Pharmalex Launches Biopharma Excellence Brand, with Ex-MHRA Scientific Lead Dr. Christian K. Schneider at the Helm

• The new service line is a fusion of three scientific powerhouses, PharmaLex, ERA Consulting and Biopharma Excellence, under the PharmaLex brand. 
• The global team of 70+ scientific, regulatory and commercial professionals will provide strategic product development & proactive regulatory services geared to developers of biopharmaceuticals such as cell & gene therapies, monoclonal antibodies (MABs), vaccines and biosimilars.
• Dr. Christian K. Schneider, formerly Chief Scientific Officer at the UK’s MHRA, is a world-class expert in adapting existing regulatory frameworks for biopharmaceuticals.

Frankfurt, Germany - October 12, 2021. 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.

“This, in turn, is opening the door for innovative biopharmaceutical developers,” he noted. “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.”

Biopharma Excellence serves biopharmaceutical companies ranging from small startups to divisions of large, established global life sciences organizations. Its global, multi-disciplinary solutions are geared to commercial as well as scientific and regulatory success, efficiently delivering new life-saving treatments to patients.

Christian is a medical doctor by training. His illustrious career to date began in research, with an emphasis on immunology. He further developed his interest in biological medicines at the Paul-Ehrlich-Institut, Germany’s Federal Agency for vaccines and biomedicines. Before joining the UK’s MRHA in 2016 (initially as Director of National Institute for Biological Standards and Control, before assuming the interim position of Chief Scientific Officer), he was Medical Head of the Division for Medicines Licensing and Availability at the Danish Medicines Agency. At the European Medicines Agency (EMA), he held various positions including member of the Committee for Medicinal Products for Human Use (CHMP), Chair of the Biosimilar Medicinal Products Working Party, and member of the Scientific Advice Working Party.

Of his move to Biopharma Excellence, Christian said: “I am deeply passionate about biological medicines and, after a career in leading roles at major Regulatory agencies, I wanted to put my expertise to use in helping next generations of drug developers bring their innovations to market. I was set on joining the best team, so the choice of PharmaLex and Biopharma Excellence was easy.”

Welcoming Christian on board, Thomas Dobmeyer, CEO of PharmaLex, said: “We are delighted to have Christian join our team.  His expertise and unparalleled experience, his passion for biological medicines, and his vision for accelerating the delivery of breakthrough biopharmaceutical developments, are the perfect match for our new company unit.

“Biopharma Excellence’s offering is ideally placed for this moment in time, with so much innovative potential to unlock across global biopharma,” he continued. “Having Christian as Head of the service line and as Chief Medical Officer is the vital final piece of the puzzle. He is an experienced, world-class expert in Regulatory Science, which looks to adapt traditional regulatory requirements for the biopharma field - bringing additional depth to our already-strong capabilities in this important area.”

Of the opportunity ahead, Christian 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.”

Biopharma Excellence will be attending and hosting a panel at the Cell & Gene Meeting on the Mesa conference which coincides with the new business unit’s formal launch. The event, which will adopt a hybrid in-person and virtual format, will be hosted from Carlsbad, California from October 12-14. It is the cell and gene therapy sector’s foremost annual conference, bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures for some of the most challenging conditions.