Pharma Focus Asia
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Somesh Sharma, Head, Discovery Chemistry group, Aragan

Digital transformation is paving way for improved efficiency and efficacy in pharmaceutical industry. With changing global business environment and shortage of resource dexterities — automation and digitisation have become key drivers for business growth, sustainability, and competitive differentiation. New technological advancements in quantum mechanics, machine learning and artificial intelligence are showing tremendous success in curtailing screening of compounds, and at same time bringing molecules faster to clinical assessment.

Drug discovery and development chevron illustrates various critical phases of progression to develop any molecule for human use. There is a pertinent desire to improve the cycle time to bring medicines as fast as possible for betterment of human health. Over the years, profound efforts were successfully accomplished in this direction. However, with the advancement of technologies in automation and robotics, there is a plausibility to enable pharmaceutical industry to further increase speed, reliability, precision and accuracy. These technologies can strengthen and enhance credibility of organisations to maintain stringent compliance, in conjunction and integrity, with operational brilliance.

Data analytics have been considered as a cornerstone and boon to develop robotics, automation, and artificial tools. With better knowledge and understanding of processes and future requirements, the information can be explored to create a differentiated business propositions. Broadly, these tools can create value in disease prediction, diagnosis interpretation, material supply projections for clinical trials, and improve patients experience, healthcare data management and precision robotic surgeries.

COVID-19 has significantly accelerated digital transformation in pharmaceutical and healthcare industry. It is able to drive organisation on the path of innovation, dexterity, resilience, adaptability and flexibility to improve production and logistics integration for healthcare business. With inherent cognizance of high research & development cost and extreme failures rates, pharmaceutical companies are focusing on alternative strategies to identify more efficient and accurate innovative paths to bring molecules faster to market.

Digitisation is not a buzz word, it is a perpetual journey towards excellence, quality, and transparency. For success of digitisation implementation, an intuitive framework needs to be constituted with competitive and intelligent business landscape assessment. It is noteworthy to mention that digitisation and automation always goes in parallel and brings different dimension to discovery and development organisations. To accomplish and establish Pharm 4.0 targets, the digital technological elements need to be devised and incorporated for a sustainable & exponential growth.

1. Machine learning (ML) and artificial intelligence (AI) tools: Quantum mechanics and AI tools have taken a big leap in driving discovery initiatives and development processes. These instruments are being used to address various challenging problems in pharmaceutical industry viz automation and optimisation of manufacturing processes, along with designing marketing and post-launch challenges.

ML tools will enable to analyse large amount of data for disease identification and diagnosis. AI technologies can assist in identifying new chemical space to get novel compounds in shorter time with deep understanding and analysis of structural relationships, improve in-vivo analysis with auto sample collection, report analysis and interpretation through BOT platforms. Convolution neural network platforms can help in predicting drugdrug interactions, an evolving technology in this field. Furthermore, web-based lab accelerator (WLA) tools allow scientists to work remotely for chemistry and biology via robotic control platforms with user friendly interfaces.

2. Data analytics: Advanced analytical techniques are giving an edge to convert historical and real-time data accessible with pharma companies to create a knowledge-based repository for prediction, diagnosis, prescription, and safety assurance of participants. Recent progression in OMIC and data analysis are providing new insights to PKPD interpretations.

3. Automation: It has different facets and applications based on the business requirements.

a. Supply chain: Digitisation has strengthened entire supply chain networking across the globe. It has become more predictable on raw material availability, supplies and cycle time. Integration of diverse vendor databases and their predictability in material supply, is a positive step on digitization of supply chain.

b. Blockchain: It has promising implications in supply chain management and healthcare for nurturing transparency, traceability, and minimising communication gap across various stakeholders. It has also been explored to tackle menace of counterfeit and substandard medicines supply.

c. Packaging: Computerised tools play significant role in accurate dispensing, sorting, labelling and distribution management. Quality control through computer vision becomes more accurate and precise.

d. Distance monitoring: Information technological platforms can bring instruments closer to users and can help in proactive maintenance, real time check, recognise compliance issues, prevent human errors, and transform operations cleaner.

e. Robotic process automation (RPA): It streamlines repeated and mundane activities, for instance, recruitment process of patients and healthy volunteers for clinical trials. Improve compliance with automatic document checks, monitoring and providing a succinct report.

4. Manufacturing: Robots are replacing standard operations (blending, drying, milling, micronisation etc.) in manufacturing, and bringing operations safer, error free and reliable. There is a paradigm shift in manufacturing environment from batch to flow technologies to control health hazards, ascertain atom economy and manage waste generation. These all efforts are well supported by advance DoE tools to get the best reaction parameters for better conversions, yields and high purity materials.

