Dear all, We are pleased to announce the leadership teams for the AAPS Translational and Clinical Science Community, including both the Scientific Areas of Focus (Teams) and the Writing, Programming, and Scientific Exchange Activity Teams. Below ...
Hi everyone, A quick reminder that our Translational and Clinical Science Community meeting is happening this Tuesday, 8:00 to 9:00 AM Pacific, at NBC. We would love to have a strong turnout. It is a good chance to connect, share what is going ...
FDA's Nakissa Sadrieh and Yanning Hao just published an analysis of NHP data from monoclonal antibody testing that supports streamlining animal testing. For those interested in NAMs, the abstract draws you into to reading more with its brief summary of ...
I am very excited to be presenting alongside Vibha Jawa in a hot topic session at NBC this year! Please stop by to listen (and participate in) a session focused on streamlining relevant immunogenicity assessment all the way from IND to BLA! ------------------------------ ...
If you like these types of discussions, feel free to reach out to any AAPS Community leaders. The Regulatory Science Community plan to schedule guidance discussions once a quarter and are open to ideas. AAPS Initiatives – SAC ...
Dear Colleagues, Does anyone have experience on the use of human in-vitro or animal in-vivo data and mechanistic models to predict human ADME performance in the context of bridging non-comparable subcutaneous drug products due to CMC changes (Biotherapeutics, ...
Hosted by the AAPS NAM Subcommittee, NAM Working Group, and Regulatory Science Community (Gene and Cell Therapy Product team) The AAPS NAM Subcommittee, NAM Working Group, and Regulatory Science Community are convening an Open Scientific ...
More insights from the FDA on implementing new approach methodologies were just published in JAMA. https://jamanetwork.com/journals/jama/fullarticle/2848148?resultClick=1 #fda #NAM ------------------------------ Mark Arnold Ph.D., FAAPS Westampton, ...
I am delighted to support the new Translational and Clinical Science Community as the SAC liaison! @Sugimoto, Hiroshi and @Alok Pandey will be amazing Chair and Vice Chair in our new AAPS Community journey together! Please join us for the ...
The first community meeting is scheduled on May 1st at 9:05 am PST , 11:05 am CST or 12:05 pm EST via Teams. Microsoft Teams meeting Join: https://teams.microsoft.com/meet/330525833440?p=FDArhOpaaluZ8fY4iM Meeting ID: ...