PharmaChemical Ireland published a major strategy document in March 2010. The document, titled, ‘Innovation and Excellence-PharmaChemical Ireland Strategic Plan’ was launched at the Drug Chemical and Allied Technologies (DCAT) meeting at the Waldorf Astoria, New York City on 16 March 2010. The document outlines the industry response to the major challenges being faced by the global industry.
PharmaChemical Ireland published a major strategy document in March 2010. The document, titled, ‘Innovation and Excellence-PharmaChemical Ireland Strategic Plan’ was launched at the Drug Chemical and Allied Technologies (DCAT) meeting at the Waldorf Astoria, New York City on 16 March 2010. The document outlines the industry response to the major challenges being faced by the global industry.
PharmaChemical Ireland published a major strategy document in March 2010. The document, titled, ‘Innovation and Excellence-PharmaChemical Ireland Strategic Plan’ was launched at the Drug Chemical and Allied Technologies (DCAT) meeting at the Waldorf Astoria, New York City on 16 March 2010. The document outlines the industry response to the major challenges being faced by the global industry.
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.
What you’ll discover:
Key trends shaping the pharmaceutical formulation sector
Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
It is well known that the global pharmaceutical, biopharmaceutical and chemical industries face a challenging decade ahead. A major driver of this will be the patent expiry of a number of blockbuster drugs manufactured in this country. Once a blockbuster comes off patent, revenues fall sharply by up to 80 per cent. Many commentators predict a drop in revenues of as much as EUR 100 billion over the next five years. In the past, research pipelines provided replacement products for these drugs, unfortunately such pipelines are now far less productive, meaning that companies will need to pursue alternative strategies to survive. An initial response by big pharma has been to merge. The recent Pfizer-Wyeth and Merck-Schering Plough mergers are examples of this as companies seek to enhance their product and research portfolios.
This scenario presents a set of real challenges for the industry in Ireland as it prepares to absorb the effects of the first of these major patent expiries – that of Pfizer’s Lipitor – in 2011. Exporting products valued at EUR 47 billion in 2009, the sector is enormously important to the Irish economy, therefore it is paramount that the industry is well prepared for these challenges.
Figure 1 Total average Big Pharma* revenue decline due to schedules patent expiries * Big Pharma average includes J&J, Novartis, Merck & Co., Abbott, Eli Lilly, GlaxoSmithKline, Pfizer, Sanofi, Bristol-Myers Squibb and Roche Copyright: Moody’s FM
Strategy Working Group
In order to come up with a coherent and well thought out response, PharmaChemical Ireland (PCI) established a group comprising industry heads to prepare a plan. They consulted widely among the sector here, with other industry sectors such as medtech and ICT, the research community and Government and its agencies. This period of consultation prompted placing this group onto a standing footing and to widen its membership to include strategic partners to the industry such as IDA Ireland, Enterprise Ireland, Science Foundation Ireland, University College Dublin, University College Cork, Trinity College Dublin, The Department of Enterprise, Trade and Innovation – part of the Irish Government, NIBRT and Forfas. This standing committee was responsible for the final strategy which was published earlier this year. The same committee is responsible for the execution of the strategy (see Box 1).
Future shape of the industry in Ireland
The membership of PCI has defined what characteristics each site must possess if it is to survive in the long term, the so-called factory of the future. These are summarised below:
Highly-efficient, cost-effective manufacturing with full implementation of the principles of lean manufacturing and operational excellence
Best practice in regulatory management, including principles of quality by design and process analytical technology
On-site process and product development capabilities fully integrated into manufacturing
Site of choice for transfer of all new entities to market
Flexible and adaptable production facility
On-site pilot plant facilities
An on-site unit aimed at training the workforce in the latest principles of Lean, Six Sigma, etc
Fully networked and research infrastructure
Best practice in systems and information management
Best in class in all aspects of environment and health and safety (EHS) management
A fully-integrated development network for overall corporate structure
Capacity and capability for clinical trials manufacture
Regional HQ status for supply chain components, where it makes economic sense to concentrate them at one location
A strong local management team
A flexible workforce that can facilitate change on an ongoing basis
Figure 2 Global Pharma: sales & sales growth 2001 – 2008 Copyright: IMS Health Market Prognosis, March 2009
How can the industry achieve this?
