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160929 avivia presentation molecule to business


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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.

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160929 avivia presentation molecule to business

  1. 1. d/29788 1 From Molecule to Business 29/9/2016 a catalyst to develop ideas into patient solutions
  2. 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. 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. 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. 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
  6. 6. 6 Pre-clinical development Market Potential Exclusivity Clinical Proof of Concept Regulatory Approach Clinical Need Concept Development & Execution Commercialization Medical &Scientific Community Commercial & Co- development Partners Regulatory Experts Intellectual Property Experts API manufacturers Public & Government al Funding Institutional Investors Formulation Experts Chemical & Analytical Experts The Approach
  7. 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. 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. 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. 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
  11. 11. 11 Hans Platteeuw CEO, Avivia BV Email: Phone: +31 6 286 75 973 Web: Connect