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Facilitating Clinical Trials

clinical trials

Facilitating Clinical Trials

On this episode I caught up with Josh Mann, Co-founder/President of a non-profit organization, shareforcures.com, a digital platform that is facilitating clinical trials.  The platform accomplishes this by creating a database that enables individuals to contribute various aspects of their personal health data that can be utilized by clinical trials.

We know securing test participants is one of the greatest challenges and sources of cost for clinical trials.  So to have resources such as this becoming available should help tackle that problem as more and more patients and individuals populate the database with ever more information.

Data can come from wearable tech such as FitBits, Apple Watch, and others, as well as diagnostic equipment like glucometers, blood pressure, and even electronic medical records.  The individuals contributing data have the ability to make as much or as little of their information accessible by clinical trials.  And when it is utilized, it is possible to de-identify the individual to protect their privacy.

Josh talked about the fact that currently, most clinical trials end up with participants who as a group are often not truly representative of the patients who will be utilizing a medicine or device.  The reason for this stems from the fact that typically, patients taking multiple medications are often not included, along with patients who have multiple diseases, or other factors that can contribute to effectiveness of a drug or treatment regimen.

Josh will be participating in the discussions at the Health Connect South event September 21, 2016 at the Georgia Aquarium, talking about the role of big data in healthcare and how its evolution and integration will impact patient outcomes and clinical trials.  Be sure to use the promo code “RadioX” when you go to register for the event.  And make sure your contacts know about our promotion for Radio X listeners!

 

Transition To Value-Based Healthcare

value-based

Sidney Welch, Tiff Wilson

Transition To Value-Based Healthcare

Recent changes in law have necessitated a transition to value-based healthcare delivery model, moving away from a volume-focused, treat-when-diagnosed approach to a pro-active, preventive “wellness” initiatives.

Sidney Welch works with clients to best position them in the explosion of heath care change. Focusing on operational, transactional, regulatory, administrative, and litigation matters nationally, Sidney works with clients to structure transactions and respond to compliance issues associated with federal and state health care laws and regulations. She is known for her work with specialty physician practices and health care technology companies across the country, and provides strategic counsel to clients regarding innovations in health care. See more.

Tiffany Wilson joined the Global Center for Medical Innovation (GCMI) in 2011 during its startup phase, directing business development activities, building strategic relationships and bringing together core members of the medical device ecosystem. She was quickly promoted to Executive Director, leading all strategic direction and day-to-day operations of the center. Her strong background in medical devices, commitment to fostering innovation and understanding of business strategies have propelled Wilson into a leadership role in the Southeast and brought her into the national spotlight. Full bio

We talked about the transition to value-based healthcare and its impacts on all parties involved, patient, payor, hospital, and physician, and how this transition affects some of the top disease states such as heart disease, diabetes, obesity, and others.

Tiff shared the news of GCMI’s recent merger with T3 Labs, bringing the lifecycle of tech innovation R&D/commercialization ecosystem and user training under one organization to capitalize on efficiencies, communication, and more.

Special Guests:

Sidney Welch, Healthcare Innovation Practice Lead, Polsinelli

 

Tiff Wilson, Executive Director, GCMI- the Global Center for Medical Innovation

Precision Medicine

precision medicine

Dr. Dan Roden

precision medicine

Damon Hostin

Precision Medicine

On this week’s episode I talked with two healthcare leaders who are experts in precision medicine.  One, Dr. Dan Roden, is one of the leading researchers on pharmacogenomic testing and its impact on patient outcomes at Vanderbilt University.  His work, along with colleagues at Vanderbilt and nationally, is contributing to the growing body of evidence supporting the value of personalized care.  The other was Damon Hostin, Administrative Vice President, Precision Medicine, at Catholic Health Initiatives, an organization that is an early adopter among health care systems putting precision medicine into action in their hospitals.  Their two perspectives give insight into the “Why’s” and “How’s” of implementing precision medicine within our healthcare delivery model.

After obtaining his MD and completing internship, Dr. Dan Roden went to Vanderbilt where he trained in Clinical Pharmacology and Cardiology, and has been a faculty member there since. His initial career focus – that he has maintained – was studies of the clinical, genetic, cellular, and molecular basis of arrhythmia susceptibility and variability responses to arrhythmia therapies.

