Category Archives: Biotechnology

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

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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.

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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

Barron's

Earnings Preview: Biotechnology Looks Healthy Barron's The iShares Nasdaq Biotechnology (IBB) has climbed 0.34%. Meanwhile the SPDR S&P Biotech ETF (XBI) has declined 0.21%. IBB could be benefiting from having a wider swath of companies, in addition to the fact that the average market cap of its index ... and more »

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Earnings Preview: Biotechnology Looks Healthy - Barron's

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-$1.86 Earnings Per Share Expected for Puma Biotechnology Inc (PBYI) This Quarter The Cerbat Gem Puma Biotechnology logo Equities research analysts expect Puma Biotechnology Inc (NYSE:PBYI) to post earnings per share of ($1.86) for the current quarter, Zacks Investment Research reports. Zero analysts have made estimates for Puma Biotechnology's ... Consensus Analysts Roundup on Puma Biotechnology, Inc. (NYSE:PBYI) Ocular Therapeutix, Inc. (NASDAQ:OCUL)Davidson Register Puma Biotechnology Inc (PBYI) Receives $70.50 Average PT from ...Chaffey Breeze Puma Biotechnology (PBYI) Given Media Sentiment Score of 0.02Markets Daily Post Analyst -TCT -Street Updates all 13 news articles »

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-$1.86 Earnings Per Share Expected for Puma Biotechnology Inc (PBYI) This Quarter - The Cerbat Gem

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Earnings Preview: Biotechnology Looks Healthy Barron's (blog) The iShares Nasdaq Biotechnology (IBB) has climbed 0.34%. Meanwhile the SPDR S&P Biotech ETF (XBI) has declined 0.21%. IBB could be benefiting from having a wider swath of companies, in addition to the fact that the average market cap of its index ... and more »

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Earnings Preview: Biotechnology Looks Healthy - Barron's (blog)

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iShares NASDAQ Biotechnology Index (IBB) Earning Very Favorable Media Coverage, Report Shows - The Cerbat Gem

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Puma Biotechnology Inc (PBYI) Expected to Announce Earnings of -$1.86 Per Share Sports Perspectives Puma Biotechnology logo Wall Street analysts predict that Puma Biotechnology Inc (NYSE:PBYI) will announce earnings per share of ($1.86) for the current fiscal quarter, according to Zacks. Zero analysts have provided estimates for Puma Biotechnology's ... Analyst Views On Top Movers In Recent Trade: Puma Biotechnology, Inc. (PBYI), Amedica Corporation (AMDA)Post Analyst The Puma Biotechnology Inc (PBYI) Shares Bought by Highbridge Capital Management LLCPetro Global News 24 Well recognized Stock of Market: Puma Biotechnology, Inc.'s (PBYI) stock price is Worth at $34.10 while ends ...Hot Stocks Point Community Financial News -MilTech all 9 news articles »

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Puma Biotechnology Inc (PBYI) Expected to Announce Earnings of -$1.86 Per Share - Sports Perspectives

In terms of pure biotechnology, Europe has embraced innovation. However, it cannot compete with the US yet because it cannot drive private investment in the field, as well as open up the market to new products, a pharmaceutical executive told EURACTIV.com in Lyon.

Despite the EUs consistent growth in the biotech business, the EBE claims that the industry is not receiving enough support from investors, universities or research institutions, thus limiting the EUs ability to keep pace with the US in biotechnology.

The EU is lagging behind due to challenges in translating scientific innovations into successful businesses, a European Biopharmaceutical Enterprises (EBE) report claims.

Biotechnology is the use of living systems or organisms in the creation of industrial products. The growth of the biotechnology industry is important for Europe and created 10,000 new jobs and 93 medicines recommended for market authorisation by the European Medical Agency in 2015, according to the EBE.

Biotechnology could help patients across Europe gain access to innovative therapies, for example, against rare diseases. Proponents of bio-medicines also claim that precision therapy, because it is more efficient, will ease the burden on member states ailing healthcare systems.

The EBE suggests that steps should be taken to create a stronger investor community for biotech products to prevent places other than Europe from benefitting economically from technology invented and developed in Europe.

License to fail

The paper suggests that European entrepreneurs may be more adverse to risk because they have no license to fail, citing the lack of a strong culture of institutions or individuals seeking useful application of their work, taking out patents and creating start-up companies.

On the other hand, universities in the US often empower scientists to be knowledgeable in business and management.

The paper recommends that European institutions improve their support of scientists in marketing their technologies through better investment in Technical Transfer Offices (TTOs). The current lack of funding for TTOs at European universities means it is difficult for them to attract and train experienced staff.

Although Europe has public research funding organisations, such as the Innovative Medicines Initiative (IMI) and the European Commissions Horizon 2020, the lack of mature biotech companies makes the investment ecosystem fragile and makes it difficult for Europe to compete with the US for funding, the paper says.

Europe needs to build a bigger and better capital market for biotech companies to overcome the funding gap that prevents the needed growth of the biotech sector, it reads. The EBE suggests the European Commission create a single capital market for biotech companies and the creation of tax incentives for investment in biotechnology.

