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WORKING WITH THE CRUK CENTRE FOR DRUG DEVELOPMENT
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Today’s Science, Tomorrow’s Medicine
AIM OF TODAY
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Today’s Science, Tomorrow’s Medicine
AIM OF TODAY
• Who we are
• What we do
• How we do it
• How we can work together
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The Drug Development Office
Today’s Science, Tomorrow’s Medicine
CRUK CDD: We’ve changed
Why?
• Representative of the expertise of the Centre
• Reflects how we conduct drug development
• In line with CRUK assets e.g. Institutes
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CRUK CENTRE FOR DRUG DEVELOPMENT
2 DRUG MANUFACTURING FACILITIES
NEW AGENTS IN CLINICAL
TRIALS 140 50
FIRST-IN-MAN TRIALS
13
FIRST-IN-CLASS DRUGS
100
1 FOCUS
DRUG DEVELOPMENT AND OPERATIONAL STAFF
12 CDP DEALS COMPLETED TO DATE
~30 PROJECTS IN PORTFOLIO
DRUGS TO MARKET
6
6 COMBINATIONS ALLIANCE PARTNERS
Today’s Science, Tomorrow’s Medicine
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A unique drug development organisation
Biotherapeutics
Manufacturing Unit
Clinical Operations
Medical Sciences
Preclinical Development
Business Development
Alliance Management
Training
Quality Assurance
Drug Safety
d Small Molecule
Formulation Unit
Legal
Medical Writing
Data Management
Project Management
Regulatory Affairs
Today’s Science, Tomorrow’s Medicine
Portfolio Management
Drug supply
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Angel Building London
CRUK CDD: Where you will find us
Formulation Unit Glasgow
Biotherapeutics Development Unit, London
Field based
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Basic Science
Discovery Preclinical Phase I Phase II Phase III
CDD
Regulatory Preclinical Development
Exploratory Preclinical Development
Early Phase Clinical Trials
Today’s Science, Tomorrow’s Medicine
CRUK CDD: What we do
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CRUK CDD: WORKING WITH US
Today’s Science, Tomorrow’s Medicine
Grant Funding
Alliance Portfolio
Sponsored Portfolio
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WORKING WITH US – SPONSORED PORTFOLIO
18
10
Type of Agent
Small molecules
Biologicals
• Ca 30 drug development projects
• 12 clinical trials open, 13 agents in preclinical development
• Combination of agents from academia & industry
• Clinical Development Partnerships
“STRONG FOCUS ON PERFORMING EXCELLENT
SCIENCE” Immatics biotechnologies
GmbG
Today’s Science, Tomorrow’s Medicine
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Basic Science
Discovery Preclinical Phase I Phase II Phase III
Today’s Science, Tomorrow’s Medicine
CRUK CDD: How we work
NEW
AGENTS
COMMITTEE
New Project Proposal
New CDD Project
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CRUK CDD: How we work
Today’s Science, Tomorrow’s Medicine
Project & Portfolio Management
Drug Manufacture
Quality and Regulatory
Business Development
Data Management
Legal
Clinical Operations
Medical Sciences
Pre-Clinical
Clinical Investigators
& ECMC Network
Academic Scientists
Industry & Academic innovators
CMOs
CROs
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CRUK CDD: How we work
Today’s Science, Tomorrow’s Medicine
Assemble project team Clinical Trial Agreement Initial feasibility, timeline, budget No/No go milestones Clinical concept development Process development Toxicology & efficacy studies Biomarker development IDDP
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CRUK CDD: How we work
Today’s Science, Tomorrow’s Medicine
GLP tox studies Large scale manufacture Formulation Drafting IMPD & IB Protocol development CTA submission Ethics submission Site feasibility IDDP
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CRUK CDD: How we work
Today’s Science, Tomorrow’s Medicine
Investigators Meeting Monitoring materials Ethics Committee Submission Trust Agreements Lab/Imaging manuals Database set-up IDDP
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CRUK CDD: How we work
Today’s Science, Tomorrow’s Medicine
Patient recruitment Compliance protocol/ GCP Data cleaning & review Safety monitoring & review PK & PD analysis Audits Horizon scanning IDDP
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CRUK CDD: How we work
Today’s Science, Tomorrow’s Medicine
Database Lock Final Study Report Archive Publications Onward development …
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CRUK CDD: WORKING WITH US
Today’s Science, Tomorrow’s Medicine
Grant Funding
Alliance Portfolio
Sponsored Portfolio
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WORKING WITH US – ALLIANCE PORTFOLIO
“WORKING WITH CDD IN THE COMBINATIONS ALLIANCE IS A WIN-WIN. UK INVESTIGATORS GET ACCESS TO NEW DRUGS EARLIER, WE GAIN INSIGHT INTO THE ACTIVITY OF OUR DRUGS IN A NEW
SETTING AND, MOST IMPORTANTLY, PATIENTS GET ACCESS TO A NEW
TREATMENT THAT MAY IMPROVE THEIR OUTCOME” Andrew Hughes
AstraZeneca
COMBINATIONS ALLIANCE
• 6 Alliance partners
• 10 clinical trials open, 1 in close down, further 4 in set-up
Today’s Science, Tomorrow’s Medicine
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Companies and Drugs
20
SMALL MOLECULES INCLUDING:
Wee1 inhibitor
mTOR inhibitor
MEK inhibitor
EGFR sensitising and T790M Resistance Mutations Inhibitor
STAT3rx antisense oligonucleotide
EGFR inhibitor
AKT inhibitor
ATR inhibitor
PI3Kβ/δ selective inhibitor
cMET inhibitor
RET, EGFR, VEGF inhibitor
PARP inhibitor
Hedgehog inhibitor
2nd gen hypomethylating agent
HSP90 inhibitor Anti-ANG2 mAb
Anti-DLL4 mAb
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Combinations Alliance – Working with us
Portfolio
• Company provides access to a portfolio of oncology agents (under MoU)
• Expressions of Interest (EOI) requested from the academic community
Review
• Proposals are reviewed by the company and Joint Steering Committee (JSC)
• Seek approval from the New Agents Committee (NAC)
Sponsor
• ECMC will sponsor the proposed study under a Clinical Trial Agreement (CTAg)
• Studies are driven by the ECMC Alliance team and overseen by the JSC
Study
• Investigator led trial opens within 12 months
• Multiple centres within 1 protocol
21
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CRUK CDD: WORKING WITH US
Today’s Science, Tomorrow’s Medicine
Grant Funding
Alliance Portfolio
Sponsored Portfolio
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Today’s Science, Tomorrow’s Medicine
Funding Stream
NAC Trial Grant •2 year grant of 150K (total)
NAC Endorsement •No funding, access to NIHR portfolio list
NAC Preclinical Combination Award •Pre-clinical in vitro and in vivo studies of new drug and radiotherapy combinations •50K for 6-12 months
• Academic Led
• Combinations Alliance
CRUK CDD: Working with us
Basic Science
Discovery Preclinical Phase I Phase II Phase III
NEW
AGENTS
COMMITTEE
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Today’s Science, Tomorrow’s Medicine
Direct Contact
Expression of Interest Calls
•Approach us with your research ideas •Contact [email protected]
•Clinical Development Partnerships Initiative •Combinations Alliance
•Calls circulated via ECMC lead/contact
CRUK CDD: Working with us Do you have a
preclinical or
clinic ready
research idea
?