Navigating the challenge of covering breakthrough therapies at MedCity INVEST Precision Medicine

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Our virtual MedCity INVEST Precision Medicine conference, December 9-11, will highlight aspects of precision medicine from the biopharma companies developing cell and gene therapies to diagnostics and the data sharing initiatives to support precision and personalized medicine.

One vexing part of any conversation on precision medicine and breakthrough therapies that have been developed and are continuing to work their way through clinical trials for cancer to rare disease is how to address the practical challenge of their high price tags. Although there are several models to cover the cost of these therapies such as Cigna’s Embarc Benefit Protection program, what happens when someone changes insurers when they change their job? What is fair for patients and what’s fair for companies? When do these conversations even start?

The panel, Reimbursement Models for Cell and Gene Therapies, will highlight some of the pros and cons of different models that are coming to market. Panelists include Laura Okpala, Director, Reimbursement Policy, Gilead Sciences, and Mark Trusheim, Strategic Director, NEWDIGS initiative at the MIT Center for Biomedical Innovation.

Here’s a preview of some of the sessions. Click here to see the agenda.

Interoperability Progress Report

How far have we progressed with sharing patient medical records? Patient data is key in unlocking riddles of medical science but interoperability is necessary to facilitate this. What companies are making an impact on a regional and national scale? What milestones are on the horizon? What obstacles continue to vex further advancement? How can we make medical records more accessible to patients?

Moderator: Elise Reuter, Senior Reporter, MedCity News
Speakers:
Kevin Chaney, Senior Program Manager, Office of the National Coordinator for Health IT
Ida Sim, M.D., Ph.D., Professor of Medicine, University of California, San Francisco
Niko Skievaski, Co-Founder and President, Redox

What It Takes To Build A Successful, Regional BioInnovation Hub
Philadelphia is one of many cities seeking to support the continued growth of cell and gene therapy and connected health industries. What do cities need to do to address education, training and other needs to support these sectors? This session will be held as part of Venture Cafe Philadelphia.

(sponsored by IBX)

Lisa Dalton, Chief People Officer, Spark Therapeutics
Audrey Greenberg, Executive Managing Director, The Discovery Labs
Tiffany Wilson, President & CEO, University City Science Center

Moderator: Michelle Histand, Director of Innovation, Independence Blue Cross

Register now and be part of the conversation at INVEST Precision Medicine.

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First-Ever Treatment Shown to Reverse Alzheimer’s Earns NeuroEM Therapeutics FDA Breakthrough Device Status

The FDA is expediting a revolutionary clinical-stage head device to beat back Alzheimer’s disease at home

NeuroEM Therapeutics is poised to deliver a knockout blow to Alzheimer’s disease. The clinical-stage medical device company is pleased to announce FDA Breakthrough Device designation for its bioengineered head device shown to reverse Alzheimer’s memory loss in its pilot study, published last fall in the Journal of Alzheimer’s Disease.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201028005376/en/

Woman pictured wearing NeuroEM Therapeutics’ bioengineered MemorEM™ cap and arm control box. This revolutionary head device has earned FDA Breakthrough Device designation, having demonstrated in a pilot study that it can reverse Alzheimer’s disease. This woman’s participation in the study resulted in her regaining the equivalent of 12 months of memory. (Photo: Business Wire)

“No other drug or device has received this highest FDA designation to accelerate a treatment for Alzheimer’s disease,” said Dr. Robert Matthews, PhD, CEO of NeuroEM Therapeutics. “No other treatment has demonstrated the clinical results we have thus far, to not only slow but in fact reverse the progressive, debilitating loss of memory caused by this devastating brain disease.”

The FDA has given Breakthrough status to over 300 devices and over 100 drugs, but none to a therapeutic for Alzheimer’s disease – until now. NeuroEM’s head device (MemorEMTM) is the first-ever Alzheimer’s treatment (device or drug) to receive FDA Breakthrough status. The FDA program is designed to expedite the development and review process of new technology for patients with life-threatening or irreversibly debilitating conditions, such as Alzheimer’s Disease.

  • NeuroEM’s novel, proprietary technology, called Transcranial Electromagnetic Treatment (TEMT), achieves what other treatments for AD have not. In fact, no other therapy comes close to MemorEM’s remarkable results, made possible by its unique modes of action.

  • In just two months of daily use, the MemorEM restored on average the equivalent of 12 months of memory for 7 of 8 participants in its pilot study, none of whom experienced adverse side effects.

  • Treatment is easy, comfortable and safe. A patient wears what appears to be a simple cap that belies the complex biomedical engineering within it. The device is worn twice a day in home for an hour at a time, and its design allows the patient to move around home as usual.

NeuroEM has pioneered TEMT to successfully penetrate the skull to reach vital nerve cells in the brain called neurons. NeuroEM’s revolutionary TEMT technology works by breaking up small aggregates (oligomers) of two toxic proteins, called β-amyloid and tau, that are made inside the brain’s neurons during the Alzheimer’s disease process. These two toxic oligomers appear to be the root cause of Alzheimer’s disease by wreaking havoc on vital functions within neurons – especially in brain areas involved in memory. The electromagnetic waves emanating from multiple emitters within NeuroEM’s MemorEM head device easily penetrate the human brain and gently disassociate the toxic oligomers inside neurons resulting in a reversal of Alzheimer’s memory impairment in key

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