<turbo-stream action="append" target="audio_clips_list"><template>
    <hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8925980-act-brief-single-pivotal-trial-stakes-configurable-fsp-strategy-and-g-csf-biosimilar-portfolio"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Single Pivotal Trial Stakes, Configurable FSP Strategy, and G-CSF Biosimilar Portfolio Expansion
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine how FDA&#39;s single pivotal trial shift raises recruitment and retention stakes, why FSP should be viewed as a configurable continuum rather than binary choice, and a new pegfilgrastim biosimilar completing a major G-CSF portfolio.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1783677600" data-format="short_date">Jul 10</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8925420-act-brief-multimodal-ai-systems-architecture-trust-based-trial-recruitment-and-big-pharma-ai-t"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Multimodal AI Systems Architecture, Trust-Based Trial Recruitment, and Big Pharma AI Transformation
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine AI-enabled systems medicine connecting fragmented clinical data, how behavioral readiness and trust drive enrollment more than eligibility criteria, and scaling concentrated AI strategy across a global pharmaceutical enterprise.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1783591200" data-format="short_date">Jul 09</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8924916-act-brief-simplifying-trials-through-selective-safety-data-ai-driven-site-partnerships-and-bio"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Simplifying Trials Through Selective Safety Data, AI-Driven Site Partnerships, and Biopharma Strategic Pivots
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine how selective safety data collection could ease operational burden and address investigator shortages, why site-specific technology limits AI adoption, and how regulatory pressure and patent cliffs are reshaping R&amp;D investment strategy.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1783504800" data-format="short_date">Jul 08</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8924836-act-brief-ctti-risk-myth-busting-hidden-epro-exclusion-criteria-and-patient-centered-care-models"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: CTTI Risk Myth-Busting, Hidden ePRO Exclusion Criteria, and Patient-Centered Care Models
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine regulatory partnerships debunking pragmatic trial concerns, how ePRO protocols create informal patient exclusions, and why system design—not patient behavior—drives disengagement.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1783439392" data-format="short_date">Jul 07</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8923156-act-brief-selective-safety-data-and-visit-reduction-protocol-design-execution-gaps-and-china-t"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Selective Safety Data and Visit Reduction, Protocol Design Execution Gaps, and China Trial Security Investigation
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine quantified reductions in trial visits through selective safety data collection, why protocol failures occur during operational transition, and congressional investigation into pharmaceutical company trials in China.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1782986400" data-format="short_date">Jul 02</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8922708-act-brief-tavneos-trial-integrity-issues-selective-safety-data-regulatory-pathways-and-fda-pre"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Tavneos Trial Integrity Issues, Selective Safety Data Regulatory Pathways, and FDA PreCheck Program Launch
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine a major trial retraction and regulatory action against a rare disease drug, regulatory scenarios for selective safety data collection, and FDA&#39;s domestic manufacturing incentive program.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1782900000" data-format="short_date">Jul 01</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8922251-act-brief-real-time-trial-infrastructure-gaps-built-in-data-security-and-ai-enabled-cdmo-value"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Real-Time Trial Infrastructure Gaps, Built-In Data Security, and AI-Enabled CDMO Value
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine what the FDA&#39;s real-time oversight initiative demands of sponsors, why clinical data security must be designed in rather than layered on, and how AI is reshaping CDMO workflows and asset value.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1782813600" data-format="short_date">Jun 30</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8922047-act-brief-dia-leadership-and-infrastructure-priorities-real-time-data-review-readiness-and-cll"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: DIA Leadership and Infrastructure Priorities, Real-Time Data Review Readiness, and CLL Treatment Expansion
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we recap key themes from DIA 2026 on operational priorities and regulatory shifts, examine infrastructure gaps in continuous data review, and report on EMA support for a new BTK inhibitor strategy.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1782739463" data-format="short_date">Jun 29</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8921007-act-brief-bridging-site-sponsor-data-gaps-major-study-retraction-and-tnbc-first-line-approval"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Bridging Site-Sponsor Data Gaps, Major Study Retraction, and TNBC First-Line Approval
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine integrating site and sponsor data systems, a high-profile trial retraction over integrity concerns, and a new first-line breast cancer treatment.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
