Advancing Bioequivalence Frameworks for Inhalation Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods

Deputy Division Director, DQMM, ORS, OGD, CDER, FDA

Dr. Andrew Babiskin is the Deputy Division Director of the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs, CDER. He previously led the Locally-acting Physiologically Based Pharmacokinetic Modeling Team and the Quantitative Clinical Pharmacology Team in DQMM. Dr. Babiskin’s expertise lies in modernization of bioequivalence evaluation practices through model-integrated evidence. Dr. Babiskin received his B.S. degree from the University of Maryland (College Park) in Chemical Engineering and his M.S. and Ph.D. degrees from the California Institute of Technology in Chemical Engineering. He joined the FDA in 2012 as an ORISE postdoctoral fellow in the OGD Science Staff (now ORS) and became an employee within DQMM in 2014.

Human Factors Team Lead, DMEPA I, OMEPRM, OSE, CDER, FDA

Mr. Matt Barlow has been with the FDA for 12 years and serves as a human factors team lead in the Division of Medication Error Prevention and Analysis (DMEPA I). His team reviews human factors related submissions for New Drug Applications (NDAs), Biologic Licensing Applications (BLAs), and Abbreviated New Drug Applications (ANDAs).

Prior to working at the FDA, he worked as a clinical nurse at the University of Maryland Shock Trauma Center. He has a Bachelor’s in nursing from University Maryland School of Nursing.

Director, CMC/Nonclinical Statistics, Respiratory R&D, Viatris

Mr. Mark Berry holds a M.Sc, in Statistics from The University of Georgia, USA.  His current role is Director, Nonclinical Statistician, Viatris R&D, with primary focus on support to respiratory product development. He has broad statistics experience across a number of industries (including aerospace and hi-tech), and specific relevance gained from providing statistical support to in vitro bioequivalence studies during development of Viatris’ approved generic DPI and MDI products. He was a contributing author to a peer-reviewed publication evaluating the performance characteristics of the population bioequivalence test applied to in vitro BE studies

Co-Founder and CTO, Ebenbuild GmbH

Dr. Jonas Biehler is co-founder and CTO of the Munich-based startup Ebenbuild.  He is responsible for the company’s product development and R&D. Ebenbuild develops a technology platform for precise, patient-specific simulation models of the human lung, so-called digital twins. Its digital toolset is based on physics-based simulation, AI, and data science and is designed to support decision-makers in healthcare and life sciences for instance through in silico trials for pulmonary drug delivery that enable subject-specific prediction of local aerosol deposition throughout the entire respiratory system.

Jonas studied Mechanical Engineering at the Technical University of Munich (TUM) and the University of Canterbury in Christchurch. Holding a Ph.D. in computational mechanics from TUM, he has extensive experience in transdisciplinary research projects and entrepreneurial endeavors at the intersection of physics, machine learning, and medicine. Both his research and his entrepreneurial work have been awarded nationally and internationally.

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

Dr. Elizabeth Bielski is a Senior Pharmacologist working at Division of Therapeutic Performance I (DTP I), Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center of Drug Evaluation and Research (CDER) at the FDA since October 2022. Prior to her role as a Senior Pharmacologist, she served as a Pharmacologist from October 2020 to October 2022 and as a Chemist from January 2020 to October 2020 within DTPI. Her areas of expertise involve orally inhaled and nasal drug products (OINDPs). She is actively involved in developing general and product-specific guidances, addressing controlled correspondences, pre-ANDA meeting requests, citizen petitions, internal consults, and collaborating on current research projects to promote generic drug development of OINDPs. Prior to joining the FDA, she served as an ORISE Fellow at FDA within DTP from August 2018-December 2019. Elizabeth completed her Ph.D. in Chemical Engineering from Wayne State University (Detroit, MI, USA) in July 2018 encompassing work also conducted at Department of Chemistry at the University of São Paulo (São Paulo, Brazil) and Department of Pharmaceutics at Virginia Commonwealth University (Richmond, VA, USA) related to novel drug delivery strategies for treatment of lung cancer and lung metastases. Prior to receiving her doctorate, she received her Bachelor of Science in Biomedical Physics Honors with University Honors in 2011, and her Master of Science in Biomedical Engineering in 2012 from Wayne State University.

Pharmacokineticist, DTP I, ORS, OGD, CDER, FDA

Dr. Susan Boc is a Pharmacokineticist in the Office of Generic Drugs’ Division of Therapeutic Performance I in the Office of Research and Standards. Specializing in inhalation and nasal drug products, Susan is responsible for the development of product-specific guidances to support generic drug development, reviewing and responding to controlled correspondences, pre-Abbreviated New Drug Application (ANDA) meeting requests, and internal consults. She also manages research projects focused on understanding and developing analytical methods and in vitro characterization tools for inhalation and nasal drug products to promote generic drug development. Prior to joining FDA, Susan was a Research Associate both at Novartis Pharmaceuticals and Nektar Therapeutics working in the development of inhalation drug products. She received her Ph.D. in Pharmaceutical Sciences from Virginia Commonwealth University in 2018.

CEO, Healthy Airways LLC

Dr. Loy Britto earned his Ph.D. in Materials Engineering from the Massachusetts Institute of Technology (MIT). He has more than 44 years of industrial experience spanning materials science, chemical engineering, advanced manufacturing, and pharmaceutical product development. Prior to joining the pharmaceutical industry, he held engineering positions at ARCO and IBM, where he worked on process modeling, product development, and manufacturing technologies.

Dr. Britto spent over 30 years at GlaxoSmithKline (GSK), where he held roles of increasing responsibility in the development and commercialization of orally inhaled and nasal drug products. His work encompassed formulations, device components, manufacturing processes, analytical methods, and technology transfer. He contributed to nearly 40 global regulatory submissions, including INDs, NDAs, and Marketing Authorization Applications(MAAs), and served as the Global Product Owner for GSK’s Metered Dose Inhaler (MDI) portfolio within the Manufacturing Sciences and Technology organization. He also served as a subject matter expert during the early development of a low-global-warming-potential (low-GWP) propellant version of Ventolin.

Following his retirement from GSK, Dr. Britto founded Healthy Airways LLC and now serves as an independent consultant to pharmaceutical companies and device manufacturers. He is an inventor or co-inventor on more than a dozen U.S. patents and continues to focus on the development, scale-up, and commercial manufacture of inhaled products and their device components using Quality by Design (QbD) principles.

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

Dr. Namhee Choi is a senior mathematical statistician in the Division of Biometrics VIII (DB VIII), Office of Biostatistics (OB), Office of Translational Sciences (OTS), Center of Drug Evaluation and Research (CDER) at the FDA. She joined the FDA in October 2016. Dr. Choi’s work focuses on the statistical review of comparative clinical endpoint studies supporting Abbreviated New Drug Applications (ANDAs) for generic drugs as well as Biologics License Applications (BLAs) for biosimilar products. In addition, she is actively involved in developing statistical methodologies for assessing bioequivalence of in vitro permeation test (IVPT) studies for topical drug products. She holds a Ph.D. in Statistics from the University of Michigan and a bachelor’s degree in Statistics from Seoul National University.

Pharmacokineticist, DQMM, ORS, OGD, CDER, FDA

Dr. Steven Chopski is a Pharmacokineticist in the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA). He received his Ph.D. in Mechanical Engineering and a B.S. degree in Biomedical Engineering from Virginia Commonwealth University in Richmond, Virginia. He joined the FDA in 2018 as an Oak Ridge Institute for Science and Education (ORISE) Fellow. His research interests include physiologically-based pharmacokinetic (PBPK) modeling and computational fluid dynamics (CFD) modeling of both nasal and orally-inhaled drug products. He has 10+ years of experience with in silico modeling and simulation of medical devices. He is engaged in regulatory science research initiatives related to generic drug-device combination products.

