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Manufacturing

Feature:

A new pharmaceutical era

Amber Stokes talks to Microsoft and its partners to find out how technology is driving change in the pharmaceuticals industry

Pharmaceutical organisations are being pulled from every direction. While they strive to deliver life-changing drugs and products in an extremely competitive market, numerous challenges threaten to get in their way.

“Besides a challenging economic situation and higher costs, process manufacturers are faced with the constant pressure to innovate in order to stay competitive,” says Claudia Roessler, worldwide industry solutions manager, process industries at Microsoft. “Organisations are therefore seeking to develop new and innovative products and features in an increasingly mature market to set them apart from the competition.”It has also become necessary for organisations to consider new geographical markets, strategic partnership and joint ventures or target groups in order to grow their business globally.

Pharmaceutical companies in particular feel this pressure for increased innovation. “Pharmaceutical organisations are born out of innovation,” adds Andrea Ruosi, CEO at AX for Pharma. “Developing, creating and providing the right medicine is still important and will remain so in the future. But today, it is vital that organisations do it in an effective and efficient way so that they can concentrate on creating improved, safer medicines instead of spending money on maintaining obsolete, rigid processes and systems.”

Roessler also adds that increased regulations and costs for clinical trials can become significant cost drivers. “Pharmaceutical organisations are also among the companies with the highest research and development (R&D) spend,” Roessler says.

“Manufacturing, quality and IT costs are rising for many reasons,” adds AX for Pharma’s Ruosi. “Regulations are becoming more stringent and organisations have to ensure they run their operations efficiently and maintain high quality standards.”

Process manufacturers are faced with constant pressure to innovate

Claudia Roessler, Microsoft
 
While pharmaceutical organisations concentrate on such challenges with products, their attention should shift to the technology that can help. “One is leveraging social and collaboration tools to fill the innovation pipeline. And creating secure innovation hubs, where R&D teams across the company or third parties such as partner companies and universities can exchange ideas and collaborate in a safe environment. Second is about minimising cost and time in the R&D process, for example by eliminating manual, paper-based processes. There is also a third category, which is about enabling talent and productivity. There is a tremendous need for clinical trials to become digital, avoiding manual, paper-based processes,” says Microsoft’s Roessler. “Microsoft and our partners also offer a wide variety of solutions along the R&D value chain, such as enterprise content management, electronic lab notebook, project management and clinical trial solutions. Many focus areas here are to eliminate manual, paper-based processes in order to comply with regulatory requirements and safe time for creating content.”

In order to avoid challenges surrounding delays in the clinical documentation process, multinational pharmaceutical company Sanofi worked closely with Microsoft partners Dita Exchange and the ArborSys Group to launch Content Re-Use Information System for Electronic Health for digital content management. The solution, part of which is based on SharePoint Server 2010, enables stakeholders to author, assemble, review, approve, reuse, publish, and deliver high-quality, consistent, and compliant content and documentation throughout the product development life cycle – aiding the submission to regulatory agencies and other industry audiences. “The greatest benefit of the implementation is the speedy time to market as a result of the better electronic organisation of clinical trial documentation,” says Sam Youness, worldwide industry technology strategist for process manufacturing at Microsoft. “The faster Sanofi brings a product to market, the sooner and longer it will sell under patent, which results in additional profits in the hundreds of millions of dollars.”

Another trend that is having a huge impact on the industry is the changing workforce. “Some of the most senior scientists are going to retire, whereas a new ‘generation X’ workforce is taking their place,” says Roessler. “It is becoming crucial to provide more flexible workstyles and meet the expectations of this new workforce, which wants a much more independent working style that is compatible with their digital lives. They want companies to promote the use of social networks and provide the flexibility to work from anywhere at any time with their own devices.”

Microsoft is uniquely positioned in this space to make computing ‘people centric’ with a wide range of devices such as Surface, other Windows 8 tablets and Windows Phone 8 smartphones to create a dynamic workplace, that accommodates the diversity and habits of workers, and a secure, centralised and unified management platform to support flexible work solutions and protect IP.

