Using images and excipient releases to inform in vivo product performance – Modified Release for Parenteral and Oral Agenda
Hourly Schedule
Agenda
- 11:30 am - 11:35 am
- Welcome
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Speakers:
Vivek Shah
- 11:35 am - 11:45 am
- Overview of the topic and speaker Introduction by Moderator
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Speakers:
Sandip Tiwari
- 11:45 am - 12:25 pm
- Roles of Imaging and Excipient Release for Elucidating Performance of Oral Modified Release Products
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Speakers:
Rob Tzuchi
- 12:25 pm - 01:05 pm
- Advanced Analytical Approaches for Developing and Evaluating Long-Acting Drug Delivery Systems.
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Speakers:
Jonah Gautreau, Li Li
- 01:05 pm - 01:30 pm
- Panel Discussion. Questions and Answers
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Speakers:
Sandip Tiwari
Speakers
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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.
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Sandip Tiwari
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.
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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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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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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.