DISCOVERY
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innovations during the drug
discovery phase.
Blog Post by Nicole Gallo
Nicole GalloApr 8, 2024 12:15:00 PM1 min read
Successful Planning for an Original NDA / BLA Submission
This comprehensive webinar offers an insightful exploration into the intricate landscape ...
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Nicole GalloJun 13, 2023 9:08:00 PM17 min read
Advanced Therapy Medicinal Products: Recent US Approvals, Upcoming Guidance
This article was originally published in Regulatory Focus by RAPS
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Nicole GalloMar 14, 2023 5:24:00 PM4 min read
FDA Issues Final Guidance About Multiple Endpoints in Clinical Trials
On October 21, 2022, the U.S. Food and Drug Administration (FDA) issued the “Multiple ...
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Nicole GalloFeb 14, 2023 3:21:00 PM5 min read
Critical Considerations to Advance Gene Therapy Products for Rare Diseases
The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research ...
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Nicole GalloMay 9, 2022 11:21:00 AM6 min read
FDA Requires Randomized Data to Support PI3K Inhibitor Approvals
The Oncologic Drugs Advisory Committee (ODAC) convened a meeting on April 21, 2022, to ...
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Nicole GalloNov 1, 2021 11:46:00 AM1 min read
The Launch of Bespoke Gene Therapy Consortium (BGTC)
On Wednesday, October 27, 2021, the NIH announced that they will be partnering with the ...
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Nicole GalloApr 13, 2021 1:54:00 PM5 min read
Cell and Gene Therapy Initial IND Submission Considerations
You’re at a small, emerging biotech and you’ve got a unique cell and gene therapy in ...
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Nicole GalloOct 28, 2020 10:39:00 AM5 min read
COVID Impacts on Agency Interaction on Cell and Gene Therapy Products
The effect of COVID-19 on therapy development has been a double-edged sword. While our ...
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Nicole GalloJan 21, 2020 2:33:00 PM8 min read
Where is Gene Therapy Heading?
Within the next decade, I expect to see ground-breaking, innovative changes in the way ...
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Nicole GalloMar 22, 2019 2:02:00 PM4 min read
“If This Is True” – What Does This Mean for Clinical Trials?
On March 19, 2019, the FDA released an Impact Story with implications for nearly everyone ...
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