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Hi Reader

Cardiovascular disease (CVD) is one of the top four leading causes of death. According to Heart Failure Society of America (HFSA), nearly 6.5 million Americans over the age of 20 have heart failure. To learn more about the topic of Heart Failure Clinical Trials, I invited Sonna Patel-Raman on the show.

In this interview, Sonna provides us with an 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, and more.

Sonna is currently the President and CEO 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 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.

I hope you enjoy my conversation with Sonna Patel-Raman.

Love,

Kunal

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 https://www.slopeclinical.com/​

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. Learn more at https://sites.veeva.com/.

Florence Healthcare is hosting a site enablement conference that explores how technology links sponsors and sites to revolutionize research. This ​Research Revolution conference​ will be held from November 15-17, 2023 in Atlanta, GA. Just for you beautiful people, the team at Florence Healthcare has set-up a special promo code which has a ​discounted price of $500​ (hotel and meals included!). Research Revolution is one of the top clinical trial conferences where you can network with likeminded individuals who believe in site-first approach and leveraging technology accelerate research. I'll be there. Will I see you? Let me know by replying to this email. Remember to use the promo code "KUNAL" at check-out to get your $500 discount.

Resources for You

The US Food and Drug Administration (FDA) recently posted two new guidance documents that might be of interest to you:

1. ​Informed Consent - ​​Guidance for IRBs, Clinical Investigators, and Sponsors​
2. ​Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products​

I LOVE reading guidance documents because they are written in plain language and reflect FDA's current line of thinking about the topic.

The concepts from the FDA guidance documents are generally applicable to clinical trial/ research projects conducted outside the US as well.

Career Opportunities

The following organizations are hiring for clinical and non-clinical roles. If you’re interested in advancing your career & meet most of the job requirements, consider applying for the role.

1. ​Florence Healthcare is hiring. Ryan Jones, who is the CEO and co-founder at Florence has been on the Clinical Trial Podcast before (here and here). Check out Florence’s careers page.
2. ​Calyx (previously known as Perceptive Informatics) is where I started my clinical research career as an Imaging Research Assistant. They have ~23 open positions. Check out their careers page.
3. ​Iovance Biotherapeutics has several interesting clinical, regulatory, quality assurance opportunities available. Check out their careers page. I also interviewed Mariam Mirgoli,Senior VP of Clinical Data Management on the show.
4. ​Society of Clinical Research Associates (SOCRA) and Association of Clinical Research Professionals (ACRP) do a great job of posting clinical research opportunities on their website. Check them out here and here.
5. ​Dexcom, one of the leading continuous glucose monitoring (GGM) medical device companies, is looking to fill ~6 clinical affairs roles. Apply for open opportunities here.​
6. *NEW* My friend, Daya Gulabani at Regeneron, is looking to hire for a Senior Manager, Clinical Study Inspection Readiness role.

Hey friend! ​ Thanks for listening to the Clinical Trial Podcast and subscribing to my blog. ​ You are the best part of my clinical research journey and I appreciate you! ​ As always, I'm here to help you accelerate your clinical research career. ​ Till next time, Kunal "grateful" Sampat

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