1m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1782468000" data-format="short_date">Jun 26</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
1m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8920552-act-brief-dia-leadership-amid-uncertainty-reimagining-cro-contracts-and-eli-lilly-expansion"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: DIA Leadership Amid Uncertainty, Reimagining CRO Contracts, and Eli Lilly Expansion
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine regulatory uncertainty and 2026 breakthroughs shaping clinical research, reimagining CRO contracting models for financial transparency, and Eli Lilly&#39;s acquisition strategy.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
1m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1782381600" data-format="short_date">Jun 25</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
1m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8920054-act-brief-operation-trialblazer-launched-protocol-complexity-rising-and-data-infrastructure-fo"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Operation TrialBlazer Launched, Protocol Complexity Rising, and Data Infrastructure for AI
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine HHS coordinated effort to restore US clinical research leadership, two decades of rising protocol complexity, and data architecture frameworks for AI sustainability.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1782295200" data-format="short_date">Jun 24</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8919600-act-brief-icon-microsoft-ai-partnership-dct-site-burden-and-ai-enabled-neuroimmune-discovery"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: ICON-Microsoft AI Partnership, DCT Site Burden, and AI-Enabled Neuroimmune Discovery
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine a major CRO-tech partnership scaling agentic AI, operational challenges sites face with decentralized trials, and AI-driven CNS drug discovery collaboration.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
1m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1782208800" data-format="short_date">Jun 23</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
1m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8918771-act-brief-mixed-fsp-strategy-dia-meeting-trends-and-patient-voice-in-oncology"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Mixed FSP Strategy, DIA Meeting Trends, and Patient Voice in Oncology
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine mixed FSP models as strategic agility tools, key themes from the 2026 DIA Global Annual Meeting, and federated AI expanding oncology research.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
1m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1782122400" data-format="short_date">Jun 22</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
1m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8918368-act-brief-real-time-evidence-generation-protocol-digitization-and-decentralized-trial-flexibility"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Real-Time Evidence Generation, Protocol Digitization, and Decentralized Trial Flexibility
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine real-time evidence generation priorities, automating protocol digitization, and fit-for-purpose decentralized trial deployment.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1781863200" data-format="short_date">Jun 19</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8916055-act-brief-real-time-data-harmonization-infrastructure-modern-trial-payments-and-sclc-drug-conf"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Real-Time Data Harmonization Infrastructure, Modern Trial Payments, and SCLC Drug Confirmatory Failure
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine building infrastructure for real-time clinical and real-world data integration, modernizing participant payments to reduce dropout, and a Phase III confirmatory trial failure for a lung cancer drug.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1781517600" data-format="short_date">Jun 15</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8915520-act-brief-rbqm-financial-value-quantified-sponsor-configurable-ai-systems-and-basket-trials-fo"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: RBQM Financial Value Quantified, Sponsor-Configurable AI Systems, and Basket Trials for Rare Pediatrics
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine quantified returns on RBQM implementation, why allowing sponsors to control AI governance builds adoption, and how basket trials reshape rare pediatric oncology development.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1781258400" data-format="short_date">Jun 12</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8914924-act-brief-enterprise-risk-management-execution-architecture-for-ai-and-rare-pediatric-regulato"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Enterprise Risk Management, Execution Architecture for AI, and Rare Pediatric Regulatory Support
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine moving beyond study-level risk management, why execution architecture is essential before AI can deliver value, and growing FDA/EMA support for rare pediatric disease development.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1781172000" data-format="short_date">Jun 11</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8914506-act-brief-quality-built-throughout-trial-lifecycle-agentic-rtsm-compression-and-state-access-p"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Quality Built Throughout Trial Lifecycle, Agentic RTSM Compression, and State Access Programs
