Formulation Characterization and Cutaneous Pharmacokinetics to Facilitate Generic Topical Product Development

Date: November 3, 2022 , 8:00 am – 5:00 pm

Co-hosts:  FDA and Center for Research on Complex Generics (CRCG)

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The limited number of certain generic topical products may have resulted from the difficulty in demonstrating bioequivalence (BE) efficiently. To address this public health issue, FDA invested in research and developed new in vitro (laboratory), in silico (computational modeling) and in vivo (clinical) approaches, which could be used to establish the BE of topical products in a far more efficient manner. Efficient characterization-based approaches to demonstrate BE are now established for prospective generic drug products, but their utility is limited to instances when the formulation composition of prospective generic products is well matched to that of the reference standard. In other instances, comparative clinical endpoint BE studies continue to be utilized.

The purpose of this workshop is to discuss efficient, science-based BE approaches in development that may be useful for certain prospective generic products that are compositionally different compared to the reference standard. These approaches may utilize sophisticated techniques that have been developed to characterize the physical, structural, sensorial and thermodynamic properties of topical drug products applied on the skin, as well as in vivo cutaneous pharmacokinetics (PK) studies. The workshop will provide an update on the progress of research activities funded by the Generic Drug User Fee Amendments, explore challenging issues that would benefit from broader discussion, identify areas that should be targeted with further research, and discuss opportunities for coordination and collaboration between FDA, the generic industry, academic institutions, contract research organizations, consultants and others involved in generic drug development.

FDA and the Center for Research on Complex Generics—which is a collaboration between the University of Maryland School of Pharmacy and the University of Michigan College of Pharmacy—are dedicated to advancing programs that stimulate scientific dialogue, disseminate current insights about complex generics, and generate new knowledge in support of FDA’s mission to promote and protect the public health by increasing access to safe and effective generic medicines.

Workshop Topics

  • Understanding the influence of inactive ingredients and other aspects of topical formulations on their performance
  • Establishing the theoretical framework and scientific principles for well-controlled in vivo cutaneous PK studies that are sensitive and discriminating
  • Elucidating practical challenges associated with method development and validation of in vivo cutaneous PK methodologies

Audience

The generic drug industry, academic institutions, contract research organizations, consultants, and others involved in, or whose work supports, the development of generic drug products.

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Headshot of Manfred BodenlenzSenior Scientist, Joanneum Research Forschungsgesellschaft Health Institute for Biomedicine and Health Sciences

Dr. Manfred Bodenlenz is a Senior Scientist at Joanneum Research Forschungsgesellschaft (mbH) Health Institute for Biomedicine and Health Sciences. He has been working with continuous sampling techniques such as microdialysis and open flow microperfusion (OFM) for the last 22 years in clinical and preclinical PK-PD and BA-BE studies and has experienced their value for drug and biomarker research at or close to the target site. He is also appointed as the PRRC – Person Responsible for regulatory compliance”, which is like the ‘Qualified Person’ in Pharma of Medical Device Regulation (MDR) in Europe. He has a broad background in medical device engineering as well as clinical and preclinical research in the field of dermatology and topical drugs. Dr. Bodenlenz studied Biomedical Engineering at the University of Patras in Greece, and Johns Hopkins University in Baltimore, U.S., and completed both his M.Sc. and Ph.D. at the University of Technology in Graz, Austria.

