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...
Expertise: Consulting 221 results
Consulting
Model-Informed Drug Development
Learn how evolving FDA programs, modern trial designs, and patient-centered practices are reshaping rare disease development.
Drug development has always required decisions to be made in the face of uncertainty. Which dose should move forward? Which patient population is most appropriate? How should a study be designed to generate meaningful evidence? For many years, those decisions have been shaped...
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...
In February 2026, the Food and Drug Administration (FDA) outlined a meaningful evolution in the Agency’s evidentiary approach to drug approval: establishing one adequate and well-controlled trial, supported by confirmatory evidence, as the default basis for marketing authorization. This position...
The Trial Master File (TMF) has long been a cornerstone of clinical research, serving as the primary record of study oversight, documentation integrity, and adherence to GCP standards. As modern programs grow in scale and complexity—often spanning multiple regions, partners,...
Consulting
Trusted Consulting from Bench to Market
From early R&D through commercialization, our team delivers scientific and regulatory expertise.
Antibody-drug conjugates (ADCs) represent one of the most dynamic areas of oncology drug development. By combining monoclonal antibodies, cytotoxic payloads, and chemical linkers, these therapies are designed to selectively target tumor cells while limiting systemic exposure. Each component contributes to...