Industry Insights

1. Time to Start Clearing Bottlenecks in Cell and Gene Therapies 5/5/2021

   With the increasing pace of new cell and gene therapies (CGT) receiving approvals and in development, the current capacity of the CGT ecosystem is unable to keep up with the clinical and commercial products coming to market. 

2. Why Elevating Responsibility To The C-suite Can Help Avoid Manufacturing Missteps 5/3/2021

   Cell and gene therapy commercial success hinges on early planning to scale manufacturing and supply. 

3. Illuminating the Need for Standards in Regenerative Medicine and Advanced Therapy 4/27/2021

   In the past, standards development in the life sciences has required years. This can be attributed to the passive process which has been primarily based on volunteer contributors from industry. The Standards Coordinating Body (SCB) accelerates the process by focusing on high priority/high impact standards and catalyzing the process. 

4. The Potential And Future Of Cell Therapy 4/22/2021

   While the field has made laudable progress in developing novel biomolecules that can be used to control cell function (e.g. mRNA, DNA, CRISPR, siRNA, proteins, peptides, etc.), very little progress has been made on reliably delivering these materials to a cell and enabling robust engineering of cell function without significantly impairing cell health. 

5. An Analysis Of The Gene Therapy Viral Vector Landscape 4/21/2021

   Over the last five years, multiple gene therapies have been approved by regulatory agencies and a bolus of late-stage pipeline assets are approaching the market. However, as the first gene therapies began to post early wins, several challenges have emerged. This article discusses the landscape of the viral vector sector.

6. Manufacturing Therapeutics In Hospitals: Re-envisioning The Bioprocessing Paradigm 4/19/2021

   Most hospital-based therapies are “patient ready,” pulled from inventory and used with minimal preparation. However, advanced therapy medicinal products (ATMPs) are changing how we think about how we deliver therapies. The success of these new and complex therapies requires partnership with those administering them, which is a new paradigm.

7. Considerations In Commercializing HSC Gene Therapies For Rare Disease 4/13/2021

   Orchard Therapeutics' CCO shares how the company works to build a commercial infrastructure that can realize the full potential of Hematopoeitic Stem Cell (HSC) gene therapy.

8. Scientists Have A Responsibility To Educate The Public On SARS-CoV-2 Vaccines 4/8/2021

   While COVID-19 vaccines represent a victory for the scientific community and should be celebrated, we also have a responsibility to educate as many people as we can about their safety and efficacy. ASGCT is doing just that.

9. Addressing The Challenges Of MSCs Will Reveal A Bright Future For This Regenerative Medicine Modality 3/24/2021

   Safety and efficacy data have started to provide a solid basis for building confidence in new and promising treatment modalities such as mesenchymal stem cells (MSCs). 

10. Medicare Braces For Expanded Use Of High-Cost CAR T-Cell Therapy 3/22/2021

    The Centers for Medicare & Medicaid Services (CMS) established a new reimbursement rate for inpatient CAR T-cell delivery in 2021 designed to more closely reflect the true costs of care and address the financial losses experienced by many healthcare institutions. This article delves into details on this and also discusses another significant change for 2021.