Transcript Objective - National University of Ireland, Galway

Funding Opportunities
at Wellcome
Fiona MacLaughlin
Heather Chaffey
The Wellcome Trust
• independent research-funding charity
• largest charity in UK
• established 1936
• founder of company that developed AZT,
FMD and Rubella
• funded from private endowment valued at
£15 billion (March 2008)
• managed for long-term stability and
growth
• interests range from science to history of
medicine
Mission and strategy
“To foster and promote research
with the aim of improving human
and animal health”
Basic Organisational Structure
Science Funding
Technology Transfer
Investments
Creative Research
Programme related
investment
Capital growth
of endowment
‘To foster and promote research with the
aim of improving human and animal health’
Equity & Equity Long/Short
Absolute Return & Buyout
Healthcare & Venture
Property & Infrastructure
Private Equity
Wellcome Trust
Philosophy
• spend up to £4bn over next 5 years
• how we work:
• people & ideas - focus on individuals
• programmes - big & brave grants
• places - fund where we can make a
difference
• partnership - strategic partnerships
• a committed funder of translational
research
• public engagement that aims to create
an informed climate within which
biomedical science can flourish
Improving innovation
Translational medicine
Key to an innovative healthcare and
pharmaceutical industry we must:
• develop bench to bedside – bedside to bench
approaches
• optimize academia & industry links
• develop innovative public private partnerships
• reinvigorate undergraduate medical curriculum
• provide flexible training routes
• streamline approval processes
Dr Heather Chaffey
Grants Adviser, Neuroscience & Mental Health
Grants Management Department
(t) +44 (0)20 7611 8786
(e) [email protected]
Overview
• What we fund
• Funding schemes
• General information
• The application process
- background & tips
What do we fund?
• Biomedical and Veterinary Research
• Technology Transfer Activities
• History of Medicine Research
• Biomedical Ethics Research
• Public Engagement Activity
• Direct Activities (e.g. Sanger Institute)
Financial Expenditure 2007/08
Support Costs,
£44m
Direct Activities,
£43m
Grants to Sanger
Institute, £90m
Medicine Society &
History Grants,
£38m
Technology Transfer
Grants, £30m
Biomedical Science
Grants, £457m
Expenditure in Ireland
Dublin City University
£626,051
University College Dublin
£2,912,892
Other Institutions
£121,500
National University of Ireland
£150,169
University College Cork
£1,202,081
Royal College Surgeons
£1,830,699
Total
£16,325,739
Trinity College Dublin
£9,479,227
Funding Schemes
• Response - Mode Funding
• Strategic Award Funding
• Fellowships
Response - Mode Funding
Eligibility Requirements
• Hold a research post in an eligible
organisation
• Have 5 years postdoctoral research
experience
• Must be able to sign up to the Trust’s
grant conditions
Project Grants
• High-quality, hypothesis-driven research
• Salaries for 1-2 posts plus equipment, travel and
materials for up to 3 years
• Awards in the region of £150-£400k.
• Support for pilot studies and international
collaborations
Programme Grants
• Internationally competitive research programmes
• Proven track record of research and funding.
• Salaries for 3-4 posts for 5years plus equipment, travel & materials
• Awards typically in the region of £900k-£1.5m
I
Other Schemes
• Equipment, Biomedical Resources &
Technology Development Grants
• Flexible Travel Awards: Sabbaticals
Strategic Awards
• Flexible forms of support to facilitate
research &/or training.
• To 'add value' to excellent research
groups.
• Must involve a partnership with the host
institution.
•Normally for 5 years.
• Open rolling call for proposals but the
Trust may highlight particular areas of
research.
