Category Archives: Biotechnology

CAMBRIDGE, Mass., April 12, 2017 /PRNewswire/ --ReadCoor, Inc. today announced that an article appearing in the April 2017 issue of Nature Biotechnology named the company among the 10 leading academic spinouts for 2016. Each year the journal identifies and features companies originating from academic institutions who have generated significant initial funding and who in the editors' assessment have demonstrated novel, potentially disruptive technology. In the words of the journal, "We believe these [ventures] represent some of the best science coming out of academia in 2016."

"It is a tremendous honor to be included in this group of amazing technologies and companies," said Shawn Marcell, ReadCoor co-founder and CEO. "The team at ReadCoor is excited to deliver on the promise this revolutionary platform holds."

The ReadCoor platform, called FISSEQ Fluorescent In-Situ Sequencing is the first application of in-situ spatial sequencing. ReadCoor was founded in 2014 by Richard Terry and George Church at the Harvard Wyss Institute, to bring Fluorescent In-Situ Sequencing into mainstream research use. Several key applications are being advanced including pathogen detection under a grant provided by the Bill & Melinda Gates Foundation, brain mapping or neural connectomics funded by IARPA, and drug development in areas such as central nervous system, neurodegenerative diseases, oncology, immunotherapy and gene therapy. Unlike traditional sequencing technologies, ReadCoor provides a method to pinpoint the precise locations of specific RNA molecules in intact tissue.

About ReadCoor

ReadCoor is leading the next generation of "omics" by delivering the first panomic spatial sequencing platform to researchers, clinicians, pharma and diagnostics companies, and ultimately patients. It is spearheading the charge with Fluorescent In-Situ Sequencing, a fundamental innovative technology that simultaneously integrates high throughput next generation sequencing, morphometric tissue analysis and three-dimensional spatial imaging. This uniquely powerful tool is the first and only implementation of "In-situ Sequencing" and will revolutionize the next phase in understanding the transcriptome, introducing vast new opportunities for important and meaningful clinical insights.

Contact Sam Inverso ReadCoor, Inc. Readcoor.com (617) 453-2660

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http://www.readcoor.com

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Nature Biotechnology Features ReadCoor as a 2016 Leading Spinout - PR Newswire (press release)

Biotech

Prof. Benjamin Ubi, the President, (BSN), says the adoption of biotechnology will facilitate sustainable agricultural production in the country.

Ubi made the declaration in an interview with News Agency of Nigeria (NAN) in Abuja on Thursday

He said that the adoption of biotechnology applications was the panacea to the current food challenges facing the country.

Biotechnology, including genetic engineering and production of Genetically Modified Organisms (GMOs), provides powerful tools for the sustainable development of agriculture, fishery and forestry, as well as meeting the food needs of the population.

GMOs currently account for about 16 per cent of the worlds crops, particularly crops like soybean, maize, cotton and canola, and there are indications that the growing trend will continue.

So, we must eat what we grow and grow what we eat. This means we ought to produce more and agricultural biotechnology is a tool for achieving this, he said.

Ubi also pledged the support of the BSN for the efforts of National Biosafety Management Agency (NBMA) to harness the potential of modern biotechnology.

READ: Kwara International Vocational Centre gets equipment

BSN, as a stakeholder in biosafety, will continue to support NBMA; we should all be rest assured that no biotechnology product will be imposed on anyone.

Hunger and peace work hand-in-hand, so lack of hunger consequently promotes peace; therefore, biotechnology and its derivatives should be adopted for the benefit of Nigerians, while maintaining regulatory standards.

Biotechnology and biosafety stakeholders must, therefore, work in tandem with global bodies because Nigeria is not a pariah nation; we are a responsible and respected member of the global community, he said.

Ubi urged anti-GMO campaigners not to play politics with issues that could engender food security and alleviate poverty, saying that tangible efforts should be made to enhance the availability and affordability of high-quality foods via biotechnology applications.

