May 17, 2020

GSK and 23andMe undergo a four-year collaboration to bring new drugs to the market

pharmaceutical
Genetics
GSK
research
Catherine Sturman
4 min
GSK and 23andMe has unveiled a new four-year collaboration where the companies will focus on new research and develop initiatives, in order to develop n...

GSK and 23andMe has unveiled a new four-year collaboration where the companies will focus on new research and develop initiatives, in order to develop new innovative new medicines and potential cures, using human genetics as the basis for discovery.

The collaboration will combine 23andMe’s large-scale genetic resources and advanced data science skills, with the scientific and medical knowledge and commercialisation expertise of GSK. The company has also made a $300mn equity investment in 23andMe.

The deal comes with an option of extending to a fifth year under which GSK will become 23andMe’s exclusive collaborator for drug target discovery programmes.

One of the leading consumer genetics and research companies, 23andme has enabled consumers to gain a greater understanding of their genomic makeup. Hailed as one of the smartest companies in 2017 by MIT Technology Review, it has also featured as Fast Company's #2 Most Innovative Health Company in 2018.

Over 80% of its customers consented to participate in research and contribute their information to a dynamic database, creating the world’s largest genetic and phenotypic resource.

GSK is now set to take full advantage of such valuable data, bringing extensive drug discovery and development capabilities across a broad range of diseases and modalities, including small molecule, biopharmaceuticals and cell and gene therapies.

Applying its world-class technologies, including access to additional data sources, in-house target validation and genetics expertise, the company will utilise its manufacturing, commercial operations and scale to support partner activities across research and development.

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said; “We are excited about this unique collaboration as we know that drug targets with genetic validation have a significantly higher chance of ultimately demonstrating benefit for patients and becoming medicines.

“Partnering with 23andMe, an organisation whose vision and capabilities are transforming the understanding of how genes influence health, will help to shift our research and development organisation to be ‘driven by genetics’, and increase the impact GSK can have on patients.”

Anne Wojcicki, CEO and Co-Founder of 23andMe, added; “This collaboration will enable us to deliver on what many customers have been asking for -- cures or treatments for diseases. By leveraging the genetic and phenotypic information provided by consenting 23andMe customers and combining it with GSK’s incredible expertise and resources in drug discovery, we believe we can more quickly make treating and curing diseases a reality.”

Focusing on translating genetic and phenotypic data into R&D activities, the companies will seek to undertake the following:

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  1. Improve target selection to allow safer, more effective ‘precision’ medicines to be discovered. Genetic data can significantly improve our understanding of diseases, their pathways and mechanisms, supporting the design and development of more targeted medicines. Use of genetic data in selecting drug targets can increase both the probability of success in a particular indication and avoid unwanted safety risks.
  2. Support identification of patient subgroups that are more likely to respond to targeted treatments. Scale is critical for the detection of genetic effects in smaller subsets of diseases and patients.

Customer’s aggregate and de-identified data could help enable the discovery of a significant number of novel associations from a diverse range of people, which would not otherwise be possible.

     3.The companies will use 23andMe's rich database and proprietary statistical analytics to fuel drug target discovery, with the goal of jointly discovering novel targets that can progress into development.

A joint GSK-23andMe drug discovery team will seek to identify new targets and prioritise based on strength of the biological hypothesis, possibility to find a medicine, and clinical opportunity.

23andMe currently has a portfolio of early stage therapeutic research programmes across a wide range of disease indications, which will be assessed for inclusion. GSK will contribute its LRRK2 inhibitor, which is currently in preclinical development as a potential treatment for Parkinson’s disease. This programme is expected to significantly progress by leveraging 23andMe’s large base of consented customers who are aware of their LRRK2 variant status as a result of 23andMe’s FDA-authorised genetic health reports.

Together, GSK and 23andMe are expected to more effectively target and rapidly recruit patients with defined LRRK2 mutations in order to reach clinical proof of concept.

All activities within the collaboration will initially be co-funded (50%/50%), with either company having certain rights to reduce its funding share for any collaboration programme. GSK will also have the right to work with 23andMe to analyse 23andMe’s database for validation of GSK’s existing therapeutic portfolio as well as leverage 23andMe’s capabilities for clinical trial recruitment. Both GSK and 23andMe will share in the proceeds from new treatments and medicines arising from the collaboration.

All findings will be published throughout the collaboration to provide transparency and fully support future research.

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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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