Headshot of Charles E. DiLiberti

President, Montclair Bioequivalence Services, LLC

Charlie DiLiberti has 39 years’ experience in the pharmaceutical industry, including 17 years at Barr Laboratories (later acquired by Teva Pharmaceuticals). Charlie built and oversaw Barr’s cutting-edge bioequivalence and pharmacokinetics program for generic drugs, small molecule proprietary drugs, and biologics. Charlie left his position as Vice President of Biopharmaceutics at Teva Women’s Health Research in 2010 to start his own firm, Montclair Bioequivalence Services, LLC, which provides strategic consulting services around the world in generic, innovative, and biological drug development, biostudy planning/risk management, formulation development guidance, and advanced troubleshooting methods, with a focus on difficult/complex products. In 2018, along with several colleagues, Charlie co-founded Scientists Advancing Affordable Medicines, Inc. (SAAMnow®), a non-profit organization which provides a dedicated platform for scientists to share innovative research that facilitates the development of high- quality, affordable medicines, thereby improving their accessibility to patients. Charlie holds a Bachelor of Arts (B.A.) in Biochemical Sciences from Princeton University and a Master of Science (M.S.) in Chemistry from Stevens Institute of Technology.

Headshot of Vaibhav DubeyDeputy General Manager, Specialty Formulations, Alembic Pharmaceuticals Ltd.

Dr. Vaibhav Dubey is working as Deputy General Manager, Specialty Formulations at Alembic Pharmaceuticals Ltd., India. He was previously associated in different roles with Sun Pharma Advanced Research Company Ltd., Sun Pharma Industries Limited, and Dr. Reddy’s Laboratories. He has been instrumental in developing numerous topical generic and novel drug products intended for filing either as 505(b)(1), 505(b)(2), or 505(j) regulatory pathways and has contributed immensely to developing bioequivalent (BE) strategies centered on in vitro characterization based approaches for several generic topical drug products. Dr. Dubey has also almost two decades of research experience in the Development and Characterization of Topical and Transdermal drug products with several publications and patents to his credit. His Master of Pharmacology and Ph.D. research imbibed studying skin permeation mechanistic of drug-laden modified liposomes.

Headshot of Candis Edwards

Senior Vice President, Regulatory Affairs, Amneal Pharmaceuticals

Candis Edwards is the Senior Vice President of Specialty Regulatory Affairs at Amneal Pharmaceuticals. Candis Edwards has over 40 years of experience in the pharmaceutical industry with significant experience in the development of regulatory policies for topical dermatological products. She holds a Bachelor of Science (B.S.) in Microbiology and Public Health from Wagner College and a M.S. in Industrial Pharmacy from St. John’s University where she also serves as an Associate Adjunct Professor. Ms. Edwards has been a presenter at many Public Health Authorities and Industry forums.

Headshot of Priyanka GhoshSenior Pharmacologist, DTP I, ORS, OGD, CDER, FDA

Dr. Priyanka Ghosh is a senior pharmacologist within the Division of Therapeutic Performance. Her areas of expertise include products in the topical and transdermal drug delivery area. In her current role, Dr. Ghosh leads regulatory science research initiatives related to topical and transdermal drug products, including projects related to the development of noninvasive imaging techniques for the evaluation of cutaneous pharmacokinetics, under the GDUFA regulatory science program. Dr.Ghosh also leads the development of general and product-specific guidance, reviews strategies for pre-ANDA meeting requests, and citizen petitions, and is the co-chair of the Bioequivalence Standards for Topicals Committee within OGD. Prior to joining FDA, Dr. Ghosh completed her Bachelor’s degree in Biotechnology from West Bengal University of Technology (India) and a Ph.D. in Pharmaceutics and Drug Design from the University of Kentucky.

Headshot of Romit Jani

Director, Formulation Research & Development, Solaris Pharma Corporation

Romit Jani is the Director and Head of Formulation R&D at Solaris Pharma, a company primarily focused on the development of complex dosage forms. Currently, he leads the research and development activities of the company includingformulation development, scale ups, and commercialization.  Prior to Solaris, he worked as a Research Scientist at Amneal Pharmaceuticals and was responsible for formulating and scaling up various complex dosage forms including topicals, extended-release powders, and ophthalmics. He received his Master of Science in Pharmaceutical Manufacturing from Stevens Institute of Technology in Hoboken, NJ, and has around 10 years of experience in the pharmaceutical industry taking products from concept to commercialization.

Headshot of Benjamin Kuzma

Research Scientist, Global Drug Metabolism and Pharmacokinetics, Vertex Pharmaceuticals Inc.

