Gaijin Panty

Nearly twelve years ago, members of the biopharmaceutical supply chain, including BIO, came together in the aftermath of Hurricane Katrina and partnered with the American Red Cross to form a coalition. The coalition was founded to resolve the coordination challenges witnessed during the Katrina response. This coalition was founded under the name Rx Response and is now Healthcare Ready.

Healthcare Ready is a national nonprofit that leverages unique relationships with government, nonprofit and medical supply chains to deliver on its mission of enhancing the resiliency of communities before, during and after disasters.

The motivating reason for our creation, and our continued existence today, is a recognition of the importance of seamlessly integrating private sector organizations into all parts of healthcare preparedness and response. When over 90% of critical healthcare infrastructure – from manufacturing and distribution facilities to pharmacies, dialysis centers, and other points of care – is owned and operated by the private sector, this kind of integration is needed, yet it remains a significant challenge.[1]

The last eighteen months have underscored this notion, reminding us that weather events continue to pose real threats to public health and patients. From impacting the production of drugs and medical products to widespread damage of facilities causing patients to become disconnected from care, we continue to see natural disasters stress and fracture healthcare operations in countless ways. For example, during the Hurricane Harvey response, we coordinated with partners to make helicopter deliveries of medical supplies to Texas hospitals because flood waters created impassable roads. In Florida after Hurricane Irma, we worked to ensure patients dependent on oxygen tanks who couldn’t leave shelters until they knew their next destination – whether it was home or another care facility – had a resupply of oxygen. Due to flooding and the impacts of high water on power and transportation, these resupplies were challenge. In Puerto Rico and the US Virgin Islands, every facet of healthcare preparedness and emergency management was strained during the 2017 hurricane season. The challenges of responding to patient needs on an island manifested in myriad ways. For the first time, we worked with Federal partners to support a mass evacuation of dialysis patients by helping to secure wrapround services for over 200 evacuated dialysis patients and their caregivers.

In our role as healthcare emergency managers, we worked between the private and public sectors to help the helpers. Our team focused on connecting private sector resources to public (sector) needs throughout all three major storms. In each activation, we spent countless hours on the phone and on email connecting first responders and medical volunteers with donated services and supplies, including medicines, hygiene kits, over-the-counter supplies, and behavioral health services.  Supporting first responders and those on the ground during a disaster is an important aspect of what we do, which would be impossible without the support from partners like BIO.

While there have been trying times, important progress and innovation in the field has been made. Preparedness is a moving target, but in public health and healthcare preparedness, we must keep pace with this target. We can stay closer to the target through public-private partnerships and the integration of private sector goodwill and resources into preparedness plans and initiatives. Healthcare Ready is one example of this, as is our signature resource, Rx Open. Rx Open is a one-of-kind map that displays open pharmacies in areas across the US impacted by a disaster, made possible by a collaboration between pharmacies, the National Council of Prescription Drug Programs, and Healthcare Ready.

Partnerships across the public and private sectors were life-saving during the last hurricane season. We were proud to help forge and participate in several of these, such as collaborating with ride-sharing apps to provide rides for patients at no cost and amplifying awareness of expanded prescription assistance programs. We were eager and grateful to amplify others partnerships, such as expanded telemedicine offers and millions of dollars’ worth of donations and in-kind support. Partnerships like these help enable us to act as an “invisible hand” to minimize gaps in response and recovery operations and avoid potential disruptions in care of those affected.

We are proud and grateful to count BIO as one of our longest-standing partners and supporters. Through their support and that of other private sector partners, Healthcare Ready has been able to act on our mission of building and enhancing resiliency before, during, and after disasters by creating partnerships with government, nonprofit, and medical supply chains. During blue skies and during emergencies, our partners play a critical role in ensuring we can continue to meet the needs of those impacted, even long after the storm hits.

We rely on relationships to be able to coordinate effectively during events. Between disasters, we spend our time improving based on lessons learned, and establishing new partnerships. All of this work is sustained by continued contributions from donors, partners, and members. This support is critical to ensure that our operations are in place and strong before the next disaster. There are many ways to partner with us: learn more about becoming a member, sign up for our notifications and situation reports during events, or contact us at ContactUs@HealthcareReady.org. If we can be helpful during an event, email us at alerts@HealthcareReady.org or call 866-247-2694.

