Formulation and Delivery
Erica Schlesinger, Ph.D. (she/her/hers)
Vice President of Technical Development
Serán Bioscience
Bend, Oregon
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This talk seeks to provide an overview of emerging technologies to address the need for delivering high doses to enable subcutaneous delivery of protein therapeutics. Over the past decade significant progress has been made in this area with three main approaches: high concentration solutions, high concentration suspensions, and high-volume delivery. Due to the complex and continually changing landscape of protein therapeutics, a variety of approaches are required to address this unmet need. The goal of this discussion is to compare and contrast these emerging technologies to offer the audience a comprehensive understanding of the current landscape available to meet their specific needs for formulation and product design. Additionally, the panel discussion presents an opportunity to identify gaps in what these technologies offer and to highlight where further advancements and alternative approaches may be needed. High concentration protein formulations are a recurring theme in recent years, but rarely does programming bring together these alternative approaches in one place. This panel offers a unique opportunity for participants and the audience to engage and learn from each other to advance our understanding of the unmet need and potential solutions. Furthermore, bringing together what may be considered competing technologies into a joint panel discussion focused on how these technologies can best serve the pharmaceutical scientist, clinician, and patient, promotes collaboration across the industry to solve hard problems.
Several different approaches are being developed for high dose subcutaneous delivery, but rarely are they considered side-by-side in a single program. This panel discussion aims to bring together thought leaders and experts in different emerging technologies for a candid conversation on the pros and cons of each.
The proposed session is intended to be a discussion panel of 3-5 speakers and a moderator. The format will include facilitated questions from the moderator in addition to questions from the audience. The moderator and participants will be encouraged to approach this as a discussion, promoting dialogue between participants in addition to dialogue with the audience, rather than a strict question & answer paradigm. I would encourage the consideration of programming this topic in a symposium that considers the different emerging technologies for high dose subcutaneous protein delivery. Ideally this symposium would include 2-3 presentations on different technologies (high concentration solutions, high concentration suspensions, and high volume delivery) followed by a discussion panel with speakers representing each technology.
The target audience for this presentation is formulators, pharmaceutical scientists, and anyone who is focused on advancing protein therapeutics. The content is relevant both for those considering life-cycle management of existing therapeutics and for emerging programs in the pre-clinical or clinical phases of development.