Dr. Benjamin A. Kuzma is currently a Research Scientist at Vertex Pharmaceuticals Inc. within the Global Drug Metabolism and Pharmacokinetics group. Before joining Vertex, his research focused on cutaneous pharmacokinetics using dermal microdialysis and coherent Raman imaging. He obtained his Ph.D. from Long Island University in Pharmaceutical Sciences under the supervision of Dr. Grazia Stagni. During his graduate studies, he collaborated with the U.S. FDA Office of Generic Drugs on dermal microdialysis studies to provide the groundwork for dermal microdialysis to be considered a regulatory tool to evaluate topical bioavailability and potentially bioequivalence. After completing his degree, he joined Dr. Conor Evans’s lab at Massachusetts General Hospital/ Harvard Medical School as a postdoctoral fellow. In the Evans Lab, he helped establish coherent Raman imaging standards for reliable and reproducible datasets and advanced the technology to serve a more significant subset of active pharmaceutical ingredients.

Headshot of Likan Liang

Branch 5 Chief, DLBP II, OLDP, OPQ, CDER, FDA

Dr. Likan Liang is a Branch Chief in the Division of Liquid-Based Products II, Office of Lifecycle Drug Products. Branches in Liquid-Based Product divisions review generic applications of liquid-based drug products which include topical drug products. Dr. Liang has served as the Office of Pharmaceutical Quality Chair in the reviews of a number of complex generic topical product development meeting requests. Before joining the FDA in 2013, Dr. Liang has worked in the pharmaceutical industry for about 16 years in various capacities, in areas including API synthesis, formulation development of various dosage forms and complex drug products, drug product manufacturing process development, scale up, technology transfer, and commercial scale manufacturing. Dr. Liang has a Ph.D. degree in Organic Chemistry.

Headshot of Robert Lionberger

Director, ORS, OGD, CDER, FDA

Dr. Robert Lionberger serves as Director of the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD). Dr. Lionberger leads OGD’s implementation of the Generic Drug User Fee Amendments (GDUFA) science and research commitments including internal research activities and external research grants and collaborations to ensure the therapeutic equivalence of generic drug products. ORS also provides pre-submission advice on complex generics through pre-Abbreviated New Drug Application (ANDA) meetings, product-specific guidance, and correspondence responses.

He received his undergraduate degree from Stanford University in Chemical Engineering, and a Ph.D. from Princeton University in Chemical Engineering. After his Ph.D., he conducted post-doctoral research in Australia in the Department of Mathematics and Statistics at the University of Melbourne. Prior to joining the FDA 18 years ago, Dr. Lionberger was an Assistant Professor of Chemical Engineering at the University of Michigan.

Headshot of Markham C. Luke

Director and Supervisory Physician (Dermatology), DTP I, ORS, OGD, CDER, FDA

Markham C. Luke, M.D., Ph.D., F.A.A.D., serves as FDA Supervisory Physician (Dermatology) and Director of the Division of Therapeutic Performance I (DTP I) in the Office of Research and Standards, Office of Generic Drugs at FDA. DTP I is responsible for facilitating pre-application development of generic drugs by conducting and promoting regulatory science research to establish standards to ensure therapeutic equivalence of new generic drug products. Markham has an M.D. and a Ph.D. in Pharmacology from Johns Hopkins University and completed his dermatology residency and fellowship at Washington University, St. Louis, MO and the National Institutes of Health, Bethesda, MD. Markham serves as Associate Professor in Dermatology at the Uniformed Services University of the Health Sciences, Bethesda, MD. Markham has research interests in dermatopharmacology, clinical pharmacology, clinical study design and endpoints assessment (including patient-reported outcomes) for medical, surgical, and aesthetic products and serves as consultant dermatologist to various parts of FDA. Markham has been at FDA since 1998 serving various roles, including as the Lead Medical Officer for dermatology drugs, Chief Medical Officer and Deputy Director for the Office of Device Evaluation in the Center for Devices and Radiologic Health, and as Acting Director for Cosmetics in the Center for Food Safety and Applied Nutrition. In each of these roles including his current one in OGD, he has been involved in programs and initiatives dealing with product innovation as related to public health for our nation.

