Dan Milam, EMBA

Roche Doubles Down on Breast Cancer With $850M for Regor’s CDK Inhibitors - BioSpace The acquisition was featured Monday in Roche’s Pharma Day presentation, which also included projections of more than $3 billion in annual sales from three early-stage obesity and diabetes drugs. A portfolio of CDK inhibitors developed by Regor Pharmaceuticals has found a home at Roche, which announced Monday it would buy the investigational cancer drugs for $850 million upfront. Cambridge, Mass.– and China-based Regor will see two ongoing Phase I trials of CDK4 inhibitor RGT-419B through to their completion, at which time Roche’s Genentech subsidiary will take over global clinical development, manufacturing and commercialization of this asset. The deal also includes additional CDK4 inhibitors for cancer. Last December, Regor announced results from a Phase Ia trial of RGT-419B, showing that the drug was safe and well tolerated in patients with HR /HER2- advanced breast cancer who have progressed on CDK4/6 inhibitors and endocrine therapy. “Monotherapy clinical efficacy” was also observed, Regor reported. The deal, which is expected to close in the fourth quarter of this year, includes the potential for Regor to claim additional cash payments based on the achievement of predetermined development, regulatory and commercial milestones. “Genentech is well-positioned to bring these novel therapeutics to their full potential to benefit patients with breast cancer around the world,” Xiayang Qiu, founder and CEO of Regor, said in a statement. https://lnkd.in/eU-gY4wQ

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Reflecting on #CDISCUS2024, it was inspiring to see so much energy around making clinical data standards work better for our industry and the patients we serve, and to connect with nearly 500 peers in Scottsdale, who are equally passionate about advancing drug development. Chris Decker’s keynote which included his personal experience during Hurricane Helene was a powerful reminder of the importance of exhibiting a sense of urgency in our line of work, as well of prioritizing doing the right thing over constantly asking the ROI question. At Bioforum’s booth, we had exciting conversations about JetConvert™—a tool that offers real-time, live SDTM conversion, making clinical data submission-ready without requiring extra programming. JetConvert, which centralizes clinical data in one accessible place, lets sponsors catch data anomalies and submission issues early, simplifying data management and helping reduce study timelines and budgets. Thank you to CDISC and everyone who stopped by and joined us for sessions. It’s clear that the need for faster, more accessible data solutions in clinical trials is a shared goal, and Bioforum is proud to be part of this community. #CDISC #ClinicalTrials #ClinicalResearch #ClinicalDataManagement #JetConvert #SDTM #SCDM #Bioforum #BionData

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By understanding our customers objectives and timelines, we can partner in a consultative fashion to determine what the best delivery model is. #clinicaltrials #clinicalresearch https://lnkd.in/eQms_qty

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