Dikla Axselbrad on FDA approval

Surgical site infections remain a major source of avoidable harm, delayed recovery, and hospital cost even when standard protocols are followed. This 2026 Global BioInnovation Forum session during JPM Week focuses on a localized, controlled release approach designed to deliver therapy precisely at the site of care and reduce post surgical complications. The discussion opens with the clinical and economic burden of infection across hospital settings, including the persistent infection rates seen in complex procedures such as open abdominal colorectal resections and breast reconstruction. The core thesis is straightforward. Improving outcomes requires elevating treatment effectiveness where care begins, with long acting delivery that maintains local concentration over time rather than relying only on systemic antibiotics. Phase 3 results in colorectal resection are reviewed in detail, including top line outcomes and a focused look at surgical site infection reduction in a large study. The practical meaning of these results is discussed in the context of what surgeons typically expect in open procedures versus minimally invasive approaches. Regulatory readiness is a central theme. Pre NDA alignment with the FDA is discussed alongside the mechanics of a rolling NDA submission under breakthrough therapy designation, including expected acceptance timing, priority review, and how the review timeline connects to a potential PDUFA date. Commercial execution is addressed through a hospital first lens. Surgical site infections sit under the umbrella of hospital acquired infections, and hospitals often bear the downstream cost when infections extend length of stay and require additional care. That economic reality shapes formulary decisions through pharmacy and therapeutics committees, clinical champions, and pilot programs in high risk patients. Eligibility for the new technology add on payment program is also discussed as an adoption catalyst because it supports separate reimbursement for product use while hospitals benefit from avoided infection costs. The session closes with a view of market segmentation across procedures with high infection rates and procedures where infection is less common but consequences are severe, an initial focus on abdominal procedures in high risk patients, and a broader look at platform versatility, including an early GLP 1 delivery program with planned additional PK and animal efficacy data. 00:00 Intro 00:22 Welcome and session framing during JPM Week 00:49 Why SSI prevention remains a persistent challenge 01:26 Mission and controlled release delivery at the site of care 02:52 Phase 3 milestone and NDA timing overview 03:18 Why localized delivery matters for post surgical complications 03:48 SSI burden and why current standard of care still leaves gaps 05:12 Phase 3 design and primary endpoint focus in colorectal resection 05:55 Top line results and what changed versus standard of care 06:32 What the SSI reduction means for patients and surgeons 06:52 SSI specific results and why the effect size stands out 08:54 Pre NDA feedback and rolling NDA mechanics 10:10 NDA acceptance timing, priority review, and PDUFA expectations 11:38 Why data consistency matters for commercial readiness 13:20 Market opportunity and where commercialization starts 14:08 Segmenting procedures by infection rate and consequence severity 15:10 High risk patient identification before surgery 16:10 Surgeon willingness to use once on formulary 17:17 Hospital economics and why hospitals bear the cost of SSI 18:36 Formulary review process and pilot pathway 19:59 NTAP and separate reimbursement dynamics 20:58 Go to market strategy and partnering approach 22:58 Platform versatility and the GLP 1 program 23:33 Ultra long delivery, no burst profile, and combination potential 24:40 50 to 60 day GLP 1 delivery and upcoming data 25:43 12 to 18 month milestones and what to watch next 27:15 Key milestones NDA, PDUFA, US deal, and additional territories 28:02 Closing remarks #Surgery #InfectionPrevention #ClinicalTrials #Biopharma #BioInnovation