Chief Executive Officer, Copley Scientific Ltd.

Mr. Jamie Clayton is Chief Executive Officer of Copley Scientific, the global leader in inhaler testing equipment, where he is responsible for driving innovation, strengthening customer relationships, and guiding the company’s continued growth. With almost 20 years’ experience in powder testing, material characterisation, and life sciences, Jamie brings a strong understanding of the analytical and practical challenges involved in developing reliable, high-quality pharmaceutical products, including orally inhaled and nasal drug products

He holds a B,Eng. in Control Engineering from the University of Sheffield and combines his engineering background with deep sector experience to support the development of practical, user-focused testing solutions. Alongside his leadership responsibilities, Jamie has contributed to the scientific community through peer-reviewed publications, conference papers, posters, and technical articles spanning material characterisation, inhaler testing, and pharmaceutical product development.

Jamie is committed to fostering collaborations that help scientists, manufacturers, and regulators advance robust testing approaches and deliver safer, more effective treatments worldwide.

Director of Formulation Development, Respiratory, Nasals, Semi Solid & Liquids (RNSSL) R&D; Hikma Pharmaceuticals

Dr. Agnes Colombani received her Ph.D. in Chemical Engineering and Analytical Sciences from the University of Manchester, UK. She has over 20 years of experience in the development of orally inhaled and nasal drug products. She recently joined Hikma Pharmaceuticals in Ohio to lead formulation and process development within the RNSSL R&D unit.

Senior Director, Respiratory Bioequivalence Strategy Lead, Respiratory R&D, Viatris

Dr. Andrew Cooper holds a Ph.D. in Pharmaceutical Analysis from University of Bath, UK. He has broad industrial experience of analytical chemistry supporting complex dosage form development, focused for around 20 years on respiratory product development.

He has long held interests at the CMC – clinical interface, particularly on the relevance of in-vitro quality tests to in-vivo performance and on the value of clinical studies to inform product development. He is committed to industry-regulatory engagement supporting the development of science-based bioequivalence strategies for respiratory products which facilitate patient access to high-quality medicines.

Senior Pharmaceutical Quality Assessor/Application Team Lead, DPQA V, OPQA I, OPQ, CDER, FDA 

Dr. Nashwa El-Gendy currently serves as a Senior Pharmaceutical Quality Assessor (SPQA) and Application Team Lead (ATL) in the Office of Product Quality Assessment I (OPQA I)/Division of Product Quality Assessment V. She is responsible for drug product quality assessment of Abbreviated New Drug Applications (ANDAs) for pre-marketing and post-marketing applications. She is a subject matter expert in assessing complex scientific submissions including Generic Inhalation products (DPIs, MDIs, and Soft Mist Inhalers), Nasal Powders, Nasal Sprays, and Dental Powders, both from a scientific and regulatory perspective. She has also worked on INDs, Bio-INDs, Pre-ANDA assessment, and Controlled Correspondences. Nashwa currently serves as a member in multiple working groups (Draft CMC MDI/DPI guidance revision working group, Expert group for Nasal and Inhalation Products, FDA liaison on USP Inhalation Joint Subcommittee ‘2025-20230’, and FDA liaison on USP Expert Committee on the Small Molecules Therapeutic Areas 5 (SMTA5)). She also served as the FDA liaison on USP Inhalation Joint Subcommittee on Lactose grade for Inhalation and Injectables ‘2021-2025’. Nashwa has presented and given talks on numerous Inhalation Products discussions both at internal and external forums. She has authored numerous peer-reviewed manuscripts and abstracts and has served on the editorial boards and as a scientific reviewer for prestigious journals in aerosol science and pharmaceutics. Prior to joining the FDA in 2017, she held various positions with a magnitude of responsibilities in Academia as Associate Professor at School of Pharmacy and in the pharmaceutical industry (both brand and generic) with industrial experience in product development, process development, product scale-up, process validation, and technology transfer. Nashwa earned her master and Ph.D. degrees in Pharmaceutics and Industrial Pharmacy from Cairo University, Egypt and a Batchelor’s degree in Pharmaceutical Sciences from Cairo University, Egypt.

Founder and CEO, Proveris Scientific

Mr. Dino Farina founded Proveris in 1995 to help its customers deliver quality orally inhaled and nasal drug products (OINDPs) to patients that need them. He chose the company name to explain our philosophy, Proveris from Latin Probare (Test, Approve, Demonstrate), And Veritas (Truth). He completed two graduate degree programs at Stanford University in mechanical engineering. He was awarded the prestigious NASA Student Fellowship grant to study advanced fluid dynamics at the NASA-Ames Research Center in Mountain View, California and was a co-author on two groundbreaking journal articles related to his work with temperature and shear-stress sensitive liquid crystal coatings while a student.

Dino has been actively involved in the development of advanced measurement systems for OINDPs for nearly his entire professional career (31 years).  His experience in the OINDP area includes extensive time spent with the company’s global customers that include generic and brand pharmaceutical companies, device makers, CDMO/CROs, and regulatory agencies around the world, including those in China.  He is a named inventor on over 40 global patents related to spray and aerosol measurements and systems, has co-authored numerous peer-reviewed journal articles, and has advised FDA on numerous occasions on topics related to OINDPs, including receiving a Faculty Recognition Award for Academic Year 2002-2003

Deputy Director, DMEPA I, OMEPA, OGD, CDER, FDA

Mr. Jason Flint is the Deputy Director for the Division of Medication Error Prevention and Analysis I (DMEPA I) within the Center for Drug Evaluation and Research. He is also co-chair for the Office of Medication Error Prevention and Risk Management (OMEPRM) Research Team, is a human factors subject matter expert for research on comparative analyses and comparative use human factors by the Office of Generic Drugs (OGD), and contributes to Agency guidance and industry standards on human factors.

Senior Director, Biopharmaceutics, Global Product Development, AstraZeneca

Dr. Markus Fridén earned his Ph.D. from Uppsala University in 2010, with a thesis on experimental and computational approaches to quantify drug exposure in the brain. He joined AstraZeneca and worked in Drug Metabolism and Pharmacokinetics, focusing on inhaled drug exposure in the lung, mathematical modelling, and translational PKPD. He has held a range of scientific and leadership roles and has extensive experience in inhalation-related research and development.

Since 2020, Markus has led the Biopharmaceutics team within Inhalation Product Development in Gothenburg, Sweden. In his current role as Senior Director, Biopharmaceutics in Global Product Development, he works across delivery routes and leads biopharmaceutics activities in product development. He also serves as a co-opted Associate Professor at Uppsala University.

Supervisory Pharmaceutical Scientist, DPQA V, OPQA I, OPQ, CDER, FDA

Mr. Dhaval Gaglani is a Supervisory Pharmaceutical Scientist in the Division of Product Quality Assessment V (DPQA V) within the Office of Pharmaceutical Quality Assessment I (OPQA I)/Office of Pharmaceutical Quality (OPQ). He started his FDA career in October 2010 as a Review Chemist in the Office of Generic Drugs (OGD) and has since held progressively responsible roles within OGD and OPQ. In his current role, he manages and mentors a team of pharmaceutical scientists engaged in science and risk-based assessments of product quality over the product lifecycle for small molecule human drug applications, including Investigational New Drugs (INDs), New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs). He and his team are recognized Subject Matter Experts in quality assessment of inhalation products, including Dry Powder Inhalers (DPIs), Metered Dose Inhalers (MDIs), Nasal Powders, and Soft Mist Inhalers.

