ACT Brief: De-Identified RWE Gains Ground, HHS Funding Stabilizes Research, and U.S. Finalizes WHO Exit
In today’s ACT Brief, we look at how FDA policy is accelerating the use of de-identified real-world evidence in clinical development, why a new bipartisan funding package could stabilize federal research agencies, and how the US withdrawal from the World Health Organization reshapes global health coordination.
2m Jan 23
2m
ACT Brief: Global Trials Scale Up, Site-Centric Startup Gains Focus, and Pfizer Expands Vaccine Partnerships
In today’s ACT Brief, we look at how global clinical development is evolving through decentralized models and emerging markets, why site-centric practices are becoming critical to faster study activation, and how a new Pfizer–Novavax agreement reflects shifting vaccine development strategies.
2m Jan 22
2m
ACT Brief: Life Sciences Hold the Line on DEI, Startup Timelines Stretch Further, and Regulators Align on AI Governance
 In today’s ACT Brief, we examine why life sciences companies are maintaining DEI commitments amid political pressure, what’s driving longer site activation timelines and how sponsors can reverse the trend, and how FDA and EMA are aligning on principles for AI use in drug development.
2m Jan 21
2m
ACT Brief: Signal Durability Redefines RBQM, AI Targets Startup Friction, and CDMOs Advance Patient-Centric Formulation
In today’s ACT Brief, we look at why durable signal closure is emerging as a defining metric in risk-based quality management, how AI can reduce startup delays without burdening sites, and how patient-centric drug design is reshaping the CDMO landscape.
2m Jan 20
2m
ACT Brief: Closing Gender Gaps in Parkinson’s Research, Startup Communication Breakdowns, and a New White House Healthcare Plan
In today’s ACT Brief, we look at efforts to address sex-based evidence gaps in Parkinson’s disease research, why communication failures continue to delay study startup, and how a new White House healthcare plan aims to reduce drug and insurance costs.
2m Jan 19
2m
ACT Brief: AI Extends Trial Registries, Contract Bottlenecks Delay Activation, and Data Integration Pushes Integrated Care
In today’s ACT Brief, we look at how AI is reshaping clinical trial registries into discovery tools, why contract and budget negotiations remain the biggest drag on site activation timelines, and how integrated data platforms are closing gaps across payer, provider, and patient care.
2m Jan 16
2m
ACT Brief: Moving Beyond AI Pilots, FDA Advances Bayesian Trials, and Sites Strained by Trial Design
In today’s ACT Brief, we examine what will separate sponsors that scale AI beyond pilots in 2026, break down the FDA’s new draft guidance on Bayesian statistical methods in clinical trials, and explore how poor planning and trial design continue to place operational strain on research sites.
2m Jan 15
2m
ACT Brief: Community Sites Prove Readiness, Platformization Reshapes Clinical Ops, and AI Targets Precision Care at JPM
In today’s ACT Brief, we look at how community research sites can stay competitive under efficiency pressure, why 2026 is shaping up as a turning point for platform-based clinical operations, and how AI is being positioned to better match patients to therapies.
2m Jan 14
2m
ACT Brief: Community Sites Compete on Readiness, COA Licensing Bottlenecks Slow Start-Up, and AI’s Foundations in Pharmacovigilance
In today’s ACT Brief, we examine how community research sites can stay competitive under rising efficiency pressures, why clinical outcome assessment licensing remains a drag on trial start-up, and what’s holding back AI-driven pharmacovigilance at scale.
2m Jan 13
2m
ACT Brief: Trial Competition Slows AI Gains, Rethinking Patient-Level Safety Decisions, and What Separates Real AI Platforms in Clinical Trials
In today’s ACT Brief, we look at how growing trial competition is undermining AI-driven efficiency gains, why pharmacovigilance is shifting toward patient-level causal reasoning, and what AI life sciences companies must demonstrate to stand out in a crowded market.
2m Jan 12
2m
ACT Brief: Recalibrating Trial Efficiency and Access, Verana-COTA Merge to Expand RWE Scale, and FDA Rejects Hetlioz Jet Lag Indication
In today’s ACT Brief, we hear how sponsors may redefine efficiency to protect patient access in 2026, review Verana Health’s merger with COTA to expand real-world evidence capabilities, and examine FDA’s latest decision on Vanda’s Hetlioz for jet lag disorder.