Globalisation has taken hold of all industries, but what effects has this trend had on pharmaceutical organisations? “The impact of globalisation on pharmaceutical companies has been both good and bad,” says Jennifer Petrosky, global marketing director, Life Sciences Industry at Dassault Systèmes. “On the one hand, it has provided tremendous opportunities to reach new markets and deliver drugs and vaccines to those that need them. However, on the other, serving new markets in new countries has also presented new regulatory requirements and suppliers, for example, which have never been managed previously.”

“Globalisation has had traditional effects on the pharmaceutical industry, where big pharmaceutical companies in the developed world have moved part of their production to developing countries for cheaper labour and better proximity to their markets,” says Youness. “However, there have also been non-traditional impacts on the industry. For instance, some of the generic producers are doing their own research and development and bringing their own products to market. This has led to some partnerships between these generic producers and big pharmaceutical companies centred on certain promising drugs that have passed initial testing.”

Youness explains that globalisation has also led to pharmaceutical companies having a new mind-set – they’re now thinking global as they make, market and sell their products. They no longer target specific markets as they develop their drugs for the fear of missing out if they did.

Many of the problems pharmaceutical organisations are experiencing today revolve around having to collaborate across cultural, language and time zone barriers. Organisations are adopting different collaboration tools and technology such as collaboration portals and document management systems, while live communication and conferencing technologies are also being implemented to allow for real-time collaboration over research matters, supply chain and even production. “We have also seen companies using social media to capture employee expertise in knowledge bases and make it transferable to other employees through search technologies,” adds Youness.

Microsoft partner Invensys is working with pharmaceutical organisations today to help them respond quickly and cost effectively to changing legal requirements while at the same time ensuring high product safety. Its suite of technology solutions were implemented at Rottendorf Pharma, which develops, manufactures and packages pharmaceutical products in a solid form. The company had in place a building control system to help manage environment conditions during the production, analysis and storage of its products, but the lack of a control room revealed the necessity of a Good Manufacturing Practice (GMP)-compliant room monitoring system.

Invensys’ ArchestrA System Platform was implemented to process data created by the alarm system, while pharmaceutical process parameters for long-term analysis are then recorded in Wonderware Historian and reports are generated accordingly. To visualise the system, the Wonderware InTouch visualisation software is used. Through the use of Invensys technology, all Rottendorf Pharma’s GMP-critical values such as differential pressure, temperature and relative humidity are now measured, analysed and filed continuously.

Another product, which can meet many of these challenges, builds on the unique capabilities on offer through Microsoft Dynamics AX. AX for Pharma has developed a commercial off-the-shelf solution that can provide real benefits across a pharmaceutical organisation’s entire value chain. “AX for Pharma is more than a enterprise resource planning (ERP) solution,” says Ruosi. It covers ERP, including regulated aspects like GMP; a laboratory information management system; weighing and dispensing; GMP plant maintenance and calibration and regulations like 21 CFR Part 11. “To get all this functionality, companies often have to buy three or four separate IT solutions. These can be very expensive to maintain and are usually based on different technologies that require in-house specialists for each application. AX for Pharma removes all of this by offering an end-to-end, feature-rich, integrated yet modular solution, which allows companies to efficiently achieve computer system validation,” Ruosi adds.

Biolab is a Brazilian pharmaceutical organisation that develops, manufactures and commercialises medicines. Through implementing AX for Pharma’s solution, Biolab is able to drive its mission of allowing for ‘health at the reach of all’. “With the growth of Biolab in recent years, our need has increased for more controls and strengthening the security and integrity of our information. AX for Pharma, Biolab’s new ERP system, is a solution that allows the company to quickly adapt to the demands of a highly competitive market that is always in transformation,” says Márcio Alcântara, Biolab’s IT manager. “One of the benefits that the software will provide us with will be the integration of processes and use of information by the organisation, facilitating the understanding of the business and strategic decision-making.”

