by Dan Stanton Fully closed and automated platforms are key to reducing the current high costs of cell and gene therapy manufacturing, say industry experts. Cell and gene therapies (CGTs) have come a long way over the past two years, resulting in two chimeric antigen receptor (CAR) T-cell therapies – Kymriah and Yescarta – and the
DHC in the News
by Dan Stanton This is the first time in history that we can make more effective medicines than we can afford, says Dark Horse Consulting. The Phacilitate conference took place in Miami this week, and in the plenary session Anthony Davies, founder of cell and gene therapy specialist firm Dark Horse Consulting, described the latest developments
by Dan Stanton The US FDA predicts it will receive more than 200 regenerative INDs per year from 2020 and will add 50 additional staff to review these products. There has been “a large upswing in the number of investigational new drug (IND) applications” for cell and gene therapies received by the US Food and Drug
by Katy Spink & Andrew Steinsapir With the 2017 FDA approvals and launches of the first gene-modified cell and pure-play gene therapy products to gain licensure in the United States, increasing attention has been paid to the high cost of this emerging class of therapies. Although currently approved therapies are for orphan indications, prices similar to
With extensive industry expertise, Dark Horse Consulting provides strategic and technical services to help clients realize their goals of bringing therapies to patients and commercialization as featured in Biopharma Dealmakers Go to Article
New Gene Therapy CMC Guidance from the FDA – A Breakthrough in Regulation or Something More Generic?
An in depth analysis and recommendations for the recently revised cell & gene therapy guidances from our founder and CEO, Anthony Davies, was featured in an editorial for Cell & Gene Therapy Insights.
Experts from North American and European organisations are also supporting the trade mission. Anthony Davies, Ph.D., CEO of Dark Horse Consulting added, “As the first and only global consulting practice focused on CMC for cell and gene therapy, Dark Horse thoroughly endorses the intent of this trade mission. We also welcome the ISCT’s participation as a
CellGenix, a global leader in providing GMP-grade raw materials for cell and gene therapy and tissue-engineered products, today announced the appointment of highly experienced and internationally respected experts in the field of cell and gene therapy to its Scientific Advisory Board (SAB). The SAB will serve as a strategic resource to CellGenix as it continues