / development and medical devices.
EXPERTISE
Pharmacology, Nonclinical Drug Discovery / Development, Management / Leadership, Regulatory Filings
(IND / NDA), Grant Applications, and Collaborations. Therapeutic and Technical Specialties: Neuroimmunology, Glial Biology, Neuropathic Pain, Analgesic Drug Discovery / Development, Translational Model Development, Implantable Intrathecal / Epidural Drug-delivery Devices. Has over 45 peer-reviewed publications
(cited > 2700 times) and holds five issued patents.
PROFESSIONAL EXPERIENCE
Principal, Skyline Biopharma, LLC
Support clients in 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.
Principal Scientist, Pharmacology, Acorda Therapeutics
Managed, mentored, trained, and provided guidance and vision to nonclinical pharmacology group studying neurologic disease. Assessed primary / secondary pharmacology, ADME, and PK / TD / PD relationships for biologics and small molecule therapeutics. Directed multiple BS and PhD research staff in development of translational models and new indication proof-of-concept. Elaborated key mechanistic insights for cimaglermin and rHIgM22 programs. Prepared nonclinical sections and/or post-filing activities (INDs, IBs, NDAs, annual reports, etc.) for cimaglermin, rHIgM22, Qutenza/NP-1998, intranasally-administered diazepam, inhaled L-DOPA and ZOLMitriptan products. Provided direction in the formulation and execution of external collaborations. Reviewed (due diligence) and prioritized in-licensing candidate therapeutics.
Senior Scientist, Analgesic Drug Discovery, Johnson & Johnson
Served as Biology Project Champion / Discovery Program Leader for TRPM8 and TRPV1 antagonist therapeutics. Conducted seminal experiments establishing TRPM8 as the primary sensory transducer of environmental cold. Established novel in vivo models to screen compounds, assess therapeutic efficacy, and verify target engagement for multiple indications. Represented analgesic therapeutic area on Compound Development Teams. Progressed multiple first-in-class compounds into early development. Established translational models to improve efficiency of Phase 1 studies.
As in vivo Pharmacology Group Leader, supervised four to six associate scientists. Worked with project leaders to develop screening and therapeutic efficacy test strategies for each target. Provided extensive pharmacologic characterization for all analgesic compounds advancing to early development. Provided scientific and technical consultation to academic and industrial collaborators. Studied drug candidate repositioning by assessing breadth of therapeutic efficacy across a broad battery of in vivo tests. Performed due diligence roles for in-licensing opportunities by vetting concepts / compounds in-house.
Director R&D, NeuroDelivery Technology
Contributed to the design, patenting, and FDA 510K approval of the ESP® Combined Spinal Epidural Needle, a dual cannula needle designed for safe combined intrathecal and epidural anesthesia / analgesia. Sourced and specified manufacturing (injection molding, laser welding), cleaning, sterilization, packaging, FDA approved labeling, and the generation of marketing materials. Designed and tested product line extensions, including catheters, kits, and autoclavable polymer needles. Worked with CEO to obtain SBA funding and field licensing enquiries.