[1] Progress Coordinating Government and Private Sector Efforts Varies by Sectors’ Characteristics, http://www.gao.gov/products/GAO-07-39

Dr. Nicolette A. Louissaint is the Executive Director of Healthcare Ready. Prior to this position, Nicolette served as the organization’s Director of Programming. Before joining Healthcare Ready Nicolette served as a Foreign Affairs Officer at the U.S. Department of State in the Bureau of Economic and Business Affairs. During the height of the Ebola Epidemic of 2014, Nicolette served as the Senior Advisor to the State Department’s Special Coordinator for Ebola.

Historically, federal dollars inadvertently flowed to medical research with a disproportionate focus on men’s health. There are several reasons for this. Decades ago, many scientists concluded men were easier to study because they weren’t subject to frequent hormonal changes that could complicate a study’s design or the interpretation of its results. Also, safety concerns for pregnant women once resulted in broad exclusions of women with “child-bearing potential” from many clinical studies.

The last quarter-century has brought a greater focus on the opportunity cost of uneven representation in clinical studies. When it comes to gender, in particular, we now know unequivocally that a person’s sex can influence disease presentation, diagnosis, severity and treatment.

For example, certain chemotherapy drugs have more side effects on women than men. Women may need lower dosages of certain medications due to differences in body weight compared to men. Research suggests that women may be 20 to 70 percent more likely to develop lung cancer than men who smoke the same number of cigarettes. Meanwhile, colon cancers are frequently misdiagnosed because the disease can present differently in women than men.

In 1993, Congress passed the National Institutes of Health (NIH) Revitalization Act – a federal rethinking of the participation levels of women and minorities in clinical research. The legislation was a much-needed breakthrough, but not a cure.

Today, the NIH review process treats inclusion of women and minority subjects as an indicator of a proposal’s scientific merit, and NIH staff tracks these metrics for consideration in making grant awards. Additionally, the U.S. Food and Drug Administration (FDA) has made significant strides in diversifying clinical trials conducted in the United States. The FDA launched an Office of Women’s Health Research focused on advancing the science of women’s health as well as an Office of Minority Health charged with increasing clinical trial data available on racial and ethnic minorities.

These federal efforts have helped the biopharmaceutical industry achieve substantial progress in diversifying trials, yet gaps persist. An FDA study published in July 2017 found that women represent 43 percent of trial subjects globally (and 49 percent in the United States) despite the fact that women make up more than half of the population. A cardiology study published this April, for example, found women to be under-represented in clinical trials for new medicines to treat artery disease, acute coronary syndrome and heart failure.

One way we can close the gender gap in clinical research is by promoting greater collaboration between drug developers and researchers who specialize in women’s health. Last month, I sat down with Nicole Oshurak, director of corporate partnerships at the Magee-Women’s Research Institute and Foundation (MWRI) – a Pittsburgh-based organization whose mission is to “change the world’s thinking on women’s health.”

With $40 million in NIH grants last year, MWRI is the country’s largest research institute devoted exclusively to women’s health research. Its researchers are making discoveries in reproductive biology, breast cancer genomics, fertility, and HIV immunization and prevention.

MWRI investigators conduct research studies with major institutions, universities and medical centers around the world. Now, the group is exploring industry partnerships beyond NIH funding with the hope of getting breakthroughs to more patients. This June in Boston, the institute participated in its first BIO International Convention, and Oshurak told me she was flooded with requests for business meetings by potential industry partners.

The growing appetite of drug developers to partner with women’s health researchers is a real trend – and, I believe, a harbinger of further strides to come. Companies interested in exploring women’s health collaborations should consider attending the Magee-Women’s Research Summit Oct. 9-10 in Pittsburgh, where MWRI will award the $1 million Magee Prize – the world’s largest for a scientific collaboration to advance women’s health.

One of MWRI’s most enduring contributions to medical research is its maintenance of the world’s largest maternal infant database containing information from more than 200,000 births spanning two decades. That project is part of its 9-90 research, which focuses on how human life in the womb for the first nine months can predict and change the course of a person’s health over the next 90 years.

