The pharmaceutical industry has been relatively slow in embracing digital technologies, but it’s possible to work around these and leverage digital technologies for optimised costs, increased productivity, and business innovations, says Joseph Kiran Kumar, Director & Head IT & HR, Eisai Pharmaceuticals India Pvt Ltd.
The pharmaceutical industry is facing challenges on multiple fronts today. Research and development is the core of any pharma company as it enables drug discovery. However, the industry has seen a drastic decrease in R&D ability in the recent past. “Some of the reasons include the increased costs of bringing the drug to market, no reduction in the time taken to commercialise and uncertainty around the success of the product,” says Joseph Kiran Kumar, Director and Head IT and HR, Eisai Pharmaceuticals India Pvt Ltd. There are also compliance issues, “especially the ones related to data integrity are causing heavy inflictions.” Then there are barriers with respect to organisational culture, strategy and customer orientation. Many companies are risk averse and some work in silos with little or no customer connect. Joseph observes that these are the key issues that have impeded digital transformation in the pharma industry.
“The pharma industry is a slow adopter of digital technologies and this is due to the industry’s cautious approach in adopting new technologies,” he says. “One of the probable reasons are the stringent regulatory requirements that companies have to adhere to, which they feel would be compromised when using digital. An organisation’s culture also plays a critical role in innovation. Sometimes the organisational structure doesn’t support initiatives, especially in the realm of digital transformation, therefore somewhere the whole initiative gets diluted.”
While compliance seems like a hurdle to any kind of transformation, it is one of the important pillars on which the pharma industry rests and any transformation initiative has to deal with it, as ever-evolving regulatory requirements are there to stay. “Transformation should cross the hurdle of compliance like any other hurdles it faces, such as budget, scope and fear of change, to be successful in pharma,” Joseph says. “Regulatory requirements cannot be compromised upon and therefore transformation should ensure there is compliance to standards, like 21 CFR Part 11, so that there is positivity among the industry to adopt digital transformation.” But then, Joseph points out, “pharma companies should also do their bit by realigning their compliance goals with the needs of the organisation.”
Joseph is keen on the adoption of digital technologies to overcome the most pressing business challenges. He believes R&D productivity issues could be solved with the infusion of new technology. “Artificial intelligence could really help in repurposing drugs or speeding up clinical trials and bring in some predictability to ensure the molecules in research are successful,” he says.
Similarly with compliance, he says, “technology solutions should be dynamic to ensure that compliance to regulatory requirements and good manufacturing practices are met at all times. AI-driven systems, which self-learn and evolve with the change in requirements, are the ones that will be embraced by the industry.”
“Many pharma companies embrace digital only when their peers do so,” he says. “Digital is considered more at the execution level and therefore not much thought is given to it while defining an organisation’s strategy. Including digital in the organisational business strategy is a must. It is important to set up centres of excellence pertaining to digital so that there is a place for ideas to be incubated and solutions derived.”
Joseph believes that until companies adopt a progressive and collaborative mindset it is impossible to change perceived risk. “Companies should make a conscious effort to share digital roadmaps with regulatory agencies for better understanding and to give them the assurance that digital solutions are compliant with regulatory requirements as well.”
At Eisai Pharma, where Joseph is leading digital transformation, he focused on the adoption of various digital initiatives in the pharma space so that stakeholders mustered enough confidence in adopting them. He also engaged all stakeholders in evaluating various vendors so that they were part of the initiative from the beginning. He says Augmented Reality (AR) and Virtual Reality (VR) solutions are making waves in the life sciences space. “We too had an AR-based solution to provide clinical information to doctors. This solution acted as a gateway for information and they were able to access it from various databases from across the world. VR can be used to impart training in various process areas in manufacturing and we are currently working on it.”
Joseph is of the view that four critical technologies will drive innovations within the pharma sector going forward. These are AI, IoT, AR, and Blockchain. “AI-based systems are going to help companies cope with the marketplace demand, in terms of how quickly they will be able to deliver products. AI is going to influence R&D in a big way by reducing the time in drug development processes.”
“IoT is revolutionising the way manufacturing will be carried out on the production floor. IoT systems can drive efficiencies through their ability to control, manage, and supervise operations remotely. They would be very handy in areas where it is hazardous for humans to work and in predicting the issues pertaining to equipment. When these issues with equipment are diagnosed early there are fewer disruptions to production.”
“Augmented reality has the potential to link all the stakeholders in the pharma value chain. For example, with augmented reality it is possible to interface with health care professionals to provide them with the data they require or to patients themselves who could use AR to access the information that would of use to them.”
“Blockchain,” points out Joseph, “could help improve the supply chain security, which is a major challenge today. Robustness of blockchain technology would enable companies deal with counterfeit drugs.” While there are hurdles to be overcome, digital technologies have the potential to make the industry more cost competitive and efficient, he sums up.