Society for Pharmaceutical Dissolution Science, US Chapter (SPDS-US Chapter) is organizing the Disso America 2024 conference at Rutgers University Campus, Piscataway, NJ. Disso America 2024 is an in-person conference where we will discuss dissolution challenges related to complex drug products with leading experts from industry and academia. The conference examines the complexity involved in the dissolution/drug release testing of Long-acting injectables and Oral complex dosage forms. The event will occur from June 11-12, 2024, at Rutgers University, Ernst Mario School of Pharmacy, 160 Frelinghuysen Rd, Piscataway, NJ 08854.
Date and time
Tue, Jun 11, 2024, 9:00 AM –
Wed, Jun 12, 2024, 5:00 PM ET
Location
Rutgers
Ernst Mario School of Pharmacy
160 Frelinghuysen Rd
Piscataway, NJ 08854
Meeting Agenda
Day 1 (June 11): Long Acting Injectables
| Welcome Session | Chair: Sanjay Patel, Merck | ||
| Time | Title | Speaker |
| 09:00 am – 09:05 am | Welcome Address | Dr. Vinod P. Shah, President, SPDS US Chapter |
| 09:05 am – 09:15 am | Keynote Speaker: SPDS and SPDS-US Chapter – Strategies and the Way Forward | Dr. Suresh Bhojraj, Pro-Chancellor, JSS Academy of Higher Education |
| 09:15 am – 09:35 am | Keynote Speaker: Biorelevant, Bioindicative and Biopredictive Dissolution: Current Perspectives and Future Challenges | Prof. Dr. Patrick Sinko, Immediate Past President, AAPS |
| 09:35 am – 10:00 am | Long Acting Injectables: Opportunities and Challenges in Product Development | Dr. Sujata Sonti, GSK |
| Session I – Biorelevant / Bio Predictive Models for LAI | Chair: Dr. Sandip Tiwari, BASF | ||
| Time | Title | Speaker |
| 10:00 am – 10:30 am | Development of Biorelevant In Vitro Models for the Prediction of Subcutaneous Drug Release and Absorption – What are the Challenges and Where are We? | Prof. Dr. Sandra Klein, University of Greifswald |
| 10:30 am – 11:00 am | Coffee break | |
| 11:00 am – 11:30 am | Computational Biopharmaceutics: Exploring the Drug Delivery Lifecycle of Complex Injectables | Prof. Dr. Matthias G. Wacker, National University of Singapore |
| 11:30 am – 12:00 am | Bio-predictive, Accelerated Release Testing of Single Agent and Combination LAIs | Dr. Kruthika Harish Jain, Gilead |
| 12:00 pm – 12:30 pm | Panel Discussion. Questions & Answers. | |
| 12:30 pm – 02:00 pm | Lunch break | |
| Session II – Leading Edge Formulations and In Vitro Techniques for LAI | Chair: Vivek Shah, Sotax | ||
| Time | Title | Speaker |
| 02:00 pm – 02:30 pm | The Next Frontier in Pharma: AI and Robotics-Driven Drug Formulation | Prof. Dr. Christine Allen, University of Toronto |
| 02:30 pm – 03:00 pm | Real-time Release and Accelerated Dissolution of an Implant | Dr. Maureen Marsales, Merck and Dr. Hyunho Kang, Merck |
| 03:00 pm – 03:30 pm | Coffee Break | |
| 03:30 pm – 04:00 pm | In Vitro Release Testing for Liposomal Formulations: Challenges and Key Considerations | Prof. Dr. Nikoletta Fotaki, University of Bath |
| 04:00 pm – 04:30 pm | Prolonged Release Single Does Antimalarial Injection of an ACT Combination | Prof. Dr. Padma V. Devarajan, Institute of Chemical Technology |
| 04:30 pm – 05:00 pm | In Vitro Release Test for Complex Drug Products: Thinking Outside the Box | Dr. Xiaoming Xu, FDA |
| 05:00 pm – 05:30 pm | Panel Discussion. Questions & Answers. | |
| 05:30 pm – 06:30 pm | Wine & Cheese | |
Day 2 (June 12): Complex Oral Drug Products
| Session III: Lipid Based Formulations – Session Chair: Dr. Deanna Mudie, Simulations Plus | ||
| Time | Title | Speaker |
| 09:00 am – 09:30 am | Roles of In-Vitro Tools for Elucidating Product Performance of Complex Oral Drug Products and their Relationship with Dissolution Testing | Dr. Ju (Rob) Tzuchi, AbbVie |
| 09:30 am – 10:00 am | Developing SNEDDS for Improving Peptide Oral Delivery | Prof. Dr. Annette Mullertz, University of Copenhagen |
| 10:00 am – 10:30 am | Innovative Soft Gel Technologies for Modulated Drug Release and Overcoming Challenges in Dissolution Method Development | Dr. Karunakar (Karu) Sukuru, Catalent |
| 10:30 am – 11:00 am | Coffee Break | |
| 11:00 am – 11:30 am | Annealing Effects on Dissolution of Oral Lipid Multi-particulates for Controlled Release | Dr. Mika Mast, Lonza |
| 11:30 am – 12:00 pm | Dissolution Testing of Lipid Based Formulations | Priti Jagani, Amneal |
| 12:00 pm – 12:30 pm | Panel Discussion. Questions & Answers. | |
| 12:30 pm – 02:00 pm | Lunch break | |
| Session IV: Amorphous Solid Dispersion – Chair: Dr. Xujin Lu, SPDS-US | ||
| Time | Title | Speaker |
| 02:00 pm – 02:30 pm | Non-Sink Dissolution Conditions for Predicting Product Quality | Dr. Andre Hermans, Merck |
| 02:30 pm – 03:00 pm | Elucidating Product Performance of Erosion-Based Dosage Forms through Assessment of Excipient-Functionality in a Non-Sink Environment and Evolution of 3-Dimensional Structure | Dr. Ricardo Sosa, AbbVie |
| 03:00 pm – 03:30 pm | Coffee Break | |
| 03:30 pm – 04:00 pm | Crystallization Inhibitors in ASD and Supersaturated Systems | Dr. Sandip Tiwari, BASF |
| 04:00 pm – 04:30 pm | Complex Oral Formulations and Dissolution Testing: FDA’s Regulatory Perspective | Dr. Payal Agarwal, FDA |
| 04:30 pm – 05:00 pm | Panel Discussion. Questions & Answers. | |
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.
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.
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.