Dhaval provides pre-submission guidance on complex drug products, with particular expertise in inhalation drug-device combination products, through pre-ANDA meeting requests and controlled correspondence. He is actively involved in several key Agency initiatives, including working groups focused on quality guidance for inhalation products and regulatory aspects of Next Generation Propellants (NGP). He and his unit members also participate in regulatory science research, serve as FDA liaisons to the USP Aerosol subcommittee, and engage in various activities related to inhalation product development and assessment.

Prior to joining the FDA in 2010, Dhaval spent 12 years in the pharmaceutical industry, including 10 years at Pfizer Inc. (formerly Wyeth), working in both brand and generic sectors. His industrial expertise spans product and process development, scale-up, process validation, and technology transfer. He holds a Master of Science degree in Pharmaceutics with a Specialization in Industrial Pharmacy from Long Island University and a Bachelor of Pharmacy (B. Pharm.).

Head of Pharmacometrics, Chiesi

Dr. Massimiliano Germani is Head of Pharmacometrics at Chiesi, a role he has held since 2024, where he leads the integration of model-informed drug development strategies across therapeutic areas. He has over 20 years of experience in the pharmaceutical industry, having held senior clinical pharmacology, pharmacometrics and modeling roles at GSK (2022-2024), UCB (2016-2022), and Ablynx (2013-2016), following his early career at Accelera former Pfizer and Pharmacia (2001-2013).

Dr. Germani holds a Ph.D, in Bioengineering and Bioinformatics from the University of Pavia and an M.Sc. in Biomedical Engineering. His work focuses on the application of population PK/PD, PBPK, and advanced quantitative methods to support clinical development, regulatory decision-making, and lifecycle management. He has extensive experience interacting with regulatory agencies, contributing to evidence-based and model-informed strategies from early development through post-marketing.

Director, Analytical R&D, Amneal Pharmaceuticals

Mr. Dipesh Gohil is a Director of Analytical Research & Development at Amneal Pharmaceuticals. He holds a Master’s degree in Pharmaceutical Chemistry from Fairleigh Dickinson University, New Jersey. Mr. Gohil has been with Amneal Pharmaceuticals since 2011. He has experience of working with a broad range of dosage forms, including oral solids, liquids (suspensions, solutions) topical products, otic, and ophthalmic products, as well as complex inhalation and other drug-device combination products.

Dipesh has extensive expertise in analytical method development and validation, product characterization, stability assessment, and in vitro bioequivalence strategies across multiple dosage forms. His current work is focused on complex inhalation products, including metered-dose inhalers (MDIs), dry powder inhalers (DPIs), and inhalation spray products, with particular emphasis on delivered dose uniformity, aerodynamic particle size distribution, particle size characterization, dissolution, and other critical performance attributes. Mr. Gohil’s work is centered on advancing robust, scientifically justified approaches for demonstrating product quality, performance, and equivalence for complex generic and drug-device combination products.

Chief Scientific Officer (CSO), Transpire Bio

Dr. Abhishek Gupta, ‘Abhi’, is Transpire Bio’s Chief Scientific Officer (CSO). Dr. Gupta is responsible for the scientific direction of Transpire Bio. As a member of the leadership team, Dr. Gupta is responsible for providing the strategic and operational leadership to develop and implement the company’s scientific strategy, overall product portfolio, and conceptualization and introduction of new product opportunities. Dr. Gupta is also responsible for the evaluation of new product opportunities and M&A to expand existing business and create new business.

Dr. Gupta is a seasoned and accomplished bio-pharmaceutical executive with over 27 years of product development experience across dosage forms, with over 20 years focused primarily on inhalation drug-device combination products. Dr. Gupta’s time in industry has included leadership positions at Novartis Pharmaceuticals, Nektar Therapeutics (formerly Inhale), Cardinal Health, Lupin, and his most recent position at Cipla as the SVP & Head of R&D, North America. Dr. Gupta has successfully led the product development and approval of several branded and generic dosage forms, including small molecules, polypeptides, proteins, and biologics for registration in the US and EU.

Dr. Gupta is a graduate of Harvard Business School’s business analytics program. Dr. Gupta has a Ph.D. in Pharmaceutical Sciences from the University of Arizona, US, with a focus on Pharmaceutics, Analytical, and Material Sciences. He is a certified project management professional (PMP) through the Project Management Institute (PMI) of America and has a Bachelor’s in Pharmacy (B. Pharm.) from India. Dr. Gupta has over 50 peer-reviewed publications and numerous granted and filed patents.

Pharmacokineticist, DTP I, ORS, OGD, CDER, FDA

Dr. Liangfeng Han is a Pharmacokineticist in the Division of Therapeutic Performance, Office of Generic Drugs, at the U.S. Food and Drug Administration (FDA). He joined the FDA in 2017 and has since contributed to the scientific and regulatory evaluation of generic drug products, with a particular focus on orally inhaled and nasal drug products (OINDPs). Dr. Han earned his M.D. degree from Shanghai Second Medical University and his Ph.D. degree from the Johns Hopkins University School of Medicine. His multidisciplinary training in medicine, pharmacokinetics, and pharmaceutical sciences provides a strong foundation for evaluating complex drug products and developing scientifically rigorous approaches to demonstrating therapeutic equivalence.

At the FDA, Dr. Han is involved in the review of Pre-Abbreviated New Drug Application (Pre-ANDA) meeting requests, Product-Specific Guidances (PSGs), and Controlled Correspondences submitted by pharmaceutical companies developing proposed generic OINDPs. In this role, he provides scientific and regulatory recommendations on a broad range of development strategies, including in vitro characterization, pharmacokinetic and clinical study design, and approaches for establishing bioequivalence. His work also encompasses the assessment of clinical efficacy and human subject safety considerations associated with proposed generic products.

Managing Director, JDP Pharma Consulting, LLC

Dr. Jayne Hastedt is the Managing Director of JDP Pharma Consulting, LLC, which she founded in 2008. The consulting firm provides CMC support to the pharmaceutical and biotech industries, with a primary focus on orally inhaled and nasal drug product development. She has extensive experience in the development of complex drug products and has held scientific and leadership roles at Boehringer Ingelheim, Glaxo/Glaxo Wellcome (GSK), Inhale Therapeutic Systems (Novartis/Mylan), and ALZA Corporation (J&J).

Throughout her career, her research has explored the relationship between drug physicochemical and biopharmaceutical properties and their effects on drug delivery, product performance, and drug disposition. Dr. Hastedt developed an inhalation-based biopharmaceutics classification system (iBCS) for inhaled medicines, a practical framework to guide candidate selection, inform testing strategy, and reduce CMC product development risk. She has co-authored five papers and delivered numerous presentations on this topic. Her current interests include the evaluation and development of biorelevant in vitro test methods for solubility, dissolution, lung dose, and permeability suitable to classify inhaled medicines based on the framework of the iBCS. She received her M.S. and Ph.D. in Pharmaceutics from the University of Wisconsin–Madison School of Pharmacy, which recognized her contributions to the field with a Citation of Merit in 2021.

