Mark Rutter. Strategist, VP, policy lead, builder.

Mark started at GSK as an analytical chemist, developing and validating the particle-size, surface-area and thermal methods that decide whether a molecule is developable. That grounding in how evidence is actually made never left. He moved into regulatory intelligence at GSK, became EFPIA topic leader for the company's positions to European regulators, and then built Celgene's European regulatory intelligence and policy team from scratch.

At AbbVie he ran policy for the US, Canada and Europe, leading the engagement with the European Commission on co-packaging and a public industry discussion on orphan significant benefit, and founding the company's policy and advocacy council. Promoted to Director and relocated from London to Chicago, he then moved across to the other side of the table as US regulatory lead for oncology small molecules and antibody drug conjugates across high-risk MDS, multiple myeloma, SCLC, NSCLC and other solid tumours, and global regulatory lead for five first-in-human assets.

At Biogen he led the US regulatory policy team, driving the Type D meeting provisions of PDUFA VII to formal adoption and reshaping the company's work on the accelerated approval pathway. In 2021, with key clinical readouts approaching and no senior strategist in the neuromuscular area, he took on the therapeutic area as well. As global and US lead for tofersen he moved the strategy onto the accelerated approval pathway, led the FDA advisory committee to a unanimous vote after a failed Phase 3, delivered FDA accelerated approval in April 2023 and EU approval under exceptional circumstances, and qualified neurofilament as a biomarker for regulatory decision-making in ALS. In the same year he sat in more than twenty Congressional meetings to sustain support for ALS drug development while his own NDA was under review.

Since then he has been Vice President of Regulatory Affairs at Vir Biotechnology, where he led the regulatory assessment for oncology due diligence through to the announced acquisition of masked T-cell engagers; Head of US Regulatory Policy and Global Intelligence at Moderna, where his accelerated approval guidance comments became BIO's industry position; Vice President of Regulatory Affairs at MannKind on the executive leadership team, hands-on from pipeline strategy to a paediatric sBLA that FDA approved in May 2026; and Vice President of Regulatory Affairs at Formation Bio, an AI-native pharma company, where he led FDA Type C meetings with CDER on AI in drug development and advised on BIOSECURE and PDUFA VIII.

Alongside that he has advised independently on regulatory strategy and due diligence for early-phase oncology assets since 2025, and founded 5010 AI to build the intelligence tooling he always wanted on his own desk. 5010 Consulting is where the strategist, the policy lead and the builder work for you.