PCI has clearly identified a range of measures that need to be taken by companies themselves if they are to become factories of the future. A number of companies are already well on the way to attaining this status and becoming strategically relevant within their own corporate networks. These are summarised below:
Companies need to strive to be regarded as lean by closely monitoring and bench – marking those key indicators that allow them to track their own efficiency and productivity
The industry must persuade companies to invest in on-site innovation – this should include process optimisation, product development and clinical trial manufacture, scale up and technology transfer
The industry must establish a rationale for conducting or co-ordinating clinical trials out of Ireland
In collaboration with the Government and the research community, industry should prepare a comprehensive marketing plan for an Irish life sciences cluster. The plan would address all components of a successful cluster such as industry, research centres, Government agencies and all other supporting cluster components. Consideration should be given to positioning the country as a bridge between the US and Asia
Companies and their supply bases must reduce their operating costs across the board in order to recover relative competitiveness within their own corporate networks. All cost components, including labour, energy, cost of capital, waste treatment, local authority charges, etc, need to be controlled
Companies need to actively invest in up-to-date regulatory approaches, such as those which have been identified by the FDA in its 21st Century Initiative, including Quality by Design, Process Analytical Technology, etc. It is important that companies apply these principles rigorously to achieve real efficiencies and cost savings through reduced testing and regulatory track streamlining
PCI operates a wide range of specialist working groups and networks that actively work to promote these areas. There is a strong tradition of collaboration in Ireland where companies regularly come together to share best practice and to learn from each other. PCI has produced two reports that benchmark the performance of the sector in operational excellence. Many Irish sites are now well advanced in this space, principles such as lean and six sigma have become the norm for Irish operations.
Figure 3 Global Pharma: Sales growth, extrapolation Copyright: IMS Health Market Prognosis, March 2009
What does Government do?
Given the strategic importance of the sector to the economy here (over 50 per cent of all merchandise exports are pharmachem related), it is vital that Government works closely with the industry to assist it in achieving its aims. Traditionally, Government has been very supportive of the sector in Ireland. This support is set to continue:
Government continues to endorse the 12.5 per cent rate for corporate tax and it is likely that it will remain in place well into the future
The government stimulates investment in R&D via a tax credit scheme; this tax credit was recently increased from 20 per cent to 30 per cent
The government has committed to fund the National Bio-processing Research and Training Centre. This is a welcome development and will provide valuable support to the bio-pharmaceutical sector. However, if the pharmachemical sector as a whole is to broaden its remit to embrace process development in a meaningful way, it will be necessary to expand the centre to support the chemical and the specifically pharmaceutical part of the industry, commonly referred to as ‘small molecule’
The Enterprise Strategy Group recommended that public funding for applied research and in-firm R&D should be progressively increased to match that provided by the Department of Enterprise Trade and Employment for basic research. This includes support for in-firm capability, development, commercialisation and cluster- led academic research and innovation partnerships. There are some notable examples of how this approach has already paid dividends through the Science Foundation Ireland (SFI) sponsored Centres for Science, Technology and Engineering (CSETs) and the Strategic Research Cluster in crystallisation, recently established out of the University of Limerick
The sector is highly regulated by a number of state bodies including the IMB, HSA and EPA. Additionally, the industry is subject to regulatory oversight from the US-based FDA and European EMA. Compliance levels remain very high in the sector in Ireland
The role of research
Central to the PCI strategy is the growth of development activities within the sector, thereby anchoring manufacturing along the so-called development + manufacturing (D+M) model and positioning Irish sites to be the sites of choice for new product launches, bringing them more centre stage in global supply chains. Therefore, it is vital that the industry collaborates actively with the research community in order to build this type of capability both on site and in the research infrastructure. The government has invested significant amounts into the research sector via the HEI-backed Programme for Research into Third Level Institutes (PRTLI), which in turn has invested in a major infrastructure programme. The government has also committed major funding to the research base via SFI, prioritising life sciences.
