Mark Rutter Email & Phone Number

Cambridge, Massachusetts, US

Chicago, IL, US

Co-founder of RxTROSPECT a company formed to provide clarity on FDA and EMA drug development decision making.Our extensive, expertly designed datasets and associated cloud-based analytics provide insights on the study design and data used in regulatory decision-making. What previously took days and weeks to identify is now available in seconds, meaning our.

San Francisco, California, US

• Provide regulatory leadership and oversight for VIR’s development portfolio.
• Ensure program regulatory objectives are aligned with overarching goals of Vir and product development.
• Provide regular communications Vir CEO and CMO on business development and pipeline.
• Assess due diligence from a regulatory and drug development perspective.
• Approve strategy for and ensure leadership of program-specific HA interactions.
• Collaborate with colleagues in Policy and Public, Private Partnerships, represent VIR in strategic discussions with multiple governmental and non-governmental agencies.

Cambridge, MA, US

• Expansion to global accountability for regulatory strategy for all of Biogen’s NMD portfolio and rare diseases.
• Engaged FDA and policy makers on critical issues as it relates to biomarker-based drug development and FDA’s assessment of substantial evidence of effectiveness
• Partnered with State and Federal government affairs colleagues to set advocacy strategies per pipeline.
• Led a team of 15 global regulatory professionals ranging from Senior Manager to Senior Director, across multiple geographies to develop fit-for-purpose global regulatory strategy(s).
• Influence across the organization to strengthen the regulatory voice and heighten the business understanding of regulatory risk.
• Member of Biogen’s Global Regulatory Leadership Team for global program strategy and policy matters.

Cambridge, MA, US

• US therapeutic area head for two therapeutic areas: strong focus on rare diseases, including ALS and SMA and more prevalent conditions (e.g., stroke and depression) across development and marketed assets.
• Led the tofersen NDA in ALS to accelerated approval, utilizing a novel surrogate endpoint in April 2023.
• Led a successful FDA advisory committee meeting in ALS, including preparation and execution (March 2023).
• Engaged FDA and policy makers on critical issues as it relates to biomarker-based drug development and FDA’s assessment of substantial evidence of effectiveness.
• Represented Biogen at 2023 Fly-in, holding over 20 meetings with representatives. Continued state-focused external advocacy in 2024, again with a focus on rare diseases.
• Direct leadership of FDA meetings inc. Type B and C meetings, pre-NDA meetings and NDA review meetings.

Cambridge, MA, US

• Led Biogen’s FDA engagement policy strategy with CDER and CBER leadership.
• Staff and prepare Biogen’s leaders for Board level engagement at PhRMA and BIO, advising on regulatory risk and opportunity from a policy and strategy perspective.
• Member of Biogen’s US regulatory leadership team for overall regulatory organizational effectiveness, budget and talent reviews.
• Lead the US regulatory policy team, including line management responsibilities from Manager to Director
• Develop and execute targeted advocacy plans aligned to policy and pipeline objectives.
• Create opportunities to present externally with leaders at FDA and other leading regulatory agencies.

North Chicago, Illinois, US

• US regulatory oncology strategy lead for various compounds and global lead for early development compounds;
• Leading regulatory strategy for hematology and solid tumors compounds; ensuring regulatory strategies adhere to therapeutic area direction and corporate objectives.
• Strategic lead, representing regulatory on cross-functional development teams and preparing teams for FDA meetings (planned milestone meetings and unplanned at FDA's request)
• Hands on experience in development of multiple breakthrough therapy designation requests, briefing books, orphan designations (US, EU and joint), DSURs and more across hematology and oncology.
• Expertise in guiding internal groups on regulatory risk and opportunity toward development of strategic and tactical plans;
• Expert in interpreting regulatory guidelines with respect to impact on development programs

North Chicago, Illinois, US

• Lead advocacy campaigns with external stakeholders including the US FDA, European Commission, the European Medicines Agency, patient groups and industry peers;
• Develop the vision and implement strategies to shape and influence the regulatory policy in AbbVie areas of interest;
• Active member on various PhRMA and BIO working groups;
• Lead and coordinate regulatory activities in partnership with the experts across the R&D organization and other key stakeholders to ensure that well-developed advocacy plans and positions are progressed with regulatory.
• Build collaborative and integrated internal partnerships with AbbVie’s technical experts, to the benefit of evidence-based advocacy and knowledge sharing;
• Lead the global advocacy and understanding of rare diseases and orphan drug development;

North Chicago, Illinois, US

• Lead advocacy campaigns with external stakeholders including the European Commission, the European Medicines Agency, patient groups and industry peers;
• Progress healthcare policy within Europe from a drug development perspective; active member of EFPIA, EuropaBio, EBE and BIA working groups
• Create and lead the development of globally aligned advocacy plans and position papers;
• Build collaborative and integrated internal partnerships with AbbVie’s technical experts, to the benefit of evidence based advocacy and knowledge sharing;
• Lead the global advocacy and understanding of rare diseases and orphan drug development;
• Provide strategic regulatory advice on drug development programs to progress AbbVie’s pipeline in oncology and virology;

Summit, New Jersey, US

• Acting European Intelligence lead from January 2013 to September 2013
• Advise on the interpretation of regulatory guidance/policy and understanding of the wider European regulatory environment
• Represent Celgene on trade associations and trade association steering committee activities
• Coordinate and develop, with subject matter aspects, globally aligned Celgene position papers and European responses to European consultation documents
• Effective monitoring of the external environment for key regulatory guidance/legislative change, communicating with impact statements in a timely manner
• Developing global best practise for effective lobbying through consultation documents

Brentford, Middlesex, GB

• Supporting the oncology, CVM and respiratory therapeutic groups in all aspects of Global regulatory intelligence (US and EU)
• Assimilate regulatory competitor information related to regulatory submission strategies and basis for approvals in close cooperation with other relevant functions
• A strong focus on the communication of competitor intelligence and filing strategies
• Developing intelligence analysis to identify trends in key topic areas (e.g., orphan drugs, centralised procedure, ODAC procedures) and presenting to key stakeholders
• Effectively managing the non-CMC consultation documents, ensuring the GSK position is effectively communicated in a timely, professional manor
• Developing effective relationships with assigned customer group heads / executives

Brentford, Middlesex, GB

• Developing and validating analytical methods in wet and dry particle size, specific surface area and thermal methods
• Planning and participating in method transfers to manufacturing sites
• Lead user of the DSC/TGA, GVS and Shear cell instrumentation
• Ensuring above mentioned instruments are compliant with cGMP, updating risk assessments and training other analysts as required
• Planning, scheduling and tracking analytical testing for the scientists in our team, agreeing deadlines with the appropriate project managers and the team
• Performing peer reviews of GMP data, scientific and data reviews

Brentford, Middlesex, GB

Performing surface chemistry on active drug substance including particle size, surface area, spectroscopy, optical microscopy, SEM, DSC/TGA, Shear Cell, and Dynamic Vapour Sorption techniques.