In Vitro Release Test (IVRT) and In Vitro/In Vivo Correlation (IVIVC) of Complex Generic Ophthalmic, Injectable, Implantable, and Inserted Products

Bioequivalence Assessor, DB I, OB, OGD, CDER, FDA

Dr. Alaa Abuznait has been a bioequivalence assessor in the Division of Bioequivalence I (DBI), Office of Bioequivalence (OB), Office of Generic Drugs (OGD), Food and Drug Administration (FDA) since 2014. He is primarily involved with the assessment of in vivo and in vitro bioequivalence portions of abbreviated new drug applications (ANDAs) and post-approval supplements of various dosage forms of generic drug products. Prior to joining FDA, Dr. Abuznait was a postdoctoral fellow at The University of Oklahoma Health Sciences Center, Oklahoma City, OK. He received his B.Sc. in Pharmacy from the University of Jordan, Amman, Jordan, his M.Sc. in Pharmaceutical Technology and Pharmaceutics from Jordan University of Science and Technology, Irbid, Jordan, and his Ph.D. in Pharmaceutical Sciences from The University of Louisiana Monroe, Monroe, LA.

Science Lead, Nanomedicine, Vifor Pharma, Inc

Dr. Amy Barton is a nephrology-trained clinical pharmacist. Prior to joining Vifor Pharma as the Science Lead for Nanomedicine, Dr. Barton had a 20+ year career as an academic researcher focused on translational investigations of intravenous iron-carbohydrate nanomedicines. She was previously funded by the Food and Drug Administration to advance bioequivalence evaluation for intravenous iron carbohydrate nanomedicines using in vitro and pre-clinical models. During her tenure as an academician, Dr. Barton maintained a clinical practice providing care to patients across the chronic kidney disease continuum with a focus on the in-center hemodialysis population. Dr. Barton holds a Master’s degree in Healthcare Innovation and is a fellow of the American Society of Nephrology, National Kidney Foundation, and the American College of Clinical Pharmacy.

Distinguished Professor of Pharmaceutics and Pfizer Distinguished Chair of Pharmaceutical Technology, University of Connecticut

Pharmacologist, DB, ONDP, OPQ, CDER, FDA

Dr. Parnali Chatterjee has more than 15 years of experience in the academia, pharmaceutical industry, and the government in cross-disciplinary areas of in silico, in vitro, and in vivo absorption, distribution, metabolism, and excretion (ADME). At the FDA, Dr. Chatterjee provides feedback to the Industry on Investigational New Drugs, Abbreviated/New Drug Applications for CDER and Investigational Device Exemptions for CDRH. Dr. Chatterjee holds a Doctoral degree in Pharmaceutical Sciences from Univ of Louisiana, Monroe, LA. She is also a Registered Pharmacist in the State of New Jersey.

Senior Manager, Skin Biology Global Pharmacology and Toxicology Department, Viatris Inc.

Bryan DeBarr has 15 years of complex drug product development experience, including various roles within Quality and Research and Development functions. For the last 12 years, he has focused on complex drug development and lifecycle management as a member of the Global Pharmacology and Toxicology Department. Currently, he specializes in the in vitro release (IVRT) and in vitro permeation (IVPT) analytical method and assay development, validation, and testing in a GMP, GCP, and GLP compliant laboratory with a particular focus on ophthalmic, topical, and transdermal drug delivery systems. He has extensive experience in applying in vitro and ex vivo test methods to aid in the optimization, pre-clinical evaluation, comparative biowaiver testing, and post marketing support of complex drug products.

