Biocitech, the Paris life sciences technology park, announces the arrival of a new resident, PupPharma, which becomes the 27th company to set up shop there. PupPharma moved into the park in May, bringing a further expansion of the range of services along the health value chain provided by Biocitech and further confirming its attractiveness. PupPharma is one of the few CROs (contract research organization) in the world specialized in perinatal and pediatric pharmacological research, an area that is now recognized as crucial in the development of drugs and therapies for children. This aspect of the research process has been neglected too often in the past, according to many industry observers. PupPharma offers innovative services of the highest quality to French and international biotech companies that contract out preclinical R&D programs for the delicate business of developing drugs for perinatal and pediatric use.
Any drug has to have its efficacy validated in a relevant experimental model, and then confirmed as active and non toxic in humans. The use of “off-label” drugs in children, which is to say drugs utilized experimentally for an unauthorized indication, is very encouraging. However, the Food and Drug Administration (FDA) in the U.S. and the European Medicines Agency (EMA) have been developing strategies since 2002 and 2006 respectively to promote the development of medicines for pediatrics (the PIP pediatric development strategy), since both these bodies think it is unreliable to predict the effects of a drug on children by extrapolating from clinical doses found to be effective in adults.
In Europe as in the United States, a pediatric development strategy is necessary before any drug in clinical development, including those destined for adults, reaches Phase II. It is thus essential for pharmaceutical companies developing drugs for children, and wishing to use a CRO, choose one that has adequate knowhow in perinatal and pediatric pharmacology. Not every CRO has the ability to design a model of these specific pathologies.
The services provided by PupPharma depend on a good grasp of the restrictive regulatory framework that governs pharmaceutical companies. This enables its clients to comply with those regulations and respond to the real medical needs of patients and practitioners (50 per cent of the drugs used in pediatrics were not tested for that utilization, any more than 70 per cent to 90 per cent of the drugs used on newborn babies). PupPharma offers a complete range of services based on innovative, high-tech R&D, including consulting services, in vivo pharmacological evaluation of drug efficacy or safety, and the development of models of newborn or young animals that emulate child pathologies. As part of the services it provides, PupPharma takes account of the physiopathological particularities associated with the organ and functional immaturity of children and neonates.
PupPharma started life in the Paris Biotech Santé incubator in December 2009 and was incorporated in August 2010. The company is now starting to grow by installing its research facilities at Biocitech.
“PupPharma, the only CRO dedicated to prenatal and pediatric pharmacology, has chosen to establish itself at Biocitech, a technology park specialized in life sciences, because of the high level of services and the very high-quality premises we have been given to expand our activities,” said PupPharma’s chairman and scientific director, David Chauvier. “Biocitech’s international reputation will also give us greater visibility and credibility for our international expansion.”
“We are delighted to welcome PupPharma to the Biocitech campus and to adapt our concept of services for all biotechnology and specialty chemical companies to its particular needs,” said the president of Biocitech, Jean-François Boussard. “PupPharma is an innovative service company that is developing its business in a fast-growing market – that of R&D into drugs developed specially for children. The company will consolidate the network of innovative CROs installed on the campus and help strengthen their visibility among client companies in France and abroad.”
For further information, go to: http://www.puppharma.fr
