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
ACT Brief: AI Partnerships, Data-Driven Site Activation, and FDA Approval for Omvoh’s Single-Injection Regimen
In today’s ACT Brief, we spotlight how new OpenAI collaborations are transforming drug development, how AI is driving smarter site activation in global trials, and how the FDA’s approval of a single-injection Omvoh regimen enhances convenience for ulcerative colitis patients.
3m Oct 29, 2025
3m
ACT Brief: AI Expands Global Site Leadership as Ozempic Shows Potential to Reverse Biological Age
In today’s ACT Brief, we examine how artificial intelligence is helping uncover site leaders in underserved regions to strengthen trial diversity—and explore new research suggesting Ozempic may reduce biological age by more than three years.
2m Oct 28, 2025
2m
ACT Brief: AI Partnerships, Global Trial Access, and a New Option for Menopause Symptoms
In today’s ACT Brief, we spotlight expanding AI collaborations transforming life sciences, the role of patient-centric technology in improving global trial diversity, and the FDA’s approval of Bayer’s Lynkuet—the first dual neurokinin antagonist for menopausal hot flashes.
3m Oct 27, 2025
3m
ACT Brief: Digital Consent, Global Diversity, and Clinical Setbacks Shape Today’s Clinical Research Landscape
Today’s ACT Brief explores how eConsent is modernizing participant engagement, highlights new data on global representation in breast cancer trials, and examines Moderna’s decision to halt its Phase III mRNA-1647 program after missing key endpoints.
3m Oct 24, 2025
3m
ACT Brief: AI Innovations, Vision Trial Breakthroughs, and a Major Industry Acquisition
In today’s ACT Brief, we revisit key insights from SCOPE Summit 2025 on AI and pragmatic trials, examine Genentech’s Phase III vamikibart data in uveitic macular edema, and highlight MJH Life Sciences’ acquisition of BPD Healthcare—expanding the bridge from discovery to delivery.
3m Oct 23, 2025
3m
ACT Brief: AI-Driven Oversight, Biotech Acceleration Strategies, and a Major Win in Bladder Cancer
Today’s ACT Brief highlights how artificial intelligence is transforming trial data management, why biotechs are embracing parallel execution to accelerate development, and new Phase III results showing Imfinzi’s potential to redefine early-stage bladder cancer treatment.
3m Oct 22, 2025
3m
ACT Brief Weekly Recap: AI Innovation, Industry Resilience, and Supply Chain Readiness
In this week’s Applied Clinical Trials Brief, we highlight key findings from the 2025 State of the Industry Survey, explore how AI is transforming trial efficiency and patient engagement, and examine strategies to safeguard global research operations against rising tariff risks.
2m Oct 20, 2025
2m
ACT Brief Weekly Recap: Clinical Research Faces Funding Strain, Data Evolution, and a Shift in Outsourcing Models
Last week’s top stories explored how NIH’s shutdown plan is testing research resilience, why data infrastructure must precede AI adoption in 2025, and how sponsors are redefining outsourcing with hybrid resourcing models focused on flexibility, quality, and collaboration.
2m Oct 13, 2025
2m
Reimagining Clinical Operations Through Artificial Intelligence
In this episode of the ACT Podcast, we highlight a recent Q&A featuring Ibrahim Kamstrup-Akkaoui, vice president of data systems innovation at Novo Nordisk; and a feature article by Chris Driver, senior director of product management, Patient Suite at IQVIA, in which they both highlight how sponsors are adopting automation to streamline operations.
7m Oct 10, 2025
7m
ACT Brief Weekly Recap: AI Monitoring, Biotech Scaling, and Site Interoperability Lead This Week’s Top Stories
A look back at last week’s most-viewed content highlights how AI-driven monitoring could improve management of cytokine release syndrome in oncology, how biotech startups are leveraging scalable platforms to accelerate clinical trial operations, and why interoperability challenges remain a top concern for research sites.
2m Oct 06, 2025
2m
ACT Brief Weekly Recap: Data Innovation, Cybersecurity, and Contracting Bottlenecks in Clinical Trials
Last week’s top stories explored the push for digital-first clinical data systems, why cybersecurity must be central in CRO qualification, and how AI-driven contracting tools are helping sponsors cut delays and accelerate trial timelines.
