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


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

By - Dr. Albrecht Läufer, CEO

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

  1. 1. Corvay at BioAsia2009 „ Transfer of novel academic research in vaccines into marketable products – a new business model “ Dr. Albrecht Läufer, CEO
  2. 2. Corvay at BioAsia2009 Corvay´s Core Competences <ul><li>Corvay is a consulting firm specialized on Life Sciences, founded 2002, based in Hannover, Germany. </li></ul><ul><li>> 20 years international experience in pharmaceuticals and biotechnology in industry and academia ! </li></ul><ul><li>Proven expertise in business strategy development AND implementation ! </li></ul><ul><li>Excellent network of researchers, associations, industry partners, external experts, government bodies both in Europe and in Asia ! </li></ul>
  3. 3. Corvay at BioAsia2009 Corvay manages BioRegioN <ul><li>Life Science Network of the State of Niedersachsen… </li></ul><ul><li>… .. 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. </li></ul>
  4. 4. 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
  5. 5. Vaccines - Global Needs, Global Markets 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. Corvay at BioAsia2009
  6. 6. Vaccines - Global Needs, Global Markets Another urgent need : In order to grow further , industry needs new, successful candidates. Corvay at BioAsia2009
  7. 7. Corvay at BioAsia2009 Where do new vaccine concepts come from ? <ul><li>academia </li></ul><ul><li>HPV vaccine invented by 2008 nobel laureate Prof. zur Hausen, DKFZ, German Cancer Research Center. </li></ul><ul><li>Diphteria serum treatment (1901) by Emil von Behring at Marburg university, later funded by Hoechst. </li></ul><ul><li>- Many others. </li></ul><ul><li>Industry, in earlier times national serum institutes. </li></ul>
  8. 8. Corvay at BioAsia2009 Situation in German academia 1995 - 2000 <ul><li>Prospering science scene with >200 research projects in > 50 scientific groups. </li></ul><ul><li>Productive collaboration between science and industry, mainly Behringwerke, sold to Chiron in 1996. </li></ul><ul><li>Working group in the Federal Ministry of Education and Research on how to foster commercialization if academic vaccine research. </li></ul>Emil von Behring, 1917
  9. 9. Corvay at BioAsia2009 Bridging the gap between academia and industry <ul><li>Main hurdle: mentality / incentive systems. </li></ul><ul><li>TLO´s (technology licence offices). </li></ul><ul><ul><li>licence oriented - several university based TLO´s. </li></ul></ul><ul><ul><li>Licence and Spin out oriented – Max Planck Innovation, Ascenion. </li></ul></ul><ul><li>Successfull Spin outs: Immatics, CureVac. </li></ul><ul><li>Project management company. </li></ul><ul><li>New concepts since 2008: Lead Discovery Center, Screening port. </li></ul><ul><li>Science Parks, associated to universities and research centers. </li></ul>
  10. 10. Corvay at BioAsia2009 Project Management Company <ul><ul><li>key principle: partner ! focus on key expertise of each partner. </li></ul></ul><ul><ul><li>research / innovation at academic institute (university, Max Planck </li></ul></ul><ul><ul><li>Institute, Fraunhofer Institute) -> creative and cost effective. </li></ul></ul><ul><ul><li>process development and manufacturing at appropriate CMO, </li></ul></ul><ul><ul><li>custom manufacturing organization -> no CapEx ! </li></ul></ul><ul><ul><li>preclinical trial at appropriate CRO. </li></ul></ul><ul><ul><li>clinical trial with appropriate CRO in appropriate endemic area. </li></ul></ul><ul><ul><li>all support services (regulatory, patent/IP, quality, legal, HR, </li></ul></ul><ul><ul><li>accounting) with expert partners. </li></ul></ul><ul><ul><li>product/indication specific advice from selected experts. </li></ul></ul><ul><ul><li>plan and manage project „with the final objective in mind“. </li></ul></ul>
  11. 11. Corvay at BioAsia2009 Vakzine Projekt Management GmbH <ul><ul><li>founded 2002, operative 2003, 5 later 8 FTE´s, based in Hannover. </li></ul></ul><ul><ul><li>projects </li></ul></ul><ul><ul><ul><li>tuberculosis – recombinant live BCG vaccine. </li></ul></ul></ul><ul><ul><ul><li>prostate cancer – recombinant LNCap cell line. </li></ul></ul></ul><ul><ul><ul><li>novel interferon-beta Soluferon®, for Multiple Sclerosis. </li></ul></ul></ul><ul><ul><ul><li>on the shelf: HCMV dense bodies and Malaria MSP-1. </li></ul></ul></ul><ul><ul><li>management team: CEO, CSO, CFO + 1 project manager per project. </li></ul></ul>
  12. 12. Corvay at BioAsia2009 Partners in the Tb vaccine project
  13. 13. Corvay at BioAsia2009 Key process steps <ul><ul><li>identify candidate -> German vaccine database. </li></ul></ul><ul><ul><li>negotiate good licence contract -> back loaded, close </li></ul></ul><ul><ul><li>communication, scientific collaboration. </li></ul></ul><ul><ul><li>identify + contract appropriate manufacturing partner (CMO). </li></ul></ul><ul><ul><li>transfer product technology to CMO partner „hands on“. </li></ul></ul><ul><ul><li>validate product technology, and key preclinical proof of concept </li></ul></ul><ul><ul><li>experiment, mechanism of action. </li></ul></ul><ul><ul><li>develop GMP process, produce preclinical material, phase I </li></ul></ul><ul><ul><li>material. </li></ul></ul><ul><ul><li>regular communication with regulatory authority. </li></ul></ul><ul><ul><li>perform state of the art preclinical and phase I clinical trials, </li></ul></ul><ul><ul><li>possibly phase II. </li></ul></ul><ul><ul><li>partner with or licence to industry. </li></ul></ul>
  14. 14. Corvay at BioAsia2009 Summary <ul><ul><li>academic research is a major source for innovation in vaccines. </li></ul></ul><ul><ul><li>a project management company can efficiently bridge the gap to </li></ul></ul><ul><ul><li>industry. </li></ul></ul><ul><ul><li>it will not be necessary to establish a new start up company for </li></ul></ul><ul><ul><ul><li>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. </li></ul></ul></ul><ul><ul><li>a public / private FIPNO... </li></ul></ul>
  15. 15. Corvay at BioAsia2009 Thank you very much Corvay GmbH Sofienstr. 6 D - 30159 Hannover phone: +49 511 44 98 95 31 fax: +49 511 44 98 95 99 [email_address]