Explorez tous les épisodes du podcast The Scope of Things
| Titre | Date | Durée | |
|---|---|---|---|
| Episode: 56 - The Clinical Trial Site of 2035 | 03 nov. 2026 | 00:50:14 | |
Imagine walking into a clinical research site in 2035. Do you see a fully virtual, site-less world, or something more grounded and human? On the latest episode of the Scope of Things, we take that thought experiment seriously and pressure-test it with two operators who live the realities of clinical trial delivery: Paul Evans from Velocity Clinical Research and Carlos Orantes, CEO of Alcanza Clinical Research. The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 55 - A Terminal Prognosis Sparks A New Model For Neurology Clinical Research | 08 oct. 2026 | 00:46:18 | |
In this month’s episode of the Scope of Things, we share an episode of a sister podcast, Breaking Health. Breaking Health host Michelle Snyder traces Sandra Abravaya’s path from the Obama White House to building Synapticure after her husband Brian’s ALS diagnosis reshapes their family’s life overnight. The two connect the access crisis in neurology to a bigger clinical research problem and lay out how virtual specialty care plus longitudinal data can improve outcomes and raise the success rate of targeted trials. Scope of Things Links Host Links Guest Links @synpaticure: https://x.com/synapticure The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 54 - Ken Getz and Rick Ward on Why Source Preparation Delays Clinical Trials | 01 sept. 2026 | 00:49:08 | |
There is a startup delay that often goes undetected: source preparation. Ken Getz, executive director at the Tufts Center for the Study of Drug Development, and Rick Ward, chief commercial officer at CRIO, break down what their joint research reveals about protocol-guided source preparation and why it quietly dictates when the first patient can actually enroll. With guest host Deena Bernstein, vice president of business development at Transformative Pharmaceutical Solutions, they walk through the surprising lag sites can face waiting for “final” source materials, why EHR-to-EDC integration is not a universal fix, and the steps sponsors, CROs, and sites can take to reduce startup friction and improve site experience. The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 53 - Daphne Smyth on the Chinese Drug Development Market Expansion | 04 août 2026 | 00:17:57 | |
With increasing efforts to scale into international markets, what can we expect from China's drug development industry? Joining the podcast is Daphne Smyth, head of global regulatory programs at Veristat, who shares her experience at this year's BioChina and what to expect for drug development on a global scale. Smyth explains why North America and Europe have been attractive market destinations for the Chinese market now more than ever, the regulatory reforms, and the potential bumps on the road getting Chinese drugs to foreign markets. Plus, host Deborah Borfitz gives you the latest news on the quantified financial value of risk-based quality management, a shingles vaccine for lowering dementia risk, a Parkinson's disease drug for treating depression, an AI for treating neuroblastoma, a link between hormonal birth control and brain health in older age, and Bayer's first strategic alliance with an academic medical center focused on clinical trials collaboration. Financial value of RBQM
Shingles vaccine may lower dementia risk Parkinson’s drug for treatment-resistant depression AI for improving neuroblastoma outcomes
Brain-protecting effect of hormone therapies Bayer’s alliance with academic medical center
Guest Daphne Smyth, head of global regulatory programs for Veristat
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 52 - Raj Indupuri on Adoption Hurdles with AI Agents | 07 juil. 2026 | 00:25:08 | |
Clinical trial support companies are rapidly adopting AI, but sponsors have been more hesitant. Raj Indupuri, CEO of eClinical Solutions, gives the top three reasons behind the holdup in AI agent deployment. He explains the specific pattern of uptake for these agents, the required human-in-the-loop oversight, and how the agents can improve clinical trial velocity. Host Deborah Borfitz also gives the latest news on a highly acclaimed treatment for pancreatic cancer, filling evidence gaps in drug safety during pregnancy, guidelines for routinely collected health data for research purposes, an innovative portal aiding bidirectional communication with patients, and more. Show Notes News Roundup KRAS inhibitor therapy for pancreatic cancer Target trial emulation in rural areas
AI for improving drug safety during pregnancy
Guidelines on the use of routinely collected data
New regulatory framework in the U.K.
Participant Engagement Portal
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 51 - Bridging the Equity Gap in Oncology with Eugene Manley, Jr. | 04 juin 2026 | 00:24:42 | |
Are medical advancements closing or widening medical disparities? Eugene Manley, Jr., Ph.D., founder and CEO of the STEMM & Cancer Health Equity Foundation, breaks down why equity is still not completely measurable in clinical trials, what proper representation in studies is, and how certain demographics are at a disadvantage for biomarker tests compared to other groups with host Deborah Borfitz. Their conversation explores whether health equity in cancer trials is different compared to commonly occurring diseases and if basket and umbrella trials may help the move the needle. Plus, the latest news on a pioneering phage therapy service, a unique cardiac arrest pilot study, new primary endpoints for cancer trials, and trial disruptions threatening diversity. Listen and let us know in a review: where do you think our time and resources are most needed for equity? Show Notes News Roundup Compassionate use phage therapy
Sudden cardiac death research New endpoints for cancer trials
USC and Tempus strategic collaboration
Trial disruptions threaten diversity
Misinterpreting effects of Alzheimer’s drugs
Eugene Manley, Jr., Ph.D., founder and CEO of the STEMM & Cancer Health Equity Foundation The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 50 - Ramona Burress and Cassandra O’Neal on Health Equity That Works | 05 mai 2026 | 00:39:49 | |
Health equity is being reorganized, renamed, or quietly deprioritized. Ramona Burress, co-founder of Onyx Health Collective, and Cassandra O’Neal, founder of Illuminated Arc Consulting, join the Scope of Things podcast for a direct, practical conversation about health equity in clinical trials. They break down what “decision-grade intelligence” looks like for site selection and community integration, why marketing-style segmentation and better storytelling can improve outreach, and why health equity needs a neutral home inside the company with real influence. Plus, host Deborah Borfitz shares the latest news on a UK initiative for accelerating dementia trials, the enterprise-wide rollout of an AI patient-finding platform at the Cleveland Clinic, and what Reddit users have to say about unreported side effects of weight loss drugs. Subscribe, share, leave a rating and review, and tell us: what’s the biggest barrier you see to making health equity measurable in your organization? The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 49 - Mike Sullivan on AI and Clinical Operations in the Year 2030 | 07 avr. 2026 | 00:32:24 | |
