The Center for Drug Safety and Effectiveness Consulting Service is a group of clinical and scientific experts at Johns Hopkins University who provide consultative services regarding prescription drug safety, effectiveness and utilization to the life sciences industry. The Service is structured around the core faculty of the Center for Drug Safety and Effectiveness who reflect the remarkable breadth and depth of expertise with Johns Hopkins Medicine and the Bloomberg School of Public Health.
The Center’s consulting services are oriented around the needs of its clients - including pharmaceutical manufacturers, biotechnology companies, and insurers – and are broadly organized into four areas: pharmacoepidemiology and outcomes research; regulatory affairs and risk/benefit appraisal; study design and analytics; and pharmacoeconomics. These services are used by clients for a number of purposes, ranging from the fulfillment of regulatory requirements to guiding strategic decision-making regarding research and development to extracting greater value from health care expenditures. The Center also has additional expertise and capabilities, including partnerships with clinicians from Johns Hopkins Medicine, as well as the ability to provide extensive training of scientists at all stages of career and professional development and at varying levels of intensity. We are equipped to provide a variety of levels of service depending upon specific clients’ needs, ranging from expert consultation regarding specific aspects of a study design to the design, implementation and analysis of complex Phase IV observational studies.
Pharmacoepidemiology and Outcomes Research
Comparative effectiveness research with observational data; advanced methods for quantifying uptake and determinants of drug utilization; pharmacovigilance and safety assessments
Regulatory Affairs and Risk/Benefit Appraisal
Advanced methods for assessing and balancing benefit and risk; evidence synthesis including bayesian, meta-analytic, network meta-analytic and systematic review techniques; assessment of patient and clinician preferences; expertise in global marketplace and international pharmaceutical policy
Study Design and Analytics
Design of sophisticated comparative effectiveness, pharmacovigilence and drug utilization research
Cost-benefit analysis; cost-effectiveness analysis
Sophisticated services available through partnership with the Johns Hopkins Biostatistical Center, reflecting advanced expertise in causal inference, management of missing data, and other areas of statistical analyses
Deep content knowledge based on scientists with active clinical practice in a variety of areas, including hematology-oncology, immunology, endocrinology, psychiatry, infectious disease and general medicine
Coursework for degree and non-degree candidates; conference and workshop development; certificate program in pharmacoepidemiology and drug safety; seminar series; onsite symposia and mini-courses
We encourage interested parties to set up an informational session with one of our Center directors, G. Caleb Alexander, MD, MS (email@example.com) or Jodi Segal, MD, MPH (firstname.lastname@example.org). These sessions can take place in-person or by phone and will explore the clients’ needs and our resources to meet those needs. From there, a contract will be prepared for the clients’ review describing the services, deliverables, timeline and payment structure.