Biotechnology FAQs | USDA

1. What is Agricultural Biotechnology?

Agricultural biotechnology is a range of tools, including traditional breeding techniques, that alter living organisms, or parts of organisms, to make or modify products; improve plants or animals; or develop microorganisms for specific agricultural uses. Modern biotechnology today includes the tools of genetic engineering.

2. How is Agricultural Biotechnology being used?

Biotechnology provides farmers with tools that can make production cheaper and more manageable. For example, some biotechnology crops can be engineered to tolerate specific herbicides, which make weed control simpler and more efficient. Other crops have been engineered to be resistant to specific plant diseases and insect pests, which can make pest control more reliable and effective, and/or can decrease the use of synthetic pesticides. These crop production options can help countries keep pace with demands for food while reducing production costs. A number of biotechnology-derived crops that have been deregulated by the USDA and reviewed for food safety by the Food and Drug Administration (FDA) and/or the Environmental Protection Agency (EPA) have been adopted by growers.

Many other types of crops are now in the research and development stages. While it is not possible to know exactly which will come to fruition, certainly biotechnology will have highly varied uses for agriculture in the future. Advances in biotechnology may provide consumers with foods that are nutritionally-enriched or longer-lasting, or that contain lower levels of certain naturally occurring toxicants present in some food plants. Developers are using biotechnology to try to reduce saturated fats in cooking oils, reduce allergens in foods, and increase disease-fighting nutrients in foods. They are also researching ways to use genetically engineered crops in the production of new medicines, which may lead to a new plant-made pharmaceutical industry that could reduce the costs of production using a sustainable resource.

Genetically engineered plants are also being developed for a purpose known as phytoremediation in which the plants detoxify pollutants in the soil or absorb and accumulate polluting substances out of the soil so that the plants may be harvested and disposed of safely. In either case the result is improved soil quality at a polluted site. Biotechnology may also be used to conserve natural resources, enable animals to more effectively use nutrients present in feed, decrease nutrient runoff into rivers and bays, and help meet the increasing world food and land demands. Researchers are at work to produce hardier crops that will flourish in even the harshest environments and that will require less fuel, labor, fertilizer, and water, helping to decrease the pressures on land and wildlife habitats.

In addition to genetically engineered crops, biotechnology has helped make other improvements in agriculture not involving plants. Examples of such advances include making antibiotic production more efficient through microbial fermentation and producing new animal vaccines through genetic engineering for diseases such as foot and mouth disease and rabies.

3. What are the benefits of Agricultural Biotechnology?

The application of biotechnology in agriculture has resulted in benefits to farmers, producers, and consumers. Biotechnology has helped to make both insect pest control and weed management safer and easier while safeguarding crops against disease.

For example, genetically engineered insect-resistant cotton has allowed for a significant reduction in the use of persistent, synthetic pesticides that may contaminate groundwater and the environment.

In terms of improved weed control, herbicide-tolerant soybeans, cotton, and corn enable the use of reduced-risk herbicides that break down more quickly in soil and are non-toxic to wildlife and humans. Herbicide-tolerant crops are particularly compatible with no-till or reduced tillage agriculture systems that help preserve topsoil from erosion.

Agricultural biotechnology has been used to protect crops from devastating diseases. The papaya ringspot virus threatened to derail the Hawaiian papaya industry until papayas resistant to the disease were developed through genetic engineering. This saved the U.S. papaya industry. Research on potatoes, squash, tomatoes, and other crops continues in a similar manner to provide resistance to viral diseases that otherwise are very difficult to control.

Biotech crops can make farming more profitable by increasing crop quality and may in some cases increase yields. The use of some of these crops can simplify work and improve safety for farmers. This allows farmers to spend less of their time managing their crops and more time on other profitable activities.

Biotech crops may provide enhanced quality traits such as increased levels of beta-carotene in rice to aid in reducing vitamin A deficiencies and improved oil compositions in canola, soybean, and corn. Crops with the ability to grow in salty soils or better withstand drought conditions are also in the works and the first such products are just entering the marketplace. Such innovations may be increasingly important in adapting to or in some cases helping to mitigate the effects of climate change.

The tools of agricultural biotechnology have been invaluable for researchers in helping to understand the basic biology of living organisms. For example, scientists have identified the complete genetic structure of several strains of Listeria and Campylobacter, the bacteria often responsible for major outbreaks of food-borne illness in people. This genetic information is providing a wealth of opportunities that help researchers improve the safety of our food supply. The tools of biotechnology have "unlocked doors" and are also helping in the development of improved animal and plant varieties, both those produced by conventional means as well as those produced through genetic engineering.

