MDC Connects: The challenges of accessing clinical samples

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Small and medium enterprises (SMEs) need access to clinical samples for core research and development activities like progressing assets and launching new products, but there are several barriers that limit their access within UK biobanks. These barriers include biobanks not being adequately promoted, lack of awareness from researchers, no unified infrastructure, slow access committees and governance requirements. Overcoming these barriers will require action from regulatory bodies like the Health Research Authority and Human Tissue Authority, patient groups, and improvements to areas like cost recovery, customer awareness and management, operational processes, and documentation standardization by biobanks. Utilizing UK bioresources benefits long term sustainability and the UK economy.

The challenges of accessing clinical
samples
Helen Hind
Biosamples Lead
MDC Connects
Webinar Series
Wednesday,
17 June 2020

© 2019 Medicines Discovery Catapult. All rights reserved.
The SME perspective..
Why SMEs need samples
Barriers to sample access
How to overcome the barriers
Who needs to act/get involved
The importance of utilizing UK bioresources

© 2019 Medicines Discovery Catapult. All rights reserved.
Why do SMEs need samples?
Core R&D activity
Progress assets
Launch new products
Collaborations
NHS/academic biobanks
Commercial sample supplier organisations
Procurement platforms
Method development
Assay validation
Regulatory submission
Analysis of biomarkers
WHY?
WHERE FROM?
WHAT DO THEY DO WITH
THEM?

© 2019 Medicines Discovery Catapult. All rights reserved.
Barriers to sample access within UK biobanks
The UK has rich sample resources, but many are never accessed?
Biobanks not adequately promoted
Researchers aren’t aware of them
No real UK wide infrastructure
Access committees
Governance requirements
Speed of access

© 2019 Medicines Discovery Catapult. All rights reserved.
How can industry help biobanks
make samples available to them?

© 2019 Medicines Discovery Catapult. All rights reserved.
Overcoming the barriers..
• Cost recovery
• Customer awareness – how easy are they to find?
• Customer management – promptness of response
• Operational processes
• Documentation/standard terms
• Delivery resources
• Patient engagement

© 2019 Medicines Discovery Catapult. All rights reserved.
Who needs to act? Why should we use UK
bioresources?
Health Research Authority (HRA)
Human Tissue Authority (HTA)
Patient groups
Long term sustainability
Benefits to UK plc

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