Meet Annie


Annie O'Keefe Coaching and Consulting

I spent over twenty years in the pharmaceutical industry, in regulatory affairs, medical operations and governance, and ethics and business integrity. I have submitted applications for medicines that changed lives, built governance structures, and identified and mitigated risks to both patients and the company.

More recently, I dedicated myself exclusively to the patients who simply cannot wait for standard routes: those who needed access to life-saving treatments before the usual pathways were available.

That work matters deeply to me, and I remain committed to it.

One side of my work helps people literally stay alive and the other helps people truly feel alive.
— Annie
Annie O'Keefe Coaching & Consulting
Annie O'Keefe Coaching & Consulting

Consulting - Early Access to Medicines


Expert input at the decision-making stage

You need someone with deep operational knowledge of the regulatory landscape who translates that into practical, implementable global policy and governance.

REMEMBER

Somatic Embodiment Coaching

I’m also a VITA™ certified coach in sex, love and relationships, trained through an advanced 600 methodology integrating neurobiology, body-centred awareness, and nervous system work.

I created REMEMBER for those of you who have lost yourselves… who feel stuck, trapped, exhausted, and longing for more and are ready to find your way back to yourself and what you want and desire in life.

VITA Certified coach in sex, love and relationships
This is what I mean when I talk about the bridge between two worlds. When we do the personal work and we truly come home to ourselves we show up differently everywhere. This is when real impact begins.
— Annie

For those who want to know more…

Credentials & Background


Coaching

VITA™ Certified Coach — advanced 600-hour certification in sex, love and relationships, integrating neurobiology, somatic healing, and body-centred awareness, with trauma-informed practice.

Consulting

20+ years across Genzyme, AstraZeneca, and Sanofi — regulatory affairs, medical governance, ethics and business integrity, compassionate use

Industry Leadership

Founder, Patient Support Program Industry Network (PSP-IN); Leader within the Managed Access Industry Forum (MAIF)

Research & Publications

Co-authored peer-reviewed publication in compassionate use and expanded access to medicine (Therapeutic Innovation & Regulatory Science, 2026)

Schlatter et al. An Industry Perspective on Compassionate Use in Europe: A Call for Change. Therapeutic Innovation & Regulatory Science. 2026;60:455–465. |

https://doi.org/10.1007/s43441-025-00902-y

Education

MA, Teaching English as a Second Language, Simmons College, Boston; BA, Human Services and Communications, George Washington University

Peer-reviewed publication in compassionate use and expanded access to medicine
Peer-reviewed publication in compassionate use and expanded access to medicine

“Working with Annie has been an exceptional experience. Her bright and spontaneous approach, combined with her willingness to speak up and maintain complete transparency, creates an environment of trust and reliability. What truly sets Annie apart is her careful monitoring and unwavering follow-up – she never gives up on finding solutions or seeing projects through to completion. Her presence instils confidence in the team, and you can always count on her to deliver. Annie’s collaborative spirit and persistent dedication make her an invaluable partner in any endeavour.”

Xavier, Former Colleague

Ready to start a conversation?

Drop me a quick message and we’ll set up a free, no-pressure chat to explore how I can help.