Headshot of Yousuf Mohammed

Senior Research Fellow/Research Leader, University of Queensland Diamantina Institute

Dr. Yousuf Mohammed is a Research leader at The University of Queensland (Australia) Diamantina Institute within the Faculty of Medicine. He currently leads multiple US FDA-funded projects which aim to improve regulatory guidelines for topical and transdermal products. Over the last decade, his work has focused on dermatological product development and assessment of performance, drug-device combinations, skin penetration and toxicology of drugs, and xenobiotics, including nanoparticulate material. He completed his Ph.D. in Pharmaceutics and Skin Drug Delivery in 2013. His collaborative work with the FDA, Office of Generic Drugs, on topical product characterization has resulted in the development and standardization of numerous assessment techniques.

Headshot of Narasimha Murthy

Chief Scientific Officer, Topical Products Testing LLC

Dr. S. Narasimha Murthy is the Chief Scientific Officer of Topical Products Testing LLC (TPT LLC), Oxford, MS. TPT. LLC provides contract services to pharmaceutical companies in the areas of development of topical formulations (dermal, mucosa, nail, and ophthalmic), characterization of products, in vitro permeation, and release testing. TPT, LLC team is currently working on two research projects funded by the FDA.  Dr. Murthy was a former Professor of Pharmaceutics and Drug Delivery and Associate Director of the Center for Pharmaceutical Technology at the University of Mississippi School of Pharmacy. Dr. Murthy is also the Founder-Director of a philanthropic non-profit research organization, the Institute for Drug Delivery and Biomedical Research in Bangalore, India.  Dr. Murthy has published over 150 research papers and presented over 250 scientific posters at various national and international scientific meetings. He has authored two books and fifteen book chapters.

Dr. Murthy has received several awards such as the New Investigator award such as the Cumberland Researcher of the year award from the University of Mississippi, the Global Indus Technovator award from MIT, the Endowed Chair for Research award at the Ohio Northern University, and he was inducted as the Fellow of American Association of Pharmaceutical Scientists in 2017. He was bestowed with the Distinguished Scientist award by the American Association of Indian Pharmaceutical Scientists (AAiPS) in 2018. He was also recognized as “Eminent Scientist” by the Association of Pharmacy Professionals (APA). Dr. Murthy is the recipient of the prestigious AAPS Pharmaceutical Global Health 2022.

Headshot of Hiren Patel

Staff Fellow, DB II, OB, OGD, CDER, FDA

Dr. Hiren Patel is a bioequivalence assessor in the Division of Bioequivalence II within the Office of Generic Drugs (OGD). Prior to joining FDA, he earned his M.S. and Ph.D. with specialization in Pharmacokinetics at Long Island University, Brooklyn, NY. At the FDA, he is responsible for assessing the bioequivalence of the various dosage forms of generic drugs. He is the lead for the topical and transdermal drug products and the advanced techniques for demonstrating bioequivalence of such complex drug products within the Office of Bioequivalence. He is the co-chair for the Bio-Equivalence Standards for Topicals (BEST) Expert Committee within OGD. He has also actively served as a consultant in the research initiatives related to advanced sampling techniques such as Microdialysis and Dermal open flow perfusion, which are the collaborative efforts of FDA and global research institutions pertaining to the topical and transdermal drug products funded through FDA. Dr. Patel is also actively involved in the review panel for the Product Specific Guidance for the generic topical drug products.

Headshot of James Polli

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

Dr. James E. Polli is a Professor of Pharmaceutical Sciences, and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at the University of Maryland. His research interest is oral drug absorption and formulation, involving laboratory and clinical research. He has served as an advisor to 24 Ph.D. graduates. Dr. Polli is co-Director of the recently initiated Center for Research on Complex Generics, an FDA-funded collaborative agreement with the Agency. He is Director of the online M.S. in Regulatory Science program (www.pharmacy.umaryland.edu/regulatoryscience).