Strategic & Themed Initiatives
• African Institutions Initiative
• Medical Engineering
• Genome-wide Association Studies in Disease
• Research in Neurodegenerative Diseases
• Capital Awards in Biomedical Science
Fellowships
Personal Support Schemes
BIOMEDICAL SCIENTISTS
CLINICAL SCIENTISTS
Principal Research Fellowships
Senior
Senior Research
Fellowships
Senior Research
Fellowships
University
Awards
Intermediate
Training
Research Career
Development
Fellowships
Sir Henry Wellcome
Postdoctoral
Fellowships
4 Year PhD
Programmes
Flexible
Travel
Awards
Research
Career ReEntry
Fellowships
Intermediate Clinical
Fellowships
Research Training
Fellowships
PhD Programmes
Schemes for nonclinical scientists
Personal Support Schemes –
Biomedical Scientists
Senior Research Fellowships
Research Career
Development Fellowships
Sir Henry Wellcome
Postdoctoral Fellowships
Schemes for clinically
and veterinary
qualified scientists
Personal Support Schemes –
Clinical Scientists
Senior Research Fellowships
Intermediate Clinical Fellowships
Research Training Fellowships
Other Personal Support Schemes
• Flexible Travel Awards: Fellowships
• Research Career Re-entry Fellowships
•University Awards
Alternatives
• Request personal salary
support on a project grant
General Information
What funding do we provide?
• Directly incurred costs of research. We do not
fund on a proportion of fEC
• Travel allowances
• Flexible funding allowance
• We also fund some additional costs, including:
–
–
animal house facility fEC charge out rates
open access publishing
– national and international resources
The Application Process –
Background & Tips
The Application
Process
Good idea!
Preliminary application
Short-listing for full applications
Full Application
4 – 6 months
Expert peer-review
Funding Committee
Short-listing for interviews
Interview Committee
Decision
Writing the Application
A ‘Good’ Application
• A strong and original central hypothesis
• Evident knowledge of the area and appropriate expertise
• Clear research plan/easy to understand
• Convincing preliminary data
• Not over- or under- ambitious
• All staff, equipment & animals carefully justified
• Seek advice!
“...it involves techniques with which the applicant appears to
have no prior experience and for which no preliminary data
are proposed.”
“...the work described in this application is over-ambitious, it
could not be achieved in the life time of the investigator.”
“The poor writing, referencing and proof reading of this
application significantly detract from its overall quality.”
“I had only one problem with this application, I had no idea
what they were trying to do...”
Peer Review Assessment
• Importance of the problem
• Strengths and weaknesses of application
- quality of science, feasibility
• Standing of applicants – track record
• Resources requested – are they appropriate?
• Fellowships: person, project, place
Thank you!
Dr Heather Chaffey
Grants Management Department
[email protected]
techtransfer@wellcome
Purpose
To maximise the impact of research
innovations on health by facilitating
their route to the ‘market’
• early-stage R&D funder
• focused on funding gaps
• motivated by public good
Translational Funding
Creative research
Government /
Philanthropic
grants
Applied Research Development
Sales / Marketing
Translational
Funding/VP
Venture Capital
Private equity /
public markets
Publication / Grants
Charitable mission
Sustainable
advantage
Sustainable
business
RISK IS DEFINED BY SECTOR DRIVER
Technology Transfer History
• 1995 - Intellectual Property and Industrial
Relations worked with Cancer Research
Campaign Technology
• 1997 – Catalyst BioMedica Limited, wholly
owned trading subsidiary with own £20 Million
fund
• 2003 – Technology Transfer Division with
Translation Awards Fund
Early stage funding : Bridging the R&D gap
Medical Engineering
Joint initiative with the Engineering and Physical Sciences
Research Council
£41 M for four centres of excellence
• Leeds University (John Fisher)
Focus on ageing in relation to early diagnosis & improved
prostheses for musculo-skeletal & cardiovascular disease
• Oxford University (Lionel Tarassenko)
Focus on personalised treatment in chronic conditions such
as asthma, diabetes & cancer using telemedicine technology
• Imperial College (Ross Ethier)
Focus on the management of osteoarthritis through improved
implants and tissue engineering approaches
• Kings College, London (Reza Razavi)
Focus on medical imaging in cardiovascular disease and
cancer for improved visualisation to guide targeted therapy
TechTransfer award commitments (£ M)
90
80
Million GBP (£)
70
60
50
Unallocated To Date
India Affordable Healthcare
Medical Engineering
Seeding Drug Discovery
Strategic Award Committee
Strategic Translation Awards
Translation Awards
£69m
£62m
£40m
40
30
20
£15m
£16m
£8m
10
£2m
0
2002/3* 2003/4 2004/5 2005/6 2006/7 2007/8 2008/9
Funding Year
What types of opportunity are
charities looking for ?
