Breaking Protocol – Détails, épisodes et analyse

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Breaking Protocol

Tilda

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Fréquence : 1 épisode/30j. Total Éps: 12

The clinical trial industry is stuck in an innovation impasse, weighed down by outdated processes, layers of bureaucracy, and a systemic inability to prioritize those on the frontlines - patients, sites, and researchers. Tune in every week as Tilda Research CEO Ram Yalamanchili interviews clinical trial leaders at the cutting edge of innovation who are breaking past the current paradigm.

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Données mises à jour le 14/07/2026

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Paulius Ojeras: AI is Changing the Clinical Trial Cost Equation

Saison 2 · Épisode 6

jeudi 9 avril 2026 • Durée 40:59

AI is about to force a much bigger conversation in clinical research than most people realize. In this episode, Ram Yalamanchili, CEO of Tilda Research, and Paulius Ojeras, VP of Clinical Operations at Perceive Biotherapeutics, dig into how AI could change the economics of running studies, not just by improving quality and accelerating timelines, but by putting real pressure on the traditional CRO pricing model.

If the work takes fewer hours, gets done faster, and delivers better outputs, what exactly should sponsors still be paying for? That question leads to one of the most fascinating parts of the discussion: whether clinical development is headed toward rebates, new pricing structures, and a very different definition of value.

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Shobhit Shrotriya: Pharma is Moving from AI Pilots to Production

Saison 2 · Épisode 6

mercredi 25 mars 2026 • Durée 45:47

In this episode, Ram Yalamanchili sits down with Shobhit Shrotriya, Managing Director of Global Life Sciences R&D Operations at Accenture, to unpack what it will actually take for AI to move beyond mere pilots to full production in clinical research. Drawing on deep AI expertise, as well as decades of experience in clinical operations, Shobhit explains why most organizations are still thinking too narrowly about AI, why pilot fatigue is real, and why point solutions often fail to solve the underlying workflow problem. The conversation explores the full evolution of clinical data operations, from paper-based studies and early EDC adoption to today’s push toward AI-led transformation. Along the way, Ram and Shobhit dig into the harder questions most vendors and sponsors still avoid: fragmented data ecosystems, weak governance, poor process redesign, limited interoperability, and the importance of building systems that can actually scale in regulated environments. They also tackle one of the most important issues in enterprise AI adoption: trust. Shobhit makes the case for responsible AI frameworks, human-in-the-loop decision making, and a more realistic approach to evaluating what “failure” actually means in AI pilots. The result is a practical, executive-level discussion for leaders in pharma, biotech, CROs, and clinical data science who want to understand where AI can create real value and where the industry still has work to do.

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Ash Jayagopal: Closing the Clinical Research Innovation Gap

Saison 2 · Épisode 5

lundi 23 mars 2026 • Durée 31:27

Clinical trials have become more scientifically sophisticated, yet many of the operational challenges behind them remain stubbornly unchanged. In this episode of Breaking Protocol, Ram Yalamanchili speaks with Ash Jayagopal, Chief Scientific and Development Officer at Opus Genetics, about the realities of running clinical trials in the era of gene therapy and ultra-rare diseases.

Ash brings a rare perspective from the front lines of ophthalmology drug development, where some programs target patient populations measured in the hundreds rather than the thousands. In these environments, traditional clinical trial infrastructure begins to break down. Finding patients becomes a global search problem. Published prevalence numbers often prove unreliable. Registries require constant maintenance. And clinical trial planning still depends on fragmented datasets that were never designed for modern drug development.

The conversation explores why patient identification remains one of the most persistent bottlenecks in clinical trials. Ash explains how inaccurate diagnostic coding, inconsistent genetic testing, and fragmented clinical data make it difficult to identify eligible patients even when they technically exist within healthcare systems. Registries and centers of excellence have helped improve visibility, but they still require significant manual effort to maintain and query.

Ram and Ash also discuss how automation, data infrastructure, and emerging AI tools could fundamentally change this landscape. If patient registries, clinical data, and eligibility criteria could be integrated and continuously updated, trial sponsors could move from a “needle in a haystack” search to a far more targeted model of recruitment. The potential for AI-assisted patient identification, registry management, and trial planning represents a major opportunity for modernizing clinical operations.

