EU Pharmaceutical Legislation Reform – Towards a Resolution

   By John McIntyre, PhD (Director, Clinical Strategy) and Sugato De, MSc (Vice President, Regulatory Strategy) Introduction In April 2023, the European Commission adopted a proposal for a new Directive1 and a new Regulation2 which revise and replace the existing general pharmaceutical legislation in the EU. The proposed change represents the largest reform of the European pharmaceutical legislation […]

Crossover Designs in Oncology: Statistical Perspectives

By Vanessa Beddo, PhD (VP, Global Head of Biostatistical Consulting) Introduction There are several factors to consider when adding a crossover design feature to an oncology study.  These designs typically allow for patients to crossover from placebo or standard of care (SoC) to investigational product after disease progression on their randomized therapy.  It is also […]

Podcast: Advancing Oncology Research: Regulatory & Development Path for ADCs & RDCs

Podcast Join Allucent experts Sugato De, MBE (VP, Regulatory Strategy, Head of MedTech) and Alex MacDonald, PhD (VP, Model Informed Drug Development) in BioPharma Dive’s new podcast. In this episode, we will delve into the innovative realm of antibody drug conjugates (ADCs) and radionuclide conjugates (RDCs) by exploring the tremendous growth potential of these targeted […]

Podcast: Strategic Alliances in the Development and Execution of Pharmacovigilance Strategy

Podcast Join Ian Kovacs (Global Head of Pharmacovigilance) for a BioPharma Dive podcast where he examines the pivotal role of strategic partnerships in pharmacovigilance (PV) between biotech companies and CROs. Ian discusses the long-term implications of the traditional study-by-study outsourcing approach versus the formation of a strategic PV alliance and how they can foster a more cohesive, cost-effective and competent PV strategy from […]

Optimizing Your Clinical Development Plan: Strategies for Biotech Success

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By Sugato De (VP, Regulatory Strategy, Head of Medtech), Josh Taylor (Sr. Director, Regulatory Affairs), Lisa R. Sanders (Sr. Director, Regulatory Affairs), John McIntyre (Director, Clinical Strategy) Critical Importance of the Clinical Development Plan Imagine you walk onto a plot of land and decide it is the perfect place to build your next home. You […]

Enabling Patient-Centric Drug Development: Opportunity for Clinical Pharmacology to Leverage Innovation and Advance Diversity and Inclusion in Clinical Trials

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Excerpted from keynote address at the American Conference on Pharmacometrics, November 2023 By Lisa Benincosa, PhD (Senior Vice President, Clinical Pharmacology Strategy) In today’s ever-evolving landscape of healthcare, the concept of patient centricity has taken center stage. Patient-centric drug development means putting the patient at the center of all we do. We strive to develop […]

Navigating Regulatory Challenges: A Collaborative Journey to FDA Approval

Puzzle pieces uncovering a seal of FDA approval

Case Study Zachary Swan, PhD (Director, Regulatory Affairs) Background and Challenge Allucent was approached by a commercial-stage biopharmaceutical company focused on infectious diseases to provide writing and strategy support for their unique and complex New Drug Application (NDA) with multiple indications. The company faced a significant challenge when the FDA’s assessment deemed their initial studies in […]

Sample Size Re-Estimation: Risk Mitigation at the Planning Stage

Discover an informative webinar to explore the intricacies of sample size re-estimation in clinical trials and how assumptions around treatment effects, endpoint variability, and practical considerations impact trial success. The planned sample size for a clinical trial involves several assumptions around expected treatment effects and endpoint variability as well as practical considerations. At the trial design stage, […]

Automated Exploratory Data Analysis to Support Pre-Specified C‑QT Models

Case Study By Payton Woodall (Director, Programming, CPMS) Background Concentration-QT (C-QT) analyses are cost-effective alternatives to thorough QT clinical trials that help establish the drug’s risk of prolonging the QT interval. Prior to conducting a C-QT analysis, several assumptions should be reviewed to ensure the validity of the pre-specified regression approach. Dozens of tabular and […]