Innovation in drug development processes - CDE themed call launch 25 June 2013

Innovation in Drug
Development Processes
Centre for Defence Enterprise

© Crown Copyright MOD 2011
The aim of CDE

Prove the value of novel, high-risk,
high-potential-benefit research

Cost-effective military
capability advantage

25 June 2013
Five key operating principles
underpin the CDE model

25 June 2013
Accessible opportunity

Minimising participation costs

CDE themed call programme
Countering insider threat attacks Call closes 27 Jun 2013
Secure communications Call closes 22 Aug 2013
Innovation in drug development
processes
Call closes 29 Aug 2013
Enhancing military medical training
and support for the medic
Call launch 16 July 2013
(Birmingham)
Novel solutions for emulating ship
signatures (countermine)
Call launch 23 July 2013
(Webinar)
Register and further details at www.science.mod.uk under ‘Events and Calls’
All call close at 17:00 hrs

Effective proposals

Challenge, pace & exploitation

01235 438445
cde@dstl.gov.uk
www.science.mod.uk/enterprise

© Crown copyright 2013 Dstl
25 June 2013

An Introduction to CBR Science and
Technology
UNCLASSIFIED© Crown copyright 2013
Dstl
25 June 2013

Chemical, Biological, Radiological
VISION
Maximise the impact of science and technology (S&T) in
realising the UK policy aim of maintaining our political and
military freedom of action despite the presence, threat, or use
of chemical, biological or radiological weapons.
SDSR: NATIONAL SECURITY TASKS & PLANNING
GUIDELINES:
We will .. tackle those who threaten the UK & our interests,
including maintenance of underpinning technical expertise in key
areas. To deliver this we require …
Retention of our CBRN science and technology capabilities that
contribute to counter-proliferation and our response to the
potential use of such materials by terrorist or state actors.
NATIONAL SECURITY STRATEGY: RISKS
Tier 1 : International terrorism including the use of CBRN
materials
Tier 2 : Attack on the UK or its Territories by a state or proxy
using CBRN weapons.
Dstl
25 June 2013

• Strategic objectives
– SUPPORT 3 Model Block (MB)
acquisitions
• More tech watch type activity. Less
development activity in research
programme
– INCREASE the amount of speculative,
high-risk, high-reward research.
• Emphasis on scientific quality and
innovation.
• Pause mature research
25 June 2013
Context
F12/13 F13/14
Threat 6.4M 6.1M
Inform 7.9M 7.1M
Prot Measures 14.9M 14.2M
StratFacilities 6.2M 6.4M
£35.4M £33.8M
CBR research programme funding
UNCLASSIFIED

Sense
Knowledge
Management
Physical
Hazard
Management
Medical
Countermeasures
Hazard
Assessment
Operational
Analysis
Counter
Proliferation
Duty
Of Care
CBR Inform
(MOD & Industry)
CBR Protective Measures
(International
Collaboration)
CBR Threat Reduction
(Cross Government)
CBR S&T
Programme
Prevention
of Supply
ProtectionElimination
Arms
Control
Disablement
Deterrence
Programme structure
Dstl
25 June 2013

Programme and Delivery Directorate
CBR programme
Other
programmes
Dstl DeptsIndustry Academia
S&T Requirements
Partners
Dstl
25 June 2013

Working across government
• Aim: programme coherency and mutual
benefit from shared investments
• Number of other government departments with
interest/requirement for CBRN S&T advice
• Different exploitation routes, similar fundamental
requirements
Dstl
25 June 2013

Impact of S&T
Dstl
25 June 2013

Exploitation of S&T and where industry is
involved
Early Innovation
Proof of concept
Assessment
Tech transfer Into service
Dstl
25 June 2013

Alternative model
N2
Sample
Inlet to Detector
Capability
Research exploitation
Non-MOD markets
Rapid
Adaptation
Dstl
25 June 2013