I assure all that modern biotechnology had been found to be safe by global certification bodies.

All the same, informed criticism is good for checks and balances but it should not be allowed to be a clog the wheel of progress, he added.

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Expert: Biotechnology will aid sustainable agricultural production - P.M. News

The Pennsylvania Biotechnology Center on Wednesday broke ground on a long-awaited expansion that will add laboratories, office space and at least 100 new jobs to its campus in Buckingham.

"This has become a real state resource," said biotechnology center President Timothy Block. "We can't exist in these two buildings anymore. We need to grow."

Because of the center's success, it's been a draw for scientists and entrepreneurs throughout the region. Lab space is at a premium, and there's a waiting list for tenants. The new wing is already 40 percent leased, Block said.

The first tenant, contract research organization FlowMetric Inc., credits the center with its growth. The company now has three dozen employees.

"I could have set up my company in New Jersey. But there was no place that was quite like this, and that has continued for us," said CEO Ren Capocasale.

"This center is why I do what I do."

While construction likely won't begin until the summer, biotech center officials chose Wednesday for the ceremonial groundbreaking in part because it also happened to be the 96th birthday of Joshua Feldstein, a longtime supporter for whom a wing of the center is named.

Feldstein was on hand for Wednesday's event, seated among a variety of state and local dignitaries that included state Rep. Marguerite Quinn, R-143, Doylestown, and state Sen. Chuck McIlhinney, R-10, Doylestown both longtime supporters of the center and Congressman Brian Fitzpatrick, R-8, Middletown.

"This is not a Republican or Democrat thing," said Quinn. "We've had support from both sides of the aisle, recognizing what you do here: jobs, cures and research. Well-paying jobs and phenomenal research."

First proposed in 2015, the expansion project stalled during a dispute between the Hepatitis B Foundation and Delaware Valley University. Unhappy with how the foundation was running the center's day-to-day operations, the university refused to sign off on the expansion plans.

The final project will cost between $12 million and $13 million, center officials said. That will be offset by a $4.6 million grant from the federal government and a $2 million state grant. The rest will be financed with a conventional loan awarded by Univest Bank.

Officials on Wednesday, however, weren't just celebrating the expansion. They were thinking about the future.

"We need to be thinking about what the next thing we're going to put the shovel in the ground (for) here with what's happening here," said Bucks County Commissioner Rob Loughery.

Block envisions a biotechnology hub within Bucks County one that equals the well-known Kendall Square area of Boston.

"There is a resource in Bucks County as vital and powerful, with as much potential, as the shale under the earth here," Block said. "That's what we're going to tap into."

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Pennsylvania Biotechnology Center begins long-awaited expansion ... - Bucks County Courier Times

SECAUCUS, N.J.--(BUSINESS WIRE)--

Caligor Opco LLC, which specializes in early access to medicines and drug life-cycle management, today announced that it will provide regulatory and logistical management for Puma Biotechnologys (PBYI) expanded access program (EAP) for its investigational breast cancer therapy, PB272 (neratinib), in the United States.

The U.S. Food and Drug Administration (FDA) permits expanded access to investigational drugs for treatment use for patients with serious or immediately life-threatening diseases or conditions who do not otherwise qualify for participation in a clinical trial and lack satisfactory therapeutic alternatives.

The EAP will provide access to neratinib for the treatment of early stage HER2-positive breast cancer (extended adjuvant setting), HER2-positive metastatic breast cancer and HER2-mutated solid tumors. Patients must not be able to participate in any ongoing neratinib clinical trial to qualify for the EAP. Caligor also is providing regulatory, logistical, and supply chain support for Pumas Managed Access Program for neratinib outside the United States.

We are gratified by the trust and confidence Puma has placed in us, said Tammy Bishop, Caligors Chief Commercial Officer. Within the past year, the FDA has introduced a streamlined application process and new guidance designed to improve its expanded access programs, and those initiatives have been extremely positive. We look forward to working with regulators and physicians to facilitate access to neratinib for patients who may benefit from this therapy.

