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This 5th edition of ACCELNEWS underlines the acceleration of the Bordeaux region clinical research activity in oncological dermatology, with the rise of recent innovating therapies; Creapharm, a Company located in Bordeaux, which takes advantage of its global network to provide academic and industry sponsors clinical with batches and their packaging; The Bordeaux TEP Research center created in 2010 and specialized in molecular imaging; and a report on ACCELENCE’s activity. Also, a link to an online questionnaire enables the readers to give an opinion and suggestions about ACCELNEWS.

Focus on oncological dermatology
Skin cancers, i.e. melanoma and non-melanoma skin cancers, are a major public health issues as recently decided by the French government, via the National French Cancer Agency (INCA). Indeed, the prevalence of melanoma has been on the increase over the last 20 years whereas its prognosis is still considered to be very poor in advanced stages.

However, since 2010 and the development of targeted therapies, mainly B-RAF inhibitors and anti CTLA-4 immunotherapy, the prognosis of melanoma at metastatic stages has been profoundly modified. These targeted therapies are now considered as possible adjuvant in the treatment of melanoma at earlier stages, i.e. presence of metastatic lymph nodes.

The University Hospital of Bordeaux is now recognized as a reference centre in this research field. Its specialized Dermato-cancerology centre, founded by Dr Michèle Delaunay in 1980 and presently led by Dr Thomas Jouary, has a priority access to therapeutic protocols. Indeed, the department is participating in several international multicentric protocols in the field of skin cancers and is part of international networks such as the EORTC and the EADO. Moreover, the department is developing partnerships with industrial groups focusing on innovative therapies for this pathology. Hence, the skin cancer unit of the Bordeaux University Hospital has set the clinical research as a priority. This has been illustrated by its participation in high input scientific publications and scientific boards of international groups (French Skin cancer group Recommendations, Boards and expertise in clinical research).

In addition, the department has set-up an exhaustive melanoma database since 2005, in link with molecular biology laboratory of Pr Merlio.

Important scientific projects have also been developed in relation with the Cancéropôle Grand Sud-Ouest, the INCA and the French Group of Dermato-cancerology. These collaborations include expert clinicians and researchers and are conducted within the framework of PAIR melanoma, a translational research program. All these collaborations are the reflect of the implication of the University Hospital of Bordeaux in a dynamic process for skin cancer experimental and translational research.

Founded in 1990 by 2 pharmacists from Bordeaux, Creapharm is an international clinical supplier specialized in Investigational Medicinal Products (IMPs), which provides academic and industry sponsors with the following IMP solutions:

IMPs Production compliant with European good manufacturing practices (Eu-GMP): The manufacturing of capsules and notably blinding of tablets or capsules into bigger capsules in order to guarantee the same appearance between active products, comparators and placebos. They are called “double blind” studies as neither patients nor practitioners know which product they have.

IMPs primary and secondary Packaging compliant with Eu-GMP and notably its annex 13: Creapharm ensures the packaging of active products, comparators and placebos used in open or double blinded studies.

Worldwide clinical trial supply of IMPs compliant with good distribution practices (GDP): Creapharm assures International distribution through its depot network, the management of cold chain distribution (Cf. publication on STP PHARMA PRATIQUES - volume 23 - N° 1 – January / February 2013) and covers the clinical batches return and destruction from the investigation site.

IMP sourcing and importation into Europe from qualified partners: Creapharm organizes the Comparators sourcing and the Importation from third countries including their pharmaceutical release in Europe.

With more than 20 years of experience, a team of 55 employees and qualified experts at all key positions, Creapharm is at the disposal of private and institutional sponsors.

  More informations :

Email: c.dacosta@creapharm.com
Website: http://www.creapharm.com
Bordeaux PET research center
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The PET research unit is a centre dedicated to the molecular imaging with positron emitter tracers, created jointly in 2010 by the Hospital and the University of Bordeaux on the site of Xavier Arnozan hospital in Pessac, Bordeaux, France. Since 2011, this unit is a core team of laboratory of excellence TRAIL.

The centre, under the co-responsibility of Professor Michèle Allard and Professor Philippe Fernandez, hosts a team of a dozen people from different departments and conducts imaging research in the CNRS laboratory INCIA (UMR 5287) directed by Jean-René Cazalets.

The research unit expertise is triple:

Participating to multicentric clinical trials promoted by academic structures (hospital, university) or industrial partners.

Developing and conducting clinical trials in oncology and neurology fields with commercial tracers or tracers without market authorization (in situ synthesis).

Developing and validating new radiopharmaceuticals (synthesis of specific peptides in collaboration with UMR 5255, or aptamers in collaboration with INSERM U869, development of new methods for fast synthesis of tracers radiolabeled with gallium 68).

For its research, the use, the development and the synthesis of radiopharmaceuticals is possible through:

A laboratory of radiochemistry equipped with some hot cells shared with an industrial partner, IBA molecular-CisBio international, which develops new tracers for the clinical use (Fcholine, for example). Various radiopharmaceuticals radiolabelled with 18-Fluorine are synthetized for clinical protocols (such as FDG, FMISO, FLT, MPPF….), but also, new tracers are under development for preclinical validation (tracer for angiogenesis imaging, tracers for multimodal (PET-MR) imaging...).

A hot cell localized in PET unit equipped with a synthetizer (FastLab) in collaboration with an industrial partner (GE healthcare) that enables the synthesis of new tracers radiolabelled with gallium 68.

Finally, the laboratory is equipped with an HPLC and a UV detector intended in the quality control of new synthesized radiopharmaceuticals.

The clinical exams are realized on a PET-CT machine (GE Discovery RX) since May 2010 (agreement number: 333180116LBD012010). This machine is under the responsability of the CNRS unit (UMS3428) directed by Pr Vincent Dousset.

Since two years, the research molecular imaging unit has obtained the European PET/CT accreditation by the European Association of Nuclear Medicine (EANM), providing a label of excellence in PET imaging research field.

Also, the research unit team develops methodologies in image processing concerning segmentation methods for radiotherapy planning treatment, pharmacokinetics modelization or imaging correction methods.

The interest of the center is to propose a PET-CT machine entirely dedicated to research which offers ability to realize dynamic and long-time acquisitions, for example, study of tumoral hypoxia during 4 hours, but also flexibility in scan scheduling compared to a PET-CT used for routine activity.

Thereby, an industrial has entrusted to our structure for the realization of a clinical trial to study the interest of fluorocholine in staging of high risk prostate cancers, allowing the enrollment of many patients during 2 years.

So, the PET centre proposes a translational research from the development and validation of new PET tracers to clinical trials in different fields such as oncology, neurology but also infection and inflammation diseases.

Accelence report
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Investigation sites involved: The Bordeaux University Hospital, the Institut Bergonier – Comprehensive Cancer Centre, the Charles Perrens Hospital Group, the Cote Basque Hospital Group, the Libourne Hospital Centre, general practitioners.

Average inclusion rate (ratio between the initial target and the number of patients actually enrolled in studies with an exceeded enrollment period) = 95%

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