PharmaLex Group has announced the formal launch of a major new service line, Biopharma Excellence, and the appointment of ex-MHRA scientific lead Dr. Christian K. Schneider as head of the new unit and as its Chief Medical Officer.
Biopharma Excellence is a fusion of three scientific powerhouses, PharmaLex, ERA Consulting and Biopharma Excellence, under the PharmaLex brand. The new service line combines 35+ years of empirical experience and respected regulator relationships. Its global team of 70+ scientific, regulatory and commercial professionals offer strategic product development and proactive regulatory services geared specifically to developers of advanced therapy medicinal products (ATMPs).
Biopharma Excellence’s launch comes as the maturation of the biopharma industry accelerates, giving commercial form to important new innovation in fields including cell and gene therapies, monoclonal antibodies (MABs), vaccines and biosimilars.
“Gene and cell therapies have reached ‘adolescence’ now,” Christian, who was previously chair of the European Medicines Agency’s Committee for Advanced Therapies, commented. “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 T-cell therapy to gene therapies designed to correct rare, hereditary diseases.
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