CBRN PROTECTION RESEARCH GOAL 9 –
Medical Countermeasures
• Explore technology optionsto
upkeep, updateand upgrade the CBRN
medical countermeasures capability.
• To prevent individualsfrom
experiencing the physiological effects
of exposure to CBRN agents by the use
of medical countermeasures, in order
to maintainoperationaleffectiveness
on operations.
• To move towards a post-exposure
treatment posture while maintaining
the current pre-exposure capability.
Dstl
25 June 2013

Desired outcome: Strategic approach
• Where practicable all future medical
countermeasures (MedCM) should be
licensed (ie possess a Marketing
Authorisation in the UK).
• Broad-spectrum MedCM: provide protection
against more than one agent.
25 June 2013
Dstl

Programme aim
• MOD long-term aim: broad-spectrum
post-exposure therapies
• Allow a flexible response to current
and emerging threats
Dstl
25 June 2013

BW MedCM strategy
Pre-exposure therapies
• Devise vaccines against biological agents
Post-exposure therapies
• BW-specific post-exposure therapies
• Broad-spectrum therapies
Lessens the need to pre-define the threat
spectrum
Delivery is dependent on collaboration
Risk
30%
70%
UNCLASSIFIED
25 June 2013
© Crown copyright 2013
Dstl

A technical challenge
• The challenge of devising broad-spectrum MedCM is
significant
– very challenging technical aspiration
• Incentivising industry to engage with MOD is difficult in this
area
• Few incentives to develop broad-spectrum therapies
– Profit is in specific therapies for chronic diseases
• Low investment means there are very few broad-spectrum
antibiotics in the pipeline
Dstl
25 June 2013

Summary
• The CBR research programme is designed to maximise the
impact of science & technology in realising the UK policy aim of
maintaining our political and military freedom of action despite
the presence, threat, or use of chemical, biological or radiological
weapons.
• Broad-spectrum medical countermeasures are mechanism to
achieve this
• This CDE themed call is aimed to help identify future medical
countermeasures
25 June 2013
Dstl

CDE Themed Call:
Innovation in Drug Development
Processes
25 June 2013
UNCLASSIFIED

CDE call:
Innovation in Drug Development Processes
Aims to stimulate the development of antibacterial drug
development processes…
• benefiting the antibacterial development industry
• supporting the UK’s defence and security needs
UNCLASSIFIED
25 June 2013
Dstl

• Research proposals for this CDE themed call will also
be assessed by representatives from Dstl’s
collaborators in US Government, the Defence Threat
Reduction Agency (DTRA) and a selection of UK
based University academics.
• The US/academia will not be funding any of the
proposals resulting from this CDE call – funding will
only be from Dstl.
25 June 2013
CDE call:
UNCLASSIFIED

Innovations in Drug
Development Processes
25 June 2013
UNCLASSIFIED

Overview
• Background: target identification at Dstl
• CDE call: improving target exploitation
UNCLASSIFIED
25 June 2013

25 June 2013
Broad-spectrum antibacterials
In order to support the development of novel antibiotics
by industry, MOD funds research to identify and validate
broad-spectrum antibacterial targets
Bacillus
anthracis
Burkholderia
pseudomallei /
mallei
Yersinia
pestis
Francisella
tularensis
Coxiella
burnetii
Brucella spp
UNCLASSIFIED

Dstl’s key capabilities
25 June 2013
Animal models
Genetic manipulation of
pathogens
In vitro models
of infection
Cytoplasmic
membrane
Cell
wall
Capsule
Dstl

25 June 2013
• Target selectionIdentification
• Biological evaluation of target
• Down-selection
Characterisation and
validation
• Collaborations
• Evaluation of novel technologies for
inhibitor selection
Exploitation
Approach to antibacterial targets
Dstl

Target identification
• Whole genome approaches
– Using high-throughput sequencing
technology
• Bioinformatics
– Database of Essential Genes
– Pathogen vs non-pathogens
• Computational systems
biology
– Mathematical modelling
25 June 2013
Dstl

Target characterisation and validation
• Genetic characterisation
– Development and construction of targeted mutants
– In vitro & in vivo evaluation
• Virulence
• Essential
• Biochemical characterisation
– Protein engineering
– X-ray crystallography
25 June 2013
Dstl

