PLM for Pharmaceutical Industry

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1 PLM for Pharmaceutica Industry Abstract The Pharmaceutica industry hods an undeniaby important pace in the Life Sciences sector word-wide as it is soey responsibe for designing and manufacturing ifesaving drugs and medications. The revenue from this industry aone has amost touched USD1 triion a over the gobe, with the United States accounting for as much as 40% of this revenue. In the year 2013, the nexus of the wordwide pharma sector managed to generate a revenue of USD980.1 biion. To break it down company-wise, one of the eading mutinationa pharma companies, Novartis AG that has its headquarters in Switzerand rose from USD38.1 biion in 2007 to USD58 biion in With severa factors infuencing the evoution and growth of an aready highy evoved industry, such as the increasing penetration of China into the sector and the outook that the goba spending on medicines wi increase to USD1, 295 biion by the year 2017, the entire Pharmaceutica industry is showing definite signs of riding an upwards wave (Statistics and facts about the pharmaceutica industry wordwide). Whie the fact remains that the demand for medicines and ifesaving drugs can ony see a spurt in growth, the emergence of severa payers into the industry that was hitherto rued by a few eite names is pushing the importance of R&D to the fore front, it is aso 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 aso the fact that drug deveopment not ony takes many years before it can be tested for safety and efficacy, approved by FDA and then patented, but it aso has to be compiant to very stringent reguations. This paper expores how the compex vaue chain of a Pharmaceutica industry can aso be streamined with a hoistic approach, which woud in turn hep in faster time to market, improved efficacy and ower operationa costs. 1. Food and Drug Administration Copyright PROLIM Goba Corporation

2 Contents Abstract 1 Introduction - What is the Pharma Industry Like? 3 Chaenges in the Pharma Sector 3 Benefits of Adopting PLM Soutions 4 Concusion 5 References 6 About the Company 7 Copyright PROLIM Goba Corporation

3 Introduction - What is the Pharma Industry Like? The Pharmaceutica industry is an extremey compex one, with stringent reguations, compex and ong drawn processes and it is estimated that the cost of deveoping one singe drug that reaches the market is approximatey USD1.5 biion (The Pharmaceutica Industry and Goba Heath Facts and Figures 2014, 2014). Researchers identify one out of roughy 10,000 compounds to begin their research to test its safety, usabiity, efficacy, which can then take up to 15 years. Ony a sma margin of these tested compounds eventuay make a the eves and quaify as drugs. For exampe, in 2012, ony 43 medicines made their way to the market (The Pharmaceutica Industry and Goba Heath Facts and Figures 2014, 2014). The research and deveopment process ooks something ike this: (The Pharmaceutica Industry and Goba Heath Facts and Figures 2014, 2014) Once the drug manufacturer manages to go through a these phases and get the stringent reguatory approvas, then the aspect of Pharmacovigiance comes into picture, which means that the manufacturers are stipuated by the nationa heath authorities to reguary monitor the patient's experiences with the drug. Industry experts say that this particuar industry invests more than five times than other industries, which makes it very difficut for the manufacturers to innovate whie at the same time ook at increasing product deveopment cyces, ower costs and meet a the compiances in time. Chaenges in the Pharma Sector Given this scenario, the main chaenges that drug manufacturing companies face are (Product Lifecyce Management for the Pharmaceutica Industry): Copyright PROLIM Goba Corporation

