In addition to establishing drug safety and efficacy under existing regulations, sponsors are increasingly required to develop comprehensive risk management programs, including risk assessment and minimization, also known as Risk Evaluation Mitigation Strategies (REMS). How pharmaceutical risk management is implemented can have considerable ramifications for labeling, regulatory decisions, legal protection, intellectual property, enforcement, marketing, and company reputation.
Pinney Associates teams have the knowledge and resources to help you find the most appropriate path to the market place by assessing the scientific and policy environment, and evaluate individual compounds and formulations within this context. We assess risks including drug-induced adverse events, those resulting from accidental use, misuse, abuse, and diversion, as well as potential regulatory hurdles, and down the road – litigation risks. We work with you to develop comprehensive risk management that will be reassuring to regulators, facilitate your commercial goals, and protect the franchise long into the future.
Our experts are recognized leaders in pharmaceutical risk management, and have participated in dialogue and collaborated with the Food and Drug Administration, Drug Enforcement Administration, National Institute on Drug Abuse, Substance Abuse and Mental Health Services Administration, Congress, the Food and Drug Law Institute, and the College on Problems of Drug Dependence.
Specific services Pinney Associates can provide in the risk management arena include:
- Identify, evaluate, collect, and analyze datasets with information relevant to treatment with and appropriate marketing of psychoactive drugs
- Interpret preclinical and clinical studies within the context of pharmacologically or structurally related drugs
- Assist in the design, coordination, analysis, and interpretation of abuse liability, pharmacokinetic, and other clinical trials, which can each impact the overall assessment of abuse liability
- Identify and assess the relative abuse risks among specific populations, e.g., youth, recreational drug abusers, drug dependent individuals
- Identify and assess circumstances where misuse and/or off-label use of the drug might occur and assess the likelihood and impact of such use
- Assist with identification of risk management tools
- Assist with preparation of risk management plans and REMS for submission to regulatory bodies
- Develop a comprehensive risk-benefit analysis
- Assist in the development and preparation of the integrated summary of benefits and risks for regulatory submissions
- Evaluate scientific and public health assessments to enhance regulatory submissions
- Write abuse liability assessments for regulatory submissions
- Develop manuscripts for peer-review publication
- Organize and facilitate abuse liability meetings, including the identification and contact of experts in the field
- Assist in the organization and staffing of postmarketing workgroups that would continue to monitor and assess postmarketing surveillance data to evaluate the efficacy of the REMS
