The Scope of Things

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https://www.clinicalresearchnewsonline.com/
19 shares
https://www.scopesummit.com/
8 shares
https://gdpr.eu/
1 share

https://pubmed.ncbi.nlm.nih.gov/36608652/
1 share
https://pubmed.ncbi.nlm.nih.gov/35925576/
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Episode: 30 - Shining the Spotlight on Rare Disease Trials With Uncommon Cures

Season 1 · Episode 30

Tuesday, September 3, 2024 • Duration 25:52

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.

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Episode 29 - Patient-Focused Drug Design, Enrollment Challenges, and More With Hannah Kemp

Season 1 · Episode 29

Tuesday, August 6, 2024 • Duration 30:49

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

Episode: 20 - Michael Ibara on Changing the Clinical Trial Process for AI Application

Season 1 · Episode 20

Tuesday, November 7, 2023 • Duration 22:52

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.

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.

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Episode:19 - Tackling The Complex Process Of Vendor Selection With Dennis Salotti

Season 1 · Episode 19

Tuesday, October 10, 2023 • Duration 26:36

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

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.

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Episode: 18 - The Clinical Reality of Chronic Wounds

Season 1 · Episode 18

Tuesday, September 5, 2023 • Duration 29:20

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

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.

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Episode: 17 - How Retail Pharmacies Are Taking on Clinical Trials

Season 1 · Episode 17

Tuesday, August 8, 2023 • Duration 30:48

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

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.

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Episode: 16 - Advancing Diversity in Clinical Development

Season 1 · Episode 16

Tuesday, July 11, 2023 • Duration 35:13

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

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.

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Episode 15 - In the Clinic: Second Wave Biomarker Tests for Osteoarthritis

Season 1 · Episode 15

Tuesday, June 6, 2023 • Duration 22:11

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

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.

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Episode: 14 - Ardy Arianpour on Seqster’s Patient-Centered Healthcare Movement

Season 1 · Episode 14

Tuesday, May 2, 2023 • Duration 30:35

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

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.

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Episode: 13 - Dr. Su Golder on Reporting Adverse Events in Clinical Research

Season 1 · Episode 13

Tuesday, April 4, 2023 • Duration 33:22

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

The Scope of Things – Details, episodes & analysis

Podcast details

Recent rankings

Apple Podcasts

Shared links between episodes and podcasts

RSS feed quality and score

Publication history

Latest published episodes

Related Shows Based on Content Similarities

Apple Podcasts

Spotify

Related Shows Based on Content Similarities

The Scope of Things – Details, episodes & analysis

Podcast details

Recent rankings

Apple Podcasts

Shared links between episodes and podcasts

Other99+

Nature20

PubMed2

RSS feed quality and score

Publication history

Latest published episodes

Similar podcasts and content

Related Shows Based on Content Similarities

Apple Podcasts

Spotify

Related Shows Based on Content Similarities

Other99+

Nature20

PubMed2