WEBVTT 1 00:00:00.000 --> 00:00:05.000 (soft introduction music) 2 00:00:05.120 --> 00:00:07.610 In the interim, 3 00:00:07.610 --> 00:00:11.510 do you have any advice for CTG companies on how to best 4 00:00:11.510 --> 00:00:14.340 engage with FDA? And do you see any opportunities 5 00:00:14.340 --> 00:00:17.840 that they have that they're not taking advantage of? 6 00:00:17.840 --> 00:00:19.700 No, I think they're generally doing a 7 00:00:19.700 --> 00:00:21.790 pretty good job taking advantage of things. 8 00:00:21.790 --> 00:00:25.110 You know, I think we have had the interact meetings, 9 00:00:25.110 --> 00:00:27.530 which is like a pre-pre-IND meeting. 10 00:00:27.530 --> 00:00:30.050 People come in for their pre-IND meetings and people 11 00:00:30.050 --> 00:00:34.210 contact us. I would say if anything, you know, we 12 00:00:34.210 --> 00:00:38.130 as an agency want to try to do better in the timeliness of 13 00:00:38.130 --> 00:00:41.410 communication around gene therapies in particular, 14 00:00:41.410 --> 00:00:46.020 because with the pandemic we've been so underwater that 15 00:00:46.020 --> 00:00:50.410 we're behind on meetings, especially for gene therapies. 16 00:00:50.410 --> 00:00:55.410 My dream is to have Type A-like meeting timelines for 17 00:00:55.450 --> 00:00:57.469 most routine interactions 18 00:00:57.469 --> 00:01:01.080 because if we could get to meetings within 30 days for 19 00:01:01.080 --> 00:01:04.450 simple questions, it would allow people to move a lot more 20 00:01:04.450 --> 00:01:07.810 quickly. And I think it would put the agency's 21 00:01:07.810 --> 00:01:11.584 actions more in line with the 22 00:01:11.584 --> 00:01:16.070 small biotech ecosystem. Because, you know, 23 00:01:16.070 --> 00:01:19.010 we kind of move at this pace, 24 00:01:19.010 --> 00:01:22.410 when it takes us, you know, 90 days to get back to someone, 25 00:01:22.410 --> 00:01:24.770 that is at the pace of large pharma. 26 00:01:24.770 --> 00:01:28.100 And so what does that mean then for you and CBER in your 27 00:01:28.100 --> 00:01:30.700 priorities? I mean, how are you thinking then about 28 00:01:30.700 --> 00:01:33.740 developing the resources and capabilities 29 00:01:33.740 --> 00:01:36.890 to help work with industry in the way that you describe? 30 00:01:36.890 --> 00:01:40.180 Yeah, so right now we're working to look at 31 00:01:40.180 --> 00:01:44.090 what we can do on our Office of Tissues and Advanced 32 00:01:44.090 --> 00:01:47.330 Therapies to essentially think about whether we can put 33 00:01:47.330 --> 00:01:50.348 together a group or a hub of people where, 34 00:01:50.348 --> 00:01:54.340 for gene therapies-particularly for small indications- 35 00:01:54.340 --> 00:01:57.350 we could essentially be somewhat transformative in what 36 00:01:57.350 --> 00:01:59.463 we're doing and kind of forward-leaning.