New Report Series Launched on The State of Innovation in Highly Prevalent Chronic Diseases

BIO’s Industry Analysis team has released its first report in a new series on the state of innovation in highly prevalent chronic diseases.

The new series of reports will dig deeper into a previously observed phenomenon: less venture dollars are heading into chronic diseases. BIO’s previous research showed recent increases in venture funding heading into oncology and rare disease, leaving highly prevalent, chronic disease behind. Disease area examples include psychiatric disorders, endocrine, cardiovascular, and respiratory diseases as shown in the figure below.

ding vs. US Venture Funding

Figure 1. Annual costs vs. a decade of venture capital funding (2007-2016) for Oncology, and other highly prevalent, chronic diseases. [Source for prevalence: Psychiatric Source for healthcare cost: Health Affairs, 35, No. 6 (2016). Source of venture data: BIO Industry Analysis, Emerging Company Trend Report, 2017.]

The persistence of this trend could have implications for the future output of innovative medicines in these disease areas. The cause for concern is magnified by the impact these chronic disease areas are having on the overall healthcare system (as shown in $ Billions in the figure above).

Depression, the first in a series of reports on the current funding and R&D landscape of highly prevalent, chronic diseases, takes an in-depth look at the state of innovation in depression therapeutics. As one of the most prevalent psychiatric disorders, depression impacts 16 million patients in the United States and is estimated to cost our health care system $105 billion annually.

The report is available for download here, where you can also sign up to receive future BIO Industry Analysis reports as they are released.

Key Takeaways

  • There is a significant unmet need for new therapies for the treatment of depression. Only 29 active substances have been approved for major depression since 1959, and work on a single hypothesis.
  • Promising new therapeutic approaches, based on unique molecular targets discovered in the 1990s and early 2000s, have experienced a significant number of setbacks. Currently, there are now only 33 drug programs in clinical trials utilizing new approaches for major depression.
  • Clinical trial initiations for new therapeutics are down 50% over the last decade, and drug candidates for new clinical studies are nearly non-existent.
  • Venture investment in companies focused on depression is at record low levels.

The next report in the series will focus on pain and addiction. Opioids will be covered in the report and a special session on the opioid epidemic will be featured at the BIO CEO & Investor Conference next month, February 12-13 in New York City. month, February 12-13, in New York City. The session will explore the most promising avenues in the neuroscience of addiction and alternatives to opioid-based pain management, as well as identify the most pressing bottlenecks in our understanding of the brain’s addiction to painkillers. Register today!

Portola Pharmaceuticals, Inc. (PTLA) Standout Insider Ownership of 0.53%- Puma Biotechnology …

Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) have diverse level of ownership with Puma Biotechnology, Inc. (NASDAQ:PBYI). The circumstantial evidence specially high/lower types of ownership has a vital gauge for investing research process and it should be done carefully, as rather than offering …

New Infographic Highlights the Remarkable Success of Medicare Part D

Since 2006, the Medicare prescription drug program – known as Medicare Part D – has provided America’s seniors and disabled individuals with access to a wide range of affordable medicines. By relying on market-based competition, this program has achieved substantial savings for taxpayers and helped provide affordable medicines to our most vulnerable population.

To learn more about the success of the Medicare Part D program, check out our new infographic: click here.

Jozy Altidore Claps Back at Trump: This ‘Shithole’s’ Living the Dream!

“Three shithole dudes just living the dream.”  That’s how Team U.S.A. soccer stud Jozy Altidore captioned his Instagram pic with Usain Bolt and P.K. Subban this weekend in the wake of Donald Trump’s comments.  The 3 superstars…

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Tip for Leveling Wood Patio Furniture – Today’s Homeowner

Tip for Leveling Wood Patio Furniture

Here’s a tip to address two common problems with wood patio furniture: the tendency to rot from sitting on wet concrete, and to wobble from sitting on an uneven slab.

If You’ve Had Chickenpox, Shingles Vaccine is Worth a Shot

If you’re an adult living in the United States, there’s a 95-percent change you’ve had chickenpox. Unfortunately, as we age, we run the risk of reactivating that virus, varicella zoster, in the form of shingles.