2m Sep 29, 2025
2m
ACT Brief Weekly Recap: Partnerships, Site Networks, and AI Reshaping Clinical Trials
This episode of the Applied Clinical Trials Brief highlights a new global collaboration between two industry leaders, explores how site networks can address enrollment and retention challenges, and examines how generative AI is transforming clinical study reporting.
3m Sep 22, 2025
3m
ACT Brief: Policy Shifts, FDA Inspections, and Tariffs Pose New Challenges for Clinical Trials
In this episode of the ACT Brief, we spotlight an earlier interview with Ron Lanton, partner at Lanton Law, in which he discussed how rising drug costs, reduced FDA inspections, and potential tariffs on active pharmaceutical ingredients could increase costs and slow progress across the clinical research landscape.
2m Sep 18, 2025
2m
ACT Brief Weekly Recap: How AI, eClinical Innovation, and Policy Shifts Are Reshaping Clinical Research
In this week’s Applied Clinical Trials Brief, we recap three top stories: Novo Nordisk’s stepwise approach to AI adoption, new perspectives on eClinical technology as a growth driver, and expert insights on how recent policy changes could impact research funding and future therapies.
2m Sep 15, 2025
2m
ACT Brief Episode 8: Expert Insights on the Future of Obesity Drug Trials
In this episode of the Applied Clinical Trials Brief, Shipra Patel, global therapeutic area section head for endocrinology and global head of pediatrics at Parexel, shares insights on what makes a standout research partner, how cross-functional teams support GLP-1 studies, the role of real-world evidence, and why patient retention will be critical to shaping the future of obesity drug development.
3m Sep 11, 2025
3m
ACT Brief Episode 7: Veeva and Merck Trial Efficiency, DCT Barriers, and Glucose Monitoring Strategies
In this episode of the Applied Clinical Trials Brief, we recap our three most-viewed articles of the week—spotlighting Veeva and Merck’s push for platform-driven trial efficiency, Sunny Kumar’s perspective on barriers slowing decentralized adoption, and the evolving role of blood glucose meters and continuous glucose monitors in clinical research.
3m Sep 08, 2025
3m
ACT Brief Episode 6: Supreme Court Ruling, VK2735 Obesity Trial, and Padcev-Keytruda Survival Gains
In this episode of the Applied Clinical Trials Brief, we recap our three most-viewed stories of the week—covering the Supreme Court’s decision to uphold NIH funding cuts tied to DEI, Phase II data showing oral VK2735 achieved over 12% weight loss, and Phase III results where Padcev plus Keytruda improved survival in muscle-invasive bladder cancer.
2m Aug 22, 2025
2m
ACT Brief Episode 5: How Digital Twins and AI Are Reshaping Clinical Trials
In this episode of the Applied Clinical Trials Brief, we spotlight a recent video interview in which Jon Walsh, founder and chief scientific officer of Unlearn.AI, shared how digital twins can improve trial efficiency, enhance patient-centric designs, align with regulatory expectations, and accelerate access to new therapies.
3m Aug 20, 2025
3m
ACT Brief Episode 4: New Data on Trial Delays, Hybrid Payment Models, and Managing Complexity
In this episode of the Applied Clinical Trials Brief, we recap our three most-viewed articles of the week—featuring updated cost estimates for trial delays, the benefits of a hybrid approach to site payments, and strategies for keeping complex protocols on track.
2m Aug 15, 2025
2m
ACT Brief Episode 3: Breaking Down Data Silos to Accelerate Clinical Trials
In this episode of the Applied Clinical Trials Brief, we spotlight a recent video interview with Luke Wilson of Thermo Fisher Scientific in which he shared insights on how data visibility, remote monitoring, and integrated systems can streamline inspections, improve patient safety, and keep decentralized trials compliant and on track.
2m Aug 13, 2025
2m
ACT Brief Episode 2: FDA Oversight, Vaccine Funding Cuts, and the Digital Future of Clinical Trials
In this episode of the Applied Clinical Trials Brief, we recap our three most-viewed stories of the previous week with a look into the FDA’s heightened scrutiny of trial design, the wind-down of federal mRNA vaccine programs, and how digital innovation is reshaping the clinical research landscape.