What will AI and clinical trials look like in the year 2030? Mike Sullivan, head of IT globally for development operations at Bristol Myers Squibb, joins The Scope of Things to discuss how creating value with AI depends on redesigning how clinical operations teams work. He covers the four pillars of what AI and clinical operations can look like in the next few years, as well as how AI will affect the job market. Plus, host Deborah Borfitz gives you the latest rundown on building the capacity to collaborate with patients, a new playbook for pediatric clinical trial reporting, lithium treatment for verbal memory decline, sex-specific effects of dementia, open-source database for scaling cancer trials, and a proposed 10-year trial of anti-obesity drugs for preventing obesity-related cancers. Show Notes News Roundup Power dynamics in researcher-patient relationships
Playbook forpediatricclinical trial reporting
Low-dose lithium for slowing verbal memory decline Parkinson's-related protein linked to faster Alzheimer's progression in women
AstroID database for studying cancer
Anti-obesity drugs for preventing cancer
Guest Mike Sullivan, head of IT globally for development operations at Bristol Myers Squibb
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 48 - Florence Mowlem on the Challenges and Solutions of Pediatric Rare Disease Trials | 10 mars 2026 | 00:22:54 | |
How can electronic capture of clinical outcome assessments (eCOA) help with the unique challenges of pediatric rare disease trials? Florence Mowlem, chief scientific officer of uMotif, joins The Scope of Things to offer her expertise on eCOA, share advice for companies on vetting technology providers, and discuss where sponsors are tripping up when it comes to pediatric rare disease trials. Plus, host Deborah Borfitz brings you the latest news on a possible probiotic for preventing immune system disorders in babies, misunderstood mechanisms of body weight regulation, a promising primary care-based weight management program, GLP-1 drugs potentially benefitting the brain, how patient-reported outcomes can improve clinician adverse event reporting, and a discovery-to-reimbursement model for cell and gene therapies. Show Notes News Roundup Preventing allergies and asthma Competing body weight regulation theories PATHWEIGH weight management process
Diabetes drugs reduce risk of dementia PRO data improved side effect grading Development model for cell and gene therapies
Guest Florence Mowlem, chief scientific officer at uMotif
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 47 - Joseph Kim on Pragmatic Solutions to Age-Old Problems | 03 févr. 2026 | 00:25:01 | |
Joining this month’s episode of The Scope of Things is Joseph Kim, chief strategy officer of ProofPilot, who talks about his company’s first-ever CORE Symposium, where pharma pros shared practical solutions to age-old trial challenges. Kim provides a pragmatic viewpoint on the problematic trio of clinical trials—study execution, recruitment, and engagement—and what change agents are needed to pave the way forward and find an exit from the bottlenecks. Plus, host Deborah Borfitz delivers the latest on a planned mapping of clinical trial deserts, the high cost of accelerated FDA approvals, the best states for cancer research, the world’s first in-ear EEG system getting approved, and a new smartphone-based outcome measure for sleep studies. News Roundup Financial hurdles to trial enrollment
Accelerated cancer drug approvals
Best states for cancer research
In-ear EEG devices
Ecological momentary assessment in sleep-focused trial
Guest Joseph Kim, chief strategy officer for ProofPilot The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 46 - Dan Drozd on How Noninterventional Studies Can Change the Clinical Research Game | 06 janv. 2026 | 00:25:31 | |
Noninterventional studies in clinical research are underutilized in clinical research and inefficient. Dan Drozd, CMO of PicnicHealth, knows we can do better. With host Deborah Borfitz, Drozd discusses the issues and ramifications researchers face from the lack of noninterventional studies, offers tactics for raising the bar for evidence generation, and shares what he expects in the clinical research space in 2026 in this episode of the Scope of Things. Plus, Borfitz shares the latest news on an expanding good pharma score card, an entirely telehealth-based cancer trial, a novel online platform for bowel cancer research, improving patient-reported outcomes in cancer trials, a virtual clinical trial for psychedelics, and identifying Type 1 diabetes in the symptom-less window stage.
News Roundup Good Pharma Scorecard Nationwide telehealth trial for cancer
Online platform for bowel cancer research
Patient-reported outcomes in cancer clinical trials
Virtual clinical trial of psychedelics
Type 1 diabetes risk prediction testing Guest Dan Drozd, M.D., CMO of PicnicHealth The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 45 - Doug Bain on Streamlining Clinical Trials | 02 déc. 2025 | 00:23:42 | |
Doug Bain, founder and consulting partner of ClinFlo, discusses his proposed regulatory blueprint for digital trials in the latest episode of The Scope of Things podcast. With host Deborah Borfitz, Bain delves into his strategy for turning 21 CFR Part 11 into a more practical regulation that streamlines rather than bogs down clinical trials, what would qualify someone to take on the role as a trusted third party (and what makes them trustworthy), and the new FDA administration’s modernization plan aligns—or squares—with his ideas. Plus, the latest news on a tool for detecting fraud and sampling bias in decentralized trials, technology for identifying potentially dangerous drugs before trials start, a novel women’s health and menopause initiative, a regenerative therapy for spinal cord injury, and a new oral treatment for preventing dementia. Show Notes : News Roundup
Real-time data integration tool
Drug toxicity prediction
Tufts Women’s Health and Menopause Initiative
Regenerative therapy for spinal cord injury
Oral treatment for preventing dementia
Guest Doug Bain, founder and consulting partner of UK-based ClinFlo
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode 44 - SCOPE Europe 2025 on AI Literacy Training, Reducing Excess Data Collection, Combating Superbugs | 04 nov. 2025 | 00:16:19 | |
This episode of the Scope of Things features an exclusive panel at SCOPE Europe 2025 covering regulatory requirements for AI literacy training, featuring industry executives Jonathan Crowther, head of the operational design center at Merck KGaA; Janie Hansen, global development information management, business systems transformation at Daiichi Sankyo; Francis Kendall, head of statistical programming, digital and data sciences at Biogen; and James Weatherall, vice president and chief data scientist of biopharmaceuticals R&D at AstraZeneca. Plus, host Deborah Borfitz gives the latest news on efforts to reduce excess data collection in studies, whole genome sequencing of breast cancer, a virus cocktail to combat superbugs, and more. Show Notes Collaborative study on data collection in trials
