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28
Jan
2021

Ideas for an FDA Reboot

The FDA needs to get healthy, and fast. Its credibility as the world’s No. 1 science-based regulator of food and drugs has been tarnished. From the start, it had to play catch-up on RT-PCR diagnostic tests in the wake of CDC’s epic screwup. Partly to make up lost ground, it swung open the floodgates for antibody tests. A Wild West...
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21
Jan
2021

A Bold Idea for the NIH

Too many people don’t believe anymore in the American dream. But if you can’t dream big, you can’t accomplish big things. Today, I’d like to propose a bold idea for the future of biomedical research. Let’s triple the National Institutes of Health budget over the next decade. Impossible? Hear me out. We know the NIH, with a $41.7 billion a...
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19
Jan
2021

Gene Editing for Transplants and Cell Therapy: Luhan Yang on The Long Run

Today’s guest on The Long Run is Luhan Yang. Luhan is the founder and CEO of Hangzhou, China-based Qihan Biotech. Qihan is using genome editing technology to engineer pigs with organs that can be safely transplanted into humans. This is what scientists call xenotransplantation. The concept has been around a long time, but new CRISPR-based gene editing technologies make it...
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17
Jan
2021

Two Doses or One? Let’s Stick To the Data

With COVID-19 surging and a chaotic political situation, we still have reasons to consider ourselves fortunate. We have two safe and effective COVID-19 vaccines authorized for emergency use by the U.S. Food and Drug Administration. While the rollout has been frustratingly slow thus far, these vaccines and others under study hold our best promise of pandemic control. Both products, the...
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14
Jan
2021

How Worried Should We Be About Emerging Strains of SARS-CoV-2?

All virus strains mutate continuously. That’s normal. There’s nothing inherently concerning about that word, “mutation.” Unless, of course, the mutations give an evolving virus new properties that make it more transmissible or more pathogenic. That’s trouble. The news has been worrisome in recent weeks with reports on the B.1.1.7 strain first detected in the UK, and other new strains of...
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13
Jan
2021

The Politics of Speaking Up

We thought we had lived through the most difficult year of our lives in 2020, from the deadly COVID-19 pandemic to the delusional and autocratic ambitions of a sitting President of the United States. Then we were shocked once more, by deadly mob violence and ominous threats of more to come at the U.S. Capitol in the days before the...
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12
Jan
2021

A Moment of Truth

Democracy is fragile. Its stability depends on the acceptance of its principles by the population as a whole, the resilience of the institutions that support it, an independent judiciary, a free press, free and open elections and, in the United States, the foundation laid by the Constitution.    The struggle to balance those critical pillars has been waged across the...
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8
Jan
2021

Biotech Is Radiant In a Dark Moment

The virus, at the start of a New Year, has arrived on all seven continents. Even Antarctica. An estimated 2 million people have died worldwide from the SARS-CoV-2 virus, and that’s surely an undercount. About 4,000 people are dying per day in the US. About 255,000 new people are being diagnosed with this dangerous and mysterious invader every day in...
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6
Jan
2021

mRNA Vaccines Inspire Hope for Emerging Technologies; Is Digital Pharma Next?

The mRNA vaccines for COVID-19, developed by Moderna and BioNTech/Pfizer, were a conspicuous bright spot in a generally devastating year. Besides giving us a chance to bring the pandemic to an end, they remind us more generally of the profoundly transformative potential of emerging technologies.  Audacious scientific and entrepreneurial ambitions can take years of grinding persistence, often sounding unrealistic or...
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