While technology is key to helping companies improve process efficiencies and bring products to market faster, the industry is also exploring how IT can be used to better serve patients. “The life sciences industry is beginning to focus on looking at the patient more holistically,” says Andrea McGonigle, managing director of Microsoft Life Sciences. “Patient engagement is an important element across the value chain in pharmaceuticals, spanning R&D, manufacturing, clinical trials to formulary, sales and marketing – the patient is at the centre of all these activities.”

McGonigle explains that patient engagement is a key part of healthcare beyond the pharmaceutical industry, as healthcare organisations are working together across life sciences, payers, providers and government organisations to share information and more seamlessly connect care and engage with patients as a way to impact patient outcomes. “It is all about looking at the grand health ecosystem and providing high-value patient centric solutions,” she says.

While this is very important to pharmaceutical manufacturers today, McGonigle notes that companies are at various stages of addressing the trend. “The industry now faces what I would describe as a ‘perfect storm’ in terms of concomitant demands for increased quality of care and clinical results from products, an ageing population exacerbated by an increase in chronic diseases, commoditisation and competitive pressures amongst healthcare manufacturers and decreasing healthcare provider resources. The pharmaceutical industry is no longer about drugs and/or devices, but rather high-value patient-centric solutions and looking at the patient more holistically.”

The value of effective patient engagement is clear, especially when you consider the impact non-compliance from patients is having in the industry. “According to the Express Scripts 2011 Drug Trend Report¸ 50 per cent of patients are not adherent and US$8 billion of revenue is lost each year to patients who do not fill their prescriptions or do not take their drugs correctly, causing more than US$300 billion annual waste,” confirms McGonigle. “The cost of non-compliance for the average pharmaceutical brand is 38 per cent of its sales and US$65 billion in lost revenue for the industry.”

“There are various challenges to consider when you’re monitoring patient usage, including regulatory implications,” adds Dassault Systèmes’ Jennifer Petrosky. “For example, in the US the Food and Drug Administration published guidance in terms of patient monitoring and social media. This is really a new frontier in the industry, however, pharmaceutical companies that do it right will be leading the industry and in the end, patients will benefit from better products.”

Microsoft and its partners are helping to drive the shift towards a more connected healthcare ecosystem. Its integrated platforms are helping life sciences, payers, providers and government organisations share information and more seamlessly connect care as a way to impact patient outcomes. And according to McGonigle, this can be something as simple as SMS texts with reminders to take medication, to social media and the cloud, to creating devices where patients can track their insulin and share with family members and doctors.

“To get legally-compliant information and interaction with more stakeholders directly, without using too much sales forces out there, organisations need a combination of new technologies, which must interact well together,” says Rainer Weissenberger, CEO of Yaveon. “There are, of course, collaborative and social media platforms that need to be integrated with the customer relationship management (CRM) system for handling contacts, dates and segmentation of the target groups. For predictive analysis and marketing controlling, organisations need geographic information and sales information combined with marketing plans.” Weissenberger explains that organisations in the future will be integrating all these technologies so that closed groups can share restricted information. “This will include a sales and marketing platform based on Microsoft SharePoint, using data from an enterprise resource planning system and CRM, which also integrates with social media channels like Yammer,” he says.

According to Dassault Systèmes, its solution truly connects everyone within the organisation with the outside world – including patients. “Today, there are various point solutions that attempt to serve the needs of a specific discipline within an organisation,” says Petrosky. “For example, there are solutions that support document management compliance, there are other solutions that serve other quality requirements, change management, ERP, supply chain and others. Licensed to Cure for Pharma & Biotech is the first industry solution experience targeted specifically for pharmaceutical companies and is unlike any other solution on the market.”

The benefits of improved patient engagement reach patients, as well as organisations. “A more educated and informed patient can drive patients to more clinical trials, create brand loyalty and create positive sentiment about a brand or drug. But compliance is also important when we think about health outcomes, as a more engaged patient is more compliant and, in turn, healthier,” concludes McGonigle.

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