Michael Bui, Dds, Mph, Jd

Michael Bui, Dds, Mph, Jd Email and Phone Number

Senior Vice President, Head of Global Regulatory Affairs at Pyxis Oncology @ Pyxis Oncology
Michael Bui, Dds, Mph, Jd's Location
Greater Boston, United States, United States
Michael Bui, Dds, Mph, Jd's Contact Details

Michael Bui, Dds, Mph, Jd personal email

Michael Bui, Dds, Mph, Jd phone numbers

About Michael Bui, Dds, Mph, Jd

Experienced strategic regulatory executive with a passion for oncology/immuno-oncology, gene therapies, rare diseases, and medical devices (e.g. companion diagnostics). Experienced in global regulatory strategies, regulatory policy analysis, regulatory intelligence, regulatory compliance, and due diligence in the life sciences industry.

Michael Bui, Dds, Mph, Jd's Current Company Details
Pyxis Oncology

Pyxis Oncology

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Senior Vice President, Head of Global Regulatory Affairs at Pyxis Oncology
Michael Bui, Dds, Mph, Jd Work Experience Details
  • Pyxis Oncology
    Senior Vice President, Head Of Global Regulatory Affairs
    Pyxis Oncology Jan 2022 - Present
    Boston, Ma, Us
    Pyxis Oncology focuses on the clinical development of antibody-drug conjugated (ADC’s) and immuno-oncology (IO’s)
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  • E&A Beacon Regulatory Solutions, Llc
    President And Principal Consultant
    E&A Beacon Regulatory Solutions, Llc Feb 2020 - Present
    Advise small to mid-sized biotech companies on global regulatory strategies and major submissions (e.g. IND, NDA/BLA, Orphan, etc) with major Health Authorities (e.g. FDA, EMA) for drugs, biologics, and devices, focusing on oncology and rare diseases. CONTACT INFO: eabeaconregulatoryllc@gmail.com
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  • Massachusetts College Of Pharmacy And Health Sciences
    Adjunct Faculty, Regulatory Affairs And Health Policy Program
    Massachusetts College Of Pharmacy And Health Sciences Jan 2019 - Present
    Boston, Ma, Us
    View
  • Fda
    Industry Representative, Fda Pharmacy Compounding Advisory Committee (Cder)
    Fda Nov 2019 - 2023
    Silver Spring, Md, Us
    View
  • Kadmon, A Sanofi Company
    Senior Vice President, Global Regulatory Affairs
    Kadmon, A Sanofi Company Mar 2020 - Dec 2021
    New York, Ny, Us
    View
  • Northeastern University College Of Professional Studies
    Adjunct Lecturer, Regulatory Affairs For Drugs & Biologics Program
    Northeastern University College Of Professional Studies Sep 2011 - Apr 2020
    Boston, Ma, Us
    Biologics Development and Regulatory Affairs, New Drug Development and Regulatory Affairs, and Regulation of Generics and Biosimilars
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  • Surface Oncology Inc.
    Vice President, Regulatory Affairs
    Surface Oncology Inc. Apr 2019 - Feb 2020
    Cambridge, Ma, Us
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  • Idera Pharmaceuticals
    Vice President, Head Of Regulatory Affairs, Immuno-Oncology & Rare Diseases
    Idera Pharmaceuticals Jul 2017 - Apr 2019
    Durham, Nc, Us
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  • Emd Serono, Inc.
    Director, Global Regulatory Lead, Immuno-Oncology
    Emd Serono, Inc. Jun 2016 - Jul 2017
    Boston, Massachusetts, Us
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  • Teva Pharmaceuticals
    Director, Global Regulatory Affairs, Internal Medicine Group (Multiple Tas And Biosimilars)
    Teva Pharmaceuticals Mar 2014 - Jun 2016
    Tel-Aviv, Il
    Global regulatory strategist focusing on stem cell therapy for cardiovascular disease, biosimilars in multiple therapeutic areas, combination products, and multiple therapeutic areas and diseases (ophthalmology, gastroenterology, women's health, endocrinology, etc) and performing due diligence
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  • Rutgers University, School Of Public Health
    Adjunct Assistant Professor Of Epidemiology
    Rutgers University, School Of Public Health 2011 - 2016
    New Brunswick, Nj, Us
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  • Bayer Healthcare
    Global Regulatory Strategist, Oncology
    Bayer Healthcare Jun 2010 - Mar 2014
    Leverkusen, North Rhine-Westphalia, De
    Participated in the NEXAVAR and early oncology development projects
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  • Hoffmann - La Roche (Roche) Pharmaceuticals
    Drug Regulatory Affairs Specialist, Pharma Development Regulatory
    Hoffmann - La Roche (Roche) Pharmaceuticals Jul 2007 - Jun 2010
    Switzerland 🇨🇭 , Ch
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  • Bristol-Myers Squibb Company
    Global Labeling Strategist, Global Labeling And Promotion Compliance
    Bristol-Myers Squibb Company 2006 - Jul 2007
    Lawrence Township, Nj, Us
    View
  • Keryx Biopharmaceuticals
    Medical Writer, Oncology Clinical Development
    Keryx Biopharmaceuticals Jul 2006 - Aug 2006
  • Genentech, Inc.
    Regulatory Intelligence Analyst
    Genentech, Inc. Apr 2005 - Apr 2006
    South San Francisco, California, Us
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Michael Bui, Dds, Mph, Jd Skills

