FDA is banking on its regulatory science initiative to reverse a decline in new
drug and biologic submissions and approvals seen over the past few years. Addressing a Drug Information Association Webinar
on regulatory science 1/28, FDA senior advisor for science, innovation and policy Vicki Seyfert-Margolis
said the agency is worried about a recent decline in submissions from industry. New drug and biologic submissions for 2010
sank to the lowest level seen in 15 years — only 26 NDA/BLAs submitted last year when the average over the past five
years has been 32 submissions per year. And the situation is mirrored in Europe, she said, with the EMA seeing fewer new
drug applications, and approvals dropping 70% last year to only 17 approvals compared with 29 in 2009.
Most clinical trial failures
are due to problems and issues in toxicology, Seyfert-Margolis told her DIA audience. “The other important point of
toxicology issues is coming in the post-market safety surveillance arena where we are also picking up unanticipated toxicity
signals in liver and cardiovascular toxicity that often have significant consequences on the marketability of different
drug products,” she said.
So with these issues in mind, Seyfert-Margolis said regulatory science is now being geared to help “de-risk”
the drug development process and to identify those key points that are contributing to a decline in the medical product
pipeline. Some examples of regulatory science projects planned for this include the continuing advancement of genomic-based
technologies and high throughput screening tools, both in the area of predictive toxicology and tailored therapies, where
genetic or other information helps to select those patients who respond. Another involves the use of clinical biomarkers
which can decrease costs by identifying better responders, reduce trial sample sizes, exclude patients early with the use
of toxicity biomarkers, shorten end-point observation times, and allow educated data mining, she said.
---- The above text is excerpted from a recent report
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