Pearls of Wisdom
Diana Caldwell invited to speak at BioCrossroads event on biopharma drug development
Drug development and the biopharmaceutical industry as a whole continues to expand, employing more people and increasing in total market value year after year. How is this evolving landscape affecting companies along the continuum, such as contract...
Novel method to predict drug stability could benefit pharma
A novel technique to predict a drug’s physical stability has piqued the interest of the biopharmaceutical industry, in-PharmaTechnologist.com reports. The method could help pharmaceutical companies de-risk early drug development. The method concerns the...
Campaign educates healthcare teams on clinical trial participation shortages – “One Person Closer”
Clinical trials create opportunities for patients to access groundbreaking, and potentially lifesaving, cancer treatments before they reach the market. However, clinical trial participation continues to be an issue, with only 5% of cancer patients...
FDA issues two draft guidances to combat drug counterfeiting
Drug counterfeiting is big business worldwide. The World Health Organization estimates that 1 in 10 medical products in low and middle-income countries either do not meet quality standards or are flat out fake. While the problem is seen with less frequency...
Best practices for communication between IND Sponsors and FDA during drug development
FDA recently published a guidance, Best Practices for Communication Between IND Sponsors and FDA During Drug Development. This is one of several guidances published by FDA in response to User Fee Legislation. This guidance is a joint effort by FDA’s Center for Drug...