Webinar – In vitro and in silico predictions of orally inhaled drug product in vivo performance
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Dr. Xujin Lu is a pharmaceutical consultant. Dr. Lu has more than 30 years of experience in pharmaceutical industry for research and development. His expertise includes development of in-vitro dissolution methodologies to assess the release of drugs from innovative formulations, predicting their bio performance, and ensuring quality control for newly developed products. Dr. Lu is active members of AAPS, ACS, and SAS, and a past Chair of the In Vitro Release and Dissolution Testing (IVRDT) Focus Group of AAPS. Dr. Lu currently serves on the USP Expert Panel on New Advancements in Product Performance Testing, USP Expert Committee of Dosage Forms, and the Editorial Advisory Board of Dissolution Technologies journal.
Dr. Sanjay has oversight for all aspects of Amneal’s Global Quality operations, including managing the overall compliance, cGMP, quality deliverables and leading Amneal as “Chief Quality Officer” based in New Jersey, USA. He has extensive experience managing Operations, Validation, Quality, Training, Projects & Engineering, Supply Chain, and merger & acquisitions. He has successfully managed multiple regulatory audits originating from the USFDA, MHRA, EU, TGA, Anvisa, MCC and Health Canada. He has expertise in fostering strong quality culture, developing quality systems, implementing operational excellence, and optimization of processes. He has authored 12 papers published in national and international journals, along with a book chapter. He is a member of the ISPE and PDA. He is on PDA’s Board of Studies. He is an accomplished speaker at various international conferences. He holds a degree in Pharmacy, a post graduate degree in Quality Management and Ph.D. in Operation management.
Deanna Mudie, Ph.D., is a Senior Principal Scientist in Physiologically Based Pharmacokinetics (PBPK) Simulation Technologies at Simulations Plus, Inc. She earned her BSE in Chemical Engineering and her PhD in Pharmaceutical Sciences from the University of Michigan. Deanna has over 20 years of experience in the pharmaceutical field. She most recently served as a technical program lead in Research and Development at Lonza Small Molecules, developing new technologies to enable successful bioavailability enhancement of poorly soluble drugs. During her doctoral and postdoctoral work, Deanna developed mechanistic in vitro and in vivo transport models to predict oral dosage form dissolution and intestinal absorption. Deanna began her career as an engineer at Merck and Pfizer characterizing, developing, and manufacturing oral dosage forms from preclinical to commercial scales.
Vivek Shah is a highly accomplished scientist with an academic background in pharmaceutical sciences and chemistry. He received his Bachelor’s degree in Pharmaceutical Sciences from Ohio State University and then pursued a Master’s degree in Chemistry from Long Island University.
After completing his studies, Vivek began his professional career at Merck. He contributed to the development of new techniques, Direct Drug Analysis in Polymeric Implants DESI-MSI Imaging and using Mixed Reality in Pharmaceutical Development. His expertise with the Apparatus 4 helped drive dissolution studies for many different programs including a program that used an in-line NMR cryoprobe with the Apparatus 4.
Vivek’s expertise and contributions to the pharmaceutical industry have not gone unnoticed. He currently serves on the USP expert panel for In Vitro Product Performance and is an Executive Board member for the US Society of Pharmaceutical Dissolution Science, demonstrating his commitment to advancing the field of pharmaceutical sciences and his deep understanding of in vitro testing methodologies.
Currently, Vivek is leading the Pharma Services team for SOTAX in Massachusetts, where he continues to demonstrate his leadership and scientific acumen. In his current role, he has helped develop and validate groundbreaking in-vitro methods for complicated drug release programs.
Sanjaykumar Patel is Principal Scientist at Merck & Co., Inc. in Rahway, NJ. He has 18 years of experience in pharmaceuticals industry. His experience includes working on novel drug delivery formulations such as self-emulsifying drug delivery systems, amorphous solid dispersion, controlled release and gastro retentive, and parental formulation. His research interest is focused on developing predictive bio-relevant in-vitro methodologies to understand in-vivo performance of oral and parental formulations. He has co-authored several scientific papers. He is an active member of AAPS and a part of the IVRDT (In Vitro Release and Dissolution Testing) focus group steering committee. He is involved in cross-organization consortium, OrBiTo, in the area focusing on a development and improvement of in-vitro analytical tools.
Hyunho Kang earned his B.S. in Chemistry from University of Illinois at Urbana-Champaign and his Ph.D. in Chemistry from University of Minnesota Twin-Cities, in Dr. Christy Haynes group. During Ph.D., Hyunho has earned the experience and knowledge on inorganic nanoparticle synthesis and related physical and hydrodynamic characterization for sensing and agricultural application. Hyunho Joined Merck as Senior Scientist in 2020, and at Merck, Hyunho has worked in Small Molecule Analytical R&D organization as an analyst for different projects, including Islatravir implant.
Anette Müllertz is professor in oral drug delivery and industrial relations at the University of Copenhagen, Denmark (UCPH) and head of Bioneer:FARMA, a business unit of Bioneer A/S, which is a research-based, non-for-profit service provider within the area of biomedicine and pharmaceutical development. She is heading the Physiological Pharmaceutics Research Group at UCPH, focusing on developing oral lipid-based drug delivery systems and predictive biopharmaceutics tools. She has >250 publications in international, peer-reviewed journals (H-index: 71, 15028 citations, (Google Scholar 26/3-24). She is / has been supervising 12 post docs, 54 PhD students and numerous master students, primarily at the University of Copenhagen, but also at other universities. She is a Fellow at the American Association of Pharmaceutical Scientists (2022), Fellow at the Controlled Release Society (2023) and recipient of the AAPS Lipid Based Drug Delivery Award (2005). She is editor of Journal of Drug Delivery Science and Technology (IF2023: 5.062).
Maureen Marsales holds a BS in biochemistry from Seton Hall University and is currently an Associate Principal Scientist in Merck’s Small Molecule Analytical R&D organization. Maureen has 19 years of experience in the pharmaceutical industry with a focus on the development and characterization of complex dosage forms. She has extensive experience working with inhalers, nasal sprays, nebulizers and subdermal implants. Most recently Maureen oversaw analytical activities for the Islatravir implant, an early phase candidate for HIV PrEP.
