Industrial Automation Magazine India

The healthcare and pharmaceutical sectors are attractive targets for cyberattacks

Published on : Monday 04-12-2023

Sunil David, Digital Technology Consultant.

What are the key digital technologies that are driving the transformation of the pharmaceutical supply chain?

Some of the key digital technologies that are driving the transformation of the pharmaceutical supply chain are Internet of Things (IoT), Analytics and AI, Cloud, and Blockchain and these can now be powered by high speed and low latency networks like 5G. The key areas where these technologies can find  relevance is in: 1) Building a digital supply chain with end to end visibility and thus work on enhancing resilience; 2) Supplier marketplace solutions; 3) Data driven predictive insights for demand management; 4) Track and trace using AI, IoT and Blockchain to prevent delays and wastages; 5) Digital innovations for building control towers or data hubs integrating internal and partner data; 6) AI enabled forecasting; 7) Analytics and insights for increasing efficiency for inventory management and managing demand and supply; and finally, 8) Zero trust supply chain cloud for data/knowledge sharing.

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 minimise losses. Also, the major challenge of counterfeit and spurious drugs, which accounts 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 a 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 optimise the whole process, from procurement and manufacturing to supply and distribution becomes extremely critical.

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. 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. Here are some key benefits of the use of generative AI in drug discovery and development:

Rapid Molecule Generation: Generative AI can very quickly generate novel molecular structures, significantly expediting the search for new drugs. It can also explore a vast chemical space to propose potential compounds that researchers might not have considered otherwise.

Cost and Resource Efficiency: By streamlining the entire drug discovery process, Generative AI can substantially reduce the time and resources required for pre-clinical testing and drug development. This can ensure substantial cost savings for pharmaceutical companies.

Targeted Drug Design: Generative AI models can design drug candidates with a focus on very specific biological targets. This precision in drug design can increase the likelihood of success and reduce the chances of investing in unsuccessful drug candidates.

Personalised Medicine: Generative AI can aid in tailoring specific drug compounds for individual patients or specific genetic profiles, potentially leading to far more effective and personalised treatments with lesser side effects.

Accelerated Drug Repurposing: Generative AI can identify new uses for the existing drugs, a process, which is known as drug repurposing. This can save considerable time and resources compared to developing entirely new compounds.

Global Collaboration: Generative AI can facilitate international collaboration in drug discovery and development by sharing and analysing data and insights across borders, thereby accelerating the pace of discovery.

What challenges do pharmaceutical companies face when implementing digital transformation initiatives, and how can these be overcome?

There are quite a few challenges that pharma companies encounter as they progress on their digital transformation initiatives.

1. Legacy Systems and Infrastructure: Many pharmaceutical companies in India have extensive legacy IT systems and infrastructure that were never designed for the digital era. These systems often lack interoperability and scalability, making it very difficult to integrate new digital solutions seamlessly. Many Indian pharma companies also have a lot of legacy machine infrastructure in their shop floors where extracting data becomes a challenge and hence the need to have external sensors to sense and measure physical attributes of the machines is the only choice. Modernising the existing internal enterprise application and systems and transferring and migrating data can be a complex and resource-intensive process and additionally changing resistive mindset is also a big challenge to address.

2. Leadership, Cultural and Organisational Resistance: Digital transformation requires a significant shift in organisational culture and mindset as any transformation initiative requires changes to the way an organisation operates internally and also in their engagement with the customer, suppliers, partners and other players in the pharma value chain. Hence the need for a digitally savvy leader who can build a digital culture that can perpetuate through the entire organisation is an absolute necessity. A few pharmaceutical companies may face resistance from employees who are accustomed to traditional ways of working. A shortage of digital skills and the reluctance to embrace new technologies can impede the adoption of digital solutions.

3. Data Management and back end system Integration: The pharmaceutical industry deals with massive amounts of complex data. Integrating and analysing these massive data sets from different sources and formats is a major challenge. Data residing in silos, inconsistent data formats, and data security concerns can impede the effective implementation of desired digital solutions.

4. Complex Regulatory Environment: The Indian pharmaceutical industry operates in a highly regulated environment with very stringent data privacy and security requirements. Adherence to regulatory guidelines while implementing Digital Technology solutions can be challenging and time-consuming. Pharma companies need to ensure 100% compliance with regulations implemented by every country which have their own inherent caveats and limitations.

