Subcutaneous Drug Development & Delivery Consortium

Our Sustainability Sub-Team is making great progress at pace! With active participation from 11 member companies and leadership from Duncan Paterson, CEng, MBA and Monica Adams, the team developed ambitious goals for 2024.  Two main deliverables to address identified knowledge gaps are being actively advanced in a precompetitive manner. The first workstream, led by Conor ONeill and Sascha Rau, is focused on benchmarking the adoption of sustainability practices within the product development functions across the member companies and expects to read out later this year. The second workstream, under Dragana CVIJANOVIC, involves a patient-focused research study in collaboration with the Consortium’s Patient Preference and Patient Experiences Sub-Team, led by Jennie Stevenson and Johanna Schoss. The goal of the research for the sustainability workstream, is to understand user expectations and concerns about the environmental sustainability of subcutaneous pharmaceuticals, as well the level of interest and engagement users have in programs and products designed to minimize environmental impact. We look forward to seeing the product of the Sub-Team's work and would like to acknowledge all of the contributing members: Christian Pommereau and Karsten Tritsch (Sanofi); Dragana CVIJANOVIC and Amit Limaye (BD) Duncan Paterson, CEng, MBA and Zahid Nazir (AstraZeneca); Sascha Rau (Boehringer Ingelheim); James Glover (Pfizer); Conor ONeill, Mahdieh Bashoor Zadeh, and Monica Adams (GSK); Wail Rasheed, Ph.D. (Merck); Kevin Swanson (Halozyme, Inc.); and Sylvain L. Lanzi (Novartis). #SCConsortium #sustainability #drugdelivery #drugdevelopment

We are excited to share our latest publication focused on Optimizing Patient Experience and Treatment Adherence through SC Product Design. In this paper, we analyze patient experience parameters and the associated literature to offer perspective and make recommendations for future studies. Thank you and congratulations to authors Jennie Stevenson, Rachel Poker, Johanna Schoss, Michael Campbell, Claire Everitt, Brian Holly, Nick Stones , Ronald Pettis, and Manuel Sanchez-Felix. #SCConsortium #subcutaneous #drugdelivery #drugdevelopment https://lnkd.in/edqQqYwg

Please join members of the Subcutaneous Drug Development & Delivery Consortium at the 2024 Annual Meeting of the Controlled Release Society. Consortium members David Kang, Beate Bittner, Nicole Buist, Sachin Mittal, Manuel Sanchez-Felix, Sylvain Huille, Gerard Bruin, and Marie Printz will hold a workshop title "Debunking the Myths of Subcutaneous Drug Delivery" on Monday, July 8, 2024. https://lnkd.in/gbmeXaXs https://lnkd.in/gNgW-eZm

Spotlight on our High-Dose High-Volume Subteam

Our latest publication is a comprehensive review of known attributes that contribute to pain/discomfort upon SC injection. We discuss (1) device and delivery factors that cause physical pain, (2) formulation factors that trigger pain responses, and (3) human factors impacting pain perception. Congratulations to authors Neil Mathias, Sylvain Huille, Marie Picci, Robert Mahoney, Ronald Pettis, Brian Case, Bernhard Helk, David Kang, Ronak Shah, Junchi Ma, Deep Bhattacharya Ph.D., Yogita Krishnamachari, Dany Doucet, Dr. Nathalie Mougin-Maksimovikj, Sahab Babaee, Patrick Garidel, Reza Esfandiary, and Rajesh Gandhi. #SCConsortium #subcutaneous #drugdelivery #drugdevelopment https://lnkd.in/ekJZQgDf

The Bioavailability Sub-Team of the Subcutaneous Drug Development & Delivery Consortium aims to build fundamental understanding and tools to inform SC bioavailability of biologics. In 2023, co-leads Sachin Mittal (Merck) and Manuel Sanchez-Felix (Halozyme, Inc.) presented at the CRS-IPEC workshop and CRS 2023 Annual Meeting, respectively, on SC product development opportunities and challenges with specific focus on bioperformance. The team also championed the consortium's first RFP, which focused on evaluating a SC tissue microperfusion pig model along with mechanistic in-silico models for predicting clinical bioavailability. The output will be published and presented at Controlled Release Society (CRS) this summer. Future plans include further validation of available models, both in-vitro (e.g. SCISSOR) and in-silico/in-situ, with a broader set of biologic clinical/ commercial candidates to improve confidence in their use to enable speed during development and minimize necessity for in-vivo animal experiments. The team will also continue to forge connectivity with academia, regulators and technology leaders to drive meaningful advancements in the field. Thank you to all of the sub-team members for helping us to drive progress - Mikolaj Milewski, Marta Venczel, PhD, MBA, Neil Mathias, Manjunatha Shivaraju, Ryan Nolan, Filippos Kesisoglou, Marc-Antoine Fabre, Jennifer Drew, Antoine Deslandes, Pratik Saha, Jenna Caldwell, Kevin Maloney, Ming Cheng, Ludovic Gil, Chris Basciano, Xianwei Zhang, Mikhail Murashov #SCConsortium #drugdelivery #drugdevelopment #bioavailability

Welcome Duncan Paterson, CEng, MBA - Sustainability Sub-Team Co-Lead Please welcome Duncan Paterson, CEng, MBA, who will be co-leading our newly formed Sustainability sub-team.  He is Senior Director, Device Development at #astrazeneca with an engineering background and over 20 years of experience in inhalation and parenteral combination product development and commercialization.  Duncan is passionate about driving sustainability forward across the industry and we are thrilled to have him to join and look forward to his contributions. #SCConsortium #drugdelivery #drugdevelopment #sustainability 

Please see latest update from our Immunogenicity Subteam!

Check out our Annual Update!

The SC Consortium intends to make an impact. As we continue into 2024, we have updated our plans to advance our efforts and expand opportunities within the field through collaborative sub-team initiatives and activities. The recent establishment of our Sustainability sub-team marks a significant milestone, and the workstream is excited to conduct benchmarking surveys and partake in global patient-facing research to understand the role of sustainability in subcutaneous drug delivery and device design considerations. Concurrently, our other sub-teams are commencing impactful initiatives, including the validation of subcutaneous delivery models, evaluation of product quality attributes, and establishing industry best practices and positions through publications and collaborative workshops.