In this episode of "In the Interim…", host Dr. Scott Berry undertakes a detailed, methodical critique of ICH-E20 draft guidance language as applied to adaptive clinical trial design. Focusing on an innocuous but corruptible paragraph in Section 3.1, Scott scrutinizes the logic behind regulatory reluctance to appreciate multiple or complex adaptations in confirmatory trials. Drawing on extensive experience, he highlights how such restrictive interpretations do not reflect practical development realities, instead setting up “false choices” where alternative designs desired by regulators are infeasible. Through operational scenarios—including the SEPSIS-ACT trial, an enrichment design, and sample size re-estimation examples—Scott illustrates the empirical benefits of seamless and multi-adaptive trials for sponsors, patients, and regulators. Technical discussion addresses misconceptions about complexity and bias and stresses the value of presenting realistic alternatives when engaging with regulatory authorities. The episode ultimately encourages a more nuanced dialogue to advance efficient and scientifically robust clinical trials.Key HighlightsDiscussion of ICH-E20 section 3.1 guidance and its operational impact on adaptive designs.Dissection of “false choice” dilemmas in regulatory interactions, referencing real adaptive trial submissions.Case-based examples: SEPSIS-ACT, enrichment, and sample size adaptation trials.Highlighting myths regarding bias and operational burden from multiple interim analyses.Emphasis on practical strategies for more effective regulatory communication about adaptive trials and realistic alternatives.For more, visit us at https://www.berryconsultants.com/

In this episode of AWM Insights, Chief Investment Officer Justin Dyer and Portfolio Manager Mena Hanna break down the complexities of private credit, a rising trend in alternative investments. They explore how structural pitfalls, tax implications, and misleading liquidity can catch even seasoned investors off guard. By drawing on real-world analogies and candid industry perspective, Justin and Mena reveal what sets truly thoughtful portfolio construction apart. Tune in for actionable advice and a deeper understanding of how to navigate private investments wisely.*Connect with Us*+ Call or test us: 626-862-0355+ Website: https://www.athletefamilyoffice.com/+ YouTube: https://www.youtube.com/channel/UCc1NxpK21N1vKWEExC45YEA+ LinkedIn: https://www.linkedin.com/company/awmcapital/+ Instagram: https://www.instagram.com/awmcapital/+ X: https://twitter.com/awmcapital+ Facebook: https://www.facebook.com/awmcapital/*Chapters*(00:37) Introduction to Private Credit(02:08) Origins and Growth of Private Credit(05:39) Retail Investor Access and Structural Risks(07:03) Liquidity Challenges and Market Distortions(10:25) Importance of Due Diligence(11:40) Tax Efficiency and Post-Tax Returns(13:58) Rigorous Research and Structuring

Where is everyone actually going this summer, and how do we know? In this episode, Rachel Satow and Ian Andersen break down the data behind 2026’s hottest travel destinations. We look at what Switchfly booking data, Condé Nast, Fora, and Amex Travel all agree on, why Southern Europe is seeing a dip, how AI is (and isn’t) changing the way people plan trips, and what all of this means for loyalty and rewards program managers heading into peak travel season.Chapters(00:00) Intro: Why summer travel trends matter for loyalty program managers(01:10) How Switchfly cross-references booking data with Condé Nast, Fora, and Amex(03:50) America 250 and the surge in domestic historic travel (DC, Philly, Boston)(05:02) International airfare down 10% YoY — what's driving the Southern Europe dip(08:19) AI trip planning and the off-the-beaten-path paradox(21:51) Bleisure travel and remote work: how the workforce is reshaping trips(26:01) On-the-ground insights from Switchfly's travel advisor head of sales(31:55) Influencers are paid — why you should cross-check every source(38:16) What all of this means for loyalty and rewards program managersResourceshttps://www.cntraveler.com/story/the-best-places-to-go-in-2026https://www.americanexpress.com/en-us/travel/discover/get-inspired/trending-destinationshttps://www.foratravel.com/join/resources/foras-hot-list-2026-what-you-need-to-knowConnect with SwitchflyWebsite: https://www.switchfly.com/LinkedIn: https://www.linkedin.com/company/switchfly/X: https://twitter.com/switchflyYouTube: https://www.youtube.com/@SwitchflyOfficial

In this inspiring interview, Chandler Harris shares his journey of faith, healing, and everyday ministry through spontaneous acts of love and prayer. Discover how simple acts like praying for Uber drivers and grocery store workers can transform lives and deepen your spiritual walk.Chapters00:00 Introduction to Breakthrough Church and Family Background01:51 Personal Testimonies and Healing Experiences12:00 Everyday Mission: Praying for Uber Drivers20:05 Engaging Conversations in Everyday Life28:07 The Impact of Community and Spiritual Growth

In this episode of "In the Interim…" Dr. Scott Berry is joined by Professors Victoria Cornelius, Danny McAuley, and Anthony Gordon, for a technical review of the PANTHER trial—an international, Phase 2 adaptive platform evaluating pharmacologic interventions for ARDS. The trial is open-label and does not employ blinding, as discussed in the episode. The primary endpoint is 28-day organ support-free days (death as -1, survivors 0–28 days), analyzed with a Bayesian proportional odds model. PANTHER uses  stratification by hyper- and hypoinflammatory subphenotypes, with fixed, equal randomization within each stratum. Analyses for treatments are separated by stratum, reflecting the potential of differential treatment effects. Quarterly interim analyses allow early stopping by stratum for efficacy or futility. Content includes explicit discussion of infrastructure: rapid device deployment, centralized data for trial and future biological discovery, and governance challenges in multinational collaboration. Funding is provided by NIHR (UK), US Department of Defense, CIHR (Canada), NHMRC and MRFF (Australia), HRB (Ireland), and additional support from Germany and Japan. PANTHER is positioned to streamline Phase 2 critical care drug testing and facilitate graduation to larger platforms such as REMAP-CAP, with potential to expedite pharmaceutical evaluation and accelerate ARDS therapeutic development.Key HighlightsReal-time phenotyping (Randox device) to stratify ARDS patients.Separate Bayesian analyses by phenotype stratum.Open-label, fixed randomization within stratum.28-day organ support-free days as a composite endpoint.Quarterly interim analyses enable early dropping or graduation of arms by strata.Central data resource and biosample collection for future research.Operational, funding, and device logistics for global trial deployment.Transition of Phase 2 results to established Phase 3 platforms (e.g., REMAP-CAP).For more, visit us at https://www.berryconsultants.com/