9b Annex HinM Outline Business Case

HInM Initial Business Case
Steering Group
2nd February 2016
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Reminder of agreed (initial) HInM priorities & their
organisational leadership
Precision Medicine
Clinical Research Excellence
MAHSC
Led
Translational Research Strategy / BRC
GM Research
Hub
GM Clinical Trial
Unit
Accelerating Innovation into
Practice
(including identifying innovation for
pan-GM implementation)
AHSN
Led
Health Informatics
Bioinformatics
Pan-GM Datawell deployment
Overall Informatics Strategy (linked to wider GMDevo planning)
Co-ordinated Business Engagement & Development
HInM
Led
Pan-organisation Communications & Engagement
2
The initial foundation priorities for HInM create an
environment to innovate across all areas of H&SC….
Testing / Validation in GM ‘clinical’ settings
Precision
Medicine
Rapid Scaled Implementation across GM
Clinical
Research
Excellence
Health
Informatics
Accelerating
Innovation
into Clinical
Practice
Business Engagement
Communications and Engagement
‘Real-Time’ ‘Real-world’ Feedback &
Improvement
3
….which when combined with an agreed panGM disease area priority list…..
Example specific disease priorities: NW England Burden of Disease (DALY) from PHE / Gates
Collaboration
4
… will enable us to develop and actively manage an
innovation pipeline directed to GM’s needs
Driven by the health needs of our population and working in partnership we will mobilise a system wide approach to the discovery,
development and delivery of innovation across Greater Manchester for the benefit of all.
Disease
priority 1
Discover
Develop
Deliver
5+ years delivery timeframe.
2-5 years delivery timeframe.
0-2 years delivery timeframe.
Gaps in research drive discovery activity
within GM.
Becomes the focus for local testing and guides
clinical research.
Drives short term implementation short list.
Project
Project
Disease
priority 2
……..
Disease
priority xx…
Project
Project
Project
Project
Project
Project
Project
Precision Medicine
Clinical Research Excellence
Scope for
foundation
workstreams
Informatics
Accelerating Innovation into practice
Business engagement
Communications and engagement
5
Turning the ‘foundation priorities’ into ‘place-based
priorities’ will be an evolutionary process
Short term working assumptions
Medium – long term determination of priorities
In the short term (first 6 months), priorities for delivery will be
determined by a combination of:
In the medium term, HInM will need to develop an evidence
based prioritisation based on actual data of disease burden
across GM. To do this, HInM will need to:
■  Existing pragmatic understanding of health burden across
the region, incorporating views from MAHSC, AHSN, SCN,
PHE to help delineate initial pilot projects.
■  Prioritising current implementation projects from recent
‘Devo transformation projects’ call, MAHSC, AHSN, SCN to
identify relevant projects that various stakeholder groups will
be likely to endorse.
–  Accelerating innovation into practice
(e.g. Atrial Fibrillation screening and treatment + others
TBD).
–  Precision Medicine
(selection of 5 projects TBD).
–  Informatics
(GM-wide governance & Pathology data-sharing,
FARSITE functionality development).
■  Agree criteria for prioritising population health burden:
–  Disease mortality/DALYs/other measures of disease
impact.
–  Diseases prevalence.
–  Consider socioeconomic determinants of health.
–  Direct economic impact of disease on the system
(demand on health and social services).
–  Indirect economic impact of disease (e.g. on employment,
economic contributions and benefits etc.)
■  Analyse recent data to understand GM population health
burden against these criteria & develop priority list of specific
diseases.
This will provide a base framework for prioritisation of all
aspects of HInM work (implementation, clinical trials, research
etc.)
This will be updated on an on-going basis to provide a current
view of disease burden across GM.
6
Precision Medicine – Summary
Ambition
■  Aim for GM to be the leading test-bed for the validation and verification of
disease and drug response endotype-based care pathways, diagnostics and
tests in the next five years.
■  Precision Medicine Manchester (PMM) will aim to get local patients onto the
right treatment plan first time.
Key priorities
Concentrate efforts on cancer and
inflammatory diseases and mental
health – aligning with Dementia
Platform UK to ensure a coordinated
local approach to combatting
mental health.
Communication and engagement with
the NHS, patients and public to raise
awareness about PM and how it can
positively impact them.