Women may be 51 percent of the world’s population, but they carry to term 100 percent of our collective future. Patients of every age, gender and background stand to benefit significantly from medical research better calibrated to reflect this reality.

Greenwood, who represented Pennsylvania’s 8^th district in the U.S. House of Representatives from 1993 to 2005, is CEO of BIO, the world’s largest trade association representing the biotechnology industry.

Last week, the House Judiciary Committee unanimously reported the bipartisan SUCCESS Act. Co-sponsored by Representatives Adams, Chabot, Comstock, Goodlatte, Handel, Jeffries, Johnson, Nadler, Velazquez and Wagner, the bill brings together important legislative efforts long supported by BIO.

First, it directs the establishment of a joint study by the United States Patent and Trademark Office (PTO) and Small Business Administration on ways to identify best practices for increasing patenting rates for women, minorities and veterans. Secondly, the bill extends the soon-to-expire authority for the PTO to adjust the fees it relies on for funding.

Women and persons of color apply for and hold far fewer patents than white men, which is contributing to an imbalance in entrepreneurial and startup success rates and missed opportunities for American innovation and competitiveness.

To directly address this disparity, BIO’s member companies, as part of our Workforce Development, Diversity, & Inclusion (WDDI) Initiatives, have set as a goal “as an industry, [to] achieve significant increase in racial diversity, increase LGBTQ representation and achieve 50 percent representation of women at functional leader and C-Suite by 2025, (gender diversity improving from ~25 percent currently).”

We believe these goals are achievable if we all work together. BIO is hopeful that the full House will take up and pass the SUCCESS Act soon and urges the Senate to do the same.

Agricultural Biotechnology Market report describes the growth of the industry by upstream & downstream, industry overall and development, key …

September’s home maintenance chores focus on preparing your home for cool weather. Here are tips for everything from servicing your HVAC system to keeping your fireplace in top shape, along with a printable to-do checklist.

Today marks the last day of the Global Climate Action Summit  in San Francisco, California. The annual event convenes leaders, policymakers and people from around the world to celebrate, and share, the extraordinary achievements of states, regions, cities, companies, investors and citizens with respect to stopping global warming and taking climate action.

As part of this week’s festivities, BIO hosted an event along with below50 and the Low Carbon Fuels Coalition to discuss how states can implement low carbon fuel standards to reduce their transportation sector’s impact on the environment. Moreover, the event, Driving Decarbonization: How Low Carbon Fuel Standards are Transforming Transportation, Saving Lives, and Igniting Innovation, explored how these types of carbon-cutting policies can benefit more than the environment by also strengthening economies and reducing human health impacts.

Here at BIO we support initiatives that leverage low carbon and renewable fuels to reduce transportation’s impact on all things. As part of our efforts to advocate for such policies, BIO hosts events year-round, including the BIO International Convention and BIO World Congress, to help our members network and partner to DRIVE growth in the renewable fuels industry. BIO’s co-hosting of the Driving Decarbonization event is a continuation of our advocacy efforts.

Bryan Sherbacow, Chief Commercial Officer with World Energy, and panelist at the Driving Decarbonization discussion, authored the following piece illustrating the widespread positive impacts that can be gained from low carbon fuel standards. The piece hones in on California’s low carbon standard, which was implemented in 2011.

Read the full piece below, or read on BiofuelsDigest.com by clicking here.

As 2018 has made all too clear, climate change is real and it’s impacting all of our lives. July 2018 was the hottest month ever recorded in California. We have dealt with the state’s largest wildfire this summer, just one year after the state’s costliest, most destructive, wildfire season.

Across the U.S., the Northeast experienced record warm overnight low temperatures and unprecedented high humidity. Europe has been blistering this summer, marked by droughts, melting glaciers, and decreased food and grain production. Japan has also experienced record heat and deadly floods throughout the summer.

Despite the impacts of climate change appearing all around us and the broad agreement from the scientific community that greenhouse gas emissions are the cause, the federal government has withdrawn the United States from our commitments in the Paris Agreement.

As a result, it is critical for states to take the lead by implementing climate policies such as low carbon fuel standards (LCFS) to reduce the environmental impact of America’s transportation sector. Moreover, such carbon cutting policies at the state level benefit human health and grow the biobased economy.