4. What are the safety considerations with Agricultural Biotechnology?

Breeders have been evaluating new products developed through agricultural biotechnology for centuries. In addition to these efforts, the United States Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA) work to ensure that crops produced through genetic engineering for commercial use are properly tested and studied to make sure they pose no significant risk to consumers or the environment.

Crops produced through genetic engineering are the only ones formally reviewed to assess the potential for transfer of novel traits to wild relatives. When new traits are genetically engineered into a crop, the new plants are evaluated to ensure that they do not have characteristics of weeds. Where biotech crops are grown in proximity to related plants, the potential for the two plants to exchange traits via pollen must be evaluated before release. Crop plants of all kinds can exchange traits with their close wild relatives (which may be weeds or wildflowers) when they are in proximity. In the case of biotech-derived crops, the EPA and USDA perform risk assessments to evaluate this possibility and minimize potential harmful consequences, if any.

Other potential risks considered in the assessment of genetically engineered organisms include any environmental effects on birds, mammals, insects, worms, and other organisms, especially in the case of insect or disease resistance traits. This is why the USDA's Animal and Plant Health Inspection Service (APHIS) and the EPA review any environmental impacts of such pest-resistant biotechnology derived crops prior to approval of field-testing and commercial release. Testing on many types of organisms such as honeybees, other beneficial insects, earthworms, and fish is performed to ensure that there are no unintended consequences associated with these crops.

With respect to food safety, when new traits introduced to biotech-derived plants are examined by the EPA and the FDA, the proteins produced by these traits are studied for their potential toxicity and potential to cause an allergic response. Tests designed to examine the heat and digestive stability of these proteins, as well as their similarity to known allergenic proteins, are completed prior to entry into the food or feed supply. To put these considerations in perspective, it is useful to note that while the particular biotech traits being used are often new to crops in that they often do not come from plants (many are from bacteria and viruses), the same basic types of traits often can be found naturally in most plants. These basic traits, like insect and disease resistance, have allowed plants to survive and evolve over time.

5. How widely used are biotechnology crops?

According to the USDA's National Agricultural Statistics Service (NASS), biotechnology plantings as a percentage of total crop plantings in the United States in 2012 were about 88 percent for corn, 94 percent for cotton, and 93 percent for soybeans. NASS conducts an agricultural survey in all states in June of each year. The report issued from the survey contains a section specific to the major biotechnology derived field crops and provides additional detail on biotechnology plantings. The most recent report may be viewed at the following website: https://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us.aspx

For a summary of these data, see the USDA Economic Research Service data feature at: https://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us.aspx

The USDA does not maintain data on international usage of genetically engineered crops. The independent International Service for the Acquisition of Agri-biotech Applications (ISAAA), a not-for-profit organization, estimates that the global area of biotech crops for 2012 was 170.3 million hectares, grown by 17.3 million farmers in 28 countries, with an average annual growth in area cultivated of around 6 percent. More than 90 percent of farmers growing biotech crops are resource-poor farmers in developing countries. ISAAA reports various statistics on the global adoption and plantings of biotechnology derived crops. The ISAAA website is https://www.isaaa.org

6. What are the roles of government in agricultural biotechnology?

Please note: These descriptions are not a complete or thorough review of all the activities of these agencies with respect to agricultural biotechnology and are intended as general introductory materials only. For additional information please see the relevant agency websites.

Regulatory

The Federal Government developed a Coordinated Framework for the Regulation of Biotechnology in 1986 to provide for the regulatory oversight of organisms derived through genetic engineering. The three principal agencies that have provided primary guidance to the experimental testing, approval, and eventual commercial release of these organisms to date are the USDA's Animal and Plant Health Inspection Service (APHIS), the Environmental Protection Agency (EPA), and the Department of Health and Human Services' Food and Drug Administration (FDA). The approach taken in the Coordinated Framework is grounded in the judgment of the National Academy of Sciences that the potential risks associated with these organisms fall into the same general categories as those created by traditionally bred organisms.

Products are regulated according to their intended use, with some products being regulated under more than one agency. All government regulatory agencies have a responsibility to ensure that the implementation of regulatory decisions, including approval of field tests and eventual deregulation of approved biotech crops, does not adversely impact human health or the environment.

The Animal and Plant Health Inspection Service (APHIS) is responsible for protecting U.S. agriculture from pests and diseases. APHIS regulations provide procedures for obtaining a permit or for providing notification prior to "introducing" (the act of introducing includes any movement into or through the U.S., or release into the environment outside an area of physical confinement) a regulated article in the U.S. Regulated articles are organisms and products altered or produced through genetic engineering that are plant pests or for which there is reason to believe are plant pests.