■  Increase the amount of private sector revenue generated by local universities
and NHS Trusts from partnering with pharmaceutical and biotech companies.
■  Attract industry to work in Manchester at sites such as Alderley Park and
Manchester Science Park.
■  Create a step change in applying PM approaches and embedding PM
principles in everyday patient care within the GM Ecosystem.
Alignment with the ‘Accelerating
Innovation to Practice’ workstream to
facilitate swift implementation of the 3
initial projects – to be selected.
■  Produce robust information on, and consider the economic impact of,
the relative cost-effectiveness of proposed new biomarkers and
companion diagnostics.
7
Clinical Research Excellence – Summary
Ambition
■  Become a global leader in high quality, high impact clinical research and trials
design and delivery through:
–  World class infrastructure, made up of the MAHSC Clinical Trials Unit,
One Manchester Clinical Research Facility, and the GM Research Hub.
–  Building reputation via GM informatics capability of delivering real world/
pragmatic trials that are able to access data and patients covering the
whole of the GM population of 2.7m.
■  Attract investment and talent into the conurbation as a result of these
capabilities and status.
■  Engender a clinical research culture across the GM workforce and
patient population.
Benefits
Key priorities
Re-locate and enhance the MAHSC
Clinical Trials Unit by August 2016.
Appoint a lead R&D Director across
clusters of research intensive trusts –
with first appointment
targeted mid-2016.
Resource requirements
MAHSC CTU
■  £523k p.a. x 3 years core staff costs.
GM Research
Hub
■  £150-200k p.a. for 4 FTE x AfC band 5 GM Research
Hub coordinators from April 2016
■  £60k p.a. for 1 FTE Project Manager
■  £50k p.a. day to day support for Research
hub delivery.
■  £200k-£400k co-location refurbishment costs.
■  £20k + £2k p.a. quality management system.
Accelerates the overall development pathway for medicines and health
interventions.
Leads to better and more innovative care for patients as well as
reducing overall healthcare costs.
Draws inward investment and talent to GM.
Embeds culture of practising world leading innovation in GM.
Set up the GM Research Hub to create
a single portal for all research requests,
with streamlined and standardised
processes and bureaucracy across GM.
One
Manchester
CRF
World class clinical trialist x each key disease area.
8
Informatics – Summary
Ambition
Establish a GM population-wide informatics capability that is able to support:
■  Reduction in variation of care across the conurbation.
■  Optimisation of care delivery.
■  Clinical trials capability across the 2.7m population to drive inward
investment into Manchester, and elevate GM’s status as a world-leading
clinical research destination.
■  Harmonises and shares data across health and social care services (and
others) across the region.
Benefits
This capability fundamentally underpins the system’s ability to
delivery successfully on other areas of ambition: Accelerating
Innovation, Precision Medicine, Clinical Trials
Datawell
Enables efficient data sharing and privacy safeguards. Accelerator
projects will be used to test and evaluate new uses on the platform. Is
foundational to success of both FARSITE and Connected Health
Cities.
FARSITE
Enables rapid patient population identification and recruitment into
trials or new treatment pathways. Already has 700k coverage and
could be rapidly deployed for 100% GM population coverage.
Connected Health Cities
The GM Ark will form part of a network across the North, that
aggregates data to produce actionable intelligence to drive
improvements in health and social care. Closely related to Datawell
and FARSITE
Key priorities / Decisions
Decision to accelerate Datawell
deployment by one year to achieve 100%
GM coverage by October 2017
Decision to rapidly expand FARSITE
coverage to achieve 100% GM coverage
and mobilise total GM population clinical
trials capability.
Support creation of high level GM &
H&SC Devo informatics governance to
ensure convergence (GM Connect).
Support & exploit the GM components
of the NHSA Connected-health cities
(CHC) initiative to deliver place-based
priorities and ensure it is part of a
coherent GM informatics ecosystem
Identify HInM informatics leadership
model within GM Connect and H&SC
IM&T leadership structure.
Rapidly engage with key stakeholders
to communicate benefits of systems –
supported by HInM Communications.
Resource requirements
A decision is required on accelerating Datawell & FARSITE
implementation & how this would be funded.
Datawell
Datawell accelerated deployment costs above
current AHSN funding:
■  £4.0m over 2016 and 2017.
