1. biomarker solutions 1.2.1
the Failure in the pharma industry has a lot to answer for: an astonishing 75% of drug research and
development budgets is whittled away on unsuccessful candidates and drug failures, the
safety-efficacy majority of which are due to lack of clinical efficacy and safety. With the cost to bring a new drug
to market now approaching a vertiginous $900 million, that’s a lot of money to whittle away.
challenge What is more, despite the billions spent on toxicity and seemingly exhaustive testing, post-launch
withdrawal of compounds due to adverse side-effects still occurs. The need to address
safety-efficacy issues has never been greater and the future sustainability of pharmaceutical
therapeutics will depend on the ability of pharma companies to take up the challenge.
the high price of failure*
• 10% of drugs entering Phase I trials reach market registration
• 62% of compounds entering Phase II trials fail
• 45% of compounds entering Phase III trials fail
• 30% of attrition due to lack of efficacy & failure to deliver clinical benefits
• 30% of attrition due to toxicology issues & clinical safety failures
the challenge of change
• more complex diseases with high unmet medical needs
• novel mechanisms of action more likely to lead to failure
• unprecedented targets more likely to lead to failure
• increasingly agressive regulatory requirements
• growing demand to demonstrate clinical efficacy (better, earlier...)
• translational medicine & personalised medicine approaches
• dwindling resources, increasing complexity & escalating risk
• changing business model & shifting paradigms
biomarker biomarkers: the key to drug success
Rising to today’s industry challenges calls for disruptive thinking and a new mindset. It demands
solutions for new approaches and new solutions. A CRO and biomarker solutions provider, Biovays offers you
specialist knowledge, innovative approaches and cost-cutting solutions for your drug research
drug success and development projects. We propose biomarker services « à la carte » and design solutions to
best answer your needs.
‘‘Several different approaches are being pursued across the pharmaceutical industry to reduce the
high attrition rates. One of these approaches is to identify biomarkers that are predictive of safety and
efficacy and can be used in early clinical trials to build confidence that the molecule is engaging the
intended target and is therefore worth investing more resources on.’’ **
• improving discovery & preclinical research better-prepared clinical trials
• improving early clinical development better chance of clinical success
• improving drug portfolio management producing better, faster, cheaper
biomarkers: the key to proof-of-concept clinical trials
The specificity and predictive value of immunohistologically-defined protein biomarkers lie
at the heart of Biovays service offering. The virtues of biomarkers as early indicators of drug
function and response constitute the extra value added of our biomarker services whereby
proof-of-concept may be determined early, rapidly and at relative low cost. Biomarkers
determining pharmacodynamic, efficacy and safety parameters offer the pharma industry
innovative and pragmatic solutions for the design of successful proof-of-concept clinical trials.
* Kola & Landis, Nature Review Drug Discovery 2004; World Pharmaceutical Frontiers Sept 2009
** Magnus Ivarsson, Head of Physiological Biomarkers, Experimental Biological Sciences, Pfizer
European Pharmaceutical Review Sept 2009
tel: +33 491 10 60 87 • email: info@biovays.com • biovays.com

2. biomarker solutions > 1.2.1
specimens
biopsies
tissues
biological fluids
blood
testing
Biovays biomarker detection & visualisation
biomarker localisation & quantification
services for cell & tissue imaging
cell identification & discrimination
clinical trials: cell morphology & morphometry
cell surface expression of receptors
signalling pathways & drug delivery pathways
your research, our solutions transcription factor activation
Drug company executives are applications
seeking new and timely solutions clinical data
to produce cheaper, better and drug efficacy
faster. As reliable and effective drug mode of action
indicators of success, biomarkers pharmacodynamics
are offering the pharma industry
safety & tolerability
some of the answers.
toxicology
Because immunohistologically-
defined protein imaging biomarkers clinical trials
are specific - target/mechanism/ stratification of patients
disease/outcome - they enable more biomarker selection
discriminating tests of function and clinical entry selection
toxicity during the early stages of the identification of potential responders
development process. Candidate
identification of non-responders
selection is optimised to preempt
patient monitoring
failures and focus research on the
most promising therapeutic solutions. drug response prediction
The benefits are threefold: improved optimal dose selection
cost-effectiveness, improved pipeline
quality and decreased cycle times - diagnostics
cheaper, better, faster. target identification & validation in vitro
(cells in cuture)
target identification & validation ex vivo
(human tissues: healthy vs. diseased tissues)
validation of animal models
diagnostic kit set-up (ELISA)
tools & techniques
histology & histomics
immunohistochemistry (fluorescence-based IHC)
confocal laser scanning microscopy
videomicroscopy
flow cytometry
ELISA
immunoblot
tel: +33 491 10 60 87 • email: info@biovays.com • biovays.com