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IND & Early Clinical Strategy
Translating preclinical science into an executable development plan — IND preparation, first-in-human design, and a regulatory pathway built for the FDA from the start.
Mindrise Medica is a senior clinical development and operations practice for early-stage oncology companies. We help founders and lean teams design the trial, build the infrastructure, and execute the regulatory path that takes a program from IND to the clinic — and beyond.
Emerging biotechs rarely need a full clinical-operations department on day one. They need a senior partner who has done it before — to set strategy, stand up the trial, and keep the regulatory path clean while the team stays lean.
Translating preclinical science into an executable development plan — IND preparation, first-in-human design, and a regulatory pathway built for the FDA from the start.
End-to-end study start-up and execution: protocol and document authoring, site activation, enrollment strategy, CRO and vendor governance, and the operational backbone trials run on.
Stepping into struggling programs to diagnose what's broken — enrollment, data quality, vendor performance, timelines — and getting the study back on a credible path.
TMF systems, SOP development, and inspection-readiness preparation that holds up to FDA scrutiny — built on a record of audits closed with no major findings.
Directed global trial operations from Phase I through FDA submission — study start-up, TMF systems, CRO governance, and regulatory deliverables. Contributed to Breakthrough Therapy Designation and the launch of a multi-billion-dollar ADC franchise.
Led clinical data reconciliation at Merck's highest-enrolling global site during the pivotal Phase I trials that supported Breakthrough Therapy Designation and Keytruda's first BLA approval.
Directed Phase I/II autologous NK-cell therapy programs in solid tumors — including a combination trial with Affimed's innate cell engager (AFM24) — and built clinical infrastructure ahead of the company's move to public markets.
Led early-phase oncology trial operations during post-IPO expansion: TMF reconciliation, CRA training, and FDA inspection preparation across 100+ sites in a lean-team environment.
Deepest in oncology — antibody-drug conjugates, cell therapy, and checkpoint immunotherapy — with the operational and regulatory fundamentals that carry into other therapeutic areas when the science calls for it.
Mindrise Medica is a clinical development and operations practice built for the stage where the science is ready but the infrastructure isn't yet. We partner with emerging oncology companies on the questions that decide whether a program reaches the clinic: IND strategy, trial design and execution, rescue, and inspection readiness. To date the practice has advised more than ten sponsors across oncology, immunotherapy, and rare disease.
The practice is led by founder and principal Dorna Pourang, who brings 15+ years directing global oncology programs across ADCs, immunotherapy, and autologous cell therapy — from first-in-human through FDA approval. That experience spans two approved oncology drugs, Padcev at Astellas and Keytruda at the site level for Merck, alongside early-phase cell therapy and kinase-inhibitor programs at venture- and public-stage companies.
The through-line of the work is translation — turning scientific complexity into plans cross-functional teams can actually run, under the timelines emerging companies live by.
Whether you're preparing an IND, designing a first-in-human study, or trying to get a stalled trial back on track — we'd welcome a conversation.