By S.R.Venkatapathy and Piyush Dewangan.
Over the years, annual new drug approvals have dropped, while the R&D costs for a drug have grown four fold. Recently, ARC discussed in one of its Insights about a global pharmaceutical company losing about $2.2 billion in shareholder value while developing a new drug with a partner. The partner used one manufacturing process for the product that was used subsequently in clinical trials; apparently this process was qualitatively different from the version that the much larger partner intended to use for mass production. The US FDA caught this discrepancy and delayed regulatory approval, sending the stocks of both companies tumbling. There is a strong possibility that this could have been avoided had both companies shared a Product Lifecycle Management (PLM) process that went from formulation to defining the manufacturing process. While the discrete industries, even in India are fairly familiar with PLM solutions, it has witnessed very little traction in the process/hybrid industries. Pharmaceutical companies must seriously consider implementing PLM solutions across the entire product lifecycle.
A major challenge in product development process for a pharmaceutical manufacturer is to discover ways to integrate regulatory requirements in the development process. Of the several factors that influence the success rate of drug development, improving clinical data and project management stand out. Aside of drug development, aligning manufacturing needs during the development process improves the speed to market. Both closely fit the capabilities that PLM can deliver to the industry.
Although the performance of India’s pharmaceutical industry has been impressive in recent times, particularly as a producer of quality drugs to global standards (in generic drug manufacturing), there is a reluctance to play a significant role in new drug discoveries. Several global manufacturers who have established presence in India, are getting into the area of new drug discoveries by leveraging the high intellectual capital base the country offers. ARC believes that this status must change for the industry to live up to its full potential, but the change may be waiting to happen with more IT solutions in pharmaceutical industry being ushered in.
A PLM solution works as a business strategy and employs collaborative software solutions to create a product-centric data record for any product over its entire lifecycle, from concept generation to decline. It facilitates identification of potential errors and conflicts early in product development cycle. The collaborative PLM solution embraces the true potential of distributed partnership-oriented supply chain where suppliers, partners, sub-contractors, and customers are involved in product definition. While PLM manages product related data and processes across the distributed environment, the strategic framework that this solution offers enables companies to have superior collaboration across the functions and decision points necessary to manage a drug for optimal profitability throughout its lifecycle. With a centralized single repository facilitated for product information throughout a product lifecycle it encourages the organization to have an efficient procurement process in place.
ARC analysts used the opportunity at the recently held ARC Process and Batch Industries Forum in Hyderabad, India, to interact with several pharmaceutical companies and solution providers. The discussions were quite encouraging as ARC discovered interest in several end-users for implementing PLM. The industry representatives were very appreciative of benefits of MES, Batch Management solutions, use of open standards, such as ISA 88 and 95, and PAT/QbD. They would however, want to be made more aware of PLM in pharmaceutical industry. The solution providers, such as Ansys, Dassault Systems, IBM, Oracle, PTC, SAP, and Siemens PLM will want to take note of this.
ARC will shortly be publishing a strategy report aimed at creating necessary awareness, addressing challenges and providing a roadmap that may be of help to the Indian pharmaceutical industry. This will be an India specific report. Write to us, if you have an opinion that could help host a discussion on this blog to Venkat@arcweb.com