Pharmalex Launches Major New Service Line, Biopharma Excellence

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

PharmaLex Group announced the formal launch on Oct. 12, 2021, of the Biopharma Excellence brand, a major new service line that fuses the scientific, regulatory, and commercialization expertise of PharmaLex, ERA Consulting, and Biopharma Excellence. Christian K. Schneider, the former scientific lead of the Medicines and Healthcare products Regulatory Agency, will head the new unit as chief medical officer.

This new service line combines over 35 years of empirical experience and respected regulator relationships and has a global team of over 70 scientific, regulatory, and commercial professionals that can offer strategic product development and proactive regulatory services that are aimed specifically at developers of advanced therapy medicinal products (ATMPs).

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

Biopharma Excellence is intended to serve biopharmaceutical companies ranging from small startups to divisions of large, established life sciences organizations. Its multi-disciplinary solutions are geared toward commercial as well as scientific and regulatory success.


“Gene and cell therapies have reached ‘adolescence’ now,” said Schneider, who was previously chair of the European Medicines Agency’s Committee for Advanced Therapies, in a company press release. “Ten years ago, there wasn’t a single treatment authorized, but now we see numerous successes emerging from clinical trials, or treatments already authorized, from CAR [chimeric antigen receptor] T-cell therapy to gene therapies designed to correct rare, hereditary diseases.”

“This, in turn, is opening the door for innovative biopharmaceutical developers. But because their ambitions invariably involve difficult clinical indications, their route to market is far from straightforward—which is where Biopharma Excellence comes in. Our combined breadth of knowledge, and the ability to apply this strategic, multi-disciplinary scientific, regulatory and commercial expertise to biopharma specifically, makes for a very powerful proposition,” Schneider added. “I’d like to see Biopharma Excellence become a clear leader in biotech: in actively enabling the advancement of cutting-edge medicines. We’re very well placed for this, and I hope my 15 years at the front end of Regulatory Science will further help to ensure that our clients strike the right balance between meeting Agency scientific requirements and creating a compelling proposition for investors and payers.”

Source: PharmaLex Group