00:27:21 Kinexum Services: Good Morning Everyone! 00:27:41 Thomas Seoh: absolutely. welcome! 00:33:30 David Wood: It's great to be here! This is a really important initiative 00:35:56 Thomas Seoh: thanks Christine 00:36:03 Thomas Seoh: great 00:38:07 Todd White: Good Morning. 00:41:06 Emilie Strand McCarthy: Morning, from Boston. 00:41:13 Jerry Colca: Hi from Kalamazoo Michigan, Jerry Colca 00:41:43 cjcleveland: Hi from Valparaiso, IN 00:41:44 Monica Feldman - Perceptrack: Hello from Los Angeles 00:41:56 Kevin McMahon: Hello from Lake Worth Beach FL. Pleased to be here. 00:41:59 Dean Calcagni: Hello from sunny Ijamsville, MD 00:42:41 HealthSpan-LLC: Hi, Tricia Cedotal here from Napa Valley! Happy to be here! 00:42:56 David Wood: I'm connecting from London, UK. Representing the Longevity Escape Velocity Foundation. The sooner we can have good products available worldwide, that reliably prevent the onset of diseases of aging, the better :-) 00:50:05 Emilie Strand McCarthy: Could we please get a copy of the recording transcript with the video webinar to cut down on notes, and allow more presence? 00:50:19 David Barzilai MD PhD: David Barzilai, longevity physician, consultant and healthspan advocate (aka "agingdoc" on X). Happy to connect with other professionals. https://www.linkedin.com/in/agingdoc 00:52:54 Thomas Seoh: @Emilie: yes, a link to the recording will be circulated in a day or so 00:54:09 Thomas Seoh: @George: we will discuss that in a few minutes under the rubric, is THRIVE passable? 00:55:22 Tom DiLenge: yes traditional approval is the better term! 00:57:39 Tom DiLenge: Tier 1 must also have clear evidence of safety presumably 01:02:49 Thomas Seoh: Tier 1 could include biomarker data, like clocks, and digital evidence (AI/ML, digital twin, etc.). It's better left to guidances than legislation to list specific elements and weighting. 01:04:23 Thomas Seoh: @Tom, absolutely, safety is critical at Tier 1. Think metformin or rapamycin, for example. 01:04:26 Jerry Colca: Can you speak to the difference in pricing for such a large population? 01:05:57 Thomas Seoh: @George, the exclusivity is extendable at Tier 2 for an additional 7 years. This is incentivizing developers to invest in additional evidence over time 01:07:17 Thomas Seoh: @Alan, that's Zan's point, that FDA has statutory authority. Vaccines, statins and contraception are examples. But culturally, the focus is on treating individual diseases. 01:07:22 Jerry Colca: Could CMS be involved in pricing negotiations in exchange for the increased exclusivity? 01:11:17 David Wood: Will approval at Tier 1 require a treatment passing through Phase 1, Phase 2, and Phase 3 trials? 01:13:13 Tom DiLenge: Do you think the ARPA-H PROSPR/Intrinsic Capacity program will be successful in getting FDA to accept this is a surrogate for age-induced health loss? 01:14:01 Jerome Schentag: I agree that we have short term benefits with weight loss, but Is there evidence that GLP1 agonists prevent any metabolic syndrome disease? I mean, before you have T2D, does taking a GLP1 prevent you from getting T2D? Same comment for MASH, PCOS, Alzheimers, ASHD. 01:14:26 Sebastien Thuault: Intrinsic capacity? 01:15:25 Thomas Seoh: @Sebastien: ARPA-H PROSPR program Technical Area 1 for a universal metric for aging. a MARS shot, but that's what ARPA-H is for. 01:15:41 Sebastien Thuault: instead of clocks I mean 01:16:22 Matt McAlister: Technical note (from an aging researcher): epigenetic clocks generally measure changes in DNA methylation. They aren’t separate. 01:30:51 Thomas Seoh: @George: like market exclusivity in other contexts, like orphan. They run, and the sponsor has the benefit disjunctively. That's distinct from proposals to alter (extend) IP terms 01:33:00 Emilie Strand McCarthy: @Eve Are you aware of how Healthspan is officially integrated into Med School curriculum? I see Tufts has an Integrated Curriculum, Harvard has a 6 week Happiness-Healthspan course (wellbeing). I'd love to follow a Med School lens, curious how biological clocks are taught as a point of origin in the medical field. 01:41:25 Thomas Seoh: what Zan is referring to is the THRIVE Act Discussion board at www.kitalys.org 01:56:47 David Wood: To follow up: What kind of proof of safety will Tier 1 approval require? 01:59:10 Alex: Does Tier 1 approval run the risk of delegitimizing FDA? We already see lots of (unfounded) skepticism over accelerated approvals or EUAs. 02:08:59 Gordon Cutler: The definition of health span, while complex, seems addressable by a consensus of clinical experts in the most relevant areas (geriatrics, cardiology, neurology, pulmonology, nephrology, etc.) and patients. Most patients regard independent living capacity as fundamental to health (both ADLs and instrumental ADLs). Most specialists can provide cutpoints for continuous or categorical variables (cardiac ejection fractions, heart failure class), MMSE, vital capacity, FEV1 that would not be consistent with acceptable “health.” 02:09:34 Todd White: Thanks everyone. 02:12:36 Jerry Colca: The main issues are people covered by Medicare. Healthspan might be defined as lowered need for any medical intervention. It would make most sense to allow CMS and FDA to work together on this. This could also be a solution to negotiated prices. Is there some precedence in the Medial tailored Meals legislation that came up in the last congress? 02:12:56 Thomas Seoh: @Christine, we ultimately want a reddit/subreddit like interactive discussion board, but yes, we will capture this chat, the Q&A, and those who post there at www.kitalys.org 02:19:51 Emilie Strand McCarthy: Thank you - wonderful body of work and framework! 02:23:00 Thomas Seoh: @Alan, I'm not saying it shouldn't. I think it SHOULD. I was saying the THRIVE Act does not expressly promote health equity. But it SHOULD be one of the drivers. That was my point in saying it's a question that deserves an answer. 02:28:41 Gordon Cutler: The WHO defines “health” as "a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.” So it has a dual aspect—the presence of certain positive domains AND the absence of disease. 02:29:26 Christine Kirk: Thank you all! This has been really interesting. 02:29:42 Sebastien Thuault: Thanks! such an important initiative! 02:29:42 Josh Mann: Thank you to the panel for the insights.