Immediate FARSITE deployment: £550k total
investment.
FARSITE
OR
Alternative is to delay deployment to align with
Datawell: £300k
9
Accelerating Innovation to Practice – Summary
Ambition
■  To develop a system that is more responsive to innovation and
improvement.
■  For Greater Manchester leaders to drive change, at scale and pace;
cultivating awareness and interest in change/improvement across GM.
■  Establish an adoption approach that enables rapid and effective adoption
of prioritised new interventions throughout GM.
■  Deliver interventions that are value for money and yet demonstrating
improved health outcomes.
■  To develop best-in-class innovation implementation environment that
attracts world-leading innovation to Greater Manchester.
Benefits
Allows the GM health economy to tap into evidenced ways of working
that are proven to reduce financial costs and/or delivers value.
Increase value to healthcare providers and payers (reduce costs) by
accelerating adoption of efficiency-increasing interventions, and
supporting disinvestment in poor value interventions.
Key priorities
Formalise link with Joint
Commissioning Board as the critical
mechanism through which decisions are
made and proposals sanctioned for
delivery across all localities.
Use 4-6 projects from the shortlisted
GM H&SC Devo innovation applications
to test the process from business case
through to delivery and evaluation in the
first 6 months.
Define a transparent but rigorous
filtering criteria to prioritise and select
interventions, which must have buy-in
across the ecosystem to drive buy-in for
the innovations it evaluates.
Manage close links with HInM
communications and engagement
workstream to build recognition of
process benefits and of specific
interventions over time.
Resource requirements
Request is for a core team primarily for the purposes of business cases, evaluation of
innovations and implementation outcomes, and programme management. This is the
resource requirement for the pilot phase and will be reviewed after the first 6 months.
Health
economics
X 2 FTE
Analytics
support
X 2 FTE
Programme
management
X 2 FTE
Evaluation
expertise
X 2 FTE
A system that is more responsive to innovation and improvement, and
which therefore generates more innovations overall.
Reduction in variation across the health economy.
Improved views and experiences of service users, carers and the
workforces involved in delivering a particular intervention.
10
Business Engagement – Summary
Vision and ambition (long-term)
Industry partnership is a key component of how we will improve health
outcomes for the population. The ambition of this strategy is to:
■  Reduce barriers for businesses to start-up, invest, innovate and grow in GM
and attract more aligned businesses into GM.
■  Improve collaboration with businesses across the world to help drive the
delivery of HInM place-based priorities.
■  Improve management of key business accounts to enable GM to be seen
as a global ‘partner of choice’ for the global health / lifescience industry.
■  Improve the access to finance for growing GM organisations.
■  Ensure GM organisations are properly informed and supported when
preparing to seek access to available funds.
■  Coordinate provision of a comprehensive suite of business support and
advisory services to drive the growth of the health / lifesciences sectors
Key initial priorities
Establish a pan-organisation business
engagement leadership team to
develop & delver a coherent placebased industry strategy
Hold initial industry roundtable
meetings / dinners to engage
businesses in planning & ensure all
activities are informed by industry
needs.
Identify opportunities to improve current
GM support ‘offer’ to business &
develop ‘one stop shop’ for business
requests and support.
Develop a pan-GM annual marketing &
inward investment strategy including a
clear ‘value proposition’ for industry.
Align organisational activities with
agreed place-based priorities.
Resource Requirement (first 6 months)
■  Creation of a pan-organisational Business Engagement Leadership Team
of nominated individuals from partner organisations.
■  Creation of a working team for a period of 6 months comprised of
nominated resources from across partner organisations to undertake the
detailed planning activities, begin to pilot the novel ways of working as
opportunities arise and define the future resourcing model. The total
resource required to undertake this resourcing work has been estimated
as:
–  2-3x FTE senior-level personnel across a range of disciplines
(marketing, financing, business support etc)
–  1-2x FTE managerial-level personnel to help manage the work
–  1x FTE administrative-level personnel
■  It is recognised that some of the activities to be undertaken align well with
current organisational activity and therefore incremental resource
requirements are minimised in these areas. Other initiatives (such as the
industry dinners/advisory board, service mapping etc) are new and will
therefore require resource to be identified. This should come from
prioritisation vs other current organisational priorities if additional new
central resources are to be avoided.
