Post-pandemic, the global pharma industry has expedited its digitalization efforts

Digitalization is significantly transforming the pharmaceutical industry, impacting various aspects of drug discovery, development, manufacturing, distribution, and patient engagement. Similar is the transformation in healthcare as patients are now more invested in their own health as much more information is readily available about various conditions and treatment options. The Covid-19 pandemic devastated the global economy, but in the process also struck a massive blow for digitalization, bringing all the fence-sitters firmly on the transformation bandwagon. So what exactly has changed? What are the key digital technologies that are driving the transformation of the pharmaceutical supply chain?

Sunil David, Digital Technology Consultant, lists some of the key digital technologies that are driving the transformation of the pharmaceutical supply chain as the Internet of Things (IoT), Analytics and AI, Cloud, and Blockchain, which can now be powered by high speed and low latency networks like 5G. “Supply chain improvement (both upstream and downstream supply chains) is one of the key requisites for pharmaceutical companies to ensure quality and availability and thus minimize losses. Also, the major challenge of counterfeit and spurious drugs, which account for more than 10% percent of drugs sold in low and middle-income countries, necessitates the use of Digital technologies to be able to counter it. As per research by Digital Supply Chain Institute, Digitising the supply chain has the potential to increase revenue by 10% across sectors. Covid-19 brought in significant focus on supply chain security and hence the need to diversify risks, improve track and trace, and optimize the whole process, from procurement and manufacturing to supply and distribution becomes extremely critical,” says Sunil.

“One of the challenges during Covid was in the supply chain and this drove the need for implementation and improvements in the supply chain. Supply chain planning and scheduling is key digital technology that is integrated to warehouse and transportation management technologies,”says Janice Abel, Principal Consultant, ARC Advisory Group. “Advanced analytics and AI are being built into and even embedded in these technologies so that the technology recognises changes and makes predictions for the workers so that they can quickly adjust to the changes. Track and trace is either a separate part of this solution or included with the solution because companies must be able to trace the product to the pharmacy or even the consumer to prevent any type of abuse,” she explains.

Dr Nivash Jeevanandam, Senior Researcher and Author, INDIAai, cites a report that predicts India's healthcare and pharmaceutical industry could reach USD 450 billion by 2047, but for that it must integrate into the global pharmaceutical supply chain, conduct value-driven research and innovation, and ensure sustainable and equitable healthcare access for all. According to him, several digital technologies are changing the pharmacy supply chain in a big way.

These include:

1. Blockchain: This technology allows for keeping safe, unchangeable records of all trades and product movement along the supply chain. It also makes it easier to track and see what's going on.
2. Internet of Things (IoT): IoT devices like sensors and RFID tags monitor temperature, humidity, location, and other environmental elements that could affect pharmaceutical product quality during shipping or storage.
3. Artificial Intelligence (AI) and Machine Learning (ML): These tools are used to make decisions, analyse data, and make predictions. AI and machine learning algorithms help manage inventory better, guess demand, find patterns, and even find and create new drugs.
4. Big Data Analytics: This method processes massive amounts of data from multiple supply chain sources to improve decision-making, prediction accuracy, and process efficiency.
5. Cloud computing: Cloud-based solutions make it easier for partners and locations to exchange, collaborate, and access data, improving pharmaceutical supply chain connection and scalability.
6. Augmented reality (AR) and virtual reality (VR) are operations, repair, and training technologies. They can help train people to do difficult jobs and make data and processes easier to understand in the pharmaceutical supply chain.
7. Robotics and Automation: Automation technologies simplify creating, packing, and distributing goods, reducing errors, increasing efficiency, and ensuring compliance.

“In the intricate landscape of the global pharmaceutical supply chain, countering counterfeiting and navigating regulatory intricacies are paramount challenges. Maintaining optimal temperature for sensitive products and ensuring timely access to medications further amplify the complexity,” says Vimal Manchanda, Chief Operating Officer, Samvardhana Motherson Health Solution Limited (SMHS). Companies recognise the imperative of building resilience and adaptability into their supply chains, responding to evolving dynamics. Digital technologies play a pivotal role, with blockchain combating counterfeiting, IoT and sensors ensuring temperature control, and AI enhancing visibility and efficiency. Advanced analytics, powered by AI, refine inventory management, mitigating risks of shortages or overstocking and minimising expiration concerns. Machine learning and AI modelling delve into process mining, addressing regulatory complexities with precision, ushering in a new era of pharmaceutical supply chain management.

