This document discusses how complementary technologies can help bridge academic research and industrial innovation. It provides examples of how the KU Leuven University uses enabling technology centers like its Center for Drug Design and Discovery and PharmAbs antibody center to translate biomedical research into new drugs, biomarkers, assays, and products. These centers help move research from basic discovery to valorization outcomes like patents, industrial contracts, spin-offs, and licensing agreements. One example described how KU Leuven used antibody assays to help optimize treatment for Crohn's disease patients losing response to Remicade therapy.
Lateral flow assays are the most robust, mature immuno sensor available today. Performance in some applications has historically been limited by difficulties in multiplexing and quantification. Novel approaches have been developed and commercialized in recent years that allow for the development and manufacturing of highly multiplexed arrays in lateral flow assays. The patented Symbolics (tm) approach is one such methodology. Symboics (tm) allows for the creation of arrays in lateral flow fields that develop evenly, allowing in turn for the creation of highly complex features such as letters and symbols and also allows for creation of multiplex assays with advanced features such as internal controls. This presentation introduces the principles of multiplexed arraying and the Symbolics technology
Lateral flow assays are the most robust, mature immuno sensor available today. Performance in some applications has historically been limited by difficulties in multiplexing and quantification. Novel approaches have been developed and commercialized in recent years that allow for the development and manufacturing of highly multiplexed arrays in lateral flow assays. The patented Symbolics (tm) approach is one such methodology. Symboics (tm) allows for the creation of arrays in lateral flow fields that develop evenly, allowing in turn for the creation of highly complex features such as letters and symbols and also allows for creation of multiplex assays with advanced features such as internal controls. This presentation introduces the principles of multiplexed arraying and the Symbolics technology
The Life Science Product Manager's Toolkitprothenberg
A discussion about market research tools that can optimize each stage of the new product development process. Prepared by BioInformatics LLC exclusively for life science product and marketing managers.
PEGS Europe Protein & Antibody Engineering Summit 2014 AgendaNicole Proulx
PEGS Europe is the largest European event covering all aspects of protein and antibody engineering. With two consecutive years of 40% growth in attendance, and another year of expanded program coverage, this year’s event will feature:
•500 attendees
•150 technical presentations
•70+ scientific posters
•40+ sponsors & exhibitors
•Dedicated networking opportunities
•Exclusive exhibit & poster hours
•Interactive roundtable, breakout & panel discussions
The successful development of a biosimilar presents unique challenges compared to that of an innovator biologic. In particular, one must prove the biosimilar candidate's structural and functional differences do not have a meaningful impact on the clinical safety and efficacy profile already established for the innovator. Comprehensive and rigorous analytical testing to assess biosimilarity is thus the foundation upon which the successful development of a biosimilar begins.
This is a presentation given at Online Northwest 2010 by Kim Griggs and Hannah Gascho Rempel about how we designed our mobile library site and recommendations for how libraries can design their own mobile library site.
The Life Science Product Manager's Toolkitprothenberg
A discussion about market research tools that can optimize each stage of the new product development process. Prepared by BioInformatics LLC exclusively for life science product and marketing managers.
PEGS Europe Protein & Antibody Engineering Summit 2014 AgendaNicole Proulx
PEGS Europe is the largest European event covering all aspects of protein and antibody engineering. With two consecutive years of 40% growth in attendance, and another year of expanded program coverage, this year’s event will feature:
•500 attendees
•150 technical presentations
•70+ scientific posters
•40+ sponsors & exhibitors
•Dedicated networking opportunities
•Exclusive exhibit & poster hours
•Interactive roundtable, breakout & panel discussions
The successful development of a biosimilar presents unique challenges compared to that of an innovator biologic. In particular, one must prove the biosimilar candidate's structural and functional differences do not have a meaningful impact on the clinical safety and efficacy profile already established for the innovator. Comprehensive and rigorous analytical testing to assess biosimilarity is thus the foundation upon which the successful development of a biosimilar begins.
This is a presentation given at Online Northwest 2010 by Kim Griggs and Hannah Gascho Rempel about how we designed our mobile library site and recommendations for how libraries can design their own mobile library site.
