Events

An Overview of the Safety Evaluation of Veterinary Pharmaceuticals

Hosted by: The Regulatory and Safety Evaluation (RSESS) and Comparative Toxicology, Pathology, and Veterinary Toxicology (CTPVSS) Specialty Sections

Drug Regulatory Authorities, which are members of ICH and have mutually confidential agreements, have independently reviewed the submitted documents and evaluated the degree of concordance with Sponsors. Data are collected solely for real world experience. Submitted CADs were finely compared to the real outcome of the two-yr carcinogenicity studies. The main objective has been the assessment of accuracy of the predictions. Eventually 48 CADs have been collected, with 24 agreed cases with the outcome of “no added value.” The presentation will discuss the strengths and weaknesses of the CADs, and the reasons why the DRA’s decided to deviate from the initial categorization by the sponsor. The Expert Working Group has developed a document as an addendum to ICH-Guideline S1B, which is now finalized.

Speaker(s):
Samuel Fletcher, Head of the Human and Environmental Safety Team at Veterinary Medicines Directorate (VMD), UK

Materials:

Webinar Recording and Materials

ASIO and CTPVSS Joint Webinar-Animal Models of COVID-19 Prevention and Treatment

Rapid development of vaccines that are protective against Covid-19 infection have been at the forefront of this war against the Sars CoV2 virus. Behind the scenes, there have been a several years of efforts in developing new modalities such as mRNA vaccines that can enable such scientific breakthroughs. In addition, advances and refinement in efficacy and safety testing animal models have been successful in building strong confidence in these vaccines’ technologies. Vaccine development for COVID-19 involves research work with multiple species to model the varied disease outcomes in humans. With each species reacting differently to the virus, we need to learn how best to exploit both differences and similarities to human responses in studies that reveal the nature of this disease and how best to control it.

Materials:

Webinar Recording

Webinar Flyer

CTSS and CTPVSS Webinar—Advanced Tissue Imaging and AI Data Analysis: The Opportunities and Challenge for Application in Supporting Drug Discovery

Speaker(s):
Richard Goodwin, PhD, Head of Imaging & AI Imaging & Data Analytics, Clinical Pharmacology & Safety Sciences, AstraZeneca R&D

Matthew Jacobsen, PhD, DipACVP, Director of Pathology Regulatory Safety Centre of Excellence, Clinical Pharmacology & Safety Sciences, AstraZeneca R&D

Novel and integrated molecular imaging technologies are offering a new view on the molecular and cellular landscape across the tissue microenvironment. They are able to map in unprecedented detail the impact of new therapies and so provide new ways to study disease, the patient population and the efficacy and safety of drugs. This is empowering its scientists to see the complexity of a disease in unprecedented detail to enable effective development and selection of new medicines. Today cutting-edge imaging technologies are increasingly used to support studies in to the efficacy and safety of drugs through the R&D pipeline. This presentation will introduce the range of novel in vivo and ex vivo imaging technologies employed, describe the data challenges associated with scaling up the use of molecular imaging technologies and address the new data integration and mining challenges. Novel computational methods are required for large cohort imaging studies that involve tissue based multi-omics analysis that integrate spatial relationships in unprecedented detail.

In parallel to the development and deployment of novel molecular imaging technologies, a revolution in toxicological digital pathology is also occurring. We are moving to a digital future where our pathologists are assessing and reviewing safety studies digitally. This requires a significant change and acceptance by regulators. During this presentation we will also hear how we are transforming toxicologic pathology peer review with the first GLP validation of the digital pathology and how this is a critical step and delivering a digital future for drug discovery and development.

Materials:

Webinar Recording

Richard Goodwin Presentation

Matthew JacobsenPresentation

Intro slides Richard Matt Presentation