(1888PressRelease)
September 17, 2009 - L2D Services’ mission statement is: “Working with you to reach the clinic.” L2D Services is a unique service provider focusing on the management of non-clinical (and, more specifically, preclinical) development for organisations wishing to outsource this highly specialised phase of drug development. Two members of the L2D Services management team will be present at the BioPartnering Europe (BPE) meeting, which will take place in London (UK) between 11 and 13 October 2009.
The specialist European company aims to advance its clients’ lead therapeutic agents into clinical trials in the most optimal and cost-effective manner, either by managing the entire preclinical development programme for the client, or by providing à la carte services. L2D Services offers expertise that covers all aspects of non-clinical development, from the design of the preclinical development plan through to the submission of the regulatory dossier to the authorities concerned.
L2D Services has been launched by an international team of developers (British, French and Belgian) who have a proven track record of working together to advance a range of therapeutic leads into clinical development. The company has chosen to be based in Paris due to the French capital’s central location within Europe, which L2D’s founders believe to be important in order to support biopharmaceutical companies across the continent.
Vincent Dubois (Director of Product Development) says, “Twenty-five years ago, it was rare to outsource clinical-trial management, yet, today, everyone uses clinical research organisations. L2D Services aims to provide a similar service, but specifically tailored to the rigorous demands of non-clinical development. Our approach will allow for the rapid initiation and progression of our clients’ development programmes, whilst reducing the risk for them, which is achieved, in part, by avoiding — or significantly cutting — the fixed charges generated by an in-house team.”
Jerome Quinonero (Director of Toxicology & Safety Pharmacology) adds, “Based on the initial response of the biotechnology community and, more specifically, of clients who have already hired our services, we are confident that there is a clear need for companies such as L2D Services.”
Jonathan Kearsey (Director of Pharmacology & Business Development) says, “We feel that the launch of L2D services just prior to the BioPartnering Europe meeting is perfect timing, as our participation at this event will be an ideal opportunity for us to meet face-to-face with decision-makers from the European biotechnology, pharmaceutical and investment communities.”
The services offered by L2D Services are divided into three strands: non-clinical development management; regulatory documentation; and strategic & business support.
Non-clinical development management includes the preclinical development plan; pharmacology; GLP toxicology; safety pharmacology; pharmacokinetics and tissue distribution; Absorption, Distribution, Metabolism, and Excretion (ADME); Active Pharmaceutical Ingredient (API) manufacturing process development; formulation development; GMP manufacture; and, stability and characterisation studies.
The regulatory documentation services that L2D provides encompass study reports; the Investigator’s Brochure (IB); the Investigational Medicinal Product Dossier (IMPD); and the clinical-trial application.
Strategic and business support covers a range of key areas, i.e. strategic planning; drug positioning; strategic advice (target drug profile, competition, intellectual property, etc.); in/out-licensing technical evaluations; due diligence; technical support for financing rounds and for mergers-and-acquisitions operations.
As a result, L2D is uniquely placed to provide its clients with a comprehensive range of services that cover every step of non-clinical development.
About BioPartnering Europe
Now in its 17th year, BioPartnering Europe (BPE) offers excellent partnering opportunities for the life-sciences industry. The event offers four days of networking in one location, bringing together decision-makers from leading biotechnology, pharmaceuticals and investment companies from around the world for one-to-one partnering meetings, presentations, expert panels and exhibitions.
BioPartnering Europe will take place at the QEII Conference Centre in London (UK) from 11 to 13 October 2009.
For further information, please go to: www.techvision.com/bpe/
About L2D Services
L2D Services is headquartered in Paris (France). L2D Services is the first independent specialist of its kind in the management of the non-clinical development of therapeutics.
L2D Services will attend the BioPartnering Europe meeting, due to be held in London (UK) in October 2009.
For more information, please go to: www.L2Dservices.com
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