00:46:30 Thomas Seoh: Hello from Manassas, a Northern Virginia suburb of Washington, DC 00:46:58 Beth Weinberg: hello from rainy, gray Indianapolis 00:46:58 Eric Edmunds: Hello from Boise, ID 00:47:36 Peter F. Kador: Good morning from Meredith New Hampshire 00:48:08 Joyce Greenleaf: Hello from rainy Southborough, MA 00:48:17 Phil Frankino: Hello from Oakland, CA 00:48:22 Amy Wotawa: Hello from Huntsville, AL 00:48:28 hkypta: Hello from Belleville, IL 00:48:31 C. Kirk: Hi to all from the Washington, DC area. 00:49:03 Myriam Triest: Bonjour from Montreal, canada 00:49:03 Cynthia Stuen: Hello from Cynthia Stuen in NYC. 00:49:41 KIZITO YANNICK: Hello From Brussels Belgium 00:51:27 Thomas Seoh: Claude, you could repost your hi from Q&A to Chat... :) 00:52:01 Michaelle Cooke: hi from NYC. Michaelle Cooke 00:53:57 Douglas Kiel: Please define CEDR or however it is spelled for attendees who may not be up on abbreviations of agencies 00:56:05 Thomas Seoh: Center for Drug Evaluation and Research (drugs), Center for Biologics Evaluation and Research (biologics and advanced therapies), Center for Devices and Radiological Health (device) 01:01:00 KIZITO YANNICK: My name is yannick kizito am from Belgium and the founder of Medictech Solutions which has 2 entities one that’s providing consultancy services in the healthcare, Life science , IT and Space industry and the other entity is MedictechLab which is an early stage Bioengineering startup that’s creating new medical technologies and conducting research to advance medical knowledge. We are looking for an USA cofounder ,partners, investors for our pre seed round , to protect our pattent and improve our product , validate it and go to the market. 01:03:02 Thomas Seoh: Center for Veterinary Medicine 01:25:30 Thomas Seoh: Center for Food Safety and Applied Nutrition (CFSAN) 01:26:48 Thomas Seoh: https://www.fda.gov/about-fda/fda-organization/fdas-proposal-unified-human-foods-program-and-new-model-office-regulatory-affairs#:~:text=The%20proposal%20includes%20additional%20improvements,reorganization%20package%20in%20December%202023. 01:27:53 Thomas Seoh: https://www.fda.gov/food/news-events-cfsan/road-jim#:~:text=James%20%E2%80%9CJim%E2%80%9D%20Jones%20joined%20the,Human%20Foods%20Program%20(HFP). 01:30:34 Thomas Seoh: @Riette: Commissioner Califf at CERSI 2024 at JPM a couple weeks ago referenced research need/spotlight on ultra-processed foods - so this is early, but what might ultimately come out of FDA on that? 01:35:33 Pepper Landson: was that Pyridoxamine? 01:36:09 Riette van Laack: No. NMN. 01:37:42 Fang Li: hi from Fang Li (NJ), good to see you Zen and Tim! 01:40:06 Beth Weinberg: Tim - you are still an infectious disease guy at heart! 01:47:02 Thomas Seoh: A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. 01:54:36 Thomas Seoh: @Dean, yes. typically recording is posted within a day or two. A rough AI transcript is actually available within a day or two too, but we have historically tried to clean it up, which can take a week or so. 02:04:08 Thomas Seoh: Sam Collaudin 11:41 AM Hello Frank The rare paediatric disease priority review voucher program is expected to end this year. What is your expectation on potential re-authorization, on what timeline. If it's not re-authorized, what could be the impact in the industry 02:04:35 Thomas Seoh: Claude Lardinois 11:48 AM When is someone going to address High Fructose Corn Syrup. Very few national socieities discuss it. Still push for less salt. Why not a push for the 'OTHER" white crystal? Claude Lardinois 12:15 PM The problem with the weight loss drugs is we are treating the "number" not the "problem". The problem is the junk food that is so plentiful including high fructose corn syrup in virtually every food. 02:05:19 Thomas Seoh: Anonymous Attendee 12:16 PM What is impact of Janet Woodcock’s retirement? 02:13:12 Thomas Seoh: C. Kirk 12:29 PM Thanks for the interesting presentations and discussion! If there is time, any thoughts on the current IP landscape (e.g., Bayh-Dole march in, TRIPS waiver, pending Section 101 legislation) and interaction with supporting innovation? For example, potential effects on support for incremental innovation for existing products, new or improved products for rare diseases, products to address antimicrobial resistance, tropical diseases, etc.). Thank you! 02:21:23 Fang Li: Many thanks! 02:21:25 Zina Manji: Thank you all. Great session. 02:21:28 Anthony Cruz: Thank you to the panelists and to Kinexum for an enjoyable, wonderfully educational seminar! 02:21:39 Beth Weinberg: This was great - thanks! 02:21:50 Meghan O: thank you! 02:21:51 C. Kirk: Thank you! 02:22:41 Daniel Valentino: Sincere thanks to both the presenters and the organizers! 02:24:31 Thomas Seoh: Thanks Dean and all for your appreciations. Makes this all worthwhile. But to answer Frank's thanks, we feel like we get to run a White House command performance kind of thing. Experts come and give us their time to educate and inform us. What a racket!