Industrial Automation Magazine India

Data analytics and AI help pharma businesses expedite and improve R&D

Published on : Thursday 07-12-2023

Dr Nivash Jeevanandam, Senior Researcher and Author, INDIAai.

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

According to a report, to reach USD 450 billion by 2047, India's healthcare and pharmaceutical industry must integrate into the global pharmaceutical supply chain, conduct value-driven research and innovation, and ensure sustainable and equitable healthcare access for all.

Several digital technologies are changing the pharmacy supply chain in a big way.

 

These technologies are meant to make things more efficient, clear, and safe. Some of the most essential tools that are causing this change are:

● 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.

● 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.

● 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.

● Big Data Analytics: This method processes massive amounts of data from multiple supply chain sources to improve decision-making, prediction accuracy, and process efficiency.

● 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.

● 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.

● Robotics and Automation: Automation technologies simplify creating, packing, and distributing goods, reducing errors, increasing efficiency, and ensuring compliance.

These digital technologies could alter the pharmaceutical supply chain by ensuring safe, high-quality, and fast delivery from production to delivery.

 

How are pharmaceutical companies leveraging data analytics and artificial intelligence for drug discovery and development?

The Drug Discovery Market is expanding at a CAGR of 6.59%, and is anticipated to reach USD 129.21 billion by 2028, from USD 93.91 billion in 2023.

Data analytics and AI are helping pharmaceutical businesses expedite and improve medication research and development:

● Target Identification and Validation: AI systems examine genomic, proteomic, and metabolic pathways to find pharmacological targets. It aids disease processes and targets validation with increased success rates.

● Pharmacological Design and Optimisation: Machine learning methods predict biological target interactions to help design and optimise pharmacological compounds. It accelerates the identification of prospective medication candidates with desired therapeutic effects and low side effects.

● Virtual Screening and Modeling: AI-driven algorithms screen enormous chemical libraries for drug-like molecules. Molecular modelling and simulations predict drug behaviour in biological systems, saving time and money in experimental testing.

● Data analytics use historical trial data, patient characteristics, and biomarker information to optimise clinical trial designs. It boosts patient recruitment, trial efficiency, and success.

● AI and data analytics analyse patient data (genetic, lifestyle, environmental factors) to anticipate therapy responses, enabling personalised medicine. Targeting medicines to specific patient populations improves efficacy and reduces side effects.

● Drug Repurposing: AI systems can assess existing medications and their attributes to find new disease-treating uses. This method can drastically reduce medication development time. 

● EHRs and wearable device data can be monitored and analysed in real-time to improve drug efficacy, safety, and patient reactions.

AI and data analytics speed up medication research and development, save costs and improve success rates by focusing on better drug prospects. These technologies enable a more targeted and accurate approach, which may lead to safer and more effective drugs.

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

The Huawei and Oxford Economics' 2016 digital transformation research estimated the global digital economy at USD 11 trillion, or 15.5% of global GDP, and predicted it to grow to USD 23 trillion, or 24.3%, by 2025. 

Yes, there are numerous obstacles that pharmaceutical companies must surmount before implementing digital transformation; these can be surmounted through proactive and strategic planning. Some significant obstacles include:

● Data security and privacy issues complicate patient data management and HIPAA compliance. Enforcing stringent data security protocols and guaranteeing adherence to regulations is critical to implementing encryption, access controls, and routine audits.

● Pharmaceutical organisations frequently possess pre-existing legacy systems that may present challenges regarding seamless integration with contemporary digital solutions. Upgrading or replacing these systems with minimal operational disruption is extremely difficult.

● 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). From the outset, organisations must ensure that their digital transformations are by regulatory standards.

● Cultural Shift and Change Management: Organisational resistance to change can hinder digital transformation initiatives. Facilitating open communication, promoting a culture of innovation, and offering sufficient training can assist personnel in embracing and acclimating to novel technologies.

● Allocation of Resources and Expenditures: The deployment of digital technologies necessitates substantial capital outlays for infrastructure, personnel, and continuous upkeep. Cost-effectiveness and return on investment (RoI) assurance are difficult to reconcile, particularly for smaller pharmaceutical companies.