Headshot of Tannaz Ramezanli

Senior Pharmacologist, DTP I, ORS, OGD, CDER, FDA

Dr. Tannaz Ramezanli is a senior pharmacologist within the Office of Research and Standard (ORS) at the Office of Generic Drugs (OGD). She specializes in topical and transdermal products. She is a senior reviewer for the development of product specific bioequivalence guidance, responding to controlled correspondences, citizen petitions, and pre-ANDA meeting packages. She leads several regulatory science research initiatives related to the development of bioequivalence standards for complex topical drug products through FDA-funded collaborations with research institutions around the world. Tannaz received her Ph.D. in Pharmaceutical Sciences from Rutgers University and her Pharm.D. from Tehran University of Medical Sciences.

Headshot of Elena Rantou

Lead Mathematical Statistician, DB VIII, OB, OTS, CDER, FDA

Dr. Elena Rantou is a lead mathematical statistician at the Office of Biostatistics (OB) in OTS/CDER/FDA. Her work is mainly focused on assessing bioequivalence of topical/dermatological generic products, characterizing outliers in replicate study designs, and the detection of data anomalies. She worked towards the development of the scaled bioequivalence test for IVPT data that first appeared in the FDA Acyclovir Guidance in 2016. Since then, she is involved in other IVPT-related research such as outliers and handling of zero values among others. Before joining OB in 2013, she worked as a statistical consultant as well as in academia, teaching Probability and Statistics for over 15 years. Dr. Rantou holds a Bachelor’s degree in Statistics from the Athens University of Economics and Business (Athens, Greece) and Master’s and Ph.D. degrees in Statistics from American University, Washington, DC.

Headshot of Sam Raney

Associate Director/Chief Scientific Advisor, ORS, OGD, CDER, FDA

Dr. Sam Raney is a thought leader in topical and transdermal drug products, with over 30 years of experience in skin research, producing numerous research manuscripts, review articles, book chapters, and patents in pharmaceutical product development. Dr. Raney has been a researcher and adjunct professor within academia, a principal or sub-investigator on over 400 pharmaceutical product studies, has held senior management roles in industry, and serves on multiple expert committees and panels for the US Pharmacopeia. He is the Associate Director for Science in the FDA’s Office of Research and Standards and serves as the Chief Scientific Advisor for topical product bioequivalence issues in the FDA’s Office of Generic Drugs. Dr. Raney holds a Bachelor’s degree in Molecular Biophysics & Biochemistry from Yale University and a Ph.D. in Biochemistry & Molecular Biology from the University of British Columbia in Canada.

Headshot of Sameer Sachdeva

Associate Director/Sr. Research Scientist, Amneal Pharmaceuticals

Dr. Sameer Sachdeva is the Associate Director/Sr. Research Scientist for Drug Product Development at Amneal Pharmaceuticals. Dr. Sachdeva’s expertise includes products in the topical and transdermal drug delivery area. Dr. Sachdeva holds a B.S. degree in Pharmacy from the University of Delhi (India) and a Ph.D. in Pharmaceutical Sciences from the University of the Pacific (CA, US). Dr. Sachdeva has published numerous research manuscripts and is also present on the reviewer board and the editorial board of many peer reviewed journals.

