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.