Industry Insights

1. Operationalizing Cell & Gene Therapy: Challenges And Solutions 9/22/2020

   Cell and gene therapy has proven to be the future of cancer treatment, however, challenges remain in getting cell therapies to the market and into routine use to be widely adopted.

2. Data-Driven Cell Therapy: Reducing Risks And Accelerating Development 9/14/2020

   Big data and machine learning are increasingly applied to cell therapy R&D. They can reduce risks and accelerate development. This article reviews some use cases.

3. Maintaining Lab Operations Amid Coronavirus Restrictions 9/8/2020

   Obsidian Therapeutics CEO Dr. Paul Wotton developed a novel solution to the workforce and resource disruption caused by COVID-19 social distancing restrictions. Here, he shares insight on the features of the application, which he's made available to other biotechs cost-free.

4. The Future of Regenerative Medicine: 3D Bioprinted Human Lungs 9/1/2020

   Part two of a three-part series on the future of regenerative medicine explores how 3D bioprinting will potentially save lives for millions of patients awaiting lung transplants.

5. Removing Barriers To Achieve Widespread Clinical Adoption Of Lentiviral Gene Therapy 8/26/2020

   Clinical evidence continues to emerge that points to busulfan’s unique capabilities, for example, its ability to support potential microglial network reconstitution with gene-modified microglia and its potential to address central nervous system (CNS) manifestations of disease. 

6. Comparison Of Health Technology Assessments And Time To Reimbursement For Orphan Drugs And Gene Therapies From Four HTA Agencies 8/24/2020

   The aim of this study was to review and compare the reimbursement recommendations for ODs issued by four European HTA bodies and assess the potential effect of HTA outcomes on the time to reimbursement (T2R). 

7. Repurposing An Aging Facility To Produce Cell & Gene Therapies 8/24/2020

   Many life sciences companies are shifting their operations to encompass new life-saving cell and gene therapy products, also known as advanced therapy medicinal products. In many cases, this requires converting legacy manufacturing facilities to produce these new therapies.

8. Cell And Gene Therapy Manufacturing As Large-Scale Biology 8/20/2020

   Scaling the production of a few million living cells in the lab to manufacturing the billions of cells needed to treat patients comes with its own unique array of complexities. 

9. Immunotherapy For Glioblastoma: A Path Forward 8/10/2020

   Since the advent of the first IO approvals, various interventions, including immune checkpoint inhibition, tumor vaccines, and cell therapies have been evaluated in GBM. To date, none of these IO modalities have led to meaningful improvements in clinical outcomes.

10. FDA Extends Enforcement Discretion Period For Regenerative Medicine Products, But This Isn't A Green Light For Bad Actors 8/6/2020

    The extension of FDA’s enforcement discretion provides a unique opportunity for companies to properly align their regulatory strategy.