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Regulators traditionally want to see a single, stable, well-characterized drug before giving the green light for it to be tested in a clinical trial, not dozens of different viruses; let alone ones that are best found in unappealing places like sewage , hospital waste, or bird poop.
I was reading a lot of molecularbiology papers about different systems, especially circadian clocks, and also a book called Biological Feedback , by Thomas and D’Ari, that sketched out really simple models for different kinds of feedback circuits. So many kinds of people have contributed to biology in different ways.
.” Wellcome Collection , London I wrapped up my series on “30 Days of Great Biology Papers.” ” This was a series of tweets in which I told brief stories behind seminal papers, mostly in molecularbiology and biophysics. You can read all of them here. And it’s true, but only in an incomplete way.
.” Wellcome Collection , London I wrapped up my series on “30 Days of Great Biology Papers.” ” This was a series of tweets in which I told brief stories behind seminal papers, mostly in molecularbiology and biophysics. You can read all of them here. And it’s true, but only in an incomplete way.
For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) Future Nobel Laureate, Paul Berg, narrated the video, which quickly became a cult classic moment in molecularbiology history. plasmidsaurus @arjunrajlab (Regulation in biology is incredible. Paper by Sha G.
For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) Future Nobel Laureate, Paul Berg, narrated the video, which quickly became a cult classic moment in molecularbiology history. plasmidsaurus @arjunrajlab (Regulation in biology is incredible. Paper by Sha G.
The History of the ICH Q5A(R1) Guideline The International Council on Harmonization (ICH) Q5A(R1) Guideline, Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin , was first adopted by regulators in 1999. This bulk product contains both the final product (e.g., also received some additions.
“Contrary to popular opinion, regulation is not a hurdle, but rather an enabler. If the data package (including safety) is well thought out and developed from the beginning, regulations can be a support to frame the development journey.
I’ve chosen these two because I think they are the linchpin by which we’ll be able to build broadly useful AI models for cell and molecularbiology. But looking ahead to the second bottleneck, what does it mean to say that biology is “complex”? It involves pragmatism and cultural sensitivity.
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