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 clients spend more time on understanding precedent implications to their own program development strategies, creating efficiencies in drug development.

• 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.

• 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.

• 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.• Direct, hands-on experience of leading NDA label and PMR negotiations.• Hired, coached, and led my direct reports (from Manager to Director) with a strong focus on their development.• 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 business matters.

• 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.• Partner internally with a variety of stakeholders and experts to drive a one-Biogen voice.• Represent Biogen at ad-hoc FDA meetings, e.g., CPIM meetings, as designated regulatory expert.• Continue to act as a regulatory advisor for US regulatory team members and Biogen’s leadership.

• 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• FDA single point of contact for my respective INDs;• A collaborative partner for regulatory interactions with external co-development partners.

• 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 authorities and trade associations;• 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;• Recognized as an expert resource for advice on regulatory policy and intelligence;• Lead regulatory competitor intelligence team and provide AbbVie with key strategic insights on health authority review and regulatory precedent;• Maintain a strong presence on Global Regulatory Teams with a focus on the US market;• Review ad-hoc regulatory strategies and key responses to agency questions;• Promoted to Director from Associate Director in September 2015 and relocated to USA;

• 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;• Provide insights and advice on European regulatory environment;• European affiliate liaison for advocacy training and external environment understanding; • Maintain a strong presence on select Global Regulatory Teams with a focus on the EU market;• Review regulatory submission documents and key responses to agency questions.

• 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• Develop targeted, Global Regulatory Intelligence communications to support the Haematology, Solid tumours and I&I therapeutic groups and global leads• Establish effective cross-functional internal networks (Business Intelligence, Market Research and Medical Information) to encourage collaborations and internal engagement• Research and respond to intelligence enquiries in an accurate, timely manner• Promoted to Associate Manager in September 2011• Provide support to Regulatory for the preparation of submissions including INDs, NDAs, briefing documents, Orphan Drug Applications, Marketing Applications and correspondences.

• 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 • Developing strong networking skills through interactions with internal and external stakeholders (trade associations)• Acting as EFPIA topic leader for the development of the industry perspectives when required • Promoted to Senior Regulatory Executive in November 2009.

• 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• Supervising a contingent worker and being accountable for his training and development.

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.