Late selection of a successful compound causes inefficient compounds also to be further developed into expensive Phase II and III trials. This inadequate drug development process has increased the cost of producing one new innovative drug to $1.8 billion. TRACER’s optical molecular imaging expertise allows for early go/no-go decisions on compounds before pricy trials. In other words, only effective compounds will be further developed.
The current drug development landscape.
The current drug development process is of significant longevity and costly. In general, the costs of developing one successful therapeutic compound has risen to a staggering number of $1.8 billion. These costs are mainly associated with the clinical phase II and III, as described a decade ago by Paul et al (Nature Reviews Drug Discovery 2010). Moreover, these costs are a result from the fact that 8-9 New Molecular Entities (NMEs) are needed in order to deliver one approved NME. Unsurprisingly, 80-90% of all NMEs mainly fail in phase II and III. These are the most complex and costly phases in the clinical drug development pathway. As a result, a significant gap in cost-effectiveness and return of investment in drug development exists.
Meeting the needs of drug development.
As appears, there is an unmet need for the search and application of an innovative disruptive technology in the early clinical phases of drug development, also called the ‘sweet spot’ of R&D, to enforce earlier go/no-go decision-making of a therapeutic compound based on its on- and off-target profile towards the next phases of evaluation and thus creating the needed paradigm shift in drug development.
TRACER provides the disruptive technology needed through the solution of applying molecular imaging technologies in early small smart clinical studies. We do this in several disease areas such as oncology, inflammatory, infectious and cardiovascular diseases. Our unique first in-human methodology creates value by using the micro-dosing concept in fluorescent and nuclear labelling of your compound. In other words, we change the drug development landscape by providing visible certainty of your compounds.
What we offer.
TRACER fluorescently labels your therapeutic compound for an accelerated drug development and strategic decision-making. We offer the full package for GLP and GMP fluorescent labelling using mainly near-infrared fluorophores, among the complete spectrum. At TRACER, we have world-renowned pharmacists, tumor-immunologists, biochemists, clinicians and pathologists available for the development and optimization of innovative fluorescent and/or theranostic agents. These vary from antibody-based, nanobody-based, peptide-based, micelles and nanoparticle-based compounds. The team can provide necessary building blocks for evaluating first in-human in vivo and ex vivo tissue distribution for its on- and off-target effects.
Our goal is to improve personalized care of patients in the field of oncology, inflammation, infectious and cardiovascular diseases. We do this by accelerating and reducing costs in the drug development process through applying fluorescent and nuclear labelling. This results in our unique analytical platform cross-correlating the in vivo distribution of your fluorescent drug from macroscopic to ex vivo microscopic imaging in humans (Koller et al Nature Communications, 2018). TRACER strictly adheres to transparency, scientific credibility, reproducibility, standardization, reliability and accountability for the better of our patients and customers.