One of the critical issues in the pharma industry is the painstakingly slow process of drug development even as patients with serious ailments are awaiting more effective treatment. The slow pace is further exacerbated by the regulatory compliances and other procedural wrangles, which do not help. Against this background, how are pharmaceutical companies leveraging data analytics and artificial intelligence for drug discovery and development?

“Pharmaceutical firms in the US have been leveraging a number of digital tools for various R&D activities, such as target identification and validation, lead identification, and use of AI models for clinical trial activities such as trial design, patient recruitment, predicting outcomes, and analysis. However, in India, while there is awareness around the benefits of digital technology solutions within the R&D function, adoption of technologies such as AI/ML is at an early stage,” says Sunil David. According to him, information management tools, collaborative tools, automation, data aggregation and analytics, AI in pre-clinical research for ligand identification, drug discovery and repurposing are some of the use cases that will see traction. “Since there is a lot of buzz around Generative AI of late, I wish to highlight the role of Generative AI in drug discovery and development. Generative AI in drug discovery offers a number of advantages that have the potential to revolutionise the pharmaceutical industry. These are reshaping the drug discovery process and accelerating the development of new treatments,” he elaborates.

Janice Abel believes data analytics including AI are being embedded into almost all digital technologies including drug discovery and development to help eliminate toxic raw materials or chemicals (including additives) from new drugs, eliminate duplicate drugs, assays to improve consistency and quality. “Most companies have a toxicity database that they have developed. There is a move for a universal toxicity database to leverage previous research & development and accelerate drug development. Some companies do not want to share their toxicity information because they believe it is their IP and have spent a lot of R&D funds developing their toxicity database and believe that by sharing their database it would make them less competitive. Another use of analytics in R&D is to eliminate duplicate drugs so that new drugs are more effective or less toxic,” says Janice.

Apart from the complex regulatory environment, the pharmaceutical industry also has issues to deal with like legacy systems and infrastructure, cultural and organisational matters that resist change, cybersecurity concerns, and above all, the reluctance to commit resources. What challenges do pharmaceutical companies face when implementing digital transformation initiatives, and how can these be overcome?

“Yes, there are numerous obstacles that pharmaceutical companies must surmount before implementing digital transformation," says Dr Nivash Jeevanandam, who also believes these can be surmounted through proactive and strategic planning. Some significant obstacles, according to him are:

• Data security and privacy issues complicate patient data management and HIPAA compliance – the Health Insurance Portability and Accountability Act (HIPAA) that sets the standard for sensitive patient data protection
• Pharmaceutical organisations frequently possess pre-existing legacy systems that may present challenges regarding seamless integration with contemporary digital solutions
• Regulatory compliance can present intricate challenges, as it necessitates the adherence of digital initiatives to standards such as Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP)
• Organisational resistance to change can hinder digital transformation initiatives, and
• Capital outlays for infrastructure, personnel, and continuous upkeep that are difficult to reconcile, particularly for smaller pharmaceutical companies.

According to Vimal Manchanda, as industries surge towards digital transformation, a myriad of challenges emerge on the path to harnessing the full potential of technology. “Critical prerequisite for digital transformation is Master Data Management (MDM), which stands as a linchpin in the realm of digital transformation; businesses are still struggling to build and maintain complete and accurate data across all touch points. Integrating new digital systems with existing infrastructure or equipment/instrument proves a complex task, raising concerns about interoperability challenges, security, and downtime. Employee skill and competency and further resistance to change become pivotal, demanding effective change management strategies to handle technological unfamiliarity. A strategic approach, encompassing thorough forward-looking planning, determining business values, continuous employee training, and collaboration, empowers businesses to successfully navigate the complexities of digital transformation, unlocking avenues for growth and innovation,” he explains at length.

At the height of the Covid-19 pandemic, the biggest concern was the risk of spreading the infection through direct contact. That is when telemedicine came to the fore as the saving grace. The pandemic is now almost forgotten, but telemedicine is here to stay. How is the adoption of telemedicine and digital health platforms influencing healthcare delivery in the pharmaceutical industry?

“There are still many parts of India without proper medical facilities and infrastructure. In such a setting, technology can play an enabling role, particularly in reaching out to the remotest of towns and villages and offering a greater standard of care at low costs. Telemedicine, which is the method of treating and diagnosing patients remotely through communication networks, has picked up significantly,” opines Sunil David. “Telemedicine has tremendous potential to greatly affect public health. The Covid-19 global pandemic clearly highlighted the need for strong primary healthcare networks for a more effective public healthcare response and delivery during health emergencies and exposed the fragmentation of current healthcare delivery systems. In the post-Covid-19 environment, telemedicine offers the potential to get through the enduring barriers to access primary care in India, such as a shortage of qualified medical professionals, issues with access, and the high cost of in-person care. Telemedicine has the power to speed up the delivery of universal health coverage and in the process strengthen primary care,” asserts David.

