Epidemiology is an essential component in developing pharmaceutical and biologic products and is used throughout the entire product lifecycle, from indentifying new target indications to post-licensure studies. Epidemiologic investigation using both primary and secondary data sources are used in early phase development to:
Indentify new target disease, or identify unmet medical needs
- Describe the natural history of target disease
- Characterize the burden of disease
- Define and measure specific population parameters for the target product profile
- Identify and measure co-morbid conditions in target population
- Provide geographic and/or location-specific incidence and prevalence data to direct clinical trial site selection
- Develop and establish an overall epidemiologic strategy to meet cross-function needs throughout product lifecycle
In later phase development conducting, analyzing and reporting of “real-world” observational studies and registries in support of clinical development, safety surveillance programs, and post-licensure commitments is done to:
- Elucidate patient and lifestyle factors associated with “real-world” use of a drug or vaccine
- Characterize target indications and existing patterns of care and outcome
- Establish background rates of potential adverse events
- Monitor adverse events phase 1 through phase 4
- Provide data to measure drug or vaccine effectiveness
Exponent’s Health Sciences professionals bring the skills and experience required to assist you in drug and vaccine development throughout the product lifecycle. Exponent’s epidemiologists have designed, implemented, and managed epidemiological studies elucidating the natural history, pathogenesis, risk factors, and clinical course of disease in support of drug and vaccine development, commercialization, and safety.
Our epidemiologists have conducted in-depth analysis of the burden of disease, ‘real world’ disease treatment pattern studies, and co-morbidity assessments. In addition, our epidemiologists have examined potential short and long-term outcomes including cause-specific mortality, cancer, connective tissue diseases, as well as symptoms associated with a number of implantable devices (e.g., breast implants, knee and hip implants, heart valves, temporomandibular jaw implants). Further, Exponent epidemiologists have extensive experience in developing and executing safety surveillance programs and can assist pharmaceutical and biotechnology companies in meeting the growing demands required for both US and worldwide product approvals.
Exponent’s Epidemiology and Safety Surveillance Services
- Develop comprehensive epidemiologic research strategy for drugs, vaccines, and biologics under development
- Provide relevant epidemiologic parameters for target product profile for drugs, vaccines and biologics
- Direct clinical trial site selection using relevant geographic and location- specific epidemiologic data
- Develop Safety Surveillance programs designed to meet regulatory requirements throughout product development
- Develop epidemiology section for risk management plans
- Design and conduct health outcomes research
- Design and conduct phase IV and post-licensure commitment studies
- Perform data mining using claims and administrative databases
- Create and maintain disease registries
- Create and maintain pregnancy registries
- Develop Risk Evaluation Mitigation Strategy (REMS) and conduct on-going analysis.