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Innovation in drug development processes - CDE themed call launch 25 June 2013
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Transcript of Innovation in drug development processes - CDE themed call launch 25 June 2013
Innovation in Drug Development Processes
Centre for Defence Enterprise
Rapid technological change
© Crown Copyright MOD 2011
The aim of CDE
© Crown Copyright MOD 2011
Prove the value of novel, high-risk, high-potential-benefit research
© Crown Copyright MOD 2011
Cost-effective military capability advantage
25 June 2013
Five key operating principles underpin the CDE model
Engaging innovators
25 June 2013
Accessible opportunity
Sustaining incentives
Minimising participation costs
Compliance
Two routes to funding
Online bid submission
Intellectual property
Themed calls
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 (counter mine)
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
Defence Open Call
Seeking the exceptional
Challenging conventions
4419 proposals received
17% proposals funded
£39M contracts awarded
Exemplar project
Fuel efficiency
‘Micro generators’
© Crown Copyright MOD 2011
Effective proposals
Challenge, pace & exploitation
The future of CDE
Network and question
© 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.
UNCLASSIFIED © Crown copyright 2013
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
© Crown copyright 2013 Dstl
F12/13 F13/14
Threat 6.4M 6.1M
Inform 7.9M 7.1M
Prot Measures 14.9M 14.2M
Strat Facilities 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
Protection Elimination
Arms
Control Disablement
Deterrence
Programme structure
UNCLASSIFIED © Crown copyright 2013
Dstl
25 June 2013
Programme and Delivery Directorate
CBR programme Other programmes
Dstl Depts Industry Academia
S&T Requirements
Partners
UNCLASSIFIED © Crown copyright 2013
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
UNCLASSIFIED © Crown copyright 2013
Dstl
25 June 2013
Impact of S&T
UNCLASSIFIED © Crown copyright 2013
Dstl
25 June 2013
Exploitation of S&T and where industry is involved
Early Innovation
Proof of concept
Assessment
Tech transfer Into service
UNCLASSIFIED © Crown copyright 2013
Dstl
25 June 2013
Alternative model
N2
Sample
Inlet to Detector
Capability
Research exploitation
Non-MOD markets
Rapid
Adaptation
UNCLASSIFIED © Crown copyright 2013
Dstl
25 June 2013
CBRN PROTECTION RESEARCH GOAL 9 – Medical Countermeasures
• Explore technology options to upkeep, update and upgrade the CBRN medical countermeasures capability. • To prevent individuals from experiencing the physiological effects of exposure to CBRN agents by the use of medical countermeasures, in order to maintain operational effectiveness on operations. • To move towards a post-exposure treatment posture while maintaining the current pre-exposure capability.
UNCLASSIFIED © Crown copyright 2013
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
UNCLASSIFIED © Crown copyright 2013
Dstl
Programme aim
• MOD long-term aim: broad-spectrum
post-exposure therapies
• Allow a flexible response to current
and emerging threats
UNCLASSIFIED © Crown copyright 2013
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
Ris
k
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
UNCLASSIFIED © Crown copyright 2013
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
UNCLASSIFIED © Crown copyright 2013
Dstl
CDE Themed Call:
Innovation in Drug Development
Processes
© Crown copyright 2013 Dstl
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
© Crown copyright 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.
