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In order to focus on the most important considerations for SC product development, developers must have a data-driven understanding of...
The Clinical Development & Regulatory Strategy (CDRS) sub-team of the Subcutaneous (SC) Drug Development and…
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Annual Update
The Subcutaneous Drug Development & Delivery Consortium efforts to address the most pressing issues in subcutaneous (SC) drug development are well underway! Our vision is to transform patient care and improve patient outcomes by leading fundamental advancements in SC drug development and delivery. The consortium recently refreshed our consortium strategic imperatives, problem statements and goals for 2024+.
Below are some highlights of the achievements and direction of our workstreams:
- The Bioavailability Sub-team championed our first Request for Proposal, awarding two companies funding to evaluate a translatable in-situ pig model and mechanistic in-silico models for predicting SC bioavailability. A preliminary predictive model has been developed, and the sub-team is going to continue to develop tools that are predictive of clinical bioperformance.
Sachin Mittal Manuel Sanchez-Felix
- The Bioavailability Sub-team championed our first Request for Proposal, awarding two companies funding to evaluate a translatable in-situ pig model and mechanistic in-silico models for predicting SC bioavailability. A preliminary predictive model has been developed, and the sub-team is going to continue to develop tools that are predictive of clinical bioperformance.
- The High Dose High Volume (HDHV) Sub-team completed a comprehensive literature search and landscape assessment of pain associated with HDHV products. A manuscript will be forthcoming near-term that provides an overview of the interdependency of meta- variables on pain associated with HDHV products, identifies knowledge gaps, and makes recommendations for future product design. The subteam plans to create a white paper to harmonize pain methodology across the industry for delivery of HDHV products, develop an integrated (e.g., clinical, CMC, regulatory) development roadmap, and also put forth an open innovation call to academia to develop a predictive pain model.
Reza Esfandiary Rajesh Gandhi
- The High Dose High Volume (HDHV) Sub-team completed a comprehensive literature search and landscape assessment of pain associated with HDHV products. A manuscript will be forthcoming near-term that provides an overview of the interdependency of meta- variables on pain associated with HDHV products, identifies knowledge gaps, and makes recommendations for future product design. The subteam plans to create a white paper to harmonize pain methodology across the industry for delivery of HDHV products, develop an integrated (e.g., clinical, CMC, regulatory) development roadmap, and also put forth an open innovation call to academia to develop a predictive pain model.
- The Patient Experience Sub-team completed an assessment and a manuscript will be forthcoming sharing the patient treatment journey starting at diagnosis, including consideration of patient characteristics and SC product design attributes to inform drug delivery design and development. This sub-team will be creating a Request for Proposal for ethnographic research to address gaps in understanding with respect to patient preferences.
Jennie Stevenson
- The Patient Experience Sub-team completed an assessment and a manuscript will be forthcoming sharing the patient treatment journey starting at diagnosis, including consideration of patient characteristics and SC product design attributes to inform drug delivery design and development. This sub-team will be creating a Request for Proposal for ethnographic research to address gaps in understanding with respect to patient preferences.
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- The Clinical Design & Regulatory Strategy Sub-team conducted an AAPS workshop on technologies that facilitate SC administration of high-dose products as well as the current status and considerations for clinical development. This year the sub-team intends to prepare a best practices white paper highlighting an aligned industry position on the clinical development of SC formulations for biotherapeutics.Beate Bittner Ryan Nolan
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- The Immunogenicity Sub-team hosted a workshop at the 2023 PEGs Boston meeting to share current thinking with respect to immunogenicity concerns after SC administration of protein therapeutics. In 2024+, the goal is to identify industry-wide in silico, in vitro and preclinical in vivo models that allow benchmarking protein therapeutics across companies and determine critical quality attributes that lead to an increase in immunogenicity.
Nicole Buist Vibha Jawa PhD FAAPS - The Governing Board approved a new Sustainability Sub-team! As first priorities, the sub-team intends to establish and publish “state of the industry” sustainability map for SC products and issue best practices for embedding sustainability into the development process and lifecycle of SC products, drug delivery devices, and packaging.
Monica Adams Duncan Paterson, CEng, MBA
- The Immunogenicity Sub-team hosted a workshop at the 2023 PEGs Boston meeting to share current thinking with respect to immunogenicity concerns after SC administration of protein therapeutics. In 2024+, the goal is to identify industry-wide in silico, in vitro and preclinical in vivo models that allow benchmarking protein therapeutics across companies and determine critical quality attributes that lead to an increase in immunogenicity.
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