A Cell and Gene Therapy (CGT) needle to needle tracking solution using Blockchain (#3053)

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Idea Description
Supplementary Information
Innovation 'Elevator Pitch':
Future-proof blockchain based provenance solution for CGT. Our digital service creates an efficient & transparent chain of identity/custody/condition & diagnostic, address compliance burdens, reduce cost & enable co-operation in a competitive arena.
Overview of Innovation:
FarmaTrust have used blockchain to create a tracking service for the latest cell & gene therapies.

Our solution is a working prototype that is able to track chain of identity, custody, condition and diagnostic for autologous cell therapies. It ensures transparency for regulators, enables efficiency by reducing HIPAA compliance requirements and records are ultimately more secure. All with the ultimate aim to support improved patient outcomes.

We also believe that the blockchain will be a key enabler in decentralising the manufacturing process to ultimately take these new therapies closer to the patient.

Because of this we are developing significant knowledge and skill based on these new technologies for the digitised healthcare and medicines agenda, and specifically in the smart and connected logistics supply chain that are applicable globally, thereby making the UK the go to place for this type of expertise.

View the FarmaTrust Explainer Infographic – click here.

Stage of Development:
Evaluation stage - Representative model or prototype system developed and can be effectively evaluated
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Overview of Innovation:
Representative model or prototype system developed & can be effectively evaluated. International patent pending.

We use blockchain technology & smart contracts to automate outcomes based contracting in a trusted fashion for pharmaceuticals, devices & healthcare services.

Digipharm have developed a platform to utilise revolutionary blockchain technology to overcome barriers to the execution of innovative pricing agreements. Our system reduces admin costs associated with reconciling value-based pricing agreements for all stakeholders through the use of smart contracts & creates a medical information infrastructure that is tamper-proof & immutable, something that is imperative when paying for performance versus a fee for service approach. We aim to accelerate the much-needed restructuring of healthcare delivery systems to a value-based approach on a fully independent, third party platform. This will provide the opportunity to evaluate the real time performance & value provided by therapies in a real-life setting without the current infrastructural limitations.

Our solution will address current delivery challenges such as:
  1. Inability to track patient adherence in real time
  2. Inconsistent practices between healthcare providers
  3. Patient privacy concerns
  4. Manual process handling - claims validation, credit not creation, adjustment calculation
  5. Inability to use a ‘fit for all’ customisable platform across all regions
  6. The admin burden of processing pricing agreements, fragmented health systems & data accessibility act as major barriers to the required restructuring of health systems
  7. Empower payers & manufacturers to negotiate meticulous pricing agreements, from truly personalised schemes based on surrogate outcomes to wider access agreements applicable to patient cohorts of interest
  8. Allowing patients to be followed & aggregates data related to patient treatment & outcomes across numerous sites
  9. Expediting integration, coordination & delivery of patient centric healthcare systems with a focus on improving patient outcomes
  10. Allowing automated dynamic pricing models to be implemented across different indications, patient subgroups, therapy lines & localities while providing consistent & comparable outputs
  11. Delays in access to life saving medicines
Benefits to the NHS - see attached

We have started our UK pilot & are finalising our pilot in Ireland. We need to create the right processes for good information governance & seek to partner & work with the NHS in order to implement our platforms.
 
Initial Review Rating
1.00 (1 ratings)
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Innovation 'Elevator Pitch':
Achiever Medical LIMS helps research institutions to improve lab efficiency, facilitates return on investment into sample collections & demonstrates compliance to legislation. Inbuilt security protects patient identifiable data with controlled access
Overview of Innovation:
With increasingly stringent regulations and greater emphasis on profitability placed on laboratories, Achiever Medical LIMS was designed in conjunction with leading scientists & clinicians to provide an easy-to-use sample management system incorporating sample tracking, clinical data management, workload & communication management. The system addresses the gap left by traditional LIMS systems by providing enhanced donor and research profile data.
 
Achiever Medical LIMS is a process driven & web browser-based laboratory & clinical data management system that is flexible/scalable to evolve as needs develop. Using Open Standards to streamline the sharing of information across existing applications Achiever Medical LIMS allows data to be imported from, e.g. Patient Information & Storage Environment Management Systems, Lab equipment, Emails & Calendars for an holistic overview of samples, equipment, environment & workload.
 
Achiever Medical LIMS enables the mapping of Standard Operating Procedures (SOP) to ensure staff adhere to agreed standards, ensuring regulatory compliance & promoting quality, efficiency & consistency. Achiever Medical LIMS can assist in compliance with the Human Tissue Act, Good Laboratory Practice & CFR 21 Part 11.
 
Sample tracking functionality delivers complete traceability with automatic generation of unique reference numbers for each sample. Core sample details e.g. location/sample type are tracked as values change for a complete audit history. Sample profile information is captured including sample & tissue type, tissue collection details and associated patient & project information. Barcode labels can be generated for single/multiple samples & customised information can be contained within each label. These labels can be scanned to facilitate rapid sample retrieval.
 
