The Scope of Things

Clinical Research News

The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News Senior Writer 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.

  1. 2d ago

    Episode: 55 - A Terminal Prognosis Sparks A New Model For Neurology Clinical Research

    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.

    Episode: 55 - A Terminal Prognosis Sparks A New Model For Neurology Clinical Research
  2. Aug 4

    Episode: 53 - Daphne Smyth on the Chinese Drug Development Market Expansion

    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.

    Episode: 53 - Daphne Smyth on the Chinese Drug Development Market Expansion
  3. Jul 7

    Episode: 52 - Raj Indupuri on Adoption Hurdles with AI Agents

    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.

    Episode: 52 -  Raj Indupuri on Adoption Hurdles with AI Agents
  4. Jun 4

    Episode: 51 - Bridging the Equity Gap in Oncology with Eugene Manley, Jr.

    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.

    Episode: 51 -  Bridging the Equity Gap in Oncology with Eugene Manley, Jr.
  5. May 5

    Episode: 50 - Ramona Burress and Cassandra O’Neal on Health Equity That Works

    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: 50 - Ramona Burress and Cassandra O’Neal on Health Equity That Works
  6. Apr 7

    Episode: 49 - Mike Sullivan on AI and Clinical Operations in the Year 2030

    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.

    Episode: 49 - Mike Sullivan on AI and Clinical Operations in the Year 2030
  7. Mar 10

    Episode: 48 - Florence Mowlem on the Challenges and Solutions of Pediatric Rare Disease Trials

    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.

    Episode: 48 - Florence Mowlem on the Challenges and Solutions of Pediatric Rare Disease Trials
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The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News Senior Writer 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.