Characterization of Complex Excipients and Formulations

Senior Staff Fellow, DQMM, ORS, OGD, CDER, FDA

Dr. Khondoker Alam is currently working as a senior staff fellow in the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD) in FDA. Dr. Alam is serving as scientific lead for complex injectables such as long acting injectables, liposomal injections etc. His role in the division is to utilize physiologically based pharmacokinetic (PBPK) modeling and other quantitative tools to address specific questions pertinent to drug development process and/or regulatory decision making. He is responsible for reviewing preabbreviated new drug applications (pre-ANDA) meeting packages, ANDA post complete response letter (post-CRL) scientific meeting packages, ANDA consults and controlled correspondences on complex injectables and topical dermatological drug products where model based alternative bioequivalence approach is proposed by ANDA applicant. He is serving as project lead and key technical member for multiple FDA research projects on complex injectables, topical dermatological drug products, buccal/sublingual drug products as well as projects related to mitigation strategy for N-nitrosamine impurities. His research interests include PBPK modeling, development of computational tools for virtual bioequivalence, studying the role of transporter proteins and metabolizing enzymes in drug disposition, and drug-drug interactions.

Senior Staff Fellow, DIMRP III, OLDP, OPQ, CDER, FDA

Dr. Cedar Boakye is a Senior Drug Product Quality Assessor in the Office of Lifecycle Drug Products within OPQ. She is a subject matter expert in the quality assessment of prospective generic implants, vaginal systems, intrauterine systems, and transdermal/topical drug delivery systems (TDS). Cedar also conducts quality assessment of semi-solid topical products, oral liquid products and modified- & immediate-release solid oral products. She is a member of the CDER Transdermal Working Group and maintains an active interest in research associated with TDS quality. Her work to evaluate intrinsic safety issues associated with fentanyl reservoir transdermal systems led to the removal of these products from the US market, and she was recognized with the FDA Scientific Achievement Award for Excellence in Review Science and the CDER Group/Team Honor Award due to the impact of this work. Cedar also serves as a TDS subject matter expert in the FDA-wide Transdermal/Topical Cannabinoid Products Working Group, and as a Government Liaison to the USP Expert Committee for Complex Excipients and the Polymer Subcommittee. She earned her Ph.D. in Pharmaceutical Sciences from Florida A&M University, Tallahassee, Florida, and she is the author of over ten publications.

Distinguished Professor, Pfizer Distinguished Chair in Pharmaceutical Technology, University of Connecticut

Dr. Diane Burgess received her B.Sc. in Pharmaceutical Sciences at the University of Strathclyde (1979) and her Ph.D. in Pharmaceutics at the University of London (1984). She is a Fellow of AAPS, CRS, APSTJ, and AIMBE, the 2010 CRS President, the 2002 AAPS President, Editor of International Journal of Pharmaceutics (2009 – 2018), and the Editorial board member of 13 international journals. Dr. Burgess is the recipient of the 2023 AAPS Alice E. Till Advancement of Women in Pharmaceutical Sciences Recognition award, the 2018 AAPS Wurster Award in Pharmaceutics, the 2014 AAPS Research Achievement Award, the 2014 AAPS Outstanding Educator Award, the 2014 CRS Distinguished Service Award, the 2013 AAPS IPEC Ralph Shangraw Award, the 2010 CRSI Fellowship, and the 2011 APSTJ Nagai International Woman Scientist Award. She has over 278 refereed publications, over 718 research presentations, over 340 invited presentations, and 28 keynote and plenary addresses.

Dr. Burgess is the founder, DIANT Pharma (2019). DIANT Pharma develops proprietary continuous manufacturing technology for nanoparticles with a wide array of applications throughout multiple industries, such as lipid nanoparticles and liposomes for pharmaceutical formulations. She is also the inventor of 13 patents/patent applications, eleven of which have been licensed to companies and five products/product lines that have already been commercialized.

