Week of May 22, 2023

This week we look at how artificial intelligence is revolutionizing voice banking for patients with conditions like amyotrophic lateral sclerosis, also known as ALS. In addition, we highlight proposed prescription drug transparency in Medicaid and how the Food and Drug Administration has changed its approach to granting pediatric exclusivity. Finally, we feature research that looks at how oxygen deprivation boosts longevity in mice, plus a paralyzed man achieves mobility with brain and spine implants.

Each week we highlight five things affecting the life sciences industry. Here’s the latest.

Voice Keeper, a company using AI, is offering voice banking services to individuals with conditions like ALS, throat cancer, cerebral palsy and Parkinson’s disease. Voice banking has become more accessible because of AI advancements, making it easier and more affordable for patients to retain their voices. Patients report that having a computer-generated voice that resembles their own provides them with confidence and a stronger connection to the world. The use of AI in voice banking has revolutionized the process, as it quickly analyzes speech samples and creates digital voices that mimic pitch, tone, resonance and accent. This technology has made voice banking more affordable, with costs ranging from $300 to $999. However, the lack of standardized phrases and limited language options remain challenges in the industry.

The Biden administration has announced a proposal to enhance prescription drug transparency in Medicaid aiming to lower costs and save money for both states and the federal government. The Department of Health and Human Services, through the Centers for Medicare and Medicaid Services (CMS), is introducing measures to reduce prescription drug costs in Medicaid, building on President Biden’s executive order. The proposed rule would increase transparency by revealing the actual cost of drugs covered by Medicaid and holding drug manufacturers accountable for pricing. Additionally, the rule would improve transparency in managed care plans and address concerns regarding pricing arrangements. It would also focus on preventing the misclassification of drugs as brand name or generic to ensure appropriate rebates for states. CMS is inviting public comment on the proposal until July 25.

The FDA is changing its approach to granting exclusivity periods to pharmaceutical sponsors for conducting pediatric studies on new drugs. Previously, the FDA would provide exclusivity based on studies required under the Pediatric Research Equity Act (PREA). However, in a new draft guidance, the agency states that exclusivity will now be granted only to sponsors that conduct additional pediatric studies that have the potential to produce health benefits in children, beyond what PREA mandates. The FDA cites data showing that studies required under PREA have been successfully completed and have resulted in increased pediatric labeling. Additionally, the FDA published another draft guidance on PREA and the Best Pharmaceuticals for Children Act, clarifying the scope of studies requested under each and providing considerations on pediatric data, extrapolation and timing of studies.

Harvard Medical School scientists determined that a strain of mice born with abnormally short life spans lived 50% longer than expected when put in an environment with low oxygen roughly equivalent to Mount Everest’s base camp. The study provides the first demonstration that oxygen restriction could extend life span in a mouse model of aging. Prior studies have suggested that oxygen restriction can also extend life span in a variety of models, including fruit flies, worms and yeast. However, this was the first time that this theory was tested in the context of live mammals. In addition to a longer life span than expected, the mice also preserved neurologic function longer, as measured by performance on a standard test of coordination and strength.

A 40-year-old man who has been paralyzed in his legs for 12 years due to a spinal cord injury has achieved the ability to climb stairs, move over ramps and switch from standing to walking with the help of brain and spinal cord implants. The implants, paired with external devices, translate his thoughts into movement. The technology shows promise in maximizing the existing hardware in the nervous system and may reactivate dormant pathways. While the system is less cumbersome than exoskeleton devices, further development is needed to improve speed and determine its effectiveness for individuals with more severe paralysis. Commercial availability of the technology is estimated to be in four to seven years, pending regulatory approval. Training for clinicians would be necessary to use the technology effectively.

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