5. Cybersecurity Risks: The healthcare and pharmaceutical sectors are attractive targets for cyberattacks due to the sensitive nature of data and intellectual property. Some of the major cyber attacks over the last 2 years were targeted towards large and mid sized pharmaceutical companies in India. Thus ensuring robust cybersecurity measures and protecting digital assets from unauthorised access or data breaches is important. Pharmaceutical companies must invest in advanced cybersecurity systems and protocols to safeguard their digital infrastructure. As companies integrate OT and IT, ensuring a secure OT environment is a big challenge and this calls for a very robust cybersecurity system and the need for establishing a comprehensive cyber security strategy, a governance framework and the use of the right set of cybersecurity tools and services is an imperative. The need to manage third party risks, data and IP risks are also essential.

Also issues around data privacy requirements, currently come from other geographies as even emerging markets gear up for privacy requirements. It is noteworthy that pharma companies in India do not have direct patient data access, and a lot of privacy considerations are currently around employee and third party data.

6. Return on Investment: Implementing digital transformation initiatives can be expensive, requiring investments in technology infrastructure, data analytics and AI tools, and acquisition of talent with Digital skills especially Data Scientists. Measuring the return on investment (RoI) for these big initiatives can be challenging, as it may take time to realise the full tangible and intangible benefits and thus measure the impact on operational efficiency of the overall value chain.

Notwithstanding these challenges, pharmaceutical companies have to recognise and realise 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.

The pharmaceutical industry in India may have been slow starters in technology adoption, but the wheels are clearly turning with digital. Of the 132 ‘lighthouses’ as on June 2023 accredited by the World Economic Forum to date, 19 sites are in the pharmaceutical and medical devices industry, of which two are in India as per Mckinsey. This clearly illustrates how the pharma industry has emerged from the historical perception of being a ‘laggard’ in technology adoption.

Drugmakers Dr Reddy’s Laboratories and Cipla are the two Indian ‘lighthouse’ examples, while other international pharma giants in this league include Johnson & Johnson, GlaxoSmithKline, Teva, Sanofi, Bayer and Novo Nordisk amongst others. The WEF describes ‘Lighthouses’ as manufacturing firms showing leadership in applying Industry 4.0 technologies at scale to drive step-change financial, operational and sustainability improvements by transforming factories, value chains and business models.

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. When more patients get access to telemedicine, the payers can realise how cost effective it is compared to traditional medicine. 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. Thus, the development and implementation of telemedicine is bound to improve patient care and India's primary healthcare system in the future and thus telemedicine's cost-effectiveness will likely be its most significant outcome.

How is digital transformation impacting the pharmaceutical industry's research and development processes?

R&D is bound to garner significant focus, as the government and the entire ecosystem gears up to position India as a pharma innovator and potentially be the ‘Pharma Hub for the World’. The success of home grown Covid-19 vaccines in India like COVAXIN and COVISHIELD and a few others has set the right precedent, and regulations are likely to move in the directions that support innovation from India. The Department of Pharmaceuticals also released a draft policy 2 years back which is expected to improve R&D and innovation. It prescribes simplification of regulatory processes, usage of digital technologies to automate dossier review and workflows, and promotion of industry academia collaboration. It also proposes to offer fiscal incentives and to incentivise private sector investment in research through various means. As more support comes from the government for organisations to foray into research and innovation, digital transformation will be increasingly leveraged (for end to end digitalisation of processes, collaboration with research partners, and use of AI/ML in drug discovery and development) to enable robust R&D and clinical development.

What regulatory considerations and compliance challenges do pharmaceutical companies encounter during their digital transformation journey?

Pharmaceutical companies undergoing digital transformation face several regulatory considerations and compliance challenges. These challenges arise due to the highly regulated nature of the pharmaceutical industry and the need to ensure patient safety, data integrity, and compliance with various global regulations. Here are some key regulatory considerations and compliance challenges:

Data Privacy and Security (e.g., GDPR, HIPAA): Pharmaceutical companies handle sensitive patient data, and compliance with data protection regulations is critical. The General Data Protection Regulation (GDPR) in the European Union and the Health Insurance Portability and Accountability Act (HIPAA) in the United States, among others, require strict measures to protect patient privacy and the secure handling of health-related data.

