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March 6, 2020

It takes on an average at least between a decade and a decade-and-a-half for a drug candidate ideation in a lab to make it to the market. This extended timeline has various reasons, with regulatory feedback loop being a critical one.

Underpinning every stage – from devising strategy, development of product, recruiting patients to making the drug cost-effective and getting approvals from regional as well as federal food and drug administrative bodies – the regulatory affairs (RA) personnel are constantly sought for their inputs.

The RA teams offer inputs at every step in the process workflow to ensure compliance and right-the-first-time filing. Their daily tasks including submissions, preparing responses to authorities, strategic decisions, and analysis to name a few are highly time-consuming and are heavily dependent on human aptitude. In this climate, expediting the drug development lifecycle begins with alleviating the burden of the RA teams. This is where AI-enabled digital avatars are proving to be true game-changers in reducing the turnaround time as well as reducing the dependence on human aptitude.

What is a Digital Avatar?

The idea of a digital avatar is inspired by digital twins, a technology that is widely discussed in different forums. A digital twin is a digital representation of a real-world entity or system. The implementation of a digital twin involves an encapsulated software object or model that mirrors a unique physical object. Gartner predicts that by 2021, half of the large companies will use digital twins, resulting in these organizations gaining a 10% improvement in effectiveness. Digital avatars are conceived to be different from digital twins in the only aspect that the digital avatar is a replica or shadow of the physical entity. Here, data is seamlessly transferred from the physical entity at the will of the physical entity to the digital avatar but not vice versa.

There is huge potential in deploying digital avatars for different aspects of regulatory processes. These avatars may engage with the advice-seekers/specialists through simple communication models or as smart bots or virtual assistants by utilizing AR/VR/MR technologies to enhance the user experience.

A Chemistry Manufacture & Controls Digital Avatar in Action

When a company decides to market a product - already sold in the US - in Brazil, the users can consult the Chemistry Manufacture & Controls (CMC) submission type digital avatar. This will help glean the possibility of using the CMC information of the US application for marketing authorization application in Brazil. Here, the digital avatar will be able to respond to the user after analyzing and validating the available information from the US submission with guidelines for Brazil. Based on this assessment, the digital avatar can recommend if stability studies for the product are to be carried out again in zone IVB (hot and very humid condition) conditions as per ICH Q1 guidance, because the stability data in the US application is as per zone II (sub-tropic condition). The AI-enabled digital avatar may also predict the possibility of the product meeting the attributes during the stability studies in zone IVB condition through analysis and extrapolation of existing data. This analysis will enable better decision making for the organization within limited time and lesser dependency.

The ability of the avatar to comprehend and analyze the situation and respond accurately to a specific situation using AI algorithms sets it apart from a database-based FAQ kind of simulation. The advanced AI and continuous learning algorithms account for a system that can identify complex solutions by evaluating the data and drawing inferences from the information available.

Leveraging digital avatars in RA can bring parity and consistency in review, as approaches and knowledge may vary in the case of human cognizance. Some of the benefits include:

  1. Reducing the time required to train and develop human resources
  2. Optimizing the bandwidth of resources so that they can be dedicated to core RA activities
  3. Enabling teams to have real-time, quick, and accurate assessments with less latency

Additionally, significant business benefits can be achieved by leveraging AI/AR/VR- or virtual-bot-enabled digital avatars. It can help bring consistency in quality, reduce cost and time, and cut overall efforts from the regulatory specialist by at least 20-30%. This in turn would help accelerate the travel time of a molecule from the laboratory to the patient and support maintenance of life cycle of the product.

The Road ahead

Digital avatars and related technologies are expected to find significant application in regulatory affairs by 2025. In essence, digital avatars will be a grand gesture for pharmaceutical companies in the effort to align with the needs of the Business 4.0 era. Down the line, more advanced analytics can be embedded to the avatars by integrating knowledge spheres to reduce the dependence on human proficiency at various levels. The immense automation and intelligence capabilities of the digital avatars can help drive exponential value for the life science industry.

Sudip has over 14 years of experience in the pharmaceutical and life sciences domain. He holds a Post Graduate degree in Pharmacy and has worked with parent as well as consulting organizations over the years. He also has a rich experience in regulation and quality domains. Sudip has participated in various regulatory submissions as well as regulatory compliance activities across the globe.


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