4 Compexities in the drug deveopment process, which incudes the Research, the trias, the reguations, the manufacturing, the marketing, and the post marketing or Pharmacovigiance stages Lack of cross functiona coaboration between the various teams and processes in the aready compex vaue chain that continue to remain disparate Leves of compexities in each phase with added compexities of time taken in each phase Handing and maintaining huge eves of inventories at every stage Other interreated processes, viz. Product registration, Packaging of medicines, etc. Sios of information in disparate sources, with no singe source that can be easiy accessed by a Interaction and coaboration with other externa CMOs who come into the picture for the trias make inventory management very hard as traditiona Exce, ERP and MES systems do not foster coaboration and cause wastage of time, resources and monetary investments as we Stringent approva systems from FDA and other nationa heath authorities With these chaenges hampering an aready compex and time consuming process, manufacturers are feeing the pressure. The need of the hour seems to have a business transformation process in pace, which can unify the drug deveopment activities and the disparate teams at work, to buid a common deveopment mode which can have a singe source of information and aso to identify the strategic business processes that can be unified in order that they can be transformed. Benefits of Adopting PLM Soutions It is obvious that uness there is a unification and transformation that happens in the industry, there wi be severa factors such as future investments, quaity contro, and compiance requirements (PLM for the Lifesciences Industry, 2015) which wi continue to hang in a deicate baance. Transforming the entire product ifecyce management process through PLM seems to be the best way to address these chaenges as, to put it in a nutshe, they unify the information structure and processes. Expedited compiance process by integrating it into the product deveopment and e-submission processes Streamined design coaboration and by easy mutiway communication between a interna and externa partners Increased visibiity and transparency of the various stages which wi improve time to market and reduce wastages of time, cost, and resources Integrated suppy history and patterns into the sourcing process which wi enabe easy interaction with a teams in the suppy chain Increased visibiity into materias specifications, requirements, modes, etc. which wi ead to increased efficiency and bring down time taken as we as costs 2. Contract Manufacturing Organizations 3. Enterprise Resource Panning 4. Manufacturing Execution Systems 5. Product Lifecyce Management Copyright PROLIM Goba Corporation

5 Increased cost savings through ean management and easy re-usabiity of materias and processes Easy coaboration via centray managed goba virtua teams and networks Expedited patent process due to easy submission and coaboration with requisite teams Easier compiance management with authorities ike FDA In order to assist in this process of business transformation, PLM soutions providers bring severa aspects to the tabe, which incude but are not imited to (Product Lifecyce Management for the Pharmaceutica Industry): Drug deveopment portfoio management Structured record management Transfer and coaboration of technoogy Integrated quaity (QbD )and risk management Coatera and management Goba product registration Suppy chain management Enterprise governance Manufacturing and production management Post market saes and support Concusion Pharmaceutica companies who seek to unify and transform their business processes benefit from increased agiity; optimised use of resources peope, costs, time; better visibiity; increased quaity standards ike QbD, easier compiance with reguations, better product governance, and most essentiay, faster time to market. 6. Quaity by Design Copyright PROLIM Goba Corporation

6 References PLM for the Lifesciences Industry. (2015). Retrieved from Technia.com: Product Lifecyce Management for the Pharmaceutica Industry. (n.d.). Retrieved from Orace.com: Statistics and facts about the pharmaceutica industry wordwide. (n.d.). Retrieved from Statista.com: The Pharmaceutica Industry and Goba Heath Facts and Figures (2014). Retrieved from ifpma.org: Copyright PROLIM Goba Corporation

7 About PROLIM: PROLIM is a eading provider PLM Software Services to industries ike Automotive, Aerospace, Manufacturing Suppier and Life Sciences. Providing these services has heped the cients to enhance efficiency and top-ine 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 sateite offices over the next few years in major metropoitan centers PROLIM envisages reaching customers beyond borders to deiver effective services in the west and east coasts of the US Canada and Europe and Asia. US OFFICE DALLAS PROLIM Goba Corporation 2805 N. Daas Parkway, Suite 610 Pano, TX Phone: US OFFICE DETROIT PROLIM Goba Corporation Northwestern Hwy, Suite 380 Farmington His, MI Phone: CANADA OFFICE PROLIM Canada Inc 4611 Rosebush Road, Mississauga L5M 5H2, Canada Phone: INDIA OFFICE PROLIM Soutions Pvt. Ltd. Word Trade Center 20th Foor, Maeswaram, Bangaore Phone: Copyright PROLIM Goba Corporation

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