 

To overcome these obstacles:

● Create a Clear Strategy: Define clear objectives, identify critical areas for transformation, and develop an execution roadmap. A comprehensive plan aids in the alignment of digital initiatives with corporate objectives.

● Collaborate and Partner: Collaborate with healthcare-focused tech specialists, startups, or established technology organisations to harness their experience and resources. Partnerships can speed up the implementation process and reduce risks.

● Prioritise and establish strong data governance mechanisms to ensure data integrity, security, and compliance. Involve stakeholders in the development of data policies and processes.

● Invest in Talent and Training: Invest in employee upskilling and employing digital technology experts. Training programs can assist staff in adapting to new tools and processes more efficiently.

● Begin with Pilot initiatives: Before spreading digital solutions across the business, start with smaller-scale pilot initiatives to evaluate and develop them. Pilots enable the learning of mistakes and the optimisation of implementation tactics.

● Maintain agility and adaptability in the face of changing technologies and market situations.

Addressing these difficulties consistently and proactively might help pharmaceutical organisations undertake digital transformation programs more smoothly.

 

How does adopting telemedicine and digital health platforms influence healthcare delivery in the pharmaceutical industry?

The Indian digital health market is growing, making it a worldwide player. Research estimates that the Indian digital health market was worth Rs 524.97 billion in 2021 and will increase to Rs 2528.69 billion by 2027 at a compound annual growth rate of 28.50%.

The integration of telemedicine and digital health platforms has significantly altered how healthcare is provided, with far-reaching consequences for the pharmaceutical sector:

● Enhanced Patient Accessibility and Engagement: By utilising telehealth platforms, pharmaceutical companies can interact directly with patients via virtual consultations, remote monitoring, and telemedicine. It promotes improved patient education, medication adherence, and the gathering of feedback regarding the effectiveness and adverse effects of the drug.

● Clinical Trials and Research Enhanced: Digital health platforms facilitate real-time insights, patient surveillance, and remote data collection throughout clinical trials. It not only reduces the development of drugs but also provides more comprehensive and diverse data sets, thereby accelerating the research process.

● Telemedicine facilitates personalised medicine and remote care by providing customised remedies informed by patient data and conducted through remote consultations. Pharmaceutical companies can create medications tailored to each patient's requirements and provide remote monitoring options for chronic conditions.

● Drug Distribution and Supply Chain Optimisation: Digital platforms enhance the visibility and efficacy of the supply chain. Pharmaceutical enterprises possess the capability to oversee inventory, monitor temperature-sensitive medications while in transit, and optimise distribution networks to ensure punctual delivery to patients and healthcare providers.

● Decision-Making Informed by Data: Integrating digital health platforms and telemedicine produces immense amounts of patient data.

Pharmaceutical companies can make more informed judgments regarding drug development, marketing strategies, and healthcare trends by analysing this data.

● Adoption of Digital Therapeutics: Digital treatments, such as medical software and apps, are increasing pharmaceutical use.

● These digital solutions may be developed in collaboration with or by pharmaceutical companies to augment their medications and improve patient outcomes.

● Regulatory and Compliance Considerations: Adherence to regulatory frameworks regulating patient privacy, data security, and healthcare standards is imperative for successfully integrating telemedicine and digital health. Pharmaceutical companies must ensure adherence to these regulations about their digital initiatives. 

● A Transition to Decentralised Healthcare Delivery Models: Telemedicine enables a paradigm transition in providing healthcare services. This paradigm shift significantly impacts pharmaceutical products' marketing, prescribing, and distribution, compelling organisations to modify their approaches accordingly.

In general, Telemedicine and digital health platforms offer pharmaceutical companies opportunities to innovate, engage with patients, streamline operations, and improve patient-centred healthcare.

 

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

A joint EY Parthenon-Organisation of Pharmaceutical Producers of India (OPPI) report predicts that transformative innovation, manufacturing and quality standards, and sustainable and equitable healthcare will grow the Indian pharmaceutical industry to USD 450 billion by 2047.

The research and development (R&D) procedures of the pharmaceutical sector have been significantly impacted by digital transformation.