Dr. Patrick J. Sinko is a Pharmacist and a Pharmaceutical Scientist at Rutgers, The State University of New Jersey. He is a Distinguished Professor and the Parke-Davis Endowed Chair in Pharmaceutics and Drug Delivery at the Ernest Mario School of Pharmacy. Dr. Sinko served as Chair of the Department of Pharmaceutics in the School of Pharmacy (1998-2008) and Associate Vice President for Research (2007-2018) in the Office of Research and Economic Development for Rutgers University. Dr. Sinko was elected Fellow in the American Association for the Advancement of Science (2011), the American Association of Pharmaceutical Scientists (2003), the Controlled Release Society (2017), and the National Academy of Inventors (2023). Dr. Sinko currently serves as the Immediate Past President of AAPS. He was also elected to the AAAS Council and the Board of Scientific Advisors of the Controlled Release Society. Dr. Sinko has served on numerous scientific advisory and review panels in the United States and Europe. He is the Editor of Martin’s Physical Pharmacy and Pharmaceutical Sciences (Fifth, Sixth, Seventh, and Eighth Editions) and is on the Editorial Advisory Board for numerous journals. He is the Editor-in-Chief for Pharmaceutics. Dr. Sinko has authored or co-authored over 540 publications, including research papers, abstracts, and book chapters (h-index = 67). He is the Principal Investigator of an active research laboratory focusing on biopharmaceutics, pharmaceutical formulations, and molecular-, nano-, and micro-scale drug delivery. The NIH has continuously funded his lab for over 30 years. During his career, Dr. Sinko has received several awards for his teaching and research, including the Rutgers University Board of Trustees Award for Excellence in Research and the highly selective National Institutes of Health FIRST and MERIT Awards.
Prof. Nikoletta Fotaki is a Professor of Biopharmaceutics at the University of Bath, UK. She graduated in Pharmacy from the National and Kapodistrian University of Athens in Greece and she holds an MSc in Toxicology and a PhD in Biopharmaceutics-Pharmacokinetics. Her expertise and research are focused on PBPK modelling/ PBBM, in vitro and in silico tools for predicting absorption in normal populations and in special populations, dissolution methods, IVIVCs and biowaivers. Her scholastic work includes more than 90 peer reviewed publications, one book, 10 book chapters, 87 published conference contributions and 2 patents. She is an AAPS Fellow and a member of the AAPS Board of Directors with leading roles in the OBAM and IVRDT AAPS Communities. She is also the chair of the Biopharmaceutics Group of APS and she is a member of a USP expert panel and of several scientific societies and has been an invited speaker at several conferences.
Dr (Ms.) Padma V. Devarajan, President Society for Pharmaceutical Dissolution Science (SPDS) is Dean Research and Innovation, Professor in Pharmacy and former Head, Department of Pharmaceutical Sciences and Technology at the Institute of Chemical Technology, Mumbai, India. She is also a member of the Board of Governors and Head of the Incubator at the Institute of Chemical Technology. She has over 100 peer reviewed publications, many granted patents, has licensed technologies to industry and some products are commercialized in India and Europe. She is editor & author of two books on Targeted Drug Delivery, published by Springer. She was actively associated with the Controlled Release Society Inc., USA as Board Member and Member on the Board of Scientific Advisors and Chair of the Global Young Scientist Mentor Protégé Program. She is a Member on the Editorial board of the Asian Journal of Pharmaceutical Sciences and the European Journal of Drug Metabolism and Pharmacokinetics.
Prof. Devarajan is a nominated Fellow of the Maharashtra Academy of Sciences, and Life Fellow of the Indian Chemical Society. She is a recipient of several awards and recognitions for Research and Innovation, including the American Association of Indian Pharmaceutical Scientists Distinguished Educator and Researcher Award, the Bengaluru Nano Innovation Award, the Outstanding Woman Scientist Award of ICAR, Government of India and recently the Leading contributor and influencer in Academic Research & Industry Award.
Dr. Suresh Bhojraj, Pro-Chancellor of JSS Academy of Higher Education and former President of the Pharmacy Council of India, is a visionary leader with over four decades of dedicated service in transforming education nationally and globally. During his tenure as President of the Pharmacy Council of India from 2003 to 2021, he pioneered initiatives such as the introduction of postgraduate “Pharmacy Practice” and Pharm.D. programs, revolutionizing pharmacy education and profession in India. As the founding Vice Chancellor of JSS Academy of Higher Education and Research for 11 years, Dr. Suresh propelled the institution to national and international acclaim, securing its position among the top 400 universities globally and top 50 universities in India. His emphasis on interdisciplinary research in medical and life sciences has led to numerous collaborations and accolades. Currently, as Director of the Technical Education Division at JSS Mahavidyapeetha, Mysuru, Dr. Suresh is elevating engineering and technological institutions across multiple locations. He also oversees JSS institutions in Dubai and Mauritius. Beyond his administrative roles, he contributes significantly to global pharmacy standards, serving as a delegate member of the United States Pharmacopeia Convention and Executive Member of the Commonwealth Pharmacists Association. Dr. Suresh’s contributions extend to numerous national and international committees, including the Scientific Committee on Problems of the Environment, where he collaborates closely with UN organizations. Recognized with prestigious awards and honorary doctorates, he is esteemed for his humane leadership and team-building skills. In addition to his prolific career, Dr. Suresh has authored numerous publications, delivered keynote addresses worldwide, and organized various conferences. His dedication to advancing education and healthcare underscores his enduring impact on society.
Dr. Shah is a pharmaceutical consultant. He retired from the US FDA (Food and Drug Administration) after serving for 30 years. While at the FDA, he developed several Regulatory Guidance for the Pharmaceutical Industry in the area of biopharmaceutics, including a guidance on the dissolution of IR and ER products. He is the author/co-author of over 330 scientific papers and co-editor of four books.
