Kala Shankle, JD, HDA’s vice president of regulatory affairs, shares that as DSCSA traceability requirements take full effect, distributors and trading partners are preparing for long-term gains in supply chain security, recall efficiency, and counterfeit prevention.
Kala Shankle, JD, HDA’s vice president of regulatory affairs, describes how FDA officials are signaling a balanced enforcement approach when it comes to DSCSA enforcement, expecting compliance efforts and documentation, but also recognizing that perfection will take time.
Kala Shankle, JD, HDA’s vice president of regulatory affairs, details that after a year of steady progress, manufacturers and distributors report over 97% data accuracy under DSCSA traceability requirements, marking a major milestone in supply chain interoperability and signaling confidence ahead of the November compliance deadline.
Kala Shankle, JD, HDA’s vice president of regulatory affairs, describes how at this year’s seminar, attendees emphasized pragmatic approaches to achieving full compliance while anticipating upcoming FDA rules that could reshape wholesale and 3PL licensure standards across the pharma supply chain.
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.
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.
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.
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.
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.
In a recent panel discussion, Krenar Komoni, founder and CEO of Tive, highlighted how combating rising supply chain theft requires a multi-layered, technology-driven security strategy.
Ammie McAsey, SVP of Supply Chain Operations, McKesson, emphasizes the critical role of collaboration, technology, and partnerships in ensuring advanced and specialty therapies reach patients safely and effectively.
Dave Malenfant, healthcare supply chain expert, reflects on LogiPharma USA’s 20-year evolution, noting its shift toward greater diversity and inclusion, particularly with more women entering the industry.
Experts from Moderna, Revelation Pharma, and Alexion offer ways to reduce risks, improve real-time visibility, and ensure product integrity in the growing ship-to-home market.
Dave Malenfant, healthcare supply chain expert, shares his excitement about the strong turnout at LogiPharma USA, noting a packed master class and his role as chair of the “people” track—a personal passion.
Dave Malenfant, healthcare supply chain expert, discusses the ramifications of a 100% tariff on branded and patented drugs entering the US.
Bayer’s Luiz Barberini highlights how artificial intelligence is transforming supply chain operations, while emphasizing the irreplaceable value of trust, transparency, and human relationships.
Supply chain leaders share strategies to address persistent drug shortages, highlighting vulnerabilities, manufacturing complexities, and the importance of cross-industry collaboration.
At the conference’s milestone 20th anniversary event in Boston, experts unpacked the final stages of DSCSA implementation, highlighting pharmacy compliance challenges, state-level variability, and the role of technology in securing the pharmaceutical supply chain.
Ullrich Mayeski, community engagement director of health with GS1 US, emphasizes the critical need to address interoperability challenges at the dispenser level, ranging from small independent pharmacies to large hospital systems.
Ullrich Mayeski, community engagement director of health with GS1 US, outlines how manufacturers, distributors, and dispensers can strengthen end-to-end traceability.
Ullrich Mayeski, community engagement director of health with GS1 US, describes the organization’s EPCIS standard for meeting DSCSA requirements while underscoring that true supply chain success depends on robust data quality practices, clear procedures, and cross-team accountability to ensure patients receive their medications without disruption.
Industry leaders—from manufacturers, distributors, and dispensers—reported increased preparedness for compliance, with discussions shifting toward exception management, governance, and enforcement readiness, note Ullrich Mayeski of GS1 US and Mark Karhoff of Ten Count Consulting.
Ruth Beadle, head, global supply chain, Sanofi, discusses how digital integration, advanced planning, and sustainability goals are transforming end-to-end supply chain operations to improve scale, speed, and environmental impact.
Ruth Beadle, head, global supply chain, Sanofi, discusses the company’s multi-year effort to build an AI-powered, end-to-end supply chain focused on improving service, resilience, and cost efficiency.
Ruth Beadle, head, global supply chain, Sanofi, explains how the company balances daily operations with long-term transformation efforts to ensure timely delivery of critical medications to patients.
In the first part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ senior director of DSCSA/serialization compliance services, shares his overall thoughts on this year’s DMC.
Doug Long, VP, industry relations, IQVIA, discusses how soaring demand for GLP-1 therapies is driving reimbursement challenges, shifting distribution models, and expanding the drugs’ potential into new therapeutic areas.
Will Pih, co-founder, Two Labs, explains how ongoing regulatory uncertainty is slowing clinical trial activity and hiring across the industry, prompting greater reliance on specialty pharmacy services and outsourced support.
Blake Powers, CEO, medigi, explains how digital tools, AI, and automation are streamlining access to biosimilars and cell and gene therapies, signaling a shift toward more tech-enabled, patient-centric care.
Fran Gregory, VP, emerging therapies, Cardinal Health, emphasizes the need for long-term outcomes tracking and robust health economic modeling to demonstrate the sustained value of advanced therapies and support future payment strategies.
