Overcoming “No Hit” and Hit Expansion Bottlenecks: An Integrated HTS, AI, and DEL Approach for Difficult-to-Drug Targets

Early-stage drug discovery is often hindered by two major challenges. The first is identifying initial hits against difficult-to-drug targets. The second is advancing HTS-derived hits into high-quality lead candidates. Many hits fail due to off-target activity, poor ADME-Tox profiles, limited SAR opportunities, or insufficient tractability for medicinal chemistry optimization. These limitations can slow project progression and reduce the likelihood of discovering differentiated candidates, highlighting the growing interest in innovative approaches to improve both hit identification and hit expansion.

2026-09-18T08:22:27+00:0009.09.2026|

A Deep Dive into the FDA NAMs Road Map with Former Senior Management of the FDA

NAMs Road Map was published in April 2025. The goal in non-clinical safety studies is to transition from animal studies into NAMs within 3 to 5 years. FDA is accelerating validation and adoption of these methods, aiming to reduce animal use while improving predictive accuracy. However, pharmaceutical companies lack this information, and there are lots of uncertainties about what kinds of studies FDA will require when submitting IND/NDA files. In this video, we have delved deeper into unclear points with Dr. McGovern, a former FDA senior manager who had produced the NAMs Road Map.

2026-09-17T05:23:10+00:0009.04.2026|
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