From Sesame Street to Pennsylvania Ave, Autism Awareness & Advocacy Take Hold

Like most American kids, my daughters loved Sesame Street growing up. The show’s cast of Muppets have made learning fun since 1969, helping to teach our children how to count, read and be a good person who shares and cares for others.

According to one study by researchers at the University of Maryland and Wellesley College, children who live in places with easy access to Sesame Street are 14 percent less likely to fall behind in school. The show’s positive influence on America’s youth is why I was so pleased to hear that the creators of Sesame Street have taken an important step forward with the introduction of their newest Muppet, Julia.

Julia is on the autism spectrum. She has already made her YouTube and Sesame Street online debuts, and during April’s Autism Awareness Month, she’s appearing on television for the first time. In the initial episode, Julia doesn’t make eye contact or speak when she meets Big Bird. She is unsure if she should shake his hand, so she keeps coloring her book. Julia is sensitive to loud noises, and becomes overly excited during a game of tag.

Through Julia, the show’s creators are illustrating certain behaviors of children with Autism Spectrum Disorders (ASD). The idea is to combat stigma and promote greater understanding among young peer groups. Julia provides educators and parents with an accessible, non-threatening way to discuss the social and communications difficulties common among those with ASD.

Autism awareness reached the highest levels of government this Sunday when the White House was lit up blue in recognition of World Autism Day. The decision to turn the White House blue was made by President Trump himself. He promised Bob Wright and his late wife Suzanne – who founded the research and advocacy organization, Autism Speaks, in 2005 – that, if he won the presidency, he would honor their grandson with ASD.

President Trump tweeted and released a statement encouraging Americans to learn the signs of ASD to improve early diagnosis and to help more people “understand the challenges faced by those with autism spectrum disorders.”

There’s a reason autism public awareness is popping up everywhere from Sesame Street to 1600 Pennsylvania Avenue. Ten years ago the Centers for Disease Control and Prevention (CDC) estimated autism’s U.S. prevalence at 1 in 166 kids. Today, it’s 1 in 68 – an increase of more than 100 percent over the last decade. Boys are four and a half times more likely to have ASD.

Why are diagnoses rising at such an alarming rate? Has there been a large increase, or are we just learning to better identify and count the number of people who are on the spectrum?

Certainly, medical professionals are more aggressive with diagnoses today. Many cases that used to be diagnosed as an “intellectual disability” are now recognized as autism. The medical community also changed the clinical definition of autism. The “spectrum” of conditions has expanded to include Asperger Disorder, which can appear to be a milder form of autism without impairment of language and cognitive skills. Children with autism are often seen as aloof, according to the Autism Society, while those with Asperger’s Disorder usually want to fit in but may not be sure how because of difficulty picking up on social cues or subtleties like sarcasm in conversation.

Doctors say diagnosing a child with ASD can be difficult since there is no medical test. Autism Speaks notes that one-third of individuals with autism are non-verbal and/or have epilepsy. Half of children with autism have gastrointestinal disorders and trouble sleeping. By asking the right questions early, a child can be diagnosed before the age of two. Then, a combination of speech, occupational, sensory integration and behavioral therapies are among the treatments that can be used to stimulate brain development and activity. The earlier the diagnosis, the better the chance for a positive outcome.

Scientists are now studying gene variations in the hopes of one-day developing medicines to treat the root cause of ASD. Studies by the CDC show if one identical twin has autism, there is a 75 percent chance both do. The disorder occurs more often in people who have certain genetic or chromosomal conditions like Down syndrome and Fragile X syndrome. Fragile X refers to one part of the X chromosome that is defective. Doctors say it is the most common form of intellectual disability with symptoms similar to ASD. Children born to older parents are also at a higher risk of having ASD.

At BIO, we are encouraged by Autism Speaks’ MSSNG genomic database and the recent news they’ve identified 18 gene variations linked to an increased risk of autism. This could be a very significant research discovery. To date, the project reports, 80 percent of the five dozen gene variations discovered through MSSNG affect biochemical pathways that have clear potential as targets for future medicines.

The genomic database project began over a decade ago as a collaboration between Google and Autism Speaks. Using a state of the art technology called DNA microarray, scientists can scan the human genome in search of autism’s genetic causes and risk factors.  The DNA of more than 10,000 families affected by autism was sequenced and made available for free to researchers worldwide. Autism Speaks is doing critical genetic analysis work that could one day lead to biopharmaceutical treatments for ASD.

In the meantime, society is developing a greater understanding that every child on the spectrum has his or her own unique set of strengths and challenges. That’s why the White House became the Blue House for an evening and why Sesame Street fans are meeting Julia this month: to raise awareness that people with ASD are exceptional and worth getting to know.

Jim Greenwood Celebrates JOBS Act Turning Five (Op-Ed in The Hill)

Five years ago today, the Jumpstart Our Business Startups (JOBS) Act became law. The JOBS Act – designed to enhance capital formation for emerging companies – passed in Congress with an overwhelming bipartisan vote.  In an Op-Ed appearing in The Hill, BIO President and CEO Jim Greenwood celebrates this anniversary with hopes to build on its success and continue working with Congress to support such sensible policies.

The JOBS Act struck the perfect balance between incentivizing companies to going public and still keeping important investor protections in place. It increased the flow of capital to innovative businesses without a revenue-generating product, yet. This law gave such biotech start-ups the opportunity to save on unnecessary compliance burdens and invest those funds into research and development – making science the priority and new life-saving treatments a reality. As Greenwood summarizes in BIO’s statement released today:

“The extraordinary impact of the JOBS Act shows the dramatic effect that smart policymaking can have on the search for groundbreaking cures and treatments.”

