Allucent

Antibody-drug conjugate development succeeds or fails on integration, not any single component. This guide examines what development teams need to align before first-in-human testing and throughout clinical development: target biology and antigen expression, antibody-linker-payload design, drug-to-antibody ratio trade-offs, biomarker/assay strategy, dose and schedule rationale (per FDA guidance a…

Why Endpoint Protection Matters Immunology and inflammation (I&I) studies frequently rely on complex clinical assessments, composite disease activity scores, imaging evaluations, endoscopic findings, histopathology interpretations, and biomarker measurements to demonstrate treatment benefit. Unlike laboratory values that can be measured objectively, many efficacy endpoints in I&I trials depend on…

Click the image below to download the infographic. From protocol design and site selection to patient recruitment, trial operations, and data analysis, artificial intelligence (AI) and other emerging technologies are reshaping the future of clinical development, offering new opportunities to accelerate timelines, improve decision-making and enhance trial efficiency. As sponsors face increasing pr…

Oncology remains one of the most active and innovative areas of biopharma research and accounts for the largest share of global clinical development activity. Advances in cancer biology, biomarker-driven patient selection, precision oncology, and novel therapeutic modalities have changed the landscape over the past few years, presenting new opportunities to tackle previously difficult-to-treat ma…

Study Background Allucent was selected to provide full-service support for a Phase IIb randomized clinical trial in patients with first line metastatic head and neck squamous cell carcinoma (HNSCC) for a leading global biopharma company. The global study was conducted across 31 sites in multiple countries and regions and enrolled 171 patients. Key study activities […] The post Achieving Critical …

In the race to bring new oncology therapies to market, patient selection is more critical than ever. With narrow windows of exclusivity and mounting competitive pressure, biotech sponsors are rethinking their clinical development strategies -starting with smarter trial enrollment.  This live panel discussion featuring Dr. Brian Barnett and other leading industry experts will explore how […] The p…

Each year, the ASCO Annual Meeting offers a glimpse into where oncology research is heading next. In 2026, the conversations extended beyond breakthrough data alone. This year’s meeting reflected a broader shift toward smarter, more adaptive, and increasingly personalized approaches to cancer treatment and development. Across tumor types and therapeutic modalities, researchers highlighted advance…

Clinical trials are undergoing a fundamental shift as emerging technologies reshape how studies are designed, executed, and evaluated. For biopharma companies, the pressure to accelerate timelines, improve efficiency, and reduce risk has made the integration of these technologies increasingly critical. This webinar will explore how artificial intelligence (AI) and other key technology-enabled app…

The success of cell therapy programs depends on a clear understanding of the differences between autologous and allogeneic treatments, from their respective development challenges to the regulatory frameworks governing their clinical use. Autologous cell therapies use the patient’s own cells to create a personalized treatment with minimal risk of immune rejections. In contrast, allogeneic cell th…

A Field in Motion: Growing Opportunity for Therapeutic Innovation For biopharma sponsors, scientific clarity, measurable outcomes, and ease of regulatory validation are important factors to consider when developing new therapies. As the industry focus on precision medicine and orphan drug innovation continues to grow, rare endocrine system disorders emerge as a strategically important area for [……

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-…