Industry Insights

1. What The Gene Therapy Sector Doesn’t Understand About CRISPR 11/25/2020

   I sat down with Sadik Kassim, Chief Technical Officer at Vor Biopharma to discuss the benefits of CRISPR-engineered stem cell therapies, the challenges and feasible solutions, what’s next, and more.

2. Understanding the Three Major Challenges Limiting Innovation In Tissue Engineering 11/17/2020

   The regenerative medicine sector, comprised of tissue engineered products and cell and gene therapies, has grown rapidly over the past decade, including significant therapeutic advances that offer the prospect of optimizing and transforming patient care. There has been a dramatic increase in the number of approved cell and gene therapies and available funding for these products, and yet both progress in development programs and approvals for tissue engineered medical products (TEMPs) have lagged behind.

3. A CLL/CAR-T Story — A Patient’s Perspective 11/10/2020

   For many of us with chronic lymphocytic leukemia (CLL), the condition is always trying to come back. That has been my experience since being diagnosed in 2002. By 2012, following FCR in 2008, my CLL relapsed and converted to the more aggressive 17p- from 13q-. Perhaps the 17p- clone was underlying.

4. Good Documentation Practices And Data Integrity: The Conjoined Twins Of Compliance And Good Business Practices 11/10/2020

   Establishing a policy of required GDP/DI for all employees from the outset is cheap insurance for the future of your projects. Here's why.

5. Cell Therapy And A New Approach To Allogeneic Hematopoietic Stem Cell Transplant 10/27/2020

   Allogeneic hematopoietic stem cell transplant (HSCT) — commonly referred to as bone marrow transplant — is a serious but potentially curative procedure that has been used to treat certain blood cancers for more than sixty years. Over that time, outcomes for patients who undergo this procedure have dramatically improved. At the same time, transplant is ripe for innovation that could be provided by the latest advances in the rapidly expanding field of cell therapy.

6. The Future Of Regenerative Medicine: A Macro View On Emerging Applications 10/27/2020

   Part three of a three-part series on the future of regenerative medicine explores how regenerative medicine will help to improve quality of life in line with continued rise in global average life expectancy.

7. Charting A Course Into The Unknown: Manufacturer Considerations In Gene Therapy 10/15/2020

   As manufacturers and other healthcare stakeholders try and chart a course in the emerging gene therapy field, there are many considerations a manufacturer should be mindful of as they plan for a future launch into this emerging space.

8. Scaling Cell and Gene Therapy Manufacturing Operations 10/13/2020

   Manufacturing autologous cell therapy products faces few key complications, which is typically why CAR-T manufacturing runs at two or three sigma operations.

9. ASGCT On The COVID-19 Vaccine 10/6/2020

   Anthony Fauci, M.D., Director of the National Institute of Allergy and Infectious Diseases kicked off the American Society of Gene & Cell Therapy’s COVID-19 Symposium with a keynote address on September 15. In his prerecorded talk, Dr. Fauci told attendees he was “cautiously optimistic that we will have an answer by the end of 2020, and we’ll be able to start distributing vaccine in a meaningful way in 2021.”

10. The Rise Of Gene & Cell Therapy And The Resulting Need For In-House Production Facilities: A Guide 9/29/2020

    Reviewing location demands emerging in experimental medicine as biopharma companies urgently seek expansion sites in commercial hubs across the U.S.