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Biopharmaceutical companies with technology platforms will soon see a smoother drug application process through the FDA’s newest program.
The FDA released a draft guidance Last month, the company was selected for the Drug Development Platform Technology Designation Program, which aims to streamline the development, manufacturing and review processes.
To participate in the program, the FDA must consider whether incorporating the platform technology would bring “significant efficiencies” to the application process and determine whether the platform meets eligibility requirements.
The FDA noted that its definition of “platform technology” may differ from industry definitions, describing it as a “well-understood, reproducible technology” that may include a nucleic acid sequence, molecular structure, mechanism of action, delivery method, vector, or combination of technologies.
As part of the program, biotechnology and pharmaceutical companies with designated technology platforms will receive advice from the FDA during their development programs and will receive priority communications for products that the FDA deems to have the “most significant public health benefit or impact.”
Evolution of R&D
Drug development has changed rapidly in the past few years, as platforms that can be used for multiple drugs enable companies to speed up the process.
Greater efficiency would be welcomed by the industry. For the top 20 pharmaceutical companies in the world, the average cost of developing a new drug is $2.3 billion According to a Deloitte report, this is likely to happen by 2022 due to lengthy development times and the high costs of the clinical trial process.
AI and automation will accelerate drug development, reducing drug development time by 60-70% Reduction PwC predicts AI will have a particularly big impact on process timelines. over 100 According to the FDA, 100 drug and biologic applications reported in 2021 contained AI or ML components. Still to be decided How will it regulate AI in drug development and will it issue guidance for the industry in the future?
The new guidance formalizes an existing pathway for drugs developed based on widely used platform technologies. FDA officials have previously discussed the potential benefits of a formal platform designation program for gene editing, and the FDA has listed gene editing as a suitable technology for the program.
“now is the time, Designated Program “Especially given the lessons learned with CRISPR products, the field is rife with opportunities where you can change one insert and not substantially change the platform,” said Philip Kurth, regulatory counsel in the FDA’s Center for Biologics Evaluation and Research, at the CASSS Well-Characterized Biotechnology Products conference in Washington, DC, in January.
The program allows companies using platform technologies that have an approved New Drug Application, Abbreviated New Drug Application, or Biologics License Application to apply for platform designation for future applications. Companies may request a pre-submission meeting for their planned platform technology designation application, but guidance outlines that the application may be submitted concurrently with or after the IND submission.
This guidance: Federal Register The comment period ends on July 29. BIO has already submitted the 30-day extension The comment period will be extended to provide stakeholders with more time to formulate feedback for the agency.