This has resulted in the establishment of an interesting research base in the country. A notable example of this is the Solid State Pharmaceutical Cluster (SSPC) which is an excellent example of collaboration between industry, Government (SFI) and the research community. The SSPC concentrates on the area of pharmaceutical crystallisation, studying the prediction and physical properties of pharmaceutical powders. A number of universities and pharmaceutical companies actively collaborate in a number of research areas and they are actively working in the developing quality by design models in the crystallisation space.
SFI also sponsors Centres for Science Technology and Engineering (CSETs) which also bring together SFI, industry and the research community. There are a number of these spanning such areas as probiotics, stem cell research and systems biology.
Figure 4 Cost of developing an innovative medicine Copyright: J.A. DiMasi & H.G. Grabowski
Conclusion
If Ireland is to sustain its leading position as a global supplier of pharmaceutical and biopharmaceutical and chemical products, the pharmaceutical, biopharmaceutical and chemical supply sectors will have to transform. This transformation will take place at company level, with the government, its agencies and the research sector playing a key collaborative role in this process.
Manufacturing alone will not be enough to ensure the long-term presence of the industry in Ireland. Research, development and innovation will drive the transformation process forward. Many factors present hurdles, including expiry of patents on blockbuster drugs manufactured in Ireland, a rising cost base, competition from Asia and other locations and the further consolidation of supply-chains. These factors will erode the country’s manufacturing base unless action is taken.
Companies need to embrace the concepts of manufacturing and supply-chain excellence, as well as those of on-site innovation, such as process and product development. Ultimately, if Irish sites achieve this goal and the country can become a global centre of excellence for development and manufacturing, they will be well positioned to participate meaningfully in discovery-related activities. In addition, opportunities for indigenous companies in areas such as high-end synthesis, biotechnology, contract research, specialist centres and contract manufacturing will inevitably emerge. Hence, a much more embedded, integrated and sustainable sector will emerge.
In order to achieve these goals, it is necessary that stakeholders are aligned in a collaborative manner. Ireland does not have the time or resources to duplicate its effort. Now is the time to be smart and agile. The existing Government support network and the local management of pharmachemical companies in this country are strong and integrated. It should be more than possible to build upon this strong history and for this country to move on to become a centre of manufacturing excellence and innovation.
Reference
1 . J.A. DiMasi & H.G. Grabowski (2007) ‘The Cost of Biopharmaceutical R&D: Is Biotech Different?, Price of Innovation: New Estimates of Drug Development Costs’, Managerial and Decision Economics 28: 649-479
About the Author
Matt Moran
Matthew Moran is Director of PharmaChemical Ireland. He graduated in Chemistry and Chemical Engineering in 1981 and also holds an MBA. He worked for over 10 years in the pharmaceutical industry where he held a number of management positions both in active ingredient and dosage form manufacture. Matthew Moran is also founder of the Irish BioIndustry Association (IBIA). He is a member the European Chemical Industry Council (CEFIC). Matthew Moran is Vice-President of the Active Pharmaceuticals Ingredients Committee of CEFIC (CEFIC/APIC). PharmaChemical Ireland represents the interests of the pharmachem sector in Ireland. The Irish BioIndustry Association promotes the needs of the biotech sector.
This website uses cookies to enable, optimise and analyse site operations, as well as to provide personalised content and allow you to connect to social media. By clicking "I agree" you consent to the use of cookies for non-essential functions and the related processing of personal data. You can adjust your cookie and associated data processing preferences at any time via our "Cookie Settings". Please view our Cookie Policy to learn more about the use of cookies on our website.
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorised as ”Necessary” are stored on your browser as they are as essential for the working of basic functionalities of the website. For our other types of cookies “Advertising & Targeting”, “Analytics” and “Performance”, these help us analyse and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these different types of cookies. But opting out of some of these cookies may have an effect on your browsing experience. You can adjust the available sliders to ‘Enabled’ or ‘Disabled’, then click ‘Save and Accept’. View our Cookie Policy page.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Cookie
Description
cookielawinfo-checkbox-advertising-targeting
The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Advertising & Targeting".
cookielawinfo-checkbox-analytics
This cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Analytics".
cookielawinfo-checkbox-necessary
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-performance
This cookie is set by GDPR Cookie Consent WordPress Plugin. The cookie is used to remember the user consent for the cookies under the category "Performance".