The regulations also provide for a petition process for the determination of non-regulated status. Once a determination of non-regulated status has been made, the organism (and its offspring) no longer requires APHIS review for movement or release in the U.S.

For more information on the regulatory responsibilities of the FDA, the EPA and APHIS please see:

https://www.fda.gov

https://www.epa.gov

APHIS Biotechnology Regulations

Market Facilitation

The USDA also helps industry respond to consumer demands in the United States and overseas by supporting the marketing of a wide range of agricultural products produced through conventional, organic, and genetically engineered means.

The Agricultural Marketing Service (AMS) and the Grain Inspection, Packers, and Stockyards Administration (GIPSA) have developed a number of services to facilitate the strategic marketing of conventional and genetically engineered foods, fibers, grains, and oilseeds in both domestic and international markets. GIPSA provides these services for the bulk grain and oilseed markets while AMS provides the services for food commodities such as fruits and vegetables, as well as for fiber commodities.

These services include:

1. Evaluation of Test Kits: AMS and GIPSA evaluate commercially available test kits designed to detect the presence of specific proteins in genetically engineered agricultural commodities. The agencies confirm whether the tests operate in accordance with manufacturers' claims and, if the kits operate as stated, the results are made available to the public on their respective websites.

GIPSA Link: https://www.gipsa.usda.gov/fgis/rapidtestkit.aspx

GIPSA evaluates the performance of laboratories conducting DNA-based tests to detect genetically engineered grains and oilseeds, provides participants with their individual results, and posts a summary report on the GIPSA website. AMS is developing a similar program that can evaluate and verify the capabilities of independent laboratories to screen other products for the presence of genetically engineered material.

2. Identity Preservation/Process Verification Services: AMS and GIPSA offer auditing services to certify the use of written quality practices and/or production processes by producers who differentiate their commodities using identity preservation, testing, and product branding.

GIPSA Link: https://www.gipsa.usda.gov/fgis/inspectionweighing.aspx

AMS Link: https://www.ams.usda.gov/fv/ipbv.htm

Additional AMS Services: AMS provides fee-based DNA and protein testing services for food and fiber products, and its Plant Variety Protection Office offers intellectual property rights protection for new genetically engineered seed varieties through the issuance of Certificates of Protection.

Additional GIPSA Services: GIPSA provides marketing documents pertaining to whether there are genetically engineered varieties of certain bulk commodities in commercial production in the United States. USDA also works to improve and expand market access for U.S. agricultural products, including those produced through genetic engineering.

The Foreign Agricultural Service (FAS) supports or administers numerous education, outreach, and exchange programs designed to improve the understanding and acceptance of genetically engineered agricultural products worldwide

1. Market Access Program and Foreign Market Development Program: Supports U.S. farm producer groups (called "Cooperators") to market agricultural products overseas, including those produced using genetic engineering.

2. Emerging Markets Program: Supports technical assistance activities to promote exports of U.S. agricultural commodities and products to emerging markets, including those produced using genetic engineering. Activities to support science-based decision-making are also undertaken. Such activities have included food safety training in Mexico, a biotechnology course for emerging market participants at Michigan State University, farmer-to-farmer workshops in the Philippines and Honduras, high-level policy discussions within the Asia-Pacific Economic Cooperation group, as well as numerous study tours and workshops involving journalists, regulators, and policy-makers.

3. Cochran Fellowship Program: Supports short-term training in biotechnology and genetic engineering. Since the program was created in 1984, the Cochran Fellowship Program has provided education and training to 325 international participants, primarily regulators, policy makers, and scientists.

4. Borlaug Fellowship Program: Supports collaborative research in new technologies, including biotechnology and genetic engineering. Since the program was established in 2004, the Borlaug Fellowship Program has funded 193 fellowships in this research area.

5. Technical Assistance for Specialty Crops (TASC): Supports technical assistance activities that address sanitary, phytosanitary, and technical barriers that prohibit or threaten the export of U.S. specialty crops. This program has supported activities on biotech papaya.

Research

USDA researchers seek to solve major agricultural problems and to better understand the basic biology of agriculture. Researchers may use biotechnology to conduct research more efficiently and to discover things that may not be possible by more conventional means. This includes introducing new or improved traits in plants, animals, and microorganisms and creating new biotechnology-based products such as more effective diagnostic tests, improved vaccines, and better antibiotics. Any USDA research involving the development of new biotechnology products includes biosafety analysis.

USDA scientists are also improving biotechnology tools for ever safer, more effective use of biotechnology by all researchers. For example, better models are being developed to evaluate genetically engineered organisms and to reduce allergens in foods.

