building the uk ecosystem for the delivery of atmps...opportunity >70 uk companies 2019 and 2024...
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Building the UK ecosystem for the
delivery of ATMPs
The Potential
Global ATMP landscape
Investment, partnerships & commercialisation: UK Strength
70+ companies in 2019 and rapidly
growing
85 clinical trials
- More advanced, more commercial
sponsors
Opportunity
>70 UK companies
2019 and 2024 forecasted difference for UK C>employees
2,284 - 4,803 =+2,519 (110% increase)
50% increase
The number of clinical trials
with ATMPs are increasing
by ~50% each year, in recent
years there has been an
increase in industry led trials
£10 Billion
UK economy estimated at £10 billion in revenue by 2035 if 15% of the global market is captured
30-60d trial approval
Regulators have introduced
a range of fast-
track programmes to enable
patients to benefit from new
treatments more quickly
73% VC increase
Substantial increase in deals
done (VC investments, IPOs,
M&As and partnerships) –
73% increase in global finance
invested in 2018 cf 2017
3rd global cluster
UK is 3rd global cluster for ATMP development –London 80% of new products
The adoption challenge: Increasing patient demand
2018
Mainly clinical trial ~200 patients per year
2019
Licensed products for larger patient numbers
2021
Increased patient delivery ~2500 patients per year
2023
Routine patient delivery ~5000 patients per year
2028
Embedded patient delivery ~10000 patients per year
The adoption challenge: Increasing patient demand
Cell based Immune-oncology Landscape Gene Therapy Landscape
Figures courtesy of John Bishai, Wells Fargo
The adoption challenge: Scale up needed
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
The adoption challenge: Scale up needed
Why develop the Ecosystem?
The ATMPs are still
developed by SMEs (90% of
the market) and the big
pharma PNL is still not
affected by ATMPs (less than
1% of revenue) though the
industry is growing rapidly and
3 unicorn companies*
coming from the sector in the
last few years
* Orchard, Autolus and Adaptimmune have each reached over $500M in value
The healthcare system is
not yet ready for a major
scale up required with
only a handful of products
currently routinely
delivered to patients in the
UK
* Yescarta, Kymriah, Strimvellis, Holoclar in routine use in the
UK with more anticipated soon
Innovative solutions are
required to address key
challenges facing ATMPs
in the UK
The industry The NHS The innovation
Northern Alliance
Advanced Therapies
Treatment Centre
iMATCH – Manchester
Advanced Therapy
Centre Hub
MW-ATTC - Midlands &
Wales Advanced Therapy
Treatment Centre
Cell and Gene Therapy
Catapult
Northern Alliance
Advanced Therapies
Treatment Centre
iMATCH – Manchester
Advanced Therapy
Centre Hub
MW-ATTC - Midlands &
Wales Advanced Therapy
Treatment Centre
Cell and Gene Therapy
Catapult
Advanced Therapy Treatment Centre network
• Disseminating the
learnings and systems from
initial centres to enable more
widespread adoption of these
innovative therapies across
the NHS
• 30 delivery partners –
collaboration between NHS,
Industry and Academia
• 200-250 people working on
the programme
• The network of Advanced
Therapy Treatment Centres will
develop and deliver systems
for the routine supply delivery
of these disruptive therapies.
London Advanced Therapy
Network
ATTC partnerships – crucial for success
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
Industrial engagement in network
Industry Advisory Group
ATTCs: Aims
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
Using exemplar products to:
• Create easily run and ready to use systems and solutions that can be rolled out more widely to
the NHS
• Increasing institutional readiness and patient access to ATMPs
Impact of ATTCs to date
Knowledge SharingOrganisational readiness toolkit for ATMPs
Platform with guidance, checklists & SOPs
>8000 views since January launch
Industry EngagementIndustry advisory group covers
major players in UK ecosystem
StandardisationNational & international partners collaborating
with best practice
PharmacyNetwork expanded to cover all UK
Guidance issued for chief pharmacists
TrainingSingle platform to host NHS ATMP education
ATMPs MSc launched at Manchester University
Supply ChainPlug and play supply chain solutions for ATMPs.
Asymptote investment in a pilot scale-up Hub
Number of trialsFivefold increase in ATTC
GovernanceSharing of Governance procedures to
accelerate hospital adoption of ATMP trials
Health EconomicsWorking with key stakeholders to
explore novel payment mechanisms
FOCUS - Plan for future
Innovative digital solutions Utilise integrated NHS data
Registry support/devlopment
Innovative tracking and tracing models
Universal data integration and exchange
Rapid alert systems & follow-up
Pull through the pipelineSupporting companies & NHS to adopt therapies
earlier
New treatment modalities
Disruptive technologies with system challenges
Driving best practiceStandards framework for Industry/NHS Innovative
Models of Tissue Procurement/Distribution
Smart supply chainComplex logistics & tracking and tracing -
leverage existing systems
Prepare for massive & rapid scale-upNew treatment modalities
Disruptive technologies with system challenges
Identify technological innovations
Production of a skilled workforce Confidence to promote physician adoption
Coordinated, multidisciplinary training
Innovative payment mechanismsWork with NHS
Unknown business models
Risked based, outcomes driven
.
Companion Diagnostics Identification of patients
Implementation of Companion Diagnostic tools
and pathways for patient identification and follow-
up
Public and Patient EngagementUnique patient, carer & public challenges
Confidence to promote public adoption
Ensuring equitable access
The Ecosystem - route to beneficial adoption
Vibrant research base
Systems to pull developers
throughDrive innovation
Scale of impact, and overall cost
Bring down the price cost
Adoption at scale, competition,
Domestic Industry
Budget impact, and verification of efficacy and
benefits
Pay as benefits realised
Outcomes based value sharing
Readiness, and rapid
technological change
Prepare for one, 100X; OR,
prepare for 100, ONCE
Innovation, knowledge
sharing, and interoperability
Challenges in the adoption of ATMPs
• SME led industry doesn’t yet have capacity to implement solutions at a scale required
• Enormous potential for patient benefit that needs to be realised
• The scale and dynamics require a new approach
• Extremely disruptive to current healthcare setting, but could be transformative (with supply
chain and logistics bringing additional barriers)
• Ongoing and long-term data requirements requiring data integration and novel collection
methods
• The budget and adoption barriers are manageable but need to be proactively managed
• Continue to build the internationally recognised UK leading ecosystem for the
development, manufacture, trial and delivery of ATMPs to make the UK the
most innovative healthcare provider for their rapid adoption and treatment of
patients in the UK
Cell and Gene Therapy Catapult is a trading name of Cell Therapy Catapult Limited, registered in England and Wales under company number 07964711, with registered office at 12th Floor Tower Wing, Guy’s Hospital, Great Maze Pond, London, SE1 9RT. VAT number 154 4214 33.
12th Floor Tower WingGuy’s Hospital
Great Maze PondLondon SE1 9RT
info@ct.catapult.org.ukct.catapult.org.uk
Twitter: @CGTCatapultCell and Gene Therapy Catapult is committed to ensuring high standards of research integrity and research best practice in the activities we carry out. We subscribe to the principles described in the UK concordat to support research integrity.
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