Insights on Clinical Trials
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Preparing Your CAR-T Therapy For Phase 2 Trials
12/6/2023
AffyImmune CEO, Matt Britz, talks about what’s next for the company as it prepares its lead CAR-T candidate for Phase 2 trials — from clinical strategy to selecting a CDMO and the headache of tech transfers.
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FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities
12/5/2023
In October , FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating their remote evaluations program, the logistics of its implementation, and what they expect of industry. The public comment period ends December 26.
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Metastatic Breast Cancer - Global Clinical Trial Landscape (2023)
11/27/2023
Uncover why the collaboration between researchers, clinicians, regulatory bodies, and CROs remains crucial for innovative solutions and improved patient outcomes in the journey to address metastatic breast cancer challenges.
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Immune Checkpoint Inhibitors Global Clinical Trials Landscape (2023)
11/27/2023
Dive into the forefront of immune checkpoint inhibitors clinical trials with an exploration of the latest trends and key findings.
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5 Stepping Stones To The Future State Of Rare Disease Clinical Development
11/17/2023
Review five essential steps that have the potential to propel rare disease clinical development into a new era of advancement and breakthroughs.
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Vor Bio Shares Progress For Patients with AML
11/17/2023
I talked to Dr. Robert Ang, President and Chief Executive Officer at Vor Bio about the company's VBP101 study for trem-cel in patients with acute myeloid leukemia (AML)
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Driving Down COGS: Leveraging Automation Technologies And Mitigating Risk
11/17/2023
The technologies aimed at automating and standardizing cell therapy production are poised to offer advanced therapy companies and CDMOs process-level improvements that streamline and accelerate workflows.
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The Eye: A Candidate For Modifier Gene Therapy
11/17/2023
Ocugen's Chairman, CEO and Co-founder, Shankar Musunuri ,Ph.D., MBA, provides an update on OCU400 and other ongoing trials, why the eye is a good target for gene therapy, the outlook for retinal gene therapy, and more.
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How To Migrate Active Studies To A New EDC
11/16/2023
Gain access to the results and lessons learned from a project involving the modernization of an electronic data capture system and mid-study data migrations.
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2023 Technology Adoption Trends And Plateaus
11/15/2023
About 85% of industry leaders and managers have had some exposure to AI. Delve into the state of AI adoption experienced throughout 2023 and where the industry is headed concerning digital tool usage.