Clinical Trial Podcast | Conversations with Clinical Research Experts – Détails, épisodes et analyse

To learn more about this important field of cardiovascular clinical research, I invited Dr. Gregg Stone on the podcast.

Dr. Stone is an Interventional Cardiologist and Director of Academic Affairs for the Mount Sinai Heart Health System and Professor of Medicine (Cardiology) and Professor of Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai in New York, NY. 

He has served as the national or international principal investigator for more than 150 national and international multicenter randomized trials and studies (many of which have led to new device approval or indications in the US), has authored more than 3000 manuscripts and abstracts published in the peer-reviewed literature, and has delivered thousands of invited lectures around the world. 

With an H-index of 202, Dr. Stone has been recognized in Nature Medicine as one of the most prolific authors in science, and by the Web of Science as among the top 0.01% of cited researchers in science. 

Dr. Stone completed medical school at Johns Hopkins University Medical Center, in Baltimore, MD, and his internship and residency at the New York Hospital-Cornell Medical Center in New York City. 

He completed his general cardiology fellowship at Cedars-Sinai Medical Center in Los Angeles, CA and subsequently a dedicated fellowship in advanced coronary angioplasty in Kansas City, MO. 

Please join me in welcoming Dr. Gregg Stone on the Clinical Trial Podcast.

Sponsor(s):

This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 12,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com

This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at slopeclinical.com

In this episode, you will learn about what type of insurance (if any) is needed to conduct a clinical trial. We also discuss different insurance provisions, choosing the right insurance partner, regulatory requirements that dictate insurance and much more.

Dan is a seasoned insurance professional with 10+ years of underwriting and broking experience. Dan and his team also assist in the implementation of alternative risk mitigation strategies, and see themselves as strategic partners to those in the life science space. Dan graduated from the Katie School of Insurance at Illinois State University where he studied Risk Management and

Enjoy!

Sponsor(s):

This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/

This podcast is brought to you by Veeva SiteVault. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit ​https://sites.veeva.com/​

In this episode, I’m excited for you to learn about Heart Failure Clinical Trials for medical devices.

Our guest today is Sonna Patel-Raman. Sonna is currently the President at NuPulse Inc, an early stage medical device company responsible for developing the first minimally invasive, long-term, ambulatory counterpulsation device that works in sync with the heart.

At NuPulse, Sonna is responsible for developing and executing on strategic initiatives for the company, building a diverse and multidisciplinary team of engineers, regulatory and quality associates, marketing, manufacturing, clinical affairs and education, and trial operations. Sonna and her team successfully completed enrollment in an FDA-approved feasibility trial and are now working towards the next phase of their medical product development lifecycle.

Sonna has extensive experience in the heart failure medical device space. Prior to joining NuPulse in 2015, she worked as the FDA Branch Chief where she managed a team of 16+ reviewers and clinicians and was responsible for the technical review and development of pre-marketing approvals (PMAs), Investigational Device Exemption (IDEs), 510k)s and more.

In this interview, Sonna provides us with a great introduction to heart failure trials, an overview of the medical device ecosystem for the treatment of heart failure, unique operational considerations for heart failure clinical trials, working as a woman leader in the medtech space, and more.

Sonna is an effective communicator (as you’ll soon find out after listening to this interview) and an amazing human being. I hope you enjoy my conversation with Sonna Patel-Raman. 

Sponsors:

This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors - to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.

This podcast is brought to you by Slope. Slope’s eClinical Supply Chain Management (eCSCM) platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by removing the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. To learn more, visit slope.io. 

To learn more about site reads and the role of medical imaging software, I invited Kelie Williams Luby, Vice President of Clinical Trials at Mint Medical. 

Kelie has 24 years of experience as a clinical trial researcher, first as a medicinal chemist, and for the past 19 years as a clinical trialist in medical imaging-based endpoints. She is passionate about optimizing clinical trial designs while reducing the cognitive burden placed on healthcare providers treating patients in those clinical trials. Kelie believes it is possible to improve the efficiency of how clinical trials with imaging-based endpoints are conducted while also improving the reliability of data abstracted from participants during clinical trials.  She holds a B.S and M.S in Chemistry along with a Master’s in Technical, Scientific, and Medical Communication. 

Sponsor: This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/

This is a special episode on risk management. It is important to understand what dictates the work we do as clinical research professionals and how our work fits into the bigger picture of medical product development. This episode serves exactly that purpose.

You’ll be introduced to ISO 14971 Application of risk management to medical devices and learn about its relationship to ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice.

You’ll also understand key terminology around risks, how to define risk, what's special about clinical studies with respect to risk management, and much more.

Our guest today is Bijan Elahi.

