David S. Email and Phone Number

Wet lab assay development, data generation, and analysis activities supporting the progression of clinical pharmaceutical drug candidates from preclinical characterization through Phase 3 registrational studies. Specific areas of focus include transcriptomic, proteomic, and cellular platforms supporting studies primarily in the Crohn’s disease (CD) and ulcerative colitis (UC) space.• Support the translation of exploratory disease profiles and predictive signatures to target engagement, proof of mechanism, and pharmacodynamic (PD) assessments in clinical studies and early development.

Wet lab assay development, data generation, and analysis activities supporting the progression of clinical pharmaceutical drug candidates from preclinical characterization through Phase 3 registrational studies. Specific areas of focus include transcriptomic, proteomic, and cellular platforms supporting studies primarily in the Crohn’s disease (CD) and ulcerative colitis (UC) space.• Support the translation of exploratory disease profiles and predictive signatures to target engagement, proof of mechanism, and pharmacodynamic assessments in clinical studies and early development.• Generated proteomic biomarker data supporting the ongoing global submission of guselkumab in Chron’s disease.• Contributed to the optimization of laminar propria mononuclear cell isolation and associated flow cytometry protocols using colonic pinch biopsy samples.• Evaluated mid- to high-throughput platforms for nucleic acid isolation from human samples including whole blood and intestinal biopsy tissue.

• Support the translation of exploratory disease profiles and predictive signatures to target engagement, proof of mechanism, and pharmacodynamic assessments in clinical studies and early development.• Generated transcriptomic and proteomic biomarker data supporting the global submission of ustekinumab in ulcerative colitis.• Developed and qualified assays that contributed to go/no go development decisions.• Developed and qualified a quantitative assay to measure OSM protein levels in human colon tissue.• Directly managed and trained laboratory-based intern.• Successfully isolated IELs & LPLs from human colon cadaver tissue.

• Generated transcriptomic biomarker data supporting the global submission of ustekinumab in Chron’s disease.• Generated qPCR OpenArray UC profile.• Developed Western assays.• Generated microarray data for Discovery collaborations.• Piloted use of automation for RNA isolation from human whole blood and colon tissues.

Responsibilities: QA/R&D testing, sample preparation, physical testing of products including: adhesion, cohesion, releases, coat weight determination, customer claims testing. SOP writing/editing, microbial presence testing, rheology and viscosity testing of various adhesive formulas. Spreadsheet design/data analysis, instrumental set up/calibration/program creation/troubleshooting/repairs, experimental design, setting up lab equipment, documentation of results, set up preventative maintenance program. Devised more efficient plate cleaning method, moisture retention test, and sample organizational system. Manufacturing floor quality auditing.

Responsibilities: setting up multiple samples for food safety testing, documentation of results, pipetting, streaking/pouring plates, running PCR and ELISA assays, transfers, making media, and autoclaving.

Working under the guidance of Dr. Janet Robishaw and her technicians on a bioinformatics/wet lab related project to associate patient phenotypes to genotypes.Common techniques used: DNA/plasmid isolation using Qiagen kits (maxi and miniprep), restriction digests, ligations, heat transformations, cell culture, mouse genotyping, PCR, site-directed mutagenesis, agarose gel electrophoresis & imaging, spectrophotometry (NanoDrop) for concentration readings, bacterial media prep, maintenance of lab notebook, designed advanced excel programs, sequence alignments

Working with another undergraduate student under the guidance of Dr. George Davis in attempts to exploit phytosiderophore action utilized by most grasses and transfer this ability to flowering plants (tomatoes) through genetic engineering.Common techniques used: DNA/plasmid isolation using Qiagen kits, restriction digests, ligations, heat transformations, cell culture, PCR, agarose gel electrophoresis & imaging, spectrophotometry (NanoDrop) for concentration readings

Collaborated with Dr. William Coleman to investigate of the role of inhibitory neurotransmission on readily releasable vesicle pool size.Common techniques used: solution preparation, earthworm dissection, florescence microscopy, ImageJ analysis, designed spreadsheets for quantitative analysis, wrote and designed poster that was presented at the Susquehanna Valley Undergraduate Research Symposium (link to poster: https://drive.google.com/file/d/0B-U4TgydGUBXXzJRRjJFb2xMMlk/edit?usp=sharing)

Shift manager for approx 1.5 years. Responsibilities: management of 2-4 person teams, inventory, enforcement of safe practices/chemical use, friendly customer service, safe countingAchievements: developed spreadsheets to simplify inventory, contributed to editing one of the employee manuals, frequently received compliments from both customers and coworkers