http://www.motaen.com/wallpapers/source/id/29788

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From Molecule to Business

29/9/2016

a catalyst to develop

ideas into patient solutions

• 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

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Avivia

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• 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

• 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

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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.

• 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

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In-house projects

Dosing Indication FormulationSpecific Patient

Population

Orphan Drugs Prodrugs Rx-to-OTC Switch Drug Combinations

Drug-device

combinations

New route of

administrationTechnology Device

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Pre-clinicaldevelopment

MarketPotential

Exclusivity

Clinical Proof ofConcept

Regulatory Approach

Clinical Need Concept Development &

ExecutionCommercialization

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

• 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

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FOS project

• 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’

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OXY project

• 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

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MRZ project

• 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

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Conclusion

http://udhao.net/mountaineer-girl-wallpaper/

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Hans Platteeuw

CEO, Avivia BV

Email: hansplatteeuw@avivia.nl

Phone: +31 6 286 75 973

Web: www.avivia.nl

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