FDA Presentations

Francis Godwin, MBA
Office Director
OMQ | OC | CDER | FDA

Francis Godwin received his undergraduate degree from MIT in Chemical Engineering in 2001. After graduation he worked as a process engineer designing, building, and optimizing chemical plants. He was certified as a Black Belt in Six Sigma performing quality improvement projects and teaching Six Sigma principals. He then worked in pharmaceutical process validation for both batch and continuous processes for APIs and finished dosage manufacturing operations. Later, he managed an analytical chemistry laboratory conducting analyses for production, QA, and research testing. In 2009 he received an MBA from Georgetown University and since then, has been working at FDA in CDER's Office of Compliance. He has served in various functions within compliance, and is currently the Director of the Office of Manufacturing Quality, overseeing regulatory and enforcement actions for both foreign and domestic drug CGMP cases.

Presentation Title: FDA's Recent Quality Concerns with Excipients

Description: Excipients are subject to Current Good Manufacturing Practice (CGMP) requirements. In the past year FDA has encountered multiple quality concerns with excipients that have led to drug product recalls and adverse events. This talk will highlight the regulatory landscape regarding the FD&C act and excipients, as well as presenting recent case examples of FDA regulatory actions taken at various levels in the supply chain when quality concerns with excipients were found. Learn more.

Susan Zuk, MS
Branch Chief
OPQ | CDER | FDA

Susan holds a BS in Chemistry from Syracuse University and a MS in Biotechnology from Johns Hopkins University. During her 19 years with the FDA, she served in the Office of Generic Drugs as a Chemistry Team Leader for many years, specializing in antibiotics. She joined the Office of Policy for Pharmaceutical Quality in 2015 and is currently a Branch Chief in the Division of Regulations, Guidance and Standards. She is the lead for the FDA’s Inactive Ingredient Database (IID). In this role, she is responsible for overseeing IID improvements. Susan has served on many FDA committees and working groups related to product safety and quality. She is currently a member of the FDA’s Center for Drug Evaluation and Research (CDER) Excipient Working Group.

Presentation Title: Update on FDA’s Inactive Ingredient Database

Description: Excipients, the inactive ingredients in pharmaceutical products, are essential drug product components that facilitate drug delivery, promote solubility, improve taste and, in general, allow active pharmaceutical ingredients to be transformed into useable dosage forms. For over 30 years, FDA has published the Inactive Ingredient Database (IID), a publicly available list of the excipients used in FDA approved drug products, as a tool for drug development. Over the years, FDA has made small gradual improvements to the IID in response to requests from industry. In this presentation, FDA will provide its vision for the IID as an essential tool for drug development.

Fang Wu, PhD
Senior Pharmacologist and Scientific Lead
Division of Quantitative Methods and Modeling
Office of Research and Standards (ORS)
OGD | CDER | FDA

Dr. Fang Wu is a senior pharmacologist reviewer and scientific lead for oral Physiologically-based Pharmacokinetic modeling in Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD) in FDA. Dr. Wu has been with FDA for more than 11 years. She is responsible for using modeling and simulations tools for reviewing pre-abbreviated new drug applications (pre-ANDA) meeting packages, ANDA consults and controlled correspondences. Prior to joining DQMM, Dr. Fang Wu was a biopharmaceutics reviewer for more than 4 years and responsible for NDA and ANDA reviews. She has been a principal and co-principal investigator for multiple FDA research projects and involved in several guidance working groups and grant review panels.

Eleftheria Tsakalozou
Senior Pharmacologist
Division of Quantitative Methods and Modeling
Office of Research and Standards (ORS)
OGD | CDER | FDA

Eleftheria Tsakalozou joined the FDA in 2015 as an Oak Ridge Institute for Science and Education (ORISE) Fellow. She is currently a Senior Pharmacologist at the Division of Quantitative Methods and Modeling at the Office of Research and Standards. Dr. Tsakalozou obtained her PhD in Pharmaceutical Sciences at the University of Kentucky in 2013 and completed a two-year Fellowship in Clinical Pharmacokinetics and Pharmacodynamics at the University of North Carolina at Chapel Hill. Her research interests include skin absorption physiologically-based pharmacokinetic modeling, interactions between excipients and molecular targets including gut transporters and development of quantitative modeling and simulation tools to support bioequivalence assessments.

Presentation Title: A Critical Overview of the Biological Effects of Excipients

Description: The objective of this talk is for the audience to become familiar with the in vitro systems and animal models that have been used to improve our understanding on potential interactions between orally administered excipients and gut transporters. The audience will also understand how excipients may impact bioequivalence assessments, especially for BCS Class III drugs. With this talk, the audience will be able to recognize that our knowledge on how excipients in oral dosage forms may interfere with the activity or expression of intestinal transporters and impact oral bioavailability is limited. Finally, the talk will highlight that research supported by state-of-the art experimental methodologies and mechanistic in silico methodologies integrating a plethora of information on the human physiology and drug product information are the basis for science-based excipient selection and for the development of safe and efficacious drug products.