In today’s ACT Brief, we examine why fragmented data systems continue to slow life sciences research, review how sponsor sourcing decisions may affect site experience and study execution, and report on topline Phase III results for Eli Lilly’s oral GLP-1 therapy orforglipron.
In today’s ACT Brief, we examine how sponsors are reassessing new engagement technologies to avoid increasing site burden, review new research on integrating unstructured health data to scale eSource-enabled trials, and cover Novo Nordisk’s NDA submission for its fixed-dose amylin–GLP-1 obesity therapy, CagriSema.
In today’s ACT Brief, we look at emerging operational changes aimed at reducing site burden, review the FDA approval of GSK’s twice-yearly biologic for severe asthma, and examine a national priority voucher granted for a new multiple myeloma treatment combination.
In today’s ACT Brief, we examine new survey data revealing what patients value most in remote clinical trials, break down Sanofi’s latest partnerships aimed at advancing Alzheimer’s and autoimmune therapies, and look at how AI-powered digital pathology is being integrated into oncology research through a new biopharma collaboration.
In today’s ACT Brief, we close out our McKinsey interview series with a look at how AI could transform clinical trials end to end, review new Phase III data supporting Gilead’s investigational HIV regimen, and examine an FDA approval that reshapes first-line treatment for HER2-positive metastatic breast cancer.
In today’s ACT Brief, we look at new evidence showing how targeted training can build research readiness at community cancer centers, explore McKinsey’s view on how digital tools can make trials more patient-centric and geographically inclusive, and review new Phase III results that could reshape obesity and osteoarthritis treatment.
In today’s ACT Brief, we examine new data on how AI is improving the accuracy and speed of COA localization, break down McKinsey’s perspective on why trials must expand beyond AMCs and into routine care settings, and highlight the FDA’s latest approval of a targeted biologic for generalized myasthenia gravis.
In today’s ACT Brief, we highlight new insights from McKinsey on where AI can meaningfully accelerate clinical development, break down the emerging design and regulatory forces reshaping obesity drug development, and examine why human-centered clinical guidance is becoming essential within an increasingly fragmented pharmacy system.
In today’s ACT Brief, we break down FDA’s new superiority requirement reshaping CAR-T development, examine Pfizer’s global move into oral small-molecule GLP-1 therapy, and highlight new MONALEESA findings that reinforce long-term disease control with Kisqali.
In today’s ACT Brief, we explore how stronger vendor–sponsor governance is speeding eCOA study startup, hear from AMR Clinical on the biggest opportunities to advance site operations and collaboration, and highlight new long-term data supporting earlier use of Carvykti in relapsed or refractory multiple myeloma.
In today’s ACT Brief, we look at how AI and in-silico methods are reshaping drug repurposing, why staggered ICH GCP rollouts are creating new operational pressure points, and the FDA’s latest CAR-T approval expanding treatment options in B-cell malignancies.
In today’s ACT Brief, we look at what’s fueling rapid growth in CNS and autoimmune research, why former FDA leaders are warning that new vaccine policies could reshape clinical development, and how the agency’s latest leadership change may influence drug review operations.
In today’s ACT Brief, we look at new insights on strategy-driven clinical development, fresh survey data revealing persistent site startup delays, and major leadership turnover inside FDA’s drug division.
In today’s ACT Brief, we look at the FDA’s deployment of an agency-wide agentic AI platform, review new data showing how structured exercise programs can improve long COVID symptoms, and explore how PROs and real-world evidence are reshaping how industry measures treatment impact.
In today’s ACT Brief, we examine how the FDA’s CNPV Program is reshaping operational planning and accelerated submission readiness, review the FDA’s accelerated approval of Voyxact for IgA nephropathy, and explore new insights from the Veeva R&D and Quality Summit on modernizing clinical reference data management.
