MANAGED ACCESS ADVISORY
Managed access, made manageable.
Managed access can feel complex, even for experienced teams. What makes the difference is a clear path through it. I bring structure, sequence, and hands-on experience, so your team knows exactly where to start and what comes next.
Toni Williams · Founder, Bright Oaks Consulting
WHEN ACCESS ARRIVES QUICKLY
The questions come before the answers.
Which pathway fits?
Who owns this internally?
What will it really cost?
How do we treat every patient fairly?
What do we need in place before we talk to a partner?
These are the right questions. Most teams just meet them all at once. I help you work through them in order, with a framework your team can use long after we’re done.
A QUICK TRANSLATION
One idea. Many names.
Managed access is how I describe programs that provide investigational or not-yet-available medicines to patients who have no other treatment option. Depending on where you are and when access happens, you’ll hear it called something different.
Expanded Access
The term used in the United States
Compassionate Use
Common across the European Union
Named Patient Supply
Access requested for an individual patient
Early Access
National schemes such as those in France and the UK
Post-Trial Access
Continued treatment for trial participants after a study ends
Different names. The same purpose. Getting the right treatment to the right patient, responsibly.
WHY BRIGHT OAKS
I know what comes first.
I’m Toni Williams. I’ve spent more than a decade working inside managed access. I know which decisions come first, which ones can wait, and where teams tend to get stuck.
I turn that experience into a step-by-step plan your team can actually follow, so a complicated, unfamiliar process starts to feel manageable.
11 years
Specialist experience in managed access
35+ programs
Hands-on program experience
20 years
In pharma and biotech
HOW I HELP
Independent advice. At every stage.
Start where you are. I bring independent guidance to the decisions ahead.
01
BEFORE PARTNER ENGAGEMENT
Prepare with clarity.
A shared foundation, an aligned team, and a clear program direction.
02
DURING PARTNER SELECTION
Choose with confidence.
Clear requirements and thoughtful comparisons to find the right partner fit.
03
IMPLEMENTATION AND BEYOND
Move forward together.
Strategic guidance as your program takes shape and evolves.
I help sponsors make informed managed access decisions, while access partners focus on execution.
Independent and partner-agnostic. Complementary to your internal team and access partners. Tailored to your organization.
INSIGHTS
A little knowledge changes the conversation.
Practical perspectives on managed access, written for sponsor teams.
INSIGHT
Managed access beyond the US
How managed access works outside the United States, and what sponsor teams should plan for when requests come from other countries.
INSIGHT
Preparing for partner conversations
How shared priorities and clear questions support a productive access partnership.
INSIGHT
The trial ends. The access questions don’t.
Planning for continued treatment after a study ends, while the medicine is not yet licensed or approved, and why that conversation should start early.
Articles coming soon
Let’s talk about where you are today.
Whether a request just arrived or you’re planning ahead, I’d love to hear what your team is working through. We’ll talk about your questions, your timeline, and what kind of support would actually help.
A 30-minute conversation. No pressure, no obligation.
WORTH A READ
Resources worth knowing.
I share trusted guidance and relevant news to help your team stay informed.
FDA GUIDANCE
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
The FDA’s own guide to how expanded access works in the United States, including who can request it, the different program types, and what sponsors and physicians are each responsible for. A helpful starting point for any team building its managed access foundation.