The Scope of Things

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.

With host Michelle Everill, the conversation keeps coming back to one inconvenient truth for anyone betting on pure decentralization: patients want options, and trust is easier to build when people meet. They get practical about what needs to change inside the site: the problems of site workflow, why so much clinical trial technology is built for sponsor back offices instead of the people juggling visits, data entry, and real-world surprises. They discuss why retention starts before a patient ever arrives, how better data access could reduce redundant eligibility questions, and why privacy and trust are the real barriers to centralized patient data. And finally, the three go bold on predictions for 2035, from designing trials around patient communities to removing access barriers like taxed patient stipends.

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.  

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.