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Investment, Integration & Patient Access with Laura Hilty

Note to File: A Clinical Research Podcast

Release Date: 07/21/2025

JPM, AI, & Cheese Lore show art JPM, AI, & Cheese Lore

Note to File: A Clinical Research Podcast

Get ready for a flavorful kickoff to 2026 with the latest Note to File podcast! 🎙️ In this episode, Denali and Brad serve up laughter and insight—from opening with comedic banter and cheese puns (did you know it’s National Cheese Lovers Day?) to swapping stories about their favorite cheeses and regional cheese culture. But that’s just the appetizer! Dive into the latest trends from the JPM conference, including industry updates, M&A highlights (or the lack thereof), and debates on the real significance of company announcements in clinical research. The hosts weigh in on the...

info_outline Dr. Les Enterline on CRO Partnerships, FSP Models, and Industry Innovation show art Dr. Les Enterline on CRO Partnerships, FSP Models, and Industry Innovation

Note to File: A Clinical Research Podcast

Denali and Brad welcome Dr. Les Enterline, a seasoned physician assistant and industry leader, to discuss the evolving landscape of CRO models—Full Service Outsourcing (FSO) vs. Functional Service Partnerships (FSP)—and their impact on sponsors, sites, and patients.  Discover: • Dr. Enterline’s compelling career journey from clinical practice to industry leadership • The inner workings and real-world differences between full service and FSP models • How sponsors choose their approach—and what it means for site operations and staff retention • The vital role of partnership,...

info_outline Bacon, Band Names, and Big Bets on AI show art Bacon, Band Names, and Big Bets on AI

Note to File: A Clinical Research Podcast

In this New Year’s special, we kick things off with gym woes, bacon vs. sausage debates, and a little dose of existential career crisis. Then it’s on to the real meat: wild AI spin-outs, the hard truths about commercializing tech in trials, AstraZeneca’s eye-opening drug recall, and bold (plus slightly pessimistic) predictions for 2026. A re rising healthcare costs going to split trial participation? Is the AI revolution real or just LinkedIn hype? And can New Year’s resolutions actually stick in our industry? Join us for candid industry takes, unscripted nonsense, and a sprinkle of...

info_outline Socks, Sites, and the Trouble with FDA Guidance show art Socks, Sites, and the Trouble with FDA Guidance

Note to File: A Clinical Research Podcast

Join Denali and Brad as we mix a little fun with some real industry insight. We kick things off with light commentary on oddball holidays before diving into the big issues in clinical research—recent FDA guidance, the ongoing push for site- and patient-centricity, and ways to make trials more inclusive. Listen in for our honest takes and predictions for 2026, including thoughts on AI, DEI, and what the future really looks like for clinical trials. As always, the conversation is open, genuine, and full of practical perspective—with a few laughs along the way. If you’re interested in...

info_outline Bop It, Buy It, Bet on AI: Trials, Toys & Turmoil show art Bop It, Buy It, Bet on AI: Trials, Toys & Turmoil

Note to File: A Clinical Research Podcast

In this episode of Note to File, Denali and Brad go deep on National Stupid Toy Day: from Tamagotchis and Furbys to pet rocks and that one toy guaranteed to make your parents question their life choices. What’s your favorite stupid toy? Tell us. We want to laugh (or cringe) with you. But it's not all just fun and games—we break down the big moves in the clinical research industry: Paradigm Health’s acquisition of Flat Iron’s clinical research business. Is it a stroke of master planning, or just companies winging it and hoping for synergy? We ask the tough questions, debate if anyone...

info_outline Deadlines, Data, and Debacles: Year-End Reflections in Research show art Deadlines, Data, and Debacles: Year-End Reflections in Research

Note to File: A Clinical Research Podcast

In this episode of Note to File, Denali and Brad navigate the strange limbo between holiday distractions and end-of-year clinical trial deadlines, sharing the whiplash of a research life in December.  Join us for candid takes on the FDA’s rumored pivot to fewer, tougher trials—will it shake up the industry, save time, or just add confusion? We unpack what “site irregularities” really mean (and how much the public ever finds out), riff on the never-ending debate over Big Pharma’s reputation, and marvel at the lengths some of us go to avoid awkward airport conversations about what...

info_outline Patient-Led Revolution: Susannah Fox on Rare Disease, Peer Networks & Rethinking Clinical Trials show art Patient-Led Revolution: Susannah Fox on Rare Disease, Peer Networks & Rethinking Clinical Trials

Note to File: A Clinical Research Podcast

Join Denali and Brad for another episode of the Note to File podcast—where clinical research meets candid conversation, friendly banter, and the occasional deep-dive into paper towel dispensers. In this episode, we welcome the always-insightful Susannah Fox, self-described "internet geologist" and champion of patient-led innovation in healthcare. Tune in as we swap stories of networking mishaps, pandemic-induced introversion, and the real deal behind patient involvement in clinical trials. Susannah shares her journey from rare disease events to the White House, plus practical lessons on...

info_outline 50k, Fake “Landmarks,” R&D Cuts & Can You Teach Common Sense? show art 50k, Fake “Landmarks,” R&D Cuts & Can You Teach Common Sense?

Note to File: A Clinical Research Podcast

Welcome to another “Sticky Notes” live session of Note to File – the only clinical research podcast that’s part insightful conversation, part general nonsense. Today, we’re braving the December chill, celebrating a totally wild (and possibly confusing) 50k YouTube subscribers, and pondering whether people forget how to drive in snow every single year (spoiler: they do). We dig into the latest so-called “landmark” UK/US pharma trade deal (cue eye rolling at historic headlines), the gritty truths about public sector R&D cuts, and why axing funding and getting stingy on...

info_outline Site Centricity, Private Equity, and Circling Back After the New Year show art Site Centricity, Private Equity, and Circling Back After the New Year

Note to File: A Clinical Research Podcast

This week, we dive headfirst into the holiday madness: the fine art of pretending things can wait till January, how stuffing a week’s worth of chaos into three days is our new normal, and why Thanksgiving is synonymous with “eating a regrettable amount of food” (parades optional). But don’t worry, we’re not just here for turkey talk. We rip into site centricity (is it more than branding?), the never-ending sponsor/CRO shuffle, and why clinical research still can’t figure out standardization to save its life. Private equity’s creeping fingers? NIH funding’s real impact?...

info_outline Abbott’s $20B Buy, CRO Controversies & the Changing Face of Clinical Trials show art Abbott’s $20B Buy, CRO Controversies & the Changing Face of Clinical Trials

Note to File: A Clinical Research Podcast

In this episode, we discuss the Abbott-Exact Sciences mega-acquisition, the nuanced world of CROs, challenges and opportunities in decentralized clinical trials (DCT), the explosive growth of clinical trial technology, and the real-world impact of NIH grant funding cuts. We also debate the ethics of drug availability in international trials and dig into site-centricity, innovation, and the ever-changing clinical research landscape. Also, Denali says "niche" wrong. Enjoy candid commentary, industry news, and some laughs along the way! Got feedback or want to be a guest? Reach out via LinkedIn...

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Join us for an insightful conversation with Laura Hilty as we dive into the latest trends and challenges in the clinical research industry. We discuss the differences between venture capital and private equity investment, the complexities of site networks, integration and interoperability hurdles, and innovative ways to increase patient access to clinical trials. Plus, hear Laura’s perspective on the future of clinical research and what it takes to drive meaningful change in the industry.