00:37:44 Andras Dinnyes: Hi From Hungary, BioTalentum Ltd 00:37:44 Paul Strumph: Hello all, such a pleasure to attend. I am a diabetes clinical development consultant 00:37:50 Neil Clegg Vancouver Bio Conscious: Neil Clegg from Bio Conscious in Vancouver, BC, Canada 00:37:50 ThomasDiLenge: Hi, thanks for this great panel! I'm Tom DiLenge, from Flagship Pioneering. And great to see Janet again! 00:38:03 David Wood: Hi, Pleasure to be attending from London (UK). I have the privilege to serve as Executive Director of Longevity Escape Velocity Foundation 00:38:18 Fang Li: Hi Zen, Tim: Good to see you! I enjoy this annual tradition and look forward to getting your perspectives especially at this time! 00:38:50 Monica Feldman - Perceptrack: Hi, Monica Feldman from Longevity Ruler in Sun City, Arizona 00:39:30 Kanwaljit Singh: Hello, good morning, logging in from Critical Path Institute in Tucson, AZ. 00:40:05 wei shen: Hi This is Wei Shen from Immunomic Therapeutics. Very happy to attend this panel! Can't wait for the discussion! 00:40:18 Ron Bartek: Ron Bartek, Co-Founder/President Friedreich's Ataxia Research Alliance (FARA); Alliance for a Stronger FDA Board of Directors 00:45:34 Anderson, Margaret: ORCHIDS! Margaret Anderson, Deloitte here. Former Alliance for a Stronger FDA (alumnus) and FasterCures... thanks for organizing this. 00:45:41 Thomas Seoh: @Janet, I heard you at the CERSI Summit a few weeks ago and were impressed with your work on food and AI 00:45:54 Thomas Seoh: was 01:16:34 Thomas Seoh: @Tim: did you say odds are good for extension of pediatric vouchers? What is Steve, others, hearing? 01:17:26 VictoriaHorstman: Victoria Horstman, MD PI, Care Access, Phoenix/Mesa Arizona. Thank you for this discussion 01:53:10 Thomas Seoh: @Kelly: 2/28/25 we will present on the draft THRIVE Act 01:59:24 Thomas Seoh: at CERSI, SVP Global Regulatory at Amgen reported they are getting 26 wks from data lock to BLA submission down to 8 wks by mid next yr. 01:59:43 Thomas Seoh: using AI to write submission, CSRs etc. 02:01:54 Rashida Karmali: Rashida Karmali, Dr. Woodcock thanks for defining "substantial evidence" in rare diseases, and the control arm-do you accept historical control when available? thank you 02:05:45 Fang Li: Great panel discussion- second to Zan- Thanks to Dr Woodcock for her service to the country and humankind 02:05:50 Kanwaljit Singh: Thank you all for hosting this amazing discussion. Such insight conversations, I liked how you focused on pediatric conditions as well. Best, Kanwaljit Singh 02:11:16 Jerry Colca: Extension of regulatory exclusivity would be transformative for drugs/treatments that could impact broad outcomes. 02:15:36 David Wood: What's the best link for info about the THRIVE act that was mentioned? (The same name seems to already apply to other acts.) 02:16:40 Thomas Seoh: @David: all registrants to today's webinar will get notice and registration link. 02:27:19 Melissa King: “Regulated” 02:36:35 Jade Byrd: Thank you so much 02:36:48 kellyclose: Thank you very much!! Phenomenal! 02:36:49 Melissa King: Thank you!