Dear AAPS members–
This has been a good week for scientific news! The NIH announced on Monday that a critical phase 3 clinical trial of the investigational vaccine for COVID-19 codeveloped by NIAID, Moderna, and Pfizer is about to begin. I think we are all keeping our fingers crossed that this trial will yield the kinds of results we are all hoping for! Scientifically, the vaccine is an exciting innovation because it is a lipid nanoparticle-encapsulated, nucleoside-modified messenger RNA (mRNA)-based vaccine that encodes the SARS-CoV-2 spike (S) glycoprotein-the critical protein that allows the virus to get into a cell. Several other vaccines based on nucleic acids like this are currently in development.
In the coming months, I look forward to learning more about the fascinating mechanistic science involved in these vaccines, and also hearing more about the manufacturing, analytical, and quality challenges that come with these completely new types of medicines. Not surprisingly, we have several sessions dedicated to this at our upcoming PharmSci 360 meeting, including a keynote on novel vaccine formulation development; case studies from vaccine developers on the COVID frontlines; and insights into the many new technologies that are available for drug development, but that also still require careful regulatory consideration to assure patient safety.
In other science news this week, there is a new paper in Science from Jennifer Doudna's laboratory about the hypercompact genome editor CRISPR-CasΦ. Now I'm even more excited about welcoming her as the opening plenary speaker for our conference in October!
Innovation and discovery come in many shapes and forms. In drug development, significant innovation often happens in areas that patients rarely hear about, for example in pharmaceutical analysis: How well and how quickly we can characterize the performance of a given formulation, or assure the absence of toxic impurities after an ingredient or process change, can have significant impact on the quality, safety, and availability of life-saving medicines. Likewise, it is critical that all those analytical dots get connected across the pharmaceutical development chain. That's why I am excited to see such a broad and expanded agenda this year at the Land O' Lakes Pharmaceutical Analysis Conference. It includes an entire plenary session on drug metabolism and pharmacokinetics issues in drug development, a topic area previously not "in the wheelhouse" of this meeting, but of course with highly relevant touch points in the analytical space.
A look across the most recent publications in our journals also shows an increasing number of discussions that consider the drug development process and associated decision-making holistically as a system, e.g., in the fascinating paper by @Arzu Selen et al., Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products. These considerations of course are possible because we live and work in a world of big data, so @Safa Damiati's review Digital Pharmaceutical Sciences is very timely as well. With so much highly engaging science going on, it is easy to forget about other things, but please do remember that the window for late-breaking abstract submissions for PharmSci 360 is closing on August 12, so don't miss out! We look forward to hearing about your research!
Here's to more hopeful progress in science this summer-thank you for your contributions and your commitment to AAPS!
Tina
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