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
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/
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