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Drug Development

What is Drug Development?

Drug development is a life sciences term used to describe the process of bringing a therapeutic product to market. It begins with a concept and ends with clinical trial development, followed by commercialization. For drug development to successfully occur, a lead compound — a chemical compound with pharmacological or biological activity that is likely to be therapeutically beneficial, such as one that can point out disease indication or a therapeutic target — must be first identified during the drug discovery stage for development to follow.

The drug development process takes a stage-gate approach where the timeline can be broken down into discrete phases, with two main halves consisting of preclinical work and clinical work. During the preclinical phase, drug development starts by identifying new chemical entities (NCEs) and making sure these entities meet new drug application requirements. Once successful in this part, drug development moves onto the clinical phase, which involves multi-step trial testing.

Other Names for Drug Development:

  • Drug design
  • Drug repositioning
  • Pharmaceutical engineering
  • Pharmaceutical manufacturing
  • Drug discovery
  • Clinical trials
  • New drug application

Why is Drug Development Important?

Drug development is important because it enables innovators to deliver therapies to the people who need them the most. Starting with drug discovery, innovators can make use of dedicated platforms to search for and organize large amounts of data, enabling them to see what dead ends and opportunities there are. As the drug development process moves along, innovators, following the stage-gate process method, can continue to look for obstacles or opportunities, such as collaborating with other entities to bolster the research and development (R&D) phase, selling their intellectual property (IP) to start on a different path, or engaging in some other form of technology transfer.

One important note is the sheer cost of drug development. As it’s typically an extremely expensive process, due in part to the decade-or-longer timeline demanding ongoing investment, drug development dictates a more conservative path compared to other innovation areas. With individual stages of clinical trials costing tens of millions of dollars, partnering up with other individuals or organizations can help smoothen the innovation process, especially when using software or artificial intelligence (AI) designed to simplify the process. Innovators can then create their own drug database or contribute to a great clinical trial database far more effectively and quickly than without specialized software and forge their own future of drug development.