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, and information technology sectors. Scientific areas of expertise include chemistry, drug development, genetics, microbiology, neuroscience, pharmacology, pharmacometrics and toxicology. Data systems and information technology experts have constructed C-Path’s databases and continually monitor and expand the data management system. C-Path’s staff also works closely with the Clinical Data Interchange Standards Consortium (CDISC) to implement CDISC standards and assist in the development of new therapeutic area user guides (TAUGs).
C-Path Drives Projects through Expert Project Managers
The management of highly collaborative projects with participation of more than 1,500 scientists from 74 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 consortium—in close consultation with the consortium scientific directors—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 experts at C-Path, including our consortia Executive Directors, have decades of experience working with regulatory agencies. C-Path assisted the FDA to develop the initial process for qualifying drug development tools. C-Path has also formed an internal team with regulatory and scientific expertise (the “Submission Readiness Review Team”) to review each regulatory submission, participate in meetings with regulatory authorities, develop internal best practices for each step in the qualification process and train new staff members. This team has produced several internal best practice guidelines for C-Path to use when planning and executing a Drug Development Tool (DDT) or novel methodology qualification project–such as how to describe the context of use and how to put together a qualification submission package. The team has also held several training seminars for C-Path staff and has led discussions with C-Path consortia leadership to share their expertise and lessons learned from individual qualification efforts. This allows C-Path to leverage its experience and infrastructure across multiple platforms in a consistent and integrated fashion.
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 CDER’s scientific liaison process, a liaison is assigned to each consortium that C-Path establishes. The regulatory liaison plays a key role in helping to advise the development programs for each biomarker, outcome assessment instrument, in vitro tool, or other project. C-Path scientific consortium directors maintain close interactions with their regulatory contacts. Other agencies support a less formal advisor role to C-Path consortia as deemed appropriate.
Additionally, in the global health arena, C-Path engages with regulators in low- and lower-middle-income countries (LMIC). The Critical Path to TB Drug Regimens (CPTR) program has engaged with regulators from Brazil, China, Kenya, South Africa, Tanzania, Thailand, Uganda, and several Eastern European regulatory agencies. The World Health Organization (WHO) is a key partner in this program.
C-Path Works Effectively with Other Public-Private Partnerships
Prior to embarking on a project, each C-Path consortium carries out a feasibility analysis to assess the current landscape and identify unmet drug development needs. An essential part of this analysis is to identify other collaborative efforts in the same disease areas to avoid duplication, and, wherever possible, establish links to leverage any ongoing initiatives. C-Path is currently collaborating with a variety of organizations, including the Foundation for the National Institutes of Health (FNIH) on clinical renal safety biomarkers, the Innovative Medicines Initiative (IMI) on a range of safety biomarkers, the Alzheimer’s Association on the Global Alzheimer’s Association Interactive Network (GAAIN), the CEO Initiative (CEOi), New York Academy of Science (NYAS), and others.
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 has actively collaborated with FDA’s Center for Drug Evaluation and Research (CDER) to pioneer and continually enhance the process for DDT qualification.
C-Path’s Proven Record of Successful Execution
Based on needs identified by consortia members, 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/or 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.