Pediatric Drug Development: Optimizing Extrapolation
Drug development in pediatrics continues to be a substrate for the application of innovative tools…
CertaraSeptember 1, 2021
Gene Therapy Based Precision Medicine Therapeutics: Clinical Pharmacology & Translational Science Considerations
The era of gene therapy may have started a couple of decades ago, but approvals…
CertaraAugust 13, 2021
Succeeding in Value Communication: Introduction
Drawn from the experiences of the BaseCase Consulting Team, this is the introduction to ‘Succeeding…
CertaraAugust 5, 2021
Why You Should Participate in the Voluntary FDA Oncology Center of Excellence Assessment Aid Program
Why You Should Participate in the Voluntary FDA Oncology Center of Excellence Assessment Aid Program
In 2018, the FDA’s Oncology Center of Excellence developed an Assessment Aid document to help…
CertaraJuly 21, 2021
Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success
Antibody drug conjugates (ADC) are a unique way to obliterate tumor cells and represent an…
CertaraJuly 8, 2021
Maximizing Oligonucleotide Therapeutic Development: Pre-clinical and Translational Considerations
This is the second of three blog posts discussing best practices for developing oligonucleotide therapeutics.…
CertaraJune 25, 2021
Top 10 Benefits to Integrating the Simcyp PBPK Simulator into your Drug Development Program
Per US FDA’s recent paper on the topic, Physiologically based Pharmacokinetic (PBPK) modeling & simulation…
CertaraJune 22, 2021
Preparing for High Stakes Meetings; How to Best Convey a New Drug’s Value to Payers
This blog post includes key takeaways from the opening session of Certara’s first Strategic Evidence…
CertaraJune 18, 2021
Watershed Moment for the Future of Cell Therapy Development – FDA Advisory Committee Meeting
Every FDA Advisory Committee meeting is unique, and the Cellular, Tissue, and Gene Therapies Advisory…
CertaraJune 15, 2021
Why Your Regulatory Writers Need eCTD Authoring Templates
If you’ve heard about eCTD authoring template suites before, but you’re not sure what they…
CertaraMay 14, 2021
