APS Developing new drugs for respiratory
diseases – how can
clinical imaging of the lungs help?
Thursday 21st and Friday 22nd January 2016
Purpose of meeting
To review the state-of-the-art in respiratory imaging as
applied to drug discovery and development. The focus will be on
how imaging can be used to benefit all aspects of the drug
discovery and development phases and which modalities may suit
some aspects, but not others. The overall aim is to define the
state of the art regarding clinical imaging of the lungs and how
this can be applied to pharmaceutical discovery and medicines
At present there is little coordination of imaging with regard
to its applications, strengths and weaknesses, best practice,
key parameter. As an outline, here are some of the main
- Is it satisfactory for everyone to be
“doing their own thing”, or could some harmonisation be of
- There appears to be a distinct lack of
early investigative work on target engagement - is anybody
working on this or is this something that needs to be
- What is the role/value of imaging in drug
discovery for both early and late phase assets?
- Does imaging have a role in long term
- Are the benefits of imaging accepted and
do they receive regulatory recognition.
- What are the practical issues (ethical
concerns, IP constraints, developing and validating new
techniques) that challenge further developments in imaging
and wider application?
When developing new drugs for the inhaled route, what needs can
be satisfied by imaging modalities – and which require further
investment to make it a reality? From a Pharma perspective,
imaging may have additive value in decision-making if it can:
- Demonstrate pharmacological engagement of
the target of interest in the lung (and if possible the
distribution of the inhaled dose).
- Provide additional information that
supports improvement of lung function beyond FEV1 to
demonstrate efficacy, so Imaging modalities can demonstrate
efficacy in their own right.
- Define new image based endpoints e.g.
airway volume and correlate with existing endpoints.
- Show improved ventilation/perfusion, gas
flow, oxygenation in patients post or during therapy that is
sustained, so look at vascular performance, density and
anatomy and correlate with physiological change.
- Can track inflammation (neutrophils,
eosinophils, macrophages, T-Cells) or patterns of fibrotic
change over time.
- Is able to also show deterioration of
lung performance as disease progresses or potential
detrimental side effects of long term drug use? So imaging
can demonstrate both acute drug effects and chronic drug
effects, and define how imaging endpoints change with drug
action eg vascular MRI changes following administration of a
pulmonary vascular vasodilator has not been looked at.
- Provide exposure to allow introduction in
to clinical practice and hence further validation.
By bringing clinical imaging groups together, it may be possible
to recognise the opportunities in emerging imaging developments
and apply these to areas of unmet need for the pharmaceutical
- State of the art publication on how
clinical imaging is used today and what it needs to do for
- To bring imaging groups closer together
and maybe develop a Respiratory Imaging subgroup?
- To identify the key gaps from a Pharma
perspective and seek to resolve them.
- Start to define which imaging techniques
are good for which endpoints and therefore which techniques
can tackle different mechanisms of drug action.
- The possibility of seeking precompetitive
funding (through IMI for example) to address gaps.
- A source of reference for justifying any
particular imaging modality on future studies