About the Neratinib Expanded Access Program

The neratinib EAP is a program for U.S. patients with early stage HER2-positive breast cancer (extended adjuvant setting), HER2-positive metastatic breast cancer and HER2-mutated solid tumors. This EAP is being administered on behalf of Puma by Caligor Opco. U.S. healthcare professionals seeking more information about the neratinib EAP can email neratinibUSA@caligorrx.com for additional information. Patients who are interested in enrolling in the neratinib EAP should speak with their physician to determine if neratinib is an appropriate option. Neratinib is an investigational agent and, as such, has not been approved by the FDA or any other regulatory agencies in any markets.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidatesPB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2.

Further information about Puma Biotechnology may be found at http://www.pumabiotechnology.com.

About Caligor

Caligor Opco LLC, a portfolio company of Diversis Capital, LLC, is a global company that manages the regulatory, logistics and supply chain needs for global access programs as well as the sourcing, storing and distribution of comparator drugs for clinical trials. Caligors global access programs help to meet the medical needs of patients worldwide by providing access to medicines in situations where the drug has not yet been approved, or is otherwise commercially unavailable. In addition, through its proprietary TrialAssist program, Caligor optimizes its services by providing for labeling, QP certification, storage, distribution and destruction of clinical trial and unlicensed medicines managed in the access programs. The company serves pharmaceutical and biotechnology companies from facilities in Secaucus, New Jersey and Dartford, UK, as well as strategically situated depot locations worldwide. More information is available at http://caligorrx.com.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170412005708/en/

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Caligor to Support Puma Biotechnology's Expanded Access ... - Yahoo Finance

By Nicolas Chahine, InvestorPlace Contributor|Apr 13, 2017, 12:59 pm EDT

The iShares Nasdaq Biotechnology Index (ETF) (NASDAQ:IBB) has been under technical pressure. For the past few weeks, IBB shares have been building a bearish head-and-shoulders pattern. To catch that breakdown I shared a trade that will do it for free, and its working already.

In the short term, the IBB ETF is tight, suggesting that a sizable move should be coming. But with no major changes in the thesis, the breakout from the current squeeze is more likely up than down. So for that reason, I want to book my small profits in the bearish setup and reset a long IBB trade for the next year.

The Bet: Sell the IBB Jan 2018 $240/$235 credit put spread. This is a bullish trade for which I collect 90 cents per contract to open.

I have a 90% theoretical chance of having it expire for maximum gains. If IBB shares close above $240, this trade would yield 20% on money risked.

By taking this risk, I accept the fact that IBB shares could fall $20 or more in the next few weeks. But with a 20% price buffer and the amount of time until expiration I am confident that I will be able to manage the short term price challenges.

Click to Enlarge The fundamentals of the components of the IBB are, for the most part, solid after all.

I also have to acknowledge the political threat that still looms from President Donald Trump. He has vowed to address the pricing models of biotech and healthcare sectors. If not for these threats I would have sold the bet as naked Jan 2018 $220 puts for $5 per contract instead. But given that we are near all-time highs in addition to the aforementioned threats, I will start the trade as a spread then decide if I want to turn it into a naked put position.

Learn options as easy as 1-2-3 here. Nicolas Chahine is the managing director of SellSpreads.com. As of this writing, he did not hold a position in any of the aforementioned securities. You can follow him on Twitter at @racernicand stocktwits at@racernic.

Article printed from InvestorPlace Media, http://investorplace.com/2017/04/ishares-nasdaq-biotechnology-index-etf-ibb-etf-confidence/.

2017 InvestorPlace Media, LLC

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Go Long the iShares Nasdaq Biotechnology Index (ETF) (IBB) ETF With Confidence - Investorplace.com

In our fast-moving world, biotech is at the forefront of developments but, by its very nature, it can provoke ethical and moral concerns.

