Stephen Boyer

Stephen Boyer Email and Phone Number

Principal Consultant @ Regulatory Science Insights, LLC
Cambridge, MA, US
Stephen Boyer's Location
Cambridge, Massachusetts, United States, United States
Stephen Boyer's Contact Details
About Stephen Boyer

Regulatory leader combining global development experience in small molecule, biologic, and gene therapy modalities together with comprehensive non-clinical drug discovery expertise.Global regulatory team leader, project leader of multifunctional drug discovery teams, chemistry team leader for development and research programs that achieved project milestones and provided key deliverables.Recognized manager and mentor of regulatory leaders, Ph.D. scientists, and lab associates,Broadly experienced managing and influencing in matrix organizations and with external partners; able to analyze and effectively communicate complex program issues and provide data-driven solutions. Led submissions, including: preIND, IND, PIP, PSP, China CTA, NDA/MAA dossier planning.Prepared for, participated in meetings with FDA (preIND, Clinical Hold, Type C, EOP2), EU (EMA, national SA), PMDA (EOP2). Worked in neurology, immunology, oncology, virology, antibiotic, gastroenterology, cardiovascular, chronic kidney disease, and pulmonary therapeutic areas

Stephen Boyer's Current Company Details
Regulatory Science Insights, LLC

Regulatory Science Insights, Llc

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Principal Consultant
Cambridge, MA, US
Stephen Boyer Work Experience Details
  • Regulatory Science Insights, Llc
    Principal Consultant
    Regulatory Science Insights, Llc
    Cambridge, Ma, Us
  • Alkermes
    Vice President, Head Of Regulatory Strategy
    Alkermes Nov 2023 - Present
    Dublin, Ie
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  • Palleon Pharmaceuticals
    Vice President, Head Of Regulatory Affairs And Quality
    Palleon Pharmaceuticals Jun 2022 - Oct 2023
    Waltham, Massachusetts, Us
    Responsible for company regulatory strategy and operations; line manager of the Director Quality AssuranceProgram Development Lead for a team developing a targeted bifunctional sialidase for the treatment of solid tumors. Accountable for overall program strategy and coordination with international partner. Standing member of Joint Steering Committee for collaboration and project portfolio.
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  • Logicbio Therapeutics
    Vice President, Head Of Regulatory Affairs And Quality
    Logicbio Therapeutics Mar 2021 - Jun 2022
    Lexington, Massachusetts, Us
    Led the regulatory and quality functions for the organization. As head of regulatory, developed a global regulatory strategy for the lead program and led a successful rapid response to a clinical hold. Also built a strong foundation for global regulatory submissions and safety reporting. As head of quality, worked with a network of consultants to migrate from a paper to an electronic QMS: performed a gap analysis, revised all existing written procedures, developed new SOPs, and launched new system. Also responsible for audit program and vendor qualification, stability program, and quality strategy.
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  • Boston Pharmaceuticals
    Vice President, Head Of Regulatory
    Boston Pharmaceuticals 2020 - 2021
    Cambridge, Ma, Us
    Leader of the team responsible for Regulatory Strategy, Regulatory CMC, and Regulatory Operations for all of Boston Pharmaceuticals' programs.
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  • Boston Pharmaceuticals
    Executive Director, Regulatory Affairs
    Boston Pharmaceuticals 2018 - 2020
    Cambridge, Ma, Us
    Regulatory lead for 6 early development programs in gastrointestinal, antibiotic, antiviral and pulmonary indications. Delivered 2 successful IND submissions that enabled on time clinical study start. Acted as point of contact for and led interactions with Biomedical Advanced Research and Development Authority (BARDA) and Defense Threat Reduction Agency (DTRA) for several anti-infective programs. Conducted regulatory assessments as part of in-licensing due diligence teams.
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  • Biogen
    Director, Head Of Early Global Regulatory Strategy
    Biogen 2017 - 2018
    Cambridge, Ma, Us
    Led Early Global Regulatory Sciences (EGRS) group. Allocated resources for a portfolio of 27 early stage programs, managed group of 5 Early Global Regulatory Lead direct reports, represented regulatory function in leadership forums, strengthened partnerships within EGRS and with Biogen stakeholders.Global Regulatory Lead for neuromuscular gene therapy. Collaborated with academic partner and drove key elements of preIND meeting, clinical strategy, and IND strategy. Also provided regulatory leadership for a pre-proof of concept Parkinson's Disease program.
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  • Biogen
    Associate Director, Early Global Regulatory Strategy Lead
    Biogen 2015 - 2017
    Cambridge, Ma, Us
    Represented regulatory function across a broad portfolio of 11 early development assets in neurology (AD, PD, MS), neuromuscular disorders, ophthalmology and immunology. Developed global regulatory strategy for all PD assets, with an emphasis on enabling critical clinical development tools: novel endpoints (movement, imaging, cognition), devices. Led successful IND submission, enabling an on-time Phase 1 start. Provided regulatory leadership on team challenged to create novel endpoint model. Coordinated a briefing package and PRO dossier that incorporated the patient perspective into choice of Clinical Outcome Assessments (COAs).Acted as Global Regulatory Lead for all Biogen gene and cell therapy programs. Worked with external IND sponsors on regulatory strategy and provided ongoing guidance to Biogen development teams.
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  • Bristol-Myers Squibb, Wallingford, Connecticut
    Associate Director, Global Regulatory Team Leader
    Bristol-Myers Squibb, Wallingford, Connecticut 2012 - Apr 2015
    Lawrence Township, Nj, Us
    Responsible for development and implementation of regulatory strategy for HCV-TRIO regimen. Represented regulatory on a registrational stage development team, matrix managed a Global Regulatory Team, oversaw implementation of global submission plan, including NDA/MAA/JNDA submission strategy. Supported preparation for and participated in global regulatory meetings. Led several submission efforts, including a team that provided an accepted, globally aligned PIP and PSP.
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  • Bristol-Myers Squibb, Wallingford, Connecticut
    Global Regulatory Strategy Manager
    Bristol-Myers Squibb, Wallingford, Connecticut 2011 - 2012
    Lawrence Township, Nj, Us
    Represented Global Regulatory Sciences on Early Development Teams for diabetes and virology assets. Led successful IND submission, contributed to global Health Authority meetings, drove Agency submissions, and led response teams. Authored global regulatory plans and supported creation of global submission plans for internal regulatory reviews at project milestones.
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  • Boehringer-Ingelheim Pharmaceuticals
    Principal Scientist
    Boehringer-Ingelheim Pharmaceuticals 2007 - 2011
    Ingelheim Am Rhein, Rhineland-Palatinate, De
    Research Project Leader for drug discovery projects in cardiovascular and chronic kidney disease therapeutic areas. Matrix managed large cross-functional teams, including international CRO resources. Also defined project intellectual property strategies and publication plans, and acted as liaison for an external collaboration.Represented chemistry department on Atherosclerosis TA Working Group, a cross-functional team providing ongoing strategic input into new target proposals to research leadership team
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  • Bayer Pharmaceuticals Corporation
    Senior Research Scientist Ii
    Bayer Pharmaceuticals Corporation 1998 - 2007
    Leverkusen, North Rhine-Westphalia, De
    Research Project Leader of several multidisciplinary lead identification and optimization teams, including global teams based both in Germany and the US. Primary representative responsible for developing, communicating and defending team strategy, including timelines, resource allocation, and probability of success.Designed and synthesized kinase inhibitors in oncology. Laboratory contributed significantly to the discovery of Stivarga (regorafenib) and the clinical candidate telatinib.Selected as a two-year transferee to Bayer HealthCare, Germany. Led chemistry team that delivered pre-clinical candidate for urology. Facilitated project prioritization during transfer of urology portfolio from Japan to Germany.
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Stephen Boyer Skills