2m Jan 09
2m
ACT Brief: EU Comparator Drug Sourcing Pressures, AI Expands Its Role in Oncology Trials, and Rethinking AI Value in Clinical Development
In today’s ACT Brief, we examine the growing challenges of sourcing comparator drugs across the EU, highlight a new AI-driven oncology collaboration between BostonGene and AstraZeneca, and explore why AI life sciences companies are being pushed to prove real operational value beyond hype.
2m Jan 08
2m
ACT Brief: Rethinking Representation in Cancer Trials, Positive Phase IIb SLE Data, and a Major Obesity Drug Partnership
In today’s ACT Brief, we examine why representative enrollment remains a barrier in US cancer trials, review Johnson & Johnson’s positive Phase IIb results for nipocalimab in systemic lupus erythematosus, and break down a new multibillion-dollar research and licensing agreement between Nimbus Therapeutics and Eli Lilly targeting oral obesity treatments.
2m Jan 07
2m
ACT Brief: Reframing Site Initiation Readiness, Operational Execution as Competitive Advantage, and a Historic Motion Sickness Approval
In today’s ACT Brief, we explore how site initiation can be leveraged to improve early trial performance through demonstrated readiness, examine how AI and decentralized infrastructure are reshaping clinical operations strategy, and review FDA’s approval of the first new pharmacologic motion sickness treatment in more than four decades.
2m Jan 06
2m
ACT Brief: Persistent Barriers to Cancer Trial Participation, Clarifying IRT Data Ownership, and Clinical Trial Opportunities in Sub-Saharan Africa
In today’s ACT Brief, we examine persistent barriers limiting cancer trial participation and emerging approaches to address them, outline new guidance clarifying investigator versus sponsor ownership of IRT data, and review evidence highlighting sub-Saharan Africa’s capacity to support controlled clinical trials.
2m Jan 05
2m
ACT Brief: Support Services and Cancer Trial Access, 2025’s Most-Watched ACT Video Interviews, and FDA Approval of Narsoplimab
In today’s ACT Brief, we examine new data from the American Cancer Society on how transportation and lodging support affect cancer trial participation, review the most-viewed Applied Clinical Trials video interviews of 2025, and break down key trial results supporting the FDA approval of narsoplimab for transplant-associated thrombotic microangiopathy.
3m Jan 02
3m
ACT Brief: FDA Approval of Oral Wegovy, 2025’s Most-Read ACT Coverage, and Data Quality as the Foundation for AI
In today’s ACT Brief, we cover the FDA approval of oral Wegovy based on Phase III OASIS 4 results, recap the most-read Applied Clinical Trials articles of 2025, and examine why data quality remains critical to enabling AI in clinical trials.
2m Dec 24, 2025
2m
ACT Brief: AI-Enabled Workflow Automation, Subcutaneous Lunsumio VELO Approval, and Pan-KRAS Early-Stage Development
In today’s ACT Brief, we look at how AI-enabled workflows can automate existing site processes, review the FDA approval of subcutaneous Lunsumio VELO for relapsed or refractory follicular lymphoma, and examine early clinical development activity for a pan-KRAS inhibitor licensed by AstraZeneca.
2m Dec 23, 2025
2m
ACT Brief: Building a Digital Thread in Life Sciences, CRO Sourcing Decisions and Site Burden, and Lilly’s Oral GLP-1 Phase III Results
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.
2m Dec 22, 2025
2m
ACT Brief: Neutral Tech Adoption at Sites, Scaling Unstructured Data for eSource, and Novo Nordisk’s CagriSema NDA
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.
2m Dec 19, 2025
2m
ACT Brief: Rethinking Site Support in 2026, GSK’s New Severe Asthma Approval, and Priority Review Momentum in Multiple Myeloma
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.
2m Dec 18, 2025
2m
ACT Brief: Patient Preferences in Remote Trials, Sanofi’s Neurology and Immunology Deals, and AI-Driven Biomarkers in Oncology
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.
2m Dec 17, 2025
2m
ACT Brief: AI-Enabled End-to-End Trials, New Phase III Data in HIV, and a First-Line Shift in HER2-Positive Breast Cancer
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.
2m Dec 16, 2025
2m
ACT Brief: Training Community Oncology Sites, Digital Tools for Patient-Centric Trials, and New Phase III Momentum in Obesity R&D
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.
2m Dec 15, 2025
2m
ACT Brief: AI-Enabled COA Migration, Expanding Trial Footprints into Routine Care, and New FDA Approval in Myasthenia Gravis
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.
2m Dec 12, 2025
2m
ACT Brief: AI’s Impact on Trial Timelines, New Strategies in Obesity R&D, and Why Patient Support Needs a Clinical Backbone
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.