Associate Director R&D Combination Products and Semi-solids, Teva Pharmaceuticals

Dr. Mark Halus is an Associate Director working within Analytical Development in TEVA’s Combination Products and Semi-Solids Group. He has a B.Sc. in Chemistry from the University of Strathclyde in Glasgow and a Ph.D. from the School of Pharmacy at Queens University of Belfast. The focus of the team he leads at TEVA is on development and validation of the full range of analytical test methods for complex combination products and he supports complex investigations throughout the TEVA network on drug products during product development and in- process, release, or stability testing. In his 20-year career in industry, he has been involved in research and development of drug release test methods for many solid oral dosage forms and more novel methods for topicals, vaginal inserts, IUDs, subcutaneous implants, and ophthalmic products, all in support of regulatory filings.

Clinical Pharmacologist, DB II, OB, OGD, CDER, FDA

Dr. Yoriko Harigaya is a clinical pharmacologist at the Division of Bioequivalence II, Office of Bioequivalence within the Office of Generic Drugs, CDER/FDA. In her role, she assesses the bioequivalence studies submitted by pharmaceutical industries through abbreviated new drug applications (ANDAs) and ANDA related submissions for a variety of dosage forms including oral, ophthalmic, topical, transdermal, and inhalers. She is responsible for the concurrence process of developing product specific guidance (PSG), conducts several research projects which include aqueous humor PK studies for topical ophthalmic corticosteroids, and contributing Generic Drug User Fee Act III (GDUFA III) work group to promote an effective ANDA assessment process.

Deputy Division Director, DTP I, ORS, OGD, CDER, FDA

Dr. Darby Kozak is the Deputy Division Director for the Division of Therapeutic Performance One in the FDA’s Office of Generic Drugs. Dr. Kozak leads a group of interdisciplinary scientists on the development of new analytical methods and equivalence evaluation methodologies for complex drug substances and parenteral, ophthalmic, otic, and inhalation formulations. Prior to joining the FDA, Dr. Kozak was Chief Scientist for Izon Science and Research Fellow at the Australian Institute for Bioengineering and Nanotechnology. Dr. Kozak has a B.Sc. in Chemical Engineering from the University of Washington (Seattle, WA) and Ph.D. in Chemistry from the University of Bristol (United Kingdom).

Director, Co-Development, Global Research and Development, Apotex

Dr. Ripen Misri obtained his Ph.D. in Pharmaceutical Sciences from the University of British Columbia (Canada) and further pursued a post-doctoral fellowship at BC Cancer Research Center. Dr. Misri’s expertise is in development of complex dosage forms such as nanoparticulate and microparticulate drug delivery systems, and peptide therapeutics. Dr. Misri joined Apotex in 2015 and is currently Director of the Co-Development R&D, leading development of complex generic drug, and drug device combination products.

Principal Scientist, Formulations, Teva Pharmaceuticals

Harshil Parikh is a Principal Formulator at Teva Pharmaceuticals within their combination product development group. He emphasizes on development of semi-solid, liquid, and transdermal dosage forms. In his 9 years with TEVA, he has developed numerous products for a variety of dosage forms including topical, transdermal, ophthalmic, long acting injectable, sublingual, and oral liquids. He received his undergraduate degree in Pharmacy from Gujarat University, India in 2011 and a Master’s in Pharmaceutical Science from Long Island University, Brooklyn, NY in 2014. Harshil is an active committee member of multiple AAPS discussion groups. He is a peered reviewer and editor on multiple international journals.

Lead Pharmacologist, DB II, OB, OGD, CDER, FDA

Dr. Eunjung (EJ) Park serves as team lead of Division of Bioequivalance II, Office of Bioequivalence in Office of Generic Drugs. Her team assesses bioequivalence of generic ophthalmic products, topical products, and inhalation products. Prior to joining OGDs, she served as pharmacologist and staff fellow of Division of Cardiovascular and Renal Products, Office of New Drugs, FDA for 5 years. Her research interest was safety pharmacology such as QT prolongation and renal function measurement. She also has experience in the biopharmaceutical company as a scientist before joining FDA, where her responsibility included anticancer drug development and discovery of chemopreventive agents. Dr. Park received her undergraduate degree from Ewha Womans University in Pharmaceutical Science and a Ph.D. degree from School of Pharmacy at Seoul National University in South Korea and completed her post-doctoral training at National Cancer Institute, US and University of Illinois at Chicago.

