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.…

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.Applied Clinical Trials által

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 …

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.…

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.…

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.…

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.Applied Clinical Trials által

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.…

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.Applied Clinical Trials által

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.Applied Clinical Trials által

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 wit…

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.Applied Clinical Trials által

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.Applied Clinical Trials által

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.…

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,…

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'…

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 i…

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.Applied Clinical Trials által

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 Or…

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.Applied Clinical Trials által

Jared Baeten, Vice President, Clinical Development, HIV Franchise Head at Gilead Sciences discusses how he chose to focus his career path on HIV research and how increased awareness combined with new innovations have advanced the therapeutic area. He also touches on the operational challenges he is currently seeing within HIV trials.…

Editor Andy Studna shares some sound bytes from KOLs he spoke with during SCOPE EUROPE 2023.Applied Clinical Trials által

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…

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…

Najat Khan, PhD, chief data science officer and global head, strategy, portfolio & operations, R&D, The Janssen Pharmaceutical Companies of Johnson & Johnson shares her career path and how she became interested in clinical data. She also discusses some current trends in artificial intelligence/machine learning such as utilizing them in drug discove…

Jimmy Bechtel, MBA, vice president of site engagement for the Society of Clinical Research Sites (SCRS) discusses his career path and how he became so interested in clinical trial sites. He also addresses some of the most pressing challenges sites are currently seeing as well as the solutions SCRS is working on to address them.…

Chris Economos, Vice President and Head of Life Sciences at Eko, discusses his career journey from pharma to digital health technology, where he recognized the power of AI and digital health to improve clinical care and research. He discusses the current ability of AI in the future use of digital measurements and biomarkers to improve clinical tria…

Michael Ibara, Chief Data Officer, Elligo Health Research, discusses the history of mining healthcare data and using it to identify safety events, as well as the evolution of bringing EHR data closer to the clinical research worlds. He also touches on the implications of AI—comparing its fundamental impact as “the new electricity”—and its potential…

Charlotte Grayson, MD, clinical research medical director, Privia Health highlights her journey to becoming a physician and eventually getting involved with clinical trials. She also discusses what integrated research organizations (IROs) are now bringing to the table and how they are effective in enrollment and building patient-physician relations…

Colleen Hoke, Co-Founder and CEO of ObjectiveHealth discusses her career in early-phase research and the transition from working with a startup to a major research organization. She also touches on what her current company, ObjectiveHealth is working on, leadership skills, and the evolution of clinical research.…

Craig Serra, Head of Commercial Solutions and Partnerships at Flatiron Health’s Clinical Research Business Unit, discusses data and its many uses in clinical trials that guide operational decision-making; how the people in that work in clinical trials make the difference and how to bring the next generation up in clinical trials.…

Jennifer Duff, General Manager, Zelta Clinical Trials Solutions, Merative (formerly IBM Watson Health), discusses her leadership philosophy, the number of name changes and product mergers her company has gone through, major technological changes are impacting clinical trials operations professionals today and in the future, plus much more.…

Chris Learn, PhD, PMP, Vice President, Cell and Gene Therapy Center of Excellence, Parexel describes highlights of his career, what originally spurred his interest in clinical research, the current landscape of CGTs and much more.Applied Clinical Trials által

Doug Warner, MD and CMO for eFFECTOR Therapeutics, a clinical stage biopharma targeting oncology, discusses the complexities of oncology clinical trials, bringing his career-long learnings with Amgen to his current role, and the important relationship medical directors should have with their clinical study teams.…

Peter Benton, President and CO-CEO for Worldwide Clinical Trials, leads a diverse team of more than 3,000 people in more than 60 countries. Benton speaks about his unconventional entrance into the pharmaceutical industry, advice for clinops professionals, significant changes coming for industry, and much more.…

In this episode of the Applied Clinical Trials podcast, we are joined by Sindhu Ramchandren, MD, Director, Clinical Leader, Neuroscience at Janssen. With experience as a principal investigator on neuromuscular trials, Ramchandren discusses the importance of having physicians involved in clinical trials. She also walks us through her career path and…

Gabriele Brambilla, CEO of Alira Health, discusses the ever-evolving landscape of real-world data; more specifically, how data sharing in clinical research should be implemented to value the person. He also highlights his career path and how he became so interested in healthcare innovation.Applied Clinical Trials által

Rose Blackburne, MD, MBA, Vice President, Global Head, General Medicine, PPD Clinical Research, Thermo Fisher and Margarita Nunez, MD, Principal Investigator, Synexus NY / Accelerated Enrollment Solutions New York discuss their panel at the recent Health Equity in Clinical Trials Congress in Boston last month; share insights into how diversity can …

In this podcast, Dr. Ira Spector discusses how his career journey has epitomized the ability to solve problems, which is essentially the role of drug development. It has also led to the formation and strategic approach to his company’s early-stage clinical trials for using the microbiome to address chronic inflammatory diseases.…

Beth MacEntee Pileggi, Head of Global Case and Safety Data Management with Janssen Pharmaceuticals of Johnson & Johnson, and Co-Lead of TransCelerate’s Pharmacovigilance Agreements Optimization Initiative, discusses the importance of safety, collaboration, TransCelerate’s positive role in the pharma industry and her passion for PV.…

Dr. Sean Bohen, CEO of Olema Oncology, discusses his career and significant contributions to the clinical research and development of numerous oncology drugs that received regulatory approval for various indications. Plus a look at Olema, how they operate, and challenges they face.Applied Clinical Trials által

Dr. Harsha Rajasimha, Founder and Chairman of IndoUSrare, discusses the emotional reason behind founding the non-profit, programs they offer that are helping rare disease parents/patients, rare disease research in India, and much more.Applied Clinical Trials által

Dan Brenner, Founder and CEO of 1nHealth, discusses his path into clinical research and patient recruitment, the Gold Eagle Next Generation Board, what millennials/next generations want from organizations they buy from or invest in, how industry can best harness patient data to accurately predict recruitment timelines, and much more.…

In this podcast, Dr. Milligan makes the case for studying drugs in pregnant and lactating women on an ongoing basis to understand long-term efficacy and safety, as well as effects of concomitant medications on these women. Sandy believes that the entire ecosystem--regulators, policymakers, governments, physicians, healthcare systems, and industry, …

Jane Myles, Vice President, Clinical Trial Innovation at Curebase, discusses her current role, what led her there, and challenges their clients face with DCTs.Applied Clinical Trials által

Chief Science Officer at Unlearn.AI, Dave Miller, discusses digital twins, their pros and cons for the industry, and developments in Bayesian design and adaptive trials for CDER and CBER.Applied Clinical Trials által

Susan Wood, president and CEO of VIDA Diagnostics, discusses her journey into healthcare from an engineering path, changes in the field of imaging, virtual control arms, and much moreApplied Clinical Trials által

Todd Luckritz, Associate Director, Patient Solutions at Myonex, recently left Mayo Clinic as the lead pharmacist for its clinical research programs. In this podcast, Luckritz discusses his journey “bringing protocols to life,” the joy of interacting with patients, and the frustrations with sourcing that led him to make a difference at Myonex. To le…

Paula Brown Stafford, CEO of Novan, came to her role via increasing clinical development role responsibilities with Quintiles, now IQVIA. In this podcast, she reflects on her professional experiences, her achievements and her advice for clinical trials professionals.Applied Clinical Trials által

Dr. Shalaan Beg, VP of Oncology for Science 37, discusses his approach to reducing the time to trial activation at an NCI designated cancer center, how to ensure a diverse representation in clinical trials, and his opinion on decentralized and hybrid trials.Applied Clinical Trials által