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Complementary technology
bridging as driver for translation
     of academic research in
    innovation and invention

           Nick Geukens
Setting the scene
Biomedical research
 “Long term” R&D programs
     Drug development: 8-10 years “discovery to market”
     Immunossay development: 2-4 years “discovery to
      market”

 Dominated by big Pharma
     Growth resistors: patent cliff, global economic downturn,
      reduced healtcare budgets, reimbursement cuts

   Strategy to drive profitability = innovation (High unmet
  need, Improved offerings, Biologics & Emerging
  technologies)
Drug Discovery and Development:
  Today’s reality
Maximal achievable clinical benefit with a given target

                                                              Generics
                                              Best in class




                          Follow on drug




     First in class

       3-5 Y                   5-10 Y             10-15 Y
The innovation challenge for a new drug

Maximal achievable clinical benefit with old target


                                               Best in class

                                                               Success

                          Follow on drug
                                              Me-Too

                          Fail
     First in class
The innovation challenge = value creation
Academic translational research challenge



 Basic research
 Scientific excellence
 New targets
                                              New Drugs
 New Biomarkers
                                              New Assays
                                              New Products
                                              New Services
                         Customized Funding
                         Key enabling technologies
Industrial Research Fund
•Fund Flemish Government since 2004
•Investment in strategic basic and applied research
•Fortification of interaction between universities and
industry
• “In 2012:
  budget ~ 19 M€ for Flemish Universities & Association
  with ~8 M€ for KU Leuven Association
•Valorisation output:
o Patents
o industrial contracts
o EU projects
o spin-offs
Industrial Research Fund
• Activity-based funding (projects):
  o   Leverage projects (79)
  o   Knowledge platforms (31)

• Person-based funding:
  o   L(euvense) Da Vinci prize (3)
  o   Industrial Research Fellows (24)



  http://www.kuleuven.be/industrieelonderzoeksfonds/
Time to value:

Enabling technologies
matching science with
medical need
Complementary technology bridging
Scientific excellence             Technology activity


                                             Enabling Technology
                                                   Centers


       Translation of research into innovation,
                                             Center for Drug Design
            Innovation into inventions &      and Discovery (CD3)
             Inventions into valorisation
                                                 PharmAbs, the KU
                                                  Leuven Antibody
                                                      Center


                   Portfolio of IPRs                    …
                   Product pipelines
Bridging research and valorisation with
   antibodies

 Antibody-                                      In vivo                            Spin-off
               Antibody                                        Antibody
   based                      In vitro         proof of
therapeutic
              generation &
                             evaluation      therapeutic
                                                                clinical
              optimisation                                     candidate           Licensing
  concept                                      concept




target

                                                                                   Spin-off
 Antibody-                                                       Confirmation
              Antibody and
   based
                reagent
                              Assay design          Assay
                                                                 of the clinical
                                                                                   Licensing
 diagnostic                  & development        validation
              development                                             utility
  concept
                                                                                   Service
                                                                                     facility
Example : Towards an optimised
  treatment of Crohn’s patients
START                        • Assay to determine
• 40% loss of response of      serum level of Remicade
  Crohn’s disease patients     in patients
  to Remicade® therapy
                             • Assay to determine anti-
• High number of severe        drug antibody (ADA)
  infusion reactions           formation


CLINICAL OUTCOME             RESEARCH OUTCOME
• 2-5% loss of response of   • Biochemical loss of
  Crohn’s disease patients     response (low serum
  to Remicade® therapy         level) preceeds clinical
                               loss of response
• No severe infusion
  reactions                  • Acute severe infusion
                               reactions are due to high
                               ADA levels
Summary
   High level of innovations @ KU Leuven

   Unique situation with UZLeuven

   Translational funding and support available to bridge
    the development gap (i.e. IOF)

   Be innovative, make use of academic key enabling
    technology centers & believe your own data

                   www.pharmabs.org

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AFC Café: Nick geukens

  • 1. Complementary technology bridging as driver for translation of academic research in innovation and invention Nick Geukens
  • 3. Biomedical research  “Long term” R&D programs  Drug development: 8-10 years “discovery to market”  Immunossay development: 2-4 years “discovery to market”  Dominated by big Pharma  Growth resistors: patent cliff, global economic downturn, reduced healtcare budgets, reimbursement cuts Strategy to drive profitability = innovation (High unmet need, Improved offerings, Biologics & Emerging technologies)
  • 4. Drug Discovery and Development: Today’s reality Maximal achievable clinical benefit with a given target Generics Best in class Follow on drug First in class 3-5 Y 5-10 Y 10-15 Y
  • 5. The innovation challenge for a new drug Maximal achievable clinical benefit with old target Best in class Success Follow on drug Me-Too Fail First in class
  • 6. The innovation challenge = value creation
  • 7. Academic translational research challenge Basic research Scientific excellence New targets New Drugs New Biomarkers New Assays New Products New Services Customized Funding Key enabling technologies
  • 8. Industrial Research Fund •Fund Flemish Government since 2004 •Investment in strategic basic and applied research •Fortification of interaction between universities and industry • “In 2012: budget ~ 19 M€ for Flemish Universities & Association with ~8 M€ for KU Leuven Association •Valorisation output: o Patents o industrial contracts o EU projects o spin-offs
  • 9. Industrial Research Fund • Activity-based funding (projects): o Leverage projects (79) o Knowledge platforms (31) • Person-based funding: o L(euvense) Da Vinci prize (3) o Industrial Research Fellows (24) http://www.kuleuven.be/industrieelonderzoeksfonds/
  • 10. Time to value: Enabling technologies matching science with medical need
  • 11. Complementary technology bridging Scientific excellence Technology activity Enabling Technology Centers Translation of research into innovation, Center for Drug Design Innovation into inventions & and Discovery (CD3) Inventions into valorisation PharmAbs, the KU Leuven Antibody Center Portfolio of IPRs … Product pipelines
  • 12. Bridging research and valorisation with antibodies Antibody- In vivo Spin-off Antibody Antibody based In vitro proof of therapeutic generation & evaluation therapeutic clinical optimisation candidate Licensing concept concept target Spin-off Antibody- Confirmation Antibody and based reagent Assay design Assay of the clinical Licensing diagnostic & development validation development utility concept Service facility
  • 13. Example : Towards an optimised treatment of Crohn’s patients START • Assay to determine • 40% loss of response of serum level of Remicade Crohn’s disease patients in patients to Remicade® therapy • Assay to determine anti- • High number of severe drug antibody (ADA) infusion reactions formation CLINICAL OUTCOME RESEARCH OUTCOME • 2-5% loss of response of • Biochemical loss of Crohn’s disease patients response (low serum to Remicade® therapy level) preceeds clinical loss of response • No severe infusion reactions • Acute severe infusion reactions are due to high ADA levels
  • 14. Summary  High level of innovations @ KU Leuven  Unique situation with UZLeuven  Translational funding and support available to bridge the development gap (i.e. IOF)  Be innovative, make use of academic key enabling technology centers & believe your own data www.pharmabs.org