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine building governance into every trial stage, how agentic AI is compressing RTSM startup timelines, and why state medical access programs could strengthen rather than undermine clinical trials.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1781085600" data-format="short_date">Jun 10</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8914033-act-brief-data-pipeline-fragmentation-vaccine-trial-pressures-and-btk-degrader-partnership"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Data Pipeline Fragmentation, Vaccine Trial Pressures, and BTK Degrader Partnership
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine how FDA continuous data review exposes trial infrastructure gaps, vaccine trial standardization amid regulatory uncertainty, and a major collaboration on a BTK degrader for blood cancers.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1780999200" data-format="short_date">Jun 09</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8912962-act-brief-cross-asset-site-partnerships-vaccine-trial-standardization-and-ovarian-cancer-care"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Cross-Asset Site Partnerships, Vaccine Trial Standardization, and Ovarian Cancer Care Gaps
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine how cross-asset site partnerships drive data sharing, standardized eCOA templates accelerating vaccine trial startup, and real-world data revealing ovarian cancer disparities.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1780912800" data-format="short_date">Jun 08</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8912324-act-brief-site-first-technology-strategy-ai-data-harmonization-architecture-and-obesity-trial"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Site-First Technology Strategy, AI Data Harmonization Architecture, and Obesity Trial Retention
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine why site technology fragmentation blocks AI adoption, how agentic orchestrators and lakehouse architectures enable real-time clinical data harmonization, and evidence-based strategies to reduce obesity trial discontinuation.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1780653600" data-format="short_date">Jun 05</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8911414-act-brief-ai-driven-enrollment-results-statistician-standards-in-early-phase-and-rna-editing-f"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: AI-Driven Enrollment Results, Statistician Standards in Early Phase, and RNA Editing for Kidney Disease
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine AI-enabled site performance in a Sanofi COPD study, why statisticians raising early phase standards matters to the entire development pathway, and a new partnership on RNA exon editing for monogenic kidney disease.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1780567200" data-format="short_date">Jun 04</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8911026-act-brief-ai-driven-patient-matching-clinical-ops-tensions-and-oral-covid-prevention-approval"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: AI-Driven Patient Matching, Clinical Ops Tensions, and Oral COVID Prevention Approval
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine AI replacing unreliable feasibility estimates with precise patient matching, three tensions reshaping clinical operations culture, and FDA&#39;s first oral post-exposure COVID-19 prevention therapy.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1780480800" data-format="short_date">Jun 03</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8910440-act-brief-process-architecture-over-autonomous-ai-real-time-rwe-integration-and-building-rwe-i"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Process Architecture Over Autonomous AI, Real-Time RWE Integration, and Building RWE Infrastructure
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine why process architecture matters more than autonomous agentic AI, shifting RWE from post-approval to concurrent validation, and organizational capabilities needed for effective RWE use.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1780394400" data-format="short_date">Jun 02</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8909466-act-brief-ai-freeing-experts-for-decision-making-community-trust-in-trial-engagement-and-lupus"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: AI Freeing Experts for Decision Making, Community Trust in Trial Engagement, and Lupus Treatment Breakthroughs
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine how AI handles rote tasks to free human experts for critical decisions, what authentic community engagement requires beyond recruitment, and recent lupus treatment advances shifting standard of care.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
1m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1780308000" data-format="short_date">Jun 01</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
1m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8909107-act-brief-data-capture-vs-execution-coordinator-performance-gaps-and-covid-vaccine-compositio"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Data Capture vs. Execution, Coordinator Performance Gaps, and COVID Vaccine Composition Vote
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine why decades of data capture progress haven&#39;t solved trial execution, study coordinator performance on document reviews, and FDA advisors voting on updated COVID-19 vaccine composition.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
1m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1780048800" data-format="short_date">May 29</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
1m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8908616-act-brief-ecoa-costs-and-paper-persistence-early-phase-statistical-foundations-and-dei-progres"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: eCOA Costs and Paper Persistence, Early Phase Statistical Foundations, and DEI Progress in Trials