Projects that relate to their mission
 Usually disease-focused
 Sometimes problem-oriented
 Always fulfil an unmet need
 Offer solutions that are ‘fit for purpose’
Projects at the appropriate stage
 Different charities engage at various stages
 Fund-raising charities are more patient-oriented
 Many charities look for leverage of their funds
Gradient of unmet need guides
where we engage
‘Neglected
Diseases’
malaria
leishmaniasis
Chagas
‘Orphan
diseases’
‘Niche
market’
$100M
cystic fibrosis
lupus
Gauchers
MS
Turners syndrome necrolepsy
‘Speciality
medicine’
<$500M
‘Blockbuster
drug’
>$500M
melanoma
osteoporosis
dermatitis
antidepressants
pain
cholesterol control
Diversity of Translation Award scheme
Applications received
Diagnostics
11%
Therapeutics
36%
Regenerative
Medicine
5%
Vaccines
6%
Enabling
Technology
21%
Medical Devices
21%
Awards made
Vaccines
6%
Therapeutics
45%
Diagnostics
10%
Enabling
Technology
10%
Regenerative
Medicine
7%
Medical Devices
22%
Venture Philanthropy
versus Private Financing?
Advantages
 Charity aims don’t keep changing
 Financial return is not the priority
 Charities are well informed & well connected
 Charity backing gives a company good PR
Disadvantages
 Cultural differences may lead to tensions
 Conflicts of interest can be tricky to manage
 Shareholders need to understand the implications
Value of Philanthropic funding?
“Increase number of scientists who can translate drug discoveries into
effective new medicines”
“One proven route to [drug discovery] is innovation forged through
synergistic industrial-academic collaborations”
“Enhance drug R & D efforts in non-profit institutes”
Funding in Europe (inc. R. of Ireland)
• Strategic mode
• Institutions/registered company
• SDDI – follow usual route
• Translation award – invite only
Strategic Translational funding
Ireland
• Core to the Trust’s own initiatives and objectives
• Exceptional science
• Trusts investment is of the order necessary to achieve
programme goals thus no financial ceiling (within
reason!)
• Co-funding is welcome
• Invite only (except SDDI)
• Funding meetings approximately every 12 weeks
• No small-molecule therapeutic programmes
• Work in partnership with the Trust to achieve the
commercial translation of targeted technologies
Key Criteria
•
•
•
•
•
•
Ultimate healthcare benefit and impact
Scientific rationale and evidence
Competitive advantage / differentiation
Downstream feasibility, risks identified
Background assets and new assets for exit
Competencies and skills for implementation
Typical Process
Preliminary Application:Invitation
Risk analysis
Full application
Scientific
/ Technical
Expert Opinions
IP / Legal
Milestones
Patent position
Commercial
Strategy
Due Diligence
Regulatory
Business
Tech Transfer Challenge Committee
(TA)
Tech Transfer Strategy Panel
(STA)
Application should have..
….feasibility, team,
market
....feasibility, validation
Risk
Technical
….timings, content,
suitability
….awareness, preparation
Milestones
Regulatory
Full Application
….current assets,
potential new IP
….informing clinical practice
Clinical
IP
….competitive advantage,
opportunity
Commercial
Business
….model, revenue generation,
further funding requirements
The Seven Deadly Sins
• Poor project plan
• Lack of key expertise/experience
• Unclear competitive advantage
• Unrealistic commercial exit
•
•
•
Under-resourced project
Major product development hurdles
Weak scientific rationale
“A few misconceptions”
“……you won’t fund companies”
Wrong - >£35M committed since 2003 with approximately 50:50 academia:
company settings
“……of course the Trust will want to have some ownership of IP arising from the
project”
No. The IP is owned by the university or company.
