Biopharma Excellence launches

A leading provider of specialized services for the pharma, biotech and medtech industries, the PharmaLex Group (www.pharmalex.com) announces the formal launch of a major new service line, Biopharma Excellence (www.biopharma-excellence.com/) and appoint ex-MHRA scientific lead Dr. Christian K. Schneider as head and Chief Medical Officer of the new unit.

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.  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,” comments Dr. Christian K. Schneider, who was previously chair of the European Medicines Agency’s Committee for Advanced Therapies.

“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.”

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.”

“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,” says Thomas Dobmeyer, CEO, PharmaLex.  

“Biopharma Excellence’s offering is ideally placed for this moment in time, with so much innovative potential to unlock across global biopharma.  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.”

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.