The work that moves a programme from question to decision.
Four practices, one advisor. Everything below has been done for real, inside a company, with the outcome on record. Engagements are scoped to the decision in front of you.
The pathway the evidence actually supports.
From first-in-human to the advisory committee and the label. Strategy that is decided on the data, tested against precedent, and carried through the organisation so that it survives the first hard meeting.
Development and pathway strategy
Target product profile, evidence plan and pathway selection for novel assets, with scenario planning that makes the trade-offs explicit for R&D leadership and the board.
Health authority meetings
Positioning, briefing package, question design and rehearsal for the meetings that set the programme's terms. Led as the sponsor's regulatory lead, not observed as an outside consultant.
Advisory committee preparation
Briefing document, core story, speaker selection, panel readiness and the question-and-answer rehearsal that decides the vote. Experience on both an FDA advisory committee and ODAC preparation.
Biomarker and surrogate endpoint strategy
Where the substantial evidence of effectiveness sits, how to argue it, and how to qualify the biomarker so that the pathway is open for the programme and for those that follow.
Submissions, labelling and lifecycle
NDA, BLA and MAA strategy, labelling negotiation, paediatric plans and supplemental submissions, including hands-on authoring where a lean team needs it.
Shape the environment before it shapes you.
Company positions that carry into industry positions, and from there into guidance, user-fee commitments and law. Built with government affairs, defended in the trade associations, and delivered by someone who has run the programmes the policy affects.
Position development and guidance comments
Draft guidance, user-fee reauthorisation, expedited pathway reform and AI in development: the company view, the evidence behind it, and the version that industry can adopt.
Trade association and coalition engagement
Representation and topic leadership at PhRMA, BIO, EFPIA, EuropaBio, ARM and the BIA, and coalition-building with patient organisations where the case needs their voice.
Congressional, state and European Commission engagement
Preparing and staffing executives for the Hill, state advocacy and Commission dialogue, in partnership with government affairs, with the technical substance an elected official needs to hear.
Building the policy function
Policy and advocacy councils, objective-setting with R&D and commercial leadership, and policy plans that make influence measurable rather than anecdotal. Done twice, at AbbVie and at Biogen.
Precedent, read properly.
What FDA and EMA actually decided in comparable programmes, why, and what has changed since. Delivered as a clear view for the executive team, the board or the deal team, with the sources attached.
Regulatory due diligence
Asset and company assessment for in-licensing, acquisition and investment: pathway, precedent, agency history, label risk and the questions to put to the target. Defended through to close.
Precedent and landscape analysis
Approval precedent in your indication, endpoints and designs accepted, confirmatory requirements imposed, and where FDA and EMA have diverged on similar evidence. Backed by the 5010 AI Nexus platform where the client wants the tooling too.
Emerging policy risk
Horizon scanning and impact assessment on the policy that will reach your programme: BIOSECURE and China-sourced molecules, PDUFA VIII, accelerated approval reform, AI expectations from CDER.
Leadership workshops
Drug development and policy workshops that build fluency in the regulatory environment and what it means for programme strategy, for R&D leadership, commercial teams and boards.
A head of regulatory, when you need one.
For lean companies between full-time hires, ahead of a financing, or facing a readout that the current team has not been through before. Executive-level accountability, hands-on delivery, and a clean hand-over to the permanent hire.
Interim or fractional VP Regulatory
The function led, the agency relationship owned, the board briefed. Scoped by days per week and by the milestones that matter.
Function build and team development
Regulatory strategy, operations, CMC and advertising-and-promotion oversight structured for the company's stage, and the hiring plan for the permanent team.
Readout and inflection support
The months around a pivotal readout, an advisory committee or a strategic review, when the regulatory judgement has to be right first time.
People who own the decision.
Every engagement has a named client who will make a call on the advice. That is who I work for.
Biotech CEOs and CMOs
Early and mid-stage companies with a novel asset, a coming readout and no room for a wrong regulatory turn.
Heads of regulatory
Established pharma and biotech regulatory leaders who want a second opinion, a policy position or a specialist for the oncology, rare or neuro programme.
Investors and BD teams
Venture, growth and corporate development teams who need the regulatory risk on an asset called honestly before the term sheet.
Boards and executive teams
Leadership groups who need the regulatory environment explained in the terms of the decision in front of them.
Scoped to the decision. Delivered in the room.
No discovery phase that produces a proposal for another discovery phase. A short conversation, a defined scope, a recommendation you can act on, and support through the meeting where it counts.
Conversation
Where the programme is, what the agency has said, what decision is pending. A frank first view, in the first call.
Scope
A written scope tied to the decision: the meeting, the diligence, the position, the pathway assessment. Fixed fee where the work allows it.
Recommendation
A clear recommendation with the precedent behind it and the trade-offs stated, built with your team so it arrives with its supporters.
Delivery
In the briefing package, in the rehearsal and in the meeting. The strategy is only finished when the agency has responded to it.
Tell me about the programme. I will tell you what I would do.
Send a paragraph on where you are and what is pending, and we will find thirty minutes.
- Typical first engagements
- Pathway assessment · Type B/C/D meeting strategy · advisory committee readiness · diligence on an in-licensing candidate · a position on an emerging policy
- Response
- Within one business day.
- Where
- Natick, Massachusetts. US and EU programmes; remote and on site.