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This market research biotechnology 2018 report gives an overview of the various key elements like Market size and growth rate. This report is made …

National Immunization Awareness Month might be coming to a close, but it’s important to continue helping people understand why vaccines are so important throughout the entire year.

To bolster these efforts, the National Vaccine Program Office teamed up with the Office of Disease Prevention and Health Promotion to create a series of short videos highlighting the importance of vaccines. Each segment focuses on a specific condition like whooping cough, shingles, or pneumococcal disease, and helps the general public understand why they should get vaccinated – and just how important vaccines are to society.

As BIO has pointed out before, vaccines have tremendous societal value, responsible for saving more than 730,000 children over the past 20 years in the U.S. One study found that the vaccination of children born in the United States in 2009 is projected to generate $184 billion in lifetime social value – or about $45,000 per child.

The truth is, vaccines have been used with great success over the years against viruses and bacteria that cause everything from polio to some forms of cancer. Beyond National Immunization Awareness Month, help spread the word about these prevention miracles and the many benefits that come along with them.

IQVIA – a nonpartisan health care research firm – is out with troubling new data showing a direct correlation between high out-of-pocket costs and patients forgoing the medicines they need. In 2017, 69% of patients covered in the commercial market did not fill a new prescription when their insurance company required them to pay out of pocket costs exceeding $250.

In recent years, patients have been subjected to spending more on deductibles and coinsurance. To offset this financial burden not covered by their insurers, many pharmaceutical companies have begun to offer various forms of patient assistance, and according to IQVIA, this assistance is making a difference for patients.

Yet in recent months, health plans have implemented “co-pay accumulator” programs – an effort to prevent funds provided by these assistance programs from applying to a patient’s out of pocket maximum or deductible. As a result, patients are left with steep costs and are less likely to fill the prescriptions they need.

It’s time for the insurance industry to step up and do its part to help ensure patients have access to the medicines they need at costs they can affordable.

See the full IQVIA report here.

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Connie Tucker, of Grand Prairie, Texas, has won a HomeHawk smart home monitoring system.

In comments filed to the EPA August 17 on the 2019 proposed volumes for the renewable fuel standard, BIO urged the agency to “seize the opportunity afforded by the RFS program to promote the type of innovation that will help grow advanced and cellulosic biofuels, create good paying jobs, and help revitalize rural America by strengthening our world-leading biobased economy.”

Specifically, BIO comments are with regards to the low number of approvals the EPA has issued for advanced and cellulosic ethanol.

As Marc Heller reports for E&E News, “EPA is sharply underestimating the amount of cellulosic ethanol that U.S. companies could produce – and its own administrative lag is partly to blame, industry sources say.”

Because yearly cellulosic ethanol volumes mandated under the RFS are determined by the number of cellulosic facilities already registered, and the number of facilities officials believe will come on line during the year, the lack of approvals by EPA significantly hinders the growth of the cellulosic ethanol industry.

As a result, biotechnology companies like Edeniq have several applications pending. Brian Thome, president and CEO of Edeniq, noted to Heller that this means cellulosic ethanol production is not reaching its full potential.

With approvals in place, the industry could provide as much as 50 million gallons more than that, Edeniq said in comments submitted to the agency. Thome told E&E News that as much as 100 million gallons of the biofuel could be at stake.

Thome later goes on to add, “This is real volume and growth that appear to be sitting still now.”

In its comments, BIO noted that EPA’s lag in approving cellulosic ethanol applications is particularly hurting rural America. In sections of the country where farmers grow the corn that is turned into cellulosic ethanol and where biorefineries are headquartered, countless good paying jobs are at stake. In a time when farmers and businesses in rural America are grappling with low crop prices and trade uncertainty, the EPA should work diligently on its backlog of applications to help grow cellulosic ethanol production, thus helping corn growers and biorefinery’s across America’s heartland.

After all, as Brian Thome notes to Heller, “the pipeline [for approving cellulosic ethanol applications] wasn’t always so slow.”

To read BIO’s comments on the 2019 proposed RFS volumes click here. To read BIO’s press release on its comments, click here.

Venture capital investment in US biotech companies has skyrocketed as Chinese investors continue to fuel the US pharmaceutical startup sector. With over $1.4 billion invested by Chinese VC funds into private US biotechnology firms in Q1 2018 alone, the Chinese investment community represents a materially significant and growing source of growth capital for the industry.

