Using images and excipient releases to inform in vivo product performance – Modified Release for Parenteral and Oral Agenda

Speakers

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  Jonah Gautreau
  

  Jonah Gautreau

  Jonah Gautreau, Lead Product Specialist at digiM Solution, works in physics-informed software development, helping create tools that apply imaging, data analysis, and computational physics to support pharmaceutical product development and better predict in vitro, in vivo and clinical performance.

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  Li Li
  

  Li Li

  Li Li is a Principal Scientist at Merck Research Labs with Ph.D. in Analytical Chemistry from Drexel University. She joined Pharmaceutical Sciences organization in 2001 and was responsible for developing predictive in vitro methodology and designing stability studies for over 20 Merck drug candidates ranging from pre-clinical to Phase III. She led the analytical effort at Merck to develop enhanced understanding of excipient structure-performance relationship, which is critical for oral delivery of a range of development candidates with diverse physical and chemical properties. More recently, she led the early development efforts for Oral PCSK9i, a potentially transformative therapy for patients with high risk for CV event. In addition, she has led the analytical efforts for mRNA drug substance with focus on innovative characterization tools for deep process understanding of IVT and purification steps.

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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.

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  Vivek Shah
  

  Vivek Shah

  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.