CerFlux CEO Shapes the Future of Drug Development at Fierce Biotech Week
BOSTON, MA, (October 10, 2025) – At a time when the biotech and life sciences industry is grappling with unprecedented regulatory, funding, and economic policy uncertainty, Dr. Karim Budhwani, CEO-Scientist of CerFlux, played a pivotal role in addressing this convergence of challenges at Fierce Biotech Week 2025, serving as both the Chair of the Drug Development track and as an expert panelist on next-generation formulation and process innovation.
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Fierce Biotech Week convenes senior leaders across discovery, development, regulatory strategy, and commercialization. As Track Chair, Dr. Budhwani opened and moderated a full day of programming designed to span the entire drug development lifecycle spanning translational science and CMC considerations to evolving FDA pathways, patient-centered R&D, and emerging therapeutic modalities.
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In his opening remarks, Dr. Budhwani framed the day around three principles he described as essential for navigating this moment: Precision, Partnerships, and Purpose.
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“In oncology, success depends not only on creating the right drug but on matching it to the right patient,” Dr. Budhwani noted, “and this duality can only be achieved through precision in our science, meaningful collaborations, and – most importantly – a shared purpose to undergird our journey.”
The Drug Development agenda reflected this systems-level approach, with sessions examining next-generation antibody-drug conjugates, regulatory uncertainty and FDA expectations, patient-centered development strategies, metabolic and obesity therapeutics beyond GLP-1s, targeted protein degradation, and the resurgence of neuroscience drug development. Sessions explored how evolving FDA standards and industry and macroeconomic volatility are raising the bar for preclinical evidence. A recurring theme was the necessity of making treatments that fit human patients, requiring a deeper understanding of human-specific responses early in the pipeline. Collectively, the program underscored a growing industry consensus: modern drug development requires early, human-relevant, integrated strategies to ensure translational success.
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Beyond chairing the track, Dr. Budhwani also contributed as a panelist on “Formulation, Product and Process Innovation Enabling Next-Gen Therapies,” where leaders from formulation science, drug discovery and delivery, and CMC explored how emerging technologies and new approach methods (NAMs) are rapidly becoming critical enablers of success. The discussion emphasized the importance of aligning discovery to delivery strategies early to reduce risk and accelerate translation from bench to IND.
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Building on this theme, he offered a clear-eyed perspective on the growing role of AI in drug discovery and development. While acknowledging the transformative potential of AI and machine learning, he cautioned against the assumption that computational advances alone can resolve the persistent gaps between discovery and clinical success.
“AI is an extraordinary tool,” he said, “but without anchoring it to human-relevant biology and outcomes, it risks becoming a synthetic echo chamber feeding – fast, elegant, and wrong.”
He emphasized that the central challenge is not the presence of AI “hallucinations,” but rather the absence of human-relevant biological grounding. In an environment increasingly desperate to fill in the blanks with synthetic data and recursive models, he argued that innovation risks becoming self-referential: optimizing predictions against abstractions rather than against the complex, heterogeneous reality of human disease.
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Instead, he outlined a forward-looking paradigm in which in silico computational capacity and ex vivo human-relevant experimental systems operate in deliberate synergy. In this model, AI is free to generate bold hypotheses and explore vast design spaces because those ideas can be rapidly stress-tested against real human tissue biology, enabling faster learning cycles while preserving biological truth.
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This distinction, Dr. Budhwani noted, is especially critical as regulators, investors, and development teams demand higher-quality preclinical evidence earlier in the pipeline. As FDA expectations continue to evolve toward NAMs and capital and pipeline efficiency become paramount, the ability to distinguish between computational features and biological reality is no longer academic, it is strategic.​
A framework for AI hallucinations
AI companies are pouring billions into eliminating hallucinations. That's the wrong fight. We don't need AI that never hallucinates. We need AI with configurable hallucination levels to match AI behavior to the risk profile and innovation objectives of each application.
Regulatory / Lab-Tech Mode: Zero tolerance for hallucination. Outputs must be repeatable, auditable, and verifiable. Appropriate for safety-critical applications, regulatory submissions, and any context where precision is paramount.
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Incremental / Post-Doc Mode: Structured extrapolation from peer-reviewed science. Suitable for systematic optimization—analog development, formulation refinement, biosimilar design—where the goal is disciplined iteration rather than conceptual leaps.
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AIShroom / Hypothesis Mode: Here, hallucinations are the feature, not the bug. AI generates novel, outside-the-box hypotheses for experts to weigh and stress-test against human-relevant biological systems. Eliminating this kind of hallucination yields only regurgitation of what we already know thus limiting the pipeline to more of the same therapies.
The real danger isn't hallucination. It's synthetic data without confirmation: a fast-reverberating echo chamber that tunes innovation out and crescendos into model collapse. We need AI built on real, human-relevant data that can be tuned by human experts from rigorous to responsibly weird.​​
The broader message resonated throughout Fierce Biotech Week: the future of drug development will not be defined by any single technology, modality, or organization. Progress will depend on integrated thinking, where precision in science is matched by collaboration across disciplines and grounded in a shared sense of purpose.
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As the industry continues to navigate uncertainty, Fierce Biotech Week underscored a growing consensus: meaningful breakthroughs will come not from isolated advances, but from leaders willing to challenge assumptions, connect tools to truth, and design development strategies that reflect the realities of human biology.
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From an industry perspective, that means staying focused on what ultimately matters – building therapies that work in real patients, in the real world – while helping guide the ecosystem toward approaches that are not only innovative but enduring.