Headshot of Anna Schwendeman

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

Dr. Anna Schwendeman is a William I Higuchi Collegiate Professor of Pharmacy and Associate Professor of Pharmaceutical Sciences at the University of Michigan. Her research focus is on the optimization of high-density lipoprotein (HDL) nanoparticles for the treatment of atherosclerosis, sepsis, and drug delivery purposes. In 2016, she co-founded a company EVOQ Therapeutics (www.evoqtherapeutics.com) focused on the use of HDL nanodiscs for the delivery of personalized neoantigen cancer vaccines. Dr. Schwendeman received her B.S. from the Moscow Institute of Physics and Technology and Ph.D. in Pharmaceutics from The Ohio State University. Prior to starting her academic career in 2012, Dr. Schwendeman spent 12 years in the pharmaceutical industry at Cerenis Therapeutics, Pfizer, and Esperion Therapeutics. She was involved in the discovery and translation of HDL drugs to clinical trials. She successfully submitted FDA INDs for seven different products including nanoparticles, liposomes, recombinant proteins, peptides, and small molecules. Her laboratory’s research in regulatory sciences is focused on the analytical characterization of liposomes, polymer microspheres, peptides, and biosimilar products. She is co-director of FDA sponsored Center for Research in Complex Generics (http://www.complexgenerics.org). Dr. Schwendeman is an Associate Editor for Nanomedicine NBM and Eur. J. Pharm and Biopharm.

Headcount of Chinmay Shukla

Clinical Pharmacology Team Leader, DII P, OCP, OTS, CDER, FDA

Chinmay Shukla, Ph.D., is serving as a Clinical Pharmacology Team Leader of the dermatology, dental, sunscreen, and topical health care antiseptic review teams with the Office of Clinical Pharmacology at the U.S. Food and Drug Administration (FDA). His work involves a review of clinical pharmacology information submitted to support approval of New Drug Applications (NDAs), Biologics License Applications (BLAs), Biosimilar, and OTC Monograph qualifications. He received his Bachelor of Pharmacy from Mumbai University, India, and Master and Doctorate in Pharmaceutical Sciences from Long Island University, NY.

His research interests are the design of clinical pharmacology studies for topical dermatological products, dermal microdialysis, and transdermal drug delivery. He has published several research papers in peer-reviewed journals and has also co-authored a book chapter addressing the regulatory aspects of microdialysis. He serves as a reviewer for several scientific journals and is also currently serving as a Scientific Advisor to the Editor of the Journal of Pharmaceutical Sciences.

With the American Association of Pharmaceutical Sciences (AAPS), he served as the Secretary and Treasurer of the Pharmacokinetics Pharmacodynamics Drug Metabolism (PPDM) Section and also served as a Chair of the AAPS Microdialysis Focus Group.
He has received several awards both at FDA and at AAPS for excellence in clinical pharmacology review and leadership.

Headshot of Frank Sinner

Vice-President Regulatory & Strategic Affairs, Institute for Biomedicine and Health Sciences, JOANNEUM RESEARCH GmbH

Dr. Frank Sinner has studied technical chemistry at the Technical University of Graz, Austria. He completed his Ph.D. in Chemistry in 2002 at the University of Innsbruck and passed his habilitation at the Medical University of Graz, Austria. He is the Vice-President of Regulatory & Strategic Affairs of the Institute for Biomedicine and Health Sciences at JOANNEUM RESEARCH. He is an expert in innovative pre-clinical and clinical methods for tissue-specific PK, PD, and bioequivalence (BE) and its use in pharmaceutical development. He is leading the development of dermal Open Flow Microperfusion for cutaneous BE studies for topically applied drugs at JOANNEUM RESEARCH. He managed numerous research and industrial projects, inter alia, he was the principal investigator of three U.S. FDA-funded research projects in the area of cutaneous bioequivalence. His institute provides innovative methods and services including to de-risk topical drug development. He has published more than 100 papers in reputed journals and book chapters and has been serving as an editorial board member.

Headshot of Nilufer Tampal

Associate Director for Scientific Quality, OB, OGD, CDER, FDA

Dr. Nilufer Tampal is the Acting Associate Director for Scientific Quality in OGD’s Office of Bioequivalence. In this role, Dr. Tampal develops strategies and oversees the implementation of data quality and the scientific integrity of bioequivalence data submitted in Abbreviated New Drug Applications (ANDAs). She provides expertise in the utilization of advanced analytic data tools supporting ANDA reviews. As a leading senior expert within the Office of Bioequivalence for international harmonization efforts regarding bioequivalence in ANDAs, she serves as the Rapporteur for the International Council for Harmonization (ICH) Generic Drug Discussion Group. She is also the FDA’s Topic Leader on the ICH M13 Expert Working Group that is developing a harmonized M13 guideline on the bioequivalence of immediate-release solid oral dosage form drugs.