While recent trade rifts between the US and China have threatened industries including US coal producers, farmers and crude oil industries, the biotechnology hubs of Cambridge and Silicon Valley continue to see Chinese investment coming in. Over this past summer, we’ve seen a flurry of retaliatory tariffs enacted by policymakers in both countries that have made many industries concerned of the future strength of their market. However, the biotechnology sector remained relatively unscathed with Q4 2017 and Q1 2018 reports reflecting a growth of almost $1.5 billion, per Pitchbook.

Just over a decade ago, the Chinese pharmaceutical market had been solely dominated by the generics industry. The significant resources required to support innovative drug development forced most domestic pharmaceutical companies to prioritize short-term revenue through developing generic drugs. While the strength of the generics industry in China still remains significant, policies that put innovation at the forefront have placed the Chinese pharmaceutical sector at a turning point. Today we are seeing a transformation in a market that once focused on solely manufacturing products to one that funds innovative cures through fostering a strong domestic sector and foreign investment.

Recent government initiatives have even further invigorated the industry making the biotech field eligible for expanded government R&D subsidies, additional funds for science parks, and incentives to innovate personalized treatment and drugs that treat critical disease. Specifically, these initiatives could provide preferential tax policies that would aid small to micro-sized enterprises that are focused on these development areas.

Further, announcements made earlier this year that the Hong Kong Stock Exchange (HKEX) will allow pre-revenue biotech companies to list onto its stock exchange has potential to further expand the Chinese market and serve a great opportunity for Chinese investors. Allowing for this second listing may provide legitimacy and help companies attract additional investment.

Despite the recent increase in political and financial support strengthening the Chinese biotech sector, the threat of deepening trade disputes has created a relatively unpredictable political climate.

Recently, on August 13, 2018, President Trump signed into effect the Foreign Investment Risk Review Modernization Act of 2018 (FIRRMA), which provides more vigilant scrutiny of foreign acquisitions and investments in the US. These FIRRMA reforms expand the jurisdiction of the Committee on Foreign Investment in the United States (CFIUS) that President Trump states, “closes the gap” between what transactions CFIUS can review and what they previously could not. While FIRRMA does not mention China specifically in the legislation, over the next few months it will be important to consider the country’s role in this narrative as Chinese investment continues to expand in the US biotech market.

But as for now, it is too close to tell what CFIUS may mean specifically for biotech deals between Chinese investors and US companies. While the logistics of the law will be flushed out in the coming months, it will be important for companies and investors alike to be aware of the potential implications these reforms may have on Chinese acquisitions of US companies and rates of investment.

To stay abreast of these important issues in the global biotech investment community, we invite you to attend the 17^th annual BIO Investor Forum in San Francisco on October 17-18, 2018. Learn more about China’s investor boom, the HK stock exchange, and the implications new CFIUS legislation may have on your investment deals during the two full days of education sessions.

Below are a few featured sessions from the 2018 BIO Investor Forum program:

Reaching Chinese Investors: Considerations for an IPO in Hong Kong

Wednesday, October 17, 2:00-2:55 pm

The Hong Kong Stock Exchange is capturing worldwide attention as it modifies listing rules to permit biotech companies, opening the door for Chinese firms seeking public market financing as well international firms eyeing the support of investors in China. In just the exchange’s first few weeks more than USD 1 billion in new offerings have generated funding that will be applied to accelerate clinical research on behalf of patients.  This session will examine cross-border perspectives on the appetite of China-based investors for biotechs and the criteria to determine the attractiveness of listing on the exchange for foreign entities as Hong Kong sets its sights at becoming a major biotech funding source.

Policy Outlook- Implications of the Trump Administration’s Healthcare Initiatives

Wednesday, October 17, 3:15-4:10 pm

Across 2018 the U.S. federal government has launched multiple new initiatives regarding how new medicines will be authorized, commercialized, and reimbursed, including in such areas as genome editing, continuous manufacturing, and Medicare rebates.  This panel of people close to the policy making process will share the latest data on FDA expectations, plus discuss the Trump Administration’s stances on healthcare spending, the opioid addiction crisis, trade tariffs, and tax policies that will affect biopharmas both immediately and in the years ahead.

Explore additional educational programming and investor partnering opportunities here. We welcome you to join us this year at the BIO Investor Forum.

In February, as part of our 25th anniversary innovation series, we profiled the discovery and subsequent harnessing of Agrobacterium to modify crops, leading to great advances in agriculture and food production. Moreover, we highlighted scientist Mary-Dell Chilton – among other researchers – and the role she played in discovering the potential of the microbe.

Sonja Begemann with Ag Professional reports that Chilton is “putting away her lab goggles for the last time,” retiring from her role at Syngenta, where she founded the company’s biotechnology lab and conducted extensive research into plant genetics.