Good Manufacturing Practices (GMP): The digitalisation of manufacturing processes, including the use of advanced technologies like automation and artificial intelligence, requires adherence to GMP regulations. Ensuring that digital tools and technologies meet GMP standards is crucial to maintain product quality and safety.

Electronic Records and Signatures (21 CFR Part 11): In the United States, pharmaceutical companies need to comply with 21 CFR Part 11, which outlines the requirements for using electronic records and signatures. Digital transformation often involves the transition from paper-based to electronic systems, necessitating compliance with these regulations.

Clinical Trial Regulations (e.g., ICH GCP): The conduct of clinical trials is a key aspect of the pharmaceutical industry. Adherence to Good Clinical Practice (GCP) guidelines, such as those outlined by the International Council for Harmonisation (ICH), is crucial. The use of digital technologies in clinical trials must comply with these standards to ensure the integrity and reliability of trial data.

Pharmacovigilance Reporting: Digital transformation can impact pharmacovigilance processes, including the monitoring and reporting of adverse events associated with pharmaceutical products. Companies must ensure that their digital systems support timely and accurate reporting in compliance with regulatory requirements.

Regulatory Submission Standards (e.g., eCTD): Many regulatory agencies require electronic submissions of regulatory documents. Compliance with standards such as the electronic Common Technical Document (eCTD) format is essential to facilitate the regulatory approval process.

Supply Chain Traceability (e.g., DSCSA): The Drug Supply Chain Security Act (DSCSA) in the United States mandates the traceability of pharmaceutical products throughout the supply chain. Digital transformation efforts should address the need for enhanced traceability and serialisation to comply with these regulations.

Regulatory Reporting and Audit Trails: Digital systems must provide comprehensive audit trails and support accurate regulatory reporting. Maintaining transparency in processes and ensuring that regulatory authorities can access necessary information is crucial for compliance.

International Regulatory Variability: Pharmaceutical companies operate in a global context, and regulations can vary between countries. Navigating the diverse regulatory landscape and ensuring compliance with multiple sets of regulations pose additional challenges during digital transformation.

Pharmaceutical companies need to engage with regulatory authorities, stay informed about evolving regulations, and implement solutions that address these challenges to successfully navigate their Digital transformation journey while maintaining compliance.

(The views expressed in interviews are personal, not necessarily of the organisations represented.)

Sunil David has 28 years of experience in the IT and Telecom industry of which close to 20 years was with AT&T, one of the top Communication Service Providers of the World and a Global Fortune 100 Firm. Until recently, Sunil was the Regional Director (IoT) India and ASEAN for AT&T India where he was responsible for building the IoT strategy, Sales, Business Development and also worked on building a robust IoT partner ecosystem; and was also actively involved in a number of marketing initiatives to help enhance the AT&T brand in the IoT space.

In his new phase of life, Sunil is Advising and Consulting AI and IoT Startups that are aspiring for the next level of growth.

Sunil has been a recipient of a number of Awards and Recognitions including 6 awards in 2021 and 3 this year from various Industry bodies and media conglomerates in recognition for his work in Digital Technology advocacy, Digital Skilling initiatives, contributing inputs towards IoT policy creation for India and for contribution to National Institute of Electronics and Info Tech, an Autonomous Scientific Society of MeITY, Ministry of Electronics and IT, Govt of India for contributing inputs on the syllabus and specific courses in the Emerging tech space (IoT, Cloud, AI ) that needs to be incorporated into the Curriculum of State and Central Govt Universities. NASSCOM Foundation and IBM India have also planted tree saplings in Sunil’s name for his contribution to the Tech Industry.

In August 2021, Sunil was awarded as ‘India’s Fastest Growing Digital Evangelist’ for FY 20-21 by a large media conglomerate Asia One Magazine at the 14th Asia Africa Business and Social Forum. The same month he was also conferred with the ‘CXO Excellence Award 2021’ by CXOTV part of TechPlus Media Group and joining the league of League of Outstanding Technology Leaders of India. This award was given on the basis of peer recommendations from the Industry.