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No More Lab Rats? FDA Shift Spurs AI Boom in Drug Development

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The explosive growth in ChatGPT users underscores the pervasive integration of artificial intelligence (AI) into everyday life, and industries are no exception. Notably, the pharmaceutical and biotech sectors, particularly drug discovery, are seeing a surge in AI demand as they seek to secure future revenue streams.

The recent decision by the U.S. Food and Drug Administration (FDA) to eliminate mandatory animal testing has further intensified interest in AI-powered drug development platforms. This shift has prompted domestic pharmaceutical companies to boost their AI capabilities to stay competitive.

FDA’s Animal Testing Policy Shift Catalyzes AI-driven Drug Development

The FDA recently highlighted the potential of AI technology to replace animal testing, promoting New Approach Methodologies (NAM). NAM represents cutting-edge techniques for evaluating drug toxicity and efficacy without animal subjects.

Effective implementation of this technology could streamline the traditional “cell testing – animal testing – clinical trials” pipeline. Instead, AI-driven predictions and organoid-based preclinical experiments may allow researchers to fast-track to clinical stages, potentially slashing drug development timelines.

AI application in drug research also proves invaluable in identifying potential drug candidates. The Ministry of Food and Drug Safety of South Korea reports that researchers typically spend five years selecting candidate substances when developing new drugs. This prolonged process stems from the need to rely on existing research papers, often leading to numerous setbacks.

However, there’s growing optimism that AI could slash this timeframe by more than half. An industry insider noted, “The search for promising candidate substances is time-consuming, but AI can efficiently sift through research results, potentially yielding significant benefits.”

South Korean pharmaceutical companies are also actively adopting AI technologies to reduce costs and time required to find candidate substances.

South Korean Pharmaceutical Giants Recruit Experts, Form AI Drug Teams, and Build Proprietary Platforms

Daewoong Pharmaceutical established its dedicated AI drug team in 2021. It developed in-house tools to expedite candidate substance R&D. A company representative explained, “We’ve recruited AI specialists to complement our existing expertise. While we’re still in the early stages, we’re confident in the long-term benefits as we build our capabilities.”

JW Pharmaceutical launched its AI-based data platforms, “Jewelry” and “Clover,” in 2010 and recently merged them into a unified platform called “JWave.” A JW Pharmaceutical representative stated, “AI integration promises a more streamlined process compared to traditional drug development methods.”

HK inno.N is leveraging its proprietary AI-based platform, “inno-SUN,” to discover effective compounds for targeted cancer therapies.

Dong-A ST has opted for collaboration, partnering with AI medical solutions firm AITRICS for joint digital healthcare research, rather than developing an in-house platform. However, the company recently concluded its partnership with AI-driven drug development firm Simplex, which began in 2021.

While the industry is increasingly pivoting towards AI, experts caution against expecting immediate breakthroughs. They emphasize that drug development remains a complex, time-intensive process requiring a long-term perspective.

An industry expert commented, “While AI promises transformative change, reality differs from expectation. Tangible results aren’t likely in the short term. Each company has its AI strategy, but outcomes remain uncertain. Nevertheless, a patient, long-term approach is crucial as new technologies are adopted.”

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