Mike Auerbach
Every year brings another round of headlines about pharma “drowning in data.” At this point, that’s less a warning than a permanent weather condition.
Melissa Mooney
Rich data sits across systems; actionable insight does not. Making clinical decisions on the back of mountains of collected data, without the systems to connect it all together, is like trying to understand the mood of a restaurant by looking at each patron individually.
Sajesh Parathath, Ph.D.
The history of oligonucleotide therapeutics illustrates that transformative medical progress occurs when foundational scientific breakthroughs are matched by equally robust advances in development infrastructure. Over the next decade, oligonucleotides are poised to expand their clinical footprint beyond reactive treatment and toward proactive preventive intervention for highly prevalent chronic conditions.
Mike Bruhns
Sponsors making decisions about device programs this year are setting more than just cost expectations for device procurement. They’re deciding whether devices will be a limiting factor on representative data or whether a partner who owns the full device strategy — not just the hardware — can enable broader, more diverse trials than would be possible by going directly to a manufacturer or managing it internally.
Michael Halaiko, Esq., CIPP/E, Alexandra Moylan, Esq., CIPP/US AIGP, Madison McMahan, Esq.
The national-security regulatory landscape now layers a geopolitical framework onto the data flows, sample logistics, and vendor relationships that make modern clinical research possible. This architecture will not simplify. The DSP’s country-of-concern list may expand, the BIOSECURE Act’s designated-entities list will likely grow, and state legislatures continue adding requirements.