Navigating the many complexities in clinical trials, manufacturing, and regulatory interaction in moving gene therapies from development to market.
David Shoemaker, PhD
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Articles by David Shoemaker, PhD
A regulatory perspective on the current state of protein science and the implications for biosimilar approval.
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Latest Updated Articles
Lightship’s Approach to Accessible, Representative, and Impactful Clinical TrialsPublished: February 13th 2025 | Updated: March 4th 2025
Accelerate Inclusive Enrollment and Delivery with LightshipPublished: February 19th 2025 | Updated: February 26th 2025
Examining the Impact of Exclusionary Behaviors on Team DynamicsPublished: March 24th 2023 | Updated:
Trials and Tribulations of Electronic Patient Consent: Removing Barriers to eConsent AdoptionPublished: April 28th 2021 | Updated:
Sticking to the Plan: Undue Burden Created by Protocol DeviationsPublished: July 26th 2024 | Updated:
Phase III PERSEUS Trial Data Show Darzalex Faspro Combo Improves Survival in Newly Diagnosed Multiple MyelomaPublished: January 31st 2024 | Updated:
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