Transfer of novel academic research in vaccines into marketable products – a new business model

1Corvay at BioAsia2009

„Transfer of novel academic research in vaccines into marketable products – a new business model“

Dr. Albrecht Läufer, CEO


Corvay´s Core Competences

Corvay is a consulting firm specialized on Life Sciences, founded 2002, based in Hannover, Germany.

> 20 years international experience in pharmaceuticals and biotechnology in industry and academia !

Proven expertise in business strategy development AND implementation !

Excellent network of researchers, associations, industry partners, external experts, government bodies both in Europe and in Asia !


Corvay manages BioRegioN

Life Science Network of the State of Niedersachsen…

….. and is coordinating the initiative „Life Science Niedersachsen goes India“ under the umbrella of the research marketing campaign of the German Federal Ministry of Education and Research.

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Vaccines - Global Needs, Global Markets

Highly unmet medical needs:

The BIG Three: HIV, Tuberculosis, Malaria.

Diarrhea causing diseases.

Hepatitis C.

Cytomegalovirus.

Dengue.

Influenza.

Cancer.

Other diseases related to infections or immune system disorder.

Corvay at BioAsia2009

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21 bn USD global vaccine sales in 2008 (18.5 bn USD in 2007).

Prevnar® 3bn USD; Gardasil 2.8 bn USD.

Several others >1 bn.

“Classical” mainly pediatric market 6 – 7 bn USD, stable.

New vaccines providing the growth.

India: 1800 crores = approx 360 mill USD.

Russia, Brazil, China, all South East Asia to become big markets.


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Another urgent need :

In order to grow further , industry needs new, successful candidates.



Where do new vaccine concepts come from ?

academia

- HPV vaccine invented by 2008 nobel laureate Prof. zur Hausen, DKFZ, German Cancer Research Center.

- Diphteria serum treatment (1901) by Emil von Behring at Marburg university, later funded by Hoechst.

- Many others.

Industry, in earlier times national serum institutes.


Situation in German academia 1995 - 2000

Prospering science scene with >200 research projects in > 50 scientific groups.

Productive collaboration between science and industry, mainly Behringwerke, sold to Chiron in 1996.

Working group in the Federal Ministry of Education and Research on how to foster commercialization if academic vaccine research.

Emil von Behring, 1917


Bridging the gap between academia and industry

Main hurdle: mentality / incentive systems.

TLO´s (technology licence offices). licence oriented - several university based TLO´s. Licence and Spin out oriented – Max Planck Innovation,

Ascenion.

Successfull Spin outs: Immatics, CureVac.

Project management company.

New concepts since 2008: Lead Discovery Center, Screening port.

Science Parks, associated to universities and research centers.


Project Management Company

key principle: partner ! focus on key expertise of each partner.

research / innovation at academic institute (university, Max Planck Institute, Fraunhofer Institute) -> creative and cost effective. process development and manufacturing at appropriate CMO, custom manufacturing organization -> no CapEx ! preclinical trial at appropriate CRO. clinical trial with appropriate CRO in appropriate endemic area. all support services (regulatory, patent/IP, quality, legal, HR, accounting) with expert partners. product/indication specific advice from selected experts.

plan and manage project „with the final objective in mind“.


Vakzine Projekt Management GmbH

founded 2002, operative 2003, 5 later 8 FTE´s, based in Hannover.

projects tuberculosis – recombinant live BCG vaccine. prostate cancer – recombinant LNCap cell line. novel interferon-beta Soluferon®, for Multiple Sclerosis.

on the shelf: HCMV dense bodies and Malaria MSP-1.

management team: CEO, CSO, CFO + 1 project manager per project.


Partners in the Tb vaccine project


Key process steps

identify candidate -> German vaccine database.

negotiate good licence contract -> back loaded, close communication, scientific collaboration. identify + contract appropriate manufacturing partner (CMO). transfer product technology to CMO partner „hands on“. validate product technology, and key preclinical proof of concept experiment, mechanism of action. develop GMP process, produce preclinical material, phase I material. regular communication with regulatory authority. perform state of the art preclinical and phase I clinical trials, possibly phase II.

partner with or licence to industry.


Summary

academic research is a major source for innovation in vaccines.

a project management company can efficiently bridge the gap to industry.

it will not be necessary to establish a new start up company for

each new project, the same core management team can be applied while the partner network will be adjusted according to the requirements of the project.

a public / private FIPNO...


Thank you very much

Corvay GmbHSofienstr. 6

D - 30159 Hannoverphone: +49 511 44 98 95 31

fax: +49 511 44 98 95 99

[email protected]

www.corvay.de

Health & Medicine

Transfer of novel academic research in vaccines into marketable products – a new business model