Liang Shang

🚨 FDA #Expands Merck’s KEYTRUDA® + Astellas Pharma/Pfizer’s Padcev® Into Perioperative Muscle-Invasive #Bladder #Cancer The U.S. FDA has approved KEYTRUDA® and KEYTRUDA QLEX™, each combined with Padcev® (enfortumab vedotin), as neoadjuvant treatment before surgery followed by adjuvant therapy after cystectomy for adults with muscle-invasive bladder cancer (MIBC). This is the first and only PD-1 inhibitor + antibody-drug conjugate (ADC) regimen approved regardless of cisplatin eligibility. 1️⃣ Phase 3 Data Redefines the Perioperative Standard The approvals are supported by KEYNOTE-B15 (EV-304) and expand the prior KEYNOTE-905 (EV-303) approval. In cisplatin-eligible patients, KEYTRUDA + Padcev reduced the risk of event-free survival (EFS) events by 47%, death by 35%, and increased pathologic complete response (pCR) to 55.8% vs. 32.5% with standard gemcitabine/cisplatin chemotherapy. 2️⃣ Expanding Treatment Options for All MIBC Patients For more than two decades, cisplatin-based chemotherapy has been the perioperative standard for eligible patients, while many others had limited options. These approvals establish an immunotherapy + ADC strategy that now covers both cisplatin-eligible and cisplatin-ineligible patients, significantly broadening access to effective perioperative treatment. 3️⃣ Strengthening Merck’s Leadership in Genitourinary Oncology The approvals further expand KEYTRUDA’s leadership across earlier-stage cancers while reinforcing the value of combining immune checkpoint inhibitors with antibody-drug conjugates. With more than 50 ongoing GU cancer trials involving over 22,000 patients worldwide, Merck continues to deepen its presence across bladder, kidney, and prostate cancer. 👥 Leadership Perspective Matthew Galsky, M.D., of the Icahn School of Medicine at Mount Sinai and Mount Sinai Tisch Cancer Center, noted that these approvals mark an important shift beyond traditional cisplatin-based chemotherapy, providing new perioperative options for patients regardless of cisplatin eligibility. Marjorie Green, M.D., Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories, emphasized that the combined KEYNOTE-B15 and KEYNOTE-905 results represent a promising step forward in improving outcomes for patients with muscle-invasive bladder cancer. 🧩 My takeaway This is more than another KEYTRUDA label expansion. It represents a new perioperative treatment paradigm for MIBC, where checkpoint inhibition plus ADC therapy moves ahead of surgery to reduce recurrence and improve survival. #Merck #KEYTRUDA #Padcev #BladderCancer #MIBC #Oncology #Immunotherapy #ADC #FDA #ClinicalTrials #PrecisionMedicine https://lnkd.in/ergjJRct

Over the past several months, I have shared 134 LinkedIn posts on RNA therapeutics, machine learning, and AI-enabled sequence design. Several LinkedIn friends encouraged me to consolidate these notes into a more structured review. I’m pleased to share Version 1.0 of my review: “Machine Learning for RNA Therapeutics: From Sequence Design to Clinically Aligned Closed-Loop Engineering.” DOI: 10.5281/zenodo.20562354 This review synthesizes public literature and recent articles/preprints available through the end of March 2026, covering RNA modality-specific design objectives, data foundations, RNA foundation models, sequence-to-function prediction, generative design, multi-objective optimization, benchmarking, uncertainty calibration, and closed-loop DBTL engineering. My central message is that machine learning will not replace experimental judgment, but can provide a calibrated, testable, and accountable framework for RNA therapeutic design. I sincerely welcome your comments, critiques, and suggestions. https://lnkd.in/eJJUbzRE

Another major U.S. biomanufacturing investment. Amgen announced an additional $300M investment in its U.S. manufacturing network, focused on expanding its biologics manufacturing facility in Juncos, Puerto Rico. This brings Amgen’s announced U.S. manufacturing and innovation investments to nearly $2B over the last year. ♦ $300M additional investment in Puerto Rico ♦ Builds on a previous $650M Puerto Rico expansion ♦ Juncos is one of the largest and most advanced biomanufacturing sites in the world ♦ Produces biologic medicines distributed to more than 60 countries ♦ Supports advanced manufacturing roles, workforce development, and hundreds of construction jobs ♦ Follows Amgen’s recent $900M Ohio expansion and $600M California science and innovation center ♦ Adds to Amgen’s more than $1.5B investment in North Carolina Pharmaceutical manufacturing investments over the last year are over $550B. This is a mind boggling number! #robotics #manufacturing #pharmaceutical

I’m excited to share that I’ve started a new role as a Scientist in the Manufacturing Science & Technology department at Thermo Fisher Scientific. I’m grateful for the opportunity to contribute to a team that plays a critical role in bridging process development and manufacturing, and ultimately in delivering life-changing therapies to patients. Looking forward to learning, growing, and collaborating with such a talented group of scientists and professionals.

Hi Everyone. I’m looking for a dynamic scientific - robotics leader to help our team deliver new automated solutions and optimize our workflows https://lnkd.in/eXzGwv2Z

I’m thrilled to announce that the Splunk Add-on for OpenTelemetry Collector is now Generally Available! Splunk Enterprise and Splunk Cloud Platform customers can now take advantage of OpenTelemetry to receive, process and export metrics and traces data into Splunk Observability Cloud easily at scale. Click on the link to learn more! Congratulations to all the team members for this achievement and thank you to all the partners who made this happen. Aunsh Chaudhari Morgan McLean Rock Baek Vinu A. James Hughes Courtney Gannon Ori Broit Greg Leffler James Barnett Alexander Binkin Doron Keller Antoine Toulme Eyal Maderer Tigran N. Jennifer Worthington Erika Edwards Robin Pille Fabrizio Ferri-Benedetti Yogesh Sontakke Chris Crocco Hal Rottenberg Dan Hosaka Steve McMaster Tedd Hellmann Faya Peng Andrzej Kubik #splunk #splunko11y

Very honored to be able to speak with young scientists and post-docs at the NIH Career Symposium 2023 about my journey to a career in laboratory capacity building, global health, and laboratory workforce advocacy. Hoping some of the best practices shared may help them navigate their own career transitions! #NIHCareerSym2023 - via #Whova