The Changing Paradigm of Regulatory Submissions: Embracing Automation, Gen AI, and Innovation for Faster Approvals
This informative webinar is aimed to be forward-looking, discuss the potential promises of emerging technological tools in expediting and radically changing submission preparation, pinpoint potential challenges and brainstorm resolutions. The current landscape of regulatory submissions is weighed down by the sheer volume of documentation required, complex guidelines and repetitive information across documents. It also involves the painstaking, cumbersome writing styles […]
Cell and Gene Therapy Clinical Trials: How to Successfully Operationalize a Trial of Prolonged Duration
Cell and Gene therapies hold revolutionary potential for treating a wide range of diseases however, operationalizing trials of such duration and complexity is a significant task. Their development demands meticulous planning and expertise across multiple disciplines. View this webinar to hear from Allucents operational A-Team as they share insights and strategies on how to successfully […]
Translational Clinical Pharmacology in Cell and Gene Therapy
Learn more about the accelerating growth caused by transformative, curative and durable effects for unmet medical needs. The challenges that come along when growth happens so rapidly. As well as translational clinical pharmacology in AAV and CAR-T therapies. Presented by Vice President of Clinical Pharmacology – Devin Welty. Watch Here
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, […]
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.
Pediatric Clinical Trials: Tackling Clinical and Therapeutic Development Challenges Head-On
There remains a crucial need to include children in clinical development as historically they have been underrepresented in clinical trials. This is due to the complexities of including children, their vulnerabilities and the lack of motivation for drug developers to pursue marketing authorization for pediatric populations. These challenges faced in developing pediatric medicine are not […]
More than Skin Deep: Considerations for Dermatology and Drugs Administered to the Skin
PBPK Modeling for Pediatric Drug Development
Watch to learn more from our A-Team on PBPK modeling for pediatric drug development.