Digitalisation, lean practices optimise, improve efficiency across pharma value chain, ET HealthWorld


Hyderabad: ETPharma while hosting the inaugural Next-Gen LabCon Conference themed ‘Building and Benchmarking Robust Pharma Labs Operations: Today and Beyond’ organised a panel discussion on ‘Streamlining Workflows: Maximising Efficiency with Digital Transformation in Drug Development and Manufacturing’.

The participants for the discussion were Satheesh K Shetty, Senior Director-Reference Standards, United States Pharmacopeia India (P) Ltd, Abhay Srivastava, President, Operations, Mankind Pharma, Ajitabh Singh, VP IT & CIO, Neuland Laboratories Limited and the session was moderated Vishwanath Swarup, Chief Operating Officer, Bharat Serums and Vaccines Limited. The discussion emphasised the role of digitalisation and lean manufacturing in the pharma industry.

To set the context of the discussion Singh shared that the pharma industry is mainly a data-driven business where data is generated at every stage whether it is drug discovery or manufacturing. He said, “There is a huge amount of data and there is a huge amount of historical data to leverage. Secondly, there is the ease of cloud computing power, the plethora of artificial intelligence (AI) and machine learning (ML) tools that are available and most importantly the change in the mindset of companies on adopting digital. If they don’t go digital they miss the bus. In terms of how digital is going to move forward, there are a lot of investments happening in bio-informatics software, genome mapping, and DNA sequencing. There is also a lot happening in the chem informatics space where molecular structure properties can be done, systems can be designed to do molecular modelling reducing the time spent in labs.”He further continued, “The best use that we are seeing is in clinical trial management. These software are helping in predicting clinical trial outcomes, reducing cost and time. Digital solutions are used for high-performance clustering for simulations and data modelling for drug discovery.”

Commenting on forecasting meeting the needs of the customer and preparing for the future, Shetty shared, “We are moving into the digital era and a standard-setting organisation we are gearing up to meet the requirements of the customer. We have a commitment from the leadership, where digital is one of the covered aspects. There is a lot of focus on digitalisation in our organisation, we have a separate digital and innovation department that is working five years ahead on AI, ML and newer technologies. Some of the initiatives have been initiated, during COVID we developed a database for stakeholders’ requirements to mitigate the risks of the supply chain, where the availability of the drugs could be seen globally. This was created using advanced analytics and ML technologies. We are also working on transformational informatics to deliver scientific content in machine-readable format. He further added that digital reference standards will be the future.”

“There has been a tremendous transformation in the last five years in our labs, all our labs’ processes are digital, all our laboratories are ELN-implemented, all the labs are paperless and everything is integrated with the data management system,” stated Shetty, “All equipment have to be integrated, and having a parcel system will be disadvantageous. All fully integrated system will help improve the efficiency of the lab,” he added.

Taking the discussion further Swarup urged Srivastava to share insights on how the digital journey enabled the scale-up at Mankind. Srivastava shared, “The journey started five years ago and COVID not only quickened the process of digitalisation but also crystallised the insights that were being missed out in the supply chain.”

We did a gap analysis, then we chose a plant as a role model plant where the solutions were going to be implemented and other plants would follow it because different plants had come up at different time zones and had their issues with automation implementation. Another important thing is we choose the right partner for our digitalisation process. We also created a business excellence transformation team and they mentored us on the process of digitalisation. We then created a roadmap where all systems are integrated. Currently, phase two of our roadmap is complete where the plant is connected to the head office, the processes are speaking to each other, and the role model plant is generating data and sharing it with its digital twin at the head office. We have two nerve centres, one is for operations and the other for logistics, as of now purchase isn’t included. These nerve centres do the routine monitoring, the relative data is sent to the supply chain control towers. There is also a centre of excellence (CoE), which is a necessity in our boardroom where we examine the ‘what-if’ scenarios,” continued Srivastava.

He added, “Once the two plants that are interacting with nerve centres complete L1, L2, L3, L4 and L5, we will roll it out to the other plants, this is the journey that we are currently embarking on.”

Commenting on the importance of lean implementation and its relevance for the pharma industry, Srivastava continued, “We have a vision around quality, affordability and accessibility. Every section of the business is tasked to give an aspirational statement, the aspirational statement on how the department is going to achieve quality, affordability and accessibility. We statement on achieving the aforementioned goals through operational excellence. Operational excellence is achieved through the digital transformation that has been implemented. As an organisation, we have come away from 5S and non-value addition. We are at a stage where we are giving green, black, and yellow belt projects to different people who are analysing the data that is being generated by the digital platform.”

Adding to this Shetty said, “Lean principle is normally associated with manufacturing but it can be applied in the lab as well. We are working on implementing lean practices in our laboratory and it is working well.”

“To implement any new initiative, the right culture is needed which comes from people. Lean culture is one area where people can be trained so that the culture is good and people are ready to accept the change. We started with 5S implementation in the laboratory with the inventory and lab consumables. The second part was the value stream mapping, looking into the process, understanding the flow and addressing the bottlenecks,” continued Shetty, “If a continuous improvement culture is developed in the lab it will lead to idea generation without which there can be no improvement. For that performance management is needed, KPIs need to be set to check where there is improvement or more improvement is needed.”

Swarup urged Singh to share insights on ownership, Singh commented, “Digital is a journey, one or two projects may fail and to deal with it a few principles need to be adopted when digital transformation projects are being undertaken. Just digital tools will not solve the problems, the business process re-engineering and digital tools need to go hand in hand.”

Adding further Singh narrated, “The management push is needed and digital is one of our key priorities. When it comes to projects such as AI and ML data is important. Fundamentally the data that is generated needs to be fine-tuned for analytics. The data needs to be curated, cleansed and then make use of it. The process is time-consuming and people run out of patience as it is a classic IT principle ‘junk in junk out’.”

“Once the business is pushed in the direction of digital skills there will be a lot of adaptability from the business. The more the employees are trained the more comfortable they become,” concluded Singh.

Sharing his viewpoints on the cultural shift, Shetty stated, “There will be resistance to change. If there is a commitment from the leadership and it is communicated well there will be a pathway for implementation. Communication and engagement empower the people, and skill gaps can be filled with proper training. Even in digitalisation if the people are not properly trained there won’t be desired results.”

Speaking on reducing failures with digital projects, Srivastava concluded, “Anything that is manual there are chances of error. Digitalisation should be embraced so that it becomes an enabler and digitalisation won’t replace jobs.”

The speakers concluded their conversation by highlighting the importance of digital transformation and lean practices. The need for persistence as some projects may fail, the need for a skilled workforce and a good working culture that is adaptive to change.

  • Published On Aug 30, 2023 at 11:34 AM IST

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