Dr. Shah was the President of American Association of Pharmaceutical Scientists (AAPS) in 2003. He is a Fellow of AAPS and FIP. Dr. Shah is a recipient of FDA Award of Merit, FIP Lifetime Achievement Award in Pharmaceutical Sciences; IDMA Eminent Pharmaceutical Analyst Award (India); Honorary Doctorate from Semmelweis University, Budapest, Hungary; Honorary Doctorate from University of Medicine and Pharmacy Carol Davila Bucharest, Romania; SPDS Award of Excellence; AAPS Distinguished Pharmaceutical Scientist Award and AAPS Global Leader Award.
Andre Hermans is Executive Director in the Small Molecule Analytical Research and Development (SM-AR&D) Division at Merck and Co., Inc. in Rahway, NJ. He received his PhD in Analytical Chemistry from the University of North Carolina in Chapel Hill before joining Merck in 2007. During his time at Merck, Andre supported analytical method development and process development in the small molecule solid oral dosage area throughout all phases of drug development. In this function, he authored several IND and NDA applications with focus on oral formulations containing amorphous solid dispersion formulations, and various drug products in the HIV franchise. As an internal and externally recognized expert in dissolution technologies he significantly expanded Merck’s toolkit and understanding on modeling and prediction of both in-vitro and in-vivo dissolution of solid oral dosage forms.
Andre is a member of the IQ dissolution working group, member of the USP expert panel for “New Advancements in Performance Testing”, and former chair of the AAPS In-vitro testing dissolution community. He is author of more than 30 publications mostly in the field of dissolution testing and clinical relevance.
Payal Agarwal, Ph. D is currently a Biopharmaceutics assessor in the Division of Product Quality Assessment VI, in the Office of Pharmaceutical Quality (OPQ), CDER. Her responsibilities include biopharmaceutics assessment of NDAs (original and supplement), ANDAs (original and supplement), INDs, and Pre-ANDAs. Before joining the FDA, Dr. Agarwal served as a Senior Manager Advisory Services, Research Scientist I at Avalere Health. In this role she applied her comprehensive blend of expertise on multiple regulatory policy and strategy projects for diverse group of clients. She was engaged in providing regulatory policy advice and guidance based on legislative trends to Avalere’s internal and external stakeholders. Prior to Avalere Health, Dr. Agarwal was a tenured faculty and worked as an Associate Professor of Pharmaceutics and Biopharmaceutics in the Department of Pharmaceutical Sciences at the School of Pharmacy, Notre Dame of Maryland University for 12 years. Due to her exceptional dedication, knowledge and skills, and service to students, in addition to her caring and compassionate personality, Dr. Agarwal was awarded as the Teacher of the Year. Along with teaching, research, and mentorship roles, she held several leadership positions at the institution. She has been actively involved with many scientific organizations, served as an editorial board member and as a scientific reviewer for various peer reviewed journals, meetings abstract, and book chapters. She authored and edited the textbook “Pharmaceutical Calculations” for the PharmD curriculum. She has executed, managed, and led multiple scientific and regulatory projects.
Dr. Agarwal has made significant contributions in the areas of oral delivery of proteins and peptide-based drugs. The novelty and significance of her research has been recognized and awarded by several scientific communities. Dr. Agarwal received her Ph.D. in Industrial Pharmacy from St. John’s University, NY, MS in Pharmacometrics from University of Maryland, Baltimore, MS in Pharmaceutics and Bachelor of Pharmacy from Dr. H.S. Gour University, India.
Mika Mast is a chemistry group lead in Lonza product development at the Bend site. She has over 17 years of industry experience across a wide range of technologies with a focus on multi-particulates. Her work encompasses formulation selection and analytical characterization of multi-particulates for taste-masking, enteric protection, controlled release, and bioavailability enhancement.
Sujatha Sonti is VP, Drug Product Development, GSK, based at the Upper Providence site in Philadelphia. In her current role she leads a global team of outstanding scientists across disciplines including formulation, packaging, biopharmaceutics, engineering, modelling, and process analytics to develop innovative and robust, patient centric medicines. This team is accountable for the design, development, and industrialization of drug products (Oral, Sterile and Inhaled) and their manufacturing processes for all GSK small molecule and biopharmaceutical products.
Sujatha obtained a bachelor’s in pharmacy from the University of Mumbai, India and received her Ph.D. in Pharmaceutical Sciences from West Virginia University. Her graduate research focused on the delivery of large molecules: antisense oligonucleotides and gene therapy for the treatment of lung inflammation. Prior to GSK, Sujatha has previously worked at Avon Products, Inc, Ionis Pharmaceuticals, SkinMedica, Inc (a division of Allergan) and Medicis Pharmaceuticals, where she worked on the development of both prescription and consumer care products. Through these opportunities, she has gained over 24 years of product development experience and has had the incredible fortune of launching several Prescription/Cosmetic/OTC products.
Dr. Ju is recognized for his in-depth knowledge and experiences in both formulation and dissolution method development, as his teams were directly responsible for the formulation development of 7 NDAs, dissolution method development of 8 NDAs/Phase III projects, including oral biologics and implants. At AbbVie, he established the Drug Release and Product Performance group with focuses on in-silico modelling, images and functional excipient release, and cross-functional alignment. He advocates in vitro release method development based on formulation design and release mechanism. Extensive interactions with global regulators on biowaiver, IVIVC, PBPK/PBBM modelling, and discrimination. Recognized expertise in biopharmaceutics, modified release formulations, pediatric formulations, amorphous solid dispersion, and FDC technologies for challenging molecules. Patents filings and litigation. Experiences with eye care products (implants and eye drops) and high-concentration biologics. Dr. Ju founded the Pediatric Working Group and chaired the Drug Product Leadership Group of IQ Consortium. He was inducted to the prestigious Vowiler Society within AbbVie, sat in the Scientific and Education Board of NIPTE, and was an Adjunct Professor of Roosevelt University. In leisure, Rob enjoys coaching sport teams, working out in the gym, and reading.
