Optimize your Laboratories and Leverage Knowledge to Improve Time to Market
Life Sciences is becoming an even more competitive, complex and regulated industry. Nimble new niche players are nipping at the heels of older, more traditional enterprises. The larger players have evolved into hierarchical silos due to a combination of legacy organizational structures, mergers and acquisitions, and lack of a holisitic approach to innovation.
These hierarchical silos behave like isolated divisions in search of new revenue streams – resulting in complex organizational structures with a natural tendency to think vertically rather than horizontally. Consequently, there’s little or no integration between them, causing cross-divisional communication and data exchange to suffer.
Then, of course, there are the pressures pertinent to Life Sciences. How do you deliver patient-centric experiences, improve quality and safety, all while keeping costs down? Is it possible to gain fast approvals in new markets while adhering to regulations and local quality requirements, all at lower expense? What’s the best way to move the business into ‘Next Generation Life Sciences’ and raise operational excellence in order to be first-to-market with patient-centric innovation? Indeed, what new business model should you adopt?
To meet these myriad demands and retain a competitive edge, Life Sciences enterprises need to adapt and evolve to deliver more patient-centric innovations. Only the fittest and most agile will survive by building competitive advantage to drive margins and profit despite the new entrants and growing organizational and regulatory complexity.
We are drowning in information but starved for knowledge.
Better decisions lead to better innovation
In the industry’s ongoing mission to continuously improve patient experiences and outcomes, while meeting previously unmet medical needs, it must not only accelerate the speed of innovation, but also enhance the quality of that innovation.
But how? The answer, in its simplest terms, is by ‘making better decisions faster and more transparently’. Clearly, the quality of decisions depends on the quality of the information that those decisions are based on. And the speed of those decisions relies on the availability and accessibility of that information.
To achieve this, it’s necessary to harness the collective knowledge of your organization and partners to ensure that the right information is being leveraged to drive better decision-making – adapting therapies to better meet patient needs, while being 100% sure that the right processes and procedures have been met.
Build data integrity, maximize data value
“Companies need to create a working environment that values data integrity.” That’s the view of the Deloitte 2018 Global Life Sciences Outlook, ‘Innovating life sciences in the fourth industrial revolution: Embrace, build, grow’.
“Data integrity is data that is complete, consistent, and accurate throughout the data lifecycle. In the next year, regulatory bodies will have high expectations for data integrity due to the adoption of automated systems and advanced technologies, including storage of data in the cloud.”
That, the report argues, is how to counter the biggest drawback to future innovation: the fact that everyone tends to work in a siloed manner. “Currently, companies, and even departments within companies, might collect data in different ways and use different terminology and definitions. This can make it difficult to identify and compare quality issues between functional groups.”
Embrace the collaborative trend
Data provides insights for value-based pricing and market access. Indeed, the linking of data and teams across silos marks a new collaborative, less internally competitive, beginning for many companies.
“One way they can break down silos is to form cross-functional teams – stressing the importance of sharing knowledge between departments and therapeutic areas,” says the report. “For example, some pharma companies have multiple groups in regulatory – corporate regulatory, R&D regulatory, supply chain regulatory.”
The crux of the argument is that data across departments must be unified, accessible, and reusable to create value for such teams. Big data analytics can help unlock the potential of disparate sources of data. Life Sciences companies can then maximize data value by using it for decision-making at an enterprise level and providing a better understanding of emerging risks.
Data value can be further increased, explains the report, “by implementing end-to-end evidence (E2E) management – unifying data across research and clinical development, through to commercialization.”
It goes on to consider the issues for Real World Evidence (RWE) stating that “lack of access to data is a big challenge for RWE programs, underscoring the importance of new collaborations with health systems, patient advocacy groups, and other digital health constituents. As the volume of real-world data grows and accessing it improves, companies will have an opportunity to leverage RWE earlier in the product life cycle, streamlining development and driving down costs and leveraging opportunities in market access and R&D.”
Seizing real world opportunities
“Real world evidence is high on the agenda at many conferences, as people mull over the possibilities that it may hold for changing the way we track a particular medicine's efficacy,” explains Matt Fellows in his Pharmafile.com article ‘Seizing opportunities in the next steps for real world evidence'. (January 2018).
“Efficacy data is what drives the pharmaceutical, medical and healthcare industries and beyond. Alongside safety data, it is the key arbiter of a medicine’s effectiveness in its primary purpose in the world, and is the essential commodity that clinicians and other professionals trade in. And the vehicle that delivers this commodity is, of course, the clinical trial, which has reliably generated such data through, in the best circumstances, carefully constructed studies based on sound science with a wide and representative participant population.