2m Dec 11, 2025
2m
ACT Brief: New CAR-T Trial Requirements, Pfizer Advances Oral GLP-1 Strategy, and Kisqali Shows Durable Long-Term Control
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.
2m Dec 10, 2025
2m
ACT Brief: Governance-Driven eCOA Acceleration, Site Operations Innovation, and New Momentum for Earlier CAR-T
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.
2m Dec 09, 2025
2m
ACT Brief: AI-Driven Repurposing Advances, GCP Adoption Challenges, and New CAR-T Milestone
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.
2m Dec 08, 2025
2m
ACT Brief: CNS Trial Expansion, Vaccine Policy Debate, and New Leadership at FDA
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.
2m Dec 05, 2025
2m
ACT Brief: Targeted Trial Growth, Site Startup Strains, and Leadership Shake-Up at FDA
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.
2m Dec 04, 2025
2m
ACT Brief: FDA’s Agentic AI Rollout, Exercise Interventions for Long COVID, and Patient-Centered Evidence Beyond the Trial
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.
2m Dec 03, 2025
2m
ACT Brief: Ultra-Compressed CNPV Review Timelines, New IgAN Therapy Approval, and Smarter Clinical Reference Data Strategies
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.
3m Dec 02, 2025
3m
ACT Brief: The Evolving CRA Role, New Immunotherapy Standard in Gastric Cancer, and Priority Review for Higher-Dose Wegovy
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.
3m Dec 01, 2025
3m
ACT Brief: AI in Clinical Research, FDA Gene Therapy Approval, and High-Performing Hospital Partnerships
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.
2m Nov 26, 2025
2m
ACT Brief: AI-Driven Pharmacovigilance, Site-Led Digital Investments, and Smarter Multi-Touch Recruitment
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.
2m Nov 25, 2025
2m
ACT Brief: Digital Recruitment Strategies, Tremfya’s Long-Term PsA Results, and Agentic AI’s Enterprise Impact
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.
3m Nov 18, 2025
3m
ACT Brief: Smarter Study Planning, New AML Approval, and Biomarker Gaps in Cancer Care
 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.
2m Nov 17, 2025
2m
ACT Brief: Site Satisfaction, eSource Data Transfers, and Gilead HIV Trial Results
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.
2m Nov 14, 2025
2m
Improving Site Satisfaction Through Better Technology and Collaboration
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 ...
19m Nov 13, 2025
19m
ACT Brief: AI Decision-Making, Sponsor Oversight Trends, and HHS Label Changes
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.
2m Nov 12, 2025
2m
ACT Brief: Adaptive Trial Designs, Wegovy’s MASH Breakthrough, and Lilly’s Expanding Partnerships
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.
3m Nov 11, 2025
3m
ACT Brief: AI, Caplyta Approval, and FDA Priority Vouchers
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.
2m Nov 10, 2025
2m
ACT Brief: Designing Feasible Protocols and Breakthroughs in Obesity and Metabolic Research
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.
3m Nov 07, 2025
3m
ACT Brief: Data Strategy, AI Integration, and Rare Disease Milestones Drive Clinical Innovation
 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.
3m Nov 06, 2025
3m
ACT Brief: Tech-Driven Data Strategies and Long-Term Vaccine Success
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.
3m Nov 05, 2025
3m
Streamlining Clinical Data to Reduce Site and Participant Burden
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 gr...
9m Nov 04, 2025
9m
ACT Brief: Lilly Seeks FDA Priority Review for Oral GLP-1 as Bispecific Antibody Trials Redefine Ethical Standards
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.
3m Nov 03, 2025
3m
ACT Brief: AstraZeneca Expands Immunotherapy Reach as Thermo Fisher’s $8.8B Deal Signals New Phase for Digital Trials
In today’s ACT Brief, we spotlight the industry’s push to reduce site technology burden, AstraZeneca’s broad survival gains from the MATTERHORN trial, and Thermo Fisher’s multibillion-dollar acquisition of Clario to advance AI-driven clinical research.
3m Oct 31, 2025
3m
ACT Brief: AI, Equity, and Innovation Drive Clinical Research Forward
In today’s ACT Brief, we explore how AstraZeneca is redefining gastric cancer care through the MATTERHORN trial, Phesi’s Gen Li shares how AI and patient data are advancing global trial equity, and FDA unveils new draft guidance streamlining biosimilar development.
3m Oct 30, 2025
3m