● Accelerated Drug Discovery: Using digital technologies, including artificial intelligence and machine learning, facilitates examining extensive datasets to identify potential drug candidates more effectively. Predicting molecular interactions with algorithms accelerates the phase of drug discovery.

● 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.

● Using computational models and simulations enables the virtual screening and prediction of compound behaviour, diminishing the necessity for laborious laboratory experiments. It optimises the properties of lead compounds and accelerates their identification.

● Clinical Trial Optimisation: Through analysing historical data, patient characteristics, and biomarkers, digital technologies optimise clinical trial designs. This results in enhanced patient recruitment, trial efficiency, and success rates.

● Real-time data analysis pertains to the ongoing surveillance and examination of patient data in clinical trials, including information from wearable devices and electronic health records (EHRs). This data provides valuable insights into the drug's effectiveness, safety, and reactions.

● Collaboration and Data Sharing: Digital platforms enable the exchange of data and insights and facilitate collaboration among institutions and researchers worldwide. This collaborative effort expedites the research and development by utilising shared expertise and resources.

● Digital transformation facilitates the acquisition and examination of patient data, enabling the development of personalised therapies customised to each individual's genetic, lifestyle, and environmental characteristics. This strategy improves the effectiveness of the substance while decreasing the occurrence of adverse effects.

● Drug Repurposing and Combination Therapies: Algorithms powered by artificial intelligence can examine pre-existing medications to detect novel applications or combinations that may effectively treat distinct diseases.

Implementing this approach can substantially diminish the cost of introducing novel therapies.

● Regulatory Compliance and Safety Monitoring: Digital technologies ensure regulatory compliance and safety monitoring throughout drug development. It includes real-time surveillance for adverse effects and adherence to Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).

 

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.

 

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

When enduring digital transformation, pharmaceutical companies encounter a multitude of regulatory considerations and compliance challenges:

● Data Security and Privacy Regulations: Compliance with HIPAA (in the United States) or GDPR (in the European Union) is necessary when handling sensitive patient data.

● Quality Assurance and Good Manufacturing Practice (GMP): Compliance with GMP standards is required when integrating digital technologies into manufacturing processes. Implementing digital systems while maintaining product quality, consistency, and adherence to GMP guidelines is critical.

● Regulatory Approval for Digital Health Solutions: Before deployment, regulatory approval (such as FDA approval in the United States) may be required for digital health solutions, including applications, software, and AI-driven tools. It is crucial to adhere to the regulations that govern software as a medical device (SaMD) and medical devices.

● Maintaining data standards and promoting interoperability among diverse digital systems is paramount. Ensuring data exchange is facilitated, and divisions are prevented through compliance with industry-standard formats and compatibility among various platforms.

● Pharmaceutical companies must modify their adverse event reporting and monitoring procedures to incorporate digital channels. Compliance requires the reporting and tracking of adverse events associated with digital health solutions in real-time.

● Legal and ethical dilemmas may arise due to digital transformation, particularly about the application of artificial intelligence, consumer data rights, liability concerns, and informed consent. Ensuring adherence to ethical principles and legal structures assumes utmost importance.

● Regulatory updates and standards are in a constant state of evolution to facilitate technological progress. Maintaining awareness of evolving regulations and standards presents a formidable task.

To address these challenges, pharmaceutical companies can take several measures:

● Collaboration with Regulatory Bodies: Establish early engagement with regulatory agencies to gain insight into compliance obligations and solicit guidance.

● Perform exhaustive risk assessments to detect regulatory deficiencies or compliance concerns in digital endeavours. 

● Establish and execute Resilient Compliance Frameworks: Construct and execute robust compliance frameworks based on prevailing industry standards and regulations.

● Consistent Training and Education: Implement measures to ensure that personnel are adequately informed about regulatory standards, data security, and privacy to comply with compliance obligations.

● 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.

Dr Nivash Jeevanandam, Senior Researcher and Author, INDIAai (Govt of India) – National AI portal of India, NASSCOM, Ministry of Electronics and Information Technology, New Delhi. He is a senior researcher and seasoned technology journalist who writes about everything from data science to machine learning and artificial intelligence. He looks at trends, problems, ideas, and changes in the industry.

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