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Experts from Quotient Sciences present a roadmap for moving novel drugs to market more quickly.
Novel therapies, such as those for rare diseases, meet vital patient needs but it can be hard to formulate the optimum regulatory approach to ensure they reach the market as quickly as possible.
Several pathways are in place to assist biopharma companies with accelerating the development of new products and, though each has different needs, there is much commonality between them.
Now, a new guide from Quotient Sciences presents a roadmap for expedited review pathways.
The fact-finding and operating principles it describes, though focusing on US designations (Fast Track, Breakthrough Therapy, Priority Review and Accelerated Approval), are also applicable to many of the processes in place at bodies such as the European Medicines Agency, Health Canada, Japan’s PMDA, NMPA in China or Brazil’s ANVISA.
Accordingly, the guide outlines:
- Questions drug developers should ask themselves to determine the most suitable pathway(s) for their product
- Key considerations for sponsors about their CDMO partners
- How to overcome turnover of subject matter experts
- Reasonable expectations to have of knowledgeable partners
CDMOs, like Quotient Sciences, have a vast array of experience and knowledge in the many challenges that can encountered during development.
They understand that speed is of the essence when manufacturing drug product to supply first-in-human (FIH) clinical trials to generate pharmacokinetic (PK), tolerability and safety data. But, without an integrated approach and calculated distribution logistics, this can be an exceedingly wasteful and time-consuming part of the process.
Flexibility in the products taken to the clinic, without a significant investment in large batches, is crucial to balancing a budget while de-risking the program as much as possible. The partners that a biopharma company chooses to work with should be able to find creative ways of overcoming hurdles such as this.
From just-in-time production to leveraging development and manufacturing synergies, drug developers should be confident they can work with their partners to find creative solutions to overcome hurdles on the path to bring a novel medicine to market.
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