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PLM for Pharmaceutical Industry
Abstract
The Pharmaceutical industry holds an undeniably important place in the Life Sciences sector world-wide as it is
solely responsible for designing and manufacturing lifesaving drugs and medications. The revenue from this
industry alone has almost touched USD1 trillion all over the globe, with the United States accounting for as much as
40% of this revenue. In the year 2013, the nexus of the worldwide pharma sector managed to generate a revenue of
USD980.1 billion. To break it down company-wise, one of the leading multinational pharma companies, Novartis AG
that has its headquarters in Switzerland rose from USD38.1 billion in 2007 to USD58 billion in 2014. With several
factors influencing the evolution and growth of an already highly evolved industry, such as the increasing
penetration of China into the sector and the outlook that the global spending on medicines will increase to USD1,
295 billion by the year 2017, the entire Pharmaceutical industry is showing definite signs of riding an upwards
wave (Statistics and facts about the pharmaceutical industry worldwide). While the fact remains that the demand
for medicines and lifesaving drugs can only see a spurt in growth, the emergence of several players into the industry
that was hitherto ruled by a few elite names is pushing the importance of R&D to the fore front, it is also true that
one-thirds of their net income is spent on marketing. Added to the pressure for in depth R&D and voracious
marketing is also the fact that drug development not only takes many years before it can be tested for safety and
efficacy, approved by FDA and then patented, but it also has to be compliant to very stringent regulations.
This paper explores how the complex value chain of a Pharmaceutical industry can also be streamlined with a
holistic approach, which would in turn help in faster time to market, improved efficacy and lower operational costs.
1. Food and Drug Administration
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Contents
Abstract 1Introduction - What is the Pharma Industry Like? 3Challenges in the Pharma Sector 3Benefits of Adopting PLM Solutions 4Conclusion 5References 6About the Company 7
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Introduction - What is the Pharma Industry Like?
Challenges in the Pharma Sector
The Pharmaceutical industry is an extremely complex one, with stringent regulations, complex and long drawn
processes and it is estimated that the cost of developing one single drug that reaches the market is approximately
USD1.5 billion (The Pharmaceutical Industry and Global Health Facts and Figures 2014, 2014). Researchers identify
one out of roughly 10,000 compounds to begin their research to test its safety, usability, efficacy, which can then
take up to 15 years. Only a small margin of these tested compounds eventually make all the levels and qualify as
drugs. For example, in 2012, only 43 medicines made their way to the market (The Pharmaceutical Industry and
Global Health Facts and Figures 2014, 2014).
The research and development process looks something like this:
(The Pharmaceutical Industry and Global Health Facts and Figures 2014, 2014)
Once the drug manufacturer manages to go through all these phases and get the stringent regulatory approvals,
then the aspect of Pharmacovigilance comes into picture, which means that the manufacturers are stipulated by the
national health authorities to regularly monitor the patient's experiences with the drug. Industry experts say that
this particular industry invests more than five times than other industries, which makes it very difficult for the
manufacturers to innovate while at the same time look at increasing product development cycles, lower costs and
meet all the compliances in time.
Given this scenario, the main challenges that drug manufacturing companies face are (Product Lifecycle
Management for the Pharmaceutical Industry):
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l Complexities in the drug development process, which includes the Research, the trials, the regulations, the
manufacturing, the marketing, and the post marketing or Pharmacovigilance stages
l Lack of cross functional collaboration between the various teams and processes in the already complex value
chain that continue to remain disparate
l Levels of complexities in each phase with added complexities of time taken in each phase
l Handling and maintaining huge levels of inventories at every stage
l Other interrelated processes, viz. Product registration, Packaging of medicines, etc.
l Silos of information in disparate sources, with no single source that can be easily accessed by all
l Interaction and collaboration with other external CMOs who come into the picture for the trials make inventory
management very hard as traditional Excel, ERP and MES systems do not foster collaboration and cause wastage
of time, resources and monetary investments as well
l Stringent approval systems from FDA and other national health authorities
With these challenges hampering an already complex and time consuming process, manufacturers are feeling the
pressure. The need of the hour seems to have a business transformation process in place, which can unify the drug
development activities and the disparate teams at work, to build a common development model which can have a
single source of information and also to identify the strategic business processes that can be unified in order that
they can be transformed.
It is obvious that unless there is a unification and transformation that happens in the industry, there will be several
factors such as future investments, quality control, and compliance requirements (PLM for the Lifesciences Industry,
2015) which will continue to hang in a delicate balance. Transforming the entire product lifecycle management
process through PLM seems to be the best way to address these challenges as, to put it in a nutshell, they unify the
information structure and processes.
l Expedited compliance process by integrating it into the product development and e-submission processes
l Streamlined design collaboration and by easy multiway communication between all internal and external
partners
l Increased visibility and transparency of the various stages which will improve time to market and reduce
wastages of time, cost, and resources
l Integrated supply history and patterns into the sourcing process which will enable easy interaction with all teams
in the supply chain
l Increased visibility into materials specifications, requirements, models, etc. which will lead to increased
efficiency and bring down time taken as well as costs
Benefits of Adopting PLM Solutions
2. Contract Manufacturing Organizations 3. Enterprise Resource Planning 4. Manufacturing Execution Systems 5. Product Lifecycle Management
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l Increased cost savings through lean management and easy re-usability of materials and processes
l Easy collaboration via centrally managed global virtual teams and networks
l Expedited patent process due to easy submission and collaboration with requisite teams
l Easier compliance management with authorities like FDA
In order to assist in this process of business transformation, PLM solutions providers bring several aspects to the
table, which include but are not limited to (Product Lifecycle Management for the Pharmaceutical Industry):
l Drug development portfolio management
l Structured record management
l Transfer and collaboration of technology
l Integrated quality (QbD )and risk management
l Collateral and management
l Global product registration
l Supply chain management
l Enterprise governance
l Manufacturing and production management
l Post market sales and support
Pharmaceutical companies who seek to unify and transform their business processes benefit from increased agility;
optimised use of resources – people, costs, time; better visibility; increased quality standards like QbD, easier
compliance with regulations, better product governance, and most essentially, faster time to market.
Conclusion
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6. Quality by Design
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References
PLM for the Lifesciences Industry. (2015). Retrieved from Technia.com: http://www.technia.com/plm/plm-by-
industries/life-sciences
Product Lifecycle Management for the Pharmaceutical Industry. (n.d.). Retrieved from Oracle.com:
http://www.oracle.com/us/products/applications/agile/lifecycle-mgmt-pharmaceutical-bwp-070014.pdf
Statistics and facts about the pharmaceutical industry worldwide. (n.d.). Retrieved from Statista.com:
http://www.statista.com/topics/1764/global-pharmaceutical-industry
The Pharmaceutical Industry and Global Health Facts and Figures 2014. (2014). Retrieved from ifpma.org:
http://www.ifpma.org/fileadmin/content/Publication/2014/IFPMA_-_Facts_And_Figures_2014.pdf
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About PROLIM:
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PROLIM is a leading provider to industries like Automotive, Aerospace, Manufacturing
Supplier and Life Sciences. Providing these services has helped the clients to enhance efficiency and top-line growth
As one of the fastest growing private Companies in America recognized by Inc 500, PROLIM being customer focused
rather than product focused, the company envisions harnessing customer requisites by adding more satellite offices
over the next few years in major metropolitan centers PROLIM envisages reaching customers beyond borders to
deliver effective services in the west and east coasts of the US Canada and Europe and Asia.
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