From pilots to production: AI across R&D, safety, regulatory and clinical

Life sciences organizations are moving quickly to explore generative and agentic AI, but many are still working through how to move from promising pilots to production-ready solutions that can scale across regulated workflows. As AI becomes embedded in areas such as pharmacovigilance, regulatory operations, clinical development, medical affairs, precision medicine and commercial processes, organizations need more than experimentation — they need trusted AI strategies that balance speed, quality, governance and human oversight.

In this webinar, experts from IBM and GNQ Insilico will discuss:

How Agentic AI and AI-first strategies have accelerated time-to-value in regulatory submission processes related to IND, NDA and BLA applications, helping bring products to market faster.
What it takes to operationalize AI across complex life sciences environments, and how biological reasoning models and quantum computing are changing what AI can actually explain — not just predict — across the molecule-to-patient journey.

The conversation will share solutions currently in use and explore how organizations can identify high-value use cases, demonstrate human-in-the-loop workflows, build trust with business and compliance stakeholders by grounding AI outputs in auditable, mechanism-based reasoning rather than opaque correlation, and measure impact beyond initial proofs of concept. Speakers will also share perspectives on the data, governance and change management foundations needed to scale AI responsibly while supporting better decision-making, efficiency and patient-centered outcomes.

Key Takeaways

How healthcare and life sciences organizations can move from AI pilots to scalable production use cases
How Agentic AI enables humans to accelerate the authoring and review of R&D, safety, regulatory and clinical documents, with support for GxP, 21 CFR Part 11 and HIPAA/GDPR requirements
How causal, mechanism-based AI reasoning — augmented by quantum computing — moves beyond pattern-matching to explain why a treatment works, not just predict that it might
Where trusted AI can create value across regulated workflows such as safety, regulatory and R&D operations
Why human oversight, auditability and governance are essential for enterprise AI adoption
How to think about ROI, adoption and operational impact when scaling AI across the life sciences business

Sudhir Saxena

Chief Technology Officer

GNQ Insilico

Sudhir Saxena is Chief Technology Officer of GNQ Insilico, Inc., a precision medicine TechBio company. Sudhir brings 25+ years of leadership building Product Strategy-through-Deployment organizations, with deep domain expertise across Healthcare and Life Sciences. Across his career as both an entrepreneur and an executive at top-tier consulting firms, he has built and scaled AI-driven Healthcare and Life Sciences platforms, taking them from ideas/concepts to commercial products. At GNQ he currently focuses on building out the GNQ flagship platform with Q-BRM, the company's Quantum infused Biological Reasoning Model, designed to move beyond correlation-based AI by reasoning across associative, interventional, and counterfactual levels of causal inference — work that recently surfaced previously unrecognized drug response mechanisms in oncology. He speaks frequently on causal AI, quantum computing, and the future of genomic medicine.

Deiva Ramachandran

Partner, Agentic AI AI-Automation Practice Leader

IBM

Deiva is a Partner at IBM Consulting, leading the Generative AI Automation practice for the Life Sciences and Healthcare sectors. With more than 20 years of experience, he has driven large-scale, transformational programs using cutting-edge AI solutions for global biopharma, medical device, and healthcare companies. Deiva’s expertise extends across the Life Sciences value chain, from clinical trials, radiology to regulatory submissions, marketing automation, and patient-centric digital health products. He is a recognized thought leader, contributing to GenAI papers and speaking at global conferences, shaping the future of AI automation in life sciences and healthcare. Deiva and his high-performance teams have pioneered innovations with industry/domain-specific GenAI assets and operationalizing Agentic AI to bring products and services to market faster for patients and providers who are waiting, driving revenue acceleration and significant cost savings, creating new business models as well as creating competitive advantages for his clients.

Stuart Pyle

Partner, Life Sciences R&D

IBM

Stuart leads IBM Consulting R&D practice and is a seasoned Life Sciences digital transformation leader with over 30+ years of experience guiding life sciences organizations, across the entire molecule to patient value chain. His expertise spans organizational transformations, operational efficiency, and Data driven AI technology advancements, with a focus on aligning data driven business and IT strategies to deliver measurable outcomes. His leadership has delivered cutting-edge capability solutions that leverage AI/ML, cloud technologies, automation and data governance-GxP frameworks to accelerate innovation, improve decision-making, and enhance patient-centric outcomes.

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From pilots to production: AI across R&D, safety, regulatory and clinical

Panelists

Moderator

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