If you contract the chickenpox virus, you will carry it for the rest of your life. It can be considered an infectious disease time bomb. For most, the virus stays dormant, remaining silent in the nervous system. However, introduce stress, a weakened immune system or the vagaries of the normal aging processes, and the virus can reactivate years later as shingles. A third of us will contract shingles in our lifetimes.

Shingles manifests as a painful rash that develops on one side of the face or body, which usually clears up within 2 to 4 weeks. Those who have suffered from shingles can tell you the pain ranges from mild to debilitating. Those who experience extreme bouts often describe the pain as the most intense of their lives. The disease can also threaten vision and cause nerve damage which can linger for months or years, long after the initial shingles rash is gone. Very rarely, shingles can lead to pneumonia, hearing problems, blindness, brain inflammation or even death.

In yet another milestone for biotechnology, the U.S. Food and Drug Administration gave the green light last fall to a new shingles vaccine called Shingrix. The vaccine is more than 90 percent effective in preventing shingles for adults 50 and older.

The U.S. Centers for Disease Control and Prevention (CDC) reports that the number of shingles cases continues to rise. Half of all shingles cases occur in people over 60. However, fewer than one-third of people over 60 have been vaccinated for shingles, according to the CDC. Most people who get shingles will have it just once, but it’s possible to get it a second and even a third time.  As we age, we become more likely to develop long-term, severe pain as a complication of shingles. There is no treatment or cure from this pain.

One million people get shingles every year. Shingrix – a two-shot regimen – can spare people a lifetime of needless anguish. So can an earlier shingles vaccine called Zostavax, a single-shot inoculation effective in more than half of those who receive it.

There is hope that the next generation of Americans will be less susceptible to shingles. In 1996, the CDC recommended universal varicella vaccination against chickenpox for healthy 1-year-olds. Doctors believe that children who receive the chickenpox vaccination will be at a much lower risk of getting shingles as they grow older. However, kids vaccinated for chickenpox in 1996 are only 21 or 22 now, so doctors can’t say for sure what will happen when they’re 50. Researchers believe if they do contract shingles, it is more likely to be a milder case.

The new shingles vaccine contains an adjuvant, a substance that boosts the immune system’s response. In October, the CDC’s Advisory Committee on Immunization Practices endorsed Shingrix for adults over 50. Once the CDC director endorses the committee’s findings, Medicaid and Medicare will begin covering the vaccine later this year.

Biotechnology vaccinations have been among the greatest achievements of the human race, for they represent our ability to prevent suffering and disease rather than mitigate it. Thanks to biotechnology innovation, we’ve moved a step closer to the day when shingles will be moved from the medical books to the history books.

 

Here Are The 20 Netflix Documentaries That Are Definitely Worth Your Time To Watch

Say goodbye to aimless browsing this weekend.

Amanda Knox (2016)

Amanda Knox (2016)

This Netflix production tells the story of Amanda Knox, the American exchange student who was arrested for the murder of her roommate in Italy. Amongst other things, it dives into the role that media sensationalism played in the case.

Netflix

Audrie & Daisy (2016)

Audrie & Daisy (2016)

For a gut-wrenching but important watch about consent and bullying in the digital age, this doc tells the story of two girls who were raped by “friends” and then humiliated for it on social media.

Netflix

Best of Enemies (2015)

Best of Enemies (2015)

While recounting the 1968 rivalry between political intellectuals Gore Vidal and William F. Buckley Jr. might sound like anything but fascinating, I recommend it for the sheer depth of debate that takes place – and proof that, well, politics have always been polarizing.

Tremolo Productions

Betting on Zero (2017)

Betting on Zero (2017)

Is the nutritional product company Herbalife for real, or a really intricate scam? Well, it’s complicated…

Zipper Bros Films

Call Me Lucky (2015)

Call Me Lucky (2015)

This doc tells the story of Barry Crimmins, a comedian with a terrible past who begins the film by announcing that he only has two things left to do in order to consider his life complete: overthrowing the United States government and closing down the Catholic church.

Type 55 Films

Chef’s Table (2015-2017)

This documentary series dedicates each episode to profiling a world famous chef – think Massimo Bottura, Niki Nakayama and Gaggan Anand. Plus, it’s basically extremely classy food porn.

youtube.com

Cosmos: A Spacetime Odyssey (2014)

Cosmos: A Spacetime Odyssey (2014)

Starring everyone’s fave astrophysicist, Neil deGrasse Tyson, this is the documentary that will actually help you understand everything ~out there~ without getting overwhelmed.