Professor and Associate Dean for Research, Department of Mechanical and Materials Engineering, Division of Pulmonology, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham

Dr. Mark Banaszak Holl is Professor and Associate Dean for Research in the School of Engineering at the University of Alabama at Birmingham. He also has an appointment in the Division of Pulmonology, Allergy, and Critical Care Medicine in the Heersink School of Medicine and is a member of the Lung Health Center, the Center for the Study of Community Health, the Gregory Fleming James Cystic Fibrosis Research Center, and the Civitan International Research Center. He has more than 20 years of experience in synthesis and characterization of polymer and aerosol vectors for drug and gene delivery. His academic path includes 20 years at the University of Michigan, including serving as Director of the Macromolecular Science and Engineering program, and 4 years as the Head of Chemical and Biological Engineering at Monash University. He received his B.S. from the University of Chicago and Ph.D. from Cornell University.

Supervisor, OPMA, OPQ, CDER, FDA

Dr. Chengjiu Hu is a Supervisor in the Office of Pharmaceutical Manufacturing Assessment (OPMA), Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) leading an unit effort  for the manufacturing process and facility assessment of Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and their supplements.

Dr. Hu has served the FDA for more than 15 years in roles of increasing responsibility including product, process, and facility evaluation across a broad range of drug applications. Prior to joining the FDA, he accumulated more than 15 years pharmaceutical industry experience as Formulation Scientist, Senior Process Engineer, Principal Scientist, and Team Leader at DuPont Pharmaceuticals/Bristol-Myers Squibb and Schering-Plough/Merck Pharmaceuticals, etc.

Dr. Hu earned his M.S. and Ph.D. degrees in Industrial Pharmacy from The University of Texas at Austin.

Leading Scientist, IVIVC Group, Pharmaceutical Research, Sandoz, Development Center

Mr. Tilen Huzjak is a Leading Scientist in the IVIVC group, Sandoz Development Center, specializing in the development of advanced, mechanistically relevant dissolution and permeation methodologies for complex generic drug products. His expertise encompasses both solid and liquid dosage forms, with particular emphasis on orally inhaled and nasal drug products (OINDP/OIDP). He has extensive experience working with compendial dissolution systems (USP Apparatus 1–4) as well as non-compendial, product-specific approaches, including modified in vitro setups designed to better reflect in vivo processes. He is particularly focused on two-compartment dissolution–permeation systems (e.g., Microflux™ and Macroflux™), enabling simultaneous assessment of drug release and membrane transport. His work supports the development of in vitro methods with enhanced biorelevance, aiming to improve product understanding, discriminate critical quality attributes, and strengthen in vitro–in vivo linkages for complex generics.

He has contributed to multiple successful regulatory submissions by developing and justifying advanced in vitro methodologies in close collaboration with cross-functional technical and regulatory teams. His background includes extensive experience in solid-state and particle characterization using advanced analytical techniques such as SEM-EDS, DSC, DLS, Raman microscopy, MRI, XPS, and ToF-SIMS, supporting reverse engineering and preformulation strategies. Tilen currently coordinates the preformulation–IVIVC platform and is actively engaged in collaborations with leading academic and research institutions. He holds a master’s degree in pharmacy from Faculty of Pharmacy, University of Ljubljana and is completing his Ph.D. on advanced approaches for assessing drug release from hot-melt extruded amorphous solid dispersions, with a focus on supersaturation behavior, microstructure–dissolution relationships, and their impact on drug absorption.

Senior Design Engineer, Product Development, Prior PLM Medical

Mr. James Jamieson is currently a Senior Design Engineer with Prior PLM Medical based in the Northwest of Ireland. His original qualifications were bachelor’s degrees in mechanical engineering and computer science and has spent the last 25 years developing new products for the automotive, consumer appliance and medical device sectors.

Currently his main research focus has been developing CFD-DEM models (CFD coupled with Discrete Element Modelling of particles), that better reflect the reality of Dry Powder Inhaler device testing. This has led to the development of new test equipment to help better control air flow as seen by an Inhalation device under routine testing.

Deputy Director, OGD, CDER, FDA

Dr. Darby Kozak is the Deputy Director for the Office of Generic Drugs (OGD) where he serves as a senior agency advisor in the development and implementation of FDA policies and long-range objectives for generic drug scientific programs and activities, including the development of a strategic plan for the Generic Drug Program. Dr. Kozak started his FDA career in April 2015 in OGD’s Office and Research and Standards where he helped develop new analytical methods and equivalence evaluation methodologies for complex generic 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 University of Queensland’s 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).

Chief Medical Officer, Transpire Bio

Dr. Mark Lepore is the Chief Medical Officer of Transpire Bio, where he leads Clinical Development, Preclinical Development, and Medical Affairs strategy for the company’s portfolio of inhaled novel investigational products targeting rare and serious lung diseases, including idiopathic pulmonary fibrosis (IPF) and other interstitial lung diseases (ILDs), as well as the company’s inhaled bioequivalence programs. He oversees the advancement of the company’s pipeline from early preclinical research through late-stage clinical development, including programs repurposing approved oral therapies for inhaled delivery as well as novel chemical entities. He earned his Doctor of Medicine (M.D.) from Jefferson Medical College at Thomas Jefferson University in Philadelphia, followed by residency training in Pediatrics at The University of Maryland Medical System in Baltimore. He completed fellowship training in Allergy and Clinical Immunology at Children’s Hospital Medical Center in Cincinnati. Prior to joining Transpire Bio, he held leadership roles at Aquestive Therapeutics, Lupin, and Teva, where he was responsible for clinical development and medical affairs activities. He began his career as a practicing physician, caring for patients with asthma and allergic diseases. His current focus is on addressing areas of significant unmet medical need by harnessing the advantages of inhalation drug delivery.

Expert Pharmacologist, Associate Director for Science, OB, OGD, CDER, FDA         

Dr. Bing V. Li is the Associate Director for Science in the Office of Bioequivalence within the Office of Generic Drugs at the U.S. Food and Drug Administration (FDA). In this role, she provides scientific leadership and expertise in the assessment of bioequivalence (BE) studies submitted through Abbreviated New Drug Applications (ANDAs) and oversees the scientific initiatives within the Office of Bioequivalence. Dr. Li is an Expert Pharmacologist at the FDA, specializing in the bioequivalence of aerosolized drug products. Before joining the FDA in 2004, Dr. Li was a Research Investigator at Bristol-Myers Squibb. She earned her Ph.D. in Pharmaceutical Sciences from the University of Wisconsin–Madison in 2001, and her bachelor’s degree in Medicinal Chemistry from Peking University, China, in 1990.

Senior Pharmacologist, OB, OGD, CDER, FDA

Dr. Xinran Li is a Senior Pharmacologist in the Division of Bioequivalence II (DB II), Office of Bioequivalence (OB), within the Office of Generic Drugs (OGD). In this role, she is responsible for assessing bioequivalence studies submitted by the pharmaceutical industry through abbreviated new drug applications (ANDAs) and ANDA-related submissions across a variety of dosage forms, as well as conducting regulatory assessments. She applies her scientific expertise to nasal and inhalation drug products and actively serves as a subject matter specialist for nasal and inhalation drug product assessments within the division. Dr. Li received her Ph.D. in Pharmaceutical Sciences from The University of Texas at Austin in 2013 and has been with the FDA since 2018.