Senior Pharmaceutical Quality Assessor, DIMRP III, OLDP, OPQ, CDER, FDA

Dr. Meenal Chavan is a Senior Pharmaceutical Quality Assessor in DIMRP III, Branch 7 within OLDP/OPQ/CDER/FDA. Her areas of expertise include complex drug products such as topical and transdermal drug delivery systems,  IUDs, implants, and intra-vaginal ring. In her current role, Dr. Chavan performs secondary risk-based review assessment of ANDAs, Pre-ANDAs and DMFs. She works as an Application Technical Lead for IQA team AT-13.  Dr. Chavan is a contributor to Transdermal working group in CDER. Additionally, she works on Developmental Technical Committee of PQRI to promote advancements in drug product of development. Dr. Chavan joined FDA in 2016. Prior to joining FDA, she worked as a Sr. Manager R&D (Transdermal) at Sun Pharma, NJ. Dr. Chavan has 20 plus years of complex drug product development experience. She received her Ph.D. in Pharmaceutical Sciences from University of Mumbai, India.

Vice President, R&D and Regulatory Affairs, Nexus Pharmaceuticals, USA

Dr. Sridhar Desikan serves as the Head of R&D and Regulatory Affairs at Nexus Pharmaceuticals where he is responsible for leading teams to develop unique portfolios of injectable products to address unmet medical needs and guide them through the Regulatory approval for the US and global markets. Dr. Desikan has over 26 years of experience in the Pharmaceutical Industry with diverse experiences in all areas of CMC, from API development to drug product development and Analytical sciences. Prior to Nexus, Dr. Desikan served in the R&D organization of global pharmaceutical companies such as Novartis, DuPont Pharmaceuticals, Bristol-Myers Squibb, and Dr. Reddy’s Laboratories. At Dr. Reddy’s Laboratories, Sridhar Desikan served as the Vertical Head of Oral Solids, Injectables, and Inhalation product development. Dr. Desikan and his team developed many Non-Biologic Complex Drugs – peptides, nanosuspensions, liposomes, and microspheres.

Dr. Desikan received his Ph.D. in Chemical Engineering from Iowa State University, and undergraduate education from BITS, Pilani, India.

Manager, EVA and Long-Acting Drug Delivery Global Technology, Celanese– Florence, KY USA

Dr. Jeffrey Haley leads a team of scientists and engineers responsible for new product development, manufacturing scale-up, customer technical support, and quality assurance of ethylene vinyl acetate copolymers, as well as a team specifically focused on the application EVA to long-acting drug delivery. He received a B.S. in Chemical Engineering from The University of Texas, a Ph.D. in Chemical Engineering from the University of Minnesota and was a postdoctoral fellow in the Chemistry department at the University of Toronto. Dr. Haley started his industrial career in 2007 developing new polyethylene products for the Lyondell Chemical Company. His work with EVA started when he joined Celanese in 2011. Prior to his current role, Dr. Haley has held various positions at Celanese working on EVA product development and technical service, and established Celanese’s long-acting drug delivery laboratory and team.

Senior Chemist, DLBP II, OLDP, OPQ, CDER, FDA

Dr. Greg Huang is a Senior Chemist in the Office of Life Cycle Drug Product/OPQ within the Division of Liquid-Based Product II, performing CMC assessment for generic drug products (Pre-ANDA, ANDA, Controlled Correspondence, PAS), and serving subject matter expert for complex drug products. Dr. Huang has been with the Food and Drug Administration (FDA) for over 9 years. Prior to joining the FDA, he worked as an R&D team leader in the pharmaceutical industry for over 12 years. Dr. Huang received a Ph.D. in Chemistry from State University of New York at Albany.

Delivery Manger, Formulation Development Complex Injectables, Dr. Reddy’s Laboratory Ltd. India

Dr. Nirav Khatri has an experience of more than 16 years in formulation development of complex injectables from organizations like Dr. Reddy’s Laboratory, Zydus Cadila, Sun Pharmaceutical Industries, and Cadila Pharmaceuticals. Currently, he serves as Delivery Manager at Dr. Reddy’s Laboratory. In his role, he is responsible for complex injectable product development for various routes of administration involving application of new technologies and difficult to scale processes at commercial level.

Dr. Khatri’s areas of focus include – liposomes, microspheres, suspensions, peptides, drug-device combinations, and conventional sterile products. During his experience he has addressed challenges involved in physico-chemical characterization of complex drug substance, excipients, reverse engineering of drug product using advanced analytical techniques. Apart from physico-chemical sameness, he plays critical role in designing in vitro and in vivo studies to establish bioequivalence for regulatory approval.