Over the last 10 years, Dr. Roden has led Vanderbilt’s broader efforts in pharmacogenomics discovery and implementation.  He is principal investigator for the Vanderbilt sites of the National Institutes of Health’s Pharmacogenomics Research Network (PGRN) and the National Human Genome Research Institute’s Electronic Medical Records and Genomics (eMERGE) Network. He directs the Vanderbilt DNA databank BioVU, a discovery resource that as of spring 2014 included >175,000 samples linked to deidentified electronic medical records.  He is a leader in Vanderbilt’s PREDICT project that since 2010 has been preemptively embedded pharmacogenomic variant data in the electronic medical records of >14,000 Vanderbilt patients; as of April 2013, PREDICT displays information on 5 drug-gene pairs and delivers point of care decision support when a target drug is prescribed to patients with variant genotypes.

Prior to joining Catholic Health Initiatives, Damon was a clinical business lead for Complete Genomics and Strategic Diagnostics. Earlier, Mr. Hostin served as VP of Scientific Operations for GenVis Labs, a genetic diagnostic company purchased by Pfizer in 2008.  At Actinium Pharmaceuticals, Hostin managed alliances and licensing for the development of oncology therapeutic  candidates.  Earlier he served as Team Leader of Sequencing, at Celera Genomics- where he was co-published on the Human and Drosophila genome papers in Science as well as contributed to the launch of the commercial genomic database.  Mr. Hostin’s education includes undergraduate studies at Tulane University; Master’s studies at Harvard University; and certificate programs at The Institute for Genomic Research, the NIH, and Wharton.

In its discussion of the Precision Medicine Initiative Cohort Program, the National Institute of Health states, “Far too many diseases do not have a proven means of prevention or effective treatments. We must gain better insights into the biological, environmental, and behavioral influences on these diseases to make a difference for the millions of Americans who suffer from them. Precision medicine is an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person. While some advances in precision medicine have been made, the practice is not currently in use for most diseases.

That’s why on January 20, 2015, President Obama announced the Precision Medicine Initiative® (PMI) (link is external) in his State of the Union address. Through advances in research, technology and policies that empower patients, the PMI will enable a new era of medicine in which researchers, providers and patients work together to develop individualized care.

The President called for $215 million in fiscal year 2016 to support the Initiative, which includes several components with efforts from across the federal government. Of this total proposed budget, $130 million was allocated to NIH to build a national, large-scale research participant group, called a cohort, and $70 million was allocated to the National Cancer Institute to lead efforts in cancer genomics as part of PMI for Oncology.

Special Guests:

Dr. Dan Roden, MD, Professor of Medicine and Pharmacology, Assistant Vice Chancellor for Personalized Medicine, Vanderbilt University Pinterest LOGO  twitter_logo_small  linkedin_small1  youtube-logo1  facebook_logo_small3  flickr (2)  tumblr logo

Damon Hostin, Administrative Vice President, Precision Medicine, Catholic Health Initiatives   facebook_logo_small3  youtube-logo1  twitter_logo_small  linkedin_small1

 

UCB on Epilepsy and Collaboration

epilepsy

Chris Clark of UCB

epilepsy

Russ Lipari, Founder, Health Connect South

UCB on Epilepsy and Collaboration

On this week’s episode I hosted CEO/Founder of Health Connect South, Russ Lipari, and Chris Clark, Portfolio Strategy and Intelligence, Epilepsy at UCB, a pharmaceutical research and development company with a US location in Smyrna, GA.  It’s been three years since I first met Russ when he joined me as a guest on the Top Docs Radio show to talk about Health Connect South and its genesis as a platform for collaboration among healthcare organizations in the region.

At the time, it was thought the primary approach to fostering introductions and the partnerships/collaborations that would follow would be via meeting events throughout the year.  Over time, the platform has grown to include the weekly Health Connect South Radio show, regional educational events with subject matter experts, and a developing digital environment that will provide another means for organizations to share what they are doing, talk about resources they need, and potentially link up with partners that can meet them.

The primary needs of Health Connect South has relating to resources are funding and health care experts who are willing to support the initiative by making themselves available as thought leaders who can share information that will promote advances in healthcare outcomes for our communities.  Historically, HCS has been funded primarily through event attendance fees.  In order to insure sustainability and growth of this useful healthcare platform, the organization is actively seeking financial benefactors who will provide endowments or other ongoing funding beyond what is achieved through HCS events.

The 2016 Health Connect South event is fast-approaching—September 21, at the Georgia Aquarium’s conference facility.  This year’s focus will be featuring health leaders talking about how they are working to tackle the World Health Organization’s Top 10 Disease States affecting large populations around the globe.  Listeners of the show can take advantage of the promo code: RadioX and receive a discount on their registration fee.

Russ shared how UCB has been one of the first partners in making Health Connect South become a reality and they continue to do so today.  Chris explained the work UCB is doing to develop medications to address a number of challenging health problems, particularly neurologic and immunologic ones such as epilepsy and rheumatoid arthritis.

More info soon!