Prof. Dr. Sandra Klein is a pharmacist by training and obtained her license to practice pharmacy and her PhD from the University of Frankfurt, Germany. She was a Postdoctoral Fellow at Eastman Chemical Company in Kingsport, TN, USA and has been a Professor of Pharmaceutical Technology at the University of Greifswald, Germany since 2010. Since starting her PhD, she has been working on the development of biorelevant in vitro methods to assess the bioavailability of orally administered drugs and meanwhile has more than 20 years of experience with biorelevant dissolution assays. Her current research focuses on the development of bio predictive in vitro models to estimate the in vivo performance of drugs for different patient populations, as well as the development of oral dosage forms for special patient populations, particularly pediatric patients. The latter activities span the spectrum from formulations for poorly soluble drugs through taste-masked formulations to controlled-release dosage forms. Other research interests include the development of predictive and accelerated in vitro release methods for lozenges, vaginal and rectal delivery systems, and long acting injectables.
Sandra is a member of the American Association of Pharmaceutical Scientists (AAPS), the European Pediatric Formulation Initiative (EuPFI), the German Pharmaceutical Society (DPhG) and the International Association of Pharmaceutical Technology (APV). She is currently also the President-elect of the APV, an Expert Member of the USP Expert Panel on New Advancements in Product Performance Testing, an Expert Member of the conect4children (c4c) Formulations Expert Group, and Editor-in-Chief of Pharmazie, An International Journal of Pharmaceutical Sciences.
Dr. Xiaoming Xu serves as a Division Director in the Office of Pharmaceutical Quality 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 Ph.D. degree in Pharmaceutical Sciences from University of Connecticut.
Krutika Harish Jain graduated in 2021 from University of Minnesota with a PhD in developing an “Artificial Gut Simulator for Simultaneous Evaluation of Drug Dissolution and Absorption” specifically of oral BCS-II compounds under Prof. Ron Siegel. Krutika developed a novel small volume hollow fiber based module to be used in a UV spectrophotometer cuvette to elucidate the important processes such as supersaturation and precipitation that are impacted at physiologically relevant rates of absorption and determine the true efficacy of enabling oral formulations.
She then joined Gilead Sciences in Foster City, CA to further her expertise in developing novel in vitro tools and in vivo PBBM models for complex long acting injectables. Recently she and her team published a paper in the Journal of Pharmaceutical Sciences outlining a novel 2-method in vitro release testing strategy to evaluate different phases of drug release from intramuscular single agent and combination long acting injectables. She is also an active member of the IQ dissolution working group and the LAI-focused sub team under this working group.
Karunakar Sukuru (Karu) R.Ph., Ph.D. is the Global Vice-President of Product Development at Catalent Pharma Solutions. With over 29 years of experience in the pharmaceutical industry, he is a well-known leader in the development and manufacturing of various drug delivery systems and technologies. He has been responsible for P&L, product development, and execution of projects globally, making him a reliable and strategic thinker. Karunakar had technical oversight of products at over more than a dozen CDMOs worldwide while working at Endo Pharma. Currently, at Catalent, he works with 100s of pharmaceutical customers, including leading BioPharma companies globally. He has developed innovative CR platform technologies in softgel form (two granted patents) and has over 20 pending patent applications in the field of modified shell and fill suitable for capsules for enteric and colonic delivery and also in the lyophilization of biologics. After completing his Ph.D. in Pharmaceutics from IIT-BHU, India, in 1995, Karu began his career at Natco Pharma in India, where he developed a variety of oral dosage forms for two years. He then joined Banner Pharmacaps in India, where he worked on softgel and gel enrobed tablets. Karu joined Endo Pharma in 2006 and Catalent in 2016 as the VP of Product Development. He is also a Registered Pharmacist.
Dr. Christine Allen is a full professor at the University of Toronto (U of T) and an internationally recognized leader with more than 170 publications in drug formulation and development. She is a member of the Scientific Leadership Team of the Acceleration Consortium, a strategic initiative at the University of Toronto awarded $200M in funding from the Canada First Research Excellence Fund. She has received numerous awards and is a distinguished fellow of prestigious societies including the American Institute for Medical and Biological Engineering, and the Canadian Academy of Health Sciences.
Christine is committed to the translation and commercialization of her research. She is a co-founder and CEO of Intrepid Labs Inc., a company that is accelerating pharmaceutical drug development through integration of AI, automation and advanced computing. She is also a co-founder and board member at Nanovista Inc. Her lab at U of T is deeply engaged in industry partnerships, playing a key role in advancing drugs from early-stage research to clinical trials.
Her leadership has been pivotal in several scientific societies, notably as President of the Controlled Release Society and the Canadian Society for Pharmaceutical Sciences. In academia, her roles have included the inaugural Associate Vice-President and Vice Provost Strategic Initiatives and Interim Dean of the Leslie Dan Faculty of Pharmacy.
Christine’s commitment to equity, diversity and inclusion (EDI) goes beyond words. She actions EDI in her research and community engagement. In 2019, she founded the Women in STEAM: Leading and Reading book club to create a community that supports women as they advance in their education and careers.
Dr. Sandip B. Tiwari is Head of Technical Services- Pharma Solutions North America at BASF and provides innovative solutions to (Bio) pharmaceutical companies to solve their formulation/ processing challenges. Prior to joining BASF, Sandip was a Fellow Manufacturing Science & Technology at Teva Pharmaceuticals, Davie FL where he led a team for development and commercial launch of complex oral modified release formulations. Sandip also worked at Colorcon Inc. as a Senior Manager, Global Technology Development focusing on innovation in modified release polymeric systems, and then as a Technical Director. Sandip did his post-doctoral fellowship from Northeastern University, Boston, MA exploring nanotechnology-based drug delivery systems. While in India, Sandip worked for Zydus Cadila in the area of novel drug delivery systems. He earned his PhD in Pharmaceutical Sciences from College of Pharmaceutical Sciences, Manipal, Karnataka, India. He has written one book, eight book chapters/ monographs and contributed more than 100 research publications, abstracts, and patents in the areas of dosage form design, new technologies, mathematical modeling, dissolution science and excipients.