Pharmacologist, DB, ONDP, OPQ, CDER, FDA

Dr. Kalpana Paudel is a Reviewer in the Division of Biopharmaceutics/Office of New Drug products (ONDP), OPQ at FDA. She joined FDA in 2015 and has been involved with review of the biopharmaceutics section of drug applications for various dosage forms such as solid orals (IR and MR), semi-solids, and complex products such as injectable suspensions, intravaginal drug delivery systems, and transdermal products. Dr. Paudel completed her Bachelor’s degree in Pharmacy from Jadavpur University (India) and Ph.D. in Pharmaceutical Sciences from Toyama Medical and Pharmaceutical University (Japan). She completed her post-doctoral research at the University of Kentucky in the area of transdermal drug delivery. Prior to joining FDA, she was an Associate Professor of Pharmaceutical Sciences at the South College School of Pharmacy, TN.

Associate VP Regulatory Strategy, Simulations Plus

Dr. Xavier Pepin is a pharmacist (University Paris XI). He has a Ph.D. in. granulation technology where he studied powder surface energy and liquid bridges during wet high-shear granulation. He has more than 25 years of experience in the pharmaceutical industry and has occupied several positions from preformulation, clinical, and commercial formulation development, industrial transfer, regulatory CMC, and biopharmaceutics. He has worked in
biopharmaceutics for 15 years using in vitro, in silico, and in vivo tools to support evaluation of drugs along the development value chain and post marketing. He was the co-leader of WP4 in silico tools for the OrBiTo IMI project 2012-2018. He has 30 publications in the field of powder surface energy, granulation technology, and biopharmaceutics.

Co-Director of CRCG, Professor of Pharmaceutical Sciences and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics, University of Maryland, Simcyp

Co-Director of CRCG, William I Higuchi Collegiate Professor of Pharmacy Associate Professor of Pharmaceutical, Sciences Biointerfaces Institute, College of Pharmacy, University of Michigan

Staff Fellow, DTP I, ORS, OGD, CDER, FDA

Assistant Professor of Pharmaceutics, University of Rhode Island

Dr. Jie Shen is Assistant Professor of Pharmaceutics at the University of Rhode Island (URI). She is also a Senior Development Scientist at the URI Pharmaceutical Development Institute, a training and clinical material development and manufacturing facility. Dr. Shen’s research is focused on formulation development, manufacturing, in vitro release testing, and in vitro- in vivo correlation (IVIVC) of complex dosage forms such as ophthalmic dosage forms, long acting parenterals, and locally acting rectal/vaginal semi-solids. her Ph.D. in Pharmaceutical Sciences from the China Pharmaceutical University, Nanjing, China. Prior to join URI in Oct. 2016, she was a postdoctoral fellow and Assistant Research Professor at the University of Connecticut. Dr. Shen is currently the Vice Chair of the AAPS IVRDT (In Vitro Release and Dissolution Testing) Community and the CRS C&DP (Consumer & Diversified Products) Division. She is on the editorial boards of several journals including the International Journal of Pharmaceutics and Pharmaceutics, and a Scientific Advisor to the Editors of the Journal of Pharmaceutical Sciences.

ORISE Fellow, DPQR, OTR, OPQ, CDER, FDA

Dr. William C. Smith (Billy) is currently an ORISE Fellow with Dr. Xiaoming Xu in the Division of Product Quality Research working on complex drug formulations from emulsions to implantable polymeric devices. His research focuses on the physicochemical characterization of nano- and micro-scale materials, including the development of analytical and in vitro release test methodologies to support assessment and review, equivalence determination,
and evaluation of drug product quality. Billy received his Bachelor of Science in Chemistry from The Evergreen State College and his Ph.D. in 2019 from the Colorado School of Mines under Dr. Kim R. Williams, with a concentration in analytical chemistry. His Ph.D. focused on the development of thermal field-flow fractionation for the characterization of hybrid colloidal nanomaterials and polymers with complex architectures. In 2017, Billy was a guest researcher at the Leibniz-Institute for Polymer Research (IPF) in Dresden, Germany investigating novel hyperbranched polyethylenes and polyesters.

