In the third part of his Pharma Commerce video interview, Brad Stewart, BDO’s national life sciences co-leader, explains that while the FDA has not defined the specific level of manufacturing commitment needed to improve US supply chain resilience, applicants for the voucher should focus on linking unique or rare disease therapies—particularly in areas like oncology—with domestic onshoring efforts to move their applications to the top of the pile for selection.
A new Pharma Pulse briefing unpacks declining RSV vaccine durability in older adults, AstraZeneca’s $2 billion expansion of its US biologics manufacturing footprint, and the stock-shaking Phase III struggle affecting Novo Nordisk’s Alzheimer’s ambitions.
In the final part of her Pharma Commerce video interview, Christy Christian, senior industry principal with Kinaxis, highlights a future where AI, cleaner data, and exception-based decision-making accelerate response times and strengthen end-to-end supply chain visibility.
In the second part of his Pharma Commerce video interview, Brad Stewart, BDO’s national life sciences co leader, reveals how National Priority Vouchers—and geopolitical pressure—are reshaping decisions around supply chain investment.
In the first part of his Pharma Commerce video interview, Brad Stewart, BDO’s national life sciences co leader, explains why large-volume, high-need drugs—especially those heavily sourced overseas—may be the strongest candidates, and how the pandemic’s supply chain lessons are influencing the program’s future direction.
In final part of his Pharma Commerce video interview, Faisal Khan, a GRC solutions expert with Vanta, points out how leadership buy-in, role-based training, and “cyber moments” can reinforce continuous awareness and shared responsibility across the organization.
In the fourth part of her Pharma Commerce video interview, Christy Christian, senior industry principal with Kinaxis, shares how reducing inefficiencies cuts waste, preserves profitability, and ultimately lowers consumer prices while increasing production capacity to meet rising demand.
In fourth part of his Pharma Commerce video interview, Faisal Khan, a GRC solutions expert with Vanta, explains how tools like Vanta offer real-time visibility, safeguard patient data, and help prevent costly violations before they occur.
In third part of his Pharma Commerce video interview, Faisal Khan, a GRC solutions expert with Vanta, emphasizes the need for a risk-based approach—grounded in clear policies, defined criteria, and tailored mitigation plans—to ensure third-party partnerships remain compliant and secure.
In the second part of her Pharma Commerce video interview, Christy Christian, senior industry principal with Kinaxis, shares how transitioning from spreadsheets to AI-driven orchestration requires more than new technology—it demands clean, reliable data and a workforce ready to interpret and act on insights.
In the first part of her Pharma Commerce video interview, Christy Christian, senior industry principal with Kinaxis, describes how manufacturers face mounting challenges managing long, complex supply chains, including limited inventory buffers, tight cash flow constraints, and constant policy changes.
In second part of his Pharma Commerce video interview, Faisal Khan, a GRC solutions expert with Vanta, urges organizations to move beyond one-time vetting toward continuous monitoring, contractual accountability, and shared responsibility for HIPAA compliance.
In first part of his Pharma Commerce video interview, Faisal Khan, a GRC solutions expert with Vanta, explains how excessive data access and poor visibility into data flows remain leading causes of HIPAA-related incidents.
In the final part of her Pharma Commerce video interview, Jen Butler, CCO at Pleio, emphasizes that as digital tools become central to patient support, there is value to balancing technology with empathy.
In the third part of her Pharma Commerce video interview, Jen Butler, CCO at Pleio, argues that addressing patients’ emotional barriers is essential to maximizing ROI, improving adherence, and ensuring that existing support programs truly reach those who need them.
In the second part of her Pharma Commerce video interview, Jen Butler, CCO of Pleio, warns that without stronger education, communication, and pharmacist involvement, digital engagement risks becoming purely transactional.
At LogiPharma USA, industry leaders from Tive, McKesson, and the broader healthcare logistics community discussed the sector’s transition from passive monitoring to real-time control, the growing influence of advanced therapies, and the importance of diversity and innovation in shaping the future of pharma supply chains.
In the final part of her Pharma Commerce video interview, Megan Wetzel, VP, product, access & affordability at CoverMyMeds, shares how the right field reimbursement model structure ensures field teams have the insights and tools they need to overcome coverage barriers and accelerate patient access to therapy.
In the third part of her Pharma Commerce video interview, Megan Wetzel, VP, product, access & affordability at CoverMyMeds, explains that by educating provider offices on payer requirements, prior authorizations, and denial trends, field reimbursement managers help streamline complex reimbursement processes and reduce treatment delays.
In the second part of her Pharma Commerce video interview Megan Wetzel, VP, product, access & affordability at CoverMyMeds, describes how high development costs, personalized treatment models, and an aging population are intensifying the imbalance.
Administrative hurdles and emotional isolation are driving therapy abandonment and worsening outcomes—Megan Wetzel of CoverMyMeds and Jen Butler of Pleio say the solution lies in combining streamlined access with stronger human connection.
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.
In the third part of her Pharma Commerce video interview, Linda Malek, JD, partner at Crowell & Moring, explains how healthcare organizations can harmonize both approaches by prioritizing fairness, transparency, and adaptable systems.
In the second part of her Pharma Commerce video interview, Linda Malek, JD, partner at Crowell & Moring, notes that by bringing regulators and innovators together, regulatory sandboxes could help US healthcare organizations test and refine AI tools responsibly, which allows oversight agencies to keep pace with rapid technological change.
In a video interview with Pharma Commerce, Mark Lee, Marqvision’s founder and CEO, and Sean O’Hearen, founder and principal consultant at 1st Line Partners, warn that counterfeiters are rapidly leveraging AI to create fake websites, social profiles, and manipulated product content—outpacing traditional protections and highlighting widespread underreporting of falsified medicines.
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.
