Drug Development 4.0: Faster, Smarter,
Quantitatively Informed Decisions to Optimize Value

Metrum Research Group's Strategic Advisory Solutions helps drug development teams make the right decisions by integrating deep development experience with expertise in the application of Model Informed Drug Development
(MIDD), leading to reduced cycle times and increased probability of technical and regulatory success.

The Four Pillars of MetrumRG’s
Strategic Advisory Solutions Impact

Effective Utilization of
MIDD Approaches

MIDD based development strategies utilizing innovative trial designs, bayesian analytics, virtual populations and systems pharmacology approaches to maximize development plan efficiency.

Aligning Clinical Development
and Marketing Decisions

Aligning Target Product Profile, label requirements, clinical development planning, and assessment of risk to maximize product and portfolio value via implementation of durable and reproducible enterprise-wide decision quality frameworks.

Quantitative Technical Review and Assessment of Product Differentiation
to Improve Investor Returns

MIDD-based reviews of emerging efficacy and safety
(with uncertainty) to determine comparative value versus competitors or standard of care to support payer and market access and for transparent investor narratives.

Linking Development Decisions to
Emerging Product Characteristics

Quantitative assessments, grounded in MIDD of emerging attributes of products and competitors using combined model systems for more accurate assessment of risk.

What Makes MetrumRG's
Strategic Advisory Solutions Different

Quantitative strategies linking emerging product characteristics to value—at enterprise scale.

Integrated expertise

Dedicated statistics, QSP, data science, pharmacometric, and clinical pharmacology expertise from across MetrumRG.

Executive leadership

Decades of early and late stage development and business development review experience guiding high-value assets.

Quantitative Decision Frameworks (QDFs)

Transparent, combined model system based assessments anchored in target product profile requirements for critical program and portfolio choices.

Outcomes We Enable

Faster, higher-quality decisions; aligned clinical and commercial strategies; and evidence
that stands up to regulatory and investor scrutiny.

Speed

Select accelerated programs to reduce risk and optimize value.

Quality

Quantitatively supported choices increase technical and regulatory confidence.

Value

Clear narratives demonstrate program and portfolio value to stakeholders.

Scalability

Frameworks and tooling scale from single assets to enterprise portfolios.

Meet the Strategic Advisory Solutions Team

The team at Metrum Research Group brings multidisciplinary expertise in biomedical modeling and simulation,
combining quantitative science with real-world drug development experience. Their scientists and consultants
specialize in areas like pharmacometrics, biostatistics, and advanced analytics to deliver data-driven insights
that support decision-making and improve outcomes across the drug development process.

Brian Corrigan
Brian Corrigan, PhD
Principal Consultant

Leader in portfolio governance and quantitative decision frameworks; former senior executive guiding PTRS and enterprise decisions; recipient of the 2026 Gary Neil Prize for Innovation in Drug Development.

Read full bio

Black-and-White-Circular-Fashion-Logo-3
Akintunde (Tunde) Bello, PhD
Principal Consultant

Former SVP & Global Head (industry) across Clinical Pharmacology, Pharmacometrics & Bioanalysis; governance on global development committees; scientific leadership contributing to numerous marketed medicines.

Read full bio

Marc Gastonguay
Marc R. Gastonguay, PhD
Founder & Chairman

Founder of MetrumRG with nearly 30 years advancing pharmacometrics through science, innovation, and education. Experience spans industry, academia, and government, establishing MetrumRG as a mission-driven leader in model-informed development.

Read full bio

CJ Godfrey
CJ Godfrey, PhD
Vice President of PKPD

23 years of drug development experience applying pharmacometrics to PK/PD and outcomes. Expertise in oncology, rare disease, inflammation, and virology with deep skills in model-based meta-analyses and real-time PK/PD modeling for timely decision support.

Read full bio

dan2_500x500
Daniel Kirouac, PhD
Vice President of Quantitative Systems Pharmacology

Leads QSP with a decade of experience across academia, biotech, pharma, and consulting. Recognized for computational modeling and translational science, Dan has co-authored 27 publications and contributes extensively to global systems pharmacology and cancer research communities.

Read full bio

Jim Rogers
James A. Rogers, PhD
Vice President of Statistics

Vice President of Statistics with over 20 years bridging genomics, nonclinical, and clinical biostatistics. At MetrumRG since 2008, Jim focuses on dose optimization, disease progression models, and causal inference, shaping the integration of statistics and pharmacometrics.

Read full bio

Valerie Nock
Valerie Nock, PhD
Vice President, PKPD Quantitative Sciences
Vice President of PKPD Quantitative Sciences with more than a decade of experience advancing model‑informed drug development across therapeutic areas. Former Global Head of Pharmacometrics at Boehringer Ingelheim, Valerie has led strategic quantitative functions, guided regulatory interactions, and built high‑performing teams to integrate pharmacometrics into enterprise decision making.

Read full bio
MattRiggsWEB (2)
Matthew M. Riggs, Ph.D.,
FISoP

Matt offers over 16 years of industry experience including the application of modeling and simulation for clinical pharmacology and later phase drug development decisions. Matt’s interests include the development and application of mechanistic exposure-response and systems pharmacology models to quantitatively integrate physiology, pharmacology, senescence and disease understandings.

Read full bio

BillKnebelWEB
William Knebel, Pharm.D.,
Ph.D.

Bill joined MetrumRG in 2004, where he was appointed President of Strategic Modeling & Simulation in 2016 after serving most recently as Principal Scientist II and Group Leader of the Pharmacology Modeling & Simulation Team. Bill has worked extensively in applying mathematical modeling and simulation techniques to optimize drug development across both academic and industrial settings. 

Read full bio

Quantitative Decision Frameworks

Enterprise-Ready Decision Frameworks

Operationalizes MIDD-based decision frameworks, enabling consistent evaluation of risk, value, and trade‑offs across programs and portfolios.

Scenario Planning & Trade-off Analysis

Quantitative tools to compare development strategies, explore clinical trial options, and align with regulatory and commercial goals.

Transparent Investor & Governance Narratives

Generates reproducible evidence packages that translate science into clear program and portfolio value stories for boards, partners, and investors.

Integrated with SAS Expertise

Combines platform capabilities with leadership experience from SAS principals to maximize impact of strategic decisions.

AI-Enabled MIDD Readiness & Vision Assessment

A structured 6–8 week review assessing Pharmacometric and QCP operations, defining a GxP-compliant vision for AI-enabled MIDD, and providing a practical roadmap for automation, standardization, and AI investment.

Why This Assessment is Needed
  • Rapidly evolving AI ecosystems require workflow-centric, future-proof integration.
  • Operational friction limits scalability, traceability, and decision speed.
  • Governance and operating models are needed to transition pilots into routine enterprise use.
Key Deliverables
  • Interview synthesis and organization-wide capability assessment.
  • Future-state AI-enabled MIDD vision incorporating combined model systems.
  • AI-enabled workflow recommendations and integration concepts.
  • Phased roadmap with 180/360/720-day investment alignment.
Implementation Pathway

From diagnostic workflow mapping and prioritization through design and executive alignment, translating assessment outputs into scalable operating models, governance structures, and measurable value demonstration sprints.

Reach out for a Consultation