Peg Foley Email & Phone Number

Cambridge, Massachusetts, Us

North Chicago, Illinois, Us

Responsible for leading, hiring, developing and inspiring a diverse team of ~20 medical directors, scientific directors and clinical scientists; 5 direct reports.

North Chicago, Illinois, Us

Responsible for leading the clinical team developing depatuxizumab mafodotin in glioblastoma multiforme; 4 direct reports. Also responsible for leading the development strategy for 2 other anti-cancer agents in early phase development.

Led the clinical team developing a novel anti-TIGIT antibody in collaboration with Potenza Therapeutics; achieved a successful IND application and opened the first-in-human study. As the clinical lead for Tarceva® (erlotinib) in alliance partnership with Genentech and Roche and in collaboration with Roche Molecular Systems, achieved a successful sNDA resulting in FDA approval of Tarceva® for the first-line treatment of metastatic NSCLC patients whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. The indication was approved concurrently with the cobas® EGFR Mutation Test, a companion diagnostic test using formalin-fixed paraffin-embedded (FFPE) tissue specimens. FDA approval granted May 2013.Achieved a successful labelling supplement in collaboration with Roche Molecular Systems and Genentech/Roche, resulting in FDA approval of the cobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.) using plasma specimens as a companion diagnostic test for the detection of EGFR exon 19 deletions or exon 21 (L858R) substitution mutations to identify patients with metastatic NSCLC eligible for treatment with Tarceva®. This was the first “liquid biopsy test” approved for use by FDA. FDA approval granted June 2016.Achieved successful sNDA under Pediatric Written Request based on a randomized Phase 2 study in pediatric ependymoma; resulted in FDA granting Pediatric Exclusivity in March 2015.Contributor to the XTANDI® (enzalutamide) NDA and MAA filings and expanded access program as an author and reviewer in collaboration with Medivation, Inc. FDA accepted the NDA on 23 Jul 2012, with Priority Review designation. FDA approval granted 31 Aug 2012. EU approval granted Jun 2013. FDA and EMA approved XTANDI® for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. Authored the XTANDI expanded access treatment protocol in North America and served as the clinical lead.

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Served as global clinical leader in oncology for small-molecule investigational agents in early phase development at Takeda and subsequently at Millennium after the acquisition. Achieved a successful IND application for an Aurora kinase B inhibitor (TAK-901), resulting in first-in-human studies in solid tumors and hematological malignancies (AML, CML, CLL, lymphomas, etc).Conducted a Phase 1 study of a novel EGFR/HER2 inhibitor (TAK-285) in breast cancer and evaluated central spinal fluid (CSF) distribution in the expansion cohort to determine if this agent differentiated from lapatinib in central nervous system (CNS) penetration.

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Served as a clinical lead on a first-in-class agent (FAK inhibitor) to enter human testing; served as the clinical lead on a global Phase 2/3 trial in glioblastoma multiforme.As the early development clinical leader, authored the first-in-human study protocol and clinical sections of Investigator Brochure and IND application; achieved a successful IND application for the focal adhesion kinase (FAK) inhibitor PF-00562271, the first FAK inhibitor to enter clinical testing. The team achieved Pfizer Oncology’s fastest time to IND submission from the decision to advance the drug to clinical development.As the global medical leader, led a global Phase 2/3 trial in recurrent glioblastoma multiforme evaluating a novel topoisomerase I inhibitor edotecarin. Responsibilities included: medical monitoring and overseeing study conduct; presenting at investigator meetings; with external neuro-oncology experts; drafting multiple protocol amendments; providing written communications to institutional review boards/ethics committees, regulators, and data safety monitoring board (DSMB) members; drafting DSMB charter, selecting DSMB members, and organizing DSMB meetings; providing substantial input on the central imaging review committee charter; and overseeing the termination of the trial due to a futility analysis.

As a member of Abbott’s highly selective Physician Training Program in Drug Development (two physicians selected in 1998), completed rotations in Investigational Drug Safety, Post-Marketed Product Safety, Outcomes Research, Clinical Pharmacology Phase 1 Research Unit, Medical Information/Medical Review, and Clinical Development. Upon completion of the program, joined the clinical team in the Urology Venture and subsequently in the Hospital Products Division.

Mankato, Mn, Us

Training included extensive rotations in oncology and hematology at the Mayo Clinic Rochester and an external oncology rotation at the Vince Lombardi Comprehensive Cancer Center’s Breast Clinic, Georgetown University Medical Center, Washington, D.C.

Tacoma, Washington, Us

Training included extensive work on the oncology in-patient service, including neuro-oncology and intrathecal chemotherapy administration.

M.D., Medicine

Bachelor Of Arts - Ba, Government/Premedicine