Central Laboratories Featured Articles

41. Cell Therapies For Solid Tumors: Optimizing Your Approach To Achieve Regulatory Approval 6/19/2024

    Developing and ultimately obtaining approval of cell therapies for solid tumors requires an organized and scientifically rigorous approach. This article is a helpful road map of considerations.

42. Beware AI Hallucinations 6/7/2024

    As the use of AI increases and expands to new functional areas within biopharmaceutical companies, leaders must understand the risks and mitigate the impact of hallucinations in AI model outputs.

43. Medical Affairs: Unlocking Insights To Drive Innovation, Access, And Value 6/3/2024

    Medical affairs (MA) professionals are playing an increasingly dynamic, strategic role across the innovation life cycle. Astellas Pharma Executive Vice President, Head Medical Affairs Shontelle Dodson explains.

44. Unlocking Next Generation Clinical Trials Through Data Sharing & Tech-Driven Approaches 5/21/2024

    New findings from a survey conducted in the U.S. indicate a significant number of trial participants are eager to have their data used by researchers. How can biopharma companies harness this?

45. New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies 5/16/2024

    The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.

46. What Can Digital Patient Twins Do For Clinical Research? 4/29/2024

    Digital patient twins have the potential to vastly improve our current healthcare systems by offering personalized therapeutics, enhanced health monitoring, and streamlined pharmaceutical manufacturing, including clinical trials.

47. Validating A Better ALS Biomarker With Coya's Fred Grossman 4/24/2024

    Coya Therapeutics President and CMO Fred Grossman, DO, FAPA discusses a potential new biomarker for ALS — 4-HNE, an oxidative stress biomarker — and how it could be more effective than the current standard, NfL.

48. Shorter, Faster, Cheaper: Powerful New Data On Digital Endpoints 4/16/2024

    The idea of leveraging novel, sensor-based measures to gather data for clinical trials is not new, but relevant evidence of their usefulness is. Here, DiMe experts discuss the impact of digital endpoints on trial success.

49. FDA Warns Industry Of Fraudulent & Unreliable Lab Testing Data In Premarket Submissions 4/11/2024

    The FDA recently announced that they have seen an increase in the number of entities that contract out testing or services where the data provided by said firms was fabricated, duplicated, or just deemed “unreliable.” Here's what you can do.

50. ICH E6(R3) And Defining What Is Critical To TMF Quality 4/9/2024

    By applying Quality by Design to clinical trials, sponsor companies can rise to meet the elevated role and importance of the TMF in the face of ICH E6 (RF3).