BIO also released new data today showing how the JOBS Act has left a significant impression in the industry after five short years. Here are some highlights that make today’s anniversary worth celebrating:

  • Compared to only 55 biotech IPOs just five years prior, there are now an unprecedented 212 biotech IPOs.
  • Emerging biotech companies have raised $17 billion through JOBS Act IPOs. As a result, an additional $16 billion was raised through follow-on offerings.
  • The FDA has approved 18 new treatments from JOBS Act companies, and an additional 696 therapies are currently in the pipeline.
  • Oncology companies make up the largest share of JOBS Act IPOs (25%).

Thanks to the JOBS Act, biotech companies currently employ over 27,000 people and have a market value of more than $111 billion. It is clear that America is the undisputed leader of a global industry transforming medicine, farming, and energy production. We hope Congress builds on the success of the JOBS Act and fosters continued growth of emerging public biotech companies.

Read Greenwood’s full Op-Ed here.

View the infographic summarizing the impact of the JOBS Act on the biotech industry here.

Greenwood: Japan Is An Elite Biotech Hub, But Recent Pricing Measures Are Destabilizing

In Tokyo, BIO CEO Jim Greenwood acknowledged Japan’s remarkable progress in biomedical innovation but warned that recent actions by the government to artificially lower prices on successful therapies could cost the country more than it saves in the long run.

Remarks Prepared for BIO CEO Jim Greenwood
BIO Asia
Tokyo, Japan
Tuesday, March 14, 2017

Welcome to our 14th BIO Asia International Conference. It’s truly a pleasure to be with you in Tokyo this morning. I’m proud to be CEO of the world’s largest biotechnology trade association. We are a truly global association with members working together, partnering together, and innovating together in 30 countries. But Japan is uniquely important –to the future of the biopharmaceutical industry and to the future of global health….

BIO Asia is our longest running international conference – and that’s no accident. Everyone now agrees: Japan has become one of the world’s truly elite biotechnology hubs. Your companies are working to heal, feed and fuel the world. Our industry is the future, and together, our countries are leading it. So thanks to each of you for the work that you do and for the hope that you deliver that, one day, we might put a stop to suffering and hunger and environmental decline.

We are honored to have as our keynote speaker this morning Vice Minister Baba from the Ministry of Health, Labour and Welfare. Vice Minister Baba was kind to meet with our delegation yesterday. The Ministry has laid out an ambitious vision in its Comprehensive Strategy for Strengthening the Pharmaceutical Industry. It is establishing clinical innovation networks. It is championing efforts to support patients with intractable diseases. And it is supporting our industry’s work to prevent pandemic influenza and address antimicrobial resistance. Thank you, Vice Minister, for your leadership.

Yesterday, a delegation of BIO Board members and I met with several senior Japanese policy makers to talk about ways we can work together. Japan and America share a number of common challenges. We both have large, aging populations placing a real strain on our health care systems. We both have brilliant innovators who are developing therapies unimaginable 10 years ago, who face pressure to innovate tomorrow’s cures with yesterday’s reimbursement systems. We both have government officials who understand the importance of value-based payment arrangements, but who must still be persuaded that value should drive private negotiations – not government price controls. And finally, we both have investors who are eager to make risky bets on new miracle cures as long as our governments don’t make policy choices that feed uncertainty and price instability.

I served in the United States Congress for 12 years. Now I’ve been the CEO of BIO for 12 years. One central lesson that I’ve learned about our industry is that biotech companies simply cannot thrive without a healthy ecosystem. That ecosystem must be equally supported by 3 groups: innovators, investors and institutions.

First, you need innovators to apply their deep scientific knowledge to solve the problems of the modern world. Second, you need investors, because the most brilliant ideas won’t become actual products without the buy-in of the investor class. Finally, you need institutions committed to creating sound policy and smart regulations.

Japan has all of these ingredients and that’s why you have made so much progress in the last few years. It’s why you’ve become a global leader in regenerative medicine. It’s why you’ve been able to eliminate what was once a six-year drug lag compared to the United States and get cutting-edge therapies to your patients sooner. It’s why you’ve built a world-class regulatory standard on par with and in some ways superior to the U.S. and the EU.

Policy makers across the world can learn a lot from what has been accomplished here. But friends are candid with one another, and we must acknowledge that we have hit some bumps in the road. In our meetings yesterday, we had an honest dialogue about how the investment and research community is reacting to emergency repricing measures. We discussed the signal being sent by the plans to reform Japan’s pricing system, such as new annual price revisions. And we talked about our industry’s need for predictability and transparency. We shared the America model of looking to the generics markets for savings, so innovators have the resources and revenues to research new breakthroughs. Yes, budgets must be balanced annually. But sometimes, the prudent decision is for budget officials to look beyond one-year savings.

In America and Japan, when our elected leaders overrule the markets and cut medicine prices for political reasons … this means less revenue, less investment, less innovation, and less economic growth. And who suffers in the end? The patients who are desperately hoping for new medicines.

As an industry, we must encourage our leaders to take a long-term view. Incentivizing innovation and solving major societal health care problems will save more money in the end. New treatments prevent surgery. They prevent hospitalization. They prevent visits to the doctor. Innovation saves lives. And it saves societies billions of dollars in avoided health care costs by ending disease and keeping people healthier for longer.

I’m appreciative that we agreed to continue this important dialogue. Industry and government must work together to strike the right balance between promoting innovation and containing costs. Working together, we can deliver the world’s most cutting-edge medicines to Japan’s patients in the quickest time frame possible, and we can ensure the Japanese biopharmaceutical sector realizes its extraordinary potential.