When we were little, one of our dreams was to become an astronaut. Now little girls everywhere have additional real life examples of women living that dream with the first all-female spacewalk.

American astronauts Jessica Meir and Christina Koch made history with their repair of a broken battery unit on the International Space Station. It has us thinking, will a woman be the first human to step foot on Mars? Bringing women in STEM to new heights.

Back here on Earth, STEM leaders are making news in other ways.


THE WEEK THAT WAS

Monday

Your teenager may no longer need to press that snooze button! At least in California. A first-in-the-nation law in bars high schools from beginning class before 8:30 a.m., and middle schools before 8:00 a.m. Supporters of later start times claim teenagers, and their still-developing brains, need extra sleep time, ideally 8-10 hours. (Can we get a later start time, too?)

Tuesday

Consumer genetics company Ancestry is getting into the healthcare space, but unlike rival 23andMe, which offers a similar product, AncestryHealth products will need to be ordered by a physician. Some argue that physician orders is a creative way for AncestryHealth to avoid regulatory oversight from the FDA, which 23andMe is subject to. Instead, it will be regulated by CMS under rules for physician-ordered diagnostics.

Wednesday

Gene therapy stocks could be boom or bust according to a note issued by analysts at Evercore ISI. Despite beating out the Nasdaq Biotech Index earlier this year, GTRx stocks have recently faced strong headwinds. Several stocks have underperformed due to regulatory and safety setbacks, a sensitive political landscape and commercial launch challenges. New technologies are often high risk/high reward, but with hundreds of gene therapy INDs being considered by the FDA, hopefully, these early pioneers will smooth out the kinks.

Thursday

Fitbit announced it is partnering with Bristol-Myers Squib-Pfizer Alliance to facilitate earlier detection of AFib for patients at an increased risk of stroke using the wearable technology. The move puts Fitbit squarely against the Apple Watch and shows how wearable devices are integrating further into the healthcare ecosystem. 

Friday

A new Kaiser Family Foundation analysis found that list prices for some of the top drugs paid for by Medicare Part D implemented price increases many times greater than the rate of inflation. The data, which was pulled from 2016-2017, could influence Congressional proposals looking to put reporting -- and even penalties -- in place surrounding price increases. However, other reports have indicated drug price increases have moderated in more recent years.  


What's (not) cooking: Biotech sector investment 

By Eric Laub

Barron's recently gathered professional investors and market strategists who expressed genuine exuberance for the innovation and prospects of the life science industry and what it may mean for patients. Yet, with excitement comes much debate about the recent perils of investing in the biotech sector.

Biotechnology market action has been tepid and there’s been a 25% slide in the NASDAQ Biotech index from its 2015 peak. This pessimism has been driven by:

  • Looming political uncertainty
  • Difficult pricing environment
  • Regulatory challenges


Our Take:

We are in unprecedented times, as our quest for finding the next biotech unicorns often tests the boundaries of antiquated financial models. We have a generally supportive FDA, especially for rare and orphan diseases, and a new generation of entrepreneurs and VC investors will to advance new medicinal approaches such as gene and cell-based therapies. But, as the next generation of “miracle medicines” emerges, the underlying question that will continue to drive investor interest in the sector: is there long-term value for my investment and will I be rewarded for my patience during the sometimes lengthy R&D process?

Bottom Line:

Barron’s reporting, while a tad gloomy, underscored why we feel so passionately about the potential of biopharma innovation and have faith that it will fulfill its promise. As our industry faces significant perception challenges, it will continue to be the innovations in science that attract new investors and help drive cutting-edge treatments for patients who need them most.

Pulse on Pricing: Advancing Amendment 

By Paul Tyahla

This week the House Energy and Commerce Committee advanced H.R. 3, the Lower Drug Costs Now Act. It is now expected to pass the full House of Representatives as soon as this month. The bill’s likelihood of becoming law is very low, but it will drive a significant amount of media coverage.  

The legislation would make several changes, and as the bill advances, the pressure is to make it more aggressive toward the industry, including:

  • Direct negotiation. Requiring the federal government to directly negotiate with manufacturers over the price of up to 250 prescription drugs per year.
  • Average International Market (AIM) price. Directing that the Department of HHS to will limit the price for drugs that do not have competition marketplace competition to be no more than 20 percent higher than the price paid by other countries with advanced economies.


The Congressional Budget Office estimates the bill would reduce Medicare spending by $345 billion - about 25% of its prescription drug program – if fully implemented.

What it means:

It is unlikely that the legislation, in its current form, will become law. The Senate Majority Leader has said the Senate would not consider this version of the bill. Instead, the bill and its core tenets – including Medicare negotiations and the differences between US and ex-US prices – will be news drivers and election topics during the next 12 months. In 2018, drug prices were the third most-common discussion point in the hundreds of thousands of campaign TV ads that aired. A similar volume is possible next year.

Life science companies need to be prepared to discuss their positions on the various components of the bill – and be prepared for a storm of scrutiny to continue.

We’re continuing to monitor the situation so stay tuned!

Who wrote this? The managing editor of TWTW is Randi Kahn, who got assistance for this week’s edition from her cat, Tabitha (among many others), who seemed to greatly enjoy lying on her warm computer. Happiness is a warm kitty, too, Charlie Brown. Syneos Health Communications' Reputation & Risk Management Practice is a team of healthcare communications consultants, policy-shapers and crisis response specialists. We provide unique solutions to the evolving communications challenges in today’s healthcare industry, using evidence-based approaches to help our clients successfully navigate the most sensitive of situations.

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Image credits: sun by Juan Pablo Bravo from the Noun Project, DNA by Lloyd Humphreys from the Noun Project, Stock by Nathan Rofkahr from the Noun Project, Fitbit Flex by Richard Slater from the Noun Project, price by designvector from the Noun Project, dollar sign by Alfredo @ IconsAlfredo.com from the Noun Project, Congress by MRFA from the Noun Project

And now please enjoy this disclaimer that prevents our team from getting in a heap of trouble: This report may contain links to external or third party websites. These links are provided solely for your convenience. Links taken to other sites are done so at your own risk and Syneos Health accepts no liability for any linked sites or their content. Syneos Health makes no warranties or representations, express or implied about such linked websites, the third parties they are owned and operated by, the information contained on them or the suitability or quality of any of their products or services. Syneos Health does not authorize the infringement of any intellectual property rights contained in material offered through these linked sites. Please refer to the use agreement and/or copyright statements of any external site you visit, or the terms and conditions of any externally provided web site for instructions, restrictions, and guidelines. If you have a question, please contact the webmaster of the external site.

About the Author:

Randi Kahn is a Senior Media & Content Director in our Reputation & Risk Management Practice, where she helps clients build and protect their brand reputations through executive thought leadership, public affairs, and issues preparation and response. She has worked for clients throughout the healthcare ecosystem including payers, providers, patient groups and pharma.