Our Expert Network

81. Future-Proofing mRNA Drug Manufacturing: IVT And Supply Chain 2/29/2024

    Regulatory and technical uncertainty surrounding mRNA necessitates predictive and proactive innovation enabling better manufacturability assessments, more robust in vitro transcription techniques, and improved downstream processing.

82. Comparability Considerations For mRNA Product Development 2/28/2024

    Given the mRNA-based products' variability and unique challenges, you may need to modify the standard comparability approach. Let’s discuss strategies for any development stage.

83. FDA's Updated Guidance On Human Genome Editing: New Implications & Remaining Questions 2/27/2024

    On Jan. 29, 2024, the FDA released the final version of the guidance document on human gene therapy products incorporating genome editing. This article shares what changed between the draft and now final version of the guidance, and what open questions remain for the industry and scientific community to help resolve.

84. How Pharma 4.0 Can Unlock The Full Potential Of External Manufacturing 2/27/2024

    To address today's challenges and other headwinds, pharma/biotech organizations and CMO/CDMO partners need to re-evaluate and improve externalized operating models. Consider further investing in digitalizing collaboration processes as part of operational excellence and digital transformation road map efforts. 

85. Risk And Supply Chain Continuity Management: Biologics Industry Perspectives 2/26/2024

    We spoke to three long-standing members of BioPhorum’s Risk and Business Continuity Workstream about their companies’ approaches to risk management, supply chain continuity, and what they learned from the pandemic. Among them are Melinda McCants, senior resiliency officer at Amgen.

86. Understanding And Navigating Diverse Regulatory Environments 2/21/2024

    Drug developers aspire to treat patients globally, but navigating diverse regulatory structures around the world gets tricky. These consultants offer a primer on the regulatory bodies of the world.

87. 1 In 300 People In The U.S. Is Living With HIV. That's Not Okay With Jeff Galvin. 2/13/2024

    By modifying CD4 T cells using miRNA, Jeff Galvin’s company thinks it can deliver a functional cure for HIV. Here’s the ongoing story of Addimmune and its unique clinical strategy.

88. 2024's Market Outlook For Cell & Gene Therapies 2/9/2024

    RSM is back for the third consecutive year to provide an outlook analysis of the cell and gene therapy market. This article discusses the 2024 state of the macroeconomy, its effects on cell and gene therapy companies, growing approval pipelines and approvals, funding factors, and the unique prospects for the market.

89. Gene Editing Versus Gene Therapy: Is There A Difference? 1/31/2024

    This article navigates the nomenclature that underlies gene therapy and gene editing technologies and explores the latest advancements in genome medicine.

90. FDA Draft Guidance On “Rare Diseases: Considerations For The Development Of Drugs And Biological Products” 1/26/2024

    Accenture Applied Life Science Solutions' Raj Bandaru, Ph.D. breaks down, summarizes, and shares detailed insight on the recent FDA Draft Guidance that addresses “Rare Diseases: Considerations for the Development of Drugs and Biological Products.”