2025 DIA Annual Meeting: The Importance of Early Patient Feedback in Digital Endpoint Development
In an interview with Applied Clinical Trials at the 2025 DIA Annual Meeting, Brian Ongioni, chief product officer, uMotif, emphasized the importance of incorporating early patient and site feedback into the digital health product lifecycle to ensure digital endpoints are accessible, intuitive, and regulatory-ready.
Developing FP&A Strategies in Today’s Environment: Q&A with Jennifer Kyle
In an interview with Pharmaceutical Executive, Jennifer Kyle, CEO, founder, Condor, discussed how the pharmaceutical industry is evolving its FP&A strategies by embracing cloud-native platforms, real-time risk modeling, and cross-functional collaboration to overcome fragmented data workflows and adapt to today’s increasingly unpredictable clinical and financial environment.
Q&A: PBM Unbundling, New Pricing Models Create More Transparency
In an interview with Drug Topics, Scott Halperin, PharmD, and Morgan Lee, PhD, MPH, of the Pharmaceutical Strategies Group discussed how PBM unbundling and alternative pricing models such as cost-plus, pass-through, and PMPM guarantees are gaining traction as health plans and employers seek greater transparency, flexibility, and regulatory compliance in drug benefit design.
Wheat Germ May Boost Immunotherapy in Cancer Patients
A UC Davis clinical trial led by oncologist Joseph Tuscano is exploring how fermented wheat germ extract may enhance the effectiveness of immunotherapy in cancer patients by boosting immune response, reducing toxicity, and potentially offering a low-cost alternative to traditional chemotherapy.
FDA GenAI Reviews Hinge on Clarity of Dossiers
The FDA’s newly launched generative AI tool, Elsa, is accelerating NDA and BLA reviews by automating repetitive tasks and highlighting dossier discrepancies—prompting sponsors to submit clear, structured, and compliant documents from the outset to benefit from faster assessments and reduce regulatory back-and-forth.