Gregory Hayes Email & Phone Number

Cincinnati, Ohio, Us

Palo Alto, California, Us

San Rafael, Ca, Us

San Rafael, Ca, Us

• Head of companion diagnostic strategy (CDx) across indications and programs, including patient selection within clinical studies, assay development and regulatory strategy (centralized LDT vs de-centralized IVD testing, cut-point threshold validations, study risk determinations & IDEs as needed, PMA/510k submissions), both internal and external CRO assay development including commercial Dx partnerships, head of CDx global regulatory affairs (FDA/EMA/PMDA), and commercial launch / life cycle management to ensure diagnostic approval and successful transition of tests to market alongside drugs• Regulatory lead responsible for filing the first CDx (PMA) in any gene therapy indication• Head global seroprevalence and epidemiology studies in rare disease programs - CRO partnering, academic / KOL collaborations, patient advocacy engagement• Biomarker discovery for multiple pre-clinical through post-approval programs covering oncology and orphan disease drug development.• Talzenna® combination therapy biomarker discovery: PDX xenografts and drug resistance modeling, patient selection and monitoring assay R&D, Myriad BRACAnalysis® CDx strategy

MOA & Biomarker Lead• Identification of anti-tumor mechanisms of action (MOA) covering Igenica’s multiple antibody programs (solid and hematological indications; naked antibodies and drug conjugates)• Core team lead for an immuno-oncology & stromal antibody target (in multiple solid and hematological indications)• Biomarker discovery and strategy for both pre-clinical & clinical assay implementation (diagnostic, patient stratification, drug activity and efficacy, safety, PK/PD)• Direct outsourcing of assays for clinical qualification and validation through bioanalytical partners; identification of critical reagents and appropriate assay platform technologies• Design and implementation of IND-enabling toxicology studies (PK & dose escalation in mice/cynomolgus monkey) at external CROs• Instrumental in the successful filing of Igenica’s first IND and detailed coordination with CRO operations/sites regarding bio-analytical strategy

Gaithersburg, Maryland, Us

Translational Biology Group – CQA Team Lead• Biomarker discovery & development of mechanism of action (MOA) assays for both pre-clinical & clinical programs• Program lead for identification, characterization, and qualification of critical quality attributes (CQAs) for novel programs (subunit + adjuvant, VLPs); serving as the link between research biology, drug product development, and clinical development• Evaluation and implementation of innovative technologies for biomarker discovery and analytical characterization of recombinant antigens• Biological & technical leader of a cancer vaccine program heading a multifunctional team into clinical trial evaluation• Identification and generation of program-specific critical reagents and reference standards• Design and qualification of analytics for drug substance & product characterization (including in vitro & in vivo potency assays)• Generation of a cGMP recombinant antigen production system that serves as a core to multiple CMC programs• Company lead for multiple academic collaborations

Emeryville, Ca, Us

Kinetic Biomarker Development• Clinical development of stable isotope labeling and kinetic cancer biomarkers • Principal Investigator of a multi-center Phase II prognostic biomarker trial (NCT00481858)• Extensive analytical assay qualification and transfer experience to outside collaborative laboratories (site monitoring & audits)• Discovery of a non-invasive biomarker for prostate epithelial cell kinetics • Correlation of tumor cell kinetics to genome wide SNPs and gene expression patterns• Development of a kinetic biomarker for breast ductal carcinoma in situ to predict aggressive disease

• Characterization of alternative pre-mRNA splice patterns in epithelial carcinomas • Identification of new therapeutic targets & strategy • Cancer biomarker discovery

• Engineering of natural killer cells to enhance anti-tumor efficacy with immunotherapy• Investigation of HLA-G expression & splice patterns in CLL and myeloma • Identification of mechanisms underlying tumor cell resistance to NK cells• cGMP production of effector cells for Phase I/II clinical trials

Doctor Of Philosophy (Ph.D.), Medicine (Pathology)

Bachelor Of Science (Bsc), Genetics