Stephen Boyer Email & Phone Number

Cambridge, Ma, Us

Dublin, Ie

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.

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.

Cambridge, Ma, Us

Leader of the team responsible for Regulatory Strategy, Regulatory CMC, and Regulatory Operations for all of Boston Pharmaceuticals' programs.

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.

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.

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.

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.

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.

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

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.

Ph.D., Organic Chemistry, Natural Product Synthesis

B.S., Chemistry