Please Join AAPS PPSTDD Community Webinar "De-risk Combination Product Development Through Scientific Solutions and Data Driven Approach" presented by Sibgat Ulla and Dr. Justyna Dudaronek on Thursday, Oct 5, from 12:00-1:00 pm EST.
Presenter Biography
Sibgat Ulla is Director of Combination Product Technology Development at ZebraSci (a BD company). Sibgat has over 15 years of medical device and pharmaceutical industry experience, taking products from concept to commercialization with an area of expertise in combination product design, testing and innovation, design history file development and commercial manufacturing. He helped across the various pharmaceutical companies and launched multiple products to the clinic/commercial by assisting 510(K) technical files, IND/BLA regulatory submissions utilizing his engineering and management experience. Sibgat served from Engineering to Managerial roles at Regeneron Pharmaceuticals, CareFusion (a BD company), Baxter International and Leica Microsystems.
Dr. Justyna Dudaronek is Director of Technical Services at BD Medical-Pharmaceutical Systems responsible for scientific advisory services and support. She has more than 15 years of combined experience in pharmaceutical and medical device industries with a broad range of expertise, including drug-container integration science and drug-device process engineering and development.
Drug Combination Product development requires a deep understanding of the components to the overall system to ensure the safe and efficient delivery of the drug.
Main challenges that impact pre-filled syringes (PFS) product development are:
• Drug-Container Interaction
• Mechanical Performances
• Container Closure Integrity
This presentation will focus on the tools & methodology can be deployed to anticipate such challenges and provide key data to de-risk your drug combination product development at an early stage.
• Introduce the predictive tools & methods for an early assessment of drug-container interaction and mechanical performance to de-risk your Drug Combination Product development
• Present a case study of how these tools can be used to make data driven decisions about PFS and Autoinjector device selection.
Please feel free to reach out here or via email if you have questions.
AAPS PPSTDD Webinar "De-risk Combination Product Development Through Scientific Solutions and Data Driven Approach"
Oct 5, 2023, 12:00 – 1:00 PM (America/New_York)
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Yuan Cheng PhD
Senior Principal Scientist
Regeneron Pharmaceuticals
Tarrytown NY
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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