He has also worked on several intradisciplinary and interdisciplinary projects in the area of targeted delivery systems and gene and siRNA delivery using liposomes and polymer-based microspheres. Many of them have culminated into several international research publications and granted patents on his name. Nirav holds a Ph.D. degree in Pharmaceutical Sciences from Maharaja Sayajirao University of Baroda, India.

Senior Application Technologies Engineer, NuSil Technology – an Avantor Company

Matthew Kihara is a Senior Application Technologies Engineer with NuSil and supports biomaterials customers with over a decade of experience working in various scientific, engineering, and leadership roles in the specialty silicones industry. Throughout his career and in collaboration with his teams, he has had multiple publications and several granted patents. Matthew holds an M.B.A. in Leadership and Marketing from Southern Utah University, a Master’s degree in Polymer Science from the University of Oregon, and a Bachelor’s degree in Chemistry from Idaho State University.

Director Regulatory Affairs – US, Pharmathen

Ameya Kohojkar currently serves as a Director, Regulatory Affairs – US at Pharmathen. He is responsible for and leads the US portfolio comprising of several complex products. In his 12+ years of experience, he has worked on combination products and a variety of complex dosage forms including topical, transdermal, buccal, injectable, ophthalmic, and otic. Prior to Pharmathen, Ameya had primarily worked on complex generics at Teva, Alvogen, Dr. Reddy’s Laboratories, Pfizer, and Sandoz. He received his undergraduate degree in Pharmacy from Mumbai University in 2010 and his M.S. in Regulatory Affairs for Drugs, Biologics and Medical Devices from Northeastern University in 2012, MA. He received a Regulatory Affairs Certification from the Regulatory Affairs Professionals Society (RAPS) in 2013.

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

Dr. Darby Kozak is the Deputy Division Director for the Division of Therapeutic Performance 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).

Senior Scientist, Research & Development, Sandoz Global Development

Dr. Ana Krese is a Senior Scientist in Sandoz’s research and development center. Her primary focus is in vitro drug release testing and correlation with in vivo performance of standard drug formulations and complex generics. She completed her Bachelor’s degree of Pharmacy and doctoral dissertation in Biomedicine at the University of Ljubljana, Slovenia (EU). She is a co-author of several research papers concerning the physiological and formulation variables affecting drug release characteristics.

Senior Chemist, DLBP I, OLDP, OPQ, CDER, FDA

Dr. Young K. Jhon is currently a senior chemist working at Division of Liquid-Based Products I (DLBPI), Office of Lifecycle Drug Products (OLDP), Office of Pharmaceutical Quality (OPQ), Center of Drug Evaluation and Research (CDER) at the FDA. He has more than 20 years of experience in the field of polymers, colloids (emulsions and suspensions), nanotechnology, drug-delivery system, fluid mechanics, thermodynamics, and rheology. In OPQ, he has been involved in the assessment of complex liquid-based dosage forms for oral, ophthalmic, parental, and topical routes, and in working groups for multiple guidances and research for complex drugs, including complex API sameness and the drug products that contain PLGA.  Also, he serves as application technical lead (ATL) for multiple applications and as USP liaison for General Chapters. Prior to joining FDA, he worked as an NRC fellow in Chemistry division at U.S. Army Research Office, Research Triangle Park (RTP), NC. He received a Ph.D. in Chemical Engineering from North Carolina State University, Raleigh.

Scientist, Orally Inhaled and Nasal Product Development, Vectura Fertin Pharma Ltd.

Dr. Mohamed Jafri serves as a Scientist specializing in Orally Inhaled and Nasal Products at Vectura Fertin Pharma. He joined the organization two years ago and possesses over 15 years of experience in both academic and industrial research and development in chemical and pharmaceutical products. His current focus areas include pulmonary, nasal, oral solid dosage forms, topical, ophthalmic, and injectable products.

Dr. Jafri’s work involves particle engineering, material science in the delivery of small and large molecules, drug-device combinations, biosimilars, topical and ophthalmic gels, and creams. In addition, he has experience in chemical engineering design, process calculations, and process modelling and simulation.

Dr. Jafri holds a Master’s degree in Pharmaceutical Science from the University of Greenwich in the UK and a Bachelor of Technology degree from the Department of Chemical Engineering at Anna University, Chennai, India.

