
Show Notes
In this episode of AI For Pharma Growth, Dr Andree Bates speaks with Clara Bernardes, co-founder and CSO of Biorce, about how AI can accelerate clinical development without sacrificing compliance or scientific rigour. Biorce was born from a deeply personal experience. After Clara's father-in-law received a terminal melanoma diagnosis, access to a clinical trial through compassionate use extended his life from an expected three months to more than a year. That experience shaped Biorce's mission: reduce the time it takes promising treatments to reach patients. Clara explains why clinical trials are still slowed by protocol amendments, patient identification problems, poorly designed criteria and human-led errors that could often be caught much earlier. The conversation explores how Biorce uses AI and almost one million annotated protocols to support protocol development, learn from previous trial amendments and provide clear rationale for recommendations. Clara also discusses why transparency, AI ethics and keeping humans in the loop are essential in regulated clinical development. The key message is that speed and compliance do not have to be opposing forces. The goal is not to replace scientists or investigators, but to give them better information faster while preserving human judgement. Topics Covered Why clinical trials start late
Protocol amendments and avoidable human error
AI-generated clinical trial protocols
Learning from previous trial failures
Transparency and explainability
AI ethics and regulatory compliance
Keeping humans in the loop
Balancing quality with velocity
What sponsors should ask AI vendors
About Eularis Eularis builds AI capability inside pharma and biotech — over 20 years applying AI to real pharmaceutical problems, inside real pharmaceutical and biotech companies. Keynotes and live sessions — Working sessions for pharma teams where nobody leaves with notes. They leave with working prompts and real capability they've already run on their own work. The AI Enablement Institute — Strategy and a workshop get you started; neither stays current. Most pharma companies already have a generic AI course library. None of it is written for a regulatory writer, an MSL or a market access lead trying to get today's work done. Training is an event; enablement is capability that stays current. The Institute runs shared foundations for the regulated constraints, then tracks by business unit function, with new content monthly, live office hours with Dr Andree Bates, and per-person records a sponsor can show an auditor. One price per business unit, no per-seat charges. AI Strategic Blueprint and Governance — Board-ready strategy that links initiatives to commercial outcomes, with the sequencing, governance, capability and financial logic to survive scrutiny. AI Custom Builds for BioPharma — Design and build of the AI solutions that make strategic sense in your operating reality, tied back to the Blueprint. Start with the Institute → https://eularis.com/institute/ Everything else → https://eularis.com About the Podcast AI For Pharma Growth is the podcast from Dr Andree Bates, helping pharma, biotech and healthcare organisations understand how AI-based technologies can save time, grow brands and improve company results. The show demystifies AI for biopharma leaders, from start-up biotech through to Big Pharma.
Dr. Andree Bates LinkedIn | Facebook | X
More from AI For Pharma Growth
In this episode of AI For Pharma Growth, Dr Andree Bates speaks with Dr. Kurt Rohloff, co-founder and CEO of Duality Technologies, about how privacy-enhancing technologies could unlock data collaboration without forcing organisations to give up control of sensitive information. Kurt explains how technologies such as fully homomorphic encryption and federated learning allow organisations to analyse encrypted or distributed data without exposing the underlying patient information. For pharma and medical research, that creates opportunities to reuse existing data, collaborate across organisations and geographies, and access populations that have historically been difficult to include. The conversation explores why data security should not be viewed only as a compliance cost. Secure collaboration can also become a value creator, helping organisations run better science, reduce administrative overhead and generate evidence that would otherwise be too expensive or difficult to obtain. They also discuss rare diseases, underserved communities, cross-border research and the role regulators and standards bodies will play in enabling wider adoption. Kurt argues that the technology is often further ahead than organisational acceptance, making policy conversations just as important as technical development. Topics Covered Privacy-enhancing technologies in pharma
