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Gerard Butler came home to find what many Californians are discovering in the middle of raging wildfires across the state — his home has been burned to ashes. The “300” star posted a devastating photo Sunday showing his Malibu home burnt to a crisp. He…

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Standing water in your yard is an eyesore and can act as a breeding ground for mosquitoes. Installing a French drain is a great way to remove standing water from your yard. Watch this video to find out how to construct a French drain.

The biotech industry recently realized its 300^th IPO since the Jumpstart Our Business Startups (JOBS) Act was enacted in 2012. This marks an important milestone for our young and quickly growing industry, culminating in $25 billion raised by promising companies developing potentially life-saving medical advances. Over 18 percent of these companies have a lead drug candidate that targets a rare disease, and companies developing novel therapeutics to address cancer, neurology disorders, and infectious diseases make up almost half (46 percent) of these newly public companies. In that sense, the JOBS Act did more than spearhead capital formation for innovative startups-it channeled historic investment volumes into some of the most promising companies developing treatments for some of the most daunting health challenges of our time.

In just six years, the JOBS Act has left a significant imprint on the biotechnology industry by significantly accelerating the pace of biotech IPOs, which is up 270 percent since the same period before its enactment. For emerging growth companies (EGCs), the JOBS Act strikes an important balance between easing the ability of early-stage biotechs to access public capital markets while keeping important investor protections in place.

And I’m happy to say that 2018 so far has been a banner year for EGCs, with 53 companies going public year-to-date – the second-best year for issuances since the law’s passage.

While the JOBS Act has helped pave the path for an unprecedented number of innovative biotechnology companies to go public, additional reforms are necessary to allow these companies to stay public.

One of the most important provisions of the JOBS Act is a temporary five-year exemption for qualifying companies from Sarbanes-Oxley section 404(b) requirements for an auditor attestation of a company’s internal controls over financial reporting. As helpful as the five-year exemption is, the fact remains that the biotech development timeline is a decades-long affair.  Many of the biotech companies that have gone public as EGCs under the JOBS Act remain in the lab and clinic when their five-year exemption expires, and they are forced to divert hundreds of thousands of dollars away from research and development toward superfluous financial disclosures that do not benefit their investors.  In just two short months, at the dawn of 2019, over 80 emerging biotech companies will lose their EGC status and be forced to siphon off funds from clinical trials and research and development towards an additional audit that often doubles their financial reporting costs without improving investor confidence in their companies.

BIO calls on the Senate to build on this success by passing the bipartisan Fostering Innovation Act (S. 2126/488), which would extend important regulatory relief to JOBS Act companies that maintain a public float below $700 million and average annual revenues below $50 million. Extending this regulatory relief provision would allow growing companies to focus their capital on groundbreaking R&D, rather than one-size-fits-all disclosure requirements.

The road to 300 wasn’t easy, but America’s small business innovators have fought tirelessly to bring medical breakthroughs like gene therapy, immunotherapy and RNAi therapy to the market. By continuing to adopt sensible capital markets reforms like the Fostering Innovation Act, Congress can support the innovation economy, helping patients to benefit from America’s unparalleled biopharmaceutical research ecosystem.

On Friday, November 2, the U.S. government joined 12 other nations in supporting policies that enable agricultural innovation, including gene editing.

This support was reflected in a statement titled “The International Statement on Agricultural Applications of Precision Biotechnology,” which was led by Argentina and released at a meeting in Geneva at the World Trade Organization Committee on the Application of Sanitary and Phytosanitary Measures. Both the U.S. Department of State and Agriculture issued statements, welcoming the U.S.’s sign-on.

The non-binding statement presents several principles that each country agrees to follow in order to create an international system that is harmonized on how to regulate products of precision biotechnology, including gene editing.

The statement is in response to frequent regulatory roadblocks that companies can face when developing agricultural applications of precision biotechnology – whether for plants or animals.

Gene editing can create highly beneficial products to more quickly meet consumer and societal needs by using the natural potential within an organism, without introducing any foreign DNA.  Examples include healthier cooking oils from gene edited crops and disease resistant, enhanced welfare animals.  In many instances, identical products could be achieved using traditional breeding and brought straight to market, but if the same product was made through a gene edit it may be met with increased regulatory process simply because of the difference in method to achieve the same result.

By aligning regulatory approaches across the globe, the U.S. hopes to create an international regulatory environment that does not hinder agricultural products just because they were developed through gene editing as opposed to conventional breeding.

Here in the U.S., USDA has taken a science-based regulatory approach to gene edited plants because the agency understands that many of these products are the same as those developed through conventionally breeding – just using a modern and more precise method.