PHPSESSID
This cookie is native to PHP applications. The cookie is used to store and identify a users' unique session ID for the purpose of managing user session on the website. The cookie is a session cookies and is deleted when all the browser windows are closed.
viewed_cookie_policy
The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
zmember_logged
This session cookie is served by our membership/subscription system and controls whether you are able to see content which is only available to logged in users.
Performance cookies are includes cookies that deliver enhanced functionalities of the website, such as caching. These cookies do not store any personal information.
Cookie
Description
cf_ob_info
This cookie is set by Cloudflare content delivery network and, in conjunction with the cookie 'cf_use_ob', is used to determine whether it should continue serving “Always Online” until the cookie expires.
cf_use_ob
This cookie is set by Cloudflare content delivery network and is used to determine whether it should continue serving “Always Online” until the cookie expires.
free_subscription_only
This session cookie is served by our membership/subscription system and controls which types of content you are able to access.
ls_smartpush
This cookie is set by Litespeed Server and allows the server to store settings to help improve performance of the site.
one_signal_sdk_db
This cookie is set by OneSignal push notifications and is used for storing user preferences in connection with their notification permission status.
YSC
This cookie is set by Youtube and is used to track the views of embedded videos.
Analytics cookies collect information about your use of the content, and in combination with previously collected information, are used to measure, understand, and report on your usage of this website.
Cookie
Description
bcookie
This cookie is set by LinkedIn. The purpose of the cookie is to enable LinkedIn functionalities on the page.
GPS
This cookie is set by YouTube and registers a unique ID for tracking users based on their geographical location
lang
This cookie is set by LinkedIn and is used to store the language preferences of a user to serve up content in that stored language the next time user visit the website.
lidc
This cookie is set by LinkedIn and used for routing.
lissc
This cookie is set by LinkedIn share Buttons and ad tags.
vuid
We embed videos from our official Vimeo channel. When you press play, Vimeo will drop third party cookies to enable the video to play and to see how long a viewer has watched the video. This cookie does not track individuals.
wow.anonymousId
This cookie is set by Spotler and tracks an anonymous visitor ID.
wow.schedule
This cookie is set by Spotler and enables it to track the Load Balance Session Queue.
wow.session
This cookie is set by Spotler to track the Internet Information Services (IIS) session state.
wow.utmvalues
This cookie is set by Spotler and stores the UTM values for the session. UTM values are specific text strings that are appended to URLs that allow Communigator to track the URLs and the UTM values when they get clicked on.
_ga
This cookie is set by Google Analytics and is used to calculate visitor, session, campaign data and keep track of site usage for the site's analytics report. It stores information anonymously and assign a randomly generated number to identify unique visitors.
_gat
This cookies is set by Google Universal Analytics to throttle the request rate to limit the collection of data on high traffic sites.
_gid
This cookie is set by Google Analytics and is used to store information of how visitors use a website and helps in creating an analytics report of how the website is doing. The data collected including the number visitors, the source where they have come from, and the pages visited in an anonymous form.
Advertising and targeting cookies help us provide our visitors with relevant ads and marketing campaigns.
Cookie
Description
advanced_ads_browser_width
This cookie is set by Advanced Ads and measures the browser width.
advanced_ads_page_impressions
This cookie is set by Advanced Ads and measures the number of previous page impressions.
advanced_ads_pro_server_info
This cookie is set by Advanced Ads and sets geo-location, user role and user capabilities. It is used by cache busting in Advanced Ads Pro when the appropriate visitor conditions are used.
advanced_ads_pro_visitor_referrer
This cookie is set by Advanced Ads and sets the referrer URL.
bscookie
This cookie is a browser ID cookie set by LinkedIn share Buttons and ad tags.
IDE
This cookie is set by Google DoubleClick and stores information about how the user uses the website and any other advertisement before visiting the website. This is used to present users with ads that are relevant to them according to the user profile.
li_sugr
This cookie is set by LinkedIn and is used for tracking.
UserMatchHistory
This cookie is set by Linkedin and is used to track visitors on multiple websites, in order to present relevant advertisement based on the visitor's preferences.
VISITOR_INFO1_LIVE
This cookie is set by YouTube. Used to track the information of the embedded YouTube videos on a website.