Finding closure: Lowering the costs of cell and gene therapies

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

Manufacturing costs the ‘biggest threat’ to cell and gene therapies

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

Dark Horse Sponsors Phacilitate Leaders World 2019 meeting in Miami

Campbell, CA, January 21st, 2019 – Dark Horse Consulting, the leading consultancy specializing in cell and gene therapy product development, today announced its planned attendance and sponsorship of the 2019 Phacilitate Leaders World meeting, scheduled for January 22-25 in Miami, FL. “The Phacilitate meetings are amongst the world’s most influential events for the cell & gene therapy

Cell and gene therapies: FDA expects 10 to 20 approvals per year by 2025

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

The long road to affordability: a cost of goods analysis for an autologous CAR-T process

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

Dark Horse Sponsors 2018 Cell & Gene Meeting on the Mesa

Campbell, CA, August 21st, 2018 – Dark Horse Consulting, the leading consultancy specializing in cell and gene therapy product development, today announced its planned attendance and sponsorship of the 2018 Cell & Gene Meeting on the Mesa, scheduled for October 3-5 in La Jolla, CA. “The Meeting on the Mesa is one of the premier

ISCT Join as Strategic Partners for Phacilitate Trade Mission to Japan and South Korea

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

Dark Horse Consulting to Present at Stem Cell Summit

Campbell, CA, April 11, 2018 — Dark Horse Consulting (DHC), a leading provider of consulting services for the cell and gene therapy industry, today announced that Katy Spink, Ph.D., Managing Partner, will be presenting at the GTCBio Stem Cell Summit, which is being held in Boston April 12-13. Dr. Spink’s presentation entitled “It’s the COGS,