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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.

Portrait von Dr. Ali Afnan

Presentation at TTC – Process Analytical Conference 2026

Title: Process Analytical Technology: a framework for innovation. A Two Decades Review.

Detailed Bio

Dr. Ali Afnan is the founder and CEO of STEP Change Pharma. He began his professional journey as a control-electrical engineer at ICI Engineering before joining the engineering team at AstraZeneca. At AstraZeneca, Dr. Afnan played a leading role in developing and implementing an innovative Process Analytical Technology (PAT) framework for solid dosage pharmaceutical facilities—the first of its kind in the industry.

In 2003, Dr. Afnan was recruited by the U.S. Food and Drug Administration (FDA) to work on their PAT and Drug Product Quality initiatives. He contributed significantly as a member of the PAT steering team, co-authored the PAT Guidance, and was part of the core team responsible for the latest FDA Guidance on Process Validation. Dr. Afnan left the FDA in March 2010.

He has been recognized with several FDA Commissioner awards and received the Industrial Pharmaceutical Federation’s Industrial Pharmacy Medal of Excellence award for his contributions to the field.