working with the cruk centre for drug development · hedgehog inhibitor 2nd gen hypomethylating...

WORKING WITH THE CRUK CENTRE FOR DRUG DEVELOPMENT

Today’s Science, Tomorrow’s Medicine

AIM OF TODAY


AIM OF TODAY

• Who we are

• What we do

• How we do it

• How we can work together

The Drug Development Office


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


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


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


CRUK CDD: What we do

CRUK CDD: WORKING WITH US


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


Basic Science



CRUK CDD: How we work

NEW

AGENTS

COMMITTEE

New Project Proposal

New CDD Project



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



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



GLP tox studies Large scale manufacture Formulation Drafting IMPD & IB Protocol development CTA submission Ethics submission Site feasibility IDDP



Investigators Meeting Monitoring materials Ethics Committee Submission Trust Agreements Lab/Imaging manuals Database set-up IDDP



Patient recruitment Compliance protocol/ GCP Data cleaning & review Safety monitoring & review PK & PD analysis Audits Horizon scanning IDDP



Database Lock Final Study Report Archive Publications Onward development …



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


http://www.wkrb13.com/markets/260558/astrazeneca-price-target-increased-to-gbx-3126-by-analysts-at-societe-generale-azn/

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

http://www.wkrb13.com/markets/260558/astrazeneca-price-target-increased-to-gbx-3126-by-analysts-at-societe-generale-azn/

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



Grant Funding

Alliance Portfolio

Sponsored Portfolio


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


NEW

AGENTS

COMMITTEE


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

?

working with the cruk centre for drug development · hedgehog inhibitor 2nd gen hypomethylating...

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