In a statement published in March, USDA stated with respect to pre-market regulatory approval processes “USDA does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional [conventional] breeding techniques…”.  USDA still retains the authority to regulate many of these products once in the market if any problems should arise.

But USDA isn’t the only U.S. agency with some oversight of products of agricultural innovation.  The Environmental Protection Agency and the Food and Drug Administration may have a role to play, too, and the picture at USDA’s sister agencies isn’t very clear.

The Environmental Protection Agency takes responsibility in regulating plants that have been developed to carry pesticide-like traits (plant incorporated protectants) – but not if achieved through conventional breeding.

Recently, EPA noted they are evaluating gene editing technology and whether such products should fall within their oversight. So, the question becomes: Will they regulate gene edited plants that are identical to those made through conventional breeding? We don’t know, but if they do it would conflict with the international statement that the U.S. has signed on to.

As the International Statement states, “In either case [whether through conventional breeding, transgenic mutation or gene editing], the food, animal, and environmental safety of such products can be adequately addressed by existing regulatory frameworks for agricultural products and existing safety standards based on the characteristics of the product or organism.”

Translation: plants with pesticide-like characteristics developed through gene editing should be judged on what they are as a product and not on the method to achieve them.  And since the product in many cases will be the same as ones that already exist or that could be created through traditional methods, they should be treated the same way from a regulatory perspective.

Therefore, EPA should not be regulating plants just because they were made through gene editing. If they were to follow the international statement, they would be more aligned with USDA’s approach: they would not require a pre-market approval process for products identical to those that could be created through traditional methods but would retain the authority to regulate if a problem arose.

The U.S. Food and Drug Administration may also have role to play in oversight of products of agricultural innovation.  For plants, FDA has not yet publicly stated how it intends to oversee products developed using gene editing.  Regarding gene edited animals, the FDA has carved out a regulatory position that treats these products as “new animal drugs,” a stance that is arguably inconsistent with the recent international statement.

However, the FDA recently announced a “Plant and Animal Biotechnology Innovation Action Plan,” which the agency says, “aims to implement and clarify risk-based policies with the goals of ensuring that developers know what they need to do to efficiently bring a product to market.” Through this program, BIO hopes the agency will establish a right-sized regulatory approach for gene editing, similar to that of USDA and consistent with the broader international statement

The international statement was drafted because gene editing is so new, and the international community has yet to get on the same page as to how to establish appropriate oversight.  BIO strongly supports the principles articulated in the international statement and encourages the adoption of these principles by governments around the world-including our own.

TOKYO — Pharmaceuticals and biotechnology topped the list of output growth across 19 sectors in Asia this October with a sharp expansion that hit an …

In a new blog post at the GMO Answers Medium page, GMO Answers volunteer expert Dr. Elizabeth Hood details the benefits of GMOs for growers, consumers and the environment. She explains how genetically engineered crops help not just farmers and consumers, but the planet, too.

She writes

The first GE plants had new characteristics that made them resistant to environmental conditions. One of the very first improved crops through genetic engineering saved the papaya industry in Hawaii.

Anyone who has ever been to Hawaii has been introduced to this wonderful, orange, creamy-fleshed fruit. However, if not for genetic engineering, this fruit would not be available.

and

Another example of how GE can help the environment (and farmers and consumers) is through control of insects.

Organic farmers use a bacterium to combat insects by sprinkling the bacterium on the leaves of their plants. Genetic Engineers took this a few steps further by taking the bacterium’s genes (called Bt genes) that kill insects and putting them directly into the plant. The bacterium has more than 50 genes that kill insects.

By learning which ones kill which insects, scientists can make the plant resistant to their most damaging predators. Bt genes in corn, cotton, soybeans and eggplant (as well as other traits) have removed 6 million tons of pesticides from the environment.

To learn more about how GMOs help the environment, please visit the GMO Answers Medium page, and the GMOs and the Environment section on the GMO Answers website.

Customising the Bio Technology to identify only the retinal blindness gene mutations has been made possible by support from the Dis-Chem …

Central AC units are a convenient option for bigger homes. Find out about the common issues and DIY fixes of these units.

In a world of continual innovation in biopharmaceuticals, how do we ensure patients have access to the medicines that work to meet their individual needs?

On Day 1 of BIO’s Patient and Health Advocacy Summit, a group of health care stakeholders joined Merck’s Dr. Julie Gerberding for a discussion about the importance of understanding policies that may stand between patients, and the treatments they need. Panelists included:

• Carl Schmid, The AIDS Institute
• Donna Cryer, Global Liver Institute
• Alan Balch, Patient Advocate Foundation and National Patient Advocate Foundation
• Anna Hyde, Arthritis Foundation

The group touched on topics ranging from the acceleration of high patient cost-sharing and barriers to patient assistance programs, including co-pay accumulators, to the adoption of utilization management tools like step-therapy, and the drive toward using cost-effectiveness analyses in coverage decisions.

