SUBCUTANEOUS DRUG DEVELOPMENT & DELIVERY CONSORTIUM INC

A.PATIENT PREFERENCE & EXPERIENCE: COMPLETED THE DESIGN AND DEVELOPMENT OF THE CONJOINT TOOL AND SURVEY ON PATIENT PREFERENCE FOR SUBCUTANEOUS DRUG DELIVERY; FIELDING IS COMPLETE WITH OVER 500 RESPONSES RECORDED FROM THE US, EU, AND JAPAN, AND ANALYSIS IS UNDERWAY. B.HIGH DOSE HIGH VOLUME: COMPLETED AN INDUSTRY-WIDE SURVEY ON "HARMONIZATION OF PAIN METHODOLOGIES FOR SC ADMINISTRATION-; DRAFT MANUSCRIPT "INTEGRATED CMC ROAD MAP FOR DEVELOPMENT OF HDHV PRODUCTS- AND THE "HDHV SELECTION CRITERIA MATRIX" ARE EXPECTED TO BE PUBLISHED IN 2026 FOLLOWING INTERNAL SC CONSORTIUM REVIEW. C.CLINICAL DESIGN & REGULATORY STRATEGY: PUBLISHED A CROSS-COMPANY SURVEY MANUSCRIPT ON CLINICAL AND REGULATORY STRATEGY IN THE JOURNAL OF CONTROLLED RELEASE AND CONDUCTED A WORKSHOP ON "DEVELOPMENT PATHWAYS AND CONSIDERATIONS FOR SUBCUTANEOUS BIOLOGIC FORMULATIONS" AT THE CRS 2025 ANNUAL MEETING & EXPOSITION IN PHILADELPHIA. D.SUSTAINABILITY: COMPLETED AND PRESENTED RESULTS OF THE INDUSTRY BENCHMARKING SURVEY AT MULTIPLE CONFERENCES THROUGHOUT THE YEAR, INCLUDING A POSTER PRESENTATION AT THE PDA UPS CONFERENCE IN VIENNA, AND SUBMITTED A MANUSCRIPT FOR PUBLICATION IN THE ON-DRUG DELIVERY JOURNAL. E.IMMUNOGENICITY: ENHANCED SC CONSORTIUM AWARENESS BY HIGHLIGHTING IMMUNOGENICITY SUB-TEAM ACTIVITIES AT THE IMMUNOGENICITY AND BIOASSAY SUMMIT, AUTHORED THE IMMUNOGENICITY PORTION OF "DEBUNKING THE MYTHS OF SC DELIVERY,- AND EXPECTS MANUSCRIPT SUBMISSION BEFORE YEAR-END. F.BIOAVAILABILITY: SUBMISSION OF "DEBUNKING THE MYTHS OF SC DELIVERY," DESCRIBING ADVANCEMENTS AND OPPORTUNITIES IN SC BIOAVAILABILITY, TO THE JOURNAL OF CONTROLLED RELEASE; A SECOND PUBLICATION, "PREDICTING HUMAN SUBCUTANEOUS BIOAVAILABILITY OF MONOCLONAL ANTIBODIES USING A NOVEL OPEN FLOW MICROPERFUSION (OFM) PORCINE MODEL," IS UNDER REVIEW.