The second half of the conference was just as exciting as the first half.
I heard a great lunchtime talk about the impact of the 2016 election on life science industry. There were great talking points and it gave me a lot to think about.
Following the lunch talk, there were two breakout sessions, I attend the talk on the FDA and PDUFA-VI presented by Mike Druckman, a partner at Hogan Lovells
The current version of PDUFA will be expiring soon and PDUFA-VI will replace it in 2018 although the changes have not been voted on yet by the Senate. One suggested change is the replacement of the establishment fee with a program fee. This is designed to remove the ambiguity as to who should be responsible for the payment.
There will also be additional provisions to improve the efficiency of the review process. This will be facilitated by increasing staffing, early consultation on biomarkers, and combination product review.
There is also a push to use real-world experience (RWE) to help decrease clinical trial size. In conjunction with this, there is a desire to link data across sectors to help provide more information about drug efficacy.
The conference was wrapped up with a talk by Andrew Fish, CSO of AdvaMed. He talked about how the medical device industry is changing and how it is affecting the biotech community as a whole. There are so many new techs that are coming out – 3D printing and robotics – that the next several years will be very exciting!
I highly enjoyed LSTCON and can’t wait till next year!