From Aspirin to AI: Revolutionizing the Drug Approval Process

Synopsis:

• SS&C Blue Prism clients are exploring deep automation and Generative AI (Gen AI) capabilities to more effectively and efficiently manage compliance while delivering better business outcomes
• It currently takes nine to 12 years for an average drug to gain regulatory approval – from discovery to government approval and appearing on the shelf. Terabytes of unstructured source data, generated and consumed at each stage of the process – from emails and phone calls to fax, chat, or text messages – must be recorded and digitally stored
• SS&C Blue Prism’s automation and orchestration technology combined with Gen AI can sort unstructured internal and external data from suppliers and vendors, safeguarding compliance for regulators or government departments that may require data at a moment’s notice.

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Byline:

Some of the biggest pharmaceutical companies in the world have been using business process automation and orchestration in recent years to support their digital transformation strategies and turbo-charge operations.

COVID-19 was a great example of this, putting automation into the spotlight and demonstrating the art of the possible when it came to speed and accuracy of delivery.

It’s clear that strong foundations have been laid in using robotic process automation (RPA), with traditional AI capabilities being embedded within processes for added intelligence and higher return on investment (ROI). However, with the recent advent of generative AI (Gen AI), the prospects are vaster than ever.

With so many opportunities on the table, we’re working with leading pharmaceutical companies to identify processes that are ripe for innovation using Gen AI.

The drug approval process is just one of those powerful use cases yet to be capitalized on, as we offer a glimpse into how Gen AI could spur further innovation across the industry.

The task ahead

Pivotal in the life saving prevention of cardiovascular disease, aspirin is the most commonly used drug globally, seeing some 100 billion tablets sold worldwide. But have you ever considered what goes into researching wonder drugs that help manage everything from cancers to COVID-19?

It takes a total of nine to 12 years for an average drug to gain regulatory approval in the med and biotech industries. This includes discovery, testing, clinical trials, government review and finally appearing on the shelf.

At each stage of the process, every single discovery, note, email, research paper and communication must be recorded and digitally stored.

This process is even more important during clinical trials and when the drug is in everyday use. Any adverse patient event must be recorded and reported in a timely manner by the pharmaceutical company, healthcare provider or pharmacist in compliance with regulatory requirements, with high severity events mandating government authority notification. Forever.

That’s terabytes of unstructured source data that must be easily accessible and available to regulators or government at a moment’s notice if required.

Reputational loss and human error

The pharmaceutical industry is one of the most highly regulated industries in the world, where transparency and traceability is vital, and human error the biggest enemy.

For global brands producing well-known products and devices worldwide, and employing thousands, failure to meet regulatory requirements or legislation will result in financial and reputational loss in the billions.

But isn’t AI and machine learning only as good as the data it trains on? And isn’t it a massive risk to leave huge decision making up to a technology in its infancy?

Traditionally, you need hundreds of people to manage the data capture process and exception handling – a mechanism separating abnormal data results – but relying completely on humans opens up the process to errors.

Managing this on a 24-hour basis is challenging, especially since supplier queries are often unpredictable and ad-hoc.

Here, the combination of Gen AI can be an invaluable tool as it has the ability to quickly sift through unstructured internal and external data – such as emails, phone calls, fax, chat, or text messages – from suppliers and vendors and garner insights. This constant communication can be effectively managed with the aid of AI, ensuring timely and accurate responses.

When governments want you to ‘prove it’

This Gen AI-driven approach is not limited to the initial stages of processes like drug discovery. It can extend beyond clinical trials to the everyday use of approved drugs. Ensuring comprehensive coverage and continued understanding and evolution throughout the lifecycle of a drug is crucial, and aids in maintaining consistent quality and compliance.

When deciding where Gen AI will have the most impact, it’s important to be aware that it isn’t limited to just one stage of a process. For example, digital workers (DWs) can provide versatile support in highly regulated environments. They can interact seamlessly with various systems, handle data collection, provide exception handling, and ensure human oversight when necessary. This flexibility is essential for regulatory compliance and process auditability, especially when government regulations require detailed reporting.

In the pharmaceutical industry, adverse event reporting is a critical and highly regulated process. Reports can come from various sources like emails, phone calls, or electronic forms. These reports need timely and accurate processing to ensure patient safety. We’re looking at Gen AI to integrate seamlessly with existing systems to automate this process. It could extract relevant information from reports, interact with regulatory bodies such as the U.S. Food and Drug Administration, and log every step for compliance.

Also Read: Taking Advantage of Gen AI With Next-level Automation

This automated approach could offer significant benefits: speed, accuracy, and scalability. Digital workers perform repetitive tasks without errors, ensuring that reports are processed quickly and accurately. This is particularly important in industries where delays can have serious consequences.

Gen AI also supports multimodal capabilities, handling various types of data like text, images, and even audio. Digital workers are versatile and work with screens much like humans can, but also work with Application Programming Interfaces (APIs) and human inputs so captured data is more easily tracked and reported on, which is important when it comes to instant auditability. This broadens the scope of automation, allowing for more comprehensive solutions.

Digital workers can enhance transparency and traceability, crucial for industries with stringent regulations like pharmaceuticals. They can ensure that every step of the process is logged immutably, allowing for complete end-to-end traceability. This will be vital for audits, enabling companies to provide detailed records of all actions taken during a process.

Should a government or regulator say ‘prove it’ when examining a process, digital workers would be able to do that and provide regulatory compliance.

Beyond the humans-in-the-loop

COVID-19 demonstrated that with pandemics, pharmaceutical companies don’t have decades of time to spot anomalies – exception handling – within terabytes of data.

In scenarios like this, the value of Gen IA and Intelligent Automation (IA) is in its power to rapidly source and provide data, so the industry is better able to manage and respond faster to supply control issues and governance.

Additionally, by using Gen AI and DWs, firms could also reduce time-to-market for pharma products and improve transparency in their research, by searching and sourcing unstructured text, paper and voice data that come through various channels. This will not only safeguard patients but also protects the reputational and financial standing of organizations in a highly competitive and regulated market.

The use of Gen AI and digital workers can provide robust solutions for managing complex and regulated processes to enhance efficiency, accuracy, and compliance, revolutionizing its research and development capabilities.

By leveraging a “physician persona” within the Gen AI platform, the pharma industry could also accurately classify adverse events more quickly, provide control and governance, and create personalized responses to patients or healthcare providers at scale.

Safeguarding the future

Integration of advanced technologies like Gen AI into the pharmaceutical industry will mark a significant evolution in managing regulatory compliance and operational efficiency.

Across multiple industries from healthcare and finance to retail, adopting Gen AI-driven solutions into your operations can ensure your processes are not only efficient and scalable but also compliant with stringent regulatory requirements.

By revolutionizing data management and regulatory compliance, human error and outdated processes also help you lead next generation innovation.

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