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine why paper-based outcome assessments persist despite clear data-quality disadvantages, why early phase statistical decisions shape entire development pathways, and the structural changes needed for representative enrollment.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
1m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1779962400" data-format="short_date">May 28</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
1m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8908101-act-brief-diversity-embedded-as-standard-practice-early-phase-statistician-collaboration-and-f"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Diversity Embedded as Standard Practice, Early Phase Statistician Collaboration, and First HDV Treatment Approved
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine how Merck embeds diversity into trial execution from design through community engagement, a new statistician special interest group for early phase research, and FDA&#39;s first approval for chronic hepatitis delta virus.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1779876000" data-format="short_date">May 27</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8907958-act-brief-cnpv-program-operational-realities-statistician-collaboration-in-complex-trials-and"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: CNPV Program Operational Realities, Statistician Collaboration in Complex Trials, and GLP-1 Market Concentration
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine what succeeding under compressed FDA review timelines requires, why statistician collaboration is essential as trial complexity grows, and GLP-1s reshaping pharma portfolio strategy.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1779805195" data-format="short_date">May 26</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8906429-act-brief-rbqm-and-ai-integration-statistician-role-in-data-stewardship-and-oncology-regulator"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: RBQM and AI Integration, Statistician Role in Data Stewardship, and Oncology Regulatory Navigation
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine operational RBQM enhanced by AI, how statisticians ensure responsible data use across development phases, and navigating oncology regulation after FDA leadership transitions.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1779444000" data-format="short_date">May 22</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8905897-act-brief-clinical-development-orchestration-career-insights-in-trials-and-fda-communication-gaps"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Clinical Development Orchestration, Career Insights in Trials, and FDA Communication Gaps
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine how program-level orchestration is becoming critical to R&amp;D success, reflections on meaningful work in clinical trials, and industry concerns about FDA communication and institutional knowledge loss.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
1m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1779357600" data-format="short_date">May 21</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
1m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8905545-act-brief-safety-monitoring-alignment-ai-performance-gap-emerging-and-real-time-data-quality-c"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Safety Monitoring Alignment, AI Performance Gap Emerging, and Real-Time Data Quality Challenges
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine safety signal prioritization in RBQM, widening performance gaps between early AI adopters and the broader industry, and data quality concerns in FDA&#39;s real-time clinical data review initiative.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1779271200" data-format="short_date">May 20</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8904998-act-brief-trial-representation-and-design-cro-revenue-recognition-risks-and-real-time-fda-data"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Trial Representation and Design, CRO Revenue Recognition Risks, and Real-Time FDA Data Review
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine how improving representation changes trial design at Merck, revenue recognition challenges in CRO contracts, and FDA&#39;s pilot program for real-time clinical data review.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1779184800" data-format="short_date">May 19</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8904128-act-brief-trust-in-clinical-trial-engagement-participant-readiness-and-adherence-and-ai-in-reg"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Trust in Clinical Trial Engagement, Participant Readiness and Adherence, and AI in Regulatory Compliance
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we explore how Let&#39;s Talk Trials addresses clinical trial awareness gaps, why participant readiness matters more than digital tools alone, and FDA&#39;s increasing scrutiny of AI use in regulatory and quality processes.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1779098400" data-format="short_date">May 18</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8903733-act-brief-diversity-embedded-in-trial-design-unified-patient-outcome-data-and-ai-informed-prot"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Diversity Embedded in Trial Design, Unified Patient Outcome Data, and AI-Informed Protocol Development
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we explore how diversity is embedded across trial planning at Merck, integration of patient-reported and wearable-derived outcome measures, and AI applications in reducing clinical trial failure rates.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1778839200" data-format="short_date">May 15</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8903195-act-brief-makary-s-turbulent-fda-tenure-pediatric-trial-experience-design-and-weight-loss-main"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Makary&#39;s Turbulent FDA Tenure, Pediatric Trial Experience Design, and Weight Loss Maintenance Data