Read more about Mary-Dell Chilton from BIO’s 25th anniversary blog exploring the innovation of Agrobacterium for plant gene modification.

As Begemann notes, Chilton recently reflected on her career:

“My career in biotechnology has been an exciting journey, and I am amazed to see the progress we have made over the years,” Chilton said in a previous interview. “My hope is that through continued scientific discoveries, we will be able to provide a brighter and better future for the generations that follow us.”

Mary-Dell Chilton (left) with 2018 Rosalind Franklin Award recipient  Krysta Harden (right).

A pioneer not only for women in science but anyone working in plant biotechnology, Chilton has received high-praise over the years, including from some influential leaders in agriculture. As Begemann puts it, “Chilton’s influence in biotech and the direction it’s moving is well-documented and respected.”

“Dr. Chilton’s research has forever changed the way we conduct plant research and her groundbreaking accomplishments have shaped the way genetic plant research is conducted today,” says former Secretary of Agriculture Tom Vilsack, when Chilton was inducted into USDA’s Hall of Heroes.

Her “personal scientific discoveries stand out on their own, but also weave together with vast commercial and academic innovative research that allows the world to benefit from productive farming and even greater positive environmental conditions,” said Jay Croom, CEO of CropLife America, a national trade association representing manufacturers, formulators and distributors of pesticides, in a recent letter to Chilton. “Her work continues to influence progress in agriculture and humanity for generations to come.”

After years as a university researcher, Chilton joined Syngenta (what was at the time CIBA-Geigy Corporation) in 1983, founding the company’s first biotechnology research lab. In 2013, Chilton, along with two other researchers, received the World Food Prize for her work in discovering the power of Agrobacterium. Additionally, Chilton is honored in USDA’s Hall of Heroes and is an inductee in the National Inventors Hall of Fame.

Read the full piece on Chilton’s retirement here.

BIO President and CEO Jim Greenwood posted the following op-ed on Linked-In today, making the case for the U.S. Senate to act on legislation that would empower the Centers for Medicaid and Medicare Services to broaden coverage of medication-assisted treatment to help Americans in the throes of opioid addiction.

How serious is our national opioid emergency? More than 115 Americans die every day from an opioid overdose. By contrast, 44 people in this country died a day during the peak of the AIDS crisis.

Decades ago, we saw how effective the HIV/AIDS community was in asserting its political power to demand a government solution. Investment into breakthrough antiretroviral treatments – and public-private collaborations to make these drugs accessible – transformed a lethal epidemic into a manageable, chronic condition.  Now, three decades later, government and industry again must work together once again to end a public health cataclysm.

Opioid addiction fundamentally alters a person’s brain chemistry, producing potent cravings and horrible withdrawal symptoms for those trying to stop using. But thanks to biotech breakthroughs made possible by our deepening understanding of neuroscience, medications already approved by the U.S. Food and Drug Administration can reduce opioid cravings, dampen euphoric side effects and diminish withdrawal symptoms.

Buprenorphine and methadone are called “essential medicines” by the World Health Organization. Using another pharmaceutical to help reverse damaging effects of opioid addiction isn’t “more of the same.” In fact, research shows that medication-assisted treatment (MAT) – where medicine is administered alongside cognitive or behavioral care – is the most successful way to facilitate long-term recovery. Administered properly, MAT decreases overdose deaths, criminal activity and infectious disease transmission, according to the National Institute on Drug Abuse, while increasing patient retention in therapy programs.

The problem is, the pathway to receive MAT is not always clear, with a patchwork system of varying coverage levels across different states and insurance carriers. Even when payers will pay, most rehab facilities still do not offer MAT. Research suggests that only 1 in 3 people enrolled in privately funded specialty treatment programs receives medication-assisted treatment for opioid dependence.

So the Biotechnology Innovation Organization (BIO) decided to go talk to Americans in recovery programs to get their perspective. We recently took a group of biotech leaders to Ohio, where 1 in 5 fatal opioid overdoses occurs. We brought together scientists working on pain and addiction therapies with recovering addicts for a candid conversation.

We met a 30-something who got lost so deep into her addiction that foster care took her daughter away. Then, she got pregnant again. She managed to stay off opioids for the last three months of her pregnancy to give birth to a healthy baby. But three minutes after her child was born, she was back on them. That’s how addiction takes your soul.