Associate Professor Matthias G. Wacker works in the Department of Pharmacy at the National University of Singapore (NUS). After finishing his undergraduate studies in Pharmacy, he earned his doctoral degree in pharmaceutical technology from Goethe University in Frankfurt (Germany), where he also was a principal investigator and completed his habilitation under the guidance of Jennifer Dressman and Jörg Kreuter at the Institute of Pharmaceutical Technology. Before joining NUS, he headed the Department of Pharmaceutical Technology and Nanosciences at the Fraunhofer IME in Frankfurt. He serves on the editorial boards of several prestigious journals (e.g., European Journal of Pharmaceutics and Biopharmaceutics, Frontiers in Chemistry, Journal of Pharmacy and Pharmacology) and has been recognized for his research excellence with awards such as the Eudragit® Best Paper Award (2015) and the Phoenix Pharmaceutics Science Award (2017). He is a member of various committees and organizations, including the United States Pharmacopeial Convention‘s General Chapters – Dosage Forms Expert Committee and the Expert Panel on New Advancements in In-Vitro Product Performance Testing, as well as the International Organization for Standardization’s Technical Committee 229, which is responsible for developing nanotechnology standards. In his current research, he specializes in employing a quality-by-design approach to create and analyze advanced dosage forms, placing a strong emphasis on bio predictive release and computational techniques to establish in vitro-in vivo correlations. This enables improved formulation designs. Since 2022, he has been acknowledged as one of the World’s Top 2% Scientists by the Standford University Ranking. His work holds immense potential in refining the selection process for optimal formulation prototypes, enabling seamless translation from preclinical to clinical stages.
Ricardo Sosa obtained his PhD in Chemical and Biomolecular Engineering from the University of Houston in 2021. Upon graduation, he joined AbbVie as a Dissolution SME, leading the dissolution method development strategy for various oral drug products (including oral disintegrating tablets and oral biologics) in the pipeline. He leverages his training in engineering and experience in microscopy and flow through cell technologies to develop a holistic understanding of product performance for complex drug products using in-silico modelling and dynamic imaging, together with functionality assessment of excipients. He is involved in new dissolution vessel design to address issues related to artifacts associated with dissolution variability and inadequate hydrodynamics.
Elizabeth Bielski, M.S., Ph.D. 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 (October 2020-October 2022) and as a Chemist (January 2020 t-October 2020) within DTP-I. Her areas of expertise involve orally inhaled and nasal drug products (OINDPs) and drug-device combination products (DDCPs). 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 and DDCPs. 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 inhaled 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.
James Mullin is a Senior Principal Scientist at Simulations Plus, Inc. and has a graduate degree in Chemical Engineering. In his role at Simulations Plus, he contributes to modeling and simulation development and consulting activities across multiple programs including GastroPlus, MembranePlus, and DDDPlus. Most recently, James is participating in an FDA grant project to extend the capability of Gastroplus to predict local tissue concentrations by enhancing the model structure. Additionally, he has developed models to predict partitioning in pulmonary tissues and simulate inhalation of vapors for purposes of toxicological modeling and assessments. James has 19 years’ experience in PBPK modeling, computational fluid dynamics, and mathematical modeling.
Dr. Ross Walenga joined the FDA in 2015 as an Oak Ridge Institute for Science and Education (ORISE) Fellow. He is currently a Chemical Engineer at the Division of Quantitative Methods and Modeling at the Office of Research and Standards. 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 modeling of orally inhaled, nasal, ophthalmic, and dermal drug products to answer questions pertaining to bioequivalence.
Navnit H. Shah is SVP and scientific advisor at Amneal. Prior to joining Amneal he was President and CSO of Kashiv Pharma, in Bridgewater, NJ. Navnit was a Distinguished Scientist in the Pharmaceutical R&D Department at Hoffmann-La Roche Inc. Nutley, N.J. and was heading dosage form development group prior to joining Kashiv Pharma in 2012. He received his Ph.D from St John’s university , New York, has over 40- years of experience and published and presented over 100 papers and 120 abstracts in drug delivery area covering improving dissolution and bioavailability of poorly water soluble molecules, Lipid delivery and controlled release. He is an inventor and co-inventor of 35 issued patents and 20 patent applications and has recently published extensively on Amorphous Solid Dispersion Technologies for poorly soluble drugs. He has received numerous awards: AAPS fellow in 1998, Thomas Alva Edison Patent Award in 2005, distinguished Alumni award in 2008, Research Leadership award from New Jersey Bio Medical Research in 2010, and New Jersey Inventor of the year award by New Jersey Inventor Hall of fame (NJIHoF) for the drug delivery technologies in October 2011. He was adjunct professor at University of Rhode Island , responsible for mentoring many graduate students for their thesis.
Dr. Vaka is a Director of Formulation R & D, specialty product division at Amneal Pharmaceuticals. He obtained his Ph.D in Pharmaceutics & Drug Delivery from the University of Mississippi. After graduating, he worked at Kashiv Pharmaceuticals LLC., for about 8 years in R & D, focusing on 505(b)(2) programs. He developed GRANDE® (advanced gastric retention system) and KRONOTEC® (advanced osmotic oral drug delivery system) proprietary technology platforms for controlled drug delivery of challenging compounds that significantly improve efficacy, tolerability and compliance. He has authored 25+ research articles in peer-reviewed international journals, 2 book chapters and is an inventor on over 15 patents.
Nilay Patel is a Director of Pre-Formulation & Analytical R&D for the Specialty & complex generics product division at Amneal Pharmaceuticals. He holds a Master’s degree in Pharmaceutical Sciences from Stevens Institute of Technology. Nilay joined Amneal in 2010 as a scientist in the Analytical R&D department and has since progressed through a series of leadership positions within the company. Throughout his tenure at Amneal, Nilay has gained extensive experience working with a wide range of dosage forms, including oral, semisolid, ophthalmic, otic, implants, transdermal, nasal, and inhalation formulations. He has played a pivotal role in suggesting in-vitro alternatives to clinical testing for complex generic products. Currently, he is actively involved in supporting 505(b)(2) programs, focusing on establishing in-vitro models for proprietary gastro-retentive oral dosage forms using multiple approaches.
