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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
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
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
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
Angel Building London
CRUK CDD: Where you will find us
Formulation Unit Glasgow
Biotherapeutics Development Unit, London
Field based
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
CRUK CDD: WORKING WITH US
Today’s Science, Tomorrow’s Medicine
Grant Funding
Alliance Portfolio
Sponsored Portfolio
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
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
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
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
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
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
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
CRUK CDD: How we work
Today’s Science, Tomorrow’s Medicine
Database Lock Final Study Report Archive Publications Onward development …
CRUK CDD: WORKING WITH US
Today’s Science, Tomorrow’s Medicine
Grant Funding
Alliance Portfolio
Sponsored Portfolio
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
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
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
CRUK CDD: WORKING WITH US
Today’s Science, Tomorrow’s Medicine
Grant Funding
Alliance Portfolio
Sponsored Portfolio
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
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
?