Bill Paxton Md Phd Fcap Email & Phone Number

San Diego, California, Us

• Clinical development lead for the MRTX849-012 phase III study of MRTX849 versus docetaxel in advanced NSCLC patients with a KRAS G12C mutation • Primary authorship for key regulatory documents including > 25 CTAs for initiation of ex-US studies, responses to questions from regulatory authorities, study amendments, and IND summary reports and investigator brochures• Medical monitor for the adagrasib phase III study including medical contact with study sites regarding patient management, eligibility and clinical issues, and ongoing assessment of safety data• Ensured study start-up, site initiation and enrollment goals by presenting site initiation visits and liaising with principal investigators• Molecular pathology and medical liaison with preclinical scientists for study genomics assays and their interpretation, and for companion diagnostic development

• Started and developed new laboratory for performing novel LDT assay for master iron metabolism regulators hepcidin and erythroferrone (ERFE)• Directed comprehensive method validations of hepcidin and ERFE competitive enzyme immunoassays• Directed successful initial CAP-CDPH inspection, two pharmaceutical sponsor audits, and three CAP inspections with no significant deficiencies

Lake Forest, Illinois, Us

• Clinical development lead for the poziotinib clinical development program for locally advanced and metastatic non-small cell lung cancer in patients with EGFR and HER2 exon 20 insertion mutations which lead to the NDA filing for poziotinib for patients with advanced NSCLC containing HER2 exon 20 mutations• Medical monitor for the ZENITH20 trial for poziotinib, consisting of seven phase 2 studies for NSCLC patients, four of which are pivotal, accelerated approval studies• Medical monitor for the poziotinib compassionate use program, performing medical assessments of advanced lung cancer patients worldwide• Clinical development lead for the FIT molecule, a rituximab-beta-interferon conjugate in phase 1 clinical development for non-Hodgken’s lymphoma

• Write validation plan, direct laboratory validation and analyze data for NY ESO-1 immunoassay, and interface with biotech staff scientists• Interpret and sign out results from unique myeloid derived suppressor cell assay• Supervise technical staff and maintain quality and regulatory compliance

San Diego, Ca, Us

• Analyzed data and sign-out results for four-color immunohistochemistry assay identifying single AR-V7 circulating cells in liquid biopsy samples from metastatic prostate cancer patients• Clinical laboratory subject matter expert for research and development scientists team to develop new generation of assay• Led laboratory team in passing biannual CAP inspection and in application for New York state license for high complexity LDT

• Analyzed data and sign-out results for plasma-based DNA NGS assays for inherited trisomies in high volume international referral laboratory• Provided quality one-on-one clinical consultation for client physicians• Validated and analyzed whole genome NGS data for all genetic insertions and deletions > 7 megabases in size

Fort Washington, Pa, Us

• Clinical development physician for the ALLEVIATE studies, (IMMU-103-03, IMMU-103-04, SL0007, and SL0008, phase II and phase III studies) of epratuzumab (an anti-CD22 monoclonal antibody) in moderate and severe systemic lupus erythematosis • As a subject matter expert performed BILAG and SLEDAI index assessments of clinical lupus disease activity in study subjects. These validated assessments are the primary efficacy endpoints for lupus clinical studies• Maintained a working knowledge of GCPs and regulatory requirements for clinical development and safety in the CRO environment, and assured compliance with ethical, legal, and regulatory standards

• Developed new molecular hematopathology laboratory offering unique FLT3 and NPM1 PCR-based assays involved in acute myeloid leukemia progression• Directly managed QC and quality management programs, CLIA-CDPH and CAP inspections and successful New York state license application and inspection• Provided medical, technical and scientific direction of clinical testing and oversight of laboratory personnel

• Medical leader for Maxipime and Azactam injectable anti-infective products, and Tysabri/Antegren, a humanized monoclonal antibody for Crohn’s disease• Participated in Clearance Committee, review of investigator grant requests, and served as a resource for MIS group, MSL group, and Marketing, Sales, and Sales Training• Strategic medical input for life cycle management and business development

• Clinical Affairs Project Leader and Core Project Team Co-Leader for AG1776, an HIV protease inhibitor, in preclinical, phase I, and phase IIA development. Responsible for strategic oversight, clinical study design and medical monitoring, and management of clinical activities. Physician for Investigator’s Brochure, IND, Annual Reports, & CSRs.• Medical monitoring in capravirine (an HIV NNRTI) AG1549-504, a 400 patient phase III pivotal study, and numerous phase II and phase I studies• Participated in numerous medical and regulatory phase IV activities for Viracept, an approved HIV protease inhibitor, including regulatory (ISS, SNDA, IND Annual Reports, PSURs), medical (monitoring, writing CSRs and manuscripts) and marketing activities.• Clinical Affairs Project Leader for LB-71350 and AG-1859, HIV protease inhibitors in preclinical and/or phase I development.

Responsible for Infectious Diseases medical consultation, for determining the reliability and medical relevance of all new and revised Infectious Diseases assays, and for the quality and clinical reliability of >280 Infectious Diseases assays.• Led and coordinated the first integrated Infectious Diseases marketing and science product development program which focused on HIV and hepatitis C assays, and authored 14 marketing documents.• Provided problem-based medical consultation to 2100 client physicians per year.• Enhanced the image and awareness of Nichols Institute in Infectious Diseases testing in the clinical diagnostics industry by expansion of the molecular microbiology testing menu, by professional activities and national presentations, and by authorship of 13 publications and abstracts.

Responsible for the overall operation, management, and performance, as well as the clinical and technical validation of all assays in the Microbiology and Virology Departments.• Managed increased productivity (18% decrease in cost/test and 36% increase in test units/FTE) and expansion of personnel to 32 FTEs in the Microbiology and Virology Departments, while increasing revenues 90% to $813,952/month.• Validated 25 new molecular microbiology diagnostic assays which provided $14.3 million of new revenue, including the first home-brew manufacture of the Chiron Quantiplex HIV-1 RNA quantitative branched DNA assay which provided $5.8 million in new annual revenue.

Bachelor Of Arts (B.A.), Biological Sciences

Demarsh Clinical Transfusion Medicine Fellow, Transfusion Medicine

Professional Certificate, Clinical Trials Design And Management

Doctor Of Philosophy (Ph.D.), Microbiology And Immunology

Doctor Of Medicine (M.D.), Clinical Medicine

Residency Program, Laboratory Medicine And Anatomic Pathology

Senior Fellow, Virology And Microbiology