Dr. Schwendeman’s long-term research goal is to design highly potent and safe synthetic high-density lipoprotein (HDL) nanomedicines for treatment of atherosclerosis. These 10 nm size particles mimic the natural HDL function of cholesterol removal from arterial plaques and subsequent cholesterol transport to the liver for elimination. Dr. Schwendeman spent 12 years in pharmaceutical industry at Cerenis Therapeutics (Fierce 15 biotech, www.cerenis.com), Pfizer, and Esperion Therapeutics. She was involved in discovery and translation of several HDL therapies to Phase II clinical trials. Her efforts led to development of a kilo-scale recombinant Apolipoprotein A-I process and highly homogeneous and safe HDL particles for the largest-to-date Phase II sHDL clinical trial (>500 patients). She successfully submitted FDA INDs for six different products including nanoparticles, liposome, proteins, peptides and small molecules.
Ajay Pydah is the Lead for Software and Data Management Solutions at SOTAX in the Americas. Prior to taking on his current customer facing role, Ajay led a software development group at Caliper Life Sciences and later all of Product Development and Production at SOTAX Corporation in Westborough, MA. He holds a Master of Science in Engineering from Northeastern University in Boston and a Bachelor of Science in Mechanical Engineering from India.
Ajay is the Treasurer for SPDS US and currently serves on the Board of the organization.
Vivek Purohit, Ph.D. has over 17 years of experience in clinical pharmacology/pharmacometrics in various disease areas such as infectious diseases, cardiovascular, rare diseases and inflammation/immunology. He is deeply committed to the application of quantitative approaches to decision making and answer key development questions for efficient drug development. He joined the Clinical Pharmacology group at Pfizer in 2007 and has extensive experience in the areas of Inflammation & Immunology with a special focus on dermatology indications. He has consistently applied Model Informed Drug Development (MIDD) principles in areas of infectious diseases, inflammation and topical dermatological agents with high impact on development decisions.
Vivek has authored/co-authored several peer-reviewed publications, book chapters and holds 4 patents.
He received his Ph.D. degree in Pharmaceutical Sciences from the University at Buffalo, State University of New York, Buffalo in 2005.
Stephen D. Stamatis is a director in Synthetic Molecule Design & Development at Eli Lilly and Company. He completed his B.S.E. in Chemical Engineering at the University of Michigan and Ph.D. in Chemical Engineering from Purdue University in 2010. His thesis work focused on Bayesian approaches to parameter uncertainty assessment in microkinetic models of catalysis. Dr. Stamatis completed a postdoctoral fellowship at the University of Iowa in pharmaceutics where he developed whole body physiologically based pharmacokinetic models to asses drug product stability risk. He joined Eli Lilly and Company in 2013 developing oral absorption models for several assets. His current work focuses on the application and development of biopharmaceutics models in drug discovery through late phase commercialization with an emphasis on drug product performance.
Dr. Prasad Panzade is an executive with a broad vision and strategic entrepreneurial mind set personality with over 24 years of experience in the multidimensional chemical industries including the Pharmaceutical and biopharmaceuticals. Dr. Panzade holds a Ph.D. degree in pharmaceutical sciences with specialization in the field of Pharmaceutical Analytical Sciences and Technology. He has been an active member of several professional organizations and a mentor who believes in developing more future leaders.
Dr. Panzade is currently working with ProtaGene Inc. as a Head of Analytical operations and Lab platforms. In the past he has worked with Apotex Inc. Canada’s number one generic pharmaceutical company as a Senior director of Analytical R&D and Quality Control for Global R&D, prior to this he worked as a senior vice president for a multibillion-dollar conglomerate Aditya Birla Group. He has held several levels of positions in the API, specialty chemicals, polymer and generic drug formulation industries. Dr. Panzade is a speaker who provides active insights on the latest in the fields of analytical sciences world. He has several peer reviewed journal publications, articles published and patents to his credits.
Before moving into the full-time positions in industries Dr. Panzade has worked as lecturer in the pharmaceutical college and Dr. Panzade spends his time in providing consulting services to various industries for analytical, quality and compliance related issues and market insights.
John Middleton began synthesizing and characterizing biodegradable polymers for drug delivery applications in the 1980’s as a chemist at Southern Research Institute. After receiving his Ph.D. in polymer science from the University of Southern Mississippi he has worked for several biomaterials companies synthesizing biodegradable polymers for customer applications. He has served in senior management roles at Birmingham Polymers, Durect Corporation, Atrix Laboratories, Lakeshore Biomaterials, Brookwood Pharmaceuticals and Surmodics. He joined Tolmar in 2012 and is the Vice President of Polymer Development. He is the coauthor on 18 publications and has approximately 15 US patents.
Zachery Custer is a Senior Scientist at Merck & Co. Inc. based in West Point, PA. He received a B.S. in Chemistry from Eastern University before joining Merck in 2016. During his time at Merck, Zach has contributed to the control strategy for several small molecule products in capacities such as analytical method development and authoring, method validation, specification setting, authoring of new drug application sections, and method transfers/ quality risk assessments. One of Zach’s key areas of focus has been the automation of analytical methods, especially disolution methods, for both pipeline and commercial products. Zach took on a role as the automation strategy lead in Merck’s Analytical Chemistry in Development and Supply organization in 1Q2022.
Dr. Ramaswamy, a graduate in chemistry (1973-78), Double post graduate in management (Marketing & HR from NMIMS, Mumbai) and a doctorate in pharmaceutical Business Administration. A Professional having nearly 4 decades of successful experience in various capacities in Indian Pharmaceutical Industry. He is currently the Managing Director of Sotax India Pvt. Ltd., a company head quartered in Switzerland, pioneer Pharmaceutical testing.
Prior to Sotax India he worked for Sarabhai Chemicals as a full time Director and CEO, Managing Director of Stiefel India Pvt. Ltd. (Which is merged with GSK later), Unichem Laboratories. He represented the Biotechnology Delegation organized by Govt of India to Canada in 2007. Dr. Ramaswamy has been a visiting faculty in reputed management Institutes in Mumbai and given many guest lectures including at IIM (Bangalore), Madurai Kamaraj University, NMIMS, etc. He has published many articles on Management and Human Resources Development and Brand Building.
