What We Offer
Unparalleled Expertise, Applied to Your Program.
Every service is grounded in firsthand regulatory decision-making experience- applied directory to your program.
A complimentary 30-minute introductory call to assess fit.
Dr. Nicole Gormley
Founder . Former Division Director, Hematology-Oncology
01.
Program Strategy & Planning
Perspective on how programs are actually evaluated, from early development through IND, pre-NDA meetings, and approval. Built on years of leading those exact decisions.
Sponsors benefit from clear-eyed understanding of the strengths and limitations of their programs- not just generic guidance- but specific insights.
02.
Endpoint Development
Deep expertise on MRD, surrogate endpoints, ctDNA, and novel evidentiary standards, shaped by direct involvement in setting them.
As Associate Director for Endpoint Development at the Oncology Center of Excellence, Dr. Gormley was not merely interpreting endpoint policy, she was helping to shape it. Her work spans MRD as a surrogate endpoint in myeloma, overall survival methodology, and the evidentiary standards the agency applies.
03.
Crisis Advisory
A Complete Response Letter, an unexpected clinical hold, an advisory committee with an uncertain outcome, these situations demand counsel from someone who has navigated them from both sides.
Sponsors in crisis benefit most from clear-eyed judgment, not reassurance. Dr. Gormley has issued complete response letters, overseen clinical holds, and led the agency team at advisory committees.
04.
Agency Interaction
The difference between a productive agency meeting and a missed opportunity is often preparation. Knowing what there review team actually looks for in a briefing document, and what questions will be raised, shapes both the content and the outcome.
05.
Accelerated Approval Guidance
Dr. Gormley’s knowledge of this landscape is current and first-hand- reflecting not just the requirements but how they are applied, under current confirmatory trial expectations
06.
Investment & Asset Diligence
Dr. Gormley’s expertise extends naturally to those evaluating assets from an investment standpoint. Rigorous scientific and regulatory judgment is essential to assessing the true risk and potential of a development program, and few consultants can offer this from a position of actual regulatory decision-making authority.
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.