In today’s ACT Brief, we examine how the CRA role is transforming alongside modern clinical trial technology, review the FDA’s approval of Imfinzi plus FLOT as the first immunotherapy regimen for resectable gastric and GEJ cancers, and look at Novo Nordisk’s fast-tracked submission of its higher-dose Wegovy injectable under the Commissioner’s Priority Review Program.
In today’s ACT Brief, we examine how AI is being integrated into administrative workflows at investigative sites, highlight the FDA’s approval of the first gene therapy for adolescents and adults with SMA, and explore strategies for pharmaceutical companies to build high-performing hospital-based clinical trial programs.
In today’s ACT Brief, we examine how AI and functional service partners are reshaping global pharmacovigilance, look at new data on how investigative sites are investing in and integrating digital solutions, and explore how Trialbee assesses ROI across emerging multi-touch recruitment platforms.
In today’s ACT Brief, we look at how Trialbee evaluates nontraditional digital platforms for patient recruitment, review new 48-week data from J&J’s APEX trial of Tremfya in psoriatic arthritis, and explore how agentic AI is poised to reshape commercial operations in life sciences.
In today’s ACT Brief, we look at how real-world data and AI are helping prevent costly study rescue, review the FDA’s approval of a first-in-class menin inhibitor for NPM1-mutated AML, and explore new insights on closing biomarker-testing gaps in oncology.
In today’s ACT Brief, we examine declining site satisfaction and strategies to improve sponsor-site collaboration, review a new partnership enabling automated eSource-to-EDC data transfer, and highlight Gilead’s positive Phase III ARTISTRY-1 trial results in virologically suppressed adults with HIV.
Melissa Hutchens, vice president of research & benchmarking at WCG, and Jimmy Garza, senior director of clinical operations at Bayer, discuss findings from the latest WCG CenterWatch Global Site Relationship Survey, revealing a decline in overall site satisfaction. They explore key drivers behind this trend, including technology usability, communication gaps, and limited site input in protocol design, and share actionable approaches to strengthen sponsor-site partnerships and improve study execution.
In today’s ACT Brief, we look at how artificial intelligence is reshaping drug development decisions across pharma, discuss evolving sponsor oversight in site selection and protocol design, and review the FDA’s decision to update menopausal hormone therapy labels for clarity and safety.
In today’s ACT Brief, we look at how adaptive trial models are reshaping precision medicine, new data showing Wegovy’s impact on liver health, and Eli Lilly’s latest collaborations advancing genetic and RNA-based therapies.
In today’s ACT Brief, we explore how AI and tokenized data are improving patient-protocol matching, highlight Caplyta’s new FDA approval for major depressive disorder, and review the FDA’s expansion of its National Priority Voucher program.
In today’s ACT Brief, we explore how real-world data can improve protocol design and feasibility, highlight new findings from Novo Nordisk’s oral semaglutide program, and review Eli Lilly’s promising Phase II results for a novel amylin receptor agonist.
In today’s ACT Brief, we highlight new insights on recruitment bottlenecks from Citeline’s Matt Holms, UCB’s first-in-class approval for TK2 deficiency, and why strong data foundations are key to realizing AI’s full potential in pharma.
In today’s ACT Brief, we highlight new insights from TransCelerate on streamlining clinical data to reduce burden, explore how Phastar is using technology to accelerate drug development, and review Takeda’s seven-year dengue vaccine results confirming long-term efficacy and safety.
In this episode of the ACT Podcast, Jeneen Donadeo, executive director of portfolio management at TransCelerate, and Laura Galuchie, senior director and TransCelerate program lead at Merck, discuss the findings from a recent TransCelerate and Tufts CSDD study revealing that nearly one-third of data collected in Phase III trials is non-essential. They explore why trial complexity continues to grow despite industry efforts toward efficiency and share strategies for reducing data burden while maintaining compliance.
In today’s ACT Brief, we explore how Eli Lilly’s orforglipron could become the first oral GLP-1 therapy reviewed under FDA’s new national priority program, and examine emerging regulatory and ethical frameworks shaping bispecific antibody research in oncology.
