INDUSTRY INSIGHT68

Regulatory developments and technological innova-tion are opening up new opportunities for companies to use life cycle collaborative management to bring together parts of the value chain that have tradition-

ally been relatively distant from each other. Collaboration will become increasingly important across the R&D/manufactur-ing interface and across the pharma/patient interface.

Until now, these interfaces have traditionally been points of disconnection rather than connection. For example, 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.

Th e US Food and Drug Administration’s ‘critical path initiative’ has paved the way for the use of process analytical technology (PAT) in manufacturing. Process understand-ing 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 com-panies can have the real possibility of continuous manu-facturing which avoids the need to scale up altogether, thus shrinking the time to get product to market. Information needs to fl ow from R&D to manufacturing but it should also be a two-way collaborative fl ow. Knowledge gained through manufacturing can, for example, be re-used to ac-celerate the product development process.

Th e second interface – between pharma and patient – is becoming increasingly important for a number of stra-tegic reasons. With fewer new molecules and blockbuster products left to be discovered and developed, companies have to turn more to optimising the particular eff ects of existing molecules for individual patients and segments of patients. 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. Because many factors infl uence 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 mecha-nisms, and to feed that information back into development, formulation and manufacturing.

Many of the technological tools to achieve collabora-tion across these vital interfaces are available. Product lifecycle management (PLM) platforms have a key part to play in providing the backbone infrastructure for shared knowledge, data and work process collaboration. How-ever, unlike other industries, their potential is relatively unexplored in pharma. PLM soft ware platforms have the ability to handle large volumes of data and to support a large number of users with diverse skill sets in globally distributed environments.

Siemens already has a strong presence in healthcare, with diagnostic devices, soft ware and other solutions, and in pharma with PAT, LIMS and other technologies. PLM soft ware, developed by UGS, is now part of the Siemens’ portfolio of solutions. By providing common access to a single repository of all molecule and product-related knowledge, data and processes, PLM can speed up the innovation and launch of successful products. PLM man-ages whole life cycle of the drug and enables networks of innovation and collaboration, capturing best practice and lessons learned, creating a storehouse of valuable intellec-tual capital for re-use.

Th e prospect of bridging these interfaces is compel-ling. It off ers the twin prize of 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 and shrink time to market.

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.

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 is an Enterprise Solution Architect in the Offi ce 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. He is responsible for translating CPG, F&B, Pharma and other consumer products customer requirements into product technology roadmaps.

“Product lifecycle management is the missing piece in the pharma discovery and development jigsaw” Sivarama Nalluri, Enterprise Solution Architect, Siemens

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