Mark Mathieu

Director Publications

Mark works with Parexel clients in the pharmaceutical and biologics industries worldwide. He also serves as the Director of Publications for Parexel Consulting. Mr. Mathieu has studied and written about the drug development and FDA New Drug Approval process for 31 years, and has authored numerous textbooks on the topic, including New Drug Development: A Regulatory Overview, currently the most widely read text on the US new drug review and approval process.

Work experience

Mark conducts detailed proprietary studies and consults with biopharmaceutical company clients on emerging developments and critical success factors in the drug development and approval processes. He has also developed Parexel’s Bio/Pharmaceutical R&D Statistical Sourcebook, industry’s leading compendium featuring data and analyses on emerging and critical trends in pharma/biotech research and development.

Mr. Mathieu frequently conducts briefings and training sessions for managers and executives regarding the major findings of his primary research, most recently on the accelerated development and regulatory pathways available for new drugs and biologics in the United States and Europe.


Mark received his B.A. in journalism from the University of Hartford, and an M.A. in science journalism from Boston University.