Last week I moderated a live webinar about the FDA's Breakthrough Therapy Designation (BTD), figuring that we'd attract a small crowd of fewer than 100 listeners because of the timing in mid-August. I was a bit surprised to have more than 200 people log in for the webinar. (Follow this link for the full recording.)
Here are 5 likely reasons why my estimate for turnout was way off, and you might deduce from my headline where I'm going with this post.
- Breakthrough Therapy status has been one of the hottest topics in drug development throughout most of 2013. The FDA has awarded more than two dozen of the designations, giving awardees an inside track on speedy development and review of their therapies. But the agency has not yet made a decision on whether to approve any of the experimental therapies with the coveted designation. It's that new. And people have a lot of questions about this program. Many of those questions were answered last week.
- True expert speakers seemed to help. Michelle Rohrer is the vice president of U.S. regulatory affairs at Genentech/Roche ($RHHBY), where she's worked closely with her colleagues on advancing the company's "breakthrough" drug GA101. And Dr. Jay Siegel, who serves as Johnson & Johnson's ($JNJ) chief biotechnology officer and head of scientific strategy and policy, worked on policies for expedited regulatory reviews during his career with the FDA before he joined J&J. Johnson & Johnson has the most breakthrough designations on record with four, including three for ibrutinib from partner Pharmacyclics ($PYCY) and one for daratumumab from partner Genmab.
- Live interviews tend to generate interesting and candid moments from speakers. Johnson & Johnson has been extremely successful in winning breakthrough designations, yet Siegel acknowledged that the FDA had denied his group the status for one undisclosed program. (Companies are not obligated to disclose rejections on applications for the status, and Siegel declined to comment on the specifics of the program that was denied.) This shows that even the largest companies continue to learn from their interactions with the agency about the designation.
- Yep, our webinars are free. It never hurts to offer a quality product at no charge. Appian sponsored our webinar last week and therefore underwrote the production. In a call prior to the webinar, J&J's Siegel told me that he appreciated that his colleagues could tune in for the webinar without having to pay.
- Readers like to get close to the source of the news. Our webinars offer this opportunity, and we've begun to incorporate more Q&A time in the programs. (Last week's webinar was 95% Q&A, and this format kept things lively.)
Please send me or John Carroll (email | Twitter) an email with your feedback about our webinars and topics you would like us to cover in the future. John and I have nothing to do with advertising, so those questions should go to our publisher, Arsalan Arif (email | Twitter). We're open to your ideas and comments. -- Ryan McBride (email | Twitter)