Director, DTP I, ORS, OGD, CDER, FDA 

Dr. Markham C. Luke serves as FDA Supervisory Physician (Dermatology) and Director of the Division of Therapeutic Performance 1 (DTP1) in the Office of Research and Standards, Office of Generic Drugs at FDA. DTP1 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. He is an Associate Professor at the Uniformed Services University of the Health Sciences, Bethesda, MD with research interests in dermatopharmacology, clinical pharmacology, clinical study design and endpoints assessment (including patient-reported outcomes) for medical, surgical, and aesthetic products.  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.

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

Dr. Tian Ma is a Lead Pharmacologist within the Division of Bioequivalence I (DB I), Office of Bioequivalence (OB), Office of Generic Drugs (OGD). She has 12 years of experience in bioequivalence assessment of generic drug related submissions, such as ANDA submissions, pre-ANDA meetings, controlled correspondences, and bio-INDs, including those for inhalation products, Prior to joining the FDA, Dr. Ma obtained her B.Sc. in Pharmacology from the University of Toronto, and her Ph.D. in Pharmacology from Dartmouth College.

Founder and Director, M2M Pharmaceuticals Limited

Dr. Mridul Majumder is the founder and director of M2M Pharmaceuticals Ltd, which is an award-winning Contract Research Organisation (CRO) specialising in material science, advanced solid-state characterisation, and pharmaceutical product development with a special emphasis on inhaled drug delivery. The company has received The King’s Award for Enterprise in International Trade in 2024 which is the highest accolade in the UK. Prior to M2M Pharma, Dr. Majumder worked for a CRO and led its physical properties team which was eventually acquired by larger CDMO.

With over twenty-five years of experience in pharmaceutical R&D, Dr. Majumder has developed a deep expertise in understanding inhaled APIs, solid-state sciences, amorphous materials, and advanced analytical methodologies. These have significantly contributed to improving particle deposition in the deep lung for Dry Powder Inhaled (DPI) products. The work conducted by Dr. Majumder and the team he led for two decades has developed highly- sensitive analytical methods to quantify small level (<1%w/w) of amorphous content in crystalline bulk and overall solid-state properties. These have been submitted for regulatory approval to the FDA, MHRA and the EMA. Dr. Majumder has also developed a “Green Chemistry” solution calorimetry method which is now commercially available as a service offering. The current research at M2M Pharma include state-of-the-art analytical techniques with orthogonal capabilities that include MDRS, chemical imaging by Raman spectroscopy, solution calorimetry, gas perfusion microcalorimetry, DVS, iGC etc.

Alongside business leadership, Dr. Majumder remained committed to scientific advancement, mentoring and education. He currently holds an Honorary Associate Professor position at UCL School of Pharmacy, London. Dr. Majumder is a Fellow of Royal Society of Chemistry and Academy of Pharmaceutical Sciences in the UK. He is an internationally recognised speaker and has presented at RDD, DDL, AAPS, APS, CRS etc. Additionally, he has published research in various publications in solid-state, novel co-crystals in solid-state and their crystal structures.

Pharmacokineticist, Device, Injectable and Peptide Team, DTP I, ORS, OGD, CDER, FDA

Dr. Karthika Natarajan is a Pharmacokineticist on the Device, Injectable, and Peptide Team within the Division of Therapeutic Performance I (DTP I), Office of Research and Standards (ORS), Office of Generic Drugs (OGD). Her work encompasses regulatory review of drug-device combination products, including nasal and inhalation products, with expertise in device user interface assessment. These responsibilities include development of product-specific guidances and addressing controlled correspondences, pre-ANDA meeting requests, and consults related to comparative analyses and device user interface considerations. She leads comparative use human factors studies for drug-device combination products to strengthen the evidence base for generic drug-device combination product approvals, serving as Contracting Officer’s Representative and providing human subject research oversight in this capacity.

Dr. Natarajan holds a Bachelor of Pharmacy degree and earned an M.S. in Pharmaceutical Sciences from South Dakota State University, as well as an M.S. in Pharmacometrics and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore. She completed a postdoctoral fellowship in Oncology at the Greenebaum Comprehensive Cancer Center, University of Maryland School of Medicine.

Lead Pharmacologist, Team Lead, Inhalation/Nasal Drug Products, DTP I, ORS, OGD, CDER, FDA

Dr. Bryan Newman is a lead pharmacologist and team lead for inhalation and nasal drug products in the Division of Therapeutic Performance I (DTP I), Office of Research and Standards (ORS), within the Office of Generic Drugs (OGD).

Dr. Newman received his Bachelor of Science degree from Louisiana State University in Biochemistry and his Masters and Ph.D. degrees from the University of Michigan in Pharmaceutical Science.

His work focuses on developing product-specific guidances along with addressing controlled correspondences, citizen petitions, consults, and pre-ANDA meeting requests. He also serves as a project officer and contracting officer’s representative for regulatory science research initiatives related to inhalation and nasal drug products.

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

Dr. Eunjung (EJ) Park is a Lead Pharmacologist in the Division of Bioequivalence II (DBII), Office of Bioequivalence, Office of Generic Drugs, CDER/FDA, where she leads bioequivalence assessments of complex generic drug products — including nasal and inhalation, and ophthalmic formulations.

Prior to her current role, Dr. Park served as an Staff Fellow in the Division of Cardiovascular and Renal Products (OND), focusing on safety pharmacology, including QT prolongation and renal function. Before joining the FDA, she contributed to anticancer drug development at EntreMed, Inc. and conducted postdoctoral research at the National Cancer Institute and the University of Illinois at Chicago.

Dr. Park has authored over 30 peer-reviewed publications, multiple book chapters, and more than 50 scientific presentations at national and international conferences. She is the recipient of numerous CDER Honor Awards, FDA Awards, the Translational Safety Pharmacology Publication Award (Safety Pharmacology Society, 2018), and multiple Generic Drug Science Day Poster Awards (2023, 2025, 2026).

She holds a B.S. in Pharmacy from Ewha Womans University and an M.S. and Ph.D. in Pharmacy from Seoul National University, South Korea.

Senior Consumer Safety Officer, OPMA, OPQ, CDER, FDA

Dr. Miral Patel started her career as a Review Chemist in the Office of Pharmaceutical Manufacturing Assessment (OPMA) under OPQ in 2018. In this role, Miral is responsible for primary review of Pharmaceutical Manufacturing Process and Facilities for new and generic drug applications which are pending FDA approval and also participate as SME in Pre-approval Inspections (PAIs) for complex dosage forms including inhalation products (MDI, Nasal powders, Nasal Spray and Soft Mist Inhalers). Miral is also a part of Data-Integrity working group within the office, where she has been involved in assessing impact of various data integrity cases on pending applications. Prior to joining the FDA in 2018, she worked in large and small pharmaceutical firms such as Barr Pharmaceuticals, Teva Pharmaceutical and Edenbridge Pharmaceuticals in Product development/ formulation, Pre-formulation, Tech transfer and scale up on various dosage forms for 11 years. She received her Ph.D. in Pharmaceutics from Long Island University, Brooklyn, NY.

Senior Director, Respiratory Drug Product Development, Respiratory R&D, Sandwich, UK, Viatris

Dr. David Pole’s current role is Senior Director, Respiratory Drug Product Development lead, Viatris R&D, with overall responsibility for pharmaceutical development strategies across the current Viatris R&D portfolio and experience gained from leading the development of Viatris’ approved generic DPI and MDI products. He has particular interest in the application of Quality by Design principles to product optimization for bioequivalence.

