Creating Consensus Science
Working in the pre-competitive research space, C-Path orchestrates the sharing of data, expertise, and knowledge among industry, government, patient advocacy groups, and academia directed toward answering specific research questions.
C-Path then engages the active participation of regulatory authorities (FDA, EMA, and others) with the goal of creating regulatory pathways to incorporate new science. This, in turn, creates efficiencies and reduces the time and effort needed to bring safe, effective medical products to market.
C-Path has established a network of nearly 1,000 scientists from 41 bioscience and pharmaceutical companies as well as regulatory agencies, disease-specific patient organizations, and research universities which participate in seven global consortia that focus on a variety of health challenges.
Consensus science is the path that will lead to global answers.
C-Path improves efficiency of the development of drugs and other medical products by identifying pathways to convey new scientific advances through existing regulatory processes (aka regulatory science).
As a trusted and neutral third party, C-Path works closely with the FDA, EMA, and other regulatory agencies to define the pathway to reach an appropriate level of regulatory input specific to the new science. When formal regulatory decisions are necessary (i.e., qualification or fitness-for-purpose determinations), C-Path gathers the necessary evidence which requires developing data, measurement and methods standards, aggregating data, as well as preparing regulatory documentation of the evidence.
Improving Global Health
The failure rate of testing new drug therapies is an astounding (and unacceptable) 95%. Making this situation even worse is that many of the failures occur during late-phase testing – after the bulk of research dollars have already been committed to the project.
Developing just ONE safe and effective medical product can take more than 12 years and $1 billion in research and testing.
These figures do not reflect the patient-related costs of living with an illness and/or tolerating less than ideal treatments, nor the indirect costs which can include loss of productivity (affecting the workplace and even the community), a new reliance on family members or caregivers for assistance, and the possible emergence of associated health issues.
C-Path aims to change this through improvements in efficiency of the medical product development process worldwide. C-Path’s work will improve health and save lives.