NIPTE Pathfinding Working Group Report: Collective Perspectives on Accelerating Drug Product Development and Approval

Editors

• Xiuling Lu, Ph.D., FAAPS , 

  Xiuling Lu, Ph.D., FAAPS

  Dr. Lu is Professor of Pharmaceutics at the University of Connecticut, Associate Director of Center for Pharmaceutical Processing Research, Past Chair of NIPTE Faculty. Dr. Lu’s research is focused on innovative nanotechnologies that target difficult-to-treat cancers, optimization of drug formulations and the use of versatile imaging tools to improve pharmaceutical product quality. Her research has been supported by NIH, American Cancer Society, NSF, FDA, industry etc. Dr. Lu has published more than 80 peer-reviewed publications in high impact journals. The innovative research has resulted in 4 issued US patents and 4 PCT patent applications.

• Vadim J. Gurvich, Ph.D., M.B.A.  &

  Vadim J. Gurvich, Ph.D., M.B.A.

  Dr. Gurvich is Associate Director of the Institute for Therapeutics Discovery and Development (ITDD) and Research Associate Professor in the Department of Medicinal Chemistry at the University of Minnesota College of Pharmacy. He is also the Executive Director of NIPTE, a national non-profit organization of 18 US universities. He holds a doctoral degree in organic chemistry along with master’s degrees in chemical engineering and business administration (MBA) and possesses over 30 years of academic and industrial research and development experience in synthetic organic and medicinal chemistry, drug synthesis, and chemical process development.

• Fernando J. Muzzio, Ph.D.

  Fernando J. Muzzio, Ph.D.

  Dr. Muzzio is Distinguished Professor of Chemical and Biochemical Engineering at Rutgers University, Director of the National Science Foundation Engineering Research Center on Structured Organic Particulate Systems, past chair of NIPTE faculty which he co-founded in 2004. He is also the director of the Rutgers/Janssen partnership in Advanced Manufacturing, the president of Integra Continuous Manufacturing Systems and the Chief Scientific Officer of Acumen Biopharma. For the past 20 years, Dr. Muzzio has worked with many companies and focused on continuous manufacturing of pharmaceutical products.