Global Technical Marketing Manager, BASF Pharma Solutions

Dr. Lindsay Johnson leads the Solubilization Platform at BASF Pharma Solutions.  In her role, Dr. Johnson manages global projects and teams to enable formulations of hydrophobic and highly crystalline active pharmaceutical ingredients through approaches like amorphous solid dispersions, self-emulsifying drug delivery systems, and softgel encapsulation.  She also leads the parenterals portfolio for small molecule delivery through injection formulations. Dr. Johnson completed her Ph.D. on Pharmaceutical Excipients at the University of Minnesota.  She has held a range of technical, innovational, and commercial roles within BASF, internationally and domestically.

Associate Director, Research and Collaboration, Simulations Plus

Dr. Maxime Le Merdy is now the Associate Director of Research and Collaboration at Simulations Plus, the world-leading company in innovative modeling and simulation software applied to pharmaceutical research and development. Before joining Simulations Plus, Dr. Le Merdy received a Pharm.D. and a Ph.D. from Paris University. In 2017, he joined the FDA as a post-doctoral fellow in the Division of Quantitative Method and Modeling within the Office of Generic Drugs, where he developed his expertise in PBPK models for locally acting drug products and published multiple papers on ocular delivery models. He then joined Simulations Plus in 2018.

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.

Professor, School of Pharmacy, University of Connecticut, Associate Director, Center for Pharmaceutical Processing Research

Dr. Xiuling Lu, Professor at the University of Connecticut, Associate Director of Center for Pharmaceutical Processing Research, and Past Chair of the National Institute for Pharmaceutical Technology & Education, received her Ph.D. in Biochemical Engineering from the Chinese Academy of Sciences. She was appointed as a Research Assistant Professor at the University of North Carolina at Chapel Hill from 2008 to 2011 prior to joining the School of Pharmacy at the University of Connecticut. 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 is supported by NIH, American Cancer Society, NSF, FDA, etc. Dr. Lu has published more than 80 peer-reviewed publications in high impact journals. The innovative research has resulted in four issued US patents and four pending patent applications. Dr. Lu received American Association of University Professors-UConn Excellence in Research and Creativity: Early Career Award in 2016, Dean Robert L. McCarthy Faculty Service Award in 2019, as well as 2023 Research Advising Award. She is newly elected as the American Association of Pharmaceutical Sciences (AAPS) Fellow in 2023.

Associate Professor, Cockrell School of Engineering, University of Texas at Austin

Dr. Nathaniel (Nate) A. Lynd is originally from Michigan and educated in the public-school system in the state. He started undergraduate research in polymer chemistry after a semester of organic chemistry with the late Gregory L. Baker at Michigan State University and has been a polymer chemist ever since. Drawn to the subject of renewable-resource-derived polymers, Dr. Lynd moved to the University of Minnesota for his graduate education under Marc A. Hillmyer where he studied the effects of molecular weight distribution on block polymer self-assembly. In late 2007, he moved to the West Coast for postdoctoral studies at the University of California-Santa Barbara under Glenn H. Fredrickson, Craig J. Hawker, and the late Edward J. Kramer. Afterwards, Dr. Lynd took a position as Staff Scientist at Lawrence Berkeley National Laboratory in the Materials Sciences Division before joining the faculty in the McKetta Department of Chemical Engineering at The University of Texas at Austin in late 2015. Nate is currently an Associate Professor and the Laurence E. McMakin, Jr., Centennial Fellow in Chemical Engineering. He is also affiliated with the Texas Materials Institute and the graduate program in the Department of Chemistry at the University of Texas at Austin.

Senior Pharmaceutical Quality Assessor, DIMRP II, OLDP, OPQ, CDER, FDA

Dr. Yogeeta Narkar is the Application Technical Lead for immediate and modified release drug products in the Office of Lifecycle Drug Products. In her current role, Dr. Narkar works as a leader of an Aligned Team with a group of multidisciplinary scientists. She is responsible for providing technical leadership, fostering a collaborative environment, completing risk-based assessments, and making team-based approval decisions for oral, topical, and parenteral generic drug products.

Prior to joining the FDA in 2016, Dr. Narkar served in various positions in generic industry where she led the product development of complex oral, parenteral, and topical formulations. She has identified and developed various strategies for effective delivery using pharmacokinetic modelling and clinical end point data. She earned her Ph.D. in Pharmaceutical Sciences from the University of Wisconsin. She also holds a B.S. and an M.S. degree in Pharmacy and Pharmaceutics from the University of Mumbai, India.

