Helion Pharma
Clinical Development.
Done right.
From strategy to execution.
I help biotech and pharma teams shape robust clinical programs and execute them with clarity, speed, and regulatory alignment. Phase I to III. EMA and FDA Scientific Advice. Lean teams. Clear decisions.
What I offer
I support biotech and pharma teams from early program shaping to late stage readiness, combining strategy with hands on execution. I work best with lean teams facing time critical decisions and high stakeholder visibility. Typical engagement formats include fractional leadership, advisory retainers, and focused sprints around value inflection points such as FIH, PoC, and pivotal readiness.
About me
I am a drug development professional with a PhD background in biochemistry and immunology and postgraduate training in pharmaceutical medicine.
I founded Helion Pharma as a consultancy in 2008.
Until April 2026, I serve as Chief Medical Officer at AdrenoMed, leading clinical and regulatory strategy in a high complexity critical care program and supporting investorand board level decision making.
Earlier roles include clinical program leadership and global development work in biotech and pharma settings, covering Phase I to Phase III programs and regulatory interactions in the EU and US.
I also support board and investor communication, duediligence workstreams, and crisp decision documents for high stakes milestones.
Selected track record
Regulatory Alignment (EMA & FDA)
Aligned EMA and FDA Scientific Advice to enable a lean and efficient Phase III development program.
Clinical Development Strategy
Restructured development approaches to establish a clear and robust path to clinical proof of concept.
Patient Recruitment Optimization
Improved patient recruitment performance in highly complex Phase III trial settings.
Lean Clinical Infrastructure Build-Up
Built lean clinical development infrastructures in small company environments, including PV and Medical Affairs interfaces.
Global Late-Stage Leadership
Led global clinical activities for late-stage assets and supported registration-relevant deliverables.
Typical support
Clinical development strategy and program assessment, with focus on derisking and value inflection points, including due diligence for partnering and investment.
Regulatory strategy and health authority interactions, including briefing packages and meeting support.
Study design and protocol development, endpoints, feasibility, timelines, and budgets.
Program troubleshooting and recovery plans for stalled trials.
Outsourcing strategy, CRO selection, and vendor oversight.
Biomarker and clinical assay strategy and integration where relevant.
Scientific Advisory Boards and KOL strategy and preparation.
Documentation and quality
Clinical Documentation
Creation and review of key clinical documents, including Clinical Development Plans, protocols, Investigator’s Brochure, and CTD clinical modules.
Quality & Compliance
Quality review of core documents and setup of pragmatic SOPs and QC processes.