Ralph F. Shangraw/Noxell Endowed Professor, Industrial Pharmacy and Pharmaceutics, University of Maryland; co-Director, CRCG

Dr. James Polli is Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at University of Maryland. His research interest is oral drug absorption, involving laboratory and clinical research. He has served as the advisor to 27 Ph.D. graduates. He is co-Director of the Center for Research on Complex Generics (CRCG). He is Director of the online M.S. in Regulatory Science program. He is a fellow of the American Association for Pharmaceutical Scientists (AAPS) and served as an editor of Pharmaceutical Research for 12 years. He is the 14th recipient of the American Pharmacists Association Takeru Higuchi Research Prize. He was the recipient of the 2024 American Association of Colleges of Pharmacy Volwiler Research Achievement Award, the 2022 AAPS Global Leadership Award, and the 2021 TOPRA Education Award. He is a member of the University of Maryland General Clinical Research Center Advisory Committee and the University of Maryland institutional review board (IRB).

Associate Director for Science & Chief Scientific Advisor, ORS, OGD, CDER, FDA

Dr. Sam Raney is the Associate Director for Science and Chief Scientific Advisor in the FDA’s Office of Research and Standards and Office of Generic Drugs, where he oversees the research portfolio of FDA’s generic drug research program. He has over 30 years of experience in pharmaceutical drug development, specializing in topical and transdermal products, and producing numerous research manuscripts, review articles, book chapters and patents. He has been a researcher and adjunct professor within academia, was the longest serving Chair of the AAPS Topical and Transdermal Community, has been a principal or sub investigator on over 400 pharmaceutical product studies, has held senior management roles in industry, serves on multiple expert committees and panels for the U.S. Pharmacopeia, and is frequently invited to speak at scientific meetings around the world. 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.

Deputy Division Director, DB III, OB, OGD, CDER, FDA

Dr. Ke Ren is the Deputy Division Director for the Division of Bioequivalence III (DB III) in the Office of Bioequivalence of Office of Generic Drugs, CDER, FDA. In this role, she leads a team of scientists responsible for the assessment of the bioequivalence section of Abbreviated New Drug Applications. During her time in DBIII, Dr. Ke Ren has developed extensive expertise in generic drug development in various therapeutic areas, including orally inhaled and nasal drug products. She has participated in the drafting of numerous Agency guidances pertaining to bioequivalence. Dr. Ren received her Ph.D. in Pharmaceutical Science from the University of Florida in 2005 and then undertook post-doctoral training at the University of Florida before joining OGD in 2008.

Respiratory Science Expert, Harro Höfliger

As Harro Höfliger’s Expert in Respiratory Science, Dr. Irene Rossi supports the team and her clients on product development and respiratory drug delivery matters. She is also part of the INTO technical team together with experts from DFE Pharma and Sterling.

Irene obtained a M.Sc. in 2014 and a Ph.D. in Drugs, Biomolecules and Health Products at the University of Parma (Italy) in 2019. In the same year she joined Nanopharm, An Aptar Pharma Company (UK) where she covered different roles. Most recently, she was leading a group focused on the development and characterization of new formulation technologies for OINDP products comprising both small and large molecules.

Irene has published her work in several original papers and filed 4 patent applications. She presented her work at more than 50 international conferences.

She also serves in the Drug Delivery to the Lungs Scientific Advisory Board and as co-chair of the ISAM Formulation Networking Group.

Director, R&D, Formulation Development, Transpire Bio Inc.

Mr. Chirag Shah currently leads the formulation development activities for multiple generic Ellipta^® franchise drug products at Transpire Bio Inc., where he is responsible for advancing complex inhalation programs from development through regulatory submission and approval.

Prior to joining Transpire Bio, Mr. Shah served as Director, Research & Development at Apotex Inc. He has also held leadership positions of increasing responsibility at EmpowerPharm Inc., Alembic Research Centre, Zydus Lifesciences Ltd., Jubilant Organosys Ltd., and Dr. Reddy’s Laboratories.

With more than 25 years of experience in the pharmaceutical industry, Mr. Shah has developed extensive expertise in complex drug product development, including a deep scientific understanding of in vitro bioequivalence methodologies and their integration with in vivo bioequivalence strategies to address evolving regulatory and legal requirements. Throughout his distinguished career, he has successfully led the development and regulatory filing of more than 150 pharmaceutical products, including numerous first-to-file and first-to-market opportunities. His broad experience encompasses complex generics, 505(b)(2) products, inhalation drug products, and other challenging formulation platforms.

Mr. Shah holds a Master of Pharmacy (M.Pharm.) degree from L.M. College of Pharmacy and a Bachelor of Pharmacy (B.Pharm.) degree from K.B. Institute of Pharmaceutical Education and Research (K.B.I.P.E.R.), Gujarat University, India. He is also an inventor on several patents and has authored numerous scientific publications in peer-reviewed journals and industry publications.

Senior Specialist, Technical Specialist Manager, Nanopharm, An Aptar Pharma Company

Mr. Lucas Silva is a Molecular and Cellular Biologist by academic training from the University of Lisbon (NOVA) and currently is working as a Technical Specialist leading the Analytical and Formulation services at Nanopharm, an Aptar Pharma company.

Prior to his experience in Nanopharm, Lucas did a research internship at University College London focused on the development of particle engineered Dry Powder Inhalers (DPIs) for pulmonary infections.

With over 10 years of immersion in the pharmaceutical industry, Lucas has cultivated expertise spanning analytical services, formulation technology, and drug delivery devices, predominantly within the realm of research and development, particularly in orally inhaled and nasal drug products.

His key research areas are the development of more realistic respiratory and nasal analytical methods, the application of specialized in vitro performance data to de-risk and accelerate drug product development.

Lucas has showcased his research findings at numerous international conferences through both poster presentations and podium talks. Additionally, he has contributed as a co-author to a peer-reviewed paper centered on enhancing impactor testing for assessing the bioequivalence of DPIs.

Currently, Lucas actively engages in discussions within the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), contributing valuable insights to navigate the evolving landscape of inhaled and nasal drug products.

Associate Director Product Development, Respiratory, Nasal, Semi Solids & Liquids (RNSSL) R&D, Hikma Pharmaceuticals

Mr. Nuno Silva is Associate Director Product Development at Hikma Pharmaceuticals, responsible for the scientific and strategic leadership of Hikma’s generic respiratory programs. Mr. Silva is a pharmaceutical industry program leader with over 20 years of product development experience focused primarily on inhalation drug-device combination products. Mr. Silva’s career in the industry has included positions at Hovione, Novartis Pharma and Hikma. Mr. Silva has been working as project/program leader since 2013, for small molecules and inhaled biologic products, including application and approvals in EU and US.

Mr. Silva has represented his different companies at EPAG and IPAC-RS, being currently Hikma’s board member at IPAC-RS.  Mr. Silva received a Degree in Pharmaceutical Sciences (pre-Bologna) from the University of Lisbon, Portugal, in 2006.

Chief Scientific Advisor, BBSG Pharm Associates, LLC

Dr. Gur Jai Pal Singh has served as Chief Scientific Advisor at BBSG
Pharm Associates since June 2023. He earned his Ph.D. from the University of
Birmingham, England, and has built a distinguished career spanning regulatory science,
pharmaceutical development, and executive leadership in respiratory drug products.
Prior to his current role, Dr. Singh served as Senior Vice President and Head of a
pharmaceutical company’s Respiratory Center of Excellence, where he provided end-toend, hands-on leadership for the development of state-of-the-art inhalation drug
products. His work included the strategic pursuit of innovative and scientifically sound
alternatives to resource-intensive clinical endpoint studies for demonstrating the safety
and efficacy of generic orally inhaled drug products. Under his leadership, multiple
orally inhaled products were successfully developed and advanced for the United
States, European Union, and other global markets.