“But, in today’s climate where efficacy and safety of healthcare treatments are increasingly scrutinized, and rightfully so, is this traditional process and dataset enough to achieve the highest standards that we expect? There is a consensus in the industry that the answer to many of the problems that arise from this methodology can be found in real-world data (RWD), and the real-world evidence (RWE) which can be drawn from them.”
The result? A seismic industry shift from the reactive to the proactive use of data. And with the rise of machine-based learning and cognitive computing, there is the possibility of generating insights with new questions that the industry hasn’t even thought to ask. Exciting times indeed.
Intelligent access to knowledge
Successful drug discovery requires individuals from disparate groups to share data and work together. However, Millennium, the Takeda Oncology Company, found that collaboration across the organization was being hindered and, therefore, drug development slowed by the disparate information management systems used by its chemists and biologists
For example, the chemists could not search across Millennium’s own proprietary chemistry. Initially, the company assumed that could be solved would need some type of chemical information system to store and retrieve proprietary reactions. However, the project scope quickly changed to an ELN, because, as Craig Tulig, Associate Director of R&D Systems at Millennium, explained, “once you’ve made chemists go through the effort of entering experimental details into an electronic system, you’re not going to get them to do more work entering all that same information in paper notebooks.”
“For us, going paperless was a means to an end, not an end in itself,” Tulig added, explaining that the primary driver for both the chemistry and the biology projects was having a way to search and retrieve information buried in paper notebooks. “When everything else you’re doing is already electronic, an electronic notebook makes a lot of sense.”
The electronic lab notebook (ELN) of choice for Millenium was the Dassault Systèmes’ BIOVIA Workbook. The company realized that by defining workflows and implementing this highly configurable device, it could begin moving its entire discovery organization, encompassing both chemists and biologists, to a single ELN system.
This has resulted in improved collaboration and productivity across both scientific disciplines. Drug candidates move faster into pre-clinical and clinical review, while the scientists themselves save time by leveraging previous work, streamlining the workflow and attaining a much higher quality of experimental records.
For that last reason, Millennium’s legal team also became a champion the move to the BIOVIA Workbook: “The legality of ELNs as a repository for intellectual property was very controversial at the time, but our legal team determined early that an ELN would be less risky than paper for two reasons,” said Tulig. “First, our IP would be easier to find, and second, our IP would be legible.”
Ensuring compliance doesn’t hinder innovation
Osstem Implant, a dental implant and medical device manufacturer, was also very aware of the legal aspect of its work. The company aims to become the world’s number one implant company by 2023, but going global also means meeting significant product compliance obligations.
“Rising scrutiny around health-related products forces us to devote much of our R&D to regulatory activities rather than on developing new products,” explained Kim Tae-yong, Head of Information Systems Management. “Gaining global market share calls for diversification and rapid delivery of innovative products to the consumer. Our regulation activities should not stand in the way of that. Satisfy regulatory requirements yes, but not at the expense of new product development.”
To achieve this, they needed to automate processes related to Unique Device Identification (UDI) with a solution that could globally manage UDI information, design change information and quality control information.
Osstem Implant chose Dassault Systèmes’ 3DEXPERIENCE platform and its License to Cure for Medical Device Industry Solution Experience.
The result? Processes previously managed separately are now connected and integrated in the system and in compliance with the different Food and Drug Administration (FDA) regulations. These include bill of materials and device master record management; management of certification documents and UDIs; document versioning; requirements management; quality control, and management of environmental substances. Integrated UDI management also improves product quality control, making it easier to track and manage all processes – joining them from beginning to end in a single smooth digital workflow.
Connecting the dots of digital continuity
It’s a broad industry, but whatever your company does within it, structured digitalization enabled by a collaborative platform that connects the entire value network at all levels, in all departments, will deliver the innovation and operational excellence necessary to be successful in today’s market.
It creates a logical path all the way from idea to discovery, delivery and beyond. It means that everyone can work together in real-time using the latest information throughout the product lifecycle. No duplications. No doubts. No delays. And stakeholders can monitor, replicate and make holistic decisions about the products and processes in the context of the product lifecycle – perfecting current and future states. This is essential for open innovation, for research and engineering, for quality and regulatory compliance, for manufacturing and ultimately, for the delivery of differentiated patient experiences.
Breaking down the silos across the enterprise and between suppliers maximizes engagement throughout your entire ecosystem by connecting the organizational dots. That is digital continuity. And that’s also how it’s possible to enhance innovation while increasing competitiveness, by fully capitalizing on your collective knowledge and know-how.
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