3m Aug 08, 2025
3m
ACT Brief Episode 1: Placebos, Politics, and the Ethics of Vaccine Trials
In this episode of the Applied Clinical Trials Brief, we examine the renewed push for placebo-controlled vaccine trials in the US, why experts warn it violates core ethical standards, and how these proposals could jeopardize both participant safety and future innovation.
3m Jul 31, 2025
3m
Unifying Industry to Better Understand GCP Guidance
David Nickerson, head of clinical quality management at EMD Serono, executive sponsor of TransCelerate's ICH E6(R3) Initiative & PhRMA topic lead on the ICH E6(R3) Expert Working Group; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, and ACRO member participating in the ICH E6(R3) Initiative with TransCelerate, discuss the newest ICH E6(R3) ...
15m May 07, 2025
15m
Improving Relationships and Diversifying the Site Selection Process
Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
11m Apr 17, 2025
11m
Reaching Diverse Patient Populations With Personalized Treatment Methods
Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including the industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
11m Jan 20, 2025
11m
Driving Diversity with the Integrated Research Model
Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, the potential impact of FDA's recent Diversity Action Plan, and more.
11m Oct 16, 2024
11m
AI in Clinical Trials - A Long, But Promising Road Ahead
Stephen Pyke, chief clinical data and digital officer, Parexel, gives a broad overview of the use of artificial intelligence in clinical development and how regulatory bodies are viewing it, how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
22m May 29, 2024
22m
Including Women of Childbearing Age in Clinical Research
In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s mo...
14m Mar 26, 2024
14m
Improving Engagement While Maintaining Data Integrity & Validity
In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland. They discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring ...
20m Mar 19, 2024
20m
Diversity in Clinical Trials: The Need to Take Action
Gadi Saarony, CEO of Advarra, examines the current state of diversity in clinical research. He discusses the need for industry to take more action in making trials more diverse, what regulatory bodies need to do to increase awareness, and how researchers can best reach diverse populations.
18m Mar 06, 2024
18m
Bringing the Clinical Trials Industry Together
Micah Lieberman, Executive Director, Conferences (CHI) & Co-Founder, VP, Community and Business Development (ClinEco) shares the origin story of ClinEco and why he felt the clinical trials industry needed a more centralized ecosystem. He also discusses the SCOPE Europe conference and what attendees can expect for the upcoming SCOPE conference in Orlando, Florida in February.
14m Jan 23, 2024
14m
Managing Digital Studies in the Current Landscape
Flo Mowlem, VP of Science at ObvioHealth highlights her career path and experience with eCOA. She discusses what is currently happening in the digital clinical trials space and how to manage the unique challenges they bring including device accessibility and remote patient monitoring.
15m Jan 09, 2024
15m
Combining Awareness and Innovation
Jared Baeten, Vice President, Clinical Development, HIV Franchise Head at Gilead Sciences highlights how awareness and clinical innovation have transformed research in the HIV space.
24m Dec 01, 2023
24m
SCOPE EUROPE 2023 Recap
Editor Andy Studna shares some sound bytes from KOLs he spoke with during SCOPE EUROPE 2023.
13m Oct 31, 2023
13m
Bringing Innovation To The Clinic
Rinol Alaj, senior director, head of clinical outcomes assessment & patient innovation at Regeneron and Jaclyn Patterson, head, clinical trial management & site head, Basking Ridge, also with Regeneron speak to advancements in the clinical trials space, specifically the use of biomarkers and how the benefits of new solutions are transferring to the clinic.
23m Oct 17, 2023
23m
Advancing Rare Disease Research and the Development of Targeted Therapies
Michael Pourdehnad, MD, senior vice president, head of early clinical development, hematology/oncology & cell therapy at Bristol Myers Squibb discusses the work his team is doing at the site-level with potential oncology, hematology, and cardiovascular therapies. He also explores the area of targeted protein degradation and its evolution as well as his passion for bringing therapies to patients...
19m Oct 03, 2023
19m