Heart benefits of semaglutide
Whole genome sequencing of breast cancers
Pan-cancer immunotherapy heads to trials
Promising NAD+ “youth molecule”
Virus cocktail to combat superbugs
AI annotates medical images
Fitbits aid precision health
Latest from the Human Epilepsy Project
Imposter study participants
Guests
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 43 - Overcoming the Deadlock in Patient Recruitment With Christine Senn | 07 oct. 2025 | 00:24:17 | |
For decades, clinical trial recruitment has been the biggest challenge in the industry. Christine Senn, senior vice president of Site-Sponsor Innovation at Advarra, offers insights into why the struggle continues, such as delays in getting regulations updated after a quarter of a century, and how to overcome the deadlock in clinical trial recruitment that is tied to current obsolete marketing guidelines. Also, host Deborah Borfitz shares the latest on beta blockers, low dose aspirin lowering the risk of recurring colorectal cancer, repurposing drugs for breast cancer relapse prevention, remote participation research on why athletes and military members face higher ALS risk, and the first agentic AI platform for life sciences from Medable. Show Notes News Roundup Rethinking beta blockers
Aspirin lowers risk of colorectal cancer recurrence
CLEVER study to prevent breast cancer relapse
Champion Insights ALS initiative
Medable’s Agent Studio
Disseminating research findings
Guest Christine Senn, Ph.D., senior vice president of site-sponsor innovation at Advarra The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 42 - Myeloma Research on a Global Scale with Joseph Mikhael | 09 sept. 2025 | 00:28:18 | |
Joseph Mikhael, chief medical officer of The International Myeloma Foundation, and his organization are pulling all the stops to find a true cure for multiple myeloma, a rare and often fatal blood cancer. He shares the origins and mission of the Black Swan Research Initiative, a research project dedicated to preventing myeloma and finding a cure, and how global collaborators are contributing to multiple myeloma research. Also, host Deborah Borfitz delivers the latest news on ChatGPT determining trial eligibility, a questionable shortcut in rectal cancer drug trials, a new no-nausea weight loss remedy heading to trial, and more. News Roundup AI for stratifying Alzheimer’s patients
Questionable shortcut in rectal cancer drug trials
ChatGPT determines trial eligibility
Major trauma study to test hemorrhage treatment
New weight loss remedy soon heads to trials The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 41 - How Non-Profits Are Filling Unique Roles in Clinical Research | 05 août 2025 | 00:35:13 | |
Children’s Tumor Foundation CEO Annette Bakker discusses what non-profit organizations uniquely bring to clinical research and new financial models sustaining their contribution. Plus, host Deborah Borfitz rounds up the latest news in clinical research: new funding approaches for ALS clinical trials, spatial biology to match patients to trials, a bio map of lung cancer tumor changes, improving diabetes treatment outcomes for patients in China, and more. Show Notes News Roundup Fund of Adaptive Royalties
TACIT algorithm matching patients to trials
Mapping biomarkers linked to treatment resistance
Pragmatic diabetes trial in China
Cough medicine to slow dementia?
Beating the EARL hurdles in the UK
Guest Annette Bakker, Ph.D., CEO of the Children's Tumor Foundation
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode 40: The Advancement and Implementation of Pragmatic Trials | 08 juil. 2025 | 00:27:49 | |
The latest on a trio of pragmatic trials for lung cancer treatment, the implementation of national-scale pharmacogenomic testing, an efficient approach to comparing commonly used intravenous fluids, improving access to gene therapy trials for a progressive heart condition, the landscape for Alzheimer’s disease studies, clinical trials that predict the most effective therapy, and the creation of AI agents for clinical research. Joining the discussion is Bethany Kwan, director of the Dissemination & Implementation Research Core at the Colorado Clinical & Translational Sciences Institute at the University of Colorado Anschutz Medical Campus, and Heather Smyth, research associate with the Center for Innovative Design and Analysis in the Colorado School of Public Health. They talk about the advancement of pragmatic clinical trials, how they differ from traditional studies, and how to handle the challenges that come with implementing them.
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 39 - Blythe Adamson on Patient-Level Real-World Data for Multinational Oncology Research | 03 juin 2025 | 00:26:17 | |
In this episode of the Scope of Things, host Deborah Borfitz brings you the latest news on AI-recommended precision dosing, organoid drug testing aiding treatment selection for bowel cancer, an AI tool for stratifying lung cancer patients, using HIV drugs to treat Alzheimer’s disease, and the potential value of magic mushrooms to remedy the mood symptoms of Parkinson’s. Blythe Adamson, international head of outcomes research and evidence generation at Flatiron Health, also joins in to discuss groundbreaking work harmonizing patient-level real-world data across four countries to enable multinational oncology research. News Roundup CURATE.AI platform FORECAST-2 clinical trial
AI tool for sorting cancer patients
HIV drugs for Alzheimer’s protection
“Magic mushrooms” for Parkinson’s disease
Guest Blythe Adamson, Ph.D., international head of outcomes research and evidence generation at Flatiron Health
Subscribe to the podcast on Apple Podcasts and leave a review to support the show. Join us at Scope Europe on October 14-15 in Barcelona - use code SOT10 for an additional 10% discount. GUEST BIO Blythe Adamson, PhD, MPH, Head of Outcomes Research and Evidence Generation, International at Flatiron Health & Founder of Infectious Economics The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 38 - Tackling the Misinformation Epidemic with Briony | 06 mai 2025 | 00:19:57 | |
In this episode of the Scope of Things, host Deborah Borfitz brings you the news on a precision medicine initiative in Sweden integrating research with healthcare, newly available cardiometabolic clinical data registries for real world evidence projects, updates to guidelines on the reporting of clinical trials, AI improving the monitoring of movement disorders, and the best-yet biomarker for stroke and dementia risk. Joining the conversation is Briony Swire-Thompson, director of the Psychology of Misinformation Lab at Northeastern University Network Science Institute, to discuss the current misinformation epidemic and how clinical trials and sites can best deal with it. News Roundup Precision Omics Initiative Sweden (PROMISE)
Cardiometabolic clinical data registries
New CONSORT reporting guidelines
VisionMD for analyzing motor function
Best-yet biomarker for stroke and dementia risk
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 37 - Using AI to Translate Clinical Trial Results with Ravi Parikh | 08 avr. 2025 | 00:25:15 | |
