International Workshop on Vaccine and Drug Ontology Studies

Drugs and vaccines have contributed to dramatic improvements in public health worldwide. Over the last decade, there have been efforts in the biomedical ontology community that represents various areas associated with drugs including vaccines that extend existing health and clinical terminology systems (e.g., SNOMED, RxNorm, NDF- RT, and MedDRA), vernacular medical terminologies, and their applications to research and clinical data. This workshop will provide a platform for discussing innovative solutions as well as the challenges in the development and application of biomedical ontologies to representing and analyzing drugs and vaccines, their administration, immune responses induced, adverse events, and similar topics. The workshop will cover two main areas: (i) ontology representation of drugs (including vaccines), and (ii) applications of the ontologies in real-world situations – administration, adverse events, etc. Examples of biomedical subject matter in the scope of this workshop: drug components (e.g., drug active ingredients, vaccine antigens, and adjuvants), administration details (e.g., dosage, administration route, and frequency), gene immune responses and pathways, drug-drug or drug-food interactions, and adverse events. Both research and clinical subjects will be covered. We will also focus on computational methods used to study these, for example, literature mining of vaccine/drug-gene interaction networks, a meta-analysis of host immune responses, and time event analysis of the pharmacological effects.

Drugs and vaccines have been critical to prevent and treat human and animal diseases. Work in both (drugs and vaccines) areas is closely related - from preclinical research and development to manufacturing, clinical trials, government approval and regulation, and post-licensure usage surveillance and monitoring. In a broader scope, a vaccine is a special type of drug. However, there are many differences between the two - for example, in the case of vaccines, dose, time, route, and frequency of administration are generally known quite precisely. But this is not always the case in drugs. Since vaccines are often administered to healthy people to prevent disease, the attribution of an adverse event following vaccination is less likely to be confounded by signs or symptoms of the underlying disease. However, the separation of the manifestation of disease from the manifestation of the drug effect is often very challenging. In the U.S.A, vaccines are regulated under different laws by the Center for Biologics (CBER) at FDA, while drugs are regulated under the Food Drug and Cosmetic Act by the Center for Drugs (CDER) at FDA. Safety surveillance for vaccines is, for the most part, carried out by the Center for Disease Control (CDC) in Atlanta, while for drugs it is carried out by the FDA. Due to these similarities and differences between vaccines and chemical drugs, closer communication between these two areas is important to create effective ontological frameworks around which we can build comparative and predictive systems for both vaccines and drugs.

Although several related ontologies have been initiated with much progress made in recent years, we still face many challenges in order to fully and logically represent drugs and vaccines, and efficiently use the ontologies. In the case of ontology representation, no consensuses have been achieved on how to ontologically represent many relevant areas, for example (i) administration dose, route, and frequency, (ii) how to accurately represent adverse events, (iii) drug-drug interactions, drug-food interactions, etc (iv) experimental testing and analysis of vaccine/drug-induced immune responses, and (v) the complexity of time constraints for clinical events post-vaccination or medication. Meanwhile, it is also a challenge to efficiently apply biomedical ontologies to solve research and clinical problems. For example, is there any advantage in applying ontologies for advanced literature mining in order to discover gene interaction networks underlying protective immunity or adverse events? How to apply ontologies for personalized medicine? How to use ontologies to improve the performance of complex vaccine/drug research and clinical data analysis? This workshop aims to bring together a diverse group of individuals from clinical, research, and pharma-biotech areas to identify, propose, and discuss solutions for important research problems in the ontological representation of vaccine and drug information covering development and preparation, administration, mechanisms of action including induced host immune responses, adverse events, etc. This workshop is expected to support a deeper understanding of vaccine and drug mechanisms and effects. More specific topics will be selected based on attendees’ submissions and interests.

We encourage submissions related to the COVID-19 pandemic. Drugs and vaccines are critical to fighting against COVID-19. We welcome papers in the domain of drugs and vaccines against COVID-19.