Beyond patient recruitment, the discussion turns to regulatory innovation. Ash outlines how agencies such as the FDA are beginning to adapt to the realities of rare disease drug development, including more flexible manufacturing requirements and adaptive trial designs such as Bayesian approaches. These changes acknowledge the practical reality that some gene therapies may require only a handful of manufacturing batches to treat an entire patient population.

Krishna Cheriath: AI is Disrupting Clinical Research Already

Saison 2 · Épisode 4

mercredi 11 mars 2026 • Durée 42:22

Enterprise software has dominated how companies operate for decades. Krishna Cheriath, Head of Clinical Research Data and AI at Thermo Fischer Scientific, believes that model is being broken by AI teammates.

In this episode of Breaking Protocol, Krishna joins Ram Yalamanchili to discuss how AI teammates are fundamentally disrupting the enterprise technology stack itself. Instead of navigating layers of applications and workflows, future knowledge workers will interact directly with data through AI agents that reason, plan, and act.

Krishna brings a rare perspective at the intersection of technology, AI, and pharmaceutical R&D. As Head of Digital and AI for Clinical Research at Thermo Fisher Scientific and former Chief Data & AI leader at Zoetis and Bristol Myers Squibb, he has spent decades deploying enterprise technology inside some of the world’s largest life sciences organizations.

The conversation explores why clinical trials still struggle with timelines and operational complexity, why automation alone has not delivered the expected breakthroughs, and why AI may represent a fundamentally different paradigm.

They also discuss the growing importance of AI fluency across the life sciences industry and why both individuals and organizations must rethink how they learn and adapt in an era of AI-augmented work.

Topics covered include:

• Why clinical trial operations have not improved as much as expected

• The limits of automation in drug development workflows

• Why AI could disrupt the entire enterprise software model

• The concept of a human-AI workspace replacing traditional applications

Alex Mok: Building Biotechs in the AI Era

Saison 2 · Épisode 3

mercredi 4 mars 2026 • Durée 59:50

Drug development is both a science challenge and timeline challenge. In this episode, Alex Mok shares what it actually takes to build a biotech company in today’s market. From launching an specialized therapeutics platforms to navigating shifting capital markets, Alex breaks down how valuation, risk, and execution intersect in modern drug development.We explore why clinical trial timelines directly shape risk-adjusted NPV, how market cycles influence platform vs. asset strategies, and why operational execution has become the real competitive advantage in biotech.Alex also shares a deeply personal story about trying to enroll his own father in a Phase 1 oncology trial — a firsthand look at how broken clinical operations can delay care and destroy value.The conversation covers timely topics such as AI-native clinical operations, agentic workflows in biotech, capital efficiency in drug development, the impact of automation on enrollment and trial velocity, and what happens when execution risk is materially reduced. If AI meaningfully lowers the cost and friction of clinical development, the biotech landscape changes. More shots on goal, faster proof of concept and different capital dynamics. This episode is for biotech founders, pharma executives, clinical operations leaders, and investors thinking about where the industry goes next.

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Paula Brown Stafford: Modernizing Trials Without Breaking Them

Saison 2 · Épisode 2

mardi 3 mars 2026 • Durée 50:26

In this episode of Breaking Protocol, Ram Yalamanchili sits down with Paula Brown-Stafford, CEO of Allucent and one of the early architects of the CRO industry.

From joining Quintiles as its 23rd employee to leading a purpose-built CRO focused on biotech innovation, Paula shares how the industry evolved from pure operational execution to intelligence-driven partnership. She explains why the real differentiator today is not scale, but regulatory intelligence, therapeutic depth, and the ability to navigate complex rare disease and cell and gene therapy trials.

The conversation also examines the economics of drug development, shifting regulatory pathways, and how AI teammates can reduce time and cost without compromising quality. For sponsors facing capital constraints and increasing pressure to deliver results, this episode offers a grounded perspective on how the CRO model must evolve to create measurable strategic advantage.

If you are leading clinical development, R&D, or portfolio strategy, this discussion will challenge how you think about partnership, value, and execution.

