Ts121 Biomarker Solutions Clinical Trials


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Ts121 Biomarker Solutions Clinical Trials

  1. 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. 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