Pharmacy Podcast Network

In this episode of the DarshanTalks Podcast, we have a discussion about Digital Health with Bakul Patel, Director, Digital Health Center of Excellence of US FDA department. He has over 28 years of leadership, business development, marketing, product management, assessing long and short-term needs, establishing objectives, improving organizational performance, and resource management. Expertise in medical device regulations, product development processes, software engineering, embedded systems, wireless communication systems, and robotics and control systems. Masters in Electronics Engineering, MBA in International Business. Six Sigma, Black-belt certified. With all the bucket of knowledge of digital health, the conversation started off with FDA going through massive changes currently. He explains his area of work in the digital health technology sphere and leading digital health with no jurisdiction boundaries, as this sector is wide in nature, and he further explains how it's always been fun to work in such an atmosphere. When it comes down to FDA there are portions of that spectrum of digital health as it may be general wellness. According to the expert, digital health is a spectrum, a continuum, a journey for an individual and purview under FDA's jurisdiction. The focus of the conversation was on the department that the expert works and the people who don't know much about can reach out to the department for advice, suggestions, reviews or portions of review depending on the products that come to different parts of the agency. There are some policy challenges, he emphasised on FDA needs to start evolving that their agency have been actively working on with other parts of the agency. Recent guidance on digital health tech in clinical trials was launched by his department and he described all the related information and implications in this podcast.

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Disclaimers:

1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact.

2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated, or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization.

3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product.

4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice, or medical advice.

5. This does not create an attorney-client relationship.

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If you have ever wondered what government affairs executives do and how they affect the practice of pharmacy then you’ll want to spend 35 minutes listening to this episode. Mark Kinney, a pharmacist, has more spent more than 30 years meeting with elected officials and other influential officials to help them better understand the complex and important role pharmacy owners play in our society. And, as you’ll learn in this podcast, government affairs work goes far beyond PBM and DIR fee battles.  

 

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Episode Description:

On this episode, Dr. Jeffrey Shaman, Chief Science Officer at Coriell Life Sciences, and I discuss the importance of population health level pharmacogenomics versus one time pharmacogenomics tests and how clinical decision support software that integrates pharmacogenomics data into patients’ medication therapy management is a key tool to optimize population health level pharmacogenomics programs.

References:

1. Real-World Impact of a Pharmacogenomics-Enriched Comprehensive Medication Management Program https://www.mdpi.com/2075-4426/12/3/421

2. Idiopathic Symptoms Resolved by Pharmacogenomics-Enriched Comprehensive Medication Management: A Case Report https://www.cureus.com/articles/81096-idiopathic-symptoms-resolved-by-pharmacogenomics-enriched-comprehensive-medication-management-a-case-report

3. Consequences of CYP2D6 Copy-Number Variation for Pharmacogenomics in Psychiatry https://www.coriell.com/resources/consequences-of-cyp2d6-copy-number-variation-for-pharmacogenomics-in-psychiatry/

4. The Coriell personalized medicine collaborative pharmacogenomics appraisal, evidence scoring and interpretation system https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978656/

5. ASP Establishes March 24th as National Adverse Drug Event Awareness Day https://www.stopadr.org/blog/asp-establishes-march-24-as-national-adverse-drug-event-awareness-day-launches-awareness-campaign

Guest’s Bio:

Jeffrey A. Shaman, PhD, MS, is the Chief Science Officer at Coriell Life Sciences (CLS), an international leader in precision medicine. Leveraging extensive experience in genetics and pharmacology, he is a leading expert in the rapidly evolving field of pharmacogenomics (PGx), the study of how an individual’s DNA impacts his or her response to medication. Most importantly, Dr. Shaman plays a critical role in bridging the gap between genetic science and clinical application. This includes translating decades of cutting-edge genetic research into actionable insights on the safest and most effective medications for individuals based on their unique DNA and dozens of other factors.

Driven to advance public health, Dr. Shaman is focused on enabling the delivery of personalized medicine at scale and empowering the most precise medical care worldwide. He consults with large employers, public and private payer organizations, healthcare systems, academic institutions, and laboratories around the globe, advising them on how to eliminate trial-and-error prescribing, improve population health, and control rising healthcare costs

Dr. Shaman is dedicated to setting the industry standard for PGx and pioneering new advancements in the field. Along with his team, he actively researches and presents findings in top peer-reviewed journals and at leading industry events. He is an active member of the Clinical Pharmacogenetics Implementation Consortium (CPIC), Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community, Personalized Medicine Coalition (PMC), Pharmacogenomics Global Research Network (PGRN), and other organizations.

