February 2019 - Bionest

25

Feb 2019

Bionest

Artificial Intelligence and Image-Based Diagnostic Tools

We have recently been hearing much about “machine learning” and “artificial intelligence” (A.I.). While many tend to use the two terms almost interchangeably, there is a distinct difference between the two. Machine learning, also known as “deep learning,” is a field of applied mathematics that uses algorithms and statistical models to build predictive systems...

18

Feb 2019

Bionest

One-and-Done Pricing Challenges

As more gene and cell therapies come to market, a big challenge facing both drug developers and payers is designing and instituting appropriate pricing models for these one-time, potentially curative treatments. Innovation should be rewarded, and a curative — or at least, very long-lasting — treatment is likely to save significant dollars in the typical...

12

Feb 2019

Bionest

Drug Pricing: A Key Political Issue for 2019?

Drug pricing is clearly going to be one of the major topics of discussion — and a key political issue — in 2019. Drug makers began the New Year with price increases in the United States on more than 250 prescription drugs. In response, House Democrats, led by the Chairman of the House Oversight Committee,...

4

Feb 2019

Bionest

FDA and Direct-to-Consumer Genetics Testing

When 23andMe launched its first genetic test to the consumer market in 2013, the U.S. Food and Drug Administration (FDA) quickly ordered the company to stop marketing the test without necessary approvals as a medical device, citing the potential for harm to patients who change medication doses or have unnecessary surgeries based on test results....