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Leveraging the draft FDA Guidance on PBPK for your drug development program
Parexel Insights
We need faster endpoints for targeted cancer drugs, and there is one
02.19.21 - 3 min - As a former regulator, Jorge shares his perspectives for the need of more faster endpoints to measure how targeted cancer drugs can benefit patients. He believes it can be created by combining two commonly used measures. Read more in this short blog.
Three ways to improve your chances that insurers will pay for a new CGT
02.18.21 - 4 min - When developing cell and gene therapies (CGTs), drug companies face significant hurdles. One of which is getting insurance companies to pay for these treatments that can potentially cure patients of debilitating diseases such as spinal muscular atrophy and retinal dystrophy but at a very high cost. In this blog, Ned outlines three steps that can help improve the chances of getting a new cell or gene therapy reimbursed by payers.
Getting the small steps right for our biotech customers to make an exponential difference in patients’ lives
01.13.21 - 4 min - Biotech companies are the driving force behind the industry’s R&D pipeline as they develop and launch increasingly complex treatments. With more than 80% of the assets in development managed by small and mid-sized biopharma companies, it is a thrilling time to be working in this field.
Challenges of 2020: Lessons for Clinical Trials in Diabetes
11.23.20 - 3 min - The extraordinary challenges of 2020—the global pandemic and the renewed campaign against racial injustice—have simultaneously presented opportunities for significant growth and change across the clinical research industry.
Fostering steady advances in data operations: FSP partnerships can spur and support change
11.12.20 - 5 min - When we discuss innovation in clinical trials, it’s easy to think first of technologies involving digital health or evolving tools such as augmented intelligence. And these are certainly meaningful advancements.