Dr. Ali Afnan
Step Change Pharma Inc., USA
Job title:
- President of Step Change Pharma, Inc.,
- Business partner of Bright Future Consulting, Inc.
Areas of work:
Facilitating change within the pharmaceutical industry.
Process design/ re-design, and development; Process Analytical Technology (PAT); Quality by Design (QbD); Regulatory innovation (CMC assessment); Establishing/ advising regulatory process for interaction with Regulatory bodies. Team & process focused.
Detailed Bio:
Process Analytical Technology: A Framework for Innovation – A Two-Decade Review
In 2002, the FDA introduced the Process Analytical Technology (PAT) framework to modernize pharmaceutical manufacturing through real-time, science-based process control. Over 20 years later, the industry still struggles to fully implement these principles—especially as the demand for personalized medicines grows.
Dr. Ali Afnan, a key architect of the original PAT Guidance and former FDA lead, will reflect on the progress made, the challenges that remain, and the untapped potential of PAT to deliver high-quality, cost-effective pharmaceutical products. This keynote will explore how a systems-based approach to manufacturing can transform the future of drug development and supply.