In this episode of The Scope of Things, host Deborah Borfitz covers the latest news, including setting expectations for Phase II cancer trials, key learnings about dementia from the Nun Study, links between cardiovascular disease and mild cognitive impairment, using aspirin to prevent cancer spread, a clinical trial map to improve study access, and a naturally occurring molecule that rivals Ozempic in its weight loss potential. Deborah also speaks with Ravi Parikh, medical director of data and technology applications shared resource at Winship Cancer Institute of Emory University, about a novel AI platform he helped develop to translate clinical trial results to real world populations. News Roundup Phase 2 cancer drug trials
Nun Study insights
DORIAN GRAY project
Aspirin for preventing cancer spread
New clinical trial map
Molecule rivaling Ozempic
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 36 - Wes Michael on Enhancing Patient Voices and Sharing Their Insights | 04 mars 2025 | 00:27:40 | |
In this episode of the Scope of Things, host Deborah Borfitz delivers the latest on an AI-powered trial screening tool that outperforms research staff, a strategy report on ways to boost cancer vaccine work, the continued absence of pregnant women in clinical trials, a program bringing studies directly to people in rural Utah, and efforts to integrate clinical trials into routine patient care in medically underserved areas of Oklahoma. Wes Michael, founder and president of Rare Patient Voice, also joins in to discuss how his company is connecting people undertaking research studies with participants eager to share their insights—and getting paid to do so. News Roundup AI clinical trial screening tool
Strategy report on cancer vaccines
Exclusion of pregnant women from trials
Bringing cancer care and trials to Utah’s rural residents
Integrating clinical research into primary care
Guest Wes Michael, president and founder of Rare Patient Voice The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 35 - SCOPE 2025, Participant Engagement Award Winners, How AI is Helping Trials, and More | 14 févr. 2025 | 00:23:44 | |
In this episode of the Scope of Things, host Deborah Borfitz provides the latest on new criteria for defining and diagnosing obesity, the case for including pregnant women in vaccine trials, the subtyping of osteosarcoma, an inert gas being tested as an Alzheimer’s treatment, and more. Joining the conversation is David Sall, president and CEO of Patient Enrollment Advisors, who talks about the origins of the Participant Engagement Award at SCOPE 2025 and how the conversation around participant engagement has changed over time (and the changes that still need to happen). Finally, we have Allison Proffitt, editorial director of Clinical Research News, interviewing Trân Lê and Sohit Gatiganti, co-founders of Grove AI and the winners of the Participant Engagement Award at SCOPE 2025. The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 34 - Ringing in 2025 With Validating Novel Digital Clinical Measures, Decentralized Trials, and More | 07 janv. 2025 | 00:27:13 | |
In this episode of the Scope of Things, host Deborah Borfitz delivers the news on an investigation into data reporting problems in major Ticagrelor clinical trial PLATO, the need for more sex-aware cancer research, Alzheimer’s studies looking at brain shrinkage associated with immunotherapies (and repurposing drugs as potential new treatments), and a large, decentralized trial that successfully uncovered disease-causing genetic variants in hundreds of participants. Benjamin Vandendriessche, chief delivery officer of Digital Medicine Society, also joins in to talk about a newly completed project with the FDA that is providing guidance and resources on how to validate novel digital clinical measures. PLATO trial investigation
“OncoSexome” project
Brain shrinkage with Alzheimer’s treatment
Repurposing drugs for Alzheimer’s
Mayo Clinic Tapestry study
Guest Benjamin Vandendriessche, chief delivery officer, Digital Medicine Society The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode:33 - Orr Inbar Discusses Saving Costs and Complications With Clinical Trial Simulations | 10 déc. 2024 | 00:34:33 | |
In this episode of the Scope of Things, host Deborah Borfitz covers concerns surrounding the study and treatment of obesity, a new “opening doors” initiative to clinical trials, debate over the European Union AI Act, the first international-level clinical study using secure multiparty computation, a hopeful treatment for kids with lethal brain tumors, and a ChatGPT tool created by the NIH to match potential volunteers to relevant studies. Joining the conversation is Orr Inbar, CEO and co-founder of QuantHealth, who discusses how his company is using AI to simulate clinical trials to alleviate costs and efficiency issues for the notoriously complicated drug development process. He also shares the proprietary tech powering QuantHealth’s AI and where he sees AI heading as 2025 unfolds. News Roundup Perspectives on the EU AI Act
Secure multiparty computation Cell therapy for childhood brain cancer
TrialGPT tool
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 32 - SCOPE Europe 2024, AI, New Cancer Treatments, More | 05 nov. 2024 | 00:18:35 | |
In this episode of the Scope of Things, host Deborah Borfitz shares the latest news on a drug repurposing AI model now being tested in rare disease clinical trials, a new way forward for triple-negative breast cancer, Jill Pellegrino’s transition from CVS to AutoCruitment, incorporating placental pathology into perspective clinical trials, making ethical oversight of clinical trials more “fit-for-purpose,” and publication bias with industry sponsored studies for psychiatric drugs. We also have Allison Proffitt, editorial director of Clinical Research News, interviewing speakers at SCOPE Europe 2024 on how AI is being used for clinical trials, their pick for the 2024 rising star in the clinical research ecosystem, and the most hotly-debated topics in trial planning and execution. News Roundup AI for drug repurposing
Window trial for new breast cancer approach Prescreening regimen of AutoCruitment
Trials needing placental pathology
Fit-for-purpose ethical oversight
“Sponsorship effect” on psychiatric drug trials
Guests
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 31 - Aaron Mackey on Trial Planning and How AI Can Help With Diversity | 01 oct. 2024 | 00:29:01 | |
Tune in for the latest news and trends in this month’s episode of the Scope of Things, where host Deborah Borfitz covers everything you need to know about a pending launch of a large treatment trial for Graves’ disease, a recruitment campaign for a diagnostic tampon, Walgreens and BARDA’s new partnership, how eligibility criteria has been excluding people of African or Middle Eastern descent from cancer studies, and more. Joining the discussion is Aaron Mackey, vice president of AI and data science at Lokavant, who talks about the unintended consequences of decisions made during trial planning that can lead to questionable conclusions, how AI and ML are helping with the diversity issue in trial participation, and his stop gap emergency plan to keep trials on track if there is no digital support available. News Roundup Phase 3 trial for Graves’ disease
