Avivia, a catalyst to develop ideas into patient solutions. Presentation by Frank Vanderdonck from Avivia during 'From Molecule to Business' event by SMB Life Sciences and Health Valley at NovioTechCampus, Nijmegen, The Netherlands on September 29, 2016.
2. • Pharmaceutical development company established in 2004
• Headquartered in Nijmegen, The Netherlands
• Combining CRO activities with internal development programs
• State-of-the-art laboratories and technology capabilities
• Team with proven industry track records
2
Avivia
3. 3
• Track records in generics, innovative small molecules and biotech from new
to mature/established products
• Experience through leading roles in discovery, formulation development, pre-
clinical and clinical development, manufacturing, regulatory affairs, marketing &
sales
• From start-ups to leading pharma companies
The TEAM
4. • In-house lab for analytical and pharmaceutical product development from bench
to commercial scale cGMP-production (Chemistry, Manufacturing and
Controls)
• Project management of preclinical and clinical development
• In-licensing and investment evaluations
• Identification of and negotiation with development/commercial partners
• Regulatory & market access strategy
• Intellectual property strategy
• Marketing and financial planning
4
The CRO
Avivia is a catalyst and an access point to a network of experts
to help evaluate and develop ideas for better patient care
into commercially viable treatment options.
5. • Our approach to innovation focuses on repurposing of tried
and tested products.
• Repurposing can adress a high unmet need for patients with
lower cost, risk and time to market but requires out-of-
the box thinking
5
In-house projects
Dosing Indication Formulation
Specific Patient
Population
Orphan Drugs Prodrugs Rx-to-OTC Switch Drug Combinations
Drug-device
combinations
New route of
administration
Technology Device
7. • Clinical need: CRPC and limited MoA choices of existing drugs
• Innovation: regulatory pathway and positioning
• Exclusivity: marketing and additional intellectual property
• Life cyle management: follow-up development
• Potential cumulative 10y revenue: €142M (EU)
• Partner: generics+ company looking to build portfolio
7
FOS project
8. • Clinical need: PPH and stability of golden standard treatment.
• Innovation: formulation and route of administration
• Exclusivity: marketing and intellectual property
• Potential cumulative 10y revenue: €61M (in partner region)
• Partner: ’international diversified distribution company’
8
OXY project
9. • Clinical need: Pouchitis and side effects of current treatment.
• Innovation: formulation
• Exclusivity: orphan drug designation
• Life cyle management: additional indications
• Potential cumulative 10y revenue: €30M (EU & US)
• Funding: Horizon 2020
• Partner: international consortium of expert centers
9
MRZ project
10. • Its all about people
• Focus on the patients’ need
• Glue the pieces together, but start with the end in mind
• Innovation can be many things, not just a new molecule
• Leverage networks and stay lean
10
Conclusion
