The work draws on the expertise the situation requires. Consequential problems rarely stay in one domain, so this index sets out the depth within each, and the work reconnects it around your question. It is here for diligence, by choice, and a conversation can start without it.
Two questions run across these five domains to find the part of a plan carrying weight it cannot bear: what impact do you want to have, and what would have to be true for it to work? Together they form the Load-Bearing Questions, the starting point for every TMDG engagement. The chapters below show the range they reach.
Is the biology real, and can it be made?
Whether a molecule becomes a medicine is decided as much by manufacturability, indication and sequencing as by the biology itself. I have carried those choices from preclinical work to approval, including on a platform with little settled precedent.
Chief Strategy Officer of a Nasdaq-listed self-amplifying mRNA company: platform, pipeline and partnership strategy across a multi-program portfolio.
Carried an asset from preclinical through clinical development, including indication selection and delivery route.
Led a self-amplifying mRNA platform from pre-IND to clinical readiness.
Set the target product profile and lead indication on a development-stage asset, and built the pre-IND package for a novel modality.
Built the development and regulatory plans that carried assets from first-in-human design and dose selection through pivotal execution and post-approval commitments, including pediatric obligations.
Protocol and pivotal study design, pivotal readiness review, trial design under constraint, technical stop criteria, novel-modality feasibility, delivery and formulation strategy, and comparator and benchmark selection.
Specialists brought inAnalytical method development, process development and tech transfer execution, preclinical toxicology, and bioinformatics and computational biology.
Who receives it, and can they?
A program reaches patients when the population, the evidence and the access path are designed together. Much of my work has been in rare, pediatric and global-health settings, where none of the three can be borrowed from a standard template.
Rare and specialty programs across more than ten indications, carried to approval.
Ran a Pediatric Written Request process with the FDA to completion and secured CHMP pediatric approval.
Negotiated a real-world evidence strategy directly with the FDA.
Built the access structure for a $451M development alliance spanning a global health funder, a vaccine alliance and a sovereign government.
Patient-reported and functional endpoints, enrollment feasibility and site assumptions, patient advocacy engagement, natural-history and registry strategy, diagnosis and referral pathway design, and global access pathway design.
Specialists brought inHealth economics and outcomes research, payer modeling and reimbursement negotiation, patient recruitment, and field implementation of health-equity programs.
Who funds this, on what terms, at what stage?
Capital shapes what a program can become, from the first financing to the partnership that carries it to scale. I have structured alliances, blended funding and public-private partnerships, and built development models that make each dollar go further.
Architected a cross-border public-private partnership representing approximately $1.3B in committed infrastructure, counted separately from the biopharmaceutical figures cited elsewhere.
Built and delivered the infrastructure for a $451M COVID-19 development alliance.
Led the partnership behind the world’s first approved self-amplifying mRNA vaccine.
Assessed multi-party pipelines across three large biopharmaceutical organizations.
Built a virtual-biotech outsourcing framework later adopted as standard by a global CRO, cutting cost per patient by up to 45%.
Capital-efficient sequencing, scenario and runway modeling, milestone and tranche design, grant and consortium positioning, entity and vehicle design including foundation and public benefit structures, investor narrative and investment committee preparation, fund-level portfolio review, build-versus-partner and in-licensing decisions, and CDMO strategy.
Specialists brought inLegal drafting and negotiation, tax structuring and entity formation, valuation modeling, and banking and placement.
What evidence does the approving body require?
The evidence a program needs is shaped in conversation with the agency, and it differs by region and by modality. I have advanced programs with five regulators and helped set the path for a modality with little precedent.
Programs advanced to approval with the FDA, EMA/CHMP, MHRA, PMDA and TGA.
Secured FDA Fast Track and Breakthrough Therapy designations.
Designed and led agency interactions, briefing books and question strategy across regions.
Established the regulatory path for self-amplifying mRNA where little settled precedent existed.
Endpoint and comparator defensibility, submission strategy and sequencing, divergence across agencies, post-approval and Phase 4 commitments, WHO prequalification pathways, realistic use of expedited and priority review, and regulatory strategy for small populations.
Specialists brought inRegulatory publishing and submission operations, biostatistics and statistical analysis plans, medical writing, pharmacovigilance operations, and IP prosecution and freedom-to-operate.
Who decides, with what authority, on what cadence?
Strategy holds when the organization can decide and deliver on it. I have built portfolio functions, governance and operating models, and led teams across regions and partners through programs that became approved medicines.
Head of Portfolio and Program Management for a global vaccines business: built the function and its Program Governance Committee.
Designed the operating model, portfolio councils and stage-gates for a global product organization, and served as the accountable executive both advocating for programs and stopping them.
Led global trial delivery on programs that became approved medicines, and delivered a global program five months ahead of schedule.
Led a multi-pathogen self-amplifying mRNA program through pivotal global milestones across sponsors, manufacturers and regulators on three continents.
Built and led development functions across four regions.
Portfolio prioritization and stage-gate design, probability-of-success frameworks, operating models and decision rights, capability gap and management team assessment, leadership team and program-leader development, resequencing and replanning, alliance governance, board and investor communication, hiring and fractional-support planning, and executive and board counsel.
Specialists brought inExecutive search, compensation design, organizational psychology and coaching, and change management delivery.
This index is the full inventory. Each page below carries only what bears on the moment you are in.
A finished brief is not needed. I read every message myself and reply with the two questions I would ask first. If I am not the right person, I will tell you who is.
Roberta Duncan, Founder and Principal