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Why Regulatory Sandboxes Offer a Safe Space for AI Innovation in Healthcare

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Krenar Komoni, founder and CEO of Tive, predicts that AI-driven automation and its accelerating impact on pharmaceutical supply chains will remain a headline topic at LogiPharma USA, as the industry faces growing pressure to innovate while balancing strict regulatory requirements.

This episode of Pharma Pulse covers how recent CDC layoffs are fueling concerns about disease surveillance, Ypsomed’s new autoinjector manufacturing site in North Carolina, and Lupin’s $250 million investment to build a respiratory and specialty drug facility in Florida.

The global generics maker’s new Florida site will produce more than 25 critical respiratory medicines, create over 200 jobs, and reinforce domestic manufacturing and drug security.

Krenar Komoni, founder and CEO of Tive, highlights the transition in pharma from passive to real-time temperature control, noting delays in technology adoption but emphasizing how AI and automation will soon drive cost savings, improved quality, and stronger customer experience.

This episode of Pharma Pulse covers how Mark Cuban’s direct-to-consumer pharmacy is challenging traditional drug pricing models, AstraZeneca’s $4.5 billion investment to expand its Virginia manufacturing site, and Bristol Myers Squibb’s $1.5 billion acquisition of Orbital Therapeutics to advance RNA-based medicines.

In the final part of his Pharma Commerce video interview, Shawn Opatka, VP and GM, Honeywell Life Sciences, explains that as pharma quality systems evolve, AI is shifting from reactive problem-solving to proactive, closed-loop risk prevention, enhancing operator insight, decision-making, and continuous process improvement.

Ammie McAsey, SVP of Supply Chain Operations, McKesson, explains the critical role of real-time visibility, digital tools, and cold chain innovation in ensuring product quality, reducing disruptions, and strengthening patient care.

The new Albemarle County site—reportedly the largest investment in AstraZeneca’s history—will focus on API and ADC production, create 3,600 jobs, while strengthening US pharma supply chain resilience.

Set to debut in California this December, Amazon’s new pharmacy kiosks aim to streamline care by letting One Medical patients pick up prescriptions right after appointments, eliminating the need for a separate pharmacy visit.

This episode of Pharma Pulse covers the CDC’s new individualized approach to COVID-19 vaccination and changes to chickenpox guidance for toddlers, new research showing how GLP-1 therapies can interfere with PET-CT imaging results, and the Third Circuit Court’s rejection of Novo Nordisk’s IRA challenge.

In the second part of his Pharma Commerce video interview, Shawn Opatka, VP and GM, Honeywell Life Sciences, notes that nearly all pharma organizations are experimenting with AI to address labor shortages, data challenges, and regulatory demands, but full-scale adoption remains on the horizon as companies balance innovation with compliance.

The appellate court upheld Medicare’s authority to negotiate lower drug prices under the Inflation Reduction Act, following similar rulings against AstraZeneca, Bristol Myers Squibb, and Novartis.

Krenar Komoni, founder and CEO of Tive, explains how the pharmaceutical industry’s transition from passive to real-time temperature control creates short-term challenges but will ultimately enable AI-driven automation, lower costs, higher quality, and better customer experiences.

This episode of Pharma Pulse covers the FDA’s approval of golimumab for pediatric ulcerative colitis, AstraZeneca’s new multi-target neuroscience partnership with Algen, and Peli BioThermal’s acquisition of Evo to strengthen its global cold chain portfolio.

As precision medicine reshapes drug distribution, Ammie McAsey, SVP of Supply Chain Operations, McKesson, highlights the need for deeper investments in technology, temperature control, and end-to-end visibility to ensure quality and patient safety in advanced therapy supply chains.