PharmaLex Group has announced the launch of a new service line, Biopharma Excellence, and the appointment of ex-MHRA scientific lead Dr Christian Schneider as its Chief Medical Officer.
Biopharma Excellence is a fusion of three scientific organisations, 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 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 new innovation in fields including cell and gene therapies, monoclonal antibodies (MABs), vaccines and biosimilars.
“Gene and cell therapies have reached ‘adolescence’ now,” Dr Schneider 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 organisations. Its global, multi-disciplinary solutions are geared to commercial as well as scientific and regulatory success, efficiently delivering new life-saving treatments to patients.
Of his move to Biopharma Excellence, Dr Schneider 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. 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, is taking place 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 research into cures for some of the most challenging conditions.
