Industry Viewpoints: Digitizing Clinical Manufacturing

12th October 2018 (Last Updated December 3rd, 2018 10:06)

Clive E. Badman, OBE, talks to CTA’s Charlie Abrines about the digitization of the clinical supply chain

Industry Viewpoints: Digitizing Clinical Manufacturing

Having been involved in the pharmaceutical industry for the last 30 years, Clive Badman, OBE, believes the current hot topics in the clinical trial supply chain center around digital manufacturing, both in commercial and clinical drug production. Furthermore, he feels it’s imperative future clinical trials are patient centric in their nature.

In this Industry Viewpoint, Badman sits down with CTA’s Charlie Abrines about the increase in digitization and precision medicine. He explains how their overall effect will make drug supplies more efficient, lowering the costs for both pharmaceutical companies and patients paying for their medication.

Charlie Abrines: How has manufacturing been carried out in the past, and what is the benefit of digitalizing this?

Clive Badman OBE: Manufacturing has traditionally been carried out on a paper-based system, which has always been prone to human error and requires more manpower than a digitized system. By automating manufacturing, the industry would be able to aggregate data in a way that would allow supply professionals to look at it retroactively and apply findings into current supply strategies. This can potentially reduce errors and minimize overall wastage.

However, from a data integrity perspective, digital manufacturing would enable companies to collate all of their information into one central point. That can then be used to ensure supply drugs are compliant with local regulations when comparing these to national databases.

CA: Are there any issues preventing the application of digital manufacturing?

Badman: The main issue preventing the digitization of drug manufacturing is the fact that, currently, the multiple systems used by companies are not synchronized. This means that they are unable to work with one another.

Therefore, the first step in moving drug supply from paper towards the cloud is by ensuring that all internal systems are integrated in such a way that seamless communication between these can be achieved. System harmonization is vital for the industry applying current technological innovations within its internal processes and making their supplies more effective.

CA: How can digital be applied to patient centric trials?

Badman: With regards to patient centricity, digitization has its own role to play here. For instance, diagnostic technology can improve the success rates of clinical trials by targeting and selecting patients much more accurately than current recruitment strategies.

By using technology to do this, the industry would be able to minimize the large quantity of clinical trial products that fall on the road to market because they fail the clinical trial. This is largely as a result of not being specific enough to the sample patient group they are seeking to cure.

Consequently, by making trials more specific to the patient’s needs, companies would be able to minimize the loss on their investment, while at the same time improving the success rates of their drugs and ensuring more patients are cured.

CA: Does this digitization have a benefit for consumers and trial participants?

Badman: Given the rising cost of health care in developed countries as a result of an aging population and the increase in chronic illness, it’s paramount to reduce the overall costs of drugs. By digitizing the manufacturing process and ensuring trials are more effective, a country’s health care bill can become less costly. Likewise, by being able to target patients in a more personalized way, national health care systems, such as the NHS, would be able to ensure patients are treated with the correct medication from the onset.

By doing this, general practitioners can ensure patients are cured quicker and therefore removed from the system swiftly and effectively. This could potentially lower wait times at local surgeries and reduce the overall costs by ensuring patients are prescribed the correct medication upon their first visit. By administering medicines in this more precise and targeted manner, the currently overburdened system can be eased and made more effective both for tax payers and patients alike.