Benjamin Stevens Email & Phone Number

Brentford, Middlesex, Gb

• Global regulatory affairs CMC policy and advocacy lead for full portfolio of GSK products (small molecules, biopharmaceuticals/CGT, vaccines).• Emphasis on development and regulatory acceptance of platform technologies, new modalities, and process modeling approaches.• GSK representative in numerous trade and professional associations including PhRMA (GQM, ICH, CGTM Teams), EFPIA (Biopharm MQEG, Agile Manufacturing Team), IQ (RAC, Co-processed API Subteam), ARM (US and EU RAC, CMC Task Force, Science and Tech Committee), BIO (Accelerating CMC Committee), ISPE (Q12 PQLI), PDA (AI for Vaccines).• Program committee member for 2022 DIA Oligonucleotide Conference, led development of 9 CMC sessions with joint team of representatives from industry and regulators.• Presented on behalf of EFPIA at the 2022 EMA QWP Interested Parties Meeting.• Conducted ICH Q12 training to Health Canada on behalf of the ISPE Q12 PQLI.• Lead and contribute to review and comment letter drafting for numerous global CMC guidelines and regulations with internal GSK policy and technical teams.• Contribute to intelligence gathering activities for industry benchmarking and global regulatory agencies positions and activities.

Cambridge, Massachusetts, Us

Cambridge, Massachusetts, Us

• Lead development and execution of robust global regulatory CMC strategy for vutrisiran (ALN-TTRSC02) siRNA program with balanced risk-based approach using scientific rationale and in alignment with regulatory guidance, working in collaboration with cross-functional CMC and Global Regulatory Teams to achieve program and company goals.• Provide regulatory CMC support for Alnylam partnerships for fitusiran and HBV-02 programs.• Lead preparation, including driving strategy and content of high-quality regulatory submission content focusing on CMC to support global clinical development, registration, and product life cycle management.• POC and Alnylam cross-program regulatory lead for combination products including aspects such as product labeling, global regulatory submission strategy, and MDR response implementation.• Regulatory lead for Alnylam starting material strategy and supply team.• Manage timely regulatory CMC submissions and support regulatory interactions for CTAs/INDs, NDA/MAA, and Agency meeting packages.• Provide routine regulatory assessments for CMC change controls and deviations.• Alnylam representative for BIO Regulatory Review Committee and DIA Oligonucleotide Conference.

Durham, North Carolina, Us

• Provided guidance to clients regarding CMC development and regulatory strategies in the innovator and generic product space.• Drafted CMC briefing documents for various stages of clinical development and represented clients at Agency face-to-face meetings.• Due diligence and gap analysis work to identify potential risks to clients regarding asset acquisition or regulatory filings.• Business development and scoping work with potential clients. Developed several new clients and contracts.

Silver Spring, Md, Us

• Responsible for coordinating and managing staff of 12 reports responsible for review of INDs, NDAs, DMFs, and meeting package submissions for nine clinical divisions (DTOP, DAIP, DAVP, DNP, DPP, DCRP, DOP1, DOP2, DHP).• Branch responsible for assessment of highly complex drug substances including oligonucleotides and antibody-drug conjugates in coordination with OBP.• Extensive coordination with CDRH for review of combination drug products including drug-eluting stents, balloons, and pacemaker leads.

Silver Spring, Md, Us

• Review of CMC sections for INDs, NDAs, ANDAs, DMFs, meeting package submissions, and draft USP monographs.• Practical knowledge and experience with the application of 21 CFR, FDA guidances, ICH guidelines, and USP/NF monographs and general chapters.• Member of the FDA Exclusivity Board.• Member of the Abuse Deterrent Formulation (ADF) working group.• FDA liaison to USP non-botanical dietary supplement expert committee.• Presentation at May 5, 2016 Advisory Committee (Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management).

Boston, Ma, Us

• Assisted associates in the firm with patent prosecution primarily in the areas of synthetic organic and organometallic chemistry, catalysis, medicinal chemistry, and chemical biology.

New York, New York, Us

• Served as “design” lead for several hit-to-lead and BIC (best-in-class) projects in the Pfizer diabetes portfolio• Coordinated compound preparation between internal groups and external vendors• Worked closely with Biology, PK-metabolism, Pharm. Sci., Drug Safety, Regulatory, and Clinical groups to advance compounds into Phase 1 clinical trials• Focused on delivery of an IV-suitable therapeutic for use in ICU requiring a considerable amount of case-specific design (e.g. solubility, hydrolytic stability)• Acted as a program lead (RPL) for two projects in the CV-MED portfolio, one focusing on design and coordination of a potential FIH study with a human-derived peptide seeking understanding of early signs of efficacy (ESOE). Worked carefully with team to draft pre-IND briefing document for FDA and assemble a body of data supporting these studies with limited in-house toxicology studies.• POC for collaborative work between analytical auto-purification, singleton purification, and medicinal chemistry• Collaborative design and implementation of a novel “electrophilicity/hardness calculator” to assist assessment of reversible covalent binding compounds and to gauge potential toxicity of inherently electrophilic leads• Extensive use of proprietary software packages for library design and enumeration• Significant experience with directing and troubleshooting external basic research via contracted vendors

Rahway, New Jersey, Us

• Progressed leads identified via a novel ‘informer library’ approach for several therapeutic areas including hypertension, diabetes, and obesity• Worked closely with high throughput purification group to rapidly generate lead-based follow-up libraries using a combination of step-wise and parallel synthetic techniques• Developed synthetic expertise with various heterocyclic structural classes and polymer-bound reagents• Routine use and maintainence of Genevac speedvac systems, Agilent LC-MS, and ISCO Rf MPLC• Received significant training in medicinal chemistry through a combination of job experience and lectures (Drew medicinal chemistry course, various additional short courses)

M.P.H., Public Health

Phd, Organic Chemistry

Bs/Ms, Biochemistry/Chemistry