President, Akina, Inc., Showalter Distinguished Professor of Biomedical Engineering, Purdue University

Dr. Kinam Park has studied drug delivery systems for more than four decades, focusing on the use of polymers for controlled drug release formulations, including oral delivery systems (fast-dissolving tablets, oral once-a-day formulations, gastric retention devices, and hydrotropic polymers for delivery of poorly soluble drugs) and intravenous administration of poorly soluble drugs (polymer micelles and drug crystals).

His recent research focuses on PLGA-based injectable, long-acting formulations for delivering small molecules, peptides, and protein drugs. His current research projects include (1) formulations of 2~6-month long-acting naltrexone/buprenorphine injectable formulations for treating opioid use disorder and (2) the development of new PLGA analytical tools for universal reverse engineering of complex long-acting injectable formulations, in particular for the formulations with limited amounts of PLGAs.

Associate Professor, Graz University of Technology, Deputy Director, Research Center Pharmaceutical Engineering (RCPE)

Dr. Amrit Paudel is an Associate Professor at Graz University of Technology and Scientific Leader of formulation drug delivery at the Research Center Pharmaceutical Engineering (RCPE), Graz, Austria.  Amrit worked in the discovery pharmaceutics team of Bristol-Myers Squibb. He completed his Ph.D. in 2013 in the drug delivery and disposition group at the University of Leuven, Belgium. He is the recipient of the Young Investigator Award of 2014, issued by the APGI. Dr. Paudel has a broad interest in the physical chemistry of formulations, drug delivery, and pharmaceutical material engineering. His current work involves predictive knowledge/model development for the stability and biopharmaceutics attributes of pharmaceutical products. In addition, design and engineering of an oral, pulmonary and diverse long acting drug delivery, are of his key interests.

Head of Regulatory Affairs, North America, Viatris

Dr. Brenda Pillari serves as Viatris’ Head of Regulatory Affairs in North America. With over 30 years of experience in the pharmaceutical, non-profit, and government sectors, she is responsible for the implementation of the regulatory strategy for the United States and Canada across the Viatris portfolio of brand and generic products.

Brenda joined Viatris from Endo Pharmaceuticals in New Jersey where she was Executive Director of Regulatory Affairs, responsible for the oversight and coordination of regulatory efforts relating to NDAs, ANDAs, amendments, and post approval supplements for internal and external R&D and approved products. Prior to Endo, she worked in various pharmaceutical roles at Merck, Pacira, and Teva in the US.

From 2003-2013, Brenda worked for the US Food and Drug Administration (FDA) in several different roles of increasing responsibility. Her work with the FDA started on the bench as a microbiologist and concluded within its Center for Drug Evaluation and Research. She holds a Ph.D. in Environmental Science and Public Policy from George Mason University, an M.S. in Biology and Pharmaceutical Marketing from Fairleigh Dickinson University, and a B.S. in Biology from Seton Hall.

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 Professor of Pharmaceutical Sciences and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at University of Maryland. His research interest is oral drug absorption and formulation, involving laboratory and clinical research. He has served as 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).

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

Dr. Bin Qin is currently a Senior Staff Fellow in the Division of Therapeutic Performance I, in OGD’s Office of Research and Standards. In his current role, Dr. Qin is responsible for the development of product-specific guidance for generic drug development, reviewing and responding to controlled correspondences, pre-ANDA meeting requests and internal consults. Dr. Qin is also a project officer on multiple regulatory science research initiatives related to complex drug products, under the GDUFA regulatory science research program.

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

Ara G. Paul Professor and Chair, Pharmaceutical Sciences, Professor of Biomedical Engineering, University of Michigan Biointerfaces Institute