“….you only fund projects arising from Trust funded research”
No. We look to fund the best projects from any background
“....only interested in Biology”
Wrong. Technology Transfer has a history of funding projects ranging from computation
through to devices
Irish projects funded to date
Jim McLaughlin
John Anderson
The VitalSens wireless vital signs
monitor
Louise Kenny
Phil Baker
Development of a metabolite
biomarker-based screening test to
predict pre-enclampsia
Neil Frankish
Preclinical and clinical development
of novel indanes as therapeutic
agents for the treatment of
inflammatory bowel disease
Liam Marnane
Development and validation of
clinically robust neonatal seizure
detection systems (based on
neonatal EEG)
Devices
Vital Signs Monitor
Objective
VitalSens Vital Signs Monitor for hospital use
Team
Jim McLaughlin, John Anderson, Michael Caulfield, ST&D
Features
Non-invasive patient worn monitor
Five Vital Signs : ECG, respiration rate, skin temperature, gait, SpO2
Data transmission via hospital wireless networks
Devices
Neonatal Seizure Detection
Objective
Development and validation of clinically robust, neonatal
seizure detection systems
Team
Liam Marnane, Geraldine Boylan, Gordon Lightbody
Janet Rennie
Features
Signal processing system using ECG, EEG
Adapt for use in neonates
Clinically test – avoid complex clinical data analysis
Devices
Stepwise Innovation
• World’s first fully portable
video laryngoscope
• Pioneering Design
• Substantial Market
• Existing equipment
1940’s based
Diagnostics
Re-profiling platform technologies
Objective
The rapid and selective detection of Mycobacterium tuberculosis by
field deployable thermochemolysis gas chromatograph mass
spectrometry
Strategic Features
Space research meets tropical medicine
WT had funded Beagle mission
Device
Pheromone baited traps for Sand-fly vectors
Objective
Field feasibility trial of synthetic sex pheromone analogue
of Sand-flies
Team
Gordon Hamilton
Features
• High efficiency trap
• Minimise spread of leishmaniasis
Device
Injectable Bone
Objective
Translating a new concept in injectable scaffolds into a regenerative
medicine product
Team
Enabling Technology
Superior Coatings
Objective
High throughput microarrays for discovery of polymers
resistant to bacterial colonisation
Team
Morgan Alexander
Martyn Davies
Paul Williams
Bob Langer
Dan Anderson
Hospital acquired infections are associated with
implanted medical devices and more than 80%
are due to the formation of biofilms
Therapeutic
Nanotechnology
Objective
Development of heavy tamponades in vitreo-retinal
surgery
Team
Michael Garvey
Device
Spider silk technology for meniscal repair
Objective
Development and evaluation of a bio-resorbable, load-bearing,
tissue regenerative meniscal cartilage implant
Team
Nick Skaer, Orthox Ltd
Silkworm silk fibres are dissolved in bulk. Super strong and resilient tissue
scaffolds (Spidrex® can be made by emulating spiders spinning techniques.
Prototype Orthox device matches target mechanical properties and supports
cell growth, osteo-inductive and shows bone deposition 8 weeks in vivo
Industry
partnerships
historically
Industry
partnerships
present
VC-backed biotech past
years
Target
Discovery
Functional
genomics
Proteomics
In vitro / in
vivo disease
association
3-9 months
Assay
Development
6-12 months
‘Hit to lead
12-24 months
Lead
Optimisation
12 months
Pre-clinical
Evaluation
1° and 2ry
assay
development
Medicinal
chemistry
optimisation
Pharmacokinetic
/ dynamics
Screening
strategy
Biochemical /
ADMET assays
Toxicology
package
Structural
genomics
In vitro / in vivo
pharmacology
Process
development
IND filing
Small scale GMP
manufacture
“To develop drug-like, small molecules that will be the springboard for further R & D by
the biotech and pharmaceutical industry in areas of unmet medical need”
Seeding Drug Discovery Portfolio
Emerging Small Molecule Drug Discovery Portfolio
ORIGIN
Liverpool School of
Tropical Medicine
Astex Therapeutics
University College London
Senexis Ltd
Institute Cancer Research
Lectus Therapeutics
Bristol University
GlaxoSmithKline plc
UCL / Pentraxin Ltd
Nottingham University
King's College London
