risk management Archives - Medical Design Sourcing

[Gorodenkoff/Adobe Stock]

There’s an old joke about chief information security officers (CISOs) being gatekeepers of new technologies and initiatives – the infamous “Department of No.” Imagine a bouncer who, strangely, doesn’t let anyone in, saying the club is already too full, even when it’s clearly empty.

But that image is outdated — especially in risk-focused industries like financial services where CISOs are integral to digital transformation projects and the broader risk management considerations.

From CIS-‘no’ to risk maestro

“Drug development is a risk-focused industry as well,” said Daniel Ayala, chief security and trust officer for Dotmatics. “There is a huge amount of risk.” Consequently, CISOs working in pharma contexts are increasingly expanding their roles from technical experts to risk-aware business leaders who happen to have deep technical expert…

MRI scan of a PML patient displaying prominent brain lesions (indicated by white signal). [Image credit: Daniel S. Reich, National Institute of Neurological Disorders and Stroke (NINDS)]

Biogen’s Tysabri (natalizumab), the first humanized monoclonal antibody for multiple sclerosis (MS), sparked optimism among MS patients following its FDA approval in 2004. The drug offered significant benefits, reducing relapses for patients resistant to other treatments. This was a significant milestone in the treatment of MS, but the journey of natalizumab and PML soon took a concerning turn.

Within a year, alarming reports surfaced: A number of patients were developing progressive multifocal leukoencephalopathy (PML), a rare and often fatal brain infection. The suspected culprit? Natalizumab’s immunomodulatory effect, which suppressed the immune cells fighting the JC (John Cunningham) virus…

risk management

From gatekeeper to strategist: The evolution of the CISO role in drug development

Natalizumab and PML: The complex dance of benefit and risk for MS