Being successful in the US

Didier Hoch, chairman of the Biovision 2017- The World Life Sciences Forum in Lyon, told EURACTIV that there are several reasons why biotechnology can flourish more easily in the US than in Europe.

According to Hoch, in terms of pure biotechnology, Europe is not lagging behind the US, as its sufficiently innovative. Where we are lagging behind is to drive investment in the field and attract private investors and open up the market to new products, he noted.

In fact, in the US the norm is to have a connection between the science, universities and private investors [] which is not yet the case in Europe, where there is a kind of fear when you are in the public sector to go private said Hoch, adding that another hindrance is the lack of trust between the public and private sector

Another difference between Washington and Brussels is the source of money. Hoch explained that money invested in the US biotech sector was coming from private investors, while in Europe, it comes from venture capital funds mainly funded by the EU institutions.

Even venture capitals are funded from EU money. This regime could eventually be thestrength for Europe, as in a way it can be competitive against private US money, he emphasised.

However, Hoch insisted that Europe still needed to convince more private sector entities to invest in biotechnology. It might be a long-term and risky field, but in the US the private sector invests in its potential, he said.

Hoch stressed that currently a biotech product could be considered successful if it has accessed the US market.

If you have a biotech company you should have in mind first to succeed in the US, even if you are based in Europe, he explained, explaining that in terms of the market, 70% of a new products success is in the US.

If you dont get your product there you will face difficulties, he said, emphasising that its mainly a political decision to have the US as an attracting market.

Last but not least, Hoch pointed out that its easier to get to the US market because there is a clear way to access and not like 27 different in the Europe, which have a country-based approach.

Making Europe innovative

In February, the centre-right European Peoples Party (EPP) presented its vision for the future of the Economic and Monetary Union (EMU) and emphasised the need for anew framework on access to financing in order for innovative companies to be encouraged to invest in Europe.

EPP President Joseph Daul told EURACTIV that the EU should become an innovation hub as this is the key to future growth and help it compete with the US.

This is where we need to concentrate our efforts to make Europe the worlds best talent hub. We should embrace radical innovations and make our continent the birthplace of the next Facebook or Apple, he told EURACTIV.

The EPP recognises that Europe was lagging behind compared to the US regarding innovative companies and, therefore, suggested the creation of an environment that will help new talents flourish.

We must understand that this follows partly from structural factors in our continent compared to our partners on the other side of the Atlantic. Venture Capital Funds in the EU are on average small. We need to support creating Funds of Funds, and we must look into existing regulations to make sure that investing in private equity funds is not discouraged by regulations and capital rules, the paper reads.

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Europe's biotechnology potential hindered by investment fears - EurActiv

Iran has made a considerable breakthrough in biotechnology inasmuch as it is able to produce GM foods and Up until 2013 it has produced 18 different kinds of recombinant medicines.

The modern biotechnology has been established nearly nine decades ago in Iran, started with vaccine production in Pasteur and Razi Institutes in 1920 and 1925. National Institute of Genetic Engineering and Biotechnology institute of Iran was established in 1989. Iranian scientists are active in various spheres of agriculture in this institute and work on medicinal plants with the aim of using their metabolites or increasing their tolerance to non-biological changes such as salinity or drought. One of the uses of biotechnology is in production of genetically modified foods; however, there are many opposing voices claiming that they are harmful for health.

Simply said, biotechnology harnesses cellular and bi molecular processes and puts them to work for us. It is used for production of GM foods and treating diseases with genetic technologies and many other fields. Biotechnology is an efficient, up-to-date and effective tool in agricultural field. Biotechnology helps you to improve plants' resistance to a considerable amount. Iran is among pioneering countries in this field. Up until 2013, 18 different kinds of recombinant drugs have been produced in Iran. This number is against 50 recombinant drugs produced globally. With the help of biotechnology and recombinant drugs, Iran has seen a 30% drop in its drug export and 50% inflation growth has been controlled.

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PressTV-Biotechnology in Iran - Press TV

The UF business incubator Sid Martin Biotechnology Institute was named the 2017 Top Global Incubator of the Year.

The International Business Innovation Association recognized the institute March 28, said Mark Long, the institutes director. The institute received $1,500 for winning the award out of 30 other incubators.

The biotechnology institute provides lab space, equipment, business and legal advice at a low cost for new biotech companies, Long said.

Scientists need help understanding business and addressing the market, he said. Were here to help them out with that.

The institutes 40,000 square foot facility is at Progress Park in Alachua. Its used as office and laboratory space thats rented out to new companies unable to afford commercial space.

Getting an award like this is a real marketing tool in attracting new companies and investors for these companies, Long said.

He said since the institute started in 1995, businesses theyve served have a 78 percent success rate, meaning 78 percent of businesses stay open after the first five years. Since 2003, the success rate has improved to 93 percent.

Meekah Chaderton, a manager at the startup food development company Captozyme, said the institute helped improve the companys business.

Chaderton said Captozyme plans to move out of the institute and into their own space in June.

Small companies cant afford to buy a lot of equipment and lab space, so renting affordable space from Sid Martin has made us more competitive, Chaderton said.

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UF biotechnology institute named Incubator of the Year - The Independent Florida Alligator