The European Patent Office (EPO) has faced opposition in the past, for instance, over patents relating to processes for re-engineering genes, for use in medical research into cancer treatment. These processes could apply to various animals, including great apes and that became a magnet for criticism from animal rights campaigners.

The number of patent filings for biotechnology increased by 0.3 percent in 2016, to 5,744 making it the tenth largest sector in its field.

Youris.com spoke to Benoit Battistelli, President of the EPO, about the role of patent protection and how it can aid biotechnology innovation and the wider bioeconomy despite the obstacles faced by some.

Benoit Battistelli -Courtesy of EPO

How much of a focus is the bioeconomy for patents and what are some of the key developments? Biosciences play an important role in patent applications at the EPO, given the growing convergence of technologies, which is widely responsible for technical progress in a wide number of sectors. Such inventions are mainly found in industrial biotechnology, for instance, in the development of novel products such as new detergents, functional food or even new eco-friendly material in construction, such as pollution-eating concrete and self-healing concrete.

The area of clean energy production is also very important. For example, when it comes to using biomass as an energy source [editors note: In 2011, a Danish inventor won a European Inventor Award organised by the EPO for developing a system which increases the types of biomass fuels that can be used. Typically, biomass materials have to be dried before they can be used as fuel, but Jens Dall Bentzens furnace design can also burn materials with a moisture content of up to 60 percent. Hes since reported to have attracted interest from Europe and the US, selling the furnace to an American manufacturer, as well as building two others for use in Denmark].

Is the bioeconomy an increasing sector? Biotech is among our top ten technical fields and it has increased. At the end of the patent granting process, its about 50 percent on average that become a patent. Its only 26 or 27 percent in the case of biotech. Why? Because it is a very sensitive issue and we are applying the patentability criteria very rigorously. There are huge European capacities in biotech and we have seen that we must find a good balance between the regulatory constraints and the economic capacities that this sector represents.

The position of the EPO is very clear and simple. There is an EU directive concerning biotech, which we respect and which we have integrated in our own legal framework, the European Patent Convention. Then you have the interpretations of the Directive by the European Court of Justice and we adapt our practice to these judgements.

Overall, how complicated is it to obtain a patent, and is it expensive? I would not say that it is complicated, but it is a difficult process, because we always start from the basis thata patent is an exception to the principle of free trade, free industry, free competition. Globally, for around20 to 25,000 euros, you can obtain a patent as the EPO. For this amount, 5,000 euros are the EPO fees and the rest is the fees of those who helped to draft a patent and then discuss it with the patent office.

So, with a patent, you are giving the holderthe exclusive right of commercially exploiting his invention, for a certain period of time, amaximum 20 years.

This article is part of the communication of theProBIO project, a support action for KBBE projects which identifies research results to facilitate their uptake into the relevant sector.

youris.com provides its content to all media free of charge. We would appreciate if you could acknowledge youris.com as the source of the content.

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Biotechnology: navigating a minefield - Youris.com

Technical Roundup On Two Stocks - Puma Biotechnology, Inc. (PBYI), Diamond Offshore Drilling, Inc. (DO) Post Analyst Puma Biotechnology, Inc. has a consensus outperform rating from 7 Wall Street analysts, and the number of shares currently sold short amount to at least 27.36% of shares outstanding. The stock sank -19.31% last month and is up 17.75 this year. Wall ... and more »

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Technical Roundup On Two Stocks - Puma Biotechnology, Inc. (PBYI), Diamond Offshore Drilling, Inc. (DO) - Post Analyst

Puma Biotechnology, Inc. (PBYI) recently sold by insider CHARNAS ROBERT Post Analyst Puma Biotechnology, Inc. (NASDAQ:PBYI) reached 85.92% versus a 1-year low price of $19.74. The stock was last seen 2.95% higher, reaching at $36.7 on Apr. 10, 2017. At recent session, the prices were hovering between $35.24 and $37.8. This company ... Brokerages Anticipate Puma Biotechnology Inc (PBYI) Will Post Quarterly Sales of $0.00The Cerbat Gem Puma Biotechnology Inc (PBYI) Expected to Announce Earnings of -$1.86 Per ShareBBNS Puma Biotechnology, Inc. (NYSE:PBYI): Trader Update on the ...Midway Monitor Sports Perspectives -NYSE Journal (press release) all 15 news articles »

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Puma Biotechnology, Inc. (PBYI) recently sold by insider CHARNAS ROBERT - Post Analyst

President Macky Sall of Senegal has thrown his weight behind the adoption of agricultural biotechnology in the country.

