20/15 Visioneers

Great science can still stall when the operational foundation isn’t ready. Kelly Cycon, Ph.D., explores biotech’s “second valley of death” and how companies can avoid it. Read more below! #Biotech #LifeSciences #OperationalExcellence #QualityManagement #DataIntegrity

Meet the panelists joining Luminari CRO for Designing Smarter Trials: AI-Augmented Protocol Optimization & Adaptive Design. Natasha Pomelova, Rohit S., Jason Dowd, Ph.D., and Meraj A. Khan, PhD, will share perspectives on how AI, clinical data, and adaptive approaches are helping teams design smarter, more efficient clinical trials. 🗓️ Wednesday, August 12 ⏰ 11:00 AM EDT Register: https://lnkd.in/ed3-Dxs6 #ClinicalTrials #ArtificialIntelligence #ClinicalResearch #Biotechnology #DataScience #AdaptiveDesign #Webinar

An open role can end up costing a company in ways that are easy to overlook. Projects get pushed back, deadlines start slipping, and the rest of the team has to pick up the extra work. The goal is not to rush the hiring process. It's to have the right people in your network before the need becomes urgent! Reach out to michael.leschinsky@20visioneers15.com for more info. #LifeSciences #Biotech #Pharma #Hiring #ScientificTalent #Recruitment

We’re excited to welcome Shannon C. Ryan as a speaker at The Paperless Lab Academy® USA 2026! For more than 20 years, Shannon has helped life sciences organizations use technology to strengthen compliance, improve efficiency, and support scalable growth. Her expertise includes AI, agentic workflows, intelligent data, automation, cloud-native architecture, and legacy system modernization in highly regulated environments. Join us in Cambridge, Massachusetts, October 12–14, to hear Shannon share how emerging technology can drive long-term business success. Register: https://lnkd.in/e9G_Q5ee #PLAUSA #LifeSciences #DigitalTransformation #ArtificialIntelligence #LabInformatics

Great science does not always guarantee a successful biotech company. At The Paperless Lab Academy® USA in Cambridge, MA, Kelly Cycon, Ph.D., will lead an interactive hands-on lab exploring the Operational Valley of Death, where promising companies often stall during fundraising, regulatory review, technology transfer, scale-up, and commercialization. Attendees will examine the operational blind spots that can reduce valuation, delay growth, and weaken investor, partner, and regulatory confidence. The 60-minute workshop will include real-world case studies, collaborative exercises, and new approaches using AI to strengthen operational readiness and help prevent failure. Scientific innovation opens the door. Operational excellence keeps it open. Register: https://lnkd.in/e9G_Q5ee #PLAUSA #Biotech #LifeSciences #OperationalExcellence #ArtificialIntelligence #BiotechInnovation #CambridgeMA

When your R&D, IT, IX, or Automation project starts slipping, the first reaction is often to replace the system, restart the project, or write off the investment. In our experience, that's rarely the best answer. At 20/15 Visioneers, we've built a reputation for rescuing or salvaging projects that others considered beyond recovery. Whether it's a LIMS, ELN, laboratory automation, or orchestration initiative, we've stepped into challenging situations, identified the root causes, and delivered successful outcomes. Saving our clients and their partner vendors money, stress, and embarrassment is our top priority. We've seen projects that were: • Over budget • Behind schedule • Missing business requirements • Struggling with user adoption • Stalled due to technical or organizational roadblocks • Poor culture (data, project/program, organizational) A troubled project doesn't always need to be scrapped, it often needs experienced leadership, an objective assessment, and a practical recovery plan from an unbiased third party set of experts who have been there and know how to fix it. Before you abandon months (or years) of investment, contact us at info@20visioneers15.com! Our commitment is simple and built on confidence from experience: We guarantee success, or you don't pay. #ExperienceMatters #LIMS #ELN #LabAutomation #DigitalTransformation #ResearchAndDevelopment #LifeSciences #Biotech #Pharma

More than a presentation, this one comes with a signed copy. 📚 We’re excited to welcome Charles Inniss, Jr DPT, PCC, NBC-HWC, author, speaker, and optimist, to The Paperless Lab Academy® USA 2026. Charles will present “Up Your Optimism Game,” sharing insights designed to help attendees approach challenges, change, and opportunity with a more intentional mindset. Following the presentation, attendees can join us for a cocktail reception featuring a book giveaway and signing with Charles. 📍 The Charles Hotel, Cambridge, MA 📅 October 12–14, 2026 Come for the ideas. Stay for the conversation, cocktails, and a new book for your shelf. Register: https://lnkd.in/e9G_Q5ee #PLAUSA #PaperlessLabAcademy #Leadership #Optimism #LifeSciences #Networking

