News & Views

Head of life sciences for Generis

Seasoned regulatory and quality expert Mark Willoughby has been appointed as Generis’ (www.generiscorp.com) new Head of Life Sciences to drive the development and application of Generis’s CARA™, the data and content management platform that helps life sciences companies transform their complex business processes.

Mark brings to the role a long and impressive track record in Regulatory and Quality, most recently as Head of Systems and Data Management in the Quality function at ADVANZ PHARMA, where he worked for five years, with a remit spanning submissions management, XEVMPD and systems strategy.  During that time, he oversaw a move to the cloud, systems consolidation and integration, and initiation of their master data management strategy.

“Generis has been on my radar for some time: they’re a very exciting company doing some really interesting things.  Their understanding of the role between data and documents, and of the potential for structured content management and authoring, is way ahead of other software companies. These developments will have a significant impact on Regulatory Affairs and how companies manage their information and activities – especially as IDMP becomes established in Europe, and as DADI [digital application dataset integration] takes over from electronic application forms in Europe as a first major step in IDMP implementation,” says Willoughby.

“What’s different about Generis’s CARA Life Science Platform is that it’s truly integrated and supports Quality, Regulatory, Safety and Clinical data and document use cases from the same single platform.   Other companies may offer different systems on a common platform, but typically they can’t talk to each other which creates new barriers for companies. CARA can transform everything from change control, regulatory submissions, safety label updates and clinical trial management – by allowing everything to be coordinated across a single platform out of the box.”

Commenting on Mark’s appointment, James Kelleher, CEO and founder of Generis, says, “We’re delighted to welcome Mark as Head of Life Sciences.  His extensive experience gained from working within Regulatory Operations will help define the ongoing enhancements to our CARA Life Science Platform, while deepening the subject-matter expertise we bring to customer implementations.”

In addition to fast-growing sales of the CARA Life Science Platform, Generis has seen soaring cases of companies extending their use of the platform across their operations.  In December, ambitious German biotech Affimed confirmed that it had selected CARA to support R&D teams across its entire product development lifecycle – beginning with CTMS, eTMF and DMS capabilities, to be followed by RIM, Labelling, QMS, SOP and learning management use cases in due course.

Eight of the top 10 global life sciences companies rely on Generis for critical data and content management, including AbbVie, AstraZeneca, Biogen, Gilead, Bayer, Pfizer, and Merck KGaA.