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine leadership instability and regulatory uncertainty during Makary&#39;s FDA tenure, how lived experience shapes pediatric trial design and performance, and Eli Lilly&#39;s weight loss maintenance data for obesity therapies.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1778752800" data-format="short_date">May 14</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8902671-act-brief-cloud-native-imaging-infrastructure-community-relationships-in-trial-design-and-fda"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Cloud-Native Imaging Infrastructure, Community Relationships in Trial Design, and FDA Leadership Transition
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine cost models for imaging infrastructure in clinical trials, how community relationships improve protocol design and site placement, and FDA leadership changes.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1778666400" data-format="short_date">May 13</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8902154-act-brief-protocol-design-as-business-strategy-site-financial-pressures-and-fda-leadership-unc"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Protocol Design as Business Strategy, Site Financial Pressures, and FDA Leadership Uncertainty
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine how protocol design decisions have become strategic business choices with outsized consequences for smaller companies, what clinical research sites need to compete and deliver, and leadership changes at the FDA.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1778580000" data-format="short_date">May 12</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8901332-act-brief-esource-data-integration-direct-to-patient-site-performance-and-pragmatic-trial-safe"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: eSource Data Integration, Direct-to-Patient Site Performance, and Pragmatic Trial Safety Framework
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine CRIO and Medidata&#39;s partnership on seamless clinical trial data flow, Tufts CSDD findings on direct-to-patient site enrollment and diversity outcomes, and TransCelerate&#39;s work with FDA on selective safety data collection for pragmatic trials.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1778493600" data-format="short_date">May 11</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8901145-crio-and-medidata-partnership-targets-clinical-trial-data-friction"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43636958/75x75/c 75w, https://audioboom.com/i/43636958/150x150/c 150w, https://audioboom.com/i/43636958/300x300/c 300w, https://audioboom.com/i/43636958/600x600/c 600w, https://audioboom.com/i/43636958/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #c0c0c0; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43636958/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
CRIO and Medidata Partnership Targets Clinical Trial Data Friction
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In this episode of the Applied Clinical Trials Podcast, Jonathan Andrus, co-CEO, CRIO, and Samir Jain, vice president of product management, healthcare data interoperability and EHR solutions, Medidata, discuss how their new partnership is enabling seamless data flow between eSource and enterprise platforms to reduce site burden and improve data quality across global clinical trials.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
12m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1778253447" data-format="short_date">May 08</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
12m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8896474-act-brief-ai-governance-lag-site-payment-experience-and-schizophrenia-relapse-prevention"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: AI Governance Lag, Site Payment Experience, and Schizophrenia Relapse Prevention
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine governance inertia when AI accelerates protocol development, why payment experience is becoming a competitive differentiator for sites, and FDA approval of Caplyta for relapse prevention in schizophrenia.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1777456800" data-format="short_date">Apr 29</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8896191-act-brief-ai-impact-faces-reality-check-supply-chain-risks-intensify-and-rwe-shapes-global-str"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: AI Impact Faces Reality Check, Supply Chain Risks Intensify, and RWE Shapes Global Strategy
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today’s ACT Brief, we highlight where AI is delivering real gains in protocol development, how geopolitical disruption is redefining supply chain resilience, and the growing global impact of real-world evidence in drug development.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
1m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1777370400" data-format="short_date">Apr 28</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
1m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8895237-act-brief-cro-consolidation-in-regulatory-services-reimbursement-in-development-planning-and-s"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: CRO Consolidation in Regulatory Services, Reimbursement in Development Planning, and Site Selection Misalignment