USDA researchers monitor for potential environmental problems such as insect pests becoming resistant to Bt, a substance that certain crops, such as corn and cotton, have been genetically engineered to produce to protect against insect damage. In addition, in partnership with the Agricultural Research Service (ARS) and the Forest Service, the Cooperative States Research, the National Institute of Food and Agriculture (NIFA) administers the Biotechnology Risk Assessment Research Grants Program (BRAG) which develops science-based information regarding the safety of introducing genetically engineered plants, animals, and microorganisms. Lists of biotechnology research projects can be found at https://www.ars.usda.gov/research/projects.htm for ARS and at https://www.nifa.usda.gov/funding-opportunity/biotechnology-risk-assessment-research-grants-program-brag for NIFA.

USDA also develops and supports centralized websites that provide access to genetic resources and genomic information about agricultural species. Making these databases easily accessible is crucial for researchers around the world.

USDA's National Institute of Food and Agriculture (NIFA) provides funding and program leadership for extramural research, higher education, and extension activities in food and agricultural biotechnology. NIFA administers and manages funds for biotechnology through a variety of competitive and cooperative grants programs. The National Research Initiative (NRI) Competitive Grants Program, the largest NIFA competitive program, supports basic and applied research projects and integrated research, education, and/or extension projects, many of which use or develop biotechnology tools, approaches, and products. The Small Business Innovation Research Program (SBIR) funds competitive grants to support research by qualified small businesses on advanced concepts related to scientific problems and opportunities in agriculture, including development of biotechnology-derived products. NIFA also supports research involving biotechnology and biotechnology-derived products through cooperative funding programs in conjunction with state agricultural experiment stations at land-grant universities. NIFA partners with other federal agencies through interagency competitive grant programs to fund agricultural and food research that uses or develops biotechnology and biotechnology tools such as metabolic engineering, microbial genome sequencing, and maize genome sequencing.

USDA's Economic Research Service (ERS) conducts research on the economic aspects of the use of genetically engineered organisms, including the rate of and reasons for adoption of biotechnology by farmers. ERS also addresses economic issues related to the marketing, labeling, and trading of biotechnology-derived products.

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Biotechnology FAQs | USDA

HudsonAlpha Institute for Biotechnology

President and Scientific Director, Ontario Institute for Cancer Research and Director, P3G (Public Population Project in Genomics)President and Scientific Director, Ontario Institute for Cancer Research Scientific Director, P3GDr. Thomas J. Hudson is president and scientific director of the Ontario Institute for Cancer Research. He is implementing the institutes strategic plan, working with cancer research institutions across Ontario to leverage existing strengths. The plan focuses on prevention, early diagnosis, cancer targets and new therapeutics. Its innovation platforms include imaging and interventions, bio-repositories and pathology, genomics and high-throughput screening, and informatics and biocomputing. Dr. Hudson is recruiting more than 50 internationally recognized principal investigators.Dr. Hudson was the founder and Director of the McGill University and Genome Quebec Innovation Centre and Assistant-Director of the Whitehead/MIT Center for Genome Research. Dr. Hudson is internationally renowned for his work in genomics. At the Whitehead Institute, Dr. Hudson led the effort to generate dense physical and gene maps of the human and mouse genomes. He is a leader in the development and applications of robotic systems and DNA-chip based methodologies for genome research. In June 1996, he founded the Montreal Genome Centre based at the McGill University Health Centre Research Institute. In 2003, this group expanded to become the McGill University and Genome Quebec Innovation Centre. Dr. Hudson and his team were founding members of the International Haplotype Map Consortium. Dr. Hudsons interests in human genetic diseases focus on the dissection of complex genetic diseases. Disease projects in Dr. Hudsons laboratory included the search for genes predisposing to lupus, inflammatory bowel disease, coronary artery disease, asthma, diabetes and colon cancer. The laboratory also used the DNA-chip technology to characterize breast and ovarian cancer.

In 2007, Dr. Hudson was appointed to the rank of professor (status-only) in the Department of Molecular Genetics at the University of Toronto. He taught in the departments of Human Genetics and Medicine at McGill University and practiced medicine at the McGill University Health Centre Montreal General Hospital.

Dr. Hudson is a fellow of the Royal Society of Canada. He was one of the co-founding members of P3G and is currently serving as its scientific director. He is editor-in-chief of the journal Human Genetics.