Dr. Tampal received her Ph.D. in Toxicology from the University of Kentucky and an M.S. in Chemistry from Bombay University, India. She started her career at the FDA in 2002 as an investigator in the Office of Study Integrity and Surveillance (PKA DSI) and has held various leadership positions in the Office of Bioequivalence for the last 12 years. Her multi- disciplinary knowledge and training in pharmacology, toxicology, chemistry, bioanalysis, site inspections, and regulatory science have positioned her to contribute to a multitude of FDA and CDER Committees working to advance regulatory science and policies in areas of ongoing importance to the Agency. Dr. Tampal’s most noteworthy contribution to the Agency is her recognition of the need for recommending additional testing of incurred samples to assure the reliability of data from the bioanalytical studies submitted to the Agency. This contribution has made a global impact in the field of bioanalysis. Prior to her FDA career as a Chemist, she gained years of experience in the synthesis and analysis of ‘small molecules’ at a multinational pharmaceutical in India.

Headshot of Nageshwar Thudi

Vice President-Global Generics and Biosimilar Clinical Development and Operations, Teva Pharmaceuticals

Dr. Thudi has 23 years of Generic as well as CRO experience in the field of Bioequivalence and Clinical efficacy trials.  Dr. Thudi got his Ph.D. degree in Pharmacy from the University of Jadavpur, India. Dr. Tehudi has 25 publications in international peer-reviewed journals and also presented at various conferences. His interest is to harmonize various regulatory requirements in the field of Bioequivalence and Efficacy trials.

Headshot of Eleftheria Tsakalozou

Senior Pharmacologist, DQMM, ORS, OGD, CDER, FDA

Dr. 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 Ph.D. 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 the development of quantitative modeling and simulation tools to support bioequivalence assessments.

Headshot of Miyoung Yoon

Team Lead, DQMM, ORS, OGD, CDER, FDA

Dr. Miyoung Yoon currently serves as the Team Lead for the quantitative clinical pharmacology team in the Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, CDER/FDA. Since she joined the team in 2019, she has been leading the team’s efforts to conduct regulatory and research activities leveraging clinical pharmacology tools and expertise and actively developing collaborations with multiple stakeholders. In addition, Dr. Yoon is contributing to applying mechanistic modeling approaches such as physiologically based pharmacokinetic models to support generic drug assessment. She received her Ph.D. degree in Pharmacology/Toxicology from the School of Pharmacy at Seoul National University in South Korea and completed her post-doctoral training at the U.S. Environmental Protection Agency through the National Research Council of the National Academies of Sciences, Engineering, and Medicine’s Research Associateship program.

headshot of Jinhui Zhang

Chemist, DPQR, OTR, OPQ, CDER, FDA

Dr. Jinhui Zhang is a Chemist at the CDER/FDA. His research at the FDA focuses on using advanced mass spectrometry and automation for clinical studies and the characterization of biotherapeutics and complex drug products.

Prior to joining FDA, he held a research faculty appointment at Texas Tech University. He has given over 50 invited podium presentations and published over 50 peer-reviewed publications on regulatory science, drug product quality, proteomics, clinical and preclinical pharmacokinetics, bio-analytical methodologies, pharmacogenomics, and omics-based pharmacodynamics biomarkers.  Dr. Zhang is an editorial advisory board member of Bioanalysis.

Workshop Recordings

Workshop Slides

SESSION 1: Understanding the Influence of Formulation Differences on Product Performance

SESSION 2: Development of Cutaneous PK Based Approaches

If you have any questions about this workshop, please contact info@complexgenerics.org