Target exploitation
• Engagement with academia and/or industry
Currently:
– Target protein structures
– Assay development
– Inhibitor screening (proof-of-concept)
Future:
– Inhibitor screening & lead molecule
development
25 June 2013
Dstl

25 June 2013
Aspiration
– Enable development of broad-spectrum
antibacterials
– Engage with academic/industrial partners at an
early stage
Dstl

25 June 2013
CDE call
Aims to stimulate the development of antibacterial drug
development processes…
• benefiting the antibacterial development industry
• supporting the UK’s defence and security needs
Dstl

Target-based antibacterial discovery
25 June 2013
Target identification
High throughput
screening or alternative
approach
Inhibitor identification
Lead inhibitor optimisation
(PK, distribution, toxicity, etc)
Structure-based drug
design
Dstl

25 June 2013
Challenge 1: Specific target inhibitor
identification
• eg
– decreasing propensity for resistance acquisition
– increasing hit rate
Technologies that improve the robustness of
inhibitors identified for targets by HTS or other
approaches
Dstl

25 June 2013
Challenge 2: Improving structure-
based drug design
• eg
– reducing the time taken to produce high-resolution
target structures
– increasing robustness of in silico small molecule
design
Technologies that improve the process of structure-
based drug design of antibacterials
Dstl

25 June 2013
Challenge 3: Potency for intracellular
pathogens
• eg
– altering physiochemical properties of inhibitors to
enhance uptake
– coupling inhibitors to other molecules to increase
intracellular retention
Technologies that improve the uptake of antibacterials
into target cells and/or reduce efflux
UNCLASSIFIED
Dstl

25 June 2013
What we WANT
• Proof-of-concept proposals
• Highly innovative approaches, tools, technologies
• Applicability to broad-spectrum targets
• Applicability to intracellular bacteria
Dstl

25 June 2013
What we DONT WANT
• Existing technologies
• Target identification
• Target-specific approaches
Dstl

25 June 2013
Proposals
• Proof of concept
• Value: no cap but likely £20-80K
• Duration: typically 3-9 months; to be completed by September
2014
• Call closes: 29 August 2013 at 1700 hrs
• Contract placement to be initiated from October 2013
Dstl

25 June 2013
Enquiries
• Technical enquiries: cbrcde@dstl.gov.uk
• General enquiries: cde@dstl.gov.uk
+44 (0)1235 438445
Dstl

Crown Copyright (c) 2012
www.science.mod.uk/enterprise cde@dstl.gov.uk
UNCLASSIFIED / FOR PUBLIC RELEASE
Submitting a Successful Proposal
Centre for Defence Enterprise (CDE)

Dstl is part of the
Ministry of Defence
UNCLASSIFIED / For Public Release
Crown Copyright Dstl 2012
Know what is available

Dstl is part of the
Ministry of Defence
Read available
information
Start with –
Quick Start Guide
plus other CDE manuals –
Account Manual, User
Manual, Technology
Application Manual
Know what is available

Dstl is part of the
Ministry of Defence
Developing a CDE proposal

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Ministry of Defence
Value from technology
Innovative
concept
Future
capability
Proofof
concept Incremental development

MOD Performance Assessment Framework
Five criteria:
Operational relevance
Likelihood of exploitation
Builds critical S&T capability to meet UK
needs
Scientific quality/innovation
Science, innovation and technology risk

Dstl is part of the
Ministry of Defence
Government-furnished X

Proposal health check

Contribution to future benefit

Based on a claim of future benefit
Contribution to realisation of future benefit
Logical programme of work
Evidential outcomes
Demonstration of progress towards goal
Health check

Dstl is part of the
Ministry of Defence
This call closes:
17:00 hrs on
Thursday 29 August 2013
Deadline

cde@dstl.gov.uk
www.science.mod.uk/enterprise
Call process queries

Dstl is part of the
Ministry of Defence
cbrcde@dstl.gov.uk
Call technical queries

Dstl is part of the
Ministry of Defence
www.science.mod.uk
Events and Calls > Current calls
for proposals > Innovation in drug
development processes
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Innovation in drug development processes - CDE themed call launch 25 June 2013

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