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 […]

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

cartoon silhouettes of people in different solid colors against a purple background

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 […]

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 […]

Translating Complex Data into Actionable Insights, to Create Big Value for Smaller Biotech Companies

Industry Featured Article Discover how Lisa Benincosa, Senior Vice President of Clinical Pharmacology Strategy at Allucent, harnesses the power of data to drive efficiency and informed decision-making in drug development for small to mid-sized biotech partners. From optimizing dosing protocols to addressing emerging trends like cell and gene therapies and enhancing diversity in clinical trials, […]

Clinical Pharmacology Studies to Support Filing Packages and Labeling

Explore with Neha Bhise, Ph.D. the clinical pharmacology studies that are critical to inform labeling and filing packages, their significance on drug development, as well as other various aspects, such as: First-in human, food effect studies, bioavailability studies, and more. https://youtu.be/ZsoWHmcF9A4 Learn more about Allucent’s clinical pharmacolgy expertise here. Click here

Risk Assessment of Novel Neurotherapeutics: Mechanistic Translation of Preclinical Safety and PK/PD Data to a Clinical Setting

Risk assessment is a complex process intended to protect human health. In drug development, this process includes identifying drug candidate-related hazards in relationship to dose and exposure via traditional in vitro and in vivo frameworks. Nonclinical studies in pharmacology, pharmacokinetics and toxicology are designed and conducted under conditions that closely mimic the clinical setting to facilitate proper risk assessment. The introduction of […]

Technical Writing Services with a Clinical Pharmacology Focus

Allucent has extensive experience with clinical pharmacology studies and analyses needed to support drug development programs and messaging of key data to support the product label. Our authoring tasks span the entire process from drafting, reviewing, and updating to full writing of regulatory documents, supporting clients with documents that meet industry standards in an efficient […]

Study Design and Conduct Leveraging Allucent’s Clinical Pharmacology Expertise

Allucent has extensive experience with designing, conducting, analyzing, and interpreting of data from each type of Phase 1 clinical pharmacology study needed for an individual drug development program. While we can conduct any Phase 1 study, our focus and expertise in clinical pharmacology is our differentiator. This is about much more than just conducting one […]