TRANSLATIONAL RESEARCH, CLINICAL DEVELOPMENT, &
BIOMARKERS 
PERSONAL PROFILE
- 40 years as a physician.20+ years of translational research and bioanalytics experience in biotech and pharma.
EXPERTISE
Preclinical Development; Translational, Molecular, and Cellular Research; Nonclinical Development Study Design; Pharmacology; Biotherapeutic Manufacturing; SBIR / STTR Grant-writing; Pre-IND / IND Writing; Biomarker Identification; Bioanalytics, Informatics, and Data Analysis, In Vivo Studies; and Imaging.
Seven invited seminars, and more than 40 publications, reviews, chapters, and abstracts.
PROFESSIONAL EXPERIENCE
Principle Consultant, Skyline Biopharma, LLC
Supports clients’ nonclinical development study design, biotherapeutic manufacturing processes, SBIR / STTR grand-writing and submission, pre-IND and IND section writing, and translational biomarker identification.
Senior Scientist / Scientist, Cellular Neuroscientist, Manager, Acorda Therapeutics
Conducted and managed research focused on preclinical characterization and validation of biologic-based therapeutics for neurological and cardiac indications. Managed direct reports (BS, MS, and PhD levels) and led multi-disciplinary projects with in-house groups and external programs with academic collaborators and CROs. Developed necessary analytical methods and provided subsequent data and information supporting investigational new drug (IND / NDA / interim FDA) submissions and go / no-go decisions on drug candidates. Reported to R&D (including VP of Research and CSO) and Scientific Advisory Board on research progress obtained with cell- and molecular-based studies aimed at predicting mechanism of action and pharmacological / toxicological properties of drug candidates. Contributed to 2 successful IND applications and supported numerous Phase 1/2 clinical trials. Designed and led iterative phenotypic screening campaign (molecular evolution) which identified novel variants of drug pipeline, with improved ADME and efficacy.
Neuroscientist, Spinal Cord Society Research Center
Supported development of cell-based therapies to promote functional recovery in a chronic spinal cord injury model. Established several clinically relevant autologous neonatal and adult stem cell-based therapies and tested them in combination with pharmacological interventions in a rat contusion-based spinal cord injury model. Developed and utilized in vitro explant and cell-based assays, testing compatibility of potential drug and cellular therapeutic combinations. Evaluated treatment paradigms for changes in functional outcome (locomotor function),cellular fate, and tissue architecture, and for adverse effects such as increased cell death and inflammation. Developed treatment paradigms for reducing glial scar and for effective cell transplantation and demonstrated positive effects in tissue remodeling towards functional gains. Wrote monthly newsletters and articles which summarized research center findings.
Post-Doctoral Fellow, Laboratory of Michael M. Tamkun, PhD, Department of Biomedical Sciences,
Colorado State University
Discovered and characterized the targeting of Kv2.1 to the axon initial segment of hippocampal neurons. Recognized as one of few fellows selected as a recipient of support from a NIH Neuroscience Training Grant.
Post-Doctoral Fellow, Laboratory of James R. Bamburg, PhD, Department of Biochemistry and Molecular Biology, Colorado State University
Demonstrated alterations in the activity of actin regulatory molecules in turning neuronal growth cones.
Involved in identification of a novel regulatory mechanism of actin dynamics. Wrote and received a grant from
Christopher Reeve Paralysis Foundation: Grant SB2-0110 entitled “Guiding Growth Cones through Integration
of Actin Dynamics.”