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Drugmakers Turn to AI to Speed Trials and Submissions

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Pharmaceutical companies are increasingly using artificial intelligence to accelerate clinical trials and regulatory submissions, even as AI has yet to deliver major breakthroughs in discovering new drugs. Industry executives say the technology is already saving weeks by automating participant recruitment, site selection, and the preparation of vast regulatory documentation.

Executives from major drugmakers including Eli Lilly, AstraZeneca, Roche, and Pfizer said at the JP Morgan Healthcare Conference that AI tools are helping manage thousands of pages of clinical, safety, and manufacturing records required by regulators worldwide.

Drug development can take more than a decade and cost around $2 billion. Companies are betting that AI can improve efficiency and success rates by handling what executives call the “messy middle” of development. Consultancy McKinsey estimates that autonomous, or agentic, AI could lift clinical development productivity by up to 45% over the next five years.

Israeli drugmaker Teva Pharmaceutical Industries said it is using AI to streamline processes so researchers can focus on bringing new medicines to market. Meanwhile, Novartis used AI to cut site selection for a large cardiovascular trial from weeks to hours, helping it hit enrollment targets with minimal overshoot.

Other companies are also reporting tangible savings. GSK said digital and AI tools helped reduce late-stage trial costs by millions of pounds, while Denmark’s Genmab plans to deploy AI agents to automate post-trial analysis and reporting.

While investors are still waiting for the first fully AI-designed blockbuster drug, executives say the technology is already reshaping how trials are run and how data is submitted. Amgen’s research chief said many AI-designed molecules are already moving through pipelines, suggesting the biggest impact may still lie ahead.

Nabla Bio and Takeda deepen AI-powered drug discovery partnership

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U.S. biotech startup Nabla Bio has expanded its collaboration with Japanese pharmaceutical giant Takeda, signing a new multi-year agreement to further integrate artificial intelligence (AI) into the drug discovery process.

The partnership, building on an initial 2022 deal, includes upfront and research payments in the double-digit millions, with Nabla eligible for success-based milestones exceeding $1 billion. The companies will use Nabla’s proprietary Joint Atomic Model (JAM) platform to design next-generation protein-based therapeutics, including multi-specific drugs targeting hard-to-treat diseases.

Nabla CEO Surge Biswas described JAM as a system that “responds to molecular queries the way ChatGPT answers text questions,” generating custom antibody designs that meet specific biological targets. The company says its technology offers one of the fastest feedback loops in the biotech sector — only three to four weeks from computational design to laboratory testing.

Takeda’s renewed focus on scalable, AI-driven drug types follows its decision to exit cell therapy research earlier this year. The Japanese firm also recently joined a consortium with Bristol Myers Squibb to develop AI models using shared pharmaceutical data.

Nabla expects to deliver first-in-human data from its AI-designed therapeutics within one to two years, marking another milestone in the industry’s growing reliance on AI to cut development timelines and boost innovation.

AstraZeneca Signs $5.3 Billion AI Research Deal with China’s CSPC to Develop Chronic Disease Therapies

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AstraZeneca has entered into a significant AI-driven research partnership with China’s CSPC Pharmaceutical Group worth up to $5.3 billion. The agreement aims to advance the development of therapies targeting chronic diseases, reinforcing AstraZeneca’s commitment to innovation in its second-largest market.

Under the collaboration, CSPC will conduct AI-led research in Shijiazhuang City to discover and develop pre-clinical candidates, including a small molecule oral therapy for immunological diseases. AstraZeneca will pay CSPC an initial upfront fee of $110 million and can receive up to $1.62 billion in development milestone payments, plus an additional $3.6 billion tied to sales milestones.

This partnership follows AstraZeneca’s broader efforts to strengthen its presence in China, including a $2.5 billion investment in a new R&D hub in Beijing announced earlier this year. It also builds on recent collaborations with AI-focused companies like Immunai, Qure.ai, and Tempus AI.

The deal also grants AstraZeneca rights to exclusive licenses for drug candidates identified through the joint research. This adds to a previous licensing deal signed in October, where AstraZeneca agreed to pay up to $1.92 billion to CSPC to enhance its cardiovascular drug pipeline.

CSPC, which derives about 80% of its revenue from finished drugs, is currently exploring additional licensing and collaboration opportunities, according to Morningstar analysts.

Sharon Barr, AstraZeneca executive, highlighted the collaboration as part of the company’s commitment to tackling chronic diseases affecting over two billion people worldwide.