Using images and excipient releases to inform in vivo product performance – Amorphous Solid Dispersion

Speakers

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  David Sperry
  

  David Sperry

  Dr. Sperry is a Sr. Research Advisor in Small Molecule Drug 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.

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  Mariana Romero-Gonzalez
  

  Mariana Romero-Gonzalez

  Mariana Romero-Gonzalez is a fifth-year Ph.D. candidate in the Department of Pharmaceutical Sciences at the University of Michigan. She holds a master’s degree in Pharmaceutical Sciences from Universidad Autónoma de Nuevo León, where she worked on developing oral controlled-release pharmaceutical dosage forms. Mariana’s doctoral research, under the guidance of Dr. Ashlee Brunaugh, focuses on developing inhalable pharmaceutical interventions to help treat opportunistic lung infections in chronic disease states. From August to December 2024, Mariana interned with the Biopharmaceutics Modeling Group, led by Dr. David Sperry, within the Synthetic Molecule Design and Development organization at Eli Lilly & Company, where she worked on developing a quantitative method for mapping the microenvironmental pH of dissolving compacts.

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  Niloufar Salehi
  

  Niloufar Salehi

  Niloufar Salehi completed her B.Sc. degree in Chemical Engineering in 2013 at the Sharif University of Technology in Tehran, Iran (2009–2013). Subsequently, she embarked on a research project at the University of Michigan, working under the supervision of Professor Ronald Larson and Professor H. Scott Fogler. During this time, her research focused on studying the aggregation and self-assembly of asphaltene molecules using molecular dynamics (MD) simulation tools. Motivated by her passion for interdisciplinary research, Niloufar pursued Ph.D. degrees in both Chemical Engineering and Pharmaceutical Sciences at the University of Michigan from 2016 to 2021. Throughout her doctoral studies, she worked under the guidance of Professor Gregory Amidon, Professor Robert Ziff, and Professor Gordon Amidon. Her dissertation was titled “Developing models to improve oral drug product delivery in the gastrointestinal (GI) tract”. Continuing her academic journey, Niloufar held a postdoctoral research position in Professor Steven Schwendeman’s Lab at the University of Michigan from 2021 to 2022 focusing on controlled release drug delivery and further expanding her expertise in these areas. Niloufar joined the Biopharmaceutics Modeling Group led by Dr. David Sperry in the Synthetic Molecule Design and Development organization at Eli Lilly & Company in 2023. Niloufar will be contributing to in silico and in vitro based predictions of oral formulation absorption in her new role.

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  Paul A. Stroud
  

  Paul A. Stroud

  Paul A. Stroud completed his B.S degree in Biochemistry at Indiana University, M.S degree in Biology at Purdue University, and Ph.D. in Polymer Science and Engineering from the University of Southern Mississippi. Paul has been working in the pharmaceutical field for over 20 years. He joined Eli Lilly and Company in 2009 and leads the material science and physical characterization team. There he drives physical and material property control strategies for solid oral dosage medicines. Paul has a large interest in understanding the physical properties of drug substances and excipients and their impact to tablet microstructure. He utilizes multiple imaging techniques, (i.e. X-ray CT, scanning electron, microscopy, and optical microscopy) to characterize the tablet structure and studies how the microstructure changes when subjected to environmental stresses such as temperature and humidity and the subsequent impact to disintegration and dissolution.

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  Rob Tzuchi
  

  Rob Tzuchi

  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.

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  Sandip Tiwari
  

  Sandip Tiwari

  Dr. Sandip Tiwari is a pharmaceutical scientist and industry leader with more than 26 years of experience spanning formulation science, drug delivery, excipient technology, manufacturing science, and translational biopharmaceutics. He serves as Head of Technical Services for Pharma Solutions, North America at BASF, where he leads scientific initiatives that connect formulation design, in vitro performance, and regulatory-relevant product development across small molecules and advanced dosage forms.
  Over the course of his career at BASF, Teva/ Actavis, Colorcon, and Zydus Cadila, Dr. Tiwari has contributed to complex oral dosage forms, modified-release systems, lipid-based and enabling formulations, excipient innovation, scale-up, technology transfer, and commercialization-oriented development. His work increasingly focuses on integrating dissolution science, model-informed development, digital tools, and AI-enabled workflows to improve formulation design, predict in vivo performance, and support risk-based decision-making.
  Dr. Tiwari is recognized for his leadership in dissolution science and professional service. He currently serves as Chair of the AAPS Formulation & Delivery Community and previously served as Vice Chair and Chair of the AAPS In Vitro Drug Release and Dissolution Testing (IVDRT) Community. He is also a Board Member and Scientific Advisory Board Member of the Society for Pharmaceutical Dissolution Science (SPDS) U.S. Chapter.
  An active scientific contributor, editor, speaker, and mentor, Dr. Tiwari is co-editor of the Desk Book of Pharmaceutical Dissolution Science and Applications and has authored over 100 publications, presentations, and patents. He also serves as Adjunct Professor in the Department of Translational Science and Medicine at the University of Alabama College of Community Health Sciences, reflecting his continued engagement in translational pharmaceutical science and academic mentorship.