Pharmalex launches a new major range of services, Biopharma Excellence


Pharmalex has launched the Biopharma Excellence brand, a new range of services that combines the expertise of PharmaLex, ERA Consulting and Biopharma Excellence.

The PharmaLex group announced the official launch, on October 12, 2021, of the Biopharma Excellence brand, a major new range of services that merges the scientific, regulatory and commercial expertise of PharmaLex, ERA Consulting and Biopharma Excellence. Christian K. Schneider, former Scientific Officer of the Medicines and Health Products Regulatory Agency, will lead the new unit as Chief Medical Officer.

This new line of services combines over 35 years of empirical experience and respected regulatory relationships and has a global team of over 70 scientific, regulatory and business professionals who can offer strategic product development and proactive regulatory services. intended specifically for developers of advanced therapy drugs. products (MTA).

The launch of Biopharma Excellence coincides with the maturation of the biopharmaceutical industry, in which the development of ATMPs has accelerated, giving rise to commercial opportunities for innovation in areas such as cell and gene therapies, monoclonal antibodies, vaccines and biosimilars.

Biopharma Excellence is intended to serve biopharma companies ranging from small startups to divisions of large established life science organizations. Its multidisciplinary solutions are geared towards commercial, scientific and regulatory success.

“Gene and cell therapies have now reached ‘adolescence’,” Schneider, who was previously chairman of the European Medicines Agency’s committee for advanced therapies, said in a company press release. “Ten years ago, there was not a single authorized treatment, but now we are seeing a lot of success emerging from clinical trials, or treatments already authorized, in CAR. [chimeric antigen receptor] From T cell therapy to gene therapies designed to correct rare and inherited diseases.

“This, in turn, opens the door to innovative biopharmaceutical developers. But because their ambitions invariably involve difficult clinical indications, their market access is far from straightforward. This is where Excellence Biopharma comes in. to biopharma in particular is a very powerful proposition, ”added Schneider. “I would like to see Biopharma Excellence become an undisputed leader in biotechnology: by actively enabling the advancement of cutting-edge drugs. We are uniquely positioned for this, and I hope my 15 years upstream in regulatory science will help ensure our clients strike the right balance between meeting the Agency’s scientific requirements and creating a compelling proposition. for investors and payers.

Source: PharmaLex Group

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