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Accelerating Process Development and Product Formulation
Mauricio Futran1, Fernando Muzzio2, Bikash Chatterjee3
1Pharmaceutical Engineering Solutions, LLC, Westfield, NJ, USA. mfutran@gmail.com.
Pharmaceutical Research
|May 2, 2024
Summary
New technologies and adaptive development can accelerate drug approval timelines, improving patient access to medications and emergency treatments. Collaboration and regulatory shifts are crucial for faster drug development.
Area of Science:
- Pharmaceutical Sciences
- Drug Development
- Regulatory Science
Background:
- Lengthy drug development and approval processes delay patient access to new medications.
- Slow response times to public health emergencies requiring novel treatments.
- Current drug formulation and process development face significant acceleration barriers.
Purpose of the Study:
- To explore opportunities for accelerating drug product development and approval timelines.
- To identify barriers hindering faster drug development and propose solutions.
- To share perspectives on overcoming development hurdles using new technologies.
Main Methods:
- Analysis of discussions from the January 2023 NIPTE pathfinding workshop.
- Review of current product formulation and process development.
- Identification of advanced manufacturing techniques and adaptive development strategies.
Main Results:
- New technologies offer potential solutions to accelerate drug development.
- Advanced manufacturing and adaptive development are key strategies for acceleration.
- Paradigm shifts in regulatory processes are necessary.
Conclusions:
- Accelerating drug development requires technological innovation and adaptive strategies.
- Increased pre-competitive collaboration among regulators, industry, and academia is essential.
- A shared strategy is needed to overcome barriers in drug development and approval.
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