Philip Tedeschi Email & Phone Number

New York, New York, United States

• Pre-clinical and non-clinical lead for IMVT-1402• Translational science lead for IMVT-1402 new indication identification and development• Contribute to the development of clinical protocols/amendments by performing literature review/analysis and soliciting input from medical, statistics, operations and external KOLs• Author clinical documents including but not limited to: clinical protocols/amendments, briefing documents, regulatory responses, IND/CTA, Investigator's Brochures, clinical study reports• Review/interpret data to produce strategically relevant abstracts, presentations, and manuscripts• Interface with a cross-functional team including Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory, Project Management, and CMC to execute and deliver milestones

New York, New York, United States

New York, New York, United States

• Lead a group of scientists across many contract laboratories for biomarker method development, validation and sample analysis in the regulated environment (GLP or CLIA).• Manage all the biomarker projects to ensure the quality, timeline and deliverable are met for each project.• Provide strong technical support to the contract laboratory on different biomarker platforms. Ability to trouble-shoot and solve technical and instrumental issues.• Review bioanalytical documentation that includes study protocols, analysis plans, data packages, validation study reports and sample analysis reports.• Act as the main point of contact for biomarker projects, discuss the projects with the clinical teams, and provide timely communication and updates.• Ensure high-quality laboratory procedures, documentation and GLP / CLIA compliance.• Write and update SOPs and ensure utilization of GLP and CLIA compliant biomarker laboratories.• Partner with the development team to develop strategy and manage clinical laboratory needs.

Oncology Research DivisionI performed CRISPR and RNAi functional genomic screens to identify new oncology targets, including synthetic lethal screens with current Pfizer assets. I then validate screen hits (knockdown/knockout, rescue, rescue with catalytic inactive enzymes and confirm with in vivo studies) and build the biology portfolio around the target for entry into the pipeline. Work with Chemistry to test and develop NCE's to novel targets. Have been granted a patent on a NCE with a new mechanism of action; currently under study in Phase 1.

Developed monoclonal antibody potency assays as well as functional characterization assays through through knowledge of mechanisms of action and assay development principals (USP 1032, 1033, 1034). Therapeutic areas under study include auto-immune disorders. Assays include ELISA, SPR, flow cytometry and cell-based assays in support of biosimilar monoclonal antibody programs' Phase I and III CTA/IMPD submissions and registration filings. Assay endpoints include potency, ADCC, CDC, binding affinity and binding kinetics to assess similarity and evaluate structure/function relationships. Support late stage programs, including authoring of CMC sections of 351 (k) BLA, PAI support and addressing RFIs.

Developed monoclonal antibody potency assays as well as functional characterization assays through through knowledge of mechanisms of action and assay development principals (USP 1032, 1033, 1034). Therapeutic areas under study include auto-immune disorders and oncology. Assays include ELISA, SPR, flow cytometry and cell-based assays in support of our biosimilar monoclonal antibody programs' Phase I and III CTA/IMPD submissions and registration filings. Assay endpoints include potency, ADCC, CDC, binding affinity and binding kinetics to assess similarity and evaluate structure/function relationships. Support QC and Process Development groups, supervise Bioassay method transfer to junior staff, author SOPs,internal guidance documents and support business development/alliance efforts

New Brunswick, New Jersey

My graduate work in the laboratory of Joseph R Bertino focused on new target discovery, drug development and rational drug combination strategies, from conception to xenograft model proof of concept in a number of diverse solid and hematological malignancies. This work was performed in collaboration with numerous academic labs across several institutions.My primary area of interest was cancer metabolism and its potential as a therapeutic target. Regardless of the particular mutations acquired by a cancer cell, metabolic changes supporting increased nucleic acid and biomass production to support proliferation must accompany transformation. This is currently exploited by antimetabolite chemotherapy. My research was focused towards NADP+/NADPH metabolism. The cofactor NADP+/H provides reducing equivalents for a variety of anabolic reactions and protects cells from oxidative stress by maintaining levels of reduced glutathione. My goal was the therapeutic disruption of NADP+/NADPH metabolism to both slow proliferation and sensitize cells to traditional chemotherapy.Additional projects included examining the serine-glycine-one carbon metabolism for novel targets. MTHFD2 and SHMT2 were identified in C13 tracing studies and are now considered promising drug targets. Also, the combination of pralatrexate and leucovorin were explored in T-cell ALL mouse models in a successful effort to improve the therapeutic index of pralatrexate.

Rockville, Maryland

Developed and executed custom assays for the detection of a range of animal viruses in both raw material and clinical samples in accordance with cGMP, GLP and regulatory (Food and Drug Administration and the European Medicines Agency) guidelines. Authored and revised batch records, protocols and SOPs. Clients included both large and small pharmaceutical/biotech firms.

Doctor Of Philosophy (Phd), Pharmacology

Master Of Science (Ms), Molecular Targets And Drug Discovery

Bachelor Of Science (Bs), Biology