Drug Discovery Drug Development Medicinal Chemistry Regulatory Affairs Pharmaceutical Industry Clinical Development Toxicology Regulatory Submissions Oncology Life Sciences Lifesciences Clinical Trials Clinical Research Cro Strategy Chemistry Regulatory Strategy

Stephen Boyer Education Details

  • University Of California, Berkeley
    University Of California, Berkeley
    Natural Product Synthesis
  • University Of Illinois Urbana-Champaign
    University Of Illinois Urbana-Champaign
    Chemistry

Frequently Asked Questions about Stephen Boyer

What company does Stephen Boyer work for?

Stephen Boyer works for Regulatory Science Insights, Llc

What is Stephen Boyer's role at the current company?

Stephen Boyer's current role is Principal Consultant.

What is Stephen Boyer's email address?

Stephen Boyer's email address is st****@****als.com

What is Stephen Boyer's direct phone number?

Stephen Boyer's direct phone number is (781) 464*****

What schools did Stephen Boyer attend?

Stephen Boyer attended University Of California, Berkeley, University Of Illinois Urbana-Champaign.

What skills is Stephen Boyer known for?

Stephen Boyer has skills like Drug Discovery, Drug Development, Medicinal Chemistry, Regulatory Affairs, Pharmaceutical Industry, Clinical Development, Toxicology, Regulatory Submissions, Oncology, Life Sciences, Lifesciences, Clinical Trials.

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