.

President Sall made it clear that he supported the implementation of biotechnology in Senegal provided necessary measures to minimise risks were taken.

Macky Sall

I must say very clearly that I am for the use of GMOs based on the precautions taken and based on a dynamic regulation, otherwise we would be against progress. We must decide and step forward. We need to move forward because we have food security imperatives.

It is undeniable that GMOs can help meet current challenges, such as food insecurity, public health issues, natural resource conservation and climate change, he stressed.

We need serious thought to develop a strategy to maximise the use of GMOs, while mitigating the risks associated with them. That is why it is necessary to strengthen the National Biosafety Authority and to have an appropriate legal system combined with an efficient information system based on objective scientific values to assess the cost/benefit/risks ratio, he further stressed.

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post:GMOs: Senegal supports adoption of agric biotech

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President of Senegal bucks anti-biotechnology pressure: 'I am for the use of GMOs' - Genetic Literacy Project

[The following is the first part of anInformation Technology and Innovation Foundation report.]

New techniques for improving plants and animals promise to reshape virtually every aspect of the relationship between humans and our environment for the better. Safer and more sustainable crops have already made enormous contributions to the economy and the environment, and genetically improved livestock and companion animals are close behind. Discovery of more precise, predictable, and easily used techniques derived directly from nature is dramatically accelerating this progress. But fears of the new have led to calls in many nations for precautionary regulation, which risks stifling agricultural innovation without any showing of need or benefit. There is a better way. This report discusses proposals for updating policies and regulations for agricultural biotechnology products in the United States to ensure they safeguard

This report discusses proposals for updating policies and regulations for agricultural biotechnology products in the United States to ensure they safeguard public and environmental health and animal welfare without discouraging needed innovations. An authoritative review of 10 years worth of academic literature has found that the scientific research conducted so far has not detected any significant hazards directly connected with the use of [genetically engineered] crops. This experience is evidence that the time is long past due for significant regulatory rollback in this field around the world. Good advice has already been offered as to the best ways for updating these regulations. Not all of it has been followed yet, leaving numerous opportunities for improvement by the new administration. This report recommends the following reforms:

BACKGROUND The single biggest obstacle slowing the wider dissemination of the considerable benefits from agricultural biotechnology innovations is unwarranted regulatory burdens across the world. The disparity between the degree of hazard or risk associated with these innovations and the regulatory hurdles they must clear has widened everywhere over the past three decades from a gap to a chasm. This has happened even while experience has shown that early safety concerns were unfounded, and that the predictability and safety associated with these innovations has been shown to be unmatched by the products of any other production method.

What Is Agricultural Biotechnology and Why Should We Care? Innovations in agriculture are being delivered today through a host of different techniques referred to with a baffling array of labels: recombinant DNA, genetically modified organisms (GMOs), genetic modification (GM), gene editing, CRISPR, TALENs, Zinc Fingers, meganucleases, advanced breeding, new breeding technologies, precision agriculture, big data, remote sensing, and more. There is some overlap among these terms both vis--vis the subject matter they cover and the ways in which they are used, but misunderstanding is widespread, and scientific justification for some of these terms is lacking or altogether absent.