In this solo episode of AI For Pharma Growth, Dr Andree Bates explores one of the biggest blind spots in pharma AI: the failures that can survive a normal review process even when the output sounds polished, plausible and well grounded. Dr Andree explains why better models and better retrieval do not remove the need for human judgement. In fact, as AI systems improve, people often scrutinise them less. Fluent prose can create a false sense of reliability, while automation bias and anchoring make reviewers less likely to challenge the underlying frame. The episode introduces three broad families of failure: invented, distorted and misdirected. These include fabricated or misattributed citations, silent interpolation, dropped qualifiers, hedge-to-claim escalation, manufactured consensus, stale guidance and planted instructions. Many of these are harder to catch because the output reads better than the truth. Dr Andree also shares practical checks teams can use, including tracing claims back to source, checking what is unsupported, looking for missing qualifiers, regenerating outputs for stability and deliberately testing the opposite case. The key message is that prompting is only half the skill. In a regulated industry, teams also need to be trained to judge what comes back. Topics Covered Why better AI can lead to less scrutiny
In this episode of AI For Pharma Growth, Dr Andree Bates speaks with cancer biologist and health educator Rebecca Maff about how AI could help shift healthcare from treating disease to preventing it. Rebecca’s interest in prevention began after seeing women in her own family diagnosed with late-stage cancers and serious autoimmune conditions. Her subsequent work has included machine learning models designed to identify patients at higher risk of cancers and encourage overdue screening before disease progresses. The conversation explores what prevention really means in practice, from early biomarkers and personalised risk modelling to screening, lifestyle, metabolic health and behavioural change. Rebecca explains how AI can help analyse electronic health records and large patient populations to identify signals that would be difficult for humans to find manually. They also discuss the commercial opportunity for pharma. If late-stage disease becomes more preventable, the industry may need to think beyond treating established illness and consider new models built around earlier detection, intervention and maintaining health. Trust remains a major challenge. Rebecca argues that patients and clinicians need to see credible, successful AI implementations before confidence grows, particularly when systems are using highly personal health, genomic and behavioural data. Topics Covered Moving healthcare upstream towards prevention
In this episode of AI For Pharma Growth, Dr Andree Bates speaks with Raviv Pryluk, co-founder and CEO of PhaseV, about why so many clinical trials still fail and where AI can genuinely improve the odds. Raviv argues that failure is often not because the drug itself is wrong. Trials can fail because of the wrong patient population, indication, dose, design, sites, monitoring or interpretation of the data. PhaseV uses causal machine learning, adaptive trial design and large-scale simulation to help sponsors make better decisions across those areas. The conversation explores why explainability and validation matter in clinical development. Raviv explains that a 95% prediction is not enough on its own. Sponsors and regulators need to understand why a recommendation is being made, which evidence supports it, and whether the result is statistically and clinically defensible. They also discuss using existing trial data to identify responder subgroups, stress-testing designs before patients are enrolled, adapting trials mid-flight and connecting protocol design more closely with clinical operations. Topics Covered Why clinical trials still fail
In this episode of AI For Pharma Growth, Dr Andree Bates speaks with Dan Pratl, founder and CEO of Quadron Inc, about a trust problem emerging as AI moves deeper into pharma: how do organisations preserve confidence when more work is generated, shaped and accelerated by machines? Dan argues that verified output alone is not enough. Pharma already has human review, MLR, regulatory sign-off and quality controls, but trust also depends on understanding where data came from, which models were used, where human judgement entered the process and whether that chain can be audited. The conversation explores why human expertise may become more valuable, not less, as AI spreads. Dan discusses shadow AI, the limits of forcing employees onto a single approved model, and why organisations need to reward people for curating, verifying and applying judgement across tools rather than treating AI usage itself as productivity. They also examine the risk of losing the junior work that traditionally builds expertise, the need for stronger audit trails, and why redesigning systems around AI may matter more than simply adding another governance dashboard. Topics Covered AI and pharma's emerging trust problem