FORBES LEADER’S TALK: The challenges of the biotech market, Sophie Guillaume & Patrick Larcier, PharmaLex France
Sophie Guillaume, General Manager and Patrick Larcier, Senior Director, Drug Development & Vigilance, PharmaLex France, discuss the challenges of the biotech market
Even though the main part of the biotech market is still in development, innovation focuses on multi-technologies, combining biology and connected devices. In Europe, France is in third position in the biotech and medtech fields, after Germany and the UK. In particular, France can rely on incentives such as the Research Tax Credit (Crédit Impôt Recherche), or the Young Innovative Company (Jeune Entreprise Innovante) status, in order to increase our country’s competitiveness.
Those national advantages support start-ups and companies to grow in the dynamic field of biotech. “New approaches exist, such as therapies for rare diseases, fecal transplant for the treatment of infectious pathologies, or a vaccination approach for some rare diseases, like lupus. We are supporting our clients with these complex projects” explains Patrick Larcier, Senior Director, Drug Development & Vigilance at PharmaLex France.
“On both sides of the Atlantic, tools exist to accelerate the marketing of new products and their access to patients, based on a positive risk-benefit ratio”, adds Patrick. Legal frameworks aim to regulate the dynamic market of biotech, while addressing two imperatives: on the one hand, ensuring safety, efficacy and quality of the products, and on the other hand, fostering research, particularly to address unmet medical needs.
PharmaLex France, which is an affiliate of the PharmaLex Group, is specialized in high-added value consulting. For all kinds of projects, PharmaLex France is able to support its clients, from the small ad-hoc question to the outsourcing of a whole product portfolio. “We work on both stages for a health product: pre-market, to develop it, and post-market, to commercialize it. We help our clients with regulatory strategy and development plan, as well as with technical dossiers, such as CE marking”, explains Patrick. In post-market, PharmaLex is able to monitor adverse events, which is called vigilance. What is the objective? To enable its clients to accelerate the marketing of their products, while ensuring its maintenance and securing its commercialization.
The PharmaLex group has a global presence and brings together a team of more than 850 experts, as well as a network of partners. “In France, we support our customers on many types of projects, leveraging the strength of our internal group network” concludes Sophie Guillaume, General Manager at PharmaLex France.