In this week’s news, growth forecast for CDMO sector, EMA preps for relocation, US FDA reopens, and more…
CDMOs set for biopharma driven boom says study
Drug industry outsourcing will surge in 2019 according to a survey, which suggests more cell and gene therapy manufacturing will be handed over to contractors.
The analysis by BioPlan Associates is based on responses from pharma industry execs. It indicates revenue generated by the contractors last year grew at around 12%, an increase on the previous year growth rate.
Writing in BioPharmInternational BioPlan’s Eric Langer said growing demand and competition is reshaping the contracting sector.
“CMOs continue to expand capacity, staff, etc., to try to retain clients as their products advance in development. Total annual biopharmaceutical CMO revenue was approximately $3.4 billion in 2018 and is expected to grow to about $3.8 billion in 2019.
Langer also predicted the growing range of innovative therapies in development would be a boon for CDMOs with the necessary cutting edge manufacturing expertise.
He said, “CMOs are often the pioneers in terms of manufacturing novel products, including antibodies with novel core structures/backbones, antibody-drug conjugates (ADCs), cellular therapies, gene therapies, RNAi, pegylated proteins, and other novel types of products.”
EMA relocation continues
The EMA officially said goodbye to its London office in preparation for its relocation to Amsterdam.
The agency, which is moving as a result of the UK’s impending withdrawal from the European Union- aka Brexit – shared details of moving plans in a tweet last week.
Today, EMA staff lowered the 28 EU flags and symbolically said goodbye to their London offices. Guido Rasi expressed his thanks to the UK for its contribution to the work of the Agency and for having been a gracious host of EMA since 1995. pic.twitter.com/KpsBvaXt42
— EU Medicines Agency (@EMA_News) January 25, 2019
In a separate statement the regulator announced it has begun relocating to the Spark building in Sloterdijk in Amsterdam, but stressed it will ensure the continuation of its main activities throughout the move.
“The focus will be on the authorisation, maintenance and supervision of medicines, ongoing Brexit preparedness/implementation activities and preparing for the implementation of the new veterinary legislation.”
The EMA also confirmed it expects to lose some 25% of its current workforce as a result of the relocation.
US FDA shutdown
President Donald Trump has signed legislation temporarily reopening the US Government, ending the longest shut-down in history and prompting the FDA to begin resuming normal operations.
According to a post on its website, the FDA resumed operations and furloughed staff began returning to work on Saturday 22.
In a letter FDA Commissioner Scott Gottlieb thanked staff for their efforts during the shutdown and promised back-pay would be made available by the end of the month.
My message to my #FDA colleagues today. I admire your continued dedication and the fortitude of your families through these challenging times. We’re finalizing plans to ensure all of our esteemed staff receive back pay as quickly as possible, and by Thursday, January 31st. pic.twitter.com/D2GcukNWuZ
— Scott Gottlieb, M.D. (@SGottliebFDA) January 26, 2019
Despite FDA operations resuming, some observers raised concerns the Trump-shutdown would have a long lasting negative impact on the agency.
An opinion piece in Lexology suggested drug reviews and even facility inspections could be delayed.
Accessible facilities attractive to customers says expert
Drug companies want to keep track of activities at their CDMOs according to an expert writing in Outsourced Pharma, who suggested this should be kept in mind during facility design.
The idea that pharmaceutical companies value CDMOs that are flexible, high tech and experienced is well established. What is less well known is that – increasingly – sponsors want to keep track of what contractors are doing on their behalf says Greg Weilersbacher from Eastlake Quality Consulting.
He wrote that, “For ages, facility design focused solely on the infrastructure needs of the CDMO without including the requirements necessary to meet the needs of the sponsor.
“The sponsor’s ability to witness productions first-hand and assurance that its product will not be contaminated by another product or process is a design requirement, not a “nice to have” feature.”
Read the full article here.
Also in the news
Biopharma looks set for a busy year of M&As according to analysis by Clarivate.
UK drug firm GSK has bought cancer drug specialist Tesaro for £4bn. The deal was prompted by products like the ovarian cancer treatment Zejula, says Pharmamarketeer.
The pharmaceutical industry needs to be more open to new ideas according to Alex Zhavoronkov, CEO of Insilico Medicine. He told the Medicine Maker that AI has a major role to play.
Evaluatepharma looked at the likely cost of gene therapies in the future. The article cites comments made by Bluebird Bio CEO Nick Leschly at the JP Morgan healthcare conference about plans for reimbursement of the group’s drug, Lentiglobin.
GEN reported the development of a stem cell based therapy for macular degeneration that is delivered using an adhesive patch.
The annual JP Morgan Healthcare conference was dissected by Pharmaphorum.