Advanced Therapy Delivery from NHS - clinical infrastructure · Patient monitoring: Development of...
Transcript of Advanced Therapy Delivery from NHS - clinical infrastructure · Patient monitoring: Development of...
Advanced Therapy Delivery from NHS -clinical infrastructure requirements
Patrick Ginty PhD, RAC(US)Head of Regulatory Affairs Cell and Gene Therapy Catapult
The scale up challenge
2018Mainly clinical trial ~200 patients per year
2019Licensed products for larger patient numbers
2021Increased patient delivery ~2500 patients per year
2023Routine patient delivery ~5000 patients per year
2028Embedded patient delivery ~10000 patients per year
Conf
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Many products– different product types and indications
Immune-oncology Landscape Gene Therapy Landscape
Source: Wells Fargo Securities/CryportSource: Wells Fargo Securities/Cryoport
Source: Wells Fargo Securities/Cryoport
The scale up challenge
Challenges• Tracking• Patient condition
Cells taken from patient
Manufacture Challenges• Cost of goods• Product release• Transport
Supply chain Challenges• Temperature• Time restrictions• Patient specific
Arrival at hospital
Challenges• Thawing• Registry• IT • Internal logistics
Delivery to patient
Challenges• Pharmacy• Tracking• Training
Payment
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Northern Alliance Advanced Therapies Treatment Centre
iMATCH – ManchesterAdvanced Therapy Centre Hub
MW-ATTC - Midlands & Wales Advanced Therapy Treatment Centre
CGT Catapult manufacturing centre
London Higher Education Funding Council for England Connecting Capabilities
• The network will increase the ability of the NHS to deliver disruptive medicines
• The centres will develop systems and processes within the trusts and hospitals capable of delivering advanced therapies at scale to patients across the NHS
• The learnings and systems from the initial centres will be rolled out to other centres in the UK
Advanced therapy adoption network
The network of Advanced Therapy Treatment Centres will develop and deliver systems for the delivery of cutting edge cell and gene therapies.
Northern Alliance Advanced Therapies Treatment Centre
iMATCH – ManchesterAdvanced Therapy Centre Hub
MW-ATTC - Midlands & Wales Advanced Therapy Treatment Centre
CGT Catapult manufacturing centre
London Advanced Therapy Network
ATTCs – different but complementary objectives
Midlands and Wales ATTC• Develop end to end supply chain
logistics• Create network of ATMP capable
hospitals
• Validate with real world manufacturing and trials
• Generate economic model for ATMP use
Northern Alliance• Development of the clinical
delivery pathway • Achieve utility at scale in
clinical pathway through use of informatics
iMATCH
• Co-ordination of patient cell collection
• Processing and storage, track and trace solutions
• Education through MSc/MResplatform
The ATTC network will work together with its partners to address the identified priorities to ensure they provide easily-run and ready to use systems and solutions that can then be
rolled out to other NHS centres, leading to enhanced patient access to ATMPs
ATTC – Industry/NHS/Academia partnerships
Objectives: • Development of the clinical
delivery pathway • Achieve utility at scale in
clinical pathway through use of informatics NHS providers
ATMP suppliers
Academia
Supporting industries
IUK funded ATTC – CGT Catapult role
Coordination of IUK funded ATTC activities and outputs
• Unifying centre projects
• Network projects• Ensure meets overall
programme outcome
• Supporting collaboration between centres
• Working with London ATN• Coordinating network
streams
• Network projects
• Communication regarding ATTC activities• Stakeholder engagement;
Regulators, Industry, Payers, International
• Dissemination of outputs
• Front door for companies
What is required to accelerate adoption
IUK ATTCs, London ATC and
other centres
Establish clear pathways to gather industry feedback:
Establishing streamlined information flow (e.g. through
industry partner group) to ensure requirements of industry are taken
into account.
Define common framework: Help companies navigate with harmonised procedures and
practices: e.g.: apheresis, treatment regimens,
patient selection.Work with companies and their
specific protocols to produce common frameworks and systems.
Clinical scale up requirements:
Understanding what is required at organisational level e.g. number of
apheresis units, ICU beds.
Contract standardisation:To ensure timely implementation
and adoption, contracts need to be standardised.
Speed of access: Streamline both procurement of starting material and delivery to product into health care system.
Define courier best practice.
Patient data collection and sharing
Bring data together, capture number of interventions post
treatment, capture data in real time, agree where data should be
held, connect with Digital Innovation hubs, development of Registries to meet both regulatory and reimbursement requirements. Patient monitoring:
Development of companion diagnostics, validated analytical methods and patient monitoring, staff training for safe patient
management will need to take place.
Access to expert knowledge by industry: Need for experts, education and physicians to
help trial design, formulating a database of knowledge network.
Patient engagement: Engaging the patients, patient
groups and charitable associations further.
The scale up challenge
2018Mainly clinical trial ~200 patients per year
2019Licensed products for larger patient numbers
2021Increased patient delivery ~2500 patients per year
2023Routine patient delivery ~5000 patients per year
2028Embedded patient delivery ~10000 patients per yearATTC & other centres
Accelerated Access Pathway/EAMS
Widespread adoption
Standardised methodology & training programmes established
Systems embedded in NHS for delivery & reimbursement
Reimbursement mechanisms established for licensed products. Rollout to other centres
Build the UK ecosystem for the delivery of these disruptive therapies
Build knowledge and shared learnings to provide a favourable environment for developers
Increase patient access to these potentially life-changing medicines
Develop new technologies and approaches to make adoption efficient, and facilitate novel payment practices
Make UK attractive to investment by accelerating UK adoption
Advanced Therapy NetworkCreating easily run and ready to use systems and solutions that can be rolled out to other NHS centres, increasing institutional readiness and patient access to ATMPs.