Impel NeuroPharma has appointed Ellen Lubman to serve as its chief business officer. Lubman comes to the Seattle biotech from Allergan (NYSE: AGN), where she was vice president of external science and innovation. Impel develops drugs that can be delivered through the nose to the brain. The company’s lead drug, INP104, is in late-stage testing for acute migraine.
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Joanne Kotz has been named CEO of Jnana Therapeutics. Kotz, a co-founder of Jnana, had been president of the company since last December, when it raised $50 million in Series A financing. Jnana is researching drugs that target solute carrier transporters, proteins that move substances across cellular membranes.
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[Source: http://ec.europa.eu/health/ageing/innovation/index_en.htm] Identifier: JUST-AG-2017Pillar: Justice programme 2014-2020Opening Date: Deadline: Tue, 19 Sep 2017 17:00:00 (Brussels local time)Modification Date: Thu, 8 Nov 2018Latest information: The call results and the abstracts of the selected projects are published under section Topic conditions – Additional Documents.
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.
Serial entrepreneur Mike Grey is launching a biotech enterprise with $120 million in new funding to advance two investigational liver disease drugs-one of which he has worked to develop before.
Called Mirum Pharmaceuticals, the startup is developing a compound, maralixibat, to treat Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC), genetic liver disorders that affect primarily children. Mirum plans to move maralixibat, its lead drug, into a Phase 3 trial next year.
Mirum’s clinical trial development will be based out of the Bay Area, where the company’s headquarters are set to be located. Grey and some of his former Lumena… Read more »
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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.
A product that reduces emissions from farm animal waste? There’s now a drug for that.
The FDA has approved an Elanco (NYSE: ELAN) drug developed to reduce the ammonia gas released from cattle manure. The agency says its Tuesday decision on the product, lubabegron (Experior), marks the first time it has approved a drug that reduces gas emissions from either an animal or its waste.
Agriculture accounted for 9 percent of the country’s greenhouse gas emissions in 2016, the most recent Environmental Protection Agency figures available. The top two sources of U.S. greenhouse gases are transportation and electricity production, with… Read more »
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[Source: http://ec.europa.eu/health/ageing/innovation/index_en.htm] Identifier: H2020-FETPROACT-2018-2020Pillar: Excellent ScienceOpening Date: Deadline: Thu, 22 Mar 2018 17:00:00 (Brussels local time)Modification Date: Wed, 7 Nov 2018Latest information: 1 proposal was submitted to topic FETPROACT-04-2019 “Community building and roadmapping for high performance and smart electrochemical energy storage” of call H2020-FETPROACT-2019-1.
BlackThorn Therapeutics has promoted Bill Martin to president and chief operating officer. Martin had served as the San Francisco company’s chief scientific officer. He succeeds Greg Vontz as president. Vontz, who also held the role of CEO, has left the company.
In other moves, BlackThorn appointed Paul Berns, a venture partner at ARCH Venture Partners, to the board of directors as its executive chair. BlackThorn, which is developing drugs to treat neurobehavioral diseases such as obsessive compulsive disorder and schizophrenia, closed its $40 million Series A round in 2016.
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