Allucent

Click below to download the infographic. Developing therapies for serious or life-threatening conditions where human efficacy trials are not ethical or feasible presents a unique set of regulatory and scientific challenges. Under the FDA’s Animal Rule, sponsors must rely on well-controlled animal studies to demonstrate efficacy, requiring a clear understanding of disease pathophysiology and estab…

Explore actionable insights for advancing pediatric rare disease programs through smarter design and integrated modeling approaches.  Download the Infographic  Developing therapies for pediatric rare diseases presents significant challenges including small, dispersed patient populations, sparse early data, and ethical constraints. To overcome these barriers, more efficient, patient-centered appro…

Introduction   Clinical trial activity is one of the clearest indicators of where the biopharma industry is directing its clinical development efforts. An analysis of ongoing and completed clinical trial activity across companies headquartered in North America and Europe reveals important shifts in therapeutic area focus, development phase distribution, and emerging innovation areas such as rare …

By Titia Tjeenk Willink, MSc, Senior Project Director, Global Project Leadership at Allucent Study Background:  Allucent was selected to perform a Phase I/II study in participants with glioblastoma for an emerging European biotech. Collaboration started early 2018 and FPI was enrolled later that year.  Challenges Faced: Managing Cohort Logistics and Operational Barriers in a Complex Dose-Escalati…

Download the infographic to discover how Allucent’s experts integrate site feasibility and patient recruitment into a unified, patient-focused strategy to help oncology sponsors reach the right patients and improve overall trial outcomes.   Oncology trials are becoming increasingly complex, driven by more stringent eligibility criteria and rising competition for patients and sites. As a result, m…

A guide to improving rare disease clinical research through ethical design, operational excellence, and patient-centered innovation This white paper explores the unique challenges of rare disease clinical research when conducted in pediatric populations where there is limited patient availability, delays in diagnosis, and geographically dispersed patient pools. In these instances, every interacti…

A guide to accelerating CNS clinical development programs with data-driven insights, targeted populations, and regulator-ready evidence This white paper explores how the early integration of modeling & simulation, as well as strategic study design, can help to de-risk CNS clinical development. CNS programs present a unique set of challenges due to limited biomarker availability, intricate […] The…

For small biopharma companies, time is money, and the clinical development plan (CDP) must identify and leverage new and emerging technologies to reduce costs and accelerate the clinical program. In Part 1 of our Clinical Development Plan blog series, Optimizing Your Clinical Development Plan: Strategies for Biotech Success, we explored how a well-constructed CDP serves […] The post Modernizing t…

Drug‑induced QT prolongation and torsades de pointes (TdP) remain critical safety concerns in drug development, driving regulators to refine guidance over the past two decades. Since 2005, ICH E14 has required a robust assessment of QTc prolongation risk, but the field has shifted from a one‑size‑fits‑all thorough QT (TQT) study toward more flexible, efficient pathways that leverage early clinica…

Drug developers face unique challenges in pediatric rare disease trials, including small and geographically dispersed patient populations, strict ethical limits on sampling, and sparse early clinical data. In a competitive landscape where speed is critical and every month can influence funding rounds and regulatory milestones; traditional development approaches often fall short. However, forward-…

RNA Therapeutics and the European Medicines Agency Framework RNA-based therapeutics, including mRNA vaccines, antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs), and others, represent a rapidly expanding class of medicines with transformative potential for a range of diseases. However, their regulatory landscape in Europe is complex and still evolving, as highlighted by the Europe…

Gaining regulatory approval for drugs targeting conditions that cannot ethically be studied in humans presents a unique challenge for drug developers. Without traditional clinical trial pathways, teams must rely on alternative methods to demonstrate efficacy and support approval. This webinar will explore how modeling and simulation are used to meet the requirements of the FDA […] The post Naviga…