RESEARCH & DEVELOPMENT
Drug Development in the Technology Era Legal Considerations for Computer-Assisted Drug Design Computer-aided drug design seeks to accelerate drug development and increase success rates, while reducing costs. With more sophisticated bespoke programs being developed, relying on advanced AI technology, we pause to consider some of the potential legal and commercial issues which might arise, including IP ownership, remuneration strategies and liability. Lydia Torne, Partner, Simmons & Simmons LLP Samuel Wilson, Trainee Solicitor, Simmons & Simmons LLP
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ith the cost of developing a new pharmaceutical product currently hovering around US$ 944m to US$2,826m1 and taking approximately ten2 years from product inception to approval, the pharmaceutical industry is understandably keen to identify ways to reduce these metrics. To this end, the industry has begun exploring computer-aided drug design (CADD) with a view to accelerate drug development and increase the success rate of products in development. What is CADD? CADD can be broadly described as the use of software algorithms in drug discovery to identify and/or develop a potential lead drug candidate. For example, using software to review and assess a small molecule library against a defined target to identify potential “hits”. Other CADD software focuses on “molecular docking” (e.g. software which predicts both the binding affinity between ligand and protein and the structure of protein–ligand complex) to develop product candidates. Using software to predict characteristics of the product, e.g. predicting the absorption, distribution, metabolism, excretion, and toxicity properties of the product candidate thereby allowing scientists to better understand the product’s safety and 1 Source: Front. Med article 2 Source: paper from 2021 RPDI industry report
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