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

Innovation in Drug Development Processes

Centre for Defence Enterprise

Rapid technological change

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

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’

Effective proposals

Challenge, pace & exploitation

The future of CDE

Network and question

01235 438445

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

25 June 2013

An Introduction to CBR Science and Technology

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.

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

Strat Facilities 6.2M 6.4M

£35.4M £33.8M

CBR research programme funding

UNCLASSIFIED

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

Control Disablement

Deterrence

Programme structure

25 June 2013

Programme and Delivery Directorate

CBR programme Other programmes

Dstl Depts Industry Academia

S&T Requirements

Partners

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

25 June 2013

Impact of S&T

25 June 2013

Exploitation of S&T and where industry is involved

Early Innovation

Proof of concept

Assessment

Tech transfer Into service

25 June 2013

Alternative model

Sample

Inlet to Detector

Capability

Research exploitation

Non-MOD markets

Adaptation

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.

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

Programme aim

• MOD long-term aim: broad-spectrum

post-exposure therapies

• Allow a flexible response to current

and emerging threats

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

UNCLASSIFIED 25 June 2013

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

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

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

• 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: Innovation in Drug Development Processes

UNCLASSIFIED

25 June 2013

Innovations in Drug

Development Processes

25 June 2013

Overview

• Background: target identification at Dstl

• CDE call: improving target exploitation

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

Capsule

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

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

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

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

Aspiration

– Enable development of broad-spectrum

antibacterials

– Engage with academic/industrial partners at an

early stage

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

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

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

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

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

25 June 2013

What we WANT

• Proof-of-concept proposals

• Highly innovative approaches, tools, technologies

• Applicability to broad-spectrum targets

• Applicability to intracellular bacteria

25 June 2013

What we DONT WANT

• Existing technologies

• Target identification

• Target-specific approaches

25 June 2013

Proposals

• Proof of concept

• Value: no cap but likely £20-80K

• Duration: typically 3-9 months; to be completed by September

• Call closes: 29 August 2013 at 1700 hrs

• Contract placement to be initiated from October 2013

25 June 2013

Enquiries

• Technical enquiries: cbrcde@dstl.gov.uk

• General enquiries: cde@dstl.gov.uk

+44 (0)1235 438445

25 June 2013

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

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

Know what is available

Dstl is part of the

Ministry of Defence

Dstl is part of the

Ministry of Defence

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

Dstl is part of the

Ministry of Defence

Dstl is part of the

Ministry of Defence

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

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

Government-furnished X

Health and safety

Ethics

Unclassified

Proposal health check

Claim of future benefit

Contribution to future benefit

Logical programme of work

Generation of evidence

Demonstration of progress

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

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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