Integrating API – Not limited to drug development

Integrating Active Pharmaceutical Ingredient (API) program into drug discovery and drug developmentBoth drug discovery and drug development are critical to the identification of novel medicines that may at one point in the future have a significant impact on global health. There are many variables that go into the processes, such as the defining of biological properties of the compound lead, and so it is essential that both phases are carefully executed, so as to reduce late-stage attrition and facilitate successful preclinical and clinical development.

API is not limited to the drug development phase in any sense - it can just as easily be applied to the drug discovery process. When a drug lead is identified, the molecule is synthesized to undergo an array of analyses. These will include target validation, metabolic profiling and of course, early-stage toxicity testing. Working to fully integrate your API strategy in the drug discovery part of the process can allow you to reap the benefits of the resulting integrated team and enjoy access to a wider range of skills, expertise, and experiences that can take a lead through to clinical trials and beyond.

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Integrating your API strategy

Integrating your API strategy can also provide the added benefit of reducing the timeline of the process. This is in part due to the fact that starting your API development strategy early can negate the need to repeat confirmation and validation steps. This is no small matter, as the reduction of timelines should be aspired to where possible, as this can lead to a healthy reduciton in costs and resources required.

In addition to this, adopting an integrated approach can have a low project management demand becuase all of the overseeing in both the drug discovery and development processes can be undertaken by the same project manager. This has obvious benefits in allowing a far smoother transition between the two processes which can be distinct. As ever, some companies will look to outsource, using a CRO for example. If this is the case, there are obvious benefits in terms of undertaking research into which partners have the expertise, facilities, and capability to support you throughout your discovery and development programs.

Multidisciplinary teams that are within the same facility with access to the same in silico, in vitro, and in vivo technologies are ideal. This is becuase these shared facilities can allow teams to take a truly collaborative approach, with the added benefit of having reduced project management and greater flexibility compared to when teams working together from various facilities.

In this way, integrating API into program can help reduce timelines and cost and can also add value to your IP and company. This strategy can be hugley beneficial if you are looking to sell your drug lead at the end of the discovery process, or if you plan to take your candidate through the necessary next steps yourself. As ever, ensuring your work with the right people, the right facilities, and the right expertise can help the drug discovery process to move along more smoothly.

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