He has also been instrumental in conceiving the idea and need for a Society For Pharmaceutical Dissolution science. and initiated the movement by bringing the Pharma Industry Scientists and Pharmaceutics Faculties from various pharmacy colleges, & Regulators under one roof and registered this Society as SPDS.
Nominated as a member in the International Scientific Advisory Board and session chair of 3rd International Symposium on Scientific and Regulatory Advances in Biological and Non-Biological Complex Drugs in Budapest, Hungary.
Mei Ou earned her M.D./B.S. and M.S. degrees from the Shanghai Medical College of Fudan University, China, and a Ph.D. degree in Pharmaceutics and Pharmaceutical Chemistry from the University of Utah in 2009. After that, she joined the Drug Metabolism and Pharmacokinetics group in Merck & Co. Inc., where her work involved RNAi Therapeutics. In 2015, Mei joined the FDA as a Biopharmaceutics Reviewer and currently she is a Senior Pharmacologist in the Office of New Drug Products, where she performs primary/secondary regulatory and scientific review work for IND/NDA/ANDA/SUPPL submissions, supporting multiple clinical therapeutic areas such as oncology, hematology, neurology, anti-infective, anti-viral, psychiatry, cardiovascular, and renal, metabolism and endocrinology, etc. Also, she has served as the Application Technical Lead and Cross Discipline Team Leader for several NDA submission under the Office of Oncology Diseases, and has contributed to multiple working groups at FDA, such as the CDER Nanotechnology working group, ONDP Breakthrough Therapy Designation working group, and KASA for NDAs initiative working group.
Dr. Heimbach is a Director at Merck in the Biopharmaceutics & Specialty Dosage Group where he serves as a biopharmaceutics expert in oral and parenteral drug development. Prior to that Tycho was at Novartis where he led a global PBPK modeling group in DMPK and served as PBPK/PBBM and biopharmaceutics expert. He served on the working groups for the PBPK renal and hepatic impairment WG and the PBBM WG for the Innovation and Quality in Pharmaceutical Development (IQ) consortium. Since 2021 Tycho is an AAPS Fellow and he is an author/co-author of more than 50 publications in ADME, PBPK and formulation sciences.
Tessa Carducci is an associate principal scientist at Merck & Co. based in Rahway, NJ working in the Analytical Commercialization Technology department. She graduated with a BS in Chemistry and minor in Psychology from Duke University and a PhD in Analytical Chemistry from UNC-Chapel Hill. At Merck, Tessa has worked on real time release strategy development and pioneered predictive dissolution modeling for release for a new drug product. Her primary areas of focus at Merck include subject matter expertise in dissolution and global filing requirements. She also enjoys implementation of novel analytical techniques, strategies for commercialization and world class supply, problem solving, and navigating new regulatory requirements. Outside of work Tessa enjoys taking care of her dog, skiing and snowboarding, traveling, and trying new foods.
B.Sc. Pharmacy, University of Strathclyde (1979) and Ph.D. Pharmaceutics, University of London (1984). Fellow of AAPS, CRS, APSTJ, and AIMBE. 2010 CRS President; 2002 AAPS President. Editor of International Journal of Pharmaceutics (2009 – 2018). Editorial board member of 13 international journals. Recipient of: 2018 AAPS Wurster Award in Pharmaceutics; 2014 AAPS Research Achievement Award; 2014 AAPS Outstanding Educator Award; 2014 CRS Distinguished Service Award; 2013 AAPS IPEC Ralph Shangraw Award; 2010 CRSI Fellowship, 2011 APSTJ Nagai International Woman Scientist Award. Over 240 refereed publications, over 640 research presentations, over 305 invited presentations, 22 keynote and plenary addresses.
Dr. James E. Polli is Professor of Pharmaceutical Sciences and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at U of Maryland. He received a B.S. in Pharmacy (Philadelphia College of Pharmacy and Science) and a Ph.D. in pharmaceutics (U of Michigan). His research interest is oral drug absorption. His two main research interests are 1) maximizing oral bioavailability through formulation and chemical approaches and 2) developing public quality standards for oral dosage forms. Dr. Polli has an active laboratory and clinical research program, with clinical pharmacokinetic studies in patients and healthy volunteers. He has served as advisor to 20 Ph.D. graduates. He is co-Director of the U of Maryland Center of Excellence in Regulatory Science and Innovation (CERSI), and FDA-funded collaborative agreement with the Agency. He is Director of the online MS in Regulatory Science program (www.pharmacy.umaryland.edu/regulatoryscience). He is an Editor of Pharmaceutical Research. He is a member of the University of Maryland General Clinical Research Center Advisory Committee. Dr. Polli is a member of the University of Maryland institutional review board (IRB). He is a member of the Scientific Advisory Board of Simulations Plus.
Dr. Sperry is an Executive Director in Synthetic Molecule Design & Development at Lilly Research Laboratories. He obtained a B.S. degree in chemistry from Indiana University, Bloomington, IN and a Ph.D. degree in chemistry from the University of Rochester, Rochester, NY. After receiving his degree, he took a postdoctoral research scientist position at Pharmacia & Upjohn where he developed an Artificial Stomach Duodenum model and studied its utility in drug development. Shortly thereafter, he accepted a research scientist position at Pharmacia (later Pfizer), working in the area of in vitro methods and biopharmaceutics. He then moved to Bausch and Lomb where he developed commercial ophthalmic formulations for late stage molecules. In 2007, Dr. Sperry joined Lilly Research Laboratories, where he created a group focusing on in vitro drug product performance techniques and predictions of in vivo performance. In 2013, Dr. Sperry joined a computational modeling group at Lilly. He now supports product development by using existing and creating new models to predict product performance and oral absorption of small molecule drug formulations.
