VivaZome’s mission is:
To be a global leader in providing novel, valuable and safe exosome-derived therapies for debilitating and life-threatening diseases
VivaZome business is based on key attributes and activities:
- Focus on developing therapies for debilitating and / or life-threatening disorders where:
- Current treatment are inadequate – low efficacy and / or poorly tolerated.
- Established pre-clinical disease models are available
- There is a rationale for the VivaZome therapy to provide a clinically dramatic treatment effect
- Global orientation from the outset with mission to take the VivaZome therapies to the world’s major markets.
- Identify and secure potential cell sources for exosomes for the target disorder. Characterisation and definition of the exosomes.
- Development of a scale-able, validated, cost-efficient GMP manufacturing process, with fully-integrated quality systems. This may include licensing of relevant technologies and/or joint projects with major technology providers.
- Early engagement with regulators in major jurisdictions.
- Conduct of small-scale pilot clinical studies to demonstrate safety and, where possible, provide efficacy signals.
- Undertaking multi-national multi-centre clinical studies to support product registration and reimbursement.
- Securing a global partner or regional partners to support clinical studies and/or market access and /or sales in major markets.
- Ongoing scientific studies to enhance the clinical utility of the therapies and further strengthen the international IP position.
- Raising investor and grant capital to fund the development and scientific work.
- Project management to ensure all activities are closely managed for cost and timing and milestones are achieved.