Projects
Case Studies
Opterion Health
CMC & Manufacturing Leadership for First-in-Human Program
Client: Opterion Health AG
Role: Head CMC / Manufacturing (Jan ’23 – present)
Therapeutic Area: Renal Care / Peritoneal Dialysis
Stage: Phase I CTA Approved (Jan 2026) | Phase II in Preparation
The Challenge
- Industrial GMP scale-up to multi-kg level
- Dual Chamber infusion bag development
- Clinical GMP batch Manufacturing
- IMPD CMC Preparation
- On-time CTA approval
Scope of Engagement
Drug Substance (Decadextrin)
GMP scale-up to multi-kg
Process control & quality
Drug Product
- Dual chamber infusion bag design
- Clinical batch production
Regulatory and Documentation
- IMPD CMC dossier
- CTA submission report
Key Outcomes
Multi-kg GMP
Drug substance produced
Clinical IMP
Delivered on Schedule
Phase I
CTA Approved (Jan 2026)
Phase II
Development Initiated
Competencies Demonstrated
- GMP scale-up execution
- Polysaccharide manufacturing
- IMPD regulatory expertise
- Clinical supply management
- Cross-functional Leadership
- Process Scale-up
- Clinical GMP
- IMPD Submission
- Phase II Preparation
AnaCardio
ACO1 CMC & Manufacturing Execution
Client: AnaCardio AB
Role: Director CMC (Sep ’21 – present)
Therapeutic Area: Heart Failure
Development Stage: Phase I CTA Approved, Phase II under Preparation
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Mentee Voices
“Marc played a vital role in guiding my early foray into entrepreneurship. He not only encouraged my vision but also provided concrete support, such as helping me understand the dynamics of startup development, navigating the biomedical sector, and connecting me with relevant contacts in industry. His own experience in bridging science and business served as a valuable reference point for me, and our discussions about transitioning from academia to entrepreneurship were both inspiring anddeeply formative. Marc’s guidance during that time contributed significantly to the career path I am forging today. I wholeheartedly support his work and mentorship and am confident in his continued positive impact on scientists seeking to make meaningful transitions in their careers.”
Amparo Jimenez Quero, Assistant Professor Chalmers U
“Marc played a pivotal role in supporting me during the early stages of building my MedTech startup, helping me navigate the transition from research to real-world impact by tuning our business case. As a first-time founder, having industry guidance was invaluable, and Marc’s expertise, leadership, and strategic vision made a significant difference. His ability to motivate, mentor, and provide clear direction is truly impressive. I am grateful for his support and totally recommend him to any entrepreneur seeking a knowledgeable and inspiring leader on their journey.”
Alvaro Morales López, CEO Akira Science
“Marc has been instrumental in my development as an entrepreneur. He mentored me during my PhD, where we had regular meetings and scientific discussions around my startup company MODSIM. He was extremely kind during the process and approached my initial naivety with curiosity and interest. He helped me grow the company, but more importantly helped me grow as a person and scientist. If you are looking for a pleasantly involved, yet sharply professional person who likes to think along on all levels, I can’t think of a better person than Marc!”
Willem Jespers, Assistant Professor U Groningen, CSO ModSim