Dear AAPS members–
There has been a lot of regulatory news this week, from FDA's release of a guidance on nitrosamines, to the ongoing discussions about how and when the first COVID-19 vaccine will be considered safe and effective enough to license. I am doing research for a couple of regulatory presentations right now, and I occasionally find myself mired in such analytical or quality conundrums. To reset my thinking, I take a step back and look at the greater picture of the scientific discovery and therapeutic opportunity. This week such inspiration was provided by our AAPS Newsmagazine's cover story, Nanorobots and Microrobots as Targeted Drug and Cell Delivery Platforms, by @Vivek Agrahari and @Puneet Tyagi. The cutting-edge developments they describe sound very sci-fi! But if you have followed the news and literature about the COVID-19 vaccines that are currently in clinical testing, you may have noticed that nanoparticles are already playing a big role-they are the sophisticated packaging and delivery vehicles for RNA-based vaccines currently in clinical testing.
I hope the success of these vaccines will also serve to accelerate the development and regulatory acceptance of future innovations in the nanotechnology space. If this story has piqued your interest, stop by the AAPS Nanotechnology Community and continue the conversation there. I'm sure Vivek and Puneet would love to hear from you-they are active leaders in this group!
If you are following the scientific developments in our scientific journals, you will have noticed that just in the past month AAPS PharmSciTech included two articles that discuss nanotechnology-based strategies for formulation advances that can unlock the full therapeutic potential of molecules with bioavailability challenges. Keshawari et al. looked at Nobiletin as a Molecule for Formulation Development: An Overview of Advanced Formulation and Nanotechnology-Based Strategies of Nobiletin. Tian et al. investigated the Fabrication of Nanosuspensions to Improve the Oral Bioavailability of Total Flavones from Hippophae rhamnoides L. and their Comparison with an Inclusion Complex.
As I read about these current examples, my mind turned to the more practical matter of how these advancements get to patients. Fortunately, earlier this year, Demetzos et al. looked into the past to see the future in their captivating review article, Nanomedicines and Nanosimilars: Looking for a New and Dynamic Regulatory "Astrolable" Inspired System. An astrolabe is an ancient navigation tool, and as I pondered their philosophic, yet pragmatic, view of how non-biological complex drugs could be regulated, I suddenly saw the answer thread to my own regulatory question. Yet again, a stroll through our rich journal content has proven inspirational!
Looking ahead to October and of course PharmSci 360, you will find many cutting-edge presentations that involve nanotechnology and the immense potential it presents for targeted drug delivery and diagnostics. Check out our new Discovery and Basic Research Track this year; it includes a theme about tackling the challenge of getting drugs across the blood-brain-barrier.
As summer draws to a close, my neighbors and I are looking forward to a relaxing Labor Day Weekend, which always marks the end of summer in the United States. No matter where you are, as always, I hope you let our science inspire you to look up and ahead!
Tina
Share your thoughts with Tina via the AAPS Community!