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Dr. Tom Mather: De-risking Drug Development with AI

Saison 2 · Épisode 1

mercredi 18 février 2026 • Durée 46:15

In this episode of Breaking Protocol, Tilda Research CEO Ram Yalamanchili sits down with Dr. Tom Mather — Chief Medical Officer of a clinical-stage biotech, early-stage venture investor, and marathoner — to unpack the real bottlenecks in drug development.From seed-stage funding to Phase III trials, Tom shares a rare perspective of clinician + operator + investor.They discuss:• Why venture capital hasn’t disappeared but is demanding de-risking• The growing gap between discovery and clinical execution• Why clinical trials remain the largest financial and operational bottleneck• How machine learning can improve early data, trial design, and protocol development• What happens when AI enables more molecules than the system can handle• Why Tom rejects the term “artificial” intelligenceIf AI accelerates discovery, but clinical infrastructure stays manual and siloed, the bottleneck only shifts downstream.This conversation explores what that future could look like.

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Dr. Mark Barakat: How AI reinvents clinical trials

Saison 1 · Épisode 5

mercredi 23 juillet 2025 • Durée 26:20

What happens when a retina specialist with a background in computer science takes on the inefficiencies of clinical research?In this insightful conversation, Dr. Mark Barakat of Retina Macula Institute joins Tilda CEO Ram Yalamanchili to explore how AI is transforming the day-to-day reality of clinical trial execution.They discuss the growing operational burdens on site staff, the silent cost of turnover, and the bottlenecks that limit research capacity. Dr. Barakat shares his firsthand experience adopting AI in a high-volume ophthalmology research site—including what’s working, what’s not, and why he believes AI will become a core collaborator, not a threat.From automating data entry and managing re-consent workflows to long-term visions of AI-assisted imaging and protocol compliance, this episode offers a grounded, site-level perspective on AI’s real potential in trial operations.⸻What you’ll learn:- How AI is reducing operational burden for clinical research coordinators and site staff- Why research sites struggle with staff burnout, turnover, and training and how AI can help- The hidden inefficiencies in clinical trial workflows (EDC, source-to-CRF, informed consent)- Real-world examples of AI improving regulatory compliance and data quality at ophthalmology sites- How sites are using AI to manage high trial volume without increasing headcount- Why adoption of AI in clinical research is slow—and what’s changing now- The role of AI in imaging analysis for retina trials, including OCT segmentation and atrophy tracking- How AI can level the playing field across high- and low-performing clinical trial sites- Practical considerations for bringing AI into day-to-day research operations- What sponsors need to know about site enablement, trial scalability, and AI’s role in quality assurance

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Dr. Houman Hemmati: Clinical Trials Fail in the Execution: It doesn't have to be this way

Saison 1 · Épisode 4

lundi 30 juin 2025 • Durée 45:34

In a recent conversation, Dr. Houman Hemmati (ophthalmologist, clinical trialist, and biotech innovator) didn’t hold back in describing the systemic inefficiencies he sees every day. From sponsor overreach to CRO micromanagement to administrative overload at research sites, the entire model is built to sustain activity, not outcomes.

He believes that AI can eliminate a lot of the operational drag that wastes time and wears people down. And he predicted a lot of the AI-centric changes that have been announced by the FDA recently.

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Dr. James Fox: Scaling Clinical Research with AI Teammates

Saison 1 · Épisode 3

lundi 2 juin 2025 • Durée 55:40

ICON Eyecare experiences 66% data quality improvement and 90% increase in efficiency.

Dr. James Fox of ICON Eyecare (Grand Junction, CO) discusses what it really takes to scale clinical research today. He walks through the burnout his team faced, the turning point that led to adopting AI teammates, and the measurable improvements in data quality, team capacity, and growth. He unpacks the staffing paradox in research, the trust that's at stake, and what it means for the future when AI and humans work side-by-side. His site, running 30 trials with a lean team, is a case study in what happens when AI meets the real-world pressure of clinical operations.

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Breaking Protocol – Détails, épisodes et analyse

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Podcasts Similaires Basées sur le Contenu

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