Weekly Policy Update: FDA Releases New Draft Guidance and the Midwest BIO CSBA Retreat

FDA Releases New Draft Guidance to advance and modernize oncology drug trials

In the FDA’s ongoing effort to modernize and create a more efficient approval process, last Friday the FDA released their draft guidance to advance and modernize oncology drug trials, “Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics”.

The draft guidance outlines how companies can use seamless trial designs to consolidate the traditional three-phase trial approach into one first-in-human study to expedite development of cancer drugs and biologics. Seamless trials use a single protocol that runs continuously and is amended to expand cohorts and/or add new ones until there is enough evidence to approve a candidate or scrap its development.

CBSA commends Commissioner Scott Gottlieb and the FDA for the release of this guidance. We see this as a great approach to help efficiently evaluate drugs, lower costs and ultimately get lifesaving innovations to our patients most in need.

To learn more about the guidance click here.

“A lot of the time and cost of clinical development is spent waiting in between the start and end of the phases of trials,” FDA Commissioner Scott Gottlieb said in a statement. “Expansion cohort trials can bring efficiency to drug development, potentially reducing development costs and time. These clinical trial improvements can help ensure that innovative new therapies can be advanced efficiently to patients confronting a cancer diagnosis.”

CBSA Vice President Attends Midwest BIO CSBA Retreat

This week CBSA vice president Jennifer Jones visited Des Moines, Iowa to attend the BIO Midwest Coalition of State Biosciences Association retreat. It was a great opportunity to meet with other state organizations, talk about best practices, and learn about some of the great new work of BIO as well as their fresh focuses—including gene editing. Another blog post will come soon on gene editing. In the meantime, you can learn more from BIO here. We spent the day learning and touring at Kemin Industries. Kemin is a global manufacturer providing local, innovative nutritional and health solutions for a changing world. Founded in 1961 by R.W. and Mary Nelson, Kemin began on a family farm in Des Moines, Iowa. Today, Kemin is a leader in the ingredient manufacturing industry, providing innovative nutritional ingredient solutions to customers in more than 120 countries.

R.W. and Mary Nelson address the CSBA group.

The CSBA group visiting the Iowa State fair.

Categories: CBSA News