Agile in Pharma? Impossible. Or Maybe Not. | Toni Garcia

Toni Garcia, Global CIO at Neuraxpharm and former CISO, comes
with a clear position: agility and pharma compliance are not
opposites — you just need to know which parts of a project
require waterfall and which can be agile. He's equally direct
about cybersecurity: people are not the weakest link, they are
the strongest layer of defense. The conversation moves between
hacker mindset, C-level leadership reality, and what actually
makes teams perform under pressure.


Key Takeaways


Agile works in pharma if you split the project correctly: URS
creation and validation follow waterfall, implementation can be
agile.

Security and digital transformation are not enemies — they
share the same path and depend on each other to succeed.

Hackers are agile by default: they try, fail, and adapt. IT
departments need to learn the same behavior.

People are the solution to cybersecurity, not the problem. No
firewall stack replaces a well-trained, alert team.

The most important KPI for a high-performing team is not a
metrics dashboard — it's whether the team experiences decisions
and priorities as clear and fair on a daily basis.

Perfect does not mean error-free. Zero-day vulnerabilities
can hit anyone. Accepting that imperfection is part of the
equation is what allows you to act at all.

As a CIO, the real job is giving the team time, budget, and
good decisions — not solving every problem yourself.



Links & Resources


DORA (DevOps Research and Assessment) – Google Cloud research
program on software delivery performance:
https://cloud.google.com/devops

DORA State of DevOps Report 2024 (:
https://dora.dev/research/2024/dora-report/

ISO 27001 – Information Security Management System (mentioned
by Toni as the most valuable framework):
https://www.iso.org/isoiec-27001-information-security.html

Neuraxpharm (Toni's current organization):
https://www.neuraxpharm.com

Book Accelerate by Nicole Forsgren, Jez Humble, Gene Kim –
scientific foundation of DORA metrics: link not found, please
search separately (ISBN: 9781942788331)