Vice President of Regulatory Affairs, Kindeva

Mr. Nick Smalley is Vice President of Regulatory Affairs at Kindeva, a global Contract Development and Manufacturing Organization (CDMO) which specializes in the development and manufacturing of inhalation, transdermal and injectable products.  He also serves as the Chair of the Board of Directors of the International Pharmaceutical Aerosol Consortium (IPAC), which advocates worldwide for proportionate environmental regulation of medical aerosols, and is a Board Member of IPAC-RS, an organization focused on ensuring that global regulations and guidance for orally inhaled and nasal drug products (OINDPs) meet the needs of the industry.

Graduating in 1995 with a B.Sc. in Chemistry from the University of Loughborough, Nick began his pharmaceutical industry career in 1996 working on formulation and analytical development for inhalation products firstly at Rhone Poulenc Rorer and then Ivax Pharmaceuticals, before moving into Regulatory Affairs in 1999.  He has since held increasingly senior regulatory roles at Ivax, Celltech, UCB Pharma, and Perrigo before joining 3M in 2019 shortly prior to the divestment of their Drug Delivery Systems business as Kindeva.

In addition to his Regulatory Affairs functional leadership role at Kindeva, Nick is also heavily involved in much of Kindeva’s external advocacy activity on sustainability, particularly with respect to the transition to next generation propellants for pMDI.

Director of Applications and Business Development, Proveris Laboratories

Ms. Maria L Smith is the Director of Applications and Business Development at Proveris Laboratories, bringing over 20 years of expertise in the contract development and manufacturing of orally inhaled and nasal drug products. She is a recognized authority in spray characterization, with a strong focus on method development and performance evaluation.

Throughout her career, Maria has collaborated with industry leaders and key opinion leaders on a wide range of nasal and oral spray devices. She has worked extensively with generic and innovator pharmaceutical companies, device manufacturers, CDMOs/CROs, and regulatory agencies worldwide.

Her deep technical knowledge has contributed to the successful submission of more than sixteen combination NDA/ANDA products. Maria has applied her knowledge and understanding across R&D and QC environments, focusing on combining scientific and regulatory rigor with innovative characterization approaches to support robust product development and identify new pathways for addressing complex development challenges. She has co-authored 10+ publications on spray characterization and is well known across the industry.

Technical Lead, Pharmaceutical Development, Sandoz

Dr. Marie Solcher is an inhalation drug product development specialist with combined industrial and academic expertise in respiratory drug delivery. As Technical Lead at Sandoz (Sandoz Development Center, Aeropharm GmbH), she leads cross-functional teams and defines scientific strategies for the development of inhaled drug products, ensuring alignment with regulatory and business objectives. Prior to her current role, Marie worked as a Scientist, leading development activities for orally inhaled drug products. She has broad experience in inhalation product development, including formulation development and analytical characterization.

Marie holds a Ph.D. in Pharmaceutics and Biopharmaceutics from Kiel University, where she specialized in nasal and pulmonary drug delivery. Her academic work included international research collaborations at King’s College London, the University of Copenhagen, and the Woolcock Institute of Medical Research, Sydney. She co-founded the DDL New Researcher Network and has presented her work at international conferences including DDL (Edinburgh) and the World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology (Granada).

President, CGT Pharma Consulting LLC

Mr. Stephen Stein is an expert in the development and characterization of orally inhaled drug products with 30 years of experience in the industry, first with 3M Drug Delivery Systems, then Kindeva and now as an independent consulting. He has been involved in the development and commercialization of numerous inhaler products – both innovator and generic products.

He has an extensive knowledge of the development of pMDI and DPI products and has experience with in vitro bioequivalence testing and the development of biologically relevant test methods. He has more than 20 granted US patents and numerous others granted worldwide and more than one hundred peer reviewed publications or conference presentations. He recently started CGT Pharma Consulting LLC to assist companies seeking to develop and commercialize inhaler products.

Senior Physician, DCR, OSCE, OGD, CDER, FDA

Dr. Christina Streets is a Senior Physician within the Division of Clinical Review (DCR), Office of Safety and Clinical Evaluation (OSCE) in the Office of Generic Drugs (OGD), where she began her career at the U. S. Food and Drug Administration in 2019. Dr. Streets provides clinical input related to the development of generic drug products. She has conducted numerous assessments related to inhalation drug products including comparative analyses, controlled correspondences, and comparative clinical endpoint bioequivalence studies. Prior to joining the FDA, Dr. Streets completed her pediatric residency at St. Christopher’s Hospital for Children in Philadelphia and her fellowship in Allergy/Immunology at Thomas Jefferson University in Philadelphia.

Associate Director Research and Development, Respiratory, Nasal, Semi Solids & Liquids (RNSSL) R&D, Hikma Pharmaceuticals 

Mr. Ryan Swart is currently leading analytical development activities for Respiratory and Nasal products at Hikma Pharmaceuticals, Columbus, Ohio.  He has extensive experience in inhalation and nasal product development, extractables and leachables and in vitro studies.  Mr. Swart was involved in the development and approval of the Hikma generic Fluticasone Propionate and Salmeterol Inhalation Powder.  Prior to joining Hikma, Mr. Swart worked in product development for AAV based gene therapies and personal care and cosmetic products.  Mr. Swart has over 20 years of experience developing complex and combination drug products.

Inhalation Product Development Specialist, Sandoz

Mr. James Tibbatts is an inhalation product development specialist with over 20 years of industrial experience. In his current role, he is responsible for the technical and scientific development strategy for Sandoz’ DPI pipeline.

James holds a master’s degree in engineering from the University of Cambridge, where he specialized in fluid mechanics and thermodynamics. After leaving University, James pursued a career in Computational Fluid Dynamics (CFD) and developed an expertise in the application of CFD to inhalation products, particularly DPIs. In parallel to his CFD work, James gained important industrial experience in all aspects of inhalation product development including device development, API processing, formulation development, and analytical testing. Since 2012 James has led several generic MDI and DPI development programs from lab-scale through to clinical development.

In recent years James has spent considerable time working with a range of Sandoz experts on in-vitro methods for the new FDA bioequivalence frameworks including rAPSD, dissolution, and MDRS.

Senior Vice President, Regulatory Affairs, Cipla Ltd.

Dr. Siva Vaithiyalingam currently serves as Senior Vice President /Head of US Regulatory Affairs at Cipla LTD.  His expertise includes pharmaceutical research, product development, complex generics and new drug reg. strategies, regulatory Initiatives, and regulatory Affairs.

Previously, He served in organizations such as Teva Pharmaceuticals, CDER, Office of Generic Drugs at FDA and Barr Laboratories.  He graduated from School of Pharmacy, Texas Tech University with a Ph.D. in Pharmaceutical Sciences and M.S. degree in Pharmaceutics from IIT, BHU.

Senior Manager, R&D, Rubicon Research Canada Limited

Dr. Vivek Viswanathan has worked in the area of pharmaceutical product development for more than 15 years & specializes in the area of orally inhaled & Nasal drug products (OINDPs). These include dry powder inhalers (DPIs), metered dose inhalers (MDIs) & nasal products. Vivek also has considerable experience around combination product development including regulatory documentation. In addition to working on novel & specialty products for delivery via nasal & inhalation route, Vivek is also involved in development of complex generic products which require extensive BE studies. He has been involved in end-to-end combination product development from formulation development, scale up, technology transfer, analytical development including niche techniques for demonstrating bioequivalence & design history file compilation. Additionally, Vivek’s area of research also involves device development with special emphasis on user interface design, verification studies & comparative studies.

