Dear all,
We are very excited to share that we have a great webinar coming up on October 29th at 12:30 to 2:00 pm EST. Ed Dere (Sr. Principal Scientist at Genentech) is a speaker, and he will address Nonclinical Considerations for Developing Intraocular Therapeutics
Registration link
OCT 29 - Nonclinical Safety Assessment Considerations for Intravitreally Administered Therapeutics (aaps.org)
Intravitreal drug administration is a relatively unique ROA that requires special considerations with respect to drug delivery and nonclinical safety assessment. This webinar aims to highlight some of these key considerations that impact the nonclinical safety strategy to satisfy regulatory expectations for developing intraocular therapeutics. The discussion will largely focus on development of biologic therapies but will highlight some of the key differences with that of a small molecule drug, and how these differences impact the nonclinical safety strategy. Species selection for toxicity testing is a critical component of the nonclinical strategy and needs to be sufficiently justified to Health Authorities. Factors such as physical structure of the eye in relevant nonclinical species in relation to the human eye, and relative potency and/or binding affinity to the target across species are all considerations in selecting the appropriate species for toxicity testing. Additionally, this webinar will also review the design of ocular toxicity studies with specialized endpoints to assess ocular toxicities, and strategies to support systemic toxicity assessment. A case study with FHTR2163, an antigen-binding fragment (Fab) against the serine protease HTRA1, will be used to draw on how all these principles were applied its completed nonclinical safety package.
Dr. Dere is a Senior Principal Scientist in the Safety Assessment Department at Genentech and serves as project toxicologist. He supports programs through early discovery through late-stage clinical development, and across different therapeutic areas and modalities. In addition to his project support at Genentech, Ed also co-leads the Developmental and Reproductive Toxicology (DART) working group. Ed earned his PhD in Biochemistry and Molecular Biology from Michigan State University and was a postdoctoral associate at Brown University prior to joining Genentech. He has authored 30 peer-reviewed journal articles and has been an active member of the Society of Toxicology (SOT) since 2006 where he has held multiple leadership positions in the Biotechnology, and Reproductive and Developmental Specialty Sections.
Please let me know if you have any questions and looking forward to great webinar. Please share this opportunity to other group members.
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Harsh Patel Ph.D.
Senior Scientist, Medical and Pharma
Celanese Industries
Cincinnati Metropolitan Area
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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