Digital Technology Week: Digital technology adoption in pharmaceuticals as a precursor for regulatory affairs

In this second part of the digital week series, we review the current adoption of technology in pharmaceuticals to explore the potential direction of travel within regulatory affairs.

As previously discussed, digital technology adoption has occurred more quickly in manufacturing and financial services but is also being applied in the healthcare sector.

Digital Technology's Role in Drug Discovery and Development

Digital technology's effectiveness hinges on the availability of robust datasets, influencing progress within the pharmaceutical industry. AI is used to trawl big data to recognize and learn patterns through various methods:

Through machine learning, protein modeling can be performed using algorithms that do not require human intervention or explicit instructions and can process vast amounts of data.

Once a potential model is generated this can be tested through what are known as generative adversarial networks (GANs), which can distinguish real data from fake data to optimize molecule design and desired properties.

Neural networks are also being used for predicting features for drug target interactions and assessing drug similarities. So modelling and design of potential therapies are rapidly accelerated versus conventional means.

In diagnosis convolutional neural networks (CNNs) are mainly used for computer vision or image classification and have been implemented for the diagnosis of diseases, such as cancer. These are more accurate than human interaction.

Insilico medicine has used digital technology to identify specific disease inhibitors in days rather than years, thus enabling drug candidates to be used in the clinic way ahead of what was possible in the past. This exciting development has the potential to revolutionize disease targeting.

Target selection has been used by companies such as Exscientia to develop precision medicine based on AI-driven platforms that examine patient data at a cellular level. Precision medicine benefits the patient through specifically developed therapies likely to be more effective and reduce the potential for side effects.

The last example in this section is the use of AI to analyze existing datasets for ‘reusing’ licensed medicines for alternative uses. Psychogenics is a company that uses AI-driven predictive phenotype modeling to show the potential of specific compounds in a range of disease areas based on behavioral signatures.

New ways of identifying potential therapies can only benefit patients in ways that are only possible through the ability to analyze and characterize data through emerging technology.

Clinical development as an indicator of change for regulatory

As a significant element of the regulatory submission, clinical development and its associated data have always been a challenge for pharma companies.

This is through vast quantities but also disparate data sets, often existing in paper hard copies. Capturing and managing, let alone harnessing such data has been an increasing need in recent times as technology advancement has continued.

AI algorithms, combined with an effective digital infrastructure enable a continuous stream of clinical trial data to be cleaned, aggregated, coded, stored, and managed. This improved electronic data capture (EDC) also reduces the impact of human error in data collection, often through live patient monitoring and mobile technology.

Networked systems facilitate seamless integration across databases and systems and emerging AI techniques are therefore able to analyze and correlate many different data sources. Whilst still in its infancy, organizations are seeking to employ enormous datasets to increase the speed of therapies to patients and save development capital in the process.

The big question for companies though is addressing potential bias within AI algorithms to ensure the ‘right’ answer is provided.

Patient-centric advances have come through the performance of internet-enabled devices (IoT) now leveraging mobile technology, cloud-based solutions, and analytics as never before. This streamlines efforts, enhances compliance, and significantly improves the patient experience.

How might this impact regulatory affairs?

Whilst the manual, document-heavy (even paper) processes in regulatory affairs remain largely unchanged, data management and the changes in clinical development and areas of pharmaceuticals indicate how the profession may need to adapt in the future.

For instance, efforts are underway to structure content for automation and data management, offering a precursor to the implementation of digital technology.

There are opportunities to align regulatory practices with advancements seen in other industries and make the process of submission preparation and assessment more streamlined.

This will be covered in detail in our concluding article.

However, the regulatory affairs professional has to be versed in the advancement of technology and how this is impacting the drug development processes as this must be captured in submission preparation and Health Authority dialogue.

Conclusion

While the pharmaceutical landscape has been characterized by manual processes, ongoing initiatives signal a significant stride toward a more streamlined and efficient regulatory environment.

In conclusion, the evolving landscape not only presents challenges but numerous opportunities for the pharmaceutical industry to meet the evolving needs of patients.

How we are addressing digital technology at G&L

At G&L Healthcare Advisors, we are committed to staying at the forefront of innovation in the provision of our industry-leading services.

We provide regular learning sessions to navigate the evolving tech landscape, dispel myths, and foster a better understanding of its impact on regulatory affairs.

We have a dedicated technology group tasked with identifying, testing, and validating the use of digital tools that will help our staff and clients.

We are undertaking trials with technology specifically targeted at regulatory affairs applications. It is important to focus efforts on technology with impact rather than the next shiny new thing!

We will continue to educate our teams and clients alike as we believe that the narrative of technology in our profession should be developed.

Get involved!

We would like your thoughts and perspectives in this area. Are you keen to see regulatory affairs transformed by digital technology? Or are you skeptical of the perceived benefits? How do you believe the industry will change? For the better or worse?

For more information visit our website or arrange a call with one of our experts.

Paul Kuiken is Vice President of Advisory Practice at G&L Healthcare Advisors.