Elsevier launches pharma and biotech startup hub, The Hive
Specialising in science and health, information analytics company Elsevier has recently launched its nominations for The Hive, which has become an essential innovation hub for biotech and pharmaceutical start-ups in the US.
Elsevier’s R&D Solutions are utilized everyday across the life science industry to enable research and accelerate confident decision making in drug discovery and development, and helps institutions and professionals progress science, advance healthcare and improve performance. The company provides digital solutions and tools in the areas of strategic research management, R&D performance, clinical decision support, and professional education.
This year, approximately eight start-ups have been working on implementing ideas which will be chosen to become part of The Hive, which has incorporated an unlimited number of places for candidates which show increased promise in these areas.
If successful, The Hive’s start-ups will receive complimentary access to Elsevier’s suite of digital solutions for 18 months, which will no doubt support the advancement of critical research and improve productivity.
Initially launched in 2016, The Hive displays significant innovation in the start-up biotech and pharma sector; as well as demonstrate to larger companies and other areas of the research community, how research and development (R&D) challenges can be overcome.
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Tamas Szarvas, CMO, Corporate R&D, Elsevier’s R&D Solutions explained: “We created The Hive to highlight the trend in the industry which has seen biotech and pharma start-ups become centers of cutting-edge science. This trend is continuing in 2017 – many of the most promising drug candidates and discoveries in R&D pipelines originate from these early stage companies.
The Hive will continue to highlight the fresh, innovative and agile world of R&D that is taking place within start-ups. Additionally, we know that the industry is always looking to learn from these innovation powerhouses, and The Hive offers a far-reaching platform for sharing success stories.”
At present, the healthcare sector is facing a number of complex challenges; from implementing new healthcare systems, overcoming antibiotic resistance in the absence of new drugs, to reducing the chance of unanticipated adverse events, and also being able to deliver on the promise of precision medicine. For health to ensure it delivers a meaningful and objective impact, this access to latest data, analytics and technologies to support R&D professionals, remains essential.
For start-ups that will be joining The Hive, Elsevier’s R&D Solutions will therefore support them to deliver rapid scientific breakthroughs, and improve the lives of patients.
Claudia A. McDonald Bøen, Ph.D., CEO of 2016 participant in The Hive, Arctic Pharma AS commented: “Elsevier’s solutions contain extensive and detailed information on chemical compounds/structures, visualization of disease mechanisms, metabolomics data, and predictions on drug-drug interactions – all of which are important to further develop our cancer therapies.”
A guide to labelling compliance for medical devices
Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes.
Validating systems and processes including labelling, to ensure they are compliant with stringent regulatory standards is tough and can be expensive. Indeed, compliance with the EU’s Medical Device Regulation (MDR) will cost more than 5% of annual sales, according to 48% of 101 companies polled by the German company Climedo Health, in July and August 2020 about their MDR-readiness.
But if companies bungle the software validation process or put incorrect and uncompliant data on the labels themselves, the penalties are likely to be more severe than just making corrections. Health and safety may be put at risk and fines imposed for failing to comply. When it comes to compliance, they may become overwhelmed with regulations in other geographic regions that focus on device traceability, each with a unique device identifier (UDI-like) component to it.
On the validation front, companies may not be familiar with the software validation process and the multiple tests and documentation necessary for validation are demanding if companies only have a small IT team that is very busy.
Putting a plan in place
MDR-compliant labelling, however, brings with it certain requirements which differ from what is demanded under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box. This is only one of many stipulations that usually require redesigned labels.
Small medical device manufacturers who rely on time-consuming and error-prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling which can lead to non-compliance. They may have limited staff and no structured processes around roles and responsibilities when it comes to label design, changes and approval. As project leads work toward a compliant labelling process, it is therefore important to establish defined roles and access for each stage of the process.
When dealing with a compliance initiative, up to date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with the EU MDR or FDA regulations. Many times, label templates are hard coded, meaning IT must be involved in making changes. And with IT staff often being tasked with multiple mission-critical projects in the organisation, labelling projects can be delayed. For many small medical device manufacturers who have limited resources, finding a solution can be a challenge.
Why labelling in the cloud offers a roadmap forward
Validation-ready cloud labelling solutions have now emerged to ease compliance with regulations and time-consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role-based access, approval workflows and electronic signatures. Outside of compliance, carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.
The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.
When it comes to validation, as with many labelling systems, those hosted in the cloud have vendor-supplied documentation that streamlines the process and significantly eases the burden when it comes to installation qualification (IQ). The manufacturer itself has a much lighter burden and a streamlined path to a validated system and process.
A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once a year rather than multiple times. This gives them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.
The manufacturer would of course need to work closely alongside the vendor and review the documentation, but, if needed, the vendor is able to do much of the work for them, providing not only the full validation acceleration pack but also professional services to assist with the validation process.
While some medical device manufacturers choose to tackle validation on their own, the vendor supplied validation acceleration pack or documentation helps to simplify the process. Consultancy and advice around validation is usually available from the vendor, tailored to the business’s specific needs.
Given the immense hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system while easing compliance and validation. This is a future-proof technology. With a cloud-based labelling system, medical device manufacturers can be confident that they are running the most up-to-date software, enabling them to address the fast-changing new regulations and cope with whatever comes their way. And especially in the current pandemic, when face-to-face meetings are still problematic, it is a perfect way to keep labelling operations moving forward.