Cosmos Studios

Gringo: The Dangerous Life of John McAfee (2016)

Gringo: The Dangerous Life of John McAfee (2016)

Of the McAfee anti-virus software fame, this is a bizarre tech tycoon profile with a murder allegation and jungle living thrown in for good measure.

Ish Entertainment

Hip-Hop Evolution (2016)

Hip-Hop Evolution (2016)

This is basically The Get Down, but in documentary form covering everything from the the birth of hip-hop birth to the rise of gangsta rap.

Netflix

Holy Hell (2016)

Holy Hell (2016)

A spooky telling of what happens when one Californian decides to leave his cult.

WRA Productions

Hot Girls Wanted (2015)

Hot Girls Wanted (2015)

A tough, heartbreaking dive into the “amateur” porn industry that showcases the perspectives of the young women who don’t get famous.

Netflix

Last Chance U (2017)

Last Chance U (2017)

Over two seasons, this docuseries follows football players from East Mississippi Community College, a huge university in a very small town that attracts players who couldn’t play anywhere else but still dream of getting into the NFL.

Netflix

Making A Murderer (2015)

Making A Murderer (2015)

This series follows the story of Steven Avery, a man who spent 18 years in prison for a crime he didn’t commit. After being released in 2003, he was once again accused of murder in 2007. It’s a deep, detailed dive into both cases that’ll leave you thinking about what really constitutes “justice.”

Netflix

Planet Earth (2006)

Planet Earth (2006)

The GOAT of nature documentaries that’ll have you wondering how the fuck did they get this on camera the whole time.

BBC

Pumping Iron (1977)

Pumping Iron (1977)

This oldie but goodie covers the modern bodybuilding movement via the story of a young Arnold Schwarzenegger.

White Mountain Films

She’s Beautiful When She’s Angry (2014)

She's Beautiful When She's Angry (2014)

An incredible primer on second-wave feminism in the U.S. during the sixties that’ll leave you feeling way more informed about how the movement’s evolution to the feminism we know today.

International Film Circuit

The Barkley Marathons: The Race That Eats Its Young (2014)

The Barkley Marathons: The Race That Eats Its Young (2014)

In its 25-year history, only ten people have finished this ultramarathon known as the Barkley Marathons. This doc dives into how it got started, what the rules are, and most importantly, why on earth people put themselves through it.

Gravitas

Cartel Land (2015)

Cartel Land (2015)

This documentary looks into the war on drugs and how it has influenced those living on the border between Mexico and the U.S. On the Mexican side, we follow a doctor’s leading some kind of citizen militia in order to fight the cartels. On the American side, we follow a retired soldier who leads a paramilitary group on border watch.

A&E IndieFilms

Valley Uprising (2014)

Valley Uprising (2014)

I’ve seen this twice and wouldn’t be surprised if I watched it a third time. This gem of a doc follows the many generations of hikers who go to Yosemite to face off with the ultimate climb on “The Captain.” Fun fact: you’ve seen this mountain before on your MacBook’s wallpaper.

Sender Films

What Happened, Miss Simone? (2015)

What Happened, Miss Simone? (2015)

Archival footage and never-before-heard recordings combine in a mesmerizing retelling of the legendary singer and activist’s early life.

Netflix

This post was translated from Spanish.

M.A. or Research Associate?

I’m currently a senior at a small liberal arts college, majoring in integrative sciences, molecular bio, and science studies. I’ve been working in a bioinformatics/molecular genetics lab for the past two years, and will be graduating in May. My school offers a tuition-free 5th year M.A. for those involved in research labs looking to continue their project. I’ve applied to the program and will likely get accepted and receive a small stipend from my adviser to cover housing if I choose to matriculate. I would graduate with an M.A. in Spring 2019.

I’m looking to apply to Ph.D. programs and, frankly, I’d like to have my pick. I want to make sure I’m a top candidate anywhere I apply. I am deciding between doing this M.A. or taking a 2 year Research Associate position at a very prestigious biomedical research institute. My undergrad university is small (~2900 undergrads, ~200 grads), and while the research I am doing is very interesting and I am invested in the project, I can’t help but run into inefficiencies that come from working in a small lab at a primarily teaching-focused institution.

