The Scope of Things – Details, episodes & analysis

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.  

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.  

News Roundup 

PLATO trial investigation 

• Findings published in The BMJ 

“OncoSexome” project 

• Paper in Nucleic Acids Research 

Brain shrinkage with Alzheimer’s treatment 

• Research in The Lancet Neurology  

Repurposing drugs for Alzheimer’s 

• Study in Alzheimer’s & Dementia  

Mayo Clinic Tapestry study 

• Article in Mayo Clinic Proceedings 

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.  

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 

• Insights about the rollout in Clinical Research News 
• Article in Clinical Research News about discussion at SCOPE Europe 

Secure multiparty computation 

• Article in Bio-IT World 
• Study in npj Digital Medicine 

Cell therapy for childhood brain cancer 

• Study published in Nature  
• Stanford Medicine press release  

TrialGPT tool 

• Study in Nature Communications  

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 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.

SHOW NOTES 

News Roundup 

AI for drug repurposing 

• Study in Nature Medicine 

Window trial for new breast cancer approach 

• Study in Science Advances 
• Article in Bio-IT World  

Prescreening regimen of AutoCruitment 

• Article in Clinical Research News 
• Episode 12 guest appearance on podcast  

Trials needing placental pathology 

• Opinion piece in Trends in Molecular Medicine 

Fit-for-purpose ethical oversight 

• Special communication in JAMA  

“Sponsorship effect” on psychiatric drug trials 

• Study in Journal of Political Economy 

Guests  
Nicole Stansbury, Head of Global Clinical Operations at Premier Research
Farrell Healion, Head of Emerging Technologies at AstraZeneca
Jonathan Crowther, Head of Predictive Analytics, PRD (OARS), Pfizer 

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.  

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. 

SHOW NOTES 

News Roundup 

Phase 3 trial for Graves’ disease 

• Article in Clinical Research News  

Quality of life measures in cancer studies 

• Study in Journal of Clinical Oncology 
• Article in Clinical Research News 

Rapid recruitment for a diagnostic tampon trial 

• Article in Clinical Research News 

Reference trial emulation 

• Study in PLOS Medicine  

Walgreens/BARDA partnership 

• News brief in Clinical Research News 

“Detective” algorithm for improving trial design 

• Study in Nature Genetics 

Exclusion of people with Duffy-null phenotype 

• Study in JAMA Network Open   

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 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. 

SHOW NOTES 

News Roundup 

Pharmaceutical-grade HMOs 

• Article in Clinical Research News 

Paradoxical cancer treatment approach 

• Study in Cancer Discovery  
• Article in Clinical Research News   

Switching on the desire the exercise 

• Study in Science Advances 

STEP stroke platform trial 

• Press release from the University of Cincinnati 

Policy interventions to improve trial equity  

• Study in Journal of Clinical Oncology 
• Article in Clinical Research News 

New drug for MS 

• Study in PNAS 

Guests 

CEO Marshall Summar, M.D., and CMO Tamanna Roshan Lal, M.D., with Uncommon Cures  

• 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.  

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. 

SHOW NOTES 

News Roundup 

AI for clinical trial screening  

• Study in NEJM AI 

AI for trial recruitment  

• Study in Ophthalmology Science  

Drug therapy for sleep apnea 

• Study in NEJM    

Investigation on departing FDA employees 

• Article in The BMJ  

N-Power Medicine/Merck collaboration 

• Press release 

Youth prediabetes/diabetes dataset 

• Link to POND web portal 

Systemic biases in randomized controlled trials 

• Study in Journal of Ethnicity in Substance Abuse 

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.  

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. 

SHOW NOTES  

News Roundup 

“Participation effect” not a benefit of cancer trials  

• Article in JAMA 
• Article in Annals of Internal Medicine 

CARE for Health initiative of the NIH 

• Editorial in Science   

Integration of clinical trials with healthcare delivery 

• Special communication in JAMA 

FQHCs conducting clinical trials 

• Episode 21 with Javara Medical Director Colleen Purcell Tenan, M.D. 

Factors influencing trial participation by pregnant and lactating women 

• Review in PLOS Medicine 

Flicker stimulation for epilepsy 

• Study in Nature Communications  

Precision medicine for kids with cancer 

• Article in Nature Medicine  

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

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 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.  

SHOW NOTES 

News Roundup 

AI for predicting treatment outcomes 

• Article in Patterns 

Minimal residual disease as an endpoint 

• FDA information package (multiple myeloma)  

Window-of-opportunity clinical trials 

• Ontario Institute for Cancer Research webpage 

HIV treatments for Alzheimer’s? 

• Proof-of-concept study in Pharmaceuticals 

Implantable device for brain disorders 

• Study published in Science Advances 
• Motif Neurotech website   

Lack of diversity in Alzheimer’s disease trials 

• Study about differences in plasma biomarker eligibility 

OMB’s updated race/ethnicity standards 

• PDF of final recommendations 

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.