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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.   • Brian and Sandra’s personal ALS diagnosis story and why it becomes a mission • Building I AM ALS and driving funding, legislation, and FDA regulatory reform • Synapticure’s “care and cures” model and how virtual neurology works • The value of longitudinal datasets for smarter clinical trial design and control groups • Mythbusting virtual dementia diagnosis, virtual care complexity, and the true scope of the access gap LINKS  Scope of Things Links https://www.clinicalresearchnewsonline.com/ https://www.scopesummit.com/ https://twitter.com/chi_healthtech https://www.linkedin.com/company/cambridge-healthtech-institute/ https://www.linkedin.com/company/clinical-informatics-news/  Host Links Michelle Snyder / McKesson Ventures: https://ventures.mckesson.com/ Michelle Snyder: https://www.linkedin.com/in/michellensnyder  McKesson Ventures: https://www.linkedin.com/company/mckesson-ventures/  Guest Links Synapticure Sandra Abrevaya: https://www.linkedin.com/in/sandra-abrevaya-26075640  Synapticure: https://www.linkedin.com/company/71207928/admin/dashboard/   @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.

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.

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  Study in Therapeutic Innovation & Regulatory Science News release from CluePoints Shingles vaccine may lower dementia risk  Study in Annals of Internal Medicine  News on the Brown University website  Parkinson’s drug for treatment-resistant depression  Study in Nature Medicine  News on the Lund University website AI for improving neuroblastoma outcomes  Research article in APL Quantum  News on the University of Utah website Brain-protecting effect of hormone therapies  Study in NeuroImage News on the University of Kansas website  Bayer’s alliance with academic medical center  News on the University of Colorado Anschutz website Guest  Daphne Smyth, head of global regulatory programs for Veristat   Article in Clinical Research News about opportunities in China 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.

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  Study in The New England Journal of Medicine  News on the Fred Hutch Cancer Center website  Target trial emulation in rural areas  Perspective in the Medical Journal of Australia News on the Griffith University website   AI for improving drug safety during pregnancy  Report from the Journal of Medical Internet Research Guidelines on the use of routinely collected data  Article in The BMJ New regulatory framework in the U.K.  Press release by the Medicines and Healthcare products Regulatory Agency  Participant Engagement Portal  Article in JNCI Cancer Spectrum Press release from the Alliance for Clinical Trials in Oncology 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.

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  Article in Nature Medicine Press release from Monash University   Sudden cardiac death research   Study in Prehospital Emergency Care News on the University of Cincinnati website New endpoints for cancer trials  Consensus paper in The Lancet Oncology News on the Medical University of Vienna website USC and Tempus strategic collaboration  News on the Keck School of Medicine of USC website Trial disruptions threaten diversity  Article in the Journal of Medical Internet Research Misinterpreting effects of Alzheimer’s drugs  Research letter in JAMA Neurology News from Brown University School of Public Health   Guest  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.

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.

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  Study published in Health Expectations Playbook forpediatricclinical trial reporting  Statement on reporting protocols published in The BMJ Statement on reprintng completed trials published in The BMJ Low-dose lithium for slowing verbal memory decline  Study in JAMA Neurology  News on the University of Pittsburgh Medical Center website  Parkinson's-related protein linked to faster Alzheimer's progression in women  Study in JAMA Network Open  Press release on the Mayo Clinic website AstroID database for studying cancer  Study in Journal for Immunotherapy of Cancer News release on the Johns Hopkins website  Anti-obesity drugs for preventing cancer  News release from the European Congress on Obesity 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.

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  Study in Nature Microbiology News from the Technical University of Denmark Competing body weight regulation theories  Study in Nature Reviews Endocrinology News on the Pennington Biomedical Research Center website PATHWEIGH weight management process  Pragmatic study in Nature Medicine News on the University of Colorado Anschutz website Diabetes drugs reduce risk of dementia  Study in Drug Safety News on McGill University website PRO data improved side effect grading  Study in The Lancet Oncology Blog post on EORTC website Development model for cell and gene therapies  Research article in Molecular Therapy, Methods and Clinical Development News on the Lund University website 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.