There are few areas like digitisation of crystallisation needs extensive evaluation for delivering right quality of drug products. As an example, to achieve consistent supply, it is important to overcome crystallisation hurdle of drug substances and establish a control process to get correct crystal morphs for therapeutic use. Process analytical tool (FTIR) and Raman spectroscopy have become powerful tools to monitor and control the solute-solvent interactions with real time spectral data. However, digitisation of crystallisation requires implementation of control strategies such as population balance modelling, concentration feedback control, predictive and generic model control. The future of research is to integrate chemistry, mathematical models and crystallography tools.

5. The internet of things (IoT): This platform can be used at various stages of drug discovery and development value chain. At discovery stage, organs-on-microchip technology is getting lot of prevalence for drug safety evaluation. Wearable devices with sensors provide real time health report of individuals for better prognosis of disease. Manufacturing facilities are utilising RFID and sensor technologies for predicting maintenance of machines, capturing work parameters, and building smart warehouses. For patient accessibility, digestible microchips in pills have already been approved by FDA for drug usage and medication compliance.

6. Robots for precision drug delivery: A fascinating field of micro/nanorobots for targeted drug deliveries to hard-toreach areas is expanding tremendously. These robots can be controlled remotely to perform critical biochemical operations with minimum invasion.

7. Extended reality: Mixed reality (MR), virtual reality (VR), and augmented reality (AR) is transforming organisation to visualise things like never before. For instance, XR reduces human dependencies through guided instructions, remote training and delivering critical information on timely basis. It can enable real-time location-agonistic interaction among research teams. In pharma industry, process validation and auditing can be executed with XR integrated platform with IoT data, and AI to ensure compliance in accordance with regulatory standards.

8. Real-world data (RWD) and real-world evidence (RWE): FDA uses RWD and RWE to monitor post market surveillance, appropriate regulatory decisions and develop new guidelines for future. The availability of real-world data through computers, mobile devices, wearables and other biosensors enabled by the Internet of Things (IoT), allows restructuring of pharma industry to develop new medical products and accelerate its approval process.

9. Digital therapeutics: Evidence based therapeutic interventions are getting tremendous tractions to prevent, manage, control and treat the behavioural condition of any individual for better health outcomes. AI abridges the gap among doctors, patients, and hospital administrators by executing tasks at minimal cost and in less time.

10. Curative therapies: Cell and gene therapies are bringing a paradigm shift in disease management. Instead of taking a pill throughout the life, genetic approaches (like CRISPR technology) are being evaluated to cure diseases in time limited manner.

The workplace of future will automate monotonous tasks and encourage employees to focus on meaningful and complicated scientific challenges. Future labs will use cloud-based applications to enable integration, collaboration across sites, combine IoT, AI and AR to remotely support harmonised lab environment, and empower decisionmaking faster.

Generally, there is an apprehension that investment in automation might eliminate the human workers and replace their tasks with machines. In contrary, automation complements human skills and strengths to provide a competitive advantage with more engaged and creative work force. Additionally, these advance technological platforms can encourage a conducive environment of nurturing, upskilling, reskilling, multi-skilling of existing talent pool, and help in attracting future talent for organisations.

For successful implementation of Pharm 4.0 technologies, organisations need to have right mindset, aspiration, vision, and agility. The proponents of these techniques should explore innovative tools that can stimulate differentiation and immediate impact, have flexibility and modulatory to meet current and future requirements. Till now, these technologies have shown immense success and benefits on repeat or mundane activities but there is tremendous potential to expand its scope with fully integrated predictive AI modules.

Digital tools from connectivity to data analytics, robotics and automation, will ensure internal process optimisation, collaboration, improved employee performance, quality, compliance, and accelerate business agility. It can transform organisation to lean structure, facilitate a robust cost management institution, foster innovation, and deliver an integrated ecosystem for business inclusiveness, diversity and expansions.


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--Issue 49--

Author Bio

Somesh Sharma

Somesh Sharma has more than two decades of rich experience in synthetic and medicinal chemistry to support integrated drug discovery programs from concept to clinical. Currently, he heads Discovery Chemistry group at Aragan, and responsible for business growth, customer engagements & assimilating new technological platforms. Prior to joining Aragen, he has held various leadership roles at Jubilant Biosys, Nicholas Piramal and Ranbaxy Research Laboratories

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