Dr. Steve Schwendeman is Ara G. Paul Professor and Chair of Pharmaceutical Sciences and Professor of Biomedical Engineering at the University of Michigan (UM) Biointerfaces Institute. He is also co-director of the UM Bioinnovations in Brain Cancer program and Advanced Materials and Drug Delivery Thrust Leader of the Biointerfaces Institute at UM. He trained in Chemical Engineering (B.S.E.) and Pharmaceutics (Ph.D.) from UM and was an NIH postdoctoral fellow at MIT. He received the Young Investigator Award and a Best Paper Award from the Controlled Release Society (CRS). He is a Fellow of CRS and American Association of Pharmaceutical Sciences and elected to the National Academy of Inventors (2019). He is co-recipient of a $15 MM UM Bioscience Initiative Award to develop technological innovations in brain cancer. He was Associate Editor of Journal of Controlled Release from 2007-2021 and Pharmaceutical Research from 2004-2007. He has co-authored >150 publications, trained >25 PhD and 12 postdoctoral students, delivered >125 invited lectures, consulted for >25 companies, published >150 abstracts, and has nine issued and several pending patents. His principal contribution to science involves the theory and application of microencapsulation, stabilization, and controlled release of bioactive agents of all sizes with/in poly(lactic-co-glycolic acid) delivery systems with a special focus on peptides and proteins. More recently his lab has investigated buccal, nasal, and pulmonary delivery of hydrophobic drugs, vaccine antigens and nitric oxide, and invented organic solvent-free PLGA microencapsulation of large molecules by self-healing and ion-pairing. He is currently funded by NIH, US FDA, large corporations and private foundations, including FHI360, Gates and USAID.

Senior Manager, Bioequivalence, Cosette Pharmaceuticals Inc.

Harshil Shah serves as a Senior Manager, Bioequivalence (BE) at Cosette Pharmaceuticals Inc.’s South Plainfield, NJ site. He is an R&D expert with over 12 years of scientific experience in the pharmaceutical industry. His vast experience includes the development of various complex generic and 505(b)2 products where he has been instrumental in the development of Analytical, Formulation and In vitro/In vivo Bioequivalence strategies.  At Cosette, he is heading Bioequivalence department which is responsible for working collaboratively with other site and departments across the US and he also leads the Bioequivalence activity with different CMO/CRO and Pharma company globally to innovate novel Bioequivalence approaches for the development of complex pharmaceutical dosage forms.

He has worked for various Pharma companies like Amneal Pharmaceuticals, G&W Labs, and Solaris Pharma with various scientific positions. Overall, his experience spans from early product development, bioequivalence, quality compliance, product filing, and post approval support for pharmaceutical dosage forms. Harshil received his M.S. in Pharmaceutics specialized in Industrial Pharmacy from Long Island University, Brooklyn, NY.

Research Scientist, DPQR, OTR, OPQ, CDER, FDA

Dr. William C. Smith (Billy) is a Research Scientist in the Division of Product Quality Research (DPQR) working on complex drug formulations from topicals to injectables and implantable polymeric devices. Billy runs the DPQR Micromeritics “Particle Size” Lab focusing on the physicochemical characterization of nano- and micro-scale materials to support regulatory assessment and review, and evaluation of drug product quality. Billy received his B.S. degree in Chemistry from the Evergreen State College before finishing his Ph.D. in 2019 from the Colorado School of Mines under Dr. Kim R. Williams, in Analytical Chemistry, focusing on the development of advanced separations techniques for the characterization of complex polymers and colloidal nanomaterials.

Senior Vice President Regulatory Affairs, Cipla Ltd.

Dr. Siva Vaithiyalingam is Sr. Vice President of Regulatory Affairs, Cipla Ltd.  He is responsible for both Generic and New Drugs at Cipla.  He led several leadership positions leading to development and approval of modified and complex dosage forms.  His expertise includes technical, regulatory, and quality aspects of drug development, approval, and life cycle management.  He has previously served at Barr Labs, FDA, and Teva in various positions.  He graduated with a Master’s degree in Pharmaceutical Sciences from Institute of Technology, BHU and a Ph.D. in Pharmaceutical Sciences from Texas Tech University Health Sciences Center.

Lead-Structural Characterization, Dr. Reddy’s Laboratories Ltd.

Dr. Dama Venugopal Rao has 22+ years of experience in Analytical Research and Development and has been associated with Dr. Reddy’s Laboratories Ltd. since 2001. He is currently the Lead of Structural Characterization and is an expert on analytical research and development for complex injectables during the last four years. His expertise includes peptide characterization, glycosaminoglycans, cross linked polymers as drug substances, random poly peptides, PLGA based depot formulations, and liposomes and ophthalmic emulsions using various advanced integrated analytical technologies. Dr. Dama has worked on 300+ drug products for ANDAs and dossiers catering to various geographies, such as North America, South America, Europe, Russia, China, Japan, and India. He is an author or co-author of more than 25 scientific papers. He currently serves as an USP-Expert committee member (BIO3 – Complex Biologics & Vaccines) during the 2020-2025 cycle.