I’d like to pursue jobs in industry after I do a Ph.D. in a field related to genomics, proteomics, or synthetic biology.

I’d like some advice weighing an M.A. vs. the research associate position.

My major pros for the M.A. are (1) the degree, (2) the opportunity to write a thesis and take more classes, and (1) the fact that it would only last 1 year instead of 2. The major cons in my mind for this: (1) lack of productivity, (2) social isolation experience typical of those in the program, (3) relatively lower prestige.

Major pros for the RA position: (1) opportunity to work on translational research, (2) large, collaborative, highly-efficient research-focused environment in one of the major biotech hubs of the country, (3) salary, (4) prestige of faculty/students/postdocs at the institute, (5) opportunity to expand my network before entering a Ph.D. The major cons seem to be: (1) non-academic role, (2) entering a Ph.D. program 1 year later, (3) less opportunity for first/second authorships.

Thanks biotech!

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BIO Applauds Support for Innovation in Trump Administration Task Force Report

Recommendations contained in a newly released report from the Interagency Task Force on Agriculture and Rural Prosperity will guide Administration policy in the year ahead, according to the White House, and one of the pillars of that report call for “Harnessing Technological Innovation.”

The report was presented this week to President Donald Trump by Secretary of Agriculture Sonny Perdue during the American Farm Bureau Federation‘s Annual Convention in Nashville, where the President spoke about “putting an end to the regulatory assault” on farmers and their way of life.

“We are streamlining regulations that have blocked cutting edge biotechnology, setting free our farmers to innovate, thrive and to grow,” the President said.

A CNN report highlights the report’s recommendation to improve the quality, nutritional value, and safety of American crops as well as addressing trade concerns:

An improved strategy for research and development of new agricultural technologies will be key, as will be a unified U.S. approach toward convincing our trading partners of the value of safe biotech products.

BIO applauded the support for biotechnology and innovation contained in the report as for the President’s remarks to Farm Bureau convention attendees.

“As the report states, scientific advancements in biotechnology have produced a thriving and successful industrial sector aimed at addressing our world’s most pressing challenges,” added Greenwood. “Further innovations in genome editing technology will unlock even more promises in agriculture production, animal health and welfare, biofuels and renewable chemical development, and biobased manufacturing.”

Greenwood also welcomed recommendations contained in the report, such as the need for policies that promotes economic growth, innovation, competitiveness and job creation.

“As recommended in the report, BIO supports a more harmonized Coordinated Framework for the regulation of biotechnology, a tax code that encourages investment in the biotech sector, and government-backed communications to further public awareness of biotech products,” Greenwood said. “We also need to integrate a recognition for the importance of science and technology into the appropriate Farm Bill titles.”

In April 2017, President Donald J. Trump issued an executive order establishing the Interagency Task Force on Agriculture and Rural Prosperity “to ensure the informed exercise of regulatory authority that impacts agriculture and rural communities.”

As Secretary of Agriculture, Sonny Perdue serves as the chairman of the Task Force, which includes 22 federal agencies as well as local leaders.

Whitepaper: Transforming Deviation Management

http://www.bioprocessintl.com/business/risk-management/transforming-deviation-management-biophorum-operations-group/

Suggested by /u/ghattoy in a previous thread.

Reading this would be like staring directly at the sun for some QA people. Deviations where I work are tracked by initiator, and QA is debating whether to make this tracking public as a way to increase pressure on mfg to increase compliance.

Some people worry that it makes people afraid to surrender bad news quickly. As a compromise, I want to suggest to QA that they display their tracking of only minor deviations and entry errors (spelling, write overs, etc). People in manufacturing only see this tracking as if its an HR type thing to document poor performance. In reality, initiating a deviation is much better than the alternative: deviating but trying to hide or minimize it. Some deviations are inevitable, for example ones that result form a poorly written batch record or SOP. If we are worrying about what HR will think of a deviation, we risk losing sight of what really matters, which is what a patient/ clinician (and after that, regulator/ client) would think of the deviation.

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