© Crown copyright 2013 Dstl
25 June 2013
CDE call: Innovation in Drug Development Processes
UNCLASSIFIED
© Crown copyright 2013 Dstl
25 June 2013
Innovations in Drug
Development Processes
25 June 2013
© Crown copyright 2013 Dstl UNCLASSIFIED
Overview
• Background: target identification at Dstl
• CDE call: improving target exploitation
UNCLASSIFIED 25 June 2013
© Crown copyright 2013 Dstl
25 June 2013
© Crown copyright 2013 Dstl
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
UNCLASSIFIED © Crown copyright 2013
Dstl
25 June 2013
• Target selection Identification
• Biological evaluation of target
• Down-selection Characterisation and
validation
• Collaborations
• Evaluation of novel technologies for inhibitor selection
Exploitation
Approach to antibacterial targets
UNCLASSIFIED © Crown copyright 2013
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
UNCLASSIFIED © Crown copyright 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
UNCLASSIFIED © Crown copyright 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
UNCLASSIFIED © Crown copyright 2013
Dstl
25 June 2013
Aspiration
– Enable development of broad-spectrum
antibacterials
– Engage with academic/industrial partners at an
early stage
UNCLASSIFIED © Crown copyright 2013
Dstl
25 June 2013
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 © Crown copyright 2013
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
UNCLASSIFIED © Crown copyright 2013
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
UNCLASSIFIED © Crown copyright 2013
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
UNCLASSIFIED © Crown copyright 2013
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 © Crown copyright 2013
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
UNCLASSIFIED © Crown copyright 2013
Dstl
25 June 2013
What we DONT WANT
• Existing technologies
• Target identification
• Target-specific approaches
UNCLASSIFIED © Crown copyright 2013
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
UNCLASSIFIED © Crown copyright 2013
Dstl
25 June 2013
Enquiries
• Technical enquiries: [email protected]
• General enquiries: [email protected]
+44 (0)1235 438445
UNCLASSIFIED © Crown copyright 2013
Dstl
© Crown copyright 2013 Dstl
25 June 2013
Crown Copyright (c) 2012
Centre for Defence Enterprise
www.science.mod.uk/enterprise [email protected]
UNCLASSIFIED / FOR PUBLIC RELEASE
Centre for Defence Enterprise Submitting a Successful Proposal
Centre for Defence Enterprise (CDE)
Maximising your chances
Dstl is part of the
Ministry of Defence
UNCLASSIFIED / For Public Release
Centre for Defence Enterprise
www.science.mod.uk/enterprise [email protected]
Crown Copyright Dstl 2012
Know what is available
Dstl is part of the
Ministry of Defence
UNCLASSIFIED / For Public Release
Centre for Defence Enterprise
www.science.mod.uk/enterprise [email protected]
Crown Copyright Dstl 2012
Know what is available
Dstl is part of the
Ministry of Defence
UNCLASSIFIED / For Public Release
Centre for Defence Enterprise
www.science.mod.uk/enterprise [email protected]
Crown Copyright Dstl 2012
Know what is available
Dstl is part of the
Ministry of Defence
UNCLASSIFIED / For Public Release
Centre for Defence Enterprise
www.science.mod.uk/enterprise [email protected]
Crown Copyright Dstl 2012
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
UNCLASSIFIED / For Public Release
Centre for Defence Enterprise
www.science.mod.uk/enterprise [email protected]
Crown Copyright Dstl 2012
Know what is available
Dstl is part of the
Ministry of Defence
UNCLASSIFIED / For Public Release
Centre for Defence Enterprise
www.science.mod.uk/enterprise [email protected]
Crown Copyright Dstl 2012
Developing a CDE proposal
Dstl is part of the
Ministry of Defence
Value from technology
Innovative concept
Future capability
Proof of
concept Incremental development
The essentials
Description
mins
Assessment
Not an exam
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
Commercial tab
Dstl is part of the
Ministry of Defence
UNCLASSIFIED / For Public Release
Centre for Defence Enterprise
www.science.mod.uk/enterprise [email protected]
Crown Copyright Dstl 2012
Government-furnished X
Health and safety
Ethics
Unclassified
Crown Copyright (c) 2012
Centre for Defence Enterprise
www.science.mod.uk/enterprise [email protected]
UNCLASSIFIED / FOR PUBLIC RELEASE
Proposal health check
Claim of future benefit
Contribution to future benefit
Logical programme of work
Generation of evidence
Demonstration of progress
Crown Copyright (c) 2012
Centre for Defence Enterprise
www.science.mod.uk/enterprise [email protected]
UNCLASSIFIED / FOR PUBLIC RELEASE
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
Early birds
Dstl is part of the
Ministry of Defence
UNCLASSIFIED / For Public Release
Centre for Defence Enterprise
www.science.mod.uk/enterprise [email protected]
Crown Copyright Dstl 2012
This call closes:
17:00 hrs on
Thursday 29 August 2013
Deadline
Crown Copyright (c) 2012
Centre for Defence Enterprise
www.science.mod.uk/enterprise [email protected]
UNCLASSIFIED / FOR PUBLIC RELEASE
Centre for Defence Enterprise
www.science.mod.uk/enterprise
Call process queries
Dstl is part of the
Ministry of Defence
UNCLASSIFIED / For Public Release
Centre for Defence Enterprise
www.science.mod.uk/enterprise [email protected]
Crown Copyright Dstl 2012
Call technical queries
Dstl is part of the
Ministry of Defence
UNCLASSIFIED / For Public Release
Centre for Defence Enterprise
www.science.mod.uk/enterprise [email protected]
Crown Copyright Dstl 2012
www.science.mod.uk
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