Quality of life measures in cancer studies Rapid recruitment for a diagnostic tampon trial
Reference trial emulation
Walgreens/BARDA partnership
“Detective” algorithm for improving trial design
Exclusion of people with Duffy-null phenotype
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 30 - Shining the Spotlight on Rare Disease Trials With Uncommon Cures | 03 sept. 2024 | 00:25:52 | |
This month’s episode of The Scope of Things features the latest trending news from host Deborah Borfitz, including a planned library of “nature’s drugs” targeting complex diseases, a paradoxical approach to treating cancer, how government policies can help improve equitable access to cancer trials, and the possibilities of reversing multiple sclerosis nerve damage. Marshall Summar, CEO of Uncommon Cures, and Tamanna Roshan Lal, Chief Medical Officer of Uncommon Cures, join the conversation to discuss how their organization is tackling the root causes of rare diseases trials that take too long and cost too much. They delve into the market interest behind rare disease trials and what Uncommon Cures is doing differently, as well as share the company’s international expansion plans and where they see this operationalized rare disease clinical trial paradigm in a few years. News Roundup Pharmaceutical-grade HMOs
Paradoxical cancer treatment approach Switching on the desire the exercise
STEP stroke platform trial
Policy interventions to improve trial equity New drug for MS
Guests CEO Marshall Summar, M.D., and CMO Tamanna Roshan Lal, M.D., with Uncommon Cures
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode 29 - Patient-Focused Drug Design, Enrollment Challenges, and More With Hannah Kemp | 06 août 2024 | 00:30:49 | |
Tune into this month’s episode of the Scope of Things, where host Deborah Borfitz covers the use of AI for trial screening and recruitment purposes, a diabetes drug that may help treat sleep apnea, questionable advice from the FDA given to departing staffers, why the entire clinical trial enterprise may need to be revamped to eliminate systemic biases, and more. Hannah Kemp, vice president of strategic client engagement at Surgo Health, also joins the conversation to talk about how Surgo Health is helping companies recruit participants and her SCOPE 2024 presentation, as well as her thoughts on patient-focused drug design and the challenge of getting study sponsors on-board with enrollment strategies. News Roundup AI for clinical trial screening
AI for trial recruitment
Drug therapy for sleep apnea
Investigation on departing FDA employees
N-Power Medicine/Merck collaboration Youth prediabetes/diabetes dataset
Systemic biases in randomized controlled trials
GUEST BIO Hannah Kemp, vice president of strategic client engagement, Surgo Health Hannah Kemp is the Vice President of Strategic Client Engagement at Surgo Health. In her role, she helps clients develop more patient-centric healthcare and clinical trials leveraging Surgo’s novel data. Ms. Kemp has led large-scale projects across multiple therapeutic areas from infectious disease, maternal health, vaccines, and cancer and published. Ms. Kemp brings an ecosystem perspective having worked across healthcare from clinical trials to digital health to payors. Prior to joining Surgo, Ms. Kemp worked with Deloitte consulting as well as directly for the US government. She has a BA from the University of Virginia and an MPA from George Washington University. The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 28 - Jonathan Kimmelman on Research Ethics and Dilemmas in Clinical Trials | 09 juil. 2024 | 00:36:29 | |
In this month’s episode of the Scope of Things, host Deborah Borfitz gives you the latest news on the fallacy of a survival benefit for cancer patients participating in clinical trials, how and why federally qualified health centers are getting involved in studies, efforts to disrupt the current practice of excluding pregnant and lactating women from participation, great news about the impact of precision medicine on the outcomes of kids suffering from aggressive cancers, and more. Jonathan Kimmelman, PhD, Professor of Biomedical Ethics at McGill University, also joins Deborah to discuss current dilemmas in clinical development and how research standards are trending. Kimmelman talks about the ethical implications when trial sponsors don’t fully disclose how patient input is utilized in drug development, key policies that are necessary and would have a big impact on regulators, and what would-be participants can do to be more informed about trials. News Roundup “Participation effect” not a benefit of cancer trials CARE for Health initiative of the NIH
Integration of clinical trials with healthcare delivery
FQHCs conducting clinical trials
Factors influencing trial participation by pregnant and lactating women
Flicker stimulation for epilepsy
Precision medicine for kids with cancer
GUEST BIO Jonathan Kimmelman, PhD, James McGill Professor of Biomedical Ethics, McGill University Jonathan Kimmelman, PhD, is James McGill Professor of Biomedical Ethics at McGill University. His research group, STREAM (Studies in Translation, Ethics and Medicine) uses empirical and theoretical methods to understand the ethical, policy, and scientific dynamics of developing new drugs. Kimmelman received the Maud Menten New Investigator Prize (2006), a CIHR New Investigator Award (2008), a Humboldt Bessel Award (2014), and was elected a Hastings Center Fellow (2018). He has sat on various advisory bodies within the U.S. NHLBI and NIAID, served for four tours of duty on U.S. National Academies of Medicine committees, and chaired the International Society of Stem Cell Research Guidelines for Stem Cell Research and Clinical Translation revision task force 2015-16. His research has been covered in major media outlets, including NPR’s All Things Considered, STATNews, and Nature. K The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 27 - Yvonne Rodriguez on Making Clinical Trials Accessible for Everyone | 04 juin 2024 | 00:25:14 | |
In this episode of the Scope of Things, host Deborah Borfitz covers the latest news on an AI model for comparing drug effectiveness, adoption of minimal residual disease as an endpoint for multiple myeloma, using HIV treatments for Alzheimer’s disease, lack of diversity in Alzheimer’s trials, and more. Yvonne Rodriguez, founder and CEO of Egality Sciences, also joins the conversation to talk about breaking down the barriers to clinical research participation in underserved communities. She also delves into her personal story of what inspired her to start her company, how Egality Sciences is teaching physicians and staff at local hospitals to get and stay involved with industry-sponsored studies, and the challenges that need to be overcome to ensure that every patient has equal access to clinical trials as a treatment option. News Roundup AI for predicting treatment outcomes
Minimal residual disease as an endpoint
Window-of-opportunity clinical trials
HIV treatments for Alzheimer’s?
