Unparalleled Expertise · Oncology Drug Development
Perspective That Shapes Programs From The Inside Out
Gormley Advisory brings senior regulatory perspective to every stage of drug development, from program inception through approval.
Dr. Nicole Gormley
Founder . Former Division Director, Hematology-Oncology
Novel Endpoint Development
Drug Development Strategy
Hematologic Malignancies Focus
NDA/BLA
Previous Signatory Authority
What We Offer
Unparalleled Expertise
01
Program Strategy & Planning
Perspective on how oncology programs are evaluated- from early development through application submission and beyond. Built on years of leading those exact decisions.
02
Endpoint Development
Deep expertise on MRD, Surrogate endpoints, ctDNA, and novel endpoint evidentiary standards- shaped by direct involvement in oncology endpoint development.
03
Crisis Advisory
Clear-eyed counsel for Complete Response Letters, clinical holds, advisory committee meetings, and high-stakes regulatory inflection points.
04
Agency Interactions
Pre-meeting strategy, meeting minute interpretation, and alignment on interaction strategies
05
Accelerated Approval Guidance
Current, firsthand knowledge of the accelerated approval framework, confirmatory trial expectations, and post-approval requirements.
06
Investment & Asset Diligence
Rigorous scientific and regulatory judgment for investors evaluating oncology and hematology assets and development risk.
About Dr. Gormley
A career built at the center of oncology regulation.
Dr. Nicole Gormley is a physician-scientist whose career has been defined by pursuing the same goal from different vantage points: getting safe and effective therapies to patients as expeditiously as possible. Rigorous regulatory science and meaningful patient access are not competing priorities, they are the same goal, pursued through better decisions made earlier in development.
She served as Division Director of Hematologic Malignancies II at the Center for Drug Evaluation and Research, where she held signatory authority over NDA and BLA decisions spanning multiple myeloma, lymphomas, bispecific programs, and immuno-oncology therapeutics.
Concurrently, as Associate Director for Endpoint Development at the Oncology Center of Excellence, she shaped the agency’s approach to novel endpoints across all oncology indications. She remains committed to that same goal, pursued now from the outside.
Would your program benefit from expert strategic advice?
Dr. Gormley works with a limited number of clients at any one time. This is a deliberate choice, the quality of judgment this practice offers depends on genuine engagement with each program, not volume.
A complimentary 30-minute introductory call to assess fit.
Frequently Asked Questions
How many clients does Dr. Gormley take on at once?
Dr. Gormley works with a limited number of clients at any given time. The practice is intentionally small, this ensures that every engagement receives the depth of attention it deserves.
How does the engagement model work?
Engagements are tailored to the needs of each program. Some clients benefit from ongoing strategic advisory relationships; others need focused project-based support around a specific submission, meeting, or regulatory challenge. The introductory call is the right place to discuss what makes sense for your situation.
What types of programs does Gormley Advisory work with?
Gormley Advisory works with biotechnology and pharmaceutical companies developing oncology and hematology therapeutics, at any stage from early development through post-approval. Investors evaluating oncology assets are also welcome to reach out.
Does Dr. Gormley work on non-hematology oncology programs?
Yes. While hematology-oncology represents the deepest area of expertise, the regulatory principles, endpoint strategies, and agency interaction dynamics that define good program development apply broadly across therapeutic areas. This experience also translates directly to investment and asset diligence Please reach out to discuss your specific situation.