Dr. Shaman holds a doctoral degree from The Johns Hopkins University School of Medicine in Pharmacology and Molecular Sciences, where his research centered on DNA, epigenetics, and nuclear structure and function. He earned his Master of Science degree from The University of Medicine and Dentistry of New Jersey in Cell & Developmental Biology. Dr. Shaman held a faculty position at the University of Hawai‘i Institute of Biogenesis Research before serving a fellowship at Harvard Medical School and implementing a translational research program at Beth Israel Deaconess Medical Center and the Bedford Stem Cell Research Foundation.

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The unethical business practices by PBMs when it comes to our nation's seniors run the gamut from unreasonable fees and metrics to underhanded pricing models and what could easily be considered larceny against taxpayers. Join PUTTcast co-hosts Monique Whitney and Lauren Young, with special guests Tim Hamrick and Greg Reybold of APCI to discuss the results of their explosive 3Axis study, possible outcomes of the proposed CMS rule change, and why moving prescription drug plans to a NADAC pricing model is so important for lowering costs and increasing transparency.

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Dave Teckman, Executive Chairman at ActiveRADAR joins the PBM Reform Podcast series about the impact of therapeutic interchange technologies on PBM pricing & the powerful data at the pharmacist's fingertips with ActiveRADAR.

Through rigorous clinical evaluation of all drugs in over 112 therapeutic categories, ActiveRADAR first establishes which drugs are clinically equivalent and therefore therapeutic alternatives to one another. This creates our Clinical Catalog of over 26,000+ therapeutically equivalent “perfect pairs”. Then ActiveRADAR determines the economic value using plan specific data to value each drug within its respective therapeutic class and sets pricing and reimbursement accordingly. This type of program has historically been called “reference pricing”, however ActiveRADAR takes it a step further by establishing both THE CLINICAL AND ECONOMIC VALUE OF EACH AND EVERY DRUG IN EACH THERAPEUTIC DRUG CLASS.

About ActiveRadar:

ActiveRADAR, formerly RxTE Health, is a healthcare analytics and patient education company providing unique data-driven, cost-saving customized prescription options. Using proprietary technology, ActiveRADAR identifies the lowest cost prescription options.

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PDS is 100% focused on equipping independent pharmacy owners with the skills they need to make their life better and their business more valuable. Each year, PDS hosts the leading independent pharmacy business conference, The PDS Super-Conference has thousands of pharmacy owners attend to discover what’s hot and what’s working right now in the industry. The Pharmacy Podcast Network was a proud media partner of the PDS 2022 Event.

Special Guests:

Jennifer Diehl, CPA, CPC, DBA

PDS | Business Coach

Drew Hegi, MBA

Loan Officer Pharmacy Owner [email protected]

Jon Allman and Mike Wilhoit

Mac's Pharmacy | Hometown Pharmacies in Tennessee

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What do Mexico, drugs, society, the Bible, and whiskey have in common? Join us on this episode of the PAIN POD, as Mark “Pain Guy” Garofoli chats with Sam Quinones, author of “Dreamland” and “The Least of Us”, with the later having just released in October 2021. It’s often hard to see the forest within the trees, but Sam clears the fog for all of us to whittle it down on how to provide patient care for those in pain and/or with addiction. Come one, come all, to the Pain Pod!!!

Sam Quinones

https://samquinones.com/

Drug/Overdose Trends

https://www.drugabuse.gov/drug-topics/trends-statistics/overdose-death-rates

https://www.iqvia.com/insights/the-iqvia-institute/reports/prescription-opioid-trends-in-the-united-states

FreeCE Substances of Abuse Specialty Pharmacist (SASP) Certificate

https://www.freece.com/Programs/SeriesCertification/ab66a419-b5e5-458b-9494-0acb6af1be92

CDC Opioid Guideline Updated Draft for Public Comment

https://www.regulations.gov/docket/CDC-2022-0024/document

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What will Cost Plus Drugs mean for your pharmacy? What New Challenges does it bring and what opportunities does it present? And then what do you do about it? Join us for a discussion on the impact of of Cost Plus Drugs on retail pharmacy with Hartig Drug CEO Charlie Hartig.

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Learn how the University of Maryland Medical Center reversed its reliance on 503B vendors through an IV robotics insourcing program for compounded sterile products (CSPs). The result is a strategic services operation delivering advanced CSP services across its organization, resulting in improved safety, increased efficiencies, and significant cost savings

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PDS is 100% focused on equipping independent pharmacy owners with the skills they need to make their life better and their business more valuable. Each year, PDS hosts the leading independent pharmacy business conference, The PDS Super-Conference has thousands of pharmacy owners attend to discover what’s hot and what’s working right now in the industry. The Pharmacy Podcast Network was a proud media partner of the PDS 2022 Event.

In this episode:

Marci Strauss PharmD, Tom Wheelwright, CPA, Nina Klemm, and Patrick Lott

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