Talia is currently Head of Product Design and Performance at UCB Pharma in Belgium. She is accountable for the design, development and manufacture of drug products from preclinical and clinical development through to commercial, and leads a multi-skilled department including biopharmaceutics, formulation, manufacturing, materials science and solid state experts. Her previous roles at UCB include Head of Biopharmaceutics, where she was accountable for biopharmaceutics strategies on projects across the portfolio from preclinical to commercial phases, and Principal Scientist, with a focus on strengthening collaboration between the Pharma Sciences, Clinical Pharmacology and DMPK functions to drive integrated risk assessment and cross-functional product development strategies. Before joining UCB in 2019, Talia worked at AstraZeneca in the UK for 12 years, most recently as an Associate Principal Scientist in Biopharmaceutics. She has extensive and diverse experience of developing and overseeing biopharmaceutics and clinically relevant dissolution strategies on drug projects, with particular focus on oral products Phase 2 to post-launch. Her research interests include clinically relevant dissolution tests and specifications, IVIVC/IVIVR, biowaivers, and biopharmaceutics in patients and special populations. Talia is active in several cross-industry collaborations and consortia, including EFPIA and IQ working groups. Talia was EFPIA Deputy Topic Lead on the ICH M9 (BCS-based biowaivers) Expert Working Group, and is currently representing EFPIA as Deputy Topic Lead on the ICH M13 (bioequivalence studies) Expert Working Group. She has been an invited speaker at several national and international conferences/workshops in the field of biopharmaceutics and clinically relevant specifications, and has authored/co-authored mor than 40 manuscripts and 3 book chapters in these fields. Talia received a Master of Pharmacy with honours (2002) and Doctor of Philosophy (2007) degrees from the Welsh School of Pharmacy, Cardiff University.
Mr. Pankaj Patel is the Chairman of Zydus Lifesciences, a discovery-driven, global Lifesciences company with operations in 55 countries worldwide. A stalwart and a visionary, Mr. Pankaj Patel combines both research and techno-commercial expertise. Mr. Patel has been nominated as a Member of the Mission Steering Group (MSG), the highest policy making and steering body constituted under National Health Mission (NHM) and of the Drug Technical Advisory Board by Ministry of Health & Family Welfare, Govt. of India, New Delhi. Mr. Patel is a Past President of the Federation of Indian Chamber of Commerce & Industry (FICCI). Mr. Patel is Chairman of IIM, Udaipur and Member of the Board of Governors of IIM Ahmedabad, Invest India, IIFT and other education institutes and universities. He is the Vice President and Trustee of the Gujarat Cancer Society and Chairman of the Gujarat Cancer and Research Institute, a Regional Cancer Centre. In recognition of his contributions to the healthcare industry in India, Mr. Pankaj Patel is conferred several awards.
Dr. Morris is the Executive Director of the American Association of Pharmaceutical Scientists (AAPS). She leads the staff team that supports all operational aspects of the Association and works with the AAPS Board of Directors and other Volunteer Leadership Committees on the strategic and direction-setting activities that guide the work of the scientific society. Prior to that, she was Vice President of Scientific and Regulatory Affairs at the Parenteral Drug Association (PDA). Until 2018, Dr. Morris held several scientific senior leadership positions at the United States Pharmacopeia (USP), including as the Global Head of Biologics and Senior Vice President of Compendial Science. Before joining USP in 2003, Dr. Morris worked in the biopharmaceutical industry, with an expertise focus on analytical development and product characterization. She completed her postdoctoral research at the National Institutes of Health. She holds a Ph.D. in molecular virology from the Medical University of Luebeck, Germany, and a master’s degree in biology from the Carl von Ossietzky University of Oldenburg, Germany.
Dr Arvind Kumar Bansal is currently Professor and Head, department of Pharmaceutics at National Institute of Pharmaceutical Education and Research (NIPER) – SAS Nagar, Punjab, India. He earned his M Pharm (Pharmaceutics) (1988) and Ph.D. (1993) from University of Delhi, India. Prof Bansal worked as Senior Scientist and Group Leader in JK Pharmaceuticals and Ranbaxy Research Laboratories, for 8 years. Therein he conceptualized, evolved formulation strategies, developed and transferred the technology to production shop floor, for NCEs and generic drug products. Prof Bansal joined NIPER in 2000 and developed expertise in areas of pre-formulation and formulation development encompassing characterization and stabilization of the amorphous form, polymorphism, pseudo-polymorphism, particle engineering, screening salt forms, improvement of oral bioavailability and lyophilization. His research group works with the mission statement – ‘developing science based industrially viable pharmaceutical technologies’ and works closely with pharmaceutical industry to create opportunities for commercial exploitation of the products. Dr Bansal was conferred prestigious Fellow of American Association of Pharmaceutical Sciences in 2016. He is the only Indian, working in India, to be awarded this Fellow status. He has won prestigious awards like AAiPS Distinguished Educator and Researcher Award, Innocentive Award, OPPI Award and IPA-ACG Scitech Innovation Award 2018 for Best Innovative Development of Solid Dosage Form. Prof Bansal’s research group has completed more than 550 industry-sponsored projects, granted 11 patents, filed 27 patents, and published 170 research articles and 27 review articles. He has total citations of 8011, with h-index of 47, in Google Scholar. He is an editorial board member of ‘Journal of Excipients and Food Chemicals’, ‘Drug Development Research’ and ‘Pharmaceutics’. He is also an Advisor to the editorial board of ‘Journal of Pharmaceutical Science’ and ‘Molecular Pharmaceutics’. Recently his lab has out-licensed a platform technology on “Nano crystalline solid dispersions – NanoCrySP”.
Patrick serves as Vice President and Deputy of the CEO of the Aesch, BL, Switzerland headquartered SOTAX Group. Raised in Switzerland and educated at ETH Zurich, he moved to Pennsylvania in 2005 and Massachusetts in 2009 to develop the presence of SOTAX in the United States. Today he oversees all activities of SOTAX in North- and South America, including Production, Product Development and Application Laboratories at SOTAX in Westborough, MA. A Chemist by training, his research interests prior to joying SOTAX were in the areas of Medicinal and Computational Chemistry.
The SOTAX Group exclusively works with scientists in AR&D, QC and Production of the pharmaceutical industry worldwide. We seek to assist them in their work with cutting edge solutions in the areas of data management, automation, dissolution testing, automated sample preparation, and at-line testing solutions.