Joseph Sergi Email & Phone Number

Kenilworth, New Jersey

BioProcess Development DepartmentRole and Responsibilities:➢ Developing, and pre-qualifying functional cell-based potency assays for all phases of clinical development that demonstrate efficacy for our biologic therapeutics based on the drug mechanism of action. Assay types measure cell proliferation, cell death, cell signaling, signal transduction, reporter gene activity, etc. ➢ Performing non-GMP testing of probe release and stability samples, isolated impurity samples, and formulation admixture study samples with electronic notebook documentation. ➢ Transferring all assays to regulated laboratories for GMP release and stability testing, and to GLP labs for clinical sample testing. ➢ (Project Potency Representative) Coordinating and writing of all IND sections and supporting technical reports (TRs) defining all project related potency sample / extended characterization testing needed to support FDA filings.

New York, Ny

CTI - Centers for Therapeutic InnovationDevelops and adapts cell-based assays for antibody discovery from collaborating academic medical partners for generation of more rigorous and robust assays to meet the standards of the pharmaceutical industry.• Developed a cell-based ELISA assay to measure monocyte polarization and to screen monoclonal antibodies (mAbs) for an SLE project targeting an immune inhibitory receptor expressed in myeloid and dendritic cells. Screened agonist mAbs in a monocyte maturation FACS assay for their ability to shift monocyte polarization from an inflammatory to anti-inflammatory lineage. Examined immunosuppressive markers after treating human PBMCs/monocytes with target mAb and inflammatory polarizing cytokine.• Developed cell-based FACS binding and competitive binding assays for a rare disease project. Determined IC50 potency and selectivity across multiple receptors involved in phosphate and vitamin D regulation utilizing engineered cell lines. The FACS competitive binding assay was developed into a release assay to support manufacture process development. Competitive binding data was used to secure a patent for the drug. • Target validation of a pathogenic pro-protein. Developed TUNEL, phospho-ELISAs, and apoptosis assays in engineered cell lines to support project termination and focusing resources on more promising projects.• Lab Safety Representative (LSR) for the Pfizer CTI-NY site with responsibilities that include: 1) acting as a liaison between EH&S and lab colleagues, 2) performing quarterly safety audits, 3) reviewing new chemical use, 4) notifying Environmental Health and Safety (EH&S) and lab supervisor of potential exposures to hazardous chemicals, 5) report safety deficiencies that need EH&S action to lab supervisor or Chemical Hygiene Officer.

Supported programs aimed at therapies for diabetes co-morbidities, such as cardiovascular, inflammatory, and renal disease. Developed and implemented cell-based assays for multiple therapeutic targets.• Developed cell assays utilizing cultured human and mouse macrophages to measure effect of compounds on cytokine release and establish potency. Performed cytotoxicity assays in parallel.• Supported an Acute Kidney Injury project by assessing ability of compounds to suppress cytokine release from renal tubular cells (HK2) stimulated with TNF-alpha.• Explored effect of compounds (ex-vivo) on signal transduction pathways by determining levels specific phospho-proteins by western blot or ELISA. • Established hypoxic assays and conditions for HK2 cells to evaluate the effects of compounds on stress-induced cellular responses. Established assay to measure ability of compounds to blunt HK2 cell stress in response to known toxicant.Biosafety Safety Compliance Officer for the Metabolic Diseases Department (2005 – 2011). • Performed database tracking, administering, and recording of all safety training for all department employees to ensure adherence to safety compliance measures (SOPs, OSHA laboratory standards, biohazard waste management, and radiation safety).Cell Inventory Database Representative for the Metabolic Diseases Department. (2003 – 2011). • Attended global meetings to optimize software and processes used for local entry of department cell line information into the company’s global database focused on local site needs. Trained department employees on the effective use of the software.

Supported numerous early and late stage lead optimization Diabetes programs.• Developed and executed assays to measure glucose uptake, glycogen synthesis, and glycogen content in cells (primary human skeletal muscle, 3T3L1 adipocytes, and hepatocytes) as well as in tissues isolated from compound treated animals. • Established a JNK-activation assay that assessed effect of compounds on c-Jun phosphorylation (serine 63) in HepG2 cells.• Developed a functional ELISA assay that was utilized by multiple project teams to assess the ability of compounds to increase fatty acid oxidation by measuring the levels of surrogate marker phospho-ACC. • Established Western blot methods to evaluate muscle, liver, and fat from drug treated animals for changes in insulin signaling pathway components (pACC, pAKT, pIRS-1) from compound treated animals for various metabolic diseases projects.• Measured a reduction of phospholipid and triglyceride synthesis through TLC analysis in HEK293 cells treated with small molecule inhibitors of an enzyme involved in the triglyceride synthesis pathway for the treatment of obesity.

Tyrosine Phosphatase Project for Type 2 Diabetes• Utilized biochemical assays to analyse small molecule SAR activity and potential leads focusing on the determination of the specificity of a target tyrosine phosphatase involved in Type 2 Diabetes. • Examined the effect of compounds to enhance insulin stimulated glucose uptake in primary human skeletal muscle cells. • Applied immunoprecipitation and western blotting to measure activation of phospho-tyrosine containing proteins in insulin stimulated cells treated with phosphatase inhibitors.

Exploratory research in Type 2 Diabetes to identify mechanisms and pathways of dephosphorylation and insulin receptor tyrosine kinase activity in adipocytes, hepatocytes, and, myoblasts.• Measured insulin responsiveness of cells pre-treated with inhibitors. Cellular lysates were immunoprecipitated with a variety of insulin signaling antibodies, and SDS/Western blot analysis were done to quantitate protein concentration and kinase activity of the proteins involved in the insulin signaling pathway. • Developed a rapid PTPase assay to screen for potential phosphatase inhibitors

Roche DermatologicsProvided in vitro support on a project aimed to identify new vitamin D analogs for treatment of psoriasis.• Cultured human keratinocytes for investigations and relationships of growth factors and cytokines to proliferative controls by vitamin D analogs. • Applied compounds topically to animals for subsequent analysis of cutaneous proteins by SDS gel electrophoresis, western blots, histology and immunohistology.

M.S., Biology / Minor In Business (Marketing)

Master Of Business Administration (Mba), Marketing

B.S., Biology

Education record