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine Veristat&#39;s acquisition of Certara&#39;s regulatory business, why reimbursement probability should inform development planning earlier, and how site selection misalignment drives downstream trial performance issues.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1777284000" data-format="short_date">Apr 27</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8894272-act-brief-organizational-shifts-in-trial-design-amyloid-antibody-evidence-review-and-compoundi"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Organizational Shifts in Trial Design, Amyloid Antibody Evidence Review, and Compounding&#39;s Role in Care Continuity
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we explore organizational factors behind CRL decisions, methodological concerns with pooling amyloid antibody trial data, and how compounding addresses care gaps when commercial options fall short.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1776938400" data-format="short_date">Apr 23</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8893671-act-brief-community-engagement-framework-for-enrollment-plausible-mechanism-framework-essential"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Community Engagement Framework for Enrollment, Plausible Mechanism Framework Essentials, and AI Scaling Foundations
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we explore practical community engagement strategies that drive representative enrollment, how sponsors should structure development plans around the plausible mechanism framework, and the organizational prerequisites for scaling AI effectively in drug development.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1776852000" data-format="short_date">Apr 22</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8893068-act-brief-plausible-mechanism-pathway-implementation-steps-behavioral-science-in-trial-design"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Plausible Mechanism Pathway Implementation Steps, Behavioral Science in Trial Design, and Psychedelic Drug Accelerated Review
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we explore practical steps sponsors can take to prepare for the plausible mechanism framework, how behavioral science addresses root causes of recruitment and diversity challenges, and FDA acceleration of psychedelic therapy reviews through executive order.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1776765600" data-format="short_date">Apr 21</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8891487-act-brief-natural-history-data-matching-challenges-execution-translation-gap-in-trials-and-acc"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Natural History Data Matching Challenges, Execution Translation Gap in Trials, and Accelerated Approval Pathway Reforms
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we explore how disease heterogeneity confounds natural history controls, the execution translation gap converting identified problems into action, and policy recommendations for strengthening FDA&#39;s accelerated approval pathway.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1776679200" data-format="short_date">Apr 20</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8890963-act-brief-master-protocol-design-considerations-early-predictive-data-integration-and-real-wor"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Master Protocol Design Considerations, Early Predictive Data Integration, and Real-World Evidence as Regulatory Standard
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we explore biological and dosing considerations for basket trial designs, how human-relevant data earlier in development reduces late-stage failures, and FDA&#39;s shift toward single-trial approvals supported by real-world evidence.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1776420000" data-format="short_date">Apr 17</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8890532-act-brief-evaluating-evidence-for-individualized-therapies-clinical-trial-reporting-compliance"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Evaluating Evidence for Individualized Therapies, Clinical Trial Reporting Compliance, and TIL Therapy Merger
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we explore how FDA evaluates effectiveness for ultra-rare individualized therapies, the agency&#39;s enforcement push for mandatory trial result reporting, and Obsidian&#39;s merger backed by $350 million to advance next-generation TIL cell therapy.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1776333600" data-format="short_date">Apr 16</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>
<hr class="mvn mhs text-black-50 opacity-25">
<div class="card rounded-0 border-0 pas qa-audio-clip-overview" style="--bs-card-bg: transparent;">
<a class="text-decoration-none" href="/posts/8890030-act-brief-protocol-interpretation-as-startup-bottleneck-plausible-mechanism-framework-and-real"><div class="Episode-list-grid card-body pan">
<div class="l-flex align-items-baseline gap-2 gap-md-3">
<img srcset="https://audioboom.com/i/43591352/75x75/c 75w, https://audioboom.com/i/43591352/150x150/c 150w, https://audioboom.com/i/43591352/300x300/c 300w, https://audioboom.com/i/43591352/600x600/c 600w, https://audioboom.com/i/43591352/1400x1400/c 1400w" sizes="(max-width: 400px) 64px, 96px" style="background-color: #f3f3f3; max-width: 96px; width: 15cqw;" class="js-img-bg ratio-square rounded-1" loading="lazy" src="https://audioboom.com/i/43591352/1400x1400/c" />
<div class="vstack gap-1 my-auto">
<h5 class="text-line-clamp text-line-clamp-3 balanced-h fs-6 fs-5-lg fw-normal mb-0">
ACT Brief: Protocol Interpretation as Startup Bottleneck, Plausible Mechanism Framework, and Real-Time Trial Tracking Systems
</h5>
<div class="text-line-clamp text-line-clamp-3 balanced-p fs-8 text-muted text-break">
In today&#39;s ACT Brief, we examine how protocol interpretation and source document preparation delay study startup, how the plausible mechanism framework accelerates individualized therapy timelines, and how real-time tracking technologies improve supply chain and sample integrity in decentralized trials.
