Paving the Way for Safer, More Effective Treatments for Children
By Jessica Roberts PhD, MSCI, Director and Head Quantitative Translational Pharmacology Developing safe and effective drugs for children has long been a challenge for drug developers. With the need to cater to a wide range of ages and sizes, pediatric drug development requires precise and innovative approaches. Our infographic highlights the transformative role of pharmacokinetic […]
Podcast: Advancing Oncology Research: Regulatory & Development Path for ADCs & RDCs
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 oncology […]
Enabling Patient-Centric Drug Development: Opportunity for Clinical Pharmacology to Leverage Innovation and Advance Diversity and Inclusion in Clinical Trials
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 […]
Efficient Clinical Programs and Decision Making Through Model-Informed Drug Development (MIDD)
Efficient Clinical Programs and Decision Making Through Model-Informed Drug Development (MIDD) Join Alex MacDonald, VP Model-Informed Drug Development, on how MIDD can help your clinical trials.
PBPK Modeling for Pediatric Drug Development
Watch to learn more from our A-Team on PBPK modeling for pediatric drug development.
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 […]