Category: Regulatory Medical Writing


The US FDA is enhancing its clinical trial transparency policy

Posted on by Yanni Wang

The FDA announces today (January 16, 2018) that

  • Starting from January 2018, clinical study reports (CSRs) and other information of pivotal clinical trials of some of the recently approved drugs will become available to the public on its new website.
  • The ClinicalTrials.gov identifier numbers (NCT#) of clinical trials will be linked to drug application materials that the FDA uses for drug approval

Regarding its Clinical Data Summary Pilot Program, the FDA clarifies that

  • Only portions of the CSR (eg, summary of clinical evidence) will be posted on its website;
  • The protocol and amendments and the statistical analysis plan for each study will also be posted; but
  • Raw data will not be posted.

 


Trends, Challenges, and Opportunities of Drug Development in China: Highlights from CBA’s 21st Annual Conference

Posted on by Yanni Wang

Hundreds of scientists, regulators, and investors from China and the US gathered in Gaithersburg, Maryland, on June 11, 2016 to attend the 21st Annual Conference of the Chinese Biopharmaceutical Association (known as CBA), a Maryland-based non-profit organization striving to serve as “the bridge of US-China biopharmaceuticals.”

From the advances in immune-oncology and precision medicine, to regulatory challenges in global drug development, the one-day conference covered a wide range of topics.

Here are a few highlights pertinent to drug development in China.

Continue reading “Trends, Challenges, and Opportunities of Drug Development in China: Highlights from CBA’s 21st Annual Conference” →


Ready, Set, Go, and Keep Going!

Posted on by Yanni Wang

Perseverance pays off. The message stuck with me when I was writing this month’s profile article on Wendy Young for the American Chemical Society.

Young, vice president of discovery chemistry at Genentech, has a stellar career that makes many people envy.  As a graduate student, she was part of the discovery team that invented Alimta®, one of the most effective chemotherapy drugs for the treatment of lung cancer. As a research scientist and project team leader at her first biotech job, she helped discover and move multiple candidates into clinical trials for oncology and thrombotic indications. As a vice president of discovery chemistry at Genentech, her team has significantly contributed to the discovery of more than 17 clinical candidates.

Drug discovery and development, however, is not for the fainthearted. As Young said in the profile article, “There are a lot of failures before you hit on success.” And “You have to be willing to keep getting up after being knocked over.”

To succeed in the field of drug discovery and development, Young believes persistence is a must. I believe the same is true with any profession, scientific and medical writing as well.

Continue reading “Ready, Set, Go, and Keep Going!” →