[隨選視訊]鑑別和降低免疫原性和免疫毒性的潛在性如何能降低風險並加速藥物開發?

[隨選視訊]鑑別和降低免疫原性和免疫毒性的潛在性如何能降低風險並加速藥物開發?

本次網絡研討會我們探討了將候選藥物首次用於人體臨床試驗(FIH)研究,評估免疫安全性所遇到的挑戰。會議專家分享了在此過程中的關鍵因素和需避免的陷阱。案例研究則強調體外免疫毒性評估如何通過早期預測風險以增加顯著性。

活動介紹

The Good, The Bad, And The Ugly:How Does Identifying And Mitigating Potential For Immunogenicity And Immunotoxicity De-Risk And Accelerate Your Drug Development?

【如何報名】

本次研討會為預錄的「隨選視訊」(登記資訊後,即提供線上連結、隨時可點閱觀看)
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*註:影片長度約為1小時。

【Summary】

本次網絡研討會我們探討了將候選藥物轉移至FIH研究時評估免疫安全性的挑戰。會議專家分享了在此過程中的關鍵因素和需避免的陷阱。案例研究則強調體外免疫毒性評估如何通過早期預測風險以增加顯著性。
 

The immune system is a potent, flexible, and programmable ally in the fight against some of the most life-threatening clinical challenges. With the field’s current pace, immune-based therapy has become a mainstay of clinical practice, with results that were unimaginable a couple decades ago.

There is huge promise in harnessing the immune system, but misdirecting this powerful response can have serious and even life-threatening consequences for your patients. An understanding of the potential immunogenicity and immunotoxicity of your candidate/s is a regulatory requirement to support your first-in-human (FIH) program and an area where, unfortunately, “standard” in vivo toxicology assessments might lack relevance. As a result, the onus is on you, the biopharmaceutical developer, to ensure you have adequately assessed the possibility of your drug candidate/s to illicit an unwanted immune response.

In this webinar, we explore the challenges of assessing the immunosafety profile when moving a drug candidate to FIH studies. Our expert shares key considerations and pitfalls to avoid along the way. Case studies highlight how in vitro immunotoxicity assessments add significant value by predicting risk early. This knowledge allows for modifications to the candidate or FIH package design to mitigate risk and increase the likelihood of a successful FIH study.

活動議程

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【Lonza Pharma & Biotech】

As one of the world’s most renowned companies for contract development and manufacturing, Lonza Pharma & Biotech is recognized for our reliable, high-quality services, our global capacity, our innovative technology platforms, and our extensive experience. From 2013 to 2016, our contributions supported 36% of launches with small-molecule breakthrough designation. In 2016 alone, we provided manufacturing services for more than 50 commercial molecules and conducted more than 250 development programs. We have helped launch pioneering autologous cell therapies.

Success for us is when you, as our partner, are fully satisfied. We continuously improve and innovate to meet your expectations and improve your chances of business success. Our broad capabilities span across biologics, small molecules, bioconjugates, and cell and gene therapies. We manage projects from pre-clinical stage through to commercialization, and our expertise covers both drug substance and drug product.

We believe that the best outcome – for you and for your patients – can only come as a result of a successful collaboration. Together, we can solve the next challenge and bring your next medicine to life.