Implantable device for brain disorders Lack of diversity in Alzheimer’s disease trials
OMB’s updated race/ethnicity standards
GUEST BIO
Yvonne Rodriguez, founder and CEO of Egality Sciences Yvonne Rodriguez is the founder and CEO of Egality Sciences. Originally from Socorro, Texas, she started working on clinical trials after receiving her BBA from St. Mary’s University, in San Antonio, Texas. She brings over 20 years of clinical research industry experience having worked at clinical research sites, IRBs, CROs, and pharmaceutical and biomedical device companies. Prior to starting Egality Sciences, Yvonne worked at AstraZeneca and led projects in the DEI space that had successful results. Yvonne holds a Master’s of Science in Health Sciences from George Washington University, and has received a professional certificate from Oxford University. The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 26 - Digital Twins, Care-For-All European Platform, and the Impact and Future of Wearables and Microsampling | 07 mai 2024 | 00:33:37 | |
In this episode of the Scope of Things, host Deborah Borfitz brings you the monthly breakdown on current events, such as tailoring medications to individual patients using digital twins, the use of a skin biopsy test to diagnose neurodegenerative diseases, and the launch of a European-wide platform promoting access to care for all. She also speaks with Michael Snyder, chair of the department of genetics at Stanford University School of Medicine and director of the Center of Genomics and Personalized Medicine at Stanford, about the growing adoption of wearables and home microsampling—and how this will dramatically change clinical trials and care. Snyder also delves into the “Amazon-ing” of healthcare and how he envisions the creation and future of personalized metrics and customized interventions and how they can improve trial outcomes. News Roundup Probabilistic approach to diagnosing cancer
Functional precision medicine
Cancer clinical trial access
Endpoints in cancer screening trials
Rate of participation in cancer research
Tailoring medications with digital twins
Skin biopsy test for neurodegenratve diseases
European Patient Observatory
GUEST BIO Michael Snyder, Ph.D., chair of the department of genetics at Stanford University School of Medicine and director of the Center of Genomics and Personalized Medicine at Stanford As a pioneer of Precision Medicine, Dr Michael Snyder has invented many technologies enabling the 21st century of healthcare including systems biology, RNA sequencing, and protein chip. Dr Snyder has initiated the Big Data approach to healthcare through his work using omics to detect early stage disease, including wearables to detect infectious diseases like COVID-19, and at-home microsampling to measure hundreds of molecules from a single drop of blood. He is the first researcher to gather petabytes of data on individuals, which is 1 million - 1 trillion times more data than the average clinician collects. He as published over 800 papers and is one of the most cited scientists. In terms of commercial success, Mike has co-founded 17 companies (including 2 unicorns) with combined enterprise value of over $6 billion. The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 25 - The Missing Link in Clinical Trials and Brain Monitoring: Consistent EEG Use | 02 avr. 2024 | 00:27:56 | |
In this month’s episode of the Scope of Things, host Deborah Borfitz covers the latest news and emerging trends, including the launch of a company using single-solution software to connect a global network of clinical trial sites to study sponsors, a pharmacy-first program in the UK, a centralized staffing initiative at the National Cancer Institute, progress in getting patient-derived organoids into clinical trials to evaluate drug response, and more. She also speaks with Lifelines Neuro’s chief scientific officer Dona Murphey, M.D., Ph.D. about shortcomings in the way EEGs are being use in clinical trials to monitor participants with potential brain damage, how EEG monitoring should be used in clinical research, and what the FDA has to say about all of this. News Roundup Launch of Pi Health
Pharmacy First initiative in the UK
Pediatric rare disease research
NCI Virtual Clinical Trials Office
Precision oncology clinical trial landscape
Translational Research Innovation Program
Patient-derived organoids in clinical trials
GUEST BIO Dona Murphey, M.D., Ph.D., chief scientific officer for Lifelines Neuro Dona is a neurologist, neuroscientist, historian of science, and community health worker educated at Harvard and Baylor College of Medicine. She currently serves as principal consultant at In Phase Neuro and fractional chief scientific officer at Synthesys Brain Health (a joint endeavor between Lifelines Neuro and Neurovative Diagnostics), specializing in the area of EEG in clinical trials. The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 24 - SCOPE 2024, AI Innovation, and Pitch Contest Winner Dezbee McDaniel | 05 mars 2024 | 00:31:14 | |
In this month’s episode of the Scope of Things, host Deborah Borfitz catches listeners up with the latest news of the clinical trials and research industry, starting with SCOPE 2024, where a record-breaking 4,000 attendees arrived to learn and discuss about new products, technology, and ideas. Other hot topics in this episode include convergence of clinical research and clinical care, patient centricity, protocol complexity, the growing use of AI, and an update on decentralized clinical trials. She also interviews CliniSpan Health founder and CEO Dezbee McDaniel, winner of the pitch contest at SCOPE, about his company’s novel social media influencer relationship management platform for improving clinical research diversity. Summit for Clinical Ops Executives (SCOPE) Convergence of clinical research and clinical care
Oliver Patch Project Conference themes ProofPilot integrates Magnol.AI TransCelerate’s Participant Data Return initiative Impact of protocol design on trial performance Use of AI in clinical development The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 23 - Discussing Review Boards, Social Media, and World Events With Donna Dorozinsky | 06 févr. 2024 | 00:28:29 | |
In this episode of The Scope of Things, host Deborah Borfitz provides a rundown of the latest news in the clinical trials field: a massive health research initiative in the UK, widespread overdosing of trial participants, a cholesterol-lowering vaccine, the growing popularity of phage therapy, a novel scoring mechanism for de-risking trials for chronic diseases, a strategy for making staph vaccines a reality, and the latest oral drugs heading to trials that could eliminate one of the chief barriers to insulin therapy for diabetics. Deborah also speaks with Donna Dorozinsky, President & CEO of Just in Time GCP, about recent changes related to expectations of institutional review boards, the use of social media for recruitment and communication purposes, and the impact of world events on clinical data management. Our Future Health Medication adherence crisis
Cholesterol-lowering vaccine
Phage therapy
Pharmagenic enrichment score
Staph vaccine trials New oral insulin drug
Guest
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 22 - Clinical News, Start-Ups, and More With Ward Lemaire and Dan Hydes | 09 janv. 2024 | 00:26:24 | |
New Year, new podcast format! In 2024’s first episode of the Scope of Things, host Deborah Borfitz gives you the latest news from the clinical trials industry, including AI’s role in the creation of digital twins, the obesity epidemic and the drugs intended to combat it, improving diversity in trial candidates, and more. We also have expert advice from Ward Lemaire, VP Head of Data Management and Central Monitoring at J&J Innovative Medicine, and Dan Hydes, Co-Founder and CEO at IgniteData, on SCOPE’s new Startup Pitch Competiton, and how start-up companies can meet multiple demands and needs, direct their limited resources, and keep the innovation train going. News Roundup AI and Chatbots
Digital Twins Obesity Clinical Trials
New areas of interest
Pharmacy Research Organization RxE2 Amplifying the patient voice The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 21 - Colleen Purcell Tenan on Providing Patients With Clinical Research Care Options | 05 déc. 2023 | 00:22:49 | |