Early in the discussion, Carl Schmid was asked about co-pay accumulator programs and the challenges they pose to patients and consumers. “These policies are usually buried in the plan documents, so people don’t even know that they are being subject to this practice,” he told the crowd.

As he explained, insurance plans and pharmacy benefit managers (PBMs) have started to implement these policies, which prevent funds provided by financial assistance programs offered by drug manufacturers, from applying to a patient’s out of pocket maximum or deductible. This can leave patients with steep costs when the value of patient assistance is exhausted. “We’re very concerned that it could impact adherence and lead to people not picking up their drugs,” he concluded.

Next, Donna Cryer shared her concerns about step therapy and explained why this policy – often referred to as “fail first” – could be dangerous for patients. “Step therapy requires that you try a drug that is something different from what you and your doctor have agreed upon,” Cryer explained while providing detail about this practice, which is used as a tool to drive a patient towards a lower cost treatment. “It is well documented in literature that patients who are subjected to step therapy or fail first utilization management tactics experience delays in care … and that is not appreciated,” she added.

To close out the session, Dr. Gerberding initiated a discussion on the Trump Administration’s American Patients First Blueprint. While the group agreed that the proposal is far from perfect, Dr. Alan Balch noted that we must “identify the pieces that we think are beneficial and will help patients, and then extrapolate … them across the board.” Balch continued, “it’s not enough to only give patients access to information about drug prices … it’s their surgery costs, diagnostic tests, hospital costs” that need to be shared as well. “There must be a common denominator, so everyone is playing under the same set of rules.”

Anna Hyde with the Arthritis Foundation echoed these comments, adding that “while we talk a lot about patient impact and patient centeredness, there is a shift in thinking that hasn’t happened yet. Not enough people who develop and implement policy ask themselves the questions of ‘What is the impact to the patient? Is this going to be a net benefit to the patient?’” On how to make that shift happen, Hyde concluded “every piece of the ecosystem” has to think about these questions, “not just the patient community, but the provider community, the pharmaceutical community, [and] the payer community … so that it becomes a more standard way of thinking.”

To watch the full panel discussion, click here. To learn about other sessions that took place at BIO’s Patient and Health Advocacy Summit click here.

A recently announced agreement between the New Jersey Economic Development Authority and the Israel Innovation Authority is a fitting testament to the theme for the upcoming BIO 2019 International Convention: It Starts with One.  In the intensely innovative biotechnology space, one meeting; one interaction; one study, one partnership, one discovery, or one presentation can change the trajectory of progress.

On October 11, 2018, the New Jersey Economic Development Authority and the Israel Innovation Authority (IIA) signed a Memorandum of Understanding that was initiated from conversations held at the 2018 BIO International Convention in Boston.

The relationship began when Choose New Jersey CEO Jose Lozano attended a presentation given at the June Convention by long-term conference attendee, IIA, ROI reports. Impressed by the presentation, Lozano and his team connected with IIA staff before the end of the conference and the rest was history.

The October memorandum was signed days before New Jersey Governor Phil Murphy set out on a nine-day global economy mission with an important stop in Israel. The partnership encourages collaboration between New Jersey corporations and Israeli businesses- specifically it aims to strengthen research and development of the innovation economy, including the biotechnology and the life sciences industries.

In a press release on the memorandum, Governor Murphy noted,

“The Garden State and Israel both have economies deeply rooted in innovation as well as brilliant scientists, researchers, and academic minds doing ground-breaking work across a broad spectrum of high-growth sectors. The New Jersey-Israel relationship already generates more than $1 billion in annual shared economic activity and we hope that, as a result of this MOU, that number will double, if not triple, in the years ahead.”

To read more about the partnership between New Jersey & Israel, visit:

• New Jersey & Israel Sign Agreement to Strengthen Economic Ties
• Innovation is the Theme of Governor Murphy’s First Full Day in Israel

This is only one of the many cross-border collaborations that have stemmed from the educational, networking, and partnering opportunities at the BIO International Convention.

As the world’s largest biotechnology event, the BIO International Convention attracts 16,000+ global biotechnology and pharma influencers for one week of intense networking to discover new opportunities and promising partnerships. Event attendees can connect with global counterparts in the industry to foster new breakthroughs in innovation that help us heal, fuel, and feed the world.

To engage in similar types of networking and collaborative partnerships, attend the 2019 BIO International Convention hosted in Philadelphia, PA. Click here to learn more.