■  This work will be governed via the proposed cross-organisational Business
Engagement Leadership team, and staff will ‘report’ to the HInM Executive
team for this aspect of their role.
Do the Steering Committee Approve:
1.  Setting up of a HInM Business Engagement Leadership Team, with membership as described
2.  The proposed resourcing model
11
Communications and Engagement – Summary
Ambition
■  Delivering a joined-up communications and engagement programme to
critically support the delivery of HInM’s priorities.
■  Bring people and organisations together in a productive way and spread
a unified message – highlighting the potential benefits of this new
collaboration.
■  Short-term, the priority is to begin to align the work done across multiple
organisations, with a longer term ambition; with a long term aim to
achieve a fully integrated communications strategy across all partner
organisations.
Key priorities
Pre-Christmas communications update
and Q1 2016 pan-workstream event to
communicate progress to date to a
wider audience.
Agree detailed HInM communications &
engagement plan, linked to wider
GMDevo communications.
Securing resource to support the
delivery of the HInM communications
strategy and plan – critical to the
success of workstreams delivery.
Formalise ways of working going
forward – to set up a pan-organisation
Communications and Engagement
Executive sub-group to drive strategy.
Develop and support communities of
practice for each workstream to support
innovation and collaboration.
Benefits
Communications and engagement will be fundamental to
establishing trust across the various groups and stakeholders,
building the trust to allow the health ecosystem to thrive based on
collaboration of communities.
Targeted ‘value propositions’ that speak to each stakeholder
group’s priorities to ensure clear and resonant articulation of the
benefits HInM can deliver. These propositions have been drafted
by the Communications and Engagement working group.
Resourcing requirements
There is a request for one additional communications officer to support a virtual team that
will be pooled from existing communications resources across MAHSC and AHSN.
Resource
request
Communications
officer
X 1 FTE
Multimedia
officer time from
MAHSC and
AHSN
Existing
communications
officer time from
MAHSC and
AHSN
Virtual team formed
of existing
resources
Associate
Director of
Communications
time from MAHSC
and AHSN
12
Summary of Human Resources Required
A bottom-up assessment of resource needs has been identified by each workstreams to deliver the work plans in the short-term. For all workstreams, a
more detailed analysis may be required for understanding resource needs in the longer term.
Workstream
Identified resource gap (Quantity and skills in addition to current)
Transition plan
Precision medicine
■  Detailed resource requirements not yet confirmed. Anticipate some need for support in Programme
management and coordination, Health informatics, analytics and economics.
-
Clinical research
excellence
Clinical trials unit
■  Existing MAHSC CTU staff and University methodologists
will be managed from the new location for the CTU but
investment in staff will be required to fill gaps in capability
based on an assessment of workforce needs.
■  £522,450 per year for three years to cover CTU core staff costs beyond UoM and MAHSC staff, to cover
transition to a financially self-sustaining operating model (Academic staff; Trial managers; Data monitors;
Database managers; New Director of the CTU)
One GM Clinical Research Facility
■  World class clinical trialist x each key disease area.
GM Research hub
■  4 FTE x AfC Band 5 GM Research Hub coordinators from April 2016, costing £150-200k per annum.
■  1 FTE Project Manager to support implementation £60k per annum.
■  There is a desire to pool and share staff – particularly
operational staff –
to provide a flexible and sustainable workforce.
■  Additional resources to support Lloyd Gregory proposed to
support set up of GM Research Hub, which could be
required for a year in the first instance, with a review to
understand any needs for extension.
■  Day to day support for the operational delivery of the Research Hub: 50% salary for Lloyd Gregory per annum
(which may be used to employ a deputy for LG) costing £50k per annum and on-costs.
Informatics
Identified lead for HInM ‘Research & innovation’ agenda within wider GMDevo ‘GMConnect’ & IM&T initiatives.
-
Accelerating
innovation to
practice
Need for a core team identified to manage and help deliver programme of work for the pilot phase:
■  2 FTE programme / project management.
■  Currently some limited support, capacity and partial post
funding available from partner organisations.
■  Skills required for business case creation. (2 FTE health economists / financial support & 2 FTE data analytics
support).
■  Resource needs will depend on volume innovations
through the process.
