Breadth of Expertise
“For more than 15 years, C-Path has made an impact through its core competencies in data management and standards, advanced quantitative analytics, biomarkers, clinical outcome assessment tools and regulatory science. It’s exciting to see C-Path advancing and growing the pipeline of collaborative pre-competitive efforts in drug development. Now, in the era of knowledge management, decision science and personalized medicine, we are presented with the best opportunity for C-Path to grow its impact in supporting the transformation of smart data into actionable cutting-edge knowledge to de-risk and expedite medical product development.”
– C-Path Chief Science Officer and Executive Director, Clinical Pharmacology, Klaus Romero, M.D., M.S., F.C.P.
C-Path Staff Have a Wide Range of Scientific and Technical Expertise
C-Path’s staff possess a wide range of scientific, medical, regulatory, technical and business expertise, and have extensive experience in the academic, government, pharmaceutical, medical device and information technology sectors. Scientific strengths include chemistry, drug development, medical device development, genetics, microbiology, neuroscience, clinical pharmacology, pharmacometrics, quantitative medicine, data science, pediatrics, regulatory science and toxicology. Data systems and information technology experts have developed C-Path’s data pipeline and continually monitor and expand the data management system.
C-Path Initiatives Driven by Expert Project Managers
The management of highly collaborative projects with participation of more than 1,800 scientists from dozens of medical products companies, numerous academic institutions, regulatory agencies and patient organizations from around the globe can be extraordinarily complex and highly technical. Consequently, professional project managers adopt an engineering mindset to drive each C-Path effort — in close consultation with the scientific staff — through the tracking of milestones and deliverables. C-Path project managers typically have either a Master of Business Administration degree and/or Professional Project Management Certification, with extensive project management experience in industry.
C-Path Leverages Deep Regulatory Experience
C-Path leads collaborative teams to advance regulatory science needs in many specific disease areas as well as across multiple methodologies that are disease agnostic. The regulatory and scientific leaders at C-Path have decades of experience working with regulatory agencies. C-Path assisted the FDA in developing the initial process for qualifying drug development tools (DDTs). C-Path operates under regulatory best practice guidelines for the generation of actionable medical product development solutions.
C-Path Works Effectively with Regulatory Agencies
Staff at C-Path have developed and maintain highly collaborative interactions with scientists at FDA, EMA, PMDA, Health Canada and other agencies. Through Center for Drug Evaluation and Research‘s (CDER) scientific liaison process, a liaison is assigned to each established C-Path collaboration. The regulatory liaison plays a key role in helping to advise and guide each effort to generate actionable medical product development solutions. C-Path staff maintain close interactions with their regulatory contacts.
C-Path Works Effectively with Other Public-Private Partnerships
Prior to embarking on a project, C-Path carries out a feasibility analysis to assess the current landscape and identify unmet medical product development needs. An essential part of this analysis is to identify other collaborative efforts in the same disease areas to avoid duplication and establish links to leverage any ongoing initiatives.
C-Path Builds Scientific Consensus
C-Path builds scientific consensus among its members from academia, government, patient organizations and industry to develop new tools to support medical product development. C-Path’s neutral presence has changed the dynamic by facilitating and fostering a productive exchange of ideas among regulators, the regulated industry, and other stakeholders.
C-Path’s Proven Record of Successful Execution
Based on needs identified by its stakeholders, C-Path currently has numerous nonclinical biomarkers, clinical biomarkers, clinical outcome assessment instruments, disease progression models and in vitro tools which have already been endorsed or are in various stages of development with regulatory authorities including FDA, EMA and PMDA. These development efforts are being driven with a focus and a sense of urgency to enable DDTs that reflect the latest science and have a positive impact on the drug development process.