🧬 Science & Technology Weekly: A Cholesterol Pill Breaks the PCSK9 Needle Barrier — Outcomes Data Waits Until 2029 The week to July 21 delivered a notable approval — the first oral PCSK9 inhibitor — plus a dose of "validated where?" in batteries. 🔬 Life Sciences: The First Oral PCSK9• FDA approved Merck's Lipfendra (enlicitide) on July 16 — the first oral PCSK9 inhibitor, a once-daily macrocyclic-peptide pill that cut LDL-C by a placebo-adjusted 56-59% in the CORALreef trials, matching injectables • The catch: the CORALreef Outcomes cardiovascular-events trial isn't due until ~2029, so an event benefit stays unproven • Celcuity's gedatolisib cleared for HR+/HER2- breast cancer (July 14) • FDA issued an EUA for screwworm prevention in horses (July 15) ⚡ Materials Science: Running, but Not in Cars• China's national solid-state battery standards took effect this month, setting a 0.5% weight-loss bar for "true" solid-state • A Beijing solid-state storage demo passed evaluation (July 15) after a year on a heating-pipe network — but stationary validation isn't automotive validation • GBT still targets mass-producible all-solid-state cells in 2026, well ahead of the early-2030s consensus • Engineers caution solid electrolytes remove flammable solvents but aren't automatically safe 🌱 AgriTech: Editing's Trade-offs Show• PPO-edited potato trials gained late-blight resistance in one variety — but the same edits raised bacterial-wilt susceptibility elsewhere, a reminder single-gene edits carry context-dependent trade-offs • DNA-free RNP delivery advances a transgene-free path around strict GMO rules • CRISPR-Combo iSpyMacCas9 lifted hormone-free rice regeneration to 42% 🤖 AI/Informatics: Capital Runs Ahead• An OpenAI researcher is in talks to launch an AI drug-discovery startup at a ~$2B valuation with no pipeline yet (July 14) — frontier-AI talent migrating in, but valuation far ahead of validation • Benchling finds biotech AI in a "builder" phase, but adoption clusters where data is clean — data, not models, is the gate. 🚀 Bottom Line Lipfendra is a real milestone — moving an injection-only class into a pill — but approval rests on LDL-lowering, with outcomes proof years away. That gap is the week's theme: China's solid-state runs in a pipeline but not a car, AI valuations outrun proof, and gene-edited crops help one variety while hurting another. Progress is real; confirmation is pending.   When the pill works on the marker but the outcomes trial waits until 2029, how should payers weigh it?   🎓 20/15 Visioneers Scientific News Channel: https://lnkd.in/eyzFRU4u #LifeSciences #MaterialsScience #AgriTech #Innovation #AI #Biotechnology Dr Raminderpal Singh John F. Conway

Regulatory submissions shouldn’t feel like navigating without a compass. Join us for an upcoming webinar introducing Lodestar™, Koneksa’s AI-assisted submission software designed to transform raw EDC data into FDA- and EMA-ready deliverables within one clear, auditable workflow. Discover how Lodestar™ can help teams improve traceability, reduce manual complexity, and bring greater clarity and efficiency to the submission process. 📅 August 13, 2026 🔗 Register here: https://lnkd.in/eN7P9AfX #RegulatorySubmissions #ClinicalData #LifeSciences #DigitalTransformation #FDA #EMA #Webinar

We’re proud to recognize the sponsors helping bring The Paperless Lab Academy® USA 2026 to life! A special thank you to our Premium Sponsor, ZONTAL, along with our Gold Sponsors: Lenovo, Veritas Automata, and Revvity Signals; our Bronze Sponsor, Greenberg Traurig, LLP; and our Start-Up Sponsors: Rowan, Q alizer AG, and Adroit AI. Their support helps make space for meaningful conversations, practical collaboration, and new ideas across scientific informatics, AI, automation, data management, and the digital laboratory. 📍 The Charles Hotel, Cambridge, MA 📅 October 12–14, 2026 Register: https://lnkd.in/e9G_Q5ee #PLAUSA2026 #PaperlessLabAcademy #ScientificInformatics #DigitalTransformation #LabAutomation #LifeSciences