Pioneering initiative to Fast-Track Antimicrobials from R&D to commercialization

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S.O.L.V.E.-AMR – Solutions for Overcoming and Leveraging Versatile Efforts Against Microbial Resistance

[Lyon – Dijon – Paris, Tuesday October 10th, 2023] – BIOASTER, Cynbiose, ICTA, and PharmaLex announced today a strategic collaboration that aims to help combat antimicrobial resistance (AMR). As part of the initiative, the organizations will leverage their collective expertise and capabilities to offer innovative and integrated support from discovery, pre-clinical and clinical drug development processes up to registration and commercialization, helping to accelerate the development of antimicrobials.

AMR, which occurs when a microorganism (bacteria, viruses, fungi, parasites) develops the ability to resist the effects of a drug, is a significant global public health threat. The World Health Organization (WHO), U.S. Government and European Commission each have initiated action plans against AMR. Boosting research, development and innovation—including developing new therapeutics and alternatives—is a key objective of the EU’s One Health Action Plan against AMR.

The services include regulatory affairs, market access strategies, in-depth risk analyses, non-clinical and clinical R&D services, aiming to support the development and commercialization of novel antimicrobials. This hub will deliver integrated support across the development and commercialization journey, thanks to fit-for-purpose solutions and innovative technologies, including client-driven, stand-alone to end-to-end antimicrobial development services.

“We are proud to collaborate with Cynbiose, ICTA, and PharmaLex in launching this initiative to combat AMR,” said Xavier Morge, CEO of BIOASTER. “Together, we are determined to address this global challenge by providing innovative solutions and accelerating the development of effective antimicrobials. We look forward to working closely with our clients/partners to contribute to providing new treatments adapted to unmet patient needs.”

“Addressing an issue as complex and far-reaching as AMR will require a coordinated approach. By leveraging the capabilities across this network of organizations, our goal is to deliver integrated support to companies developing and willing to register and commercialize anti-microbials, devices and solutions,” said Patrick Larcier, Senior Director, Development Consulting Services, at PharmaLex.
“In collaboration with our partners, we are delighted to make available our preclinical translational expertise and state-of-the-art BSL2/3 AAALAC-accredited facility to advance innovative therapies such as vaccines, antibodies, immunomodulating candidates and phages to the clinical pipeline”, said Hugues Contamin, CEO of Cynbiose.

“This joint platform combining our partners’ early-stage development capabilities, regulatory and commercial support and ICTA’s recognized clinical expertise is a highly motivating objective for ICTA’s clinical R&D teams and is fully in line with our policy of improving disease management for the benefit of patients, particularly in infectious diseases” said Aline Hantzperg, CEO of ICTA.
For more information about the S.O.L.V.E-AMR network, please contact:

ABOUT BIOASTER TECHNOLOGICAL RESEARCH INSTITUTE
Created in 2012, following the French initiative of Technology Research Institutes, BIOASTER is a not-for-profit foundation developing a unique technological and innovative model to support the latest challenges in microbiology & infectious diseases. BIOASTER uses and develops high value technological innovations that accelerate development of medical solutions for populations and personalized medicine.
The aim of BIOASTER is to bring together academic and industry and use its capacities and specific knowledge to develop and execute high impact collaborative projects requiring industry compatible innovative technologies.
Press contact for BIOASTER: Olivier.charzat@bioaster.org / www.bioaster.org

About CYNBIOSE
Incorporated in 2008, Cynbiose is a unique European non-clinical CRO specialized in translational research and pharmacology to derisk biologics, vaccines, antimicrobials candidates.
Our preclinical services ranges from exploratory non-GLP DMPK, safety and efficacy studies with in-depth expertise and capabilities in infectious diseases.
Our state-of-the-art France-based animal facility is AAALAC-accredited. Our proven platform can operate studies in biosafety levels up to level 3 as well as GMOs C1-2 in a GLP-like environment.
Press contact for CYNBIOSE: hugues.contamin@cynbiose.com / www.cynbiose.com

About ICTA
Founded in 1983 and France based, ICTA is a full-service European privately-owned CRO with international experience in clinical R&D including pharmaceutical development consulting, expertise in regulation, development strategy. Our services span the entire product clinical development from Phase I to Phase IV and can be tailored to suit small trials or global programs, whatever the type of product under development (APIs, cell/gene therapies, diagnostics and medical devices.).
ICTA’s international strength lies in the active interaction between a high-level of experts and academic network and skilled operational teams in well-established subsidiaries and strategic partnerships. With a team of 140 full-time employees/collaborators and offices in France (HQ), Germany and the UK, and a pool of repeat strong partnerships in Europe and in the USA, ICTA offers experienced operational services on a global field through local expertise
Press Contact for ICTA: christophe.clement@icta-group.com / www.icta.fr

About PHARMALEX
PharmaLex, a part of Cencora, is a global healthcare and life sciences consulting and outsourcing provider. PharmaLex’s team of scientific, regulatory, safety and compliance (GxP) experts that provide strategic guidance and regulatory support to biopharma and medical technology companies throughout a product’s lifecycle. PharmaLex provides tech-enabled services ranging from clinical development to marketing authorization enabling clients to efficiently bring products to global markets and diverse patient populations.
Customer contact for PHARMALEX: patrick.larcier@pharmalex.com / www.pharmalex.com

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