September 2025
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00 issues in this vol.

FROM PILOTS TO PRODUCTION: AI BECOMES PRIORITY FOR PHARMA LEADERS

A Define Ventures survey of 16 of the top 20 pharma companies shows thatpharma leaders are moving from pilots to enterprise rollouts: 70% (85% at BigPharma) call AI an immediate priority and >80% are raising budgets. Spend isconcentrated on low-risk, measurable workflows (e.g., medical writing andadmin reduction), while operating models split across build/buy/partner.Governance is normalizing (ethics/safety committees now standard), whichshould shorten internal approvals and clarify procurement criteria.

Near-term demand will favor vendors with enterprise security, governance artifacts, and clear ROI; for pharmas, expect faster internal greenlights where use cases cut cost or cycle time.

TWO PATHS TO AI DRUG DISCOVERY: PLATFORM VS. OPERATOR

Eli Lilly and Formation Bio are advancing AI-enabled discoveryfrom two angles. Lilly is opening TuneLab, an AI platformtrained on >$1B of data from “hundreds of thousands” ofmolecules, accessed from partners like Circle Pharma andinsitro. Formation Bio recently expanded it’s leadership teamwith former top 20 pharma executives to accelerate AI-drivendrug development. Formation Bio has created an AI-poweredmodel that acquires under-prioritized drug assets andaccelerates their development with greater efficiency, lowercosts, and faster delivery of new medicines to patients.

Together, these updates signal a maturing market where incumbents productize AI while AI-natives prosecute portfolios with faster, less animal-dependent research.

AI-DISCOVERED DRUG DELIVERS PHASE IIA SIGNAL IN IDIOPATHIC PULMONARY FIBROSIS (IPF)

Insilico Medicine recently published the results of a Phase IIA trial forRentosertib, in Nature, which showed a +98.4 mL FVC gain vs. −20.3 mL vs.placebo over 12 weeks with a manageable safety profile (71 patients, 22 sites).Exploratory biomarkers aligned with the mechanism (TNIK inhibition),supporting the dose-response observed. As the first clinical proof-point for anAI-discovered therapeutic, this positions the asset for larger trials and potentialpartnering, with value inflection tied to durability and scale of effect.

This milestone signals the beginning of AI-discovered drugs moving from theory to clinical reality, with which comes faster, more efficient R&D, though it also raises questions about long-term efficacy validation, regulatory adaptation, and how traditional pharma models will evolve.

AI PROJECTED TO UNLOCK HUGE FINANCIAL AND DRUG DEVELOPMENT BENEFITS

Recent industry analyses project a multibillion-dollar impact for AI in healthcare,primarily through reduced R&D timelines (up to ~40% faster to PCC) and costs(~30% lower), while also improved clinical execution via decentralization, EHRbased eligibility matching, and digital twins. Forecasts place the AI-in-pharmamarket near $1.9B in 2025 with strong CAGR through 2034, as near-termexpenditures center on operational levers that shorten cycle time and reducerisk involved with early-stage asset development.

The upside of AI appears clear for manufacturers, but regulatory bodies have yet to define concrete approval pathways or guidelines, which will be the final hurdle in realizing the full impact projected across the industry.

FUNDING SURGE FOR HEALTHCARE AI PROJECTS FOCUSED ON STREAMLINING ACCESS

As AI innovation soars across the landscape, recent investments havebeen concentrated on “agent” platforms and other access-enabling tools.EliseAI, a startup automating healthcare front-desk and call centeroperations, recently raised $250M (Series E) on the promise of saving 2-3hours saved per staffer/day, and up to 25% overhead reduction. HelloPatient raised $22.5M (Series A), scaling HIPAA-compliant voice/text/chatagents handling 10k–20k daily provider-patient conversations.Surrounding infrastructure is scaling too: Develop Health raised $14.3M fortheir prior auth automation, Twin Health raised $53M for a metabolicdigital twin, and Eyebot raised $20M for self-service vision kiosks.

For pharma brands reliant on provider workflows, these platforms are plug-in channels to improve time-to-therapy and adherence without building new field infrastructure, presenting an opportunity to streamline operations.

JOINT COMMISSION ISSUES NEW RULEBOOK FOR USE OF AI SOLUTIONS IN HOSPITALS

The Coalition for Health AI (CHAI) and the Joint Commission, one of the largestaccreditors of hospital and health systems nationally, recently released theResponsible Use of AI in Healthcare (RUAIH) guidance to set hospitalexpectations for AI. The guidance includes formal governance, patientdisclosure & consent, HIPAA-grade security, vendor transparency on validation& bias, and will be further reinforced through workshops, webinars, and acertification program for hospitals through the Joint Commission.

While the RUAIIH guidance is geared toward hospitals, it has significant implications for healthcare AI vendors. Vendor readiness with model cards, local validation plans, and monitoring SLAs will become table stakes in hospital procurement, and the solutions that meet guidelines the fastest are likely to see faster uptick in adoption.
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