When scientifically nonsensical terms are used as the foundation of discriminatory regulations, without due regard for hazard or risk, the resulting policies do not advance the protection of public and environmental health. This is the case for any and all regulations that single out GM processes or GMOs for regulatory scrutiny. Scientists and policy mavens spent years examining these issues in the late 1970s and early 1980s. They reached consensus that the process of genetic modification tells regulators nothing useful about any possible hazards of the resulting product, or the risks associated with different levels of exposure; these require consideration of the final characteristics and qualities of a productits phenotype. To use an example from manufacturing, a products safety does not depend on how a chemical is made, but rather on its chemical composition and structure. The same is true for food, feed, fiber, and animal products. Yet, for ideological or political reasons unsupported by data or experience, many nations regulators have adopted explicitly process-based regulations. Even countries that have avoided this fundamental error have drifted in that direction through

Yet, for ideological or political reasons unsupported by data or experience, many nations regulators have adopted explicitly process-based regulations. Even countries that have avoided this fundamental error have drifted in that direction through uncritical implementation of otherwise less flawed regulations that slow ag-biotech innovation. These different developments have combined to create the gross disparity between and within nations regarding risk and regulatory burden as manifested in regulatory proposals we examine here.

GM Food Is Safe The foundation of confidence in the safety of agricultural products produced through biotechnology, no matter what breeding method was used, lies in a concept known as substantial equivalence. This is based on the work of an international expert group at the Organization for Economic Cooperation and Development (OECD), which published a series of landmark policy papers in the 1980s and 1990s. The concept of substantial equivalence emerged from the recognition that plants and animals we have long used for food provide a familiar baseline for comparison and for the evaluation of novel traits as we consider their safety. A number of factors are important, including:

The U.S. National Academy of Sciences explicitly endorsed this approach in its first paper on this topic, and reaffirmed it in 11 subsequent reports, which corroborated the safety of products produced with these methods. The safety of these products was reaffirmed in a comprehensive review of more than 1,700 peer-reviewed papers from the scientific literature over a decade, published in 2013, adding to a database of more than 2,000 such papers compiled by independent academics. It is noteworthy that based on their findings, independent academics and industry scientists reach identical conclusions. For these reasons, more than 275 scientific organizations have embraced the global scientific consensus on the safety of GM crops and foods. The European Union has summarized the safety issue thus:

Indeed, the use of more precise technology and the greater regulatory scrutiny probably make them even safer than conventional plants and foods; and if there are unforeseen environmental effectsnone have appeared as yetthese should be rapidly detected by our monitoring requirements. On the other hand, the benefits of these plants and products for human health and the environment become increasingly clear.

Process-Based Regulation Doesnt Work In the early 1980s, when the potential of recombinant DNA techniques to deliver solutions to problems in agriculture was first widely noted, two main schools of thought emerged on the best way to ensure their safety without discouraging innovation. Expert bodies around the world repeatedly found no unique or novel hazards associated with crops, livestock, microbes, or foods improved through biotechnology. They found that the foreseeable risks were similar to those with which we were long familiar with from classical plant and animal breeding throughout 10 millennia of domestication and agriculture. As a result, the United States, Canada, and Australia aimed to base regulations on experience and scientific data. U.S. policymakers, for example, concluded that existing regulations for risk assessment and management were sufficient, and determined to move forward with products of agricultural biotechnology under close scrutiny, with a watchful eye for surprises. This was attended by the expectation that regulations would be adapted regularly as knowledge and understanding accrued.

European politicians chose a different approach, and crafted new, process-specific regulations unrelated to any concrete demonstration of real hazards or actual risks, based instead on hypothetical potential harms. Following this lead, a number of other countries have also taken this precautionary approach and subordinated the findings of scientific risk assessment and experience to political and ideological interests. The results have been clear and dramatic; innovative products have rapidly swept to market dominance in countries that have chosen science-based approaches, while European farmers have become increasingly uncompetitive as innovators have fled the continent. The harshest condemnations of the failed European precautionary approach have come from Europeans.

