IMI-PainCare: Public-private partnership tackles major challenges in the care of pain patients

Aachen (ots) - To improve the care of patients with acute or
chronic pain, a consortium from academia, small and medium-sized
enterprises (SMEs), pain societies, patient organizations and
pharmaceutical industry launched the research project "IMI-PainCare -
Improving the care of patients suffering from acute or chronic pain"
on April 01, 2018. The consortium strives to develop a toolbox that
can streamline the research and development process for novel
analgesic drugs and improve treatment quality in clinical practice.
The project comprises three sub-projects across all phases of the
pharmaceutical value chain - from early research to clinical practice
- addressing major challenges in the care of patients suffering from
acute or chronic pain in a complementary manner. It is anticipated
that tools will be validated that will allow patient stratification
and enrichment as recommended by the recent EMA/CHMP/970057/2011
guideline on pain treatment.

IMI-PainCare is set within the framework of the Innovative
Medicine Initiative (IMI), the largest public-private partnership for
health research worldwide. The project is driven by a consortium of
40 partners from 14 countries, while the lead is shared by
Rolf-Detlef Treede, University of Heidelberg, and Petra Bloms-Funke,
Grünenthal. IMI-PainCare is supported by the IMI 2 Joint Undertaking
with EUR 11.2 million provided by the European Union. The industrial
partners will provide EUR 12.0 million through direct and in-kind
contributions, e.g. employees working on the project in partnerships
with the consortium. The project runs over four years and will end on
March 31, 2022.

Pain management is essential for all medical conditions, as it is
one of the major dimensions of Quality-of-life scores that patients
report. Additionally, chronic pain may outlast the normal healing
process (e.g. after surgery). It can be a symptom of a chronic
disease (e.g. endometriosis, bladder pain syndrome, diabetic
neuropathy) or may occur without any signs of an underlying disease.
The treatment of both acute and chronic pain is often inadequate,
which underlines the high need for innovative solutions to improve
pain management. This is partly due to a poor translation of results
from preclinical models into clinical trials, and partly due to a
lack of sophistication in outcome reporting and accurate division of
patients into subgroups in clinical trials.

"Acute and persistent pain of different origins represent a common
medical, social, and economic burden, and improvement of its
management is still a major challenge for all health care systems. I
look forward to working towards innovative solutions to these unmet
medical needs together with my partners of IMI-PainCare which
represents an unprecedented close cooperation between academia, SMEs,
patient organizations, pain societies and pharmaceutical companies,"
Rolf-Detlef Treede, University of Heidelberg, explained. "I am
delighted that we were able to bring together the expertise of 40
partners to drive innovative solutions in pain management. The joint
work of these best-in-class experts may enable us to provide pain
patients with the appropriate prevention or treatment for their
condition at the right time", Petra Bloms-Funke, Grünenthal, stated.

"Providing standardized consented patient-reported outcome
measures" (PROMPT) is the first sub-project, led by Winfried
Meissner, University of Jena, and Hiltrud Liedgens, Grünenthal. It is
located in a key area of both clinical research and clinical practice
and has the patient's perspective in its focus. "We aim to improve
the management of pain by defining a consented set of
patient-reported outcome measures which is suitable to assess acute
and chronic pain in controlled trials as well as real world
conditions. It would be beneficial for patients if success is
documented routinely after pain treatment, and the tools we aim to
identify can help with this", Winfried Meissner stated. "A defined
set of patient-reported outcome measures in clinical trials of novel
analgesics could become a discussion basis in our exchange with
regulatory authorities, especially when defining claims in submission
documents, and with Health Technology Assessment Agencies (HTAs) when
we have to discuss relevant clinical benefits to gain reimbursement",
Hiltrud Liedgens, Grünenthal, added.

"Functional pain biomarkers" (BioPain) - the second subproject -
is led by Rolf-Detlef Treede, University of Heidelberg, and Keith
Phillips, Eli Lilly and Company. It is located in the transition
stage from pre-clinical to early clinical development and aims to
establish pharmacokinetic / pharmacodynamic models in healthy humans
and rodents. "Functional electrophysiological and imaging tests
validated in experimental pain models could be a basis for the
creation of purposeful clinical endpoints, also in patients",
Rolf-Detlef Treede, University of Heidelberg explains. "If these
clinical markers prove their reliability, we could aim to carry them
into preclinical models as well. This could improve our candidate
selection and may increase the chance of a successful translation
from preclinical to clinical development", Keith Phillips, Eli Lilly
and Company, added.

The subproject "Translational research in pelvic pain" (TRiPP) is
led by Katy Vincent, University of Oxford, and Jens Nagel, Bayer. It
has a special focus on pain related to endometriosis and interstitial
cystitis / bladder pain syndrome and is located in clinical practice
as well as the early stage of disease understanding to provide a
robust pre-clinical environment for drug development. "We aim to
determine subgroups within these diseases and identify biomarkers of
these clinical phenotypes. Ultimately, we hope this strategy will
move towards more personalised treatments for these distressing
conditions", Katy Vincent stated. "It is of key importance to
understand better the molecular pathways leading to inflammation and
chronic pelvic pain both in endometriosis and bladder pain syndrome
and to assure that these are reflected in pre-clinical models to
improve their translational value for clinical research", Jens Nagel
added.

About the Innovative Medicines Initiative

The Innovative Medicines Initiative (IMI) is a partnership between
the European Union and the European pharmaceutical industry,
represented by the European Federation of Pharmaceutical Industries
and Associations (EFPIA). It is working to improve health by speeding
up the development of, and patient access to, the next generation of
medicines, particularly in areas where there is an unmet medical or
social need. It does this by facilitating collaboration between the
key players involved in healthcare research, including universities,
pharmaceutical companies, and other companies active in healthcare
research, small and medium-sized enterprises (SMEs), patient
organizations, and medicines regulators. This approach has proven
highly successful, and IMI projects are delivering exciting results
that are helping to advance the development of urgently-needed new
treatments in diverse areas.

More info on IMI: www.imi.europa.eu

Follow IMI on Twitter: @IMI_JU

Please visit our website for more information on the IMI-PainCare
project www.imi-paincare.eu

Acknowledgement

This project has received funding from the Innovative Medicines
Initiative 2 Joint Undertaking under grant agreement No 777500. This
Joint Undertaking receives support from the European Union's Horizon
2020 research and innovation programme and EFPIA Companies.

Disclaimer

This communication reflects the views of the IMI-PainCare
consortium and neither IMI nor the European Union and EFPIA are
liable for any use that may be made of the information contained
herein.

Pressekontakt:
Project Office/General Enquires:
Email: info@imi-paincare.eu
Project Leader: Petra Bloms-Funke, Grünenthal GmbH. +49 241 569 2697
Project Coordinator: Rolf-Detlef Treede, Ruprecht-Karls-Universität
Heidelberg. +49 621 383-9926.
Project Manager: Daniel Schubart, ConsulTech GmbH. +49 3077205920.

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