Virtual Twin Patients Can Bridge Data Gaps for COVID-19 Halted Clinical Trials
The virtual twin approach combines limited clinical data with biological principles to make patient level predictions which could help recover halted trials.
Tag: Central Nervous System
Biohaven achieves FDA approval with Nurtec™
In February 2020, Biohaven announced that the U.S. Food and Drug Administration (FDA) approved Nurtec™ ODT (rimegepant) for the acute treatment of migraines in adults. It is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting, orally disintegrating tablet (ODT).
Salvaging CNS Clinical Trials Halted Due to COVID‐19
The coronavirus disease 2019 (COVID‐19) pandemic has halted many ongoing central nervous system (CNS) clinical trials, especially in Alzheimer’s disease. These long‐duration trials involve many stakeholders, especially the patients and their family members, who have demonstrated their commitment to developing new therapeutic interventions for this devastating disease. We certainly do not want to lose all … Continued
A QSP Modeling Approach for Neurodegenerative Disease Drug Development
A QSP model was built to evaluate its use in drug discovery for complex neurodegenerative diseases, e.g. Alzheimer’s.
Certara’s Best of the Blog 2019
A selection of short essays from our blog, written to empower our clients with modeling and simulation (M&S), regulatory science, and real-world value assessment solutions to help them solve the toughest drug development problems. In the Best of the Blog, Certara’s scientists and regulatory experts share their learnings, technological advances, and thought leadership.
How Model-Based Meta-Analysis Leverages Public Data to Support Strategic Drug Development Decision Making
Model-based meta-analysis (MBMA) helps sponsors to make the wisest, most informed decisions about the next steps in their drug’s development and market positioning.
Advanced Analytics Using RWD Mitigates Risks in AD Drug Development & Reimbursement
This webinar explained how advanced analytics using real-world data can mitigate challenges in Alzheimer’s disease drug approval, reimbursement and utilization.
Development of a Physiologically-Based Pharmacokinetic Model for Topical Lidocaine in Order to Predict Systemic Absorption in Healthy Volunteers, Geriatrics, and Pediatrics
Building an MBMA Framework to Support Developing New Neuropathic Pain Drugs
In this webinar, Leticia Arrington (Merck) and Richard Franzese (Certara) discussed data considerations, analysis methods, and learnings from a recent network MBMA analysis of relevant endpoints in NP that will be used for general competitive landscaping questions to support Merck’s ongoing mission to develop better NP therapies.
Centers for Disease Control and Prevention (CDC) Selects Certara to Develop Technology Platform to Strengthen the Agency’s Death Investigation and Surveillance Systems
PRINCETON, NJ – March 5, 2019 – Certara will partner with CDC to create OpenMDI (Open Medicolegal Death Investigation), a national system that will collect and share mortality data efficiently, allowing CDC to respond rapidly to critical public health priorities, such as tracking and understanding the toxicology behind drug overdoses from opioids.
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