Can clinical trials be a helpful treatment option for patients? In this episode of The Scope of Things, host Deborah Borfitz speaks with Colleen Purcell Tenan, MD, Medical Director at Javara, about providing clinical research as a care option for patients. Tenan talks about the benefits of receiving clinical research care from one’s own physician, Javara’s process of matching patients with the right healthcare system for clinical trials, and how Javara supports providers who haven’t done sponsor research before. She also shares her thoughts on where decentralized trial components best fit in clinical studies in a post-pandemic world and using remote technologies for convenient medical care and research. Javara Links: The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 20 - Michael Ibara on Changing the Clinical Trial Process for AI Application | 07 nov. 2023 | 00:22:52 | |
There are concerns surrounding the uses of AI in clinical trials, particularly on the regulations side. In this episode of the Scope of Things, host Deborah Borfitz discusses with Michael Ibara, Pharm.D., Chief Data Officer at Elligo, about the roadblocks and challenges obstructing AI’s potential in clinical trials. Ibara also talks about his perspective on the necessary changes to the clinical trial process to further apply AI, why innovation is a key factor, and what can be done in terms of regulations both domestically and internationally. He also shares his experiences with building a better system of organizing and processing EHR data with the Astra Project. The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode:19 - Tackling The Complex Process Of Vendor Selection With Dennis Salotti | 10 oct. 2023 | 00:26:36 | |
Selecting a vendor to do business with can be a tricky, convoluted process. How do you know who is the right fit? In this episode of the Scope of Things podcast, host Deborah Borfitz speaks with Dennis Salotti, Executive Director & Head, Clinical Outsourcing & Innovation at Jazz Pharmaceuticals, who shares what he knows about the complex vendor qualification process and the various ways sponsors and CROs are going about the expensive and time-consuming exercise. With two decades of experience in the field and having co-authored a report with Tuft’s Center for the Study of Drug Development, Salotti provides valuable insight on what to prioritize during vendor assessment, what factors can affect customized assessments, and the importance of building—and sometimes rebuilding—relationships with vendors. He also delves into how effective internal data and precompetitive info sharing on routinely assessed areas can help reduce cycle time and how companies can act on this. Scope of Things Links: Jazz Pharmaceuticals:
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 18 - The Clinical Reality of Chronic Wounds | 05 sept. 2023 | 00:29:20 | |
What can be done to improve clinical trials for patients with chronic wounds? In this new episode of the Scope of Things, host Deborah Borfitz speaks with Dr. Caroline Fife, world-renowned wound care physician and Chief Medical Officer at Intellicure, about the clinical realities of chronic wounds and wound treatment. Dr. Fife shares her thoughts on the “sorry state” of clinical trials for wound care products and what she has learned as the Executive Director of the U.S. Wound Registry that shed some light on the matter. She also discusses how her first clinical trial sparked her drive to improve conditions and the barriers that prevent innovation in the development of new products and technology.
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 17 - How Retail Pharmacies Are Taking on Clinical Trials | 08 août 2023 | 00:30:48 | |
What role do retail pharmacies have in research studies? In this episode of the Scope of Things, host Deborah Borfitz speaks with Ramita Tandon, Chief Clinical Trials Officer at Walgreens. Tandon discusses how retail pharmacies can play an important role in increasing access and retention in sponsor-lead drug development research. She also shares the specific approaches Walgreens is adopting in the US that have been gaining traction. Finally, she talks about why it is important to begin diversity and inclusion planning early in the drug development process and how it can allow researchers to think more holistically through the phases of clinical trials. Scope of Things Links: Walgreens Links: The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 16 - Advancing Diversity in Clinical Development | 11 juil. 2023 | 00:35:13 | |
In this episode of The Scope of Things, Deb Borfitz speaks with Murray Aitken, Executive Director of the IQVIA Institute, about diversity in clinical development, DEI methods that are and are not working, and the impact diversity has on clinical trials. Aitken also discusses FDA-issued policies to advance diversity and efforts to reduce disparities between subpopulations. He also talks about factors that contribute to those disparities, such as socio-economic backgrounds, genetics, and trust in the system. Finally, he delves into the importance of having diverse groups of participants—particularly Black and Hispanic Americans—in clinical trials to ensure that patients receive the best treatment options and healthcare access. The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode 15 - In the Clinic: Second Wave Biomarker Tests for Osteoarthritis | 06 juin 2023 | 00:22:11 | |
Years after serving in the Vietnam War, Virginia Byers Kraus’s father had his hip replaced—three different times. Each time, she said, outcomes were worse. Joint replacement is often the result of osteoarthritis, a degenerative joint disease commonly known as “wear and tear” arthritis. There are no disease-modifying drugs for osteoarthritis and early diagnosis is difficult. But even though the CDC estimates that nearly one in four people in the United States has osteoarthritis, Kraus rejects that idea that the disease—and resulting pain and surgical treatment—is inevitable. Her group at Duke is developing a proteomic panel of biomarkers that will be able to identify people with active disease before the evidence is visible on an MRI or X-ray. The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 14 - Ardy Arianpour on Seqster’s Patient-Centered Healthcare Movement | 02 mai 2023 | 00:30:35 | |
When Seqster was first founded in 2016, co-founder Ardy Arianpour had a lot of experience in next-gen sequencing and a vision for how consumers could control their health information. Arianpour envisioned a place where anyone can bring all their health data together in one place and share it on their terms. Since then, Arianpour says he has found many parts of the business challenging. There have been shifts in the business model over time, which began as direct-to-consumer. He credits Seqster’s 2020 agreement with Takeda Pharmaceuticals as a tipping point. Now, with several pharma partnerships to boast, Seqster is more than a company, Arianpour insists to host, Deborah Borfitz, in the latest Scope of Things podcast. “This is a movement.” The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 13 - Dr. Su Golder on Reporting Adverse Events in Clinical Research | 04 avr. 2023 | 00:33:22 | |
Dr. Su Golder, associate professor and senior research fellow in the Department of Health Sciences at the University of York, has dedicated a significant portion of her career to improving the reporting of adverse events in clinical research. In this episode, she speaks with host Deborah Borfitz about why adverse events are vital to address but often difficult to ascertain for any given therapeutic intervention. Golder talks about the strategic ways data can be manipulated—often leading to underreporting or misleading reporting—and the preferred guidelines that help researchers relay accurate information to clinicians and patients. She also discusses why data from randomized controlled trials are not always the best indicator of adverse advents in the real world and why social media provides valuable insights into why patients discontinue drug usage even when symptoms are considered minor. She says, “If something stops a patient from taking [a drug], then it doesn’t matter how effective [that drug] is. So [patient experience] is the most important thing.”