Senior Pharmacokineticist, DQMM, ORS, OGD, CDER, FDA

Dr. Ming-Liang Tan is a Senior Pharmacokineticist in the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD). In his current role, Dr. Tan’s responsibilities include managing research projects to support bioequivalence studies, addressing controlled correspondences and citizen petitions, providing response to pre-ANDA meeting requests and internal consults, and developing product specific guidance. His main research interests include the physiologically-based pharmacokinetics (PBPK) modeling and simulations, with a focus on the area of locally-acting complex products such as ophthalmic drug products.

Team Lead Complex Drug Products, DTP I, ORS, OGD, CDER, FDA

Dr. Yan Wang is the team lead for Complex Drug Products Team in the Division of Therapeutic Performance I (DTP I), Office of Research and Standards (ORS), Office of Generic Drugs (OGD). In her current role, Dr. Wang leads a group of interdisciplinary scientists developing product specific guidances, addressing controlled correspondences, pre-ANDA meeting requests, citizen petitions and internal consults in the areas of complex drug substances and complex formulations for various routes of administration and dosage forms. She also manages research projects on developing new analytical methods, in vitro characterization, and drug release testing methodologies for complex drug products. She specializes in complex parenteral, ophthalmic, otic, intravaginal, and intrauterine formulations. Dr. Wang received Ph.D. in Pharmaceutical Sciences from the University of Connecticut.

Lab Chief, Division of Product, DPQR, OTR, OPQ, CDER, FDA

Dr. Xiaoming Xu serves as Lab Chief in Division of Product Quality Research in Office of Testing and Research in FDA, where he leads multiple regulatory research areas such as complex formulations, nanomaterials, and advanced manufacturing. Dr. Xu is a member of FDA Nanotechnology Task Force and is responsible for developing international collaborative programs and standards in areas related to nanotechnology. He is also an editorial board member of the International Journal of Pharmaceutics. He received his B.S. and M.S. degrees in Pharmaceutics from China Pharmaceutical University and Ph.D. degree in Pharmaceutical Science from University of Connecticut.

Associate Professor, Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin

Dr. Feng Zhang is an Associate Professor of Molecular Pharmaceutics and Drug Delivery at The University of Texas at Austin. Dr. Zhang received his Ph.D. in Pharmaceutical Science at the University of Texas at Austin in 1999. He worked at PharmaForm and Gilead Sciences, prior to joining the College of Pharmacy at the University of Texas at Austin in Jan 2014. His team’s research interests include (1) formulation, processing, and characterization of melt-extruded long-acting implants, (2) investigation of process-induced transformation of API during twin-screw continuous granulation, and (3) simulation and modeling of melt extrusion for preparing amorphous solid dispersions to enhance bioavailability of BCS Class 2 and 4 drugs. He has published over 80 papers in peer reviewed journals, supervised 6 students to their Ph.D. degree, and mentored 2 post-docs. He is the inventor of 15 patents.

Managing Director, DigiM Solution LLC

Dr. Shawn Zhang is a co-founder and managing partner at DigiM. Dr. Zhang graduated from Rutgers University with a Ph.D. in Computational Physics and a minor in Computer Engineering. Before starting Boston-based DigiM, he held senior positions at leading CAE software company Fluent (now Ansys) and leading electron microscopy company FEI (now ThermoFisher). He is passionate about the combined power of imaging, AI, and computational physics. He has authored over a hundred publications, patents, and software. Dr. Zhang leads DigiM to becoming a trusted partner in microstructure science for pharmaceutical development and quality testing.