About

Experience shaped by the work.

TMDG is principal-led by design. Senior expertise is directly engaged in the work from beginning to end.

Roberta Duncan, MBA

Founder and Principal, The Modeste Duncan Group · a woman-owned firm

Much of my career has gone into two kinds of work: fixing programs, teams and organizations that were badly broken, and building new ones. Both taught me that the analysis is the part most leaders and teams focus on, each through the lens of their own function. The harder part is turning the dynamic tension of a problem or an opportunity into a decision strong enough to carry the weight of the whole.

I built The Modeste Duncan Group so leaders can use that tension to make deliberate choices, instead of drifting into silent foregone conclusions. You work with me directly. When the work needs specialist depth, people I know and trust join it, and the accountability stays with me.

Underneath all of it is something simple. Every decision ends with a patient who either receives a therapy or keeps waiting.

Roberta Duncan
Founder & Principal
Roberta Duncan, Founder and Principal of The Modeste Duncan Group

Selected credentials.

  • Former Chief Strategy Officer, Arcturus TherapeuticsNasdaq: ARCT · platform, pipeline and partnership strategy
  • Former VP, mRNA Program, and Head of Portfolio & Program Management, CSL SeqirusFounded the mRNA vaccine franchise; oversight and execution of the Investment Board and Program Governance Committee
  • Early clinical cGMP manufacturing, Holly Springs, NCBuilt to deliver first-in-human clinical trial material
  • Global Head, Kendle InternationalThen the fourth-largest global CRO · departmental P&L and a large customer portfolio
  • Earlier roles at Shire, Bristol Myers Squibb, IQVIA/Quintiles, Eli Lilly, Acorda Therapeutics and Trevi TherapeuticsRare and specialty, immuno-oncology, CNS including multiple sclerosis
  • Executive Committee and Board MemberAlliance for mRNA Medicines
  • Scientific Advisory BoardsAMPTIV Biosciences · Intelisci
  • MBA, International ManagementPurdue (Krannert) · TiasNimbas · BA, Biochemistry, New York University

Accountable, at scale.

Decisions carried in executive roles, where the outcome was measured in years of development, capital and patients reached.

Benlysta
33-country lupus program rescued and subsequently approved.
$1.76B
Rare and specialty portfolio at Shire: three products, including Gattex.
KOSTAIVE®
World’s first approved sa-mRNA vaccine, through the ARCT–CSL partnership.
$4.6B
Multi-pathogen sa-mRNA program advanced through pivotal global milestones.
$1.4B
Global influenza franchise, seasonal and pandemic, stewarded end to end.
$451M
COVID-19 access alliance with CEPI, GAVI and a sovereign government.
Global CRO
Global Head at Kendle International, then the fourth-largest global CRO.
First-in-human
Early clinical cGMP manufacturing built at Holly Springs, NC.
BMS
Supported regulatory submissions for Opdivo, Yervoy and Daklinza.

Across modalities, therapeutic areas and markets.

MODALITIES

  • Small molecule and biologics
  • Protein and subunit
  • mRNA and self-amplifying mRNA
  • Viral vector
  • Gene and base editing

THERAPEUTIC AREAS

  • Vaccines and infectious disease
  • Immuno-oncology and immunology
  • Rare and ultra-rare
  • Hepatology: PFIC, ALGS, PBC, PSC, OTC
  • CNS, including multiple sclerosis
  • GI, renal and dermatology

REGULATORY MARKETS

  • FDA (US) · EMA (EU)
  • MHRA (UK) · TGA (Australia)
  • PMDA (Japan)
  • WHO PQ
  • Global access pathways through CEPI and GAVI

On the record.

The full Capability Index →
Roberta Duncan moderating a panel at the Alliance for mRNA Medicines forum in Washington DC
Washington DC, January 2025.

What are you working through?

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

Confidential, and NDA-first if you prefer.
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