PassionBio: Creating Ventures

PassionBio offers strategic & operational drug development support from clinical stage to dossier submission, and beyond.

https://sites.google.com/site/helmutbrunar/home/

Active contribution to more than a dozen drug development projects (NCEs, NBEs). Leading role in the development of Grastofil (filgrastim biosimilar). Project and supply chain management. Coordination of interdisciplinary teams and contractors (CMOs, CROs). Set-up of electronic data rooms for investors' due diligences. Budgets for R&D and commercial phase. Cost effectiveness analysis.

Extensive experience with pre- and post-approval regulatory processes, and with regulatory intelligence. Versed with EU-EMA and US-FDA regulatory environments, and with the review and submission of relevant documentation. Managed multiple client/agency interactions concerning GMP-related legislation, data integrity, GxP compliance, freedom-to-operate analysis and patent litigation.


Ultimately, our support aims to develop successful market entry strategies. To this end, we create and enhance value propositions by providing analysis, planning and engagement across the product life cycle.