What was the most talked about topic at BIO?
In the sessions I attended, gene therapy was the most talked about topic. In fact, every session I attended that remotely touched on the topic had an overflowing crowd. It was interesting because for as much certainty that was brought up about the therapy, there was just as much uncertainty.
Many of the questions from the audience, and even the ones asked by the moderators, were met with an answer of “TBA” (to be announced). Life science executives were very hesitant when asked specific questions about the topic. One went so far as to say, “On paper, gene therapy sounds amazing, but it’s not that simple.” The cautiously optimistic perspective was felt throughout the conference.
A major reason for the caution, according to several session speakers, was due to the fact that results are going to vary depending on the patient, because it’s an immune reaction.
“There is never going to be a one-size-fits-all for gene therapy diseases,” one CEO speaker explained.
One major barrier that came up multiple times during the conference was the manufacturing aspect. For gene therapy to become mainstream, there needs to be a disruptive improvement in technology, including manufacturing.
It reinforced the notion that gene therapy is truly in its infancy, and while right now the future may hold more questions than answers, the life science community is very optimistic about its potential.
What discussions did you find most interesting at BIO?
There were two: Digital therapeutics, and the state of the FDA, which was a sit-down Q&A with Acting FDA Commissioner Norman E. Sharpless.
Obviously, there were a number of sessions that touched on digital health and digital therapeutics, but the one I attended was a state-of-the-industry talk and focused on where the industry is right now. One point that hit home was when a panelist said that even after 10 years, the industry is still trying to figure out exactly how to handle digital therapeutics and digital health. With potential disruptor companies nipping at the heels of the industry, life science companies are working to make significant strides in their efforts.
What I find most exciting when it comes to this topic is that for companies in the life science space, digital therapeutics opens a host of new opportunities for them. For example, it creates the opportunity to take something that’s off patent, meld it with a digital therapeutic, and have a renewal.
That said, the digital world moves much faster than the therapeutic world, so blending them together can cause some friction. Sharpless spoke about how the agency needs to be conscious of this when looking at clinical data.
If I have an AI tool that reads mammograms, and I make an update to it, does that mean a whole new approval process is needed?
These are the types of questions that the FDA is trying to wade through. To make sure they are staying ahead of the curve, the agency is trying to hire people in the digital therapeutics area to help set policy; however, Sharpless explained that competing within the industry for that talent has been challenging.
Being in the life sciences space, what did you find most inspiring about the future of the industry?
“We make heroes out of athletes and actors, but really, the people in this room are heroes. They have the courage to go after things that there are no cures for, and they stay at it for a long period of time trying to find one.”
That quote is from Ken Frazier, the CEO of Merck, during a fireside chat at BIO, and it really puts into perspective the work that life science companies do every day. It’s exciting to think about the future of the industry, because there are such talented scientists dedicated to solving some of the biggest health and social issues facing the world today. And they are not going to give up.
Hearing Frazier talk about new vaccines that are being developed for Ebola, or the investment that is being made to develop new antibiotics, is inspiring. They aren’t always headline-grabbing, but they are just as important, and to know there is an unwavering commitment to it makes me hopeful for the future.