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The EU approved a framework to support data sharing with the U.S.—here’s what it means for research and collaboration. Plus, creative use of gene therapy gave a boy his sight back—but policy might discourage this kind of innovation. (490 words, 2 minutes, 27 seconds) |
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EU and U.S. agree to enhanced data sharing framework – here’s what to know |
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International research collaboration just got easier thanks to a new agreement that allows for more secure and robust sharing of data between Europe and the United States. The EU-U.S. Data Privacy Framework, approved by the European Commission (EC) last week, enhances data security and privacy controls, allowing for personal data, including scientifically relevant data, to be shared with entities based in the US BIO has been advocating for this agreement.
How we got here: The Biden administration worked with the EC to prove the U.S. sufficiently safeguards the privacy of EU citizens’ data. This led to EC’s “Adequacy Decision,” welcomed by the White House.
What do U.S. biotech researchers get? More efficient processes for the transfer of clinical trial data from the EU to the US and other relevant health data critical for driving biomedical research. This also includes clearer access to the European Health Data Space, a network of detailed, anonymized health records established to help improve medical care and research. It includes databases like Estonia’s Biobank, a trove of genomic information from 20% of the country’s adult population.
Why it matters: “Data flows between the United States and the European Union are critical for advancing biomedical research,” according to Justin Pine, BIO Sr. Director of International Affairs. “Collaborations between researchers on both sides of the Atlantic resulted in COVID-19 vaccines, have revolutionized healthcare and advanced personalized medicine.”
Where do I sign up? Right here. Using this online certification, you can gain permission to exchange data with European partners. |
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Gene therapy returns a boy’s sight |
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A boy with a rare genetic condition has regained sight thanks to creative use of a gene therapy—an innovation that current policy might discourage.
The case: Antonio Vento Carvajal, 14, has dystrophic epidermolysis bullosa, a rare genetic disorder causing skin lesions. For about 3,000 people worldwide, it also affects their eyes. Antonio received Food and Drug Administration (FDA) “compassionate use” permission for then-experimental skin cream Vyjuvek, AP reports.
The first innovation: Vyjuvek, which ultimately received FDA approval for skin treatment in May, contains genetically modified herpes-simplex virus to deliver healthy copies of the COL7A1 gene directly to patients’ wounds.
The second innovation: After Vyjuvek helped Antonio’s skin, his doctor reasoned it could help the boy’s eyes. The maker, Krystal Biotech, reformulated the cream for “off-label” use as an eye drop.
The result: Following surgery to remove scars on his eyes and treatment, Antonio can see, AP reports.
The context: Using rare-disease targeting “orphan drugs” for a second indication has enabled breakthroughs. But developing drugs for a second indication is discouraged by the Inflation Reduction Act (IRA), which exempts orphan drugs from price controls—only if they’re developed for a single indication.
Why it matters: The Orphan Drug Act spurred innovation, but a study supported by BIO shows the IRA will reduce orphan drug development. |
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