To Janice Abel, Covid also led to an advancement and acceptance of telemedicine using digital health platforms. The ability to have telemedicine makes healthcare more accessible to people in remote locations, or in situations where they could not obtain healthcare previously. “Having a digital health platform is an enabler for the provider whether for telemedicine or in the office,” she says.

Once pharma companies embrace digitalisation, several things happen like digitising of records, systematic collection and storage of data and more effective utilisation of the accumulated knowledge through real time data analysis. So how is digital transformation impacting the pharmaceutical industry's research and development (R&D) processes?

“R&D procedures of the pharmaceutical sector have been significantly impacted by digital transformation,” says Dr Nivash Jeevanandam. As example, he cites how the target identification and validation process is facilitated through advanced analytics, which examines biological data from diverse sources. It enables the comprehension of disease mechanisms and the identification of the most prospective drug development targets. “Digital transformation has revolutionised pharmaceutical R&D by improving stakeholder participation, accuracy, and efficiency. This method has greatly reduced costs, accelerated medication research and development, and enhanced quality,” he emphasises.

According to Janice Abel, digital transformation is involved in automating research and development particularly in clinical trials. However, the biologics processes have not caught up with automation as yet. “For example, at ARMI – which is Advanced Regenerative Manufacturing Institute in the US – their R&D and clinical trials areas have automated many processes include producing raw materials for the biologists, but the problem is that they have not determined the biologics yet to produce, although they are almost there – a new pancreas or liver. They have automated the process of producing personalised skeletal and ACL tissue using Rockwell Automation technology, so it is just a matter of time before all R&D are almost as automated as production. Other companies like AspenTech and Siemens are also advancing their automation technologies into R&D,” she elaborates.

Finally, what regulatory considerations and compliance challenges do pharmaceutical companies encounter during their digital transformation journey?

“There are quite a few challenges that pharma companies encounter as they progress on their digital transformation initiatives,” says Sunil David. He lists them under different heads such as: legacy systems and infrastructure; leadership, cultural and organisational resistance; data management and back end system integration; complex regulatory environment; cybersecurity risks; and concerns over return on investment. For example, pharmaceutical companies must invest in advanced cybersecurity systems and protocols to safeguard their digital infrastructure. “Notwithstanding these challenges, pharmaceutical companies have to recognize and realize the importance of digital transformation to stay competitive in the ever-evolving healthcare landscape as adopting digital technologies is a strategic necessity. They should actively invest in technologies such as IoT, AI and Analytics, Cloud, and 5G to drive innovation, improve patient care, and streamline the overall value chain process,” suggests David.

 Acknowledging the multitude of challenges, Dr Nivash Jeevanandam believes pharmaceutical companies can take several measures to address these challenges. These measures include collaboration with regulatory bodies by early engagement with them to gain insight into compliance obligations and solicit guidance; perform exhaustive risk assessments to detect regulatory deficiencies or compliance concerns in digital endeavors; establish and execute resilient compliance frameworks; implement measures to ensure that personnel are adequately informed about regulatory standards, data security, and privacy to comply with compliance obligations; and collaborating closely with legal and compliance specialists with expertise in healthcare and technology is advisable to guarantee strict adherence to regulations. “Effectively managing the regulatory environment amid digital transformation necessitates a proactive stance, cooperative efforts with regulatory entities, and an unwavering dedication to sustaining conformance throughout the transformation process,” he recommends.

“The regulatory agencies expect digital transformation in the pharmaceutical industry to elevate regulatory standards, operational efficiency, and innovation. Emphasizing data integrity and security, these agencies encourage the adoption of electronic submissions, reinforcing transparency and traceability,” says Vimal Manchanda. Central to these challenges is the imperative to safeguard data security and privacy in adherence to regulations like HIPAA and GDPR. Regulatory compliance in digitalized clinical trials demands meticulous adherence to Good Clinical Practice standards. “The validation of digital systems, from software to algorithms, becomes a complex process requiring alignment with guidelines such as GAMP. Electronic documentation introduces challenges in meeting regulatory expectations for electronic signatures, data integrity, and audit trails. Adhering to Good Manufacturing Practice (GMP) is vital in the digitalization of manufacturing processes. Change management and training pose compliance challenges, emphasizing the need for personnel competency. Addressing these challenges demands a comprehensive strategy to harmonize digital transformations with pharmaceutical industry standards and regulations,” concludes Vimal Manchanda.