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  Study in the Journal of the National Comprehensive Cancer Network News on the Case Western Reserve University website  Accelerated cancer drug approvals  Study in BMJ Medicine Best states for cancer research  Blog on SmileHub website In-ear EEG devices  Article in Diagnostics World News Ecological momentary assessment in sleep-focused trial  Study in JAMA Network Open    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.

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. Show Notes     News Roundup  Good Pharma Scorecard  Study in JAMA Internal Medicine News on the Yale Scool of Medicine website  Nationwide telehealth trial for cancer  News on The Ohio State University website Online platform for bowel cancer research  News on the Newcastle University website Patient-reported outcomes in cancer clinical trials  Paper in The Lancet Oncology News on the European Organisation for Research and Treatment of Cancer website Virtual clinical trial of psychedelics  Research article in Advanced Science Type 1 diabetes risk prediction testing  Study in The Lancet News on the University of Exeter website 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.

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 Data collection tools for decentralized trials  MyTrials platform study in the Journal of Clinical and Translational Science  Real-time data integration tool  Press release on the Mount Sinai website Drug toxicity prediction  Article in EbioMedicine  Tufts Women’s Health and Menopause Initiative  News from Tufts University  Regenerative therapy for spinal cord injury  Article in Nature Oral treatment for preventing dementia  Press release from Aarhus University  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.

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 News Roundup    Collaborative study on data collection in trials  News posted on the TransCelerate website Heart benefits of semaglutide  Study in The Lancet Whole genome sequencing of breast cancers  Study in The Lancet Oncology Pan-cancer immunotherapy heads to trials  Research article in Cell Article in Bio-IT World Promising NAD+ “youth molecule”  Review article in Nature Aging  Virus cocktail to combat superbugs  Article in Nature Microbiology AI annotates medical images  News posted on the MIT website Fitbits aid precision health  American Life in Realtime study in PNAS Nexus Latest from the Human Epilepsy Project  Study in JAMA Neurology Imposter study participants  Editorial in The BMJ Guests  Jonathan Crowther, Ph.D., Head, Operational Design Center, Merck KGaA, Darmstadt, Germany Janie Hansen, Global Development Information Management, Business Systems Transformation, Daiichi Sankyo Francis Kendall, Head of Statistical Programming, Digital and Data Sciences, Biogen James Weatherall, Ph.D., Vice President & Chief Data Scientist, BioPharmaceuticals R&D, AstraZeneca   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.

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  Press release on the Mount Sinai website Subgroup analysis study in the European Heart Journal Aspirin lowers risk of colorectal cancer recurrence  Study in The New England Journal of Medicine  CLEVER study to prevent breast cancer relapse  Study in Nature Medicine News release on Penn Medicine website   Champion Insights ALS initiative  News release on Answer ALS website Medable’s Agent Studio  Press release on the Medable website Disseminating research findings  Systematic review in PLOS Medicine  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.

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  Study in Nature Communications  Questionable shortcut in rectal cancer drug trials  Investigation in JAMA Network Open ChatGPT determines trial eligibility  Paper in Machine Learning: Health Major trauma study to test hemorrhage treatment  News release by University of Colorado Anschutz Medical Campus New weight loss remedy soon heads to trials  News on Syracuse University website Study in Science Translational Medicine 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.

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  Research article in PLOS One TACIT algorithm matching patients to trials  Article in Nature Communications Mapping biomarkers linked to treatment resistance  Press release on the City of Hope website  Pragmatic diabetes trial in China  Paper about China-specific genetic risk score in Diabetologia News of trial launch on the University of Exeter website Cough medicine to slow dementia?  Study in JAMA Neurology Beating the EARL hurdles in the UK  Study in JAMA Network Open Guest  Annette Bakker, Ph.D., CEO of the Children's Tumor Foundation  Article in 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.