Trends in pediatric drug development and age related biopharmaceutics and dissolution

Speakers

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  Fang Wu Senior Pharmacologist, Office of Research and Standards/Office of Generic Drugs, CDER/U.S. Food and Drug Administration
  

  Fang Wu

  Senior Pharmacologist, Office of Research and Standards/Office of Generic Drugs, CDER/U.S. Food and Drug Administration

  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), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA).

  Dr. Wu has been with FDA for more than 9 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 biopharmaceutics 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.

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  Nikoletta Fotaki Pharmacist, MSc, PhD, Centre of Therapeutic Innovation (CTI), Department of Pharmacy and Pharmacology, University of Bath, UK
  

  Nikoletta Fotaki

  Pharmacist, MSc, PhD, Centre of Therapeutic Innovation (CTI), Department of Pharmacy and Pharmacology, University of Bath, UK

  Dr Nikoletta Fotaki is a Reader in Biopharmaceutics at the University of Bath, UK. She graduated in Pharmacy from the National and Kapodistrian University of Athens in Greece and she holds an MSc in Toxicology and a PhD in Biopharmaceutics-Pharmacokinetics. She participated in several research projects in the School of Pharmacy of the National and Kapodistrian University of Athens and in Hoffman La Roche (USA) before her academic appointment at the University of Bath. She has also worked in the National Organisation for Medicines in Greece. Her expertise and research are focused on Biopharmaceutics Tools used in all stages of drug development, Physiologically Based Pharmacokinetic (PBPK) modeling/ Physiologically Based Biopharmaceutics modeling (PBBM), in vitro and in silico tools for predicting absorption in normal populations and in special populations, dissolution methods, IVIVCs and biowaivers. Her scholastic work includes more than 80 peer reviewed publications, one book, 5 book chapters, 86 published conference contributions and 2 patents. She is a reviewer and scientific advisor of several scientific journals. She was a Deputy Editor for AAPS Open and member of the editorial board of Journal of Pharmacy and Pharmacology, Dissolution Technologies and DiePharmazie. She is an Associate Fellow of the Higher Education Academy and has been involved in the evaluation of several research proposals. She is also an Adjunct Associate Professor in the University of Waterloo (Canada) and a visiting Lecturer in King’s College London. She is the vice chair of the Oral Biopharmaceutics and Absorption Modeling (OBAM) Community of AAPS and she has been the chair of the In Vitro Release and Dissolution Testing (IVRDT) Focus Group of AAPS. She is a member of a USP expert panel and of several scientific societies and has been an invited speaker at several conferences.

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  Sanjaykumar Patel
  

  Sanjaykumar Patel

  Sanjaykumar Patel is Sr. Principal Scientist at Merck & Co., Inc. in Rahway, NJ. He has more than 22 years of experience in the pharmaceutical industry. His experience includes working on novel drug delivery formulations such as self-emulsifying drug delivery systems, amorphous solid dispersion, controlled release and gastroretentive, and parental formulation. His research interest is focused on developing predictive bio-relevant in-vitro methodologies to understand the in-vivo performance of oral and parental formulations. He has co-authored 18 scientific papers. He is an active member of AAPS and an immediate past Chair of the IVRDT (In Vitro Release and Dissolution Testing) community. He is a board member of the Society of Pharmaceutical Sciences-US Chapter in the area focusing on dissolution.

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  Terry Ernest GSK Senior Fellow, Director, PDS – PD Oral & Inhaled, MST Product Dev & Supply, Pharma R&D, GSK, UK
  

  Terry Ernest

  GSK Senior Fellow, Director, PDS – PD Oral & Inhaled, MST Product Dev & Supply, Pharma R&D, GSK, UK

  Dr. Terry Ernest is a Chartered Biologist and GSK Senior Fellow with a Masters degree in Industrial Pharmacy and PhD in Pharmaceutics. Currently working as a Director in Pharmaceutical Development (PD), Terry has over 25 years experience in the pharmaceutical industry at GSK, spanning Research & Development and Commercial Supply. Terry has developed a range of drug products including modified release formulations, tablets, capsules, oral liquids and sterile liquids across a wide number of projects for various diseases and indications. At GSK, Terry leads a global group focused on age appropriate product development and is a member of a number of age appropriate focus groups within and external to GSK. Terry is passionate about age appropriate drug development and continues to actively research and collaborate with academia and other industry partners in this field. Terry often engages with regulatory bodies such as the FDA, EMA etc in association with age appropriate drug development strategy.

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  Xujin Lu
  

  Xujin Lu

  Dr. Xujin Lu is a pharmaceutical consultant. With 30+ years of experience in pharmaceutical industry spanning analytical sciences, CMC, and formulation development across early‑ and late‑stage drug products, his career includes major contributions to the research, development, regulatory approval, and commercial launch of multiple innovative drug products in diverse dosage forms. His latest focus before retiring from Bristol Myers Squibb Company was in charge of the in‑vitro biopharmaceutics function, overseeing multi‑site and multi‑national teams responsible for evaluating drug release and predicting bioperformance of novel formulations, with dedication in advancing the scientific validity and strategic application of in‑vitro methodologies to support product development pipelines.
  Dr. Lu is an active member of AAPS and a past Chair of the In Vitro Release and Dissolution Testing (IVRDT) Focus Group. He serves on the USP Expert Panel on New Advancements in Product Performance Testing, the USP Expert Committee on Dosage Forms, and the Editorial Advisory Board of Dissolution Technologies. He is also a member of the Scientific Advisory Board of the Society for Pharmaceutical Dissolution Science – US Chapter.