■  Expert input into designing and delivering evaluations – key to building a
learning system: 2 FTE project delivery /evaluation experts.
■  Delivery implementation: Ad hoc project specific skills.
■  Review of needs and underlying assumptions is proposed
after 6 months.
Proposal to pilot a cross-organisational ‘seconded resource’ model for an initial 6 month period to undertake
detailed planning and pilot implementation. Estimated that will require 2-3x FTE senior-level personnel, 2x FTE
managerial-level personnel & 1x FTE administrative-level personnel.
-
Business
engagement
This will enable a full evaluation of the scale and type of resource required in the long-term, and of the optimal
balance between seconded and HinM based staff.
Communications and
engagement
■  To support other existing communications staff in a virtual team to deliver HInM communications strategy and
plan.
–  1 FTE supplemental Communications officer (within MAHSC).
■  Pool existing communications resources across MAHSC
and AHSN without cross-charging.
■  Additional officer would support this virtual team and
ensure there is adequate resource to deliver this work and
support the comms needs of all workstreams.
13
Summary of Additional Financial Investment
Required
A bottom-up assessment of additional financial investment requirements has been identified by some workstreams on the basis of the workplan
developed.
Workstream
Identified resource gap
Transition plan
(Quantity and skills in addition to current)
Clinical research
excellence
Clinical Trials Unit
■  Space – relocation of existing CTU staff to the University campus in close contact with
University methodologists in the fields of biostatistics, informatics, health economics,
behavioural scientists and qualitative research.
■  There is an estimated one off cost ranging between £15-20k with further
maintenance costs of £2k per annum.
GM Research Hub
■  A robust quality management system (e.g. Q-Pulse including web-access to facilitate
multicenter trial management) in order to support sponsor oversight responsibilities.
■  Refurbishment costs for co-location.
Informatics
■  Estimated £200-£400k.
Datawell deployment acceleration
■  Phase 2: £0.95m – October 2016.
■  If central funding of accelerated deployment is agreed, there may be significant
investment costs required from GM Devo to support this [NB. This funding would have to
have come from the system, but from individual sites in the original plan].
■  Phase 3: £0.95m – April 2017.
■  Please see Informatics workstream outline business case for more detail.
■  Phase 4: £2.1m – October 2017.
■  TOTAL: £4.0m
FARSITE deployment
■  If immediate deployment option is selected, there will be some investment requirement.
■  If delayed deployment option is selected, costs may be less as some can be streamlined
with Datawell deployment.
■  Plus investment in additional functionality.
■  Please see Informatics workstream outline business case for more detail.
■  £550k with £100k p.a. ongoing support cost and possibly some reduced data
acquisition costs.
■  £350k with £100k p.a. ongoing support cost.
■  £200k one off development cost.
14
Overall Milestone Delivery Plan
Key delivery milestones across the workstreams are shown here
Oct-Dec
‘15
Jan-Mar
‘16
Apr-Jun
‘16
Jul-Sep
‘16
Oct-Dec
‘16
Jan-Mar
‘17
Apr-Jun
‘17
Jul-Sep
‘17
3 projects identified for rollout – link to
accelerating innovation workstream
Precision Medicine
Clinical Research
Excellence
Jan-Mar
‘18
Apr-Jun
‘18
Agreement on PM MRes
course
Planning and
implementation
PMM strategy and
press release
Oct-Dec
‘17
Jul-Sep
‘18
Oct-Dec
‘18
Full MRes course
outline agreed
Full GM coverage from
3 projects
GM research hub go live
CRF – NIHR application
CTU implementation
Informatics
Datawell deployment
FARSITE deployment
Datawell total 29 sites coverage
FARSITE 100% GM coverage
CHCs Ark development begins
Accelerating
innovation into
Practice
Business
Engagement
First business cases approved
Joint commissioning
board agrees
approach & first
projects for adoption
Funding source
assessment
Implementation begins
Regular (frequency TBC) reviews to agree new projects for business case and implementation
Key account
One stop shop business support
management set up
implementation begins
Industry advisory board set up
GM Healthcare/Life Sciences business
development strategy agreed
Communications &
engagement
Pre Xmas
updates
and comms
HInM panworkstream event
Business development strategy annually revisited
Regular updates to website and other media channels begin
Events and conference series kick off
Ongoing programme
15