Are you getting ready for Community Manager Appreciation Day? How will you thank your community manager? Here are a few suggestions of things to do on the day.
http://en.wikipedia.org/wiki/Community_Manager_Appreciation_Day
The 10 Commandments of Electromagnetic CompatibilityJaymie Murray
Have you ever wondered how many turns per foot should you twist all pairs of wires to minimize magnetic pickup? Or where ferrite cores and beads should be installed to minimize common mode emissions? Now all your electromagnetic compatibility questions will be answered in this handy infographic! Learn more by visiting http://eis.apitech.com/magnetics
This presentation highlights findings from my work as a visualization designer. The seven principles are distilled pieces from projects I reviewed or worked on myself. I believe it's important to learn from every project as much as you can and share this experience with the community to grow collectively.
The Exit Poll Report is released quarterly by the National Venture Capital Association (NVCA) and Thomson Reuters to provide data on venture-backed initial public offerings (IPOs) and M&A activity.
Suzanne McDonald of Designated Editor explains how Fundraising can be more effective with the utilization of social media. Suzanne explains many easy methods to use social media to maximize your return on investment (ROI) in your non-profit fundraising efforts.
TetraQ - Integrated Preclinical Drug Development Solutions Presentationguest55305
TetraQ is a leading Australian preclinical contract research organization focused on providing a broad range of integrated preclinical drug development solutions in the disciplines of ADME, Bioanalytics, Efficacy, Toxicology and Pharmaceutics. TetraQ’s Toxicology, ADME and Bioanalytics laboratories are GLP recognised and in collaboration with NATA, TetraQ’s ADME team pioneered ISO17025-2005 (R&D) research & development accreditation becoming the first laboratory in Australia to obtain this accreditation in 2005.
Each of our world-class facilities is equipped with state-of-the-art instrumentation including LC-MS/MS, HPLC & ELISA. Essentially, TetraQ is a one-stop-shop for early stage drug development and we are recognized as world leaders in bioanalytical method development & sample analysis of drugs / metabolites in biological fluids with both human and animal samples.
Blueprints to blue sky – analyzing the challenges and solutions for IHC compa...Candy Smellie
Manual assessment of biomarker expression is associated with significant inter- and intra reader variability. In some cases there are also limitations when it comes to sensitivity and specificity of manual biomarker assessment.
In one example to the left, the “pure” contribution of inter-reader variability associated with Ki67 assessment was quantified across 20 tumors and 126 participating labs. In that study, it was demonstrated how image analysis can be used to significantly reduce inter-reader variability.
In a another study, the National Danish Validation study of Her2, it was demonstrated how improved sensitivity/specificity of quantitative HER2 protein expression wrt gene amplification lead to significant cost savings in reflex testing.
By automating aspects of stain quality control, it will become scalable to he point where EQA organizations may be able and willing to offer more frequent – perhaps even on-demand – proficiency testing and calibration services.
It is possible that objective and quantitative standards will contribute to improve compliance with protocol recommendations.
In clinical multi-center trials it will be easier to standardize and monitor data from each center.
And it is our hope tha larger diagnostic pathology labs will be able to benefit from such a method by closely monitoring drift in staining quality for biomarkers.
Well-trained clinical research professionals are in high demand. The tremendous increase in medical technology and information in the last decade has resulted in an explosion of potential new drugs, devices and biologics that must be tested before being released for use by the public. The profession is constantly challenged to improve and streamline the clinical research programs in order to shorten the development timelines and control the cost for new product development
Medical Imaging Seminar Company PresentationsSpace IDEAS Hub
Medical Imaging - Opportunities for Business Seminar
24/01/12
Short Company Presentations
14 companies took the opportunity to present a short sales pitch of their work and interests to the audience.
The F-word. Jens Oreel, a 21 year old entrepreneur, brought his personal story of the founding and failing Cup O', now working on the commercialisation of insect farming.
Hive, a modular window farming system. Yannis De Cleene brought the story of six study mates, designing and bringing to market a kitchen garden as part of their entrepreneurship studies, winning several national and international prizes.
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