The recipient of numerous awards, Dr. Hudson has received the 2005 Achievement of the Year in Healthcare from Macleans magazine, the 2005 Award for Research in Immunology by the Canadian Society for Allergy and Clinical Immunology, the Andr-Dupont 2002 Young Investigator Award given by Quebecs Clinical Research Club, an Investigator Award from the Canadian Institutes of Health Research, a Burroughs-Wellcome Clinician-Scientist Award, The 2002 Prix de la Sant from the Armand-Frappier Foundation, the 2001 Young Scientist Award by the Genetics Society of Canada, the 2000 Scientist of the Year by Radio-Canada, and the 1999 Canadas Top 40 Under 40.

http://oicr.on.ca/person/oicr-investigator/tom-hudson

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HudsonAlpha Institute for Biotechnology

Biotechnology Degree, Online Biotechnology Degree

Biotechnology is a branch of biology. It deals with modifying some traits of living things so that they are of better use to human beings. The field of biotechnology has informally been around for more than a thousand years, in fact ever since agriculture and domestication of animals was started by humans. Selective breeding to produce high yielding crops and to breed the fittest horses are some of the earlier examples of the field whereas development of bacteria that can treat oil spills and genetic engineering of crops are some of the newer examples.

Degrees Offered in BiotechnologyAs in other disciplines, biotechnology may be taken through five degree levels which include Certificate, Associate, Bachelor, Master and Doctorate programs. Certificate courses may be taken mid-career in biotechnology to develop a certain skill that is desired in a job or they may be taken to earn credits towards completing a college degree.

The most common degree most people take in Biotechnology is a Bachelor degree. This program is a comprehensive path to Biotechnology. It also incorporates principles of biology and other related fields that may come in useful for a Biotechnologist. A Masters degree gives a jump to your career and usually involves two years of independent study along with a research dissertation.

People may also choose to take dual degrees, like Biotechnology along with Business Administration. This equips the students to take up a challenging job in a related field with administrative responsibilities. This is obviously a much more prestigious degree and people with it can look forward to a more progressive career in the companies they may choose to work in.

All programs aim to develop critical and analytical thinking in the students and make them proficient in the laboratory procedures that they will invariably be required to use in their career.

Online Degrees in BiotechnologyBiotechnology degrees are also offered online now by accredited colleges. These are flexible and you may take them at the convenience of your time and place. Some degrees are completely online while some can be taken partly online with a few hours of lab work put in on college premises.

careers that a Degree Leads to in BiotechnologyLike all other fields, biotechnology is further divided into many sub-areas. After obtaining a degree in biotechnology, a student may choose to work in either of the following branches of biotechnology, if they fulfill the basic requirements for the area.

BioinformaticsAlso known as computational biology, this branch of biotechnology serves to solve biological problems by using computerized models and techniques.

Blue BiotechnologyBlue biotechnology refers to applications of biotechnology to marine resources. This field needs to be developed a lot as yet.

Green BiotechnologyThis field refers to the use of biotechnology in agriculture and is probably the most common field chosen by biotechnologists.

White BiotechnologyWhite Biotechnology refers to applications of biotechnology for industrial uses such as production of useful chemicals and enzymes.

Red BiotechnologyRed Biotechnology refers to the medical applications of biotechnology and typically involve production or modification of bacteria and other micro biota to develop medicines and vaccines.

Frequently Asked Question(s)

Q:What careers can I pursue with a Biotechnology degree?

A:Students can pursue a number of careers with a Biotechnology degree. Some of the careers are as Biotechnology Laboratory Technician, Quality Control Analyst, Senior Research Analyst, Biomedical Engineer, Validation Technician, Crime Lab Technician, Biotechnology Research Associate and Clinical Research Associate. With the health care industry expanding all over the United States, there is huge potential for students interested in this qualification.

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Biotechnology Degree, Online Biotechnology Degree

Panel Woes For Puma And Statistical Uncertainties For Emmaus – Seeking Alpha

Welcome to your weekly digest of approaching regulatory and clinical readouts. Puma's (NYSE:PBYI) breast cancer project neratinib will go before a US panel on May 24, but Roche's (OTCQX:RHHBY) rival Perjeta could soon show clinical data that render neratinib almost irrelevant, and the recent departure of a senior member of Puma's staff has fueled rumors of a negative outcome at the adcom.

On the same day Emmaus Life Sciences will go before the same FDA panel for its sickle cell disease project Endari, currently availbale as a nutraceutical. Regulators have questioned the efficacy analysis in the past, but with few options for patients approval could still ensue.

Puma becomes the prey

In just over a week a panel will discuss Puma's neratinib for use as an adjuvant treatment in Her2-overexpressing breast cancer. The filing was based on the phase III Extenet trial, in which patients received neratinib monotherapy after a year's Herceptin.

Puma has a number of hurdles in its path, the biggest of which is Perjeta. A positive result in Roche's phase III Aphinity study indicated that Perjeta could