Bill Paxton Md Phd Fcap Email and Phone Number
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Executive-senior director level board certified medical physician with seventeen years of experience engaged in clinical research and drug development in pharmaceutical, biotechnology and CRO environments in oncology, rheumatology/immunology, infectious diseases and gastroenterology therapeutic areas. Modest team player with well-developed communication skills and deep and broad drug development experience from pre-clinical through phase III studies and medical affairs. Skilled in medical monitoring, regulatory document authorship, translational medicine, and drug safety/pharmacovigilance. Board certified laboratory director, clinical pathologist, and molecular pathologist with fifteen years of experience directing small to very large esoteric clinical laboratories which test for genetic, oncology, immune, and infectious disease-based conditions. Subject matter expert on the validation and interpretation of molecular pathology lab-developed tests and next generation sequencing (NGS) DNA tests. Skilled at the medical, technical, quality and interpersonal oversight of clinical laboratories, and at successful passing CLIA, CAP and New York state licensing inspections. Critical thinking skills from Ph.D. basic science training in microbiology and immunology combined with medical and pathology training.drbillpaxton@yahoo.com
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Senior Medical DirectorMirati Therapeutics 2020 - PresentSan 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
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Medical DirectorIntrinsic Diagnostics 2014 - Present• 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
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Executive Medical Director, Clinical DevelopmentSpectrum Pharmaceuticals, Inc. Apr 2019 - Aug 2020Lake 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 -
Clinical Laboratory DirectorSerametrix 2018 - Apr 2019• 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
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Medical Director And Clinical Laboratory DirectorEpic Sciences 2016 - 2017San 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 -
Associate Laboratory DirectorSequenom Center For Molecular Medicine 2011 - 2016• 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
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Consulting Physician And Central Bilag ReaderResearch Pharmaceutical Services And Pra International Jun 2006 - Jun 2015Fort 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 -
Medical DirectorLaboratory For Personalized Molecular Medicine 2007 - 2013• 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
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Medical Irb ReviewerAspire Irb 2005 - 2006
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Medical DirectorElan Pharmaceuticals, Inc 2003 - 2006• 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
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Associate Medical Research DirectorAgouron/Pfizer 1998 - 2003• 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.
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Medical Director, Infectious DiseasesQuest Diagnostics At Nichols Institute 1996 - 1998Responsible 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.
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Scientific Director, Microbiology And Virology, And Medical Director, Microbiol. Virology & SerologyQuest Diagnostics At Nichols Institute 1995 - 1996Responsible 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.
Bill Paxton Md Phd Fcap Skills
Bill Paxton Md Phd Fcap Education Details
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University Of ChicagoBiological Sciences -
Puget Sound Blood Center, SeattleTransfusion Medicine
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Uc San DiegoClinical Trials Design And Management
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University Of Illinois ChicagoMicrobiology And Immunology
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University Of Minnesota Medical SchoolClinical Medicine
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University Of Washington - School Of MedicineLaboratory Medicine And Anatomic Pathology
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University Of Washington - School Of MedicineVirology And Microbiology
Frequently Asked Questions about Bill Paxton Md Phd Fcap
What company does Bill Paxton Md Phd Fcap work for?
Bill Paxton Md Phd Fcap works for Mirati Therapeutics
What is Bill Paxton Md Phd Fcap's role at the current company?
Bill Paxton Md Phd Fcap's current role is Senior Medical Director at Mirati Therapeutics.
What is Bill Paxton Md Phd Fcap's email address?
Bill Paxton Md Phd Fcap's email address is fc****@****ati.com
What schools did Bill Paxton Md Phd Fcap attend?
Bill Paxton Md Phd Fcap attended University Of Chicago, Puget Sound Blood Center, Seattle, Uc San Diego, University Of Illinois Chicago, University Of Minnesota Medical School, University Of Washington - School Of Medicine, University Of Washington - School Of Medicine.
What skills is Bill Paxton Md Phd Fcap known for?
Bill Paxton Md Phd Fcap has skills like Clinical Trials, Clinical Development, Biotechnology, Medicine, Pharmaceutical Industry, Drug Development, Clinical Research, Infectious Diseases, Oncology, Assay Development, Validation, Microbiology.
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