The AI in Business Podcast

Rethinking Clinical Trials with Faster AI-Driven Decision Making - with Shefali Kakar of Novartis

Dec 9, 2025
Shefali Kakar, Global Head of PK Sciences and Oncology at Novartis, shares her insights on how AI is revolutionizing drug development. She discusses the use of in silico modeling to predict safety and efficacy before producing molecules. Shefali emphasizes the importance of strategic capital allocation through advanced modeling to optimize R&D investments. Additionally, she highlights challenges like fragmented data and urges companies to learn from past failures to refine their approaches. Her advocacy for a 'fail fast' ethos aims to enhance patient safety while streamlining drug development.
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INSIGHT

Atomic-Level Modeling Redefines Discovery

  • Advanced in-silico modeling can predict how every atomic change affects safety and PK of small molecules.
  • These models let teams evaluate candidates before physical synthesis, changing early discovery choices.
INSIGHT

Designing Biologics For Market Fit

  • Protein engineering tools enable designing biologics for specific half-life, potency, and off-target avoidance.
  • This allows teams to build molecules with market-differentiating properties before clinical work begins.
ADVICE

Use In-Silico Trials To Guide Investment

  • Use in-silico clinical trials and probability-of-success models to inform investment decisions.
  • Refine those models with cross-functional inputs to improve financial portfolio allocations.
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