Constanze Ochmann-Harding
Director CMC Epitopea Ltd
Constanze Ochmann is Director of CMC at Epitopea, where she supports the development of the company’s oncology pipeline. She brings extensive experience in CMC strategy and pharmaceutical development across RNA-based therapeutics, biologics and oncology.
Prior to joining Epitopea, Constanze spent more than four years at BioNTech, most recently as Director of CMC and CMC Lead for the company’s FixVac cancer vaccine pipeline. In this role, she provided strategic oversight for the development of RNA-LPX assets, leading cross-functional teams spanning drug substance, drug product, quality, regulatory, clinical supply and GMP manufacturing.
Earlier in her career, Constanze held CMC and product development roles at Mundipharma, supporting biologics development, regulatory submissions and lifecycle management.
Seminars
- Sharing learnings of how preclinical data can link to clinical functionality
- Exploring how different RNA therapeutics have different assumptions on clinical functionality and how to translate that into assays (e.g. personalised vs gene replacement etc.)
- Incorporating these considerations early in the preclinical thought process and early-stage clinical development
- Differentiating mode-of-action assays from simple protein expression readouts: demonstrating clinical relevance
For emerging RNA developers, deciding where to invest limited CMC resources can be just as challenging as the technical development itself.
Designed as an informal, networking session, this peer exchange offers early-stage biotech teams the opportunity to connect with others facing similar challenges, share lessons learned and exchange practical advice in an open, collaborative setting.
An interactive discussion for early-stage mRNA developers to compare how they are:
- Deciding when to invest in internal CMC capabilities versus external support
- Prioritising spend across process development, assay development and regulatory preparation
- Selecting CDMOs and consultants that understand the needs of smaller companies
- Avoiding early development decisions that create expensive problems later
