Main Street District’s Post

🧗♀️ The concept of resilience is one that every biotech is familiar with. It is the ability to adapt to difficult circumstances or a challenging environment.   Drug development isn’t for the timid, or for those easily deterred by failure (because failure, in some capacity or another, is inevitable in this journey).  If it all went perfectly, everyone would be doing it. (This applies to all of us. CROs, sites, even each of us in our individual roles.) 🔹 Progress and true innovation will come when honesty and transparency, and the determination to retain our resilience no matter what the circumstances, become the heart of what we do. 🕰 Flashback to the time I stepped out on a limb and started my own trial site, somehow managed to get everything running smoothly, and then overnight was told to halt all trials and operations due to a mysterious new virus making its way across the globe. What could be done? My team and I pivoted, and changed gears overnight. We reinvented our roles as infectious disease clinicians, gowning up in biosafety PPE and making house calls to test patients for COVID-19.😷 In the face of adversity, all we can do is persevere.

This is such a hot topic right now, as a health plan this is a hard decision to make for so many reasons. A great webinar to listen to.

Brighton case definitions are of vital importance regarding the harmonization of "vaccinovigilance" across the globe and more and more countries are becoming the part of this international forum. Case definitions have different levels of diagnostic certainity and can be applied effectively in varied settings.

Last month, Alaska quietly passed a bill creating a task force to explore in-state regulation of psychedelic medicines as they are newly approved by the FDA. House Bill 228 passed both House & Senate easily, in large part because it’s so darn conservative. It’s simply saying “Let’s be ready at home to implement the FDA’s changes in scheduling.” It’s not a decriminalization bill. Not even close. The one win by the decrim community was including, as one of the 4 mandates for the task force, “(2) consider barriers to implementation and equitable access.” (I crafted that language and got it included 😁.) The task force will be required to address equitable access, which has been one of the largest criticisms of how regulatory changes are rolling out in other places, such as Oregon and Australia. Building in 1000+ safeguards, out of fear or distrust of these substances and associated practices, makes the treatment financially out of reach for most. I applaud Alaska legislature for being forward-thinking. If the FDA reschedules* MDMA, and eventually other meds, we will be ready to implement. (*Until this week, it seemed likely that rescheduling was set to happen in August of this year. A negative response from an FDA advisory panel now throws that into question. I'll be sure to post here once the final ruling comes through.)

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The COVID-19 pandemic exposed vulnerabilities in our global response to emerging infectious diseases, and it also ignited a critical conversation about preparedness. Download our latest white paper to learn more about how the experts here at Southern Research are building a comprehensive pandemic preparedness program.

Great read. Be sure to read his article in CAPTODAY.

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As promised, the slides about the methodology behind Safety Competitive Intelligence presented at the World Drug Safety Conference. Thanks to George Mullens for inviting me and Rui Yang MD, PhD for hosting the session. Many thanks to the colleagues (previous and current) and attendees. I hope I made my case that competitive intelligence could become structural and increase public health. #OpenSourcePV #RSV #WDSEU

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