Marcin Ufnal, MD, PhD

I advise CVRM biotech companies, VC and life science investors from early concept through Phase 3, combining independent scientific strategy with practical recruitment support through a proven investigator network. 🔹 Clinical & Regulatory Strategy — Development plans, trial design, dose and endpoint strategy, and regulatory pathways from Phase 1 to 3 🔹 Investment Decision Support — Scientific diligence for go/no-go decisions, indication strategy, portfolio prioritization, licensing, and financing milestones, with a focus on hidden risks and weak assumptions 🔹 Translational & PoC De-Risking — Mechanism, biomarkers, patient selection, and endpoints aligned to maximize probability of proof-of-concept success 🔹 KOL & Scientific Engagement — Advisory boards, steering committees, and investigator strategy to pressure-test programs 🔹 Label, Regulatory & Payer Strategy — Early integration to avoid late-stage surprises that erode value 🔹 Investigator Network & Recruitment — I work with a trusted network of cardiologists and investigators across Poland and Central-South-Eastern Europe who actively run trials and deliver on enrollment timelines. I provide site identification and recruitment support for CVRM studies with enough depth to support a full Phase 2 program. This is not a contact list, but a network built through direct collaboration and trust.

Clinical development lead for a novel CRF2 agonist in pulmonary hypertension and RV failure. Strong hands-on contribution to the IND submission — clinical strategy, protocol design, translational rationale. Taking this first-in-class program from preclinical through regulatory filing and into human studies.

• Plan and execute clinical development in cardiovascular and metabolic diseases, focusing on heart failure, pulmonary hypertension, CKD, and obesity. Develop new strategic indications, TPPs, and designs for Phase 1 to Phase 3 studies. • Provide medical and clinical expertise for business development projects, including evaluating potential opportunities, supporting due diligence processes, and contributing to strategic decision-making. • Provide scientific and clinical input to preclinical projects, ensuring seamless integration of preclinical and early clinical findings into planned clinical programs. • Serve as Medical Lead in clinical studies, including preparation/revision of IBs, CSPs, ICFs and CSRs. • Regulatory submissions.

Leading the team of approximately 15 people, including physicians, scientists and lab assistants. Successful execution of international scientific projects. The department has been consistently funded by extramural and internal grants, continuously supporting the work of Ph.D. students and post-doctoral fellows. I have designed and supervised preclinical and clinical studies in cardiovascular and metabolic disease area. I have authored over 100 publications, including over 70 as a corresponding author in international peer-reviewed high-impact journals. https://pubmed.ncbi.nlm.nih.gov/?term=ufnal&sort=date. Teaching human physiology, pathophysiology and pharmacology

Internal Medicine physician

medical monitoring