Mahendra Hasabnis
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While many of the global pharmaceutical giants have a robust drug pipeline, improving the speed to market of new drugs continues to be a key challenge. According to Pharmaceutical Research and Manufacturers of America (PhRMA), the average time to develop a drug in the US is 15 years the average time to develop a drug in the US is 15 years and only a meagre 12% of the drugs make it to the clinical trials stage. Pharmaceutical companies are adopting digital solutions across drug discovery, development, and commercial manufacturing, to reduce the number of experimental batches and hasten technology transfer. But at the same time, they also understand that it is important to comply with the US Food and Drug Administration (FDA) regulations across the New Product Introduction (NPI) cycle, to protect consumers. How can industry players balance these objectives? Digitization is key to standardizing laboratory and production operations, thereby enabling faster commercialization of new drugs.

Information silos impede technology transfer

Information silos mar the technology transfer process, even at advanced pharmaceutical companies. Departments such as R&D, pilot plant, and commercial manufacturing, typically share information through document management solutions in portable document format (PDF).  Large-scale mergers and acquisitions in the industry have also resulted in a variety of manufacturing execution systems (MES) and automation systems on the plant floor, across company-owned and contract manufacturing sites. The outcome:  non-standard nomenclature, varying data structures, and information fog on the plant floor.

Currently, the technology transfer exercise for a product usually takes six to nine months – from the time the drug recipe is received from the lab to the time it is commercially manufactured. By building a connected digital enterprise, industry players can substantively cut the time to market by 30% to 40%. For instance, automotive, medical devices, and fast-moving consumer goods (FMCG) industries have achieved faster time to market by adopting this approach. A connected digital enterprise drives faster time to market by bridging Enterprise Resource Planning (ERP), Enterprise Asset Management (EAM), Enterprise Data Management (EDM), Product Lifecycle Management (PLM), MES, and control systems.

PLM platform lays the foundation for a connected digital enterprise

How can you reimagine the pharmaceutical technology transfer process by building a connected digital enterprise? A possible starting point is to build a PLM platform for global drug recipe management. The PLM platform provides a single source of product information for both R&D and manufacturing. The platform harmonizes enterprise-wide master data on materials, equipment, operations, as well as operational parameters such as quality and process variables. This enforces a uniform nomenclature across systems and builds a semantic layer that acts as a common language between systems. After establishing a single source for product information with a PLM platform, the next step is to establish a data lake that encompasses design and operations. The data lake helps build the product digital thread and the digital twin of  operating plants, enabling organizations to digitally scale operations over a period of time  and build a connected digital enterprise.

The question is, how does the reimagined technology transfer process deliver value? First of all, it makes recipe information searchable and available across lab and plant operations to reduce the time for standardization and the time to scale up. While enhancing collaboration between labs across the enterprise, it also improves the traceability of recipes across R&D and manufacturing. Issue resolution becomes easier as R&D scientists can directly access manufacturing operations information. Digitally-driven standardization also reduces the number of validation steps required and the cost of quality. Finally, it helps stakeholders leverage analytics for data-driven decision-making.

Talent and system integration are key to successful digital technology transfer  

Introducing the PLM solution is not without its challenges. The fact is PLM is traditionally not used in industries with S88 batch process control standard-based operations management such as the pharmaceutical industry.  This makes skill development a critical success factor. Effective change management can help transform the way R&D and manufacturing units work today. Vendor alignment with the changes is also critical as many of the overlapping functions between vendors and the company such as specification management and recipe authoring are moved to the PLM layer. Above all, system integration and interface validation must be managed smoothly. In essence, by adopting a holistic approach to digital technology transfer, it is possible to build the expertise necessary to effectively address the challenges and ensure faster time to market for new drugs.

We will be at the MES 2017 & Process Minds conference being held in Berlin, Germany, on September 28th and 29th, 2017. At the event, we will showcase TCS’ platform for technology transfer during the World café session. We would like to meet you and understand your company’s approach to technology transfer, what are some of the probable challenges, how they can be resolved, and so on. Look forward to meeting you.


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