The Importance of Continuity of Operations Plans for Gene Therapy Manufacturers Blog Post
By: James Zoshak The COVID-19 pandemic has added increased risk and uncertainty to gene therapy supply chains. To mitigate this risk, it is critical for biopharmaceutical manufacturers to properly maintain…
Getting Gene Therapies to Patients Blog Post
This blog discusses the challenges that drug developers face in getting patients access to cell and gene therapies as well as some potential solutions.
Early Value Assessment in Gene Therapy Clinical Trial Design Blog Post
A global biotechnology company engineering precision genetic medicine for rare diseases was in need of expertise in early assessment of proposed clinical trial designs and their potential payer coverage. They...
Why Consistency in Patient Safety Narratives is Crucial Blog Post
“You would not be able to tell 40 different writers were authoring these. It looked as though one person was writing them! The writers wrote a streamlined and visually-cohesive and…
Patient Narratives Page
Expertly written patient narratives, enhanced by CoAuthor, ensuring consistency, quality, and improving safety reporting.
Leveraging Biosimulation to Inform Optimal Use of COVID-19 Vaccines Blog Post
Download PDF 8 Tips for Successfully Developing Oligonucleotide Therapies Blog Post
By Eva Gil Berglund and Nathalie H Gosselin Oligonucleotide therapeutics are a validated class of drugs that can modulate a multitude of genetic targets with gene silencing to prevent expression…
Simcyp Biologics Page
Certara’s Simcyp Biologics platform enables scientists to model and predict the pharmacokinetics and pharmacodynamics of biologics, enhancing drug development and safety assessments.
Simcyp™ PBPK Simulator Blog Post
Streamlines drug development by using PBPK modeling to predict drug behavior in virtual populations, optimize clinical study design, assess drug-drug interactions, and support regulatory decisions.