To understand a low carbon fuel standard, it’s best to look at California as an example. California is one of two states (neighboring state, Oregon, is the other) to enact a low carbon fuel standard. Typically, these state policies set a limit to the amount of carbon that can be emitted from fuel per unit of energy, which decreases annually. To comply with the rule, fuel companies must reduce the average carbon intensity level of the fuel they sell or buy credits from low carbon fuel suppliers.

California’s LCFS considers the full life cycle of fuel when setting carbon intensity standards. The Air Resources Board calculates carbon emissions not just from combustion on the roadways, but also from production and distribution of the fuel as well.

As a result, California’s LCFS reduces the environmental impact of transportation.

Since 2011, California’s LCFS has prevented more than 13.7 billion gallons of petroleum from being combusted on the state’s roadways. This equates to avoiding 38 million tons of carbon pollution. And as we have already met our 2020 target, we look to make even more gains in the next decade by increasing the carbon reduction targets even further for 2030 and 2050.

The benefits of a low carbon fuel standard, however, extend beyond environmental impact. According to California’s American Lung Association, the state’s low carbon fuel standard has helped Californians avoid $1.84 million in public health costs and averted more than 200 premature deaths from pollution. And as the carbon intensity standards become more stringent, the health benefits stemming from the rule will increase. The state’s lung association, along with the Environmental Defense Fund, reports that by 2025 California’s LCFS, along with cap and trade, will save $8.3 billion in pollution-related health costs and prevent 600 heart attacks, an additional 680 premature deaths, 38,000 asthma attacks and almost 75,000 lost work days.

And more available work days means more capital that can be gained and invested into the economy. Furthermore, low carbon fuel standards increase investment in companies working on new, innovative renewable fuel sources that emit less carbon.

Since its implementation, California’s program has increased the value of the clean fuels market by an estimated $2.8 billion. And as investment in low-carbon fuels increases, the biobased economy – an economy that spans from the farmers in rural America growing corn and other feedstocks to the researchers identifying new processes for creating low carbon fuel to the biorefineries where the fuel is produced and distributed from – strengthens.

With the lack of concrete federal policies to reduce our environmental impact from fuel, it’s now up to the states to take the wheel and drive towards decarbonization.

States should introduce their own low carbon fuel program to reduce their transportation sector’s environmental impact, save lives, and strengthen America’s biobased economy.

At the Global Climate Action Summit this week in San Francisco, I’ll be joined by policymakers and other leaders at an event co-hosted by below50, the Biotechnology Innovation Organization and the Low Carbon Fuels Coalition to explore California’s LCFS as a model for other states and the benefits these type of fuel policies can have. Already, California, Oregon and British Columbia are reaping the benefits of such carbon-cutting policies. If more states implement a LCFS we can strategically reduce our nation’s carbon footprint in a manner that will benefit our nation’s economy, our citizens’ health and the global environment.

Bloomberg has authored an investigative piece exposing drug cost middlemen, better known as pharmacy benefit managers (PBMs), for their role in marking up prices for common drugs and pocketing the difference.

At issue is a little-known tactic called “spread pricing”, a strategy designed to pad the pockets of PBMs at the expense of the client, who in this particular case were Iowa taxpayers funding the state’s Medicaid program. As pharmacist Mark Frahm learned firsthand, what one PBM charged the pharmacy, and what the PBM then billed the state for a common prescription differed dramatically.

“For years, Frahm’s South Side Drug bought pills from distributors, and dispensed prescriptions to the Wapello County jail. In turn, the pharmacy got reimbursed for the drugs by CVS Health Corp., which managed the county’s drug benefits plan.

“As he compared the newspaper notice with his own records, and then with the county’s, Frahm saw that for a bottle of generic antipsychotic pills, CVS had billed Wapello County $198.22. But South Side Drug was reimbursed just $5.73.”

So where did the $192.00 difference go? To the bottom line of the middlemen.

“’Middlemen have to make some money, but we didn’t expect it to be this extreme,’ said Frahm, who said his pharmacy lost money in the jail account last year because CVS paid so little. ‘We figured everyone was playing fair.’”