</div>
<div class="text-muted df align-items-baseline gap-2 fs-8">
<span class="numeric-tabular d-sm-none">
2m
</span>
<span class="d-sm-none">
&bull;
</span>
<span><span class="js-time" data-epochtime="1776247200" data-format="short_date">Apr 15</span></span>
</div>
</div>
</div>
<div class="d-none d-sm-grid" style="justify-self: center; align-items: center;">
<div class="fs-8 numeric-tabular text-nowrap text-muted phs">
2m
</div>
</div>
</div>
</a></div>

</template></turbo-stream>
  <turbo-stream action="replace" target="turbo_pagination"><template><turbo-frame loading="lazy" id="turbo_pagination" src="/channels/5120065.turbo_stream?page=3"><div aria-hidden="true" class="card rounded-0 border-0 border-bottom">
<div class="card-body df align-items-center placeholder-glow text-black-50">
<div class="w-100">
<h5>
<div class="placeholder col-6"></div>
</h5>
<div class="placeholder placeholder-sm" style="width:15ch"></div>
</div>
<div class="mla">
<span class="placeholder placeholder-sm" style="width:4ch"></span>
</div>
</div>
</div>
<div aria-hidden="true" class="card rounded-0 border-0 border-bottom">
<div class="card-body df align-items-center placeholder-glow text-black-50">
<div class="w-100">
<h5>
<div class="placeholder col-6"></div>
</h5>
<div class="placeholder placeholder-sm" style="width:15ch"></div>
</div>
<div class="mla">
<span class="placeholder placeholder-sm" style="width:4ch"></span>
</div>
</div>
</div>
<div aria-hidden="true" class="card rounded-0 border-0 border-bottom">
<div class="card-body df align-items-center placeholder-glow text-black-50">
<div class="w-100">
<h5>
<div class="placeholder col-6"></div>
</h5>
<div class="placeholder placeholder-sm" style="width:15ch"></div>
</div>
<div class="mla">
<span class="placeholder placeholder-sm" style="width:4ch"></span>
</div>
</div>
</div>
<div aria-hidden="true" class="card rounded-0 border-0 border-bottom">
<div class="card-body df align-items-center placeholder-glow text-black-50">
<div class="w-100">
<h5>
<div class="placeholder col-6"></div>
</h5>
<div class="placeholder placeholder-sm" style="width:15ch"></div>
</div>
<div class="mla">
<span class="placeholder placeholder-sm" style="width:4ch"></span>
</div>
</div>
</div>
<div aria-hidden="true" class="card rounded-0 border-0 border-bottom">
<div class="card-body df align-items-center placeholder-glow text-black-50">
<div class="w-100">
<h5>
<div class="placeholder col-6"></div>
</h5>
<div class="placeholder placeholder-sm" style="width:15ch"></div>
</div>
<div class="mla">
<span class="placeholder placeholder-sm" style="width:4ch"></span>
</div>
</div>
</div>
<div class="visually-hidden">
<a href="/channels/5120065?page=3">next page</a>
</div>
</turbo-frame></template></turbo-stream>