Bijan has worked in risk management for medical devices for over 29 years at the largest medical device companies in the world, as well as small startups. He is a technical fellow and Medtronic corporate advisor on safety risk management of. medical devices. 

In this capacity, he offers education and consulting on risk management to all Medtronic business units, worldwide. 

Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering. At the invitation of the FDA, he also teaches a graduate course on medical device risk management at Drexel University in Philadelphia.

Bijan is the founder of MedTech Safety, Inc., an education and advisory company. He has educated over 6,500 individuals worldwide. Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. 

Last but not least, he is the author of Safety Risk Management for Medical Devices, published by Elsevier publishing.

Enjoy!

Sponsor:

This podcast is brought to you by Slope.

Slope provides an online eClinical Supply Chain Management (eCSCM) platform for sponsors and research sites collaborating on complex, sample-intensive, early-stage clinical trials. The Slope eCSCM platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by moving the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. 

To learn more, visit slope.io and ask to speak with a solutions coordinator today.

In this episode, I’m excited to share with you 5 Strategies for planning and conducting investigator and steering committee meetings.  Now that the world is starting to re-open after the COVID-19 pandemic, more sponsors are conducting in-person meetings with key opinion leaders (KOLs). 

These meetings are exceptionally critical to the success of any medical product development. The purpose of these meetings is to discuss the clinical trial strategy, clinical investigational plan, patient enrollment initiatives, publication plan, and more.

Although it entirely possible to conduct these meetings virtually (and sometimes you’re better off conducting them virtually), the focus of this episode is on in-person meetings. But most meetings tend to poorly organized with lack of purpose and defined objectives i.e. what is it that you hope to achieve by conducting this meeting. If you’re directly or in-directly involved in organizing a meeting with KOLs, this episode will serve you well.

This episode is brought to you by Calyx. To learn more on how Calyx can help you with your medical imaging needs, please visit calyx.ai

When a new drug or device undergoes “first in human” experience, the primary focus is on participant safety. How will the drug or device interact with the human body? And will this interaction be safe?

To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinical trials.

To learn more about the complexities in early phase clinical trials, I invited Dr. Oren Cohen, President of Clinical Pharmacology Services and Chief Medical Officer at Labcorp Drug Development on the show.

Dr. Cohen has more than 30 years of healthcare experience which includes his work on clinical development. 

I hope you enjoy this conversation with Dr. Oren Cohen.

Podcast Sponsor:

This podcast episode is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit calyx.ai 

Phase I trials are generally conducted in healthy participants or in patients with no treatment options such as oncology patients.

Unlike late phase trials, Phase I (also known as early phase) studies have different patient recruitment challenges.

To learn more, I invited Dr. Graham Wood, Executive Vice President, USA at Nucleus Network.

Dr. Wood is a leader in the conduct and design of clinical pharmacology studies having held senior executive roles in a number of the top clinical research sites in the world.

In total, he has over 22 years of experience and has been involved with more than 200 first-in-human studies as well as over 2,000 studies across all areas of clinical pharmacology.

After finishing his PhD in Neurology and Neurosurgery, Graham worked at MDS Pharma Services, Cetero Research, Manna Research and Altasciences as well as spending two years working at biotechnology companies.

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This podcast is brought to you by Slope.

Slope provides an online eClinical Supply Chain Management (eCSCM) platform for sponsors and research sites collaborating on complex, sample-intensive, early-stage clinical trials. The Slope eCSCM platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by moving the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. 

To learn more, visit slope.io and ask to speak with a solutions coordinator today. 

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Medical Imaging in Clinical Trials with Elizabeth Dalton

In this episode, I’m excited to talk about medical imaging in clinical trials. 

We’ll discuss the role of a medical imaging CRO, imaging endpoints in clinical trials, expensive mistakes to avoid as a trial Sponsor/ CRO, saving money on medical imaging services, imaging data collection process, and more.

The guest for today’s show is a long time friend of mine, Elizabeth Hartunian Dalton, Vice President at Calyx.  

Liz is a seasoned clinical trial professional with 17+ years of experience working with sponsors, sites, and CROs in centralized medical imaging and clinical trials.

Driven by a passion for service, Liz’s ethos is rooted in honesty, productivity, commitment, and the power of positive energy. 

In addition to her primary role of growing the Calyx partnership/CRO channel, Liz leads a team of technical solution consultants and is a medical imaging consultant herself. 

Liz attended the University of Massachusetts where she achieved dual Bachelor degrees in Anthropology and Economics (magna cum laude) and will graduate in May 2023 with her MBA from Boston University’s Questrom School of Business. 

Please join me in welcoming Liz on the Clinical Trial Podcast. 

This episode is brought to you by Calyx. To learn more about Calyx, please visit https://www.calyx.ai/