Vivek holds a Ph.D. degree in Pharmaceutical Sciences from University of Mumbai (India). In his current position, Vivek is heading Rubicon’s Canada R&D center based out of Concord, ON in which he is responsible for OINDP product development.

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

Dr. Ross Walenga joined the FDA in 2015 as an Oak Ridge Institute for Science and Education (ORISE) Fellow. He is currently a Senior Pharmacokineticist and the Acting Team Lead for the Locally Acting PBPK Team in the Division of Quantitative Methods and Modeling within the Office of Generic Drugs. He began his career at Virginia Polytechnic Institute and State University (Virginia Tech), where he earned a Bachelor Science in Aerospace Engineering. He later earned his Ph.D. in Engineering (mechanical track) from Virginia Commonwealth University in 2014, where he also spent seven months as a postdoctoral fellow prior to joining the FDA. His research interests include computational fluid dynamics (CFD) and physiologically based pharmacokinetic (PBPK) modeling of orally inhaled, nasal, ophthalmic, topical, and long-acting injectable drug products to answer questions pertaining to bioequivalence.

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

Dr. Yan Wang is the Deputy Division Director in the Division of Therapeutic Performance I (DTP-I), ORS, OGD at the U.S. Food and Drug Administration. The division advances regulatory science to support generic drug development and establish standards for demonstrating therapeutic equivalence.

Since joining FDA in 2013, Dr. Wang has served in multiple scientific and leadership roles, including as a subject matter expert in complex long-acting drug products and Team Lead for the Complex Drug Substance and Complex Formulation Team. Her work focuses on analytical methods, in vitro characterization, and drug release testing for complex drug products.

Her expertise spans complex parenteral, ophthalmic, otic, intravaginal, and intrauterine products, with an emphasis on linking formulation and manufacturing to product performance and bioequivalence.

Senior Director, Regulatory Affairs, Complex Gx, Teva Pharmaceuticals USA, Inc.

Mr. Brandon Wood is an accomplished regulatory affairs leader with 15+ years of experience in the pharmaceutical industry, specializing in complex generic drug development. As Senior Director of Regulatory Affairs at Teva Pharmaceuticals USA, Inc., he leads regulatory strategy, submissions, and lifecycle management for complex generics spanning complex APIs, long acting injectables, respiratory therapies, combination products, and non sterile complex products. Brandon has played a pivotal role in advancing and securing approvals for complex generic submissions, including GLP 1–based therapies, navigating scientific, CMC, and regulatory challenges to enable first to market or highly differentiated generic outcomes. Since joining Teva in 2018, he has driven regulatory strategies for some of the company’s most technically demanding programs, building on prior experience in regulatory affairs, quality assurance, and R&D at CorePharma and Impax Laboratories, and an early technical foundation as a chemist at West Ward Pharmaceuticals. He holds a B.S. in Chemistry with a concentration in Organic Chemistry from Monmouth University.

Senior Staff Fellow, DB III, OB, OGD, CDER, FDA

Dr. Zhen Xu currently serves as a Senior Pharmacologist in the Office of Bioequivalence in FDA. In his role, he reviews abbreviated new drug applications, study protocols, control correspondences, and other regulatory submission for generic drug products. He also serves as a subject matter expert on orally inhaled and nasal drug products in the Office of Bioequivalence.

Dr. Xu earned his Ph.D. in Pharmaceutical Sciences from Eshelman School of Pharmacy, University of North Carolina, focusing on dry powder inhalers. He also received his M.S. degree in Chemistry at Michigan State University, exploring the structural richness of carbohydrates for chiral synthesis. Prior to joining the FDA, he had extensive experience in both academia and industry across a variety of aerosol drug delivery systems at different stages of development.

Research Staff Fellow, DPQR V, OPQR, OPQ, CDER, FDA

Dr. Yang Yang is a Research Staff Fellow in the Office of Pharmaceutical Quality Research at the U.S. Food and Drug Administration (FDA). She earned her bachelor’s degree in Biopharmaceutical Sciences and master’s degree in Molecular Pharmacology from Peking University, China, followed by a Ph.D. in Biopharmaceutical Sciences from the University of Illinois Chicago. Her doctoral research focused on the development of polymeric nanoparticles for drug delivery.

Dr. Yang’s research focuses on advancing regulatory science through the development and implementation of in vitro methods to evaluate the quality and absorption of complex drug products, including nasal, orally inhaled, and dermal drug products. Her work also encompasses the manufacturing of complex drug products and directly supports the development of FDA Product-Specific Guidances, helping to advance safe and effective drug formulation and regulatory decision-making.

CEO, Transpire Bio Inc.

Dr. Xian-Ming Zeng is CEO and founder of Transpire Bio Inc., where he leads the development and manufacturing of inhaled medicines designed to improve patient access and address unmet medical needs. He holds a Ph.D. in Pharmaceutical Sciences, with a focus on inhalation drug delivery, from King’s College London. His career spans more than 30 years across academic research and global pharmaceutical R&D leadership in the US and UK. Dr. Zeng previously served as a Maplethorpe Fellow and Visiting Professor at King’s College London, and as Professor of Pharmaceutics and Director of Research at the Medway School of Pharmacy, University of Kent. He also established Teva’s Respiratory R&D center in Miami and Lupin’s Inhalation Research Center in Coral Springs. He has co-authored three textbooks and more than 50 peer-reviewed publications, is named on more than 20 patents and patent applications, and has led the successful development of multiple generic and branded inhalation products. He is a frequent invited speaker at national and international conferences and currently serves as a board advisor for BioFlorida.

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

Dr. Jinglin Zhang joined the FDA in 2024 as an Oak Ridge Institute for Science and Education (ORISE) Fellow. She is currently a Staff Fellow in the Division of Therapeutic Performance I (DTP I) at the Office of Research and Standards (ORS). Dr. Zhang earned her Ph.D. in Food Science from the University of Maryland, College Park, where her research focused on characterizing interfacial properties of food polymers in colloidal systems. Prior to joining the FDA, she was a postdoctoral fellow at the University of Delaware, where her research focused on in vitro release, in vivo bioavailability, and toxicity evaluation for nano-delivery systems. Her research interests include the characterization of nanoparticles, nano-emulsions, and other colloidal drug delivery systems, as well as the development of drug release testing methodologies for these complex formulations. She currently supports product-specific guidance (PSG) developments for complex long-acting formulations as well as inhalation and nasal drug products.

Senior Research Pharmacologist, DPQR V, OPQR, OPQ, CDER, FDA

Dr. Ahmed S. Zidan is a Senior Research Pharmacologist in the Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, U.S. Food and Drug Administration (FDA). He has more than 25 years of experience in pharmaceutical sciences spanning academia, industry, and regulatory science. His work focuses on pharmaceutical quality, biopharmaceutics, bioequivalence, drug product performance, and the development and application of in vitro and model-informed approaches for complex drug products. At FDA, Dr. Zidan conducts and leads regulatory research supporting the assessment and development of generic drug products, including orally inhaled and nasal drug products. His research interests include clinically relevant in vitro performance testing, dissolution and drug release, in vitro–in vivo relationships, and integration of product quality and biopharmaceutic evidence to support bioequivalence assessment. He has authored numerous peer-reviewed publications and contributes to multidisciplinary FDA research and regulatory initiatives for complex generic drug products.