Frahm’s case, however, is not isolated. Bloomberg analyzed the data of PBM markups in Medicaid plans around the country, finding massive spreads on dozens of drugs. For example, of “the 90 drugs analyzed, which includes more than 500 dosages and formulations, PBMs and pharmacies siphoned off $1.3 billion of the $4.2 billion Medicaid insurers spent on the drugs in 2017.”

But middlemen working behind the scenes to protect their profit margins is nothing new. In a state-commissioned report, Ohio officials found that PBMs billed taxpayers roughly $220 million more for prescription drugs than they reimbursed pharmacies to fill those prescriptions over the course of a year.

Source: Bloomberg News

Similarly, private Medicaid plans in Indiana spent more than $800 for a 30-day supply of a hepatitis B pill that cost pharmacies less than $140 to buy.

Source: Bloomberg News

As we explain in our “Follow the Pill” video, the drug cost ecosystem is more complex than most people think. Insurers and PBMs largely decide how much people pay out of pocket for the medicines they need. As Bloomberg and others have shown, the decisions these middlemen make can have costly consequences for both patients and taxpayers.

Read the full Bloomberg story here, and learn more about how the drug cost ecosystem works here.

The numbers are staggering. The opioid epidemic is costing our nation more than $500 billion annually in health and social costs. What’s more, 1 in 5 deaths among young adults in 2016 were opioid related. This crisis is plaguing communities across the country, leaving in its wake countless victims, devastated families and economic ruin.

Jim Greenwood, BIO’s President and CEO, has been on the air describing for radio listeners across the country the urgent need to spur access to, and greater innovation of, novel therapies to help treat both pain and addiction.

Don’t miss Jim’s recent radio interviews:

• The Steve Gruber Show
• The Lars Larson Show
• Jimmy Lakey Show
• The Bill Meyer Show
• WSGO Ringside Politics

And for more information about the biopharmaceutical industry’s commitment to combating the opioid crisis, please visit www.bio.org/opioid.

BidaskClub downgraded shares of Puma Biotechnology (NASDAQ:PBYI) from a sell rating to a strong sell rating in a research note published on …

Congress, the Food and Drug Administration (FDA), drug developers, researchers and patient groups have all recognized the contribution patients and caregivers can make to the drug development process. Since 2012, the FDA has incorporated the patient’s voice in disease-specific “patient-focused drug development” (PFDD) meetings to help inform the regulatory drug approval process. Who better to tell the story of how a disease manifests, or what they are experiencing on a daily basis or what side-effects are emerging from certain treatments.

Just as regulators and drug developers need and want to hear from patients, the patients, themselves, are anxious to hear about the latest developments and policies that can impact their lives. By staying informed on the latest policies, and by engaging across stakeholder groups, patient advocacy organizations serve as the voice of patients they represent, ensuring access to care and support for the pathways to effective treatment.

This October, BIO invites patient advocacy organizations to engage with the entire array of stakeholders in the drug development journey, from regulators to researchers to biopharma companies. The Patient and Health Advocacy Summit will run October 25 – 26 at the Park Hyatt hotel in Washington, DC.  During the two-day Summit, attendees can meet with other groups to learn best practices and hear from expert panelists on patient access and affordability and ways to support the discovery of new and safer treatments for pain and addiction.

This is the seventh year BIO is hosting the summit. Dean Suhr, President of the MLD Foundation has attended in the past and had this to say about the event: “The BIO Patient & Health Advocacy Summit is a very powerful intersection of pharma, biotech, and advocacy. The exchange of challenges, ideas, concerns, and opportunities at this BIO conferences is a very powerful force in refining the perspectives, thinking, and impacting future plans of those attending. The setting is modest in size allowing not just for superficial networking, rather there is time and space for in depth conversation and follow-up.”

Enhancing conference networking is BIO One-on-One Partnering™.-a unique and efficient way to schedule individual meetings with other attendees. The versatile program allows users to create profiles and send meeting requests. When the meeting is accepted, the program schedules the meeting.

Registration for the BIO Patient and Health Advocacy Summit is open.

The event is made possible through the generous contributions of our sponsors.

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Sponsors as of September 6, 2018