Nov 5, 2020

Pharma sector needs better data infrastructure, experts say

pharma
research
covid-19
Data
Leila Hawkins
3 min
Pharma sector needs better data infrastructure, experts say
A panel of life science experts discussed the need for a central data sharing platform...

The pharmaceutical industry needs a centralised data platform so companies can share data easily, a panel of experts has advised. 

This was one of the topics discussed at a virtual roundtable by The Pistoia Alliance, a global, not-for-profit alliance that works to lower barriers to innovation in life science and healthcare research and development.  

Leaders from pharma giants including Gilead and Roche were among the attendees at the event, which focused on learnings to date from the COVID-19 pandemic. The panel highlighted the power of collaboration in an emergency and called for continued co-operation post-pandemic. 

Attendees heard a call to action from the president of the Alliance, Dr. Steve Arlington, on the need for more companies to invest in and build on the work of the pharma and life sciences world so far. Participants discussed their increased willingness to share data among companies but drew attention to the need for a better collaboration infrastructure to make widespread data-sharing a reality.

“During COVID-19, collaboration has been the lifeblood of R&D" Dr. Merdad Parsey, Chief Medical Officer at Gilead Sciences said. "From the outset, we’ve been dependent on working together – initially diagnostics in vivo and in vitro could only be done through government laboratories, and we also worked with the I-SPY network, the NIH and WHO to conduct trials. 

"We couldn’t have got to where we are now if we didn’t all work together. There is an opportunity for us all to get much better at data sharing and to develop this ethos, because we also need the expertise of those outside the industry to advance the causes we are working on right now and in the future.”

Several of the panel members agreed that getting data ‘back’ from partners due to a lack of infrastructure had been a challenge. There was also consensus on the need to remove barriers to sharing information outside of the pharma ecosystem – for example to encourage data sharing between pharma companies and those in chemicals, technology, manufacturing, and supply chain, amongst others. 

This was underlined by the discussion between the panel that all nations have faced huge challenges pulling together the various moving parts needed to get national testing programs up to speed. 

Participants also referenced the long-term impact that COVID-19 is set to have by discussing its influence on plans for the “next pandemic” that are currently being made.

“2020 has been a hugely challenging year for all of our members, but I’ve been blown away by the outstanding efforts to help humanity overcome the COVID-19 crisis" Dr Arlington added. 

"Between our members and beyond, the fruits of collaborative projects have underlined the very reason behind the founding of the Alliance. We now need to bring other industries into the fold and be willing to work with those outside of our immediate circle, as well as create a long-term infrastructure for sharing data. 

"Though it’s an unprecedented time, we need to carry this momentum forward and ensure this collaborative instinct continues post-pandemic. We also need governments around the world to lead the charge; the importance of following the science remains paramount but a spirit of openness is required that allows us all to work together to understand the real reasons why we take a certain path and avoid the trap of politically motivated actions being blamed on science.”

Digital technologies will be key to further breakthroughs and particularly important to help overcome the limitations caused by social distancing. The Pistoia Alliance launched a collaborative project this summer to explore technology for collecting data during clinical trials. 

The panel discussed how other digital technologies that can be applied during COVID-19 must also be investigated. Data collection and symptom monitoring will be critical to efforts to treat COVID-19 they said, particularly as the virus isn't fully understood yet. 

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Jul 24, 2021

A guide to labelling compliance for medical devices

medicaldevices
Technology
healthcare
Compliance
Susan Gosnell
4 min
A guide to labelling compliance for medical devices
Susan Gosnell, Product Manager at Loftware, explains labelling compliance for small medical device manufacturers

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.  

Future-proof technology

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.

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