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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.
26 Episodes
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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.
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. LINKS Summit for Clinical Ops Executives (SCOPE) Conference website Convergence of clinical research and clinical care Story in Clinical Research News [link to come, story runs 2/27?] Oliver Patch Project Website Conference themes Savvy Cooperative’s #AskPatients website Barnett International’s GCP reference guide ProofPilot integrates Magnol.AI Press release TransCelerate’s Participant Data Return initiative Resource pack Impact of protocol design on trial performance Study in Therapeutic Innovation & Regulatory Science Use of AI in clinical development FDA-issued discussion paper
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.
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. New Advisory Board Ken Getz podcast episode Ramita Tandon podcast episode News Roundup AI and Chatbots Belong.Life Microsoft’s Trial Matcher UF and NVIDIA’s GatorTronGPT Genentech’s smart digital assistants Digital Twins Pan-European project simulating stroke treatments Obesity Clinical Trials JAMA paper on unintended consequences of weight-loss drugs FDA’s Ozempic label change Physicians in Europe preferentially recommend lifestyle changes New areas of interest Trial begins for Insilico Medicine’s latest AI-discovered drug Brain metastases studies in Italy and Spain Drug repurposing study in Australia for type 1 diabetes Anti-aging TAME trial of Metformin to start Pharmacy Research Organization RxE2 Platform for independent community pharmacists launches Gerald Finken podcast episode Amplifying the patient voice FDA’s patient- focuse
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. Scope of Things Links: Clinical Research News Scope Summit Javara Links: Javara
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.
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. Links from this episode: Scope of Things Links: Clinical Research News Scope Summit Jazz Pharmaceuticals: Jazz Pharmaceuticals
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. Links from this episode: Clinical Research News Scope Summit Intellicure
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: Clinical Research News Scope Summit Walgreens Links: Walgreens
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. Links from this episode: Clinical Research News Scope Summit IQVIA Institute
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. Scope of Things Links: Clinical Research News Scope Summit Europe
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.” Links from this episode: Seqster’s Perfect Timing, Powerful Platform Might Change Health Clinical Research News Seqster
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.” Links from this episode: Clinical Research News University of York Adverse Event Reporting May Need A Total Redo Medicines & Healthcare products Regulatory Agency Yellow Card reporting Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) PRISMA harms checklist: improving harms reporting in systematic reviews Consolidated Standards of Reporting Trials (CONSORT) OpenTrials: towards a collaborative open database of all available information on all clinical trials Cochrane Adverse Effects Methods Group
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. Links from this episode: Clinical Research News CVS Health CVS Health Clinical Trial Services CVS MinuteClinic
1Healthcare 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. Links from this episode: Clinical Research NewzUniversity of Pittsburgh Phage Therapy of Mycobacterium Infections: Compassionate Use of Phages in 20 Patients With Drug-Resistant Mycobacterial Disease SEA-PHAGES (Science Education Alliance-Phage Hunters Advancing Genomics and Evolutionary Science) FDA Expanded Access for Compassionate Use Phage Australia
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. Links from this episode: Clinical Research News AbbVie 21st Century Cures Act Patient-Centered Outcomes Research Institute (PCORI) PCORnet SCOPE Summit
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.” inks from this episode: Clinical Research News Massive Bio US National Library of Medicine: Clinical Trials Cancer Moonshot Program A New Approach to Simplifying and Harmonizing Cancer Clinical Trials-Standardizing Eligibility Criteria
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. Links from this episode: Clinical Research News Janssen Global Sustainable Healthcare Coalition The Pistoia Alliance
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.Links from this episode: Clinical Research News University College London UCL EGA Institute for Women's Health Innovative Medicines Initiative ConcePTION Project Accelerating Innovation for Mothers International Council for Harmonisation Healthy Mum, Healthy Baby, Healthy Future Paediatric Investigation Plan (PIP) Maternal and Fetal Adverse Event Terminology
Pharmacists demonstrate tremendous expertise in drug counseling and dispensation, so it seems undeniable that they should play a prominent role in clinical research. Surprisingly, their skill sets are rarely used in clinical trials. That’s why Founder and CEO Gerald Finken created RxE2, a community-based decentralized trial technology company spearheaded by pharmacists, offering primary stakeholders their rightful seat at the clinical research table. In this episode, host Deborah Borfitz speaks with Finken about the challenges of delivering a new clinical trial concept and how the industry could benefit if pharmacists had more influence. He says, “I firmly believe that if pharmacists were involved, some of the issues that we’re having today in clinical trials wouldn’t exist. I don’t think recruitment would be a problem. I don’t think adherence and compliance would be a problem because pharmacists are medication experts who are trained to counsel patients and find out things real-time.” Finken also talks about the industry’s response to his new venture and the company’s plans to scale in the future. Links from this episode: Clinical Research News RxE2 American Pharmacists Association American Association of Pharmaceutical Scientists
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