“Wendi helps us see beyond the immediate decision. Her perspective connects what we are doing today with what our program will need next.”
Healthcare Executive
Pending approval
Rare deserves better.
Strategic consulting for the decisions that shape rare disease and gene therapy programs before and after approval.
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I help start-up to mid-size biopharma companies in rare disease and gene therapy see what's coming prior to approval and on the day when everything goes sideways.
Wendi Carroll, PharmD, Founder, Carroll & Morrisette Consulting
Approval is not the finish line.
Rare disease programs can fail because decisions were made with approval as the ultimate goal, rather than a milestone on the way to post-approval success.
Pressure-test a major decision before a program milestone or at a crossroads.
Post-approval success must be designed earlier.
Science can be right and strategy can still fail.
Expertise in numbers
25+
Years in biopharma
$200M
Program leadership
4,000+
Patients impacted
17
Countries, global advisory
30+
Post-approval studies
8 → 25
Team growth
Rare disease programs
Key decisions often focus on approval as the end game, not what happens after.
Endpoint selection, trial population, evidence strategy, expanded access, and post-approval readiness are connected decisions.
Early to mid-size companies need experienced strategic judgment at critical inflection points.
The convenient choice is not always the strategic choice.
The best time to pressure-test a decision is before it becomes difficult to reverse.
Frequently asked questions
Who are my clients?
I work with early to mid-size rare disease and gene therapy companies, typically teams of 15–100 people, making important development, evidence, or post-approval decisions.
What stage of development is the best fit?
The best fit is a team approaching a major decision about endpoints, trial population, evidence, expanded access, or readiness for approval and beyond.
Do you work with leadership teams or individuals?
I primarily work with founders, executives, and program leaders who make or influence cross-functional decisions.
What makes your experience different?
I bring 25+ years in biopharma, including Amgen and BioMarin leadership, global clinical and medical affairs experience, and graduate-level teaching in clinical trial design.
Testimonials
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