PLM in pharma is a very new industry and is still evolving in India. Rathinakumar Vaidyanathan, Director of SCM, PLM & Logistics Applications, Oracle Asia Pacific, in an e-mail interview with AD Pradeep Kumar gives an overview of Oracle's latest offering on PLM and how it can can be helpful to pharmaceutical companies.
What are the challenges being faced by the pharmaceutical companies and what according to you should they do to meet these challenges?
Pharmaceutical companies cannot rely any longer as they did in the past on major 'blockbuster' drugs to sustain them and be profitable. The major challenges facing the industry are:
● Increased competition among generic pharma companies that eat into profits and put pressure on faster time-to-market requirements
● Patent expirations that lead to a drastic reduction in revenues
● A over-reliance on 'blockbuster' drugs that resulted in small product portfolios at some companies
● Heightened quality principles and regulatory requirements in different countries
● A dynamic R&D environment driven by the desire to uncover the next 'wonder drug'
Increasingly, technology is playing a key role in ensuring companies are able to address these challenges:
● Speed the time for new drug development, introduction, and commercialization
● Reduce pain and cost of achieving regulatory compliance
● Manage effectively the changes to products, packaging components, and processes
● Cut direct material and operating costs
● Minimize the cost of managing product variations and extensions
● Supplement the product pipeline through partnerships and licensing agreements
● Allocate and monitor R&D resources effectively by improving the ability to remove bad products or doubtful products early
● Collaborate efficiently with partners to accelerate innovation, reduce product and process costs, and mitigate non-compliance risks
How can PLM help pharmaceutical companies?
For a pharmaceutical company, drug development is an extremely expensive and time-consuming process, costing millions of dollars and years to develop a single product. PLM technology can help make drug development more efficient and effective.
Oracle Agile Product Lifecycle Management for Life Sciences helps companies bring together disparate organizations, information, and systems in order to deliver products to market faster, at a lower cost than their competitors, while maintaining compliance with regulatory requirements. It offers a complete product lifecycle management solution suite, built on the industry's best practices, that enables organizations to manage - from a single interface - the product and its data-set throughout its entire lifecycle.
Agile PLM includes functionality for key business processes that enables life sciences companies to do the following:
● Drive product innovation and introduction with one central solution for collaboration across research networks both internally and externally, and managing all product portfolio aspects such as project and resource management, automating the design control process across the organization
● Lower inefficiency and compliance exposure with a secure workflow-enabled change management processes for core product record components such as development documents and records, product and process specifications, through regulatory submission information providing a compliant archive to support regulatory audits.
● Support enterprise quality management by providing one central solution for aggregating, analysing, and acting on product quality issues from customer complaints to manufacturing deviations to adverse-event information or supplier corrective actions, and closing the loop on these quality events by resolving the product quality problem and communicating the resolution to all parties involved, including compiling necessary medical device reports for submission to authorities
● Enable regulatory compliance by providing the infrastructure to meet the requirements outlined by the regulator's quality system regulations, as well as providing a platform for full compliance with required standards. Agile also provides solutions to help speed the validation of the customer's Agile PLM system implementation
What are the processes supported by Oracle PLM solutions ?
Agile PLM integrates product definition and collaboration, quality, governance and compliance, and portfolio management capabilities with research, discovery, pre-clinical development, clinical trials, manufacturing and operations functions. Agile PLM is designed with deep functionality for the pharmaceutical industry (see figure below). The solution includes the following capabilities:
Product Record: All eDR, change, supplier, NDA/BLA and QMS records in one enterprise solution aligned to FDA guidelines and regulations.
Enterprise Quality Management: Closed loop system linking quality events to all enterprise records providing quality evidence.
Product Portfolio Management: All regulated projects integrated with global document and quality system to enable quality by design
Enterprise Quality Analytics & Dashboards: Comprehensive schema and reports to support enterprise quality management reviews
Centralized Knowledge Management: Complete product record for sourced and developed compounds, packaging, labelling, ingredient sourcing specifications and workflow/ version control. Helps prepare development records for electronic submission.
How will it benefit the Indian pharmaceutical industry?
India's pharmaceutical industry was US$54 billion in 2010, growing at nine per cent a year, exporting its products to 65 countries worldwide. As R&D and manufacturing continue to escalate globally, international drug manufacturers are moving more of their drug development and clinical trial activities to the subcontinent, capitalizing on India's high levels of scientific expertise and cost effective operations.
The Indian pharmaceutical industry aims to achieve global industry influence, seeking to focus on meeting standards set by international regulatory authorities, e.g. FDA compliance, while getting new drugs to market quickly. This is a big challenge for the industry. The benefit of PLM solutions to address time-to-market and compliance concerns is clear and unambiguous.
On another front, generic pharmaceutical companies in India are now focusing on streamlining their R&D processes to prepare them to achieve a viable QBD (Quality By Design) framework eventually. However, the distributed nature of people, processes and data involved in innovation makes it a very challenging process. A PLM solution can help in accelerating product innovation and maximizing product profitability, via managing the information, processes, and decisions about products throughout their lifecycles and across the global product network.
Oracle's Agile PLM can enable companies to implement an integrated and collaborative innovation framework. This can result in faster product and packaging development cycles, higher sales and margins, lower costs, higher quality, and more compliant products responding to consumer needs, all of which can decisively differentiate a pharmaceutical company in the market.