Blog
Virus-free CRISPR could lead to more precise gene editing for T-cell therapies
A team from the University of California, San Francisco, created a new electroporation-based CRISPR-Cas9 method, which eliminates viruses from the gene editing process and lays the groundwork for “safer, more precise and more efficient editing for CAR-T...
New Draft Guidance on Gene Therapy
On July 11, 2018 the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) offered 6 new draft guidance documents on human gene therapies. The documents offer a look at what it expects from an industry that is becoming...
Revisions to the Federal Policy for the Protection of Human Subjects (Common Rule) have been delayed 6 months
The Department of Health and Human Services (DHHS) and other federal departments and agencies announced that there will be an additional six-month delay in the general compliance date for changes made to the Federal Policy for the Protection of Human...
Pearl Pathways to exhibit at DIA 2018 in Boston
Join us at the DIA 2018 Global Annual Meeting in Boston from June 24-28. Gretchen Bowker, Chad Pannucci, Nancy Kant and Waylon Wright will all be in attendance from Pearl. Learn more about regulatory challenges, industry trends, evolving clinical research...
Gretchen Bowker and Diana Caldwell spoke at IMDMC’s Reg 101 event
Gretchen Bowker (COO) and Diana Caldwell (CEO) at Pearl Pathways recently presented at IMDMC’s 2018 Reg 101. The workshop took place on Tuesday, June 12, 2018 from 8am to 5pm at the Montage in Indianapolis, Indiana. The workshop was designed for...