Collaborative platforms key to future pharma success

Bringing together the worlds of the scientist, engineer, patient and payer will be increasingly important for future pharmaceutical success, argue Siemens’ Rebecca Vangenechten and Sivarama Nalluri. The linear rather than holistic relationship of R&D, manufacturing and patient hinders development and increases the time to market of new products. It also limits the ability of companies to make a reality of new opportunities for continuous manufacturing and prepare for a future of more personalised medicine.

“Product lifecycle management is the missing piece in the pharma discovery and development jigsaw.”
-Sivarama Nalluri, enterprise solution architect, Siemens

Now, regulatory developments and technological innovation are opening up new opportunities for companies to use lifecycle collaborative management to bring together parts of the value chain that have traditionally been relatively distant from each other. Collaboration will become increasingly important across the R&D / manufacturing interface and across the pharma / patient interface.

Until now, these interfaces have traditionally been points of disconnection rather than connection. The first of these interfaces, for example, has quite distinct scientific and engineering cultures on either side of it. As a product moves from the development stage to the production stage, it is more likely to be 'thrown over the wall' between R&D and manufacturing rather than be part of an ongoing process where knowledge gained by the scientists has already been shared collaboratively with the engineers.

A key factor changing the nature of the R&D / manufacturing interface has been the US Food and Drug Administration's 'critical path initiative' which has provided regulatory encouragement for the use of process analytical technology (PAT) in manufacturing. Process understanding gained in the process development lab needs to provide the foundation for process control and optimisation that PAT enables at the manufacturing stage. Indeed, with good process understanding and control, pharmaceutical companies can have the real possibility of continuous manufacturing which avoids the need to scale up altogether, thus shrinking the time to get product to market.

To make this possible, it is important for information to flow from R&D to manufacturing but it should also be a two-way collaborative flow. Knowledge gained through manufacturing can, for example, be re-used to accelerate product development with the characteristics and behaviour of production equipment and machines in the manufacturing process inputting into the process scale-up phase of new product development.

The second interface - between pharma and patient - is becoming increasingly important for a number of strategic reasons. With fewer new molecules and blockbuster products left to be discovered and developed, companies have to turn more to optimising the particular effects of existing molecules for individual patients and segments of patients. This requires much greater collaboration with healthcare settings and users of the drug to gather data on its bioavailability and outcome characteristics among different subgroups within the patient population.

In parallel with the decline of the blockbuster drug, governments and healthcare payers are coming under immense pressure to contain costs. In the future, most medicines will be paid for on the basis of the results they deliver. Healthcare payers are going to demand more and more often to link the price of a drug to its' therapeutic outcome, even for each individual patient using electronic patient records. Because many factors influence outcomes, pharma companies will need to have more knowledge and understanding of how and why outcomes vary at the point of use and to be able to use that insight to optimise drug characteristics to a patient's therapeutic needs, whether that is through product formulations or delivery mechanisms. Such different drug characteristics will by definition imply different manufacturing scenarios, with implications for manufacturers who will increasingly be judged on their manufacturing flexibility.

Many of the technological tools to achieve collaboration across these vital interfaces are available. Product lifecycle management (PLM) platforms have evolved over the last

15 years meeting the complex enterprise knowledge and information management requirements of sectors such as aerospace, automotive, consumer packaged goods, food and beverage and medical devices. They have an important part to play in providing the backbone infrastructure for shared knowledge, data and work process collaboration. However, unlike other industries, their potential is relatively unexplored in pharma.

PLM software platforms have the ability to handle large volumes of data and to support a large number of users with diverse skillsets in globally distributed environments. Secure access control features provide the means to share knowledge and information with suppliers, partners and customers, enabling team based work-in-progress collaboration. Linked in with discovery informatics platforms, a PLM platform provides a means of improving research productivity and enabling a seamless transition into manufacturing by breaking down the barriers that can exist between different functions and enabling cross-functional synergy. Other features relevant to pharma companies are scalable n-tier architecture and support for government regulations such as FDA 21 CFR Part 11. As discussed above, the need to integrate more closely with healthcare settings and the patient can be addressed by the PLM architecture, which is capable of being extended to embrace all stakeholders.

Siemens already has a strong presence in healthcare, with diagnostic devices, software and other solutions, and in pharma with PAT, LIMS and other technologies. PLM software, developed by UGS, is now part of the Siemens' portfolio of solutions. It saves and keeps track of all the information gathered on the product/molecule. By providing common access to a single repository of all product-related knowledge, data and processes, PLM can speed up the innovation and launch of successful products. PLM spans the whole lifecycle of the drug and enables networks of innovation and collaboration, capturing best practice and lessons learned, creating a storehouse of valuable intellectual capital for re-use. In the future, the document management functionality of PLM system will also support the (e-) regulatory submission and approval process, enabling companies to automate this process by extracting all the relevant "fields" to compose a submission file ready to be submitted to the regulatory authorities.

The opportunity to bridge the gaps between R&D and manufacturing and between pharma and patient through the use of lifecycle collaborative platforms offers pharma companies a powerful tool to accelerate learning, improve process understanding and bring together the worlds of the scientist, engineer, the clinician and the patient.  The twin prize is being able to build the right product, using the interface with healthcare to develop a product that the patient needs, and to build the product right, using data and process understanding from R&D all the way down through manufacturing to get quality right always and shrink time to market.

Biographies

Rebecca Vangenechten is a Life Sciences Industry Consultant with Siemens. She is responsible for business development life sciences US and focuses on innovative technologies, including Process Analytic Technology (PAT).

Sivarama Nalluri, Ph.D. is an Enterprise Solution Architect in the Office of Architecture and Technology, Siemens PLM Software. He has More than 20 years of experience in research, planning, architecting, developing and deploying innovative PLM and other enterprise software solutions for Fortune-500 corporations such as Procter & Gamble, Target Corporation, Lockheed Martin, Ford, Bath Iron Works, NASSCO, Ingalls Shipyard. As a member of office of architecture and technology team he is responsible for translating CPG, F&B, Pharma and other consumer products customer requirements into product technology roadmaps. Siemens profile for Life Sciences

Siemens profile for Life Sciences

Siemens is a leading supplier to manufacturers in the Life Science Industry, with product and solution offerings in the area of automation (building and process), drives, electrical infrastructure, power distribution, fire, safety, logistics, and water systems.

In addition to a broad and innovative product portfolio, Siemens offers services and competencies from dedicated engineering services to a multidisciplinary optimization approach throughout bio and pharmaceutical manufacturing to address the key issues of the industry and improve their business. This covers not only state-of-the-art technology but also work on strategic, long-term and comprehensive concepts to benefit the customer's business worldwide.