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Inovia Bio Insights

Keep Up To Date With All Things Inovia Bio &
Drug Development

Diagram explaining the ICH E9(R1) estimands framework and the five intercurrent-event strategies in clinical trial design

Same trial, two right answers: the estimands framework in plain English

Inovia Bio insight on how clinical trial protocol design determines the FDA or EMA label indication, from population to comparator choice.

Strategydrug development

Design for the label you want, not the trial you can run

Comparison of six competitors' clinical trial protocols in obesity drug development, showing how registered endpoints, comparators and eligibility criteria serve as competitive intelligence

Strategydrug development

The competitive design teardown: reading a rival's protocol for the strategy their press release hides

Three-stage real-world evidence sequence for label expansion: sizing, signal and settlement toward a new drug indication.

Strategydrug development

Building the case for a new indication: why label expansion is won on the sequence, not the single study

Illustration of regulator, payer and prescriber evidence requirements diverging at the comparator choice in an integrated evidence plan

One evidence plan for payer, regulator and prescriber: the comparator is the fork where it breaks

Inovia Bio guide to post-marketing commitment design: the endpoint, comparator and data-source choices that decide whether a PMR or PMC can support a later label expansion

StrategyIEPdrug development

Single-use evidence: designing a post-marketing commitment that can do more than tick the box

Diagram showing how to structure the RWE section of a regulatory briefing document for FDA and EMA reviewers

RWEReal world evidenceregulatory strategy

How to write the RWE section of a regulatory briefing document: structure it for the reviewer, not the study report

Conceptual illustration of a re-indication strategy: diagnosing a local versus systemic drug trial failure before selecting a new indication

Strategydrug development

Re-indication: the failure you don't diagnose comes with the molecule

Line chart of required sample size for a first efficacy trial climbing steeply as the assumed effect size narrows, illustrating the plausible-range 'cone'

Powering your first efficacy trial: stop defending the number, start reading the curve

Diagram comparing basket, umbrella and platform trial designs and which master-protocol design a single-asset biotech can sponsor

drug developmentMethodology

Basket, umbrella, platform: which master-protocol design a single-asset biotech can actually sponsor

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