Sentinel Oncology ltd
Manchester University
St George's
Edinburgh University
Imperial College London
Prolysis Ltd
Novacta
Achaogen Inc
TARGET
THERAPEUTIC AREA
Alternative Complex 1
Malaria
HCV protease
Hepatitis C Virus
DDAH1
Sepsis
plaque disruption
Alzheimer's
Lysyl Oxidase
Metastatic Pancreatic
KV1.3 /b2 ion channel
Multiple Sclerosis
PH domain PKB
Lung Cancer
Confidential
Gram -ve antibacterials
Confidential
Amyloidosis
b1 adrenoceptor
Cardiovascular
Retinoic Acid Receptor
Alzheimer's
Chk1
Clioblastoma
Glucocorticoid Receptor
Inflammatory Arthritis
Derp1
Allergic Asthma
11-b HSD1
Dementia / Metabolic Syndrome
PP(Y4) receptor
Obesity
Bacterial FtsZ
Staphylococcal infection
Aminoglycoside
Lipid II
Clostridium difficile
analogues
Gram -ve antibacterials
Hit
Finding
Hit-toLead
TERMINATED
TERMINATED
Lead
optimisation
Preclinical
IND
Phase
1
Drug Discovery
New Drug: Old Target
Objective
Development of highly selective β-1 adrenoceptor antagonists
for therapeutic application in patients with concomitant
respiratory and cardiovascular disorders
Team
Jillian Baker
β-blocker
β1
β2
Steve Hill
Nebivolol
14.1
Barry Kellam
Bisoprolol
13.5
Atenolol
4.7
Peter Fischer
Metoprolol
2.3
Labetalol
2.5
Propranolol
8.3
Timolol
25.7
β-agonists
Salbutamol
28.8
Salmeterol
2818.4
The Problem and the Market
“In 2004, total U.S. sales of beta blockers were
approximately $1.9 billion, a 20% increase over 2003
sales. The market leader is AstraZeneca’s Toprol XL
(metoprolol). Total U.S. sales of Toprol XL in 2004 were
approximately $1.2 billion”
If 1% population should be on a b-blocker but cannot be
because of side effects = $ 190 million in sales (2003 data)
BUT…
Will market use the product?
Pharma
Longevity of safety and efficacy data
Translation funding to date
Input
Output
180 projects supported
Range: £25K - £11.2M
£229 million committed
£419 million leveraged
10 exits via M&A/listing or licensing
6 products launched
TT Funding Commitment ( £ M)
Total Follow-on Fundraising (£ M)
Numbers of awards
35
30
Companies
25
Institutions
450
400
350
20
300
15
250
200
10
150
5
100
50
0
2002/3*
2003/4
2004/5
2005/6
2006/7
2007/8
2008/9
*2002/3 was a partial funding year
only
0
1998/9 1999/0 2000/1 2001/2 2002/3 2003/4 2004/5 2005/6 2006/7 2007/8 2008/9
Dr Fiona MacLaughlin
Senior Business Analyst
Technology Transfer Division
(t) +44 (0)20 7611 8310
(e) [email protected]
Funding Mechanisms
Managing Wellcome Trust-funded
Intellectual Property:
Revenue/Equity Sharing
Funding Terms and Conditions
• ACADEMIA
– Funding Agreement aligning with principles of Grant conditions
– Trust leads on exploitation of commercialisable assets
• SME
– Unsecured Convertible loan (Equity conversion at 20% discount
to next professional investment round)
– Repayment options at Trust discretion (LIBOR + 2%)
• PHARMA
– Milestone / royalties based deals
– Step in rights to ensure achievement of charitable mission
• OTHER (based on circumstance)
– Bespoke
Key Aims of IP Management
• Achieve health care benefits
• Promote & Maintain supportive environment
for future biomedical research
- Encourage open & innovative approach
- Partnerships of funders, scientists,
institutions and companies
Managing IP from Trust Grants
•
Wellcome Trust IP Policy & Grant Conditions
•
IP to vest in Host-Institution / University
•
Systems for identifying and managing IP
•
Incidental private benefit only
•
Appropriate way to achieve public benefit?
–
Case-by-case
–
IP protection?: Patent filing
–
Unprotected access?: Publication of research results
–
Need to attract follow-on R&D funding? (VCs; Pharma)
–
No reputational risk to Trust
Revenue / Equity Sharing
•
Trust sole funder: revenue / equity share applies to the
total gross income / equity received
•
Trust not sole funder: revenue / equity share applies
pro-rata to gross income / equity received taking into
account:
–
Inventive contribution of inventors
–
Proportionate funding contributions of Trust, Institution and third party
funders
–
Importance / value of respective funding contributions to the deal
Dr Fiona MacLaughlin
Senior Business Analyst
Technology Transfer Division
(t) +44 (0)20 7611 8310
(e) [email protected]