New approach methodologies (NAMs) and model-informed drug development (MIDD) offer biotech sponsors new opportunities to generate human-relevant evidence, reduce uncertainty, and inform critical development decisions. Realizing their value requires a program-specific, risk-based strategy grounded in the scientific and regulatory questions...
Expertise: Consulting 209 results
A strong marketing application depends on more than the evidence itself. It must also be complete, technically compliant, internally consistent, and organized to support regulatory review. Gaps in regulatory commitments, CMC and manufacturing, datasets, labeling, or submission operations can become...
Drug development begins with uncomfortable odds. For most early-stage assets, the likelihood of approval (LOA) and probability of technical and regulatory success (PTRS) are low. Depending on therapeutic area, modality, stage of development, and the benchmark being used, only a...
A marketing application is judged on the strength of its scientific evidence. But regulators can only evaluate that evidence when it has been translated into a complete, technically compliant, internally consistent, and navigable application. That is why a complete dossier...
In clinical trials, the trial master file (TMF) is more than a collection of required documents. It is the evidence base that demonstrates how a study was planned, conducted, monitored, and overseen. As trials become more global, digital, and outsourced, that evidence...
The U.S. Food and Drug Administration’s (FDA) renewed focus on drug repurposing is bringing fresh attention to a regulatory pathway that has quietly shaped drug development for decades: 505(b)(2). Starting out as a critical mechanism bridging the gap between traditional 505(b)(1) new drug applications and abbreviated...
Consulting
Model-Informed Drug Development
Make better development decisions—earlier, faster, and with greater confidence Model-informed drug development uses modeling and simulation to predict how a drug may perform across doses, populations, and development scenarios. By applying the right quantitative approach at each stage, sponsors can...
Consulting
BIO International
Recent regulatory developments are reshaping how sponsors think about evidence, oversight, and operational readiness. In a New England Journal of Medicine Sounding Board, FDA leadership announced that one adequate and well-controlled clinical trial — supported by confirmatory evidence — could become the...
In our recent blog examining the FDA’s move toward a one pivotal trial approval pathway, we explored what this shift means for clinical strategy, regulatory engagement, and evidentiary rigor. As development programs concentrate approval decisions into a single adequate and well-controlled study, the implications extend well...