He received his Master’s in Organic Chemistry from Sri Krishnadevaraya University, Ananthapur, Anadhrapradesh and his Doctorate in Analytical Chemistry from Sri Krishnadevaraya University, Ananthapur. He also received his M.B.A. from the Narsee Monjee Institute of Management Studies (NMIMS), Mumbai and is a certified six sigma black belt from the American Society for Quality (ASQ).

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

Dr. Yan Wang is the team lead for Complex Drug Substances & Formulation Team in the Division of Therapeutic Performance, Office of Research and Standards. In her current role, Dr. Wang works with 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.

Division Director, DPQR, OTR, OPQ, CDER, FDA

Dr. Xiaoming Xu is the Director of 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. In support of GDUFA III implementation, Xiaoming co-leads the complex PSG working group, with a focus of better integrating research in complex PSG development. He is also a member of FDA Nanotechnology Task Force and is responsible for developing international collaborative programs and standards in areas related to nanotechnology. Xiaoming is 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 his Ph.D. degree in Pharmaceutical Sciences from the University of Connecticut.

Research Scientist, DCDA, OTR, OPQ, CDER, FDA

Dr Huzeyfe Yilmaz is a research scientist at the FDA Division of Complex Drug Analysis in St. Louis, MO. He has a Ph.D. in Materials Science and Engineering from the Washington University in St. Louis and B.Sc. in Physics from the Bilkent University in Turkey. Since joining FDA in 2018, he has led projects in development of advanced characterization methods for complex drugs including nanomaterial containing drugs, implants, and intrauterine devices, biologics, and amorphous solid dispersions, as well as rapid screening methods for medical countermeasures. Dr. Yilmaz is the recipient of several intramural FDA grants and currently serves as co-chair for pharmaceutical analysis and characterization center of excellence within the Office of Pharmaceutical Quality.

Staff Fellow, DPQR, OTR, OPQ, CDER, FDA

Dr. Rokon Zaman is a research scientist in the Division of Product Quality Research, Office of Testing and Research (OTR), under the Office of Pharmaceutical Quality (OPQ). Dr. Zaman’s work focuses on understanding drug release mechanism and development of in vitro release test (IVRT) methods for polymeric implants. He is currently working on studying the effect of formulation and process variables on drug release from polymeric implants to help development of product-specific guidance.  He received his Ph.D. in Pharmaceutical Sciences from Mercer University College of Pharmacy, Atlanta, Georgia.

Associate Professor, College of Pharmacy, University of Texas at Austin

Dr. Feng Zhang is an Associate Professor at the Division of Molecular Pharmaceutics and Drug Delivery in the College of Pharmacy at The University of Texas (UT) at Austin. He received his Ph.D. in Pharmaceutics from the UT at Austin. He worked in the industry for 14 years prior to joining the Department of Pharmaceutics at the UT at Austin in 2014. He was the Director of Product Development at PharmaForm from 2007 to 2010 and Senior Scientist in the Formulation and Process development department at Gilead from 2011 to 2013.

His principal research interest at UT Austin includes formulation and process design of implants for long-term drug delivery and amorphous solid dispersions for bioavailability enhancement.  His research also focuses on continuous granulation and powder blending enabled by twin-screw extrusion. He is the editor of 2^nd edition of “Pharmaceutical Extrusion Technology”, published in 2018. He has authored four book chapters on twin-screw extrusion process. He has published 95 peer-reviewed papers articles.  He is also the inventor on 12 issued patents covering a wide range of drug delivery systems. He serves on the editorial board of AAPS PharmSci Tech and is the North American editor for the Journal of Drug Delivery Science and Technology.

Founder and Managing Director, DigiM

Dr. Shawn Zhang is founder and managing director of DigiM. Shawn graduated from Rutgers University with a Ph.D. in Computational Physics and a minor in Computer Engineering. Before starting Boston-based DigiM, Shawn held senior positions at leading CAE software company Fluent (now Ansys) and leading electron microscopy company FEI (now ThermoFisher). Shawn and his DigiM team are passionate about the combined power of experimental data and in silico simulations. With over hundreds of publications, patents, and software products, Shawn leads DigiM to becoming a trusted partner in the characterization, institutionalization, and democratization of microstructure science across multiple industries. Learn more about Shawn’s work in Google Scholar or LinkedIn.