SETAC Sacramento Pharmaceutical-related sessions
There are two sessions at the upcoming SETAC meeting in Sacramento that might be of interest to PhIG members:
“Environmental Assessments for Human and Veterinary Pharmaceuticals- Evolving Regulations” Thursday (November 8), with the platform portion in the afternoon.
“Exposure assessment and modeling for ecological risk assessment of veterinary pharmaceuticals and pesticides”
Monday (November 5), with the platform portion in the afternoon.
See below for a more detailed description of the sessions:
Environmental Assessments for Human and Veterinary Pharmaceuticals- Evolving Regulations
Session chairs: Donna Davila, Jane Staveley, and Holly Zahner
An assessment of the potential environmental impact of pharmaceuticals is required as part of the approval or authorization process for new drug applications in the US, Europe, and other countries. For example in the US, under the National Environmental Policy Act, the US Food and Drug Administration (FDA) requires the preparation of an environmental assessment for certain regulated products, including human and animal pharmaceuticals, prior to approval. The continued application of new technologies to drug development, such as antibody-drug conjugates, targeted delivery of highly toxic warheads, viral vectored vaccines, endocrine active compounds, etc., prompt uncertainty in terms of requirements for environmental assessments. The FDA has recently published Guidance for Industry to address some of this uncertainty, such as the 2016 FDA Guidance on drugs with estrogenic, androgenic, or thyroid activity and the 2015 FDA guidance on gene therapies/vectored vaccines, and similar guidances are anticipated from the European Medicines Agency (EMA) or other countries. However, uncertainty still exists when developing environmental programs for some types of drugs, and when harmonizing between different centers at FDA, (such as the Center for Drug Evaluation and Research, the Center for Veterinary Medicine, and the Center for Biologics Evaluation and Research), as well as with Europe, Canada, Japan, or other countries. During this session, the approaches recommended in guidance for preparing environmental assessments for drugs will be discussed by regulators and industry. This session invites presentations that describe environmental programs for pharmaceuticals that have been designed with new guidances or agency (FDA, EMA, Canada, or other countries) recommendations in mind, along with discussions of challenges encountered along the way. Presentations on the practical application of some of the tests supporting newer regulations, such as those for endocrine disrupting compounds, and overcoming technical challenges associated with those tests are welcome.
This session is co-sponsored by the Endocrine Disrupter Testing and Risk Assessment Interest Group and the Pharmaceuticals Interest Group
Exposure assessment and modeling for ecological risk assessment of veterinary pharmaceuticals and pesticides
Session chairs: Andrew Miglino, Wesley Hunter, Jane Staveley, and W. Martin Williams
Veterinary pharmaceuticals and pesticides have similar environmental routes of exposure and may enter the soil, water, or sediment environment with little or no prior treatment. In addition, both often possess potent biological activities; therefore, low environmental concentrations may be of concern. Thus, the exposure assessment for ecological risk assessments of veterinary pharmaceuticals and pesticides share many similarities.
Environmental risk assessments of veterinary pharmaceuticals and pesticides are often complex and may require generation of new exposure data. This is especially true when moving past screening level assessments to more realistic, higher-tier, assessments, including mixture and cumulative exposure assessments. Historically, veterinary pharmaceutical and pesticide regulatory needs have fostered the development of many new approaches to environmental exposure modeling. The purpose of this session is to highlight approaches used in exposure assessment and call for increased collaboration between research and regulatory groups by discussing new approaches to old problems with a specific focus on veterinary pharmaceuticals and pesticides in the environment.
Interested parties are encouraged to present research and findings relevant to the environmental exposure and risk assessment of veterinary pharmaceuticals and pesticides. This may include monitoring data, environmental fate data (e.g., degradation, transport), integration of computer modeling software for predicting environmental exposure, statistical models for environmental distributions, watershed/national scale fate modeling, and the use of higher-tier exposure data to support environmental risk assessments. It may also include use of Quantitative Structure Activity Relationship (QSAR) and/or Linear Free-Energy Relationship (LFER) models to derive environmental fate properties.
This session is co-sponsored by the Exposure Modeling Interest Group and the Pharmaceuticals Interest Group