Dear AAPS members–
Tuesday was World Hepatitis Day-if you follow AAPS on Twitter or LinkedIn you may have enjoyed the scientific resources we pulled together for you on this topic. As always, our excellent peer-reviewed journals have a lot to offer. I trace my own humble scientific beginnings to the study of the molecular mechanisms of hepatitis A virus (HAV), and in reviewing some of the recent literature in the hepatitis field was reminded (again) how much persistence and patience is required to understand and battle just one disease or public health issue on all scientific fronts-even with the every-multiplying number of tools at our disposal.
It is an important reminder going well beyond the current pandemic to the many other issues we encounter in pharmaceutical development. In the quality and CMC space for example, the issue of detecting and minimizing impurities in drug substances and drug products will never go away, but how we address them will continue to evolve with new technologies and new regulatory approaches. This has been very much on my mind, as I actively prepare for and look forward to my own session at the Land O' Lakes Pharmaceutical Analysis Conference. My particular focus will be on lifecycle management and what can be expected for the implementation of the recently finalized ICH Q12 guideline. We will also be talking about nitrosamines and assessing the risk of their presence.
If you are following impurities, do not miss next week's eChalk Talk about how to Simplify Residual Solvents Analysis Through Technology. It is another example of a topic with a long scientific horizon-ICH Q3C on Residual Solvents goes back to 1996 and is now on revision 8, and I cannot recall a single year in my involvement with pharmaceutical quality when we have NOT talked about this issue! Every time our manufacturing and ingredients landscape changes, so does the conversation about this particular impurity.
If you are not worrying about impurities right now but have a vacuum technology problem to solve in your laboratory, plan on spending additional time with us on August 4 to hear about Creating Vacuum in the Pharma Lab. It's a topic that can really pull you in! (I could not resist.)
A lot of lively conversations are also going on in our AAPS Communities right now. If you are interested in doing more with your community or communities of interest, please consider volunteering for a leadership role in your community: it will enrich your membership experience by connecting you to like-minded scientists in your field, and significantly widen your networking and knowledge-sharing opportunities. This is the time of year when positions are turning over in the communities, so now is when you should raise your hand and volunteer! If you are not sure how to get more involved in your community, contact @Maria Nadeau at nadeaum@aaps.org.
Speaking of raising your hand: there is still time to volunteer for the Scientific Programming Committee of next year's National Biotechnology Conference (NBC), which will be held in Anaheim, CA, in May.
With the Land O' Lakes Pharmaceutical Analysis Conference on the immediate horizon, I am reading relevant material from our journals that will undoubtedly enrich my conference experience. Take a look at this article in The AAPS Journal on FDA's Poly (Lactic-Co-Glycolic Acid) Research Program and Regulatory Outcomes and see what our friendly regulators are up to in the area of PLGA polymer research. I'm always so glad to see the agency keeping pace with the rapidly accelerating development in industry, and if we can help disseminate this important science, even better! Do not let the speed of their advancement rush past you-continue to let our science inspire you to look up and ahead.
Tina
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