Regulatory Affairs Clinical Development Oncology Clinical Trials Pharmaceutical Industry Fda Drug Development Biotechnology Clinical Research Medical Devices Life Sciences Pharmacovigilance Gcp Regulatory Submissions Medical Writing Biopharmaceuticals Infectious Diseases Ctms Strategy Medicine Immunology Pharmacology Pharmaceutics Medical Affairs Biologics Lifesciences Cro Epidemiology Drug Discovery Diabetes Regulatory Requirements Hardware Diagnostics R&d Molecular Biology Cancer Informatics Neuroscience Protocol Vaccines Hematology Commercialization Neurology Technology Transfer Sop Healthcare Biochemistry Biomarkers Public Health Health Economics Glp

Michael Bui, Dds, Mph, Jd Education Details

  • Columbia University College Of Dental Medicine
    Columbia University College Of Dental Medicine
    Dental Medicine
  • University At Buffalo School Of Law
    University At Buffalo School Of Law
    Law
  • Columbia University Mailman School Of Public Health
    Columbia University Mailman School Of Public Health
    Public Health
  • University Of California, Berkeley
    University Of California, Berkeley
    Molecular Biology
  • Veterans Affairs Medical Center - Brooklyn
    Veterans Affairs Medical Center - Brooklyn
    General Practice Residency

Frequently Asked Questions about Michael Bui, Dds, Mph, Jd

What company does Michael Bui, Dds, Mph, Jd work for?

Michael Bui, Dds, Mph, Jd works for Pyxis Oncology

What is Michael Bui, Dds, Mph, Jd's role at the current company?

Michael Bui, Dds, Mph, Jd's current role is Senior Vice President, Head of Global Regulatory Affairs at Pyxis Oncology.

What is Michael Bui, Dds, Mph, Jd's email address?

Michael Bui, Dds, Mph, Jd's email address is md****@****ail.com

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What schools did Michael Bui, Dds, Mph, Jd attend?

Michael Bui, Dds, Mph, Jd attended Columbia University College Of Dental Medicine, University At Buffalo School Of Law, Columbia University Mailman School Of Public Health, University Of California, Berkeley, Veterans Affairs Medical Center - Brooklyn.

What are some of Michael Bui, Dds, Mph, Jd's interests?

Michael Bui, Dds, Mph, Jd has interest in Science And Technology, Health.

What skills is Michael Bui, Dds, Mph, Jd known for?

Michael Bui, Dds, Mph, Jd has skills like Regulatory Affairs, Clinical Development, Oncology, Clinical Trials, Pharmaceutical Industry, Fda, Drug Development, Biotechnology, Clinical Research, Medical Devices, Life Sciences, Pharmacovigilance.

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