We met with addicts at different stages of recovery who could easily be anyone’s friend or neighbor. These were good people wrestling with powerful chemical dependency. The statistics show that the vast majority will relapse. Even addicts clean for years told us the monster never leaves their brain. They said that once they succumb and start to use again, they don’t care about their families, jobs or reputations. They care only about getting that drug back into their system. That’s why MAT is so important, because it can help their resolve overpower their cravings.

Of course, the ultimate solution lies in stopping addiction before it starts. That means innovating more non-addictive painkillers for people living with severe and chronic pain. One in three Americans – roughly 100 million people – report suffering from some type of pain, according to the National Academy of Science’s Institute of Medicine. That’s more people than suffer from diabetes, cancer and heart disease combined.

We need to expand coverage for alternative painkillers and innovate new ones. There are non-opioid analgesics on the market for certain painful conditions, but too many insurers are pushing beneficiaries to cheaper alternatives. They’re effectively saying, “First, go ahead and try a generic opioid. If you fail on that, maybe we’ll cover a different approach.” This utilization management practice hooks more people.

It’s in the interest of insurers to step up to the plate and be part of the solution. Otherwise, they’ll end up paying for rehabilitation, hospitalization and all kinds of health problems that will be more expensive in the long run.

We need to cover existing treatments and invest in new ones. There are 125 new painkillers being tested in clinical trials, 87 percent of which are non-opioids. But compare that to a pipeline of 1,700 novel cancer programs, a disease area that receives 17 times more venture capital than novel pain meds. Meanwhile, R&D investment for new addiction medications is virtually non-existent. Why? If insurance won’t pay, investors won’t invest, innovation stalls and American families wrestling with opioid dependency ultimately pay the price.

About four in 10 of our country’s more than 2 million opioid addicts are covered by state Medicaid programs. This makes the Centers for Medicare & Medicaid Services (CMS) a pivotal agency in addressing this crisis.

This summer, the U.S. House of Representatives passed comprehensive legislation to address the opioid crisis by a vote of 396-14.  The House bill directs CMS to create an Opioid Action Plan that can help ensure medication-assisted treatment is not placed on expensive specialty tiers or priced at levels where high patient out-of-pocket costs preclude access. The bill would encourage CMS to work with state Medicaid programs in using waivers to cover holistic addiction treatment. Finally, it would empower CMS to educate treatment providers about the latest research on the efficacy of innovative treatment options.

Companion opioid legislation now awaits floor consideration in the Senate. Inclusion of a stand-alone bipartisan bill by Senators Dean Heller (R-NV) and Bob Menendez (D-NJ) to authorize the CMS Opioid Action Plan is a crucial piece of the puzzle if we’re serious about helping Americans get off and stay off these drugs.

Overdose deaths from prescription painkillers, fentanyl and heroin have quadrupled in the last 15 years. Every 20 minutes, another American dies from an opioid overdose. The urgency of Senate action this year cannot be overstated. The only long-term solution is to innovate our way out of the opioid crisis – and work together to ensure patient access to the breakthroughs that scientists discover. We did it during the AIDS epidemic, and we can and must again.

The U.S. leads the world in biotech innovation, delivering solutions to combat debilitating and rare diseases, reduce our environmental footprint and feed the hungry. However, our weakening patent system has reduced the incentives and safeguards small biotech companies rely upon to deliver over 65% of the industry’s innovative products and technologies.

Unfortunately, changes to our patent laws over the last 15 years, through legislation, agency actions, and court decisions, have severely weakened the patent rights of inventors and innovators. Although it was once considered the gold standard for the rest of the world, in the latest global survey conducted by the U.S. Chamber of Commerce, our patent system was rated only 12th in the world, behind nations like Singapore, France, and South Korea.

A new documentary on the patent system highlights the fact that the crisis is not just a concern of the biotech industry. Invalidated: The Shredding of the US Patent System – demonstrates the real-world impact caused by United States Patent and Trademark Office’s (PTO) flawed policies.

Misuse of the PTO’s administrative tribunal, known as the Patent Trial and Appeal Board (PTAB), is at the heart of the problem. Anyone- from anywhere in the world-can file a petition at the PTAB to invalidate any U.S. patent. As the documentary explains, valuable patents have been invalidated at the PTAB even though they were successfully defended in federal court multiple times.

BIO supports balanced reforms to reduce such abusive practices, while enhancing the strong incentives necessary to sustain our nation’s global leadership in biotechnology innovation and the creation of high-wage, high-value jobs throughout our country.

BIO supports the STRONGER Patents Act and will continue to advocate for passage of legislation to curb abusive patent practices, while strengthening the ability of patent owners to defend their inventions and businesses against infringement.