Achiever Medical LIMS integrates data and processes across multiple faculties/diverse into a single solution. This enables authorised users to gain an holistic oversight, having full access to complete donor/patient records. Robust security filters and flexible tools within the LIMS allow the creation of custom levels of user security access to samples, donors or project information. This flexibility is especially useful for biobank or bio-repository management or when conducting multiple studies/clinical trials/projects with multiple collaborators. These tools support collaborative working and simplify a task that can otherwise be legislatively difficult and time-consuming.
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Advanced diagnostics, genomics and precision medicine / Clinical trials and evidence / Digital health
Benefit to NHS:
Achiever’s LIMS ability to quickly and efficiently organise samples for tracking, storage and retrieval, enables the full economic and scientific value of existing samples to be effectively realised and more efficient processing of sample requests and tests.
 
Achiever Medical LIMS enables sample aliquots to be easily generated from the parent record for complete traceability with a sample ‘family history’ view available, from both the parent & child records, allowing rapid navigation between samples within the same family.
 
Tools to enable the detailed tracking & monitoring of a sample via comprehensive sample location & check in/out auditing are provided. These include recording each time the sample is removed from its location, who checked it out and for what purpose. Samples that have been ‘checked out’ are easily identifiable and can be quickly ‘checked in’ when required along with their full audit trail information.
 
Samples used and associated stock depletion during testing or analyses are automatically flagged with Achiever Medical LIMS.
 
Composite samples such as Tissue Microarrays can be easily created within Achiever Medical LIMS, with each individual sample’s position within the composite sample recorded, any requests for removal can be easily and effectively managed.
 
External sample requests received by biobanks & bio-repositories can be managed through Achiever Medical LIMS using its built in management protocols. This facility provides staff with complete chain of custody details for each sample ((the person who requested the sample, reason for request, who approved the request & expected return date (if required) are captured)). Rejected requests are appropriately managed with reasons for rejection being recorded. Where only part of the sample is required, aliquots can be generated for the required amount along with accompanying complete family history record. Dashboards highlight samples due for return, allowing staff to monitor/chase up samples where required.
 
Achiever’s complete sample auditing & sample tracking functionality records changes by staff to core sample information. Audit trail information includes details of specific information fields changed, values pre & post change, date, time and name of the user who made the change etc. Chain of Custody details, including who checked in the sample, to whom it is checked out (where relevant), storage location, details of processing and projects included in are also captured.
Initial Review Rating
4.20 (1 ratings)
Benefit to WM population:
The West Midlands population has access to the most extensive range of specialist tests from a range of stakeholders, showcasing the potential of laboratory contributions to raise the profile of the research, clinical and diagnostic expertise of the region’s NHS laboratory staff.
 
For laboratories, biobanks and bio-repositories sample tracking & donor management capabilities are of huge importance in donor profiling, consent management, traceability, chain of custody & regulatory compliance.
 
The integration of a potentially region-wide system to manage tissue tracking across multiple teams, hospitals and sites can avoid duplication of data entry and maximise data quality while working within the IT and legislative constraints imposed by disparate working environments of the users.
 
Having sought approval for sample collection, samples need to be treated in line with SOPs and available for use in research both internally and with permitted collaborators.  Utilisation of samples is important to maximise the potential benefit from the donor and to make best use of the resources available to clinicians and researchers.  Cost recovery models allow for income generation to promote the sustainability of the biobank.
 
Improving the value of data quality enables laboratory staff and researchers to search for tissue samples from specific cohorts of donors, filtering by level of consent given by donors, allowing them to search for tissues that have not opted out of specific elements of research. This level of capability will allow biobanks and bio-repositories to service very specialist research requests, increasing value.
 
The quality of the donor, consent, storage and tissue viability data greatly increases the value of the tissues to laboratory staff and researchers. Once cleansed, Achiever Medical LIMS’s storage management capabilities help to increase levels of utilisation, reducing overhead costs per sample.
 
The ‘Achiever Medical Researcher Portal’ allows authorised collaborators to view restricted data for relevant samples.  This external view portal promotes the management of sample requests all within a single system, giving an easy means of sharing samples and the relevant data.  Automatic alerts ensure applications are managed efficiently.
 
In addition, reports and analysis providing real-time data, can be run at the touch of a button instead of valuable laboratory personnel spending days (sometimes weeks) painstakingly collating information from various spreadsheets.
Current and planned activity: 
We are a West Midlands based company wishing to work with our regional health providers.  
 
Our current users include Leeds (LTHT), Nottingham (NUH) and Cambridge (CUH) Trusts all of whom use the system to manage their research samples, donor data and to support HTA Audits.
 
Both NUH and CUH use Achiever Medical as part of their involvement with GEL.
 
Achiever Medical is being used to pioneer the data standards being promoted by UKCRC.
 
We would like to work with WMAHSN who are leading the collaboration of The West Midlands Genomic Medicine Centre (WMGMC), a partnership of 18 NHS Acute Trusts across the region, working collaboratively to help to deliver the UK 100,000 Genomes Project.   
We would welcome the opportunity to discuss any requirements for sample management and donor management, projects and disease specific systems for either single organisations or multi-institutional requirements.
What is the intellectual property status of your innovation?:
All IP is owned by Interactive Software Limited.
Return on Investment (£ Value): 
medium
Return on Investment (Timescale): 
2 years
Ease of scalability: 
Simple
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