Clinical Development Gene Therapy Packaging 
Camargo
MAY 2, 2021
Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Background: The Advancement of Cell and Gene Therapies.
Pharmaceutical Technology
AUGUST 17, 2022
These molecules synthesised newly are packaged densely into custom lipid nanoparticles (LNPs), which Orna has made to act on the body’s crucial tissues. Preclinical data showed the potential of oRNA expression and delivery as a method for advanced development in various areas, including vaccines and oncology treatments.
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Camargo
JULY 30, 2021
But now it’s a warning in their package insert. Well, the first obstacle was that the pharmaceutical industry does not want to develop drugs for children. In the Pediatric Study Plan, you have a defined timeline and a defined plan, a clinical development plan that has to be approved by the FDA.
Camargo
AUGUST 11, 2021
Meeting Package Due. To address a stalled product development plan or an important safety issue. Sponsors whose products qualify for the centralized procedure can also seek scientific advice from the EMA anytime during development. All four types are free of charge to the sponsor, in contrast to EU meetings (discussed below).
FDA Law Blog
NOVEMBER 2, 2023
While on the surface this may not seem like major advance for the field, this could be a game changer for the gene therapy space. These meetings have a question-and-answer format to provide clarity to sponsors about the particular topics at hand.
XTalks
FEBRUARY 10, 2023
Jeff Vassallo, Senior Director of Clinical Trial Management, at the global clinical contract research organization (CRO) Medpace. These details must be thoughtfully considered early in clinical development to ensure studies are completed within the projected timeline and budget,” added Dr. Vassallo.
The Pharma Data
AUGUST 7, 2020
As the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19. Regenerative medicine and advanced therapies thriving despite Covid-19 disruption.
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