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 12 - Jill Pellegrino of CVS Health Clinical Trial Services on Using RWE to Improve Clinical Trial Efficiency and Applicability | 07 mars 2023 | 00:19:31 | |
In 2020, retail pharmacy giant CVS launched CVS Health Clinical Trial Services in response to the COVID-19 pandemic. They aimed to increase patient recruitment and encourage equitable participation in clinical research to accelerate COVID trials. In this episode, Jill Pellegrino, vice president of recruitment and RWE at CVS Health Clinical Trial Services, speaks with host Deborah Borfitz about CVS’ service offerings and its collaborative work to improve the efficiency and applicability of clinical trials beyond vaccines. Pellegrino discusses how the company secured nearly 33,000 clinical trial participants in just two years and their work with pharmaceutical companies to understand patient behaviors and drive positive behavioral change through real-world evidence. She also talks about their cohesive data set of “100 million lives” and how the business works seamlessly with CVS’ MinuteClinics to execute pragmatic trials. Finally, she discusses the company’s goal to expand into multiple therapeutic areas—including oncology trials—and partner with Aetna to access a new potential patient base. The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 11 - Dr. Graham Hatfull on the Benefits of Phage Therapy and the Future of Phage Clinical Trials | 07 févr. 2023 | 00:32:11 | |
Healthcare professionals are searching for new ways to fight bacterial infections as growing concerns around antibiotic resistance reach new heights. Though bacteriophages or phages—viruses that infect only bacteria—have long since captured scientists’ attention, they are quickly gaining popularity as a new and promising therapeutic tool. In this episode, Graham Hatfull, professor of biological sciences at the University of Pittsburgh, speaks with host Deborah Borfitz about his team’s research and diligent work to showcase phages as versatile therapeutic agents. Hatfull also talks about the impressive findings produced by experimental phage therapy clinical trials and the barriers that currently prevent phages from ubiquitous antibacterial clinical use. He discusses his team’s efforts to sequence phages and build a therapeutic library, the role of phage therapy in combating tuberculosis and cystic fibrosis, and the novel benefits phages bring to transplant recipients. Hatfull also addresses the FDA’s support of phage therapy through expanded access for compassionate use and the global push to enter phages into their first-ever randomized controlled trial. The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 10 - Abbvie’s Christopher Boone on Disrupting the Clinical Research Enterprise | 03 janv. 2023 | 00:27:01 | |
A self-described “data hippie,” Christopher Boone, vice president and global head of health economics and outcomes research at AbbVie, knows a great deal about using real-world data and generating real-world evidence in clinical trials. Boone sits with host Deborah Borfitz to talk about the disruptive presence of real-world evidence within the clinical trial enterprise and how it encourages researchers to reimagine trial design from start to finish. He says, “Much of the data we care about is captured outside the walls of the provider environment… Now, with all the digital technology, you can really understand the [patient’s] environment and experience in real-time.” Boone assesses how effective the industry has been in democratizing data, how the 21st Century Cures Act was “probably the single biggest catalyst” in the expansion of real-world data, the industry’s transition to patient-centered research, and the systemic and cultural barriers challenging clinical studies today. He also shares tidbits from his upcoming talk at SCOPE Summit 2023 in early February. The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 09 - Dr. Loaiza-Bonilla on Massive Bio’s Efforts to Make Clinical Trials More Accessible for Cancer Patients | 06 déc. 2022 | 00:31:50 | |
Dr. Loaiza-Bonilla details the importance of equity in increasing access to medical care, the reignition of the National Cancer Institute’s Cancer Moonshot program, and the U.S. Food and Drug Administration’s intention to standardize eligibility criteria. He also talks about the Massive Bio platform that could, one day, deliver medication via drones or offer at-home phlebotomy services to assist cancer patients from start to finish. He says, “My dream is that if a patient is unfortunately diagnosed with cancer, they can say, ‘Hey Siri or Cortana, help me find a clinical trial,’ and then the system does an e-consent, gets the records… screens them, and in 17 seconds you have the options. Then, [we get] them to the finish line.” The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 08 - Janssen’s Jason LaRoche on Reducing Greenhouse Gas Emissions and the Environmental Impact of Clinical Trials0z | 01 nov. 2022 | 00:23:56 | |
Jason LaRoche, Director of Clinical Innovation at Janssen Pharmaceuticals, speaks with host Deborah Borfitz about the global efforts launched to shrink the carbon footprint in the clinical trial and healthcare spaces. “If the global healthcare sector were a country, it would be the fifth largest emitter of greenhouse gases, and clinical research is a contributor,” explains LaRoche. In this episode, LaRoche discusses the pre-competitive space designed to inventory individual trials and their greenhouse gas (GHG) emissions to predict the total GHGs for future studies. He also talks about the semi-public database created to share GHG findings across the industry, how regulators and research organizations worldwide are taking action to diminish their carbon footprint, and the standalone project he developed to significantly reduce the massive waste generated from wearable health devices.
The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||
| Episode: 07 - University College London’s Dr. Anna David on Increasing the Representation of Pregnant Patients in Clinical Trials | 04 oct. 2022 | 00:28:17 | |
Pregnant women have consistently been underrepresented in clinical trials. With pregnancy studies posing significant risks to the mother and fetus, requiring extensive follow-up procedures, and potentially jeopardizing market approvals, many pharmaceutical companies avoid this demographic almost entirely. As a result, healthcare providers often struggle to access data regarding drug safety in pregnancy, preventing them from administering the best care possible. “Pregnant people make decisions in a vacuum of evidence. Very often, their healthcare providers don’t know the evidence, so the women actually make the decision and take the risk that everyone else is ignoring. I think that has to stop,” says podcast guest Dr. Anna David, obstetrician and director of the University College London Institute for Women's Health. In this episode, host Deborah Borfitz speaks with David about the obstacles facing pregnant patients in today’s medical landscape and the past and present strides made to increase their representation in clinical research. David also talks about her work creating the first standardized vocabulary for drug safety and maternal-fetal adverse events, how COVID-19 changed the industry’s perspective regarding pregnancy studies, and the novel trials currently fostering change across the globe. Clinical Research News The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today. | |||