Dear AAPS members–
Registrations for online events have increased generally, but once in a while one of our events still catches my attention with how fast and high its headcount is moving. This has been the case for our upcoming webinar ICH M9: Harmonization of Biopharmaceutics Classification System (BCS)-Based Biowaivers, which will take place this coming Thursday, September 3. We are presenting it in collaboration with the IQ Consortium. The hundreds of registrations we've received so far reflect the impact that these new, internationally harmonized regulatory documents have. This is especially true in our industry, where supply chains and drug development pathways are driven by global dependencies, yet often affected by local or regional disparities.
In addition to the ICH M9 discussion spear-headed by the AAPS Regulatory Sciences Community, the AAPS CMC Community will be hosting a virtual panel discussion on ICH Q12 Implementation Challenges on September 25. Registration is not required, but "digital seats" are limited, so please mark your calendar (and remember to thank @Kin Tang and his colleagues for organizing this!). ICH Q12 capstones the ICH Quality Guidelines with recommendations for the harmonized management of post-approval changes. Right now, as many manufacturers look at the sudden potential relevance of existing medicines that may be repurposed in response to COVID-19, increased demand may prompt manufacturing changes that require regulatory attention. In many ways the arrival of this guideline could not be timelier. It will be interesting to hear discussion around how implementation has gone for manufacturers thus far!
Between the discussions hosted by our AAPS Communities, and the AAPS webinar program, there is a lively, free-to-members event to attend every week! This past Thursday, I tuned into Govind Rao's excellent presentation on Disruptive Innovations for Next Generation Bio-manufacturing where he discussed the development of an automated and portable medicines-on-demand device that enables consistent, small-scale GMP manufacturing of therapeutic-grade biologics on a timescale of hours. As global and local demands for medicines evolve, these types of advances will be critical for future public health preparedness efforts.
As the summer winds down, my excitement grows for the fall and PharmSci 360. I have been browsing the hundreds of poster abstracts now available, and I look forward to hosting a Special Poster Collection at the meeting. I am determined to challenge myself in picking research a bit outside of my comfort zones of virology, analytical biochemistry, and regulatory/CMC. Like other Special Poster Collection hosts, I'll moderate a panel of poster authors discussing their research. Which to choose? It's a very pleasant task.
Even if you're not part of a Special Poster Collection, you can still view and present posters through Connect 360. Registrants will be invited to start using Connect 360, our virtual match-making tool, in September. Once you do, you can message other registrants-including poster authors!-arrange to meet, and then video-chat. This tool will be vital for you when you're ready to talk to poster authors and exhibiting partners. Good discussions will abound once you add details to your profile, connect, and schedule meetings there. Come and find me, as well as other AAPS leaders who have already signed up and are looking to connect with you.
If you have been following the latest research on COVID-19, antivirals, and vaccine development, you will be very excited about the fantastic speaker line-up of our closing plenary session at PharmSci 360, with Gregory Poland and Rolf Hilgenfeld. So much good science to look forward to!
Before you get too carried away (like me!) by all this exciting research going on-please don't forget to support our collaboration with UC Dublin on decision-making in drug development: you have until August 31 to participate in the online experiment that will only take 15 minutes of your time. If you have more time to give to AAPS, please consider these great volunteer opportunities.
I hope you are still enjoying your summer, and as always: let our science inspire you to look up and ahead.
Tina
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