But despite this reasoned approach early on, regulations in the United States more recently have not evolved to match our accumulated experience and the dramatic growth in our understanding. Regulations first laid down in 1987 have been significantly adapted to experience only once, in 1992. Since then, the disparity between the level of risk and the degree of regulation has expanded dramatically. This led the White House Office of Science and Technology Policy in 2015 to call for an updating of regulatory agencies responsibilities under the Coordinated Framework, the 1986 roadmap set forth to guide regulators into the new landscape. The new Trump administrations directive that each new regulation must be accompanied by repeal of two already in place is, in this arena at least, a step in the right direction.

The Purpose of Regulation Is to Manage Risk Regulations exist for a purpose: to manage and mitigate risks. Reasonable and effective regulations will also incorporate a consideration of economic costs and dynamic innovation effects. Thus, under the 1986 Coordinated Framework, the Animal and Plant Health Inspection Service is charged with managing risks that crops improved through biotechnology may present to American agriculture; the Environmental Protection Agency with ensuring that pesticides are used safely to manage pests and protect human and environmental health; and the Food and Drug Administration with ensuring that food and feed derived from crops or animals improved through biotechnology are as safe to consume as other food and feed.

But much of the oversight applied to crops improved through biotechnology in the United States has lost sight of the fundamental principle for determining risk, expressed in the equation: risk equals hazard times exposure. If there is no prospect for exposure to a hazard, then the hazard, no matter how great, presents no risk. If there is no hazard, or if it is present only at very low levels, then even high levels of exposure may be entirely irrelevant to human or environmental health. But in the regulatory systems now in place there is no relationship among the presence of a hazard, the level of exposure, and the degree of regulatory scrutiny applied. If innovation is to be enabled, much less encouraged, that must be remedied. But the importance of one other objective driving the adoption of regulations to deal with biotechnological innovations in agriculture cannot be overstated:

But the importance of one other objective driving the adoption of regulations to deal with biotechnological innovations in agriculture cannot be overstated:

In response to public concern [t]he goal in developing the Coordinated Framework was to explain to the American public that, for questions involving the products of biotechnology (more specifically, organisms derived from recombinant-DNA technology), human health and the health of the environment were of paramount concern and were adequately protected.

There is no denying the virtuous intent of that sentiment, for if consumers are not convinced that biotech foods are safe they will not buy them. But in fact, the promulgation of regulations in advance of any confirmed finding of hazard or demonstration of risk has not assuaged public concerns. Nor has the subsequent confirmation of safety led to areduction in regulatory oversight or regulatory delays in the deployment of innovative technologies and products. In fact, entrenched opposition from the very beginning has taken every emplacement of regulation as confirmation of the need for yet more stringent regulation, driven by the unfounded assertion of unique and technology-specific hazards.

This discordance between the degree of regulatory oversight and the actual hazards and risks confirmed by experience has only grown over the years, exacerbated by the emergence of regulation for the purpose of litigation-avoidance by the agencies. Special interest groups have brought a significant number of procedural lawsuits against USDA for approving specific crops improved through biotechnology, leading to lengthy delays in the dissemination of new products.23 The ephemeral success of these lawsuits hinged on deficiencies noted by the courts in the documentation of USDAs decision-making process. In no case have they identified any genuine hazard, and, after USDA repaired the paper record for its decision making, the products are now on the market. But the opportunity costs, both economic and environmental, imposed by the delays remain on the ledgers.

[Read the rest of the report here.]

This article originally appeared on The Information Technology and Innovation Foundations website under the title How the Trump Administration Can Unshackle Innovation in Agricultural Biotechnology and has been republished with permission from the author.

Val Giddings is Senior Fellow at the Information Technology & Innovation Foundation. He previously served as vice president for Food & Agriculture of the Biotechnology Industry Organization (BIO) and at the Congressional Office of Technology Assessment and as an expert consultant to the United Nations Environment Programme, the World Bank, USDA, USAID, and companies, organizations and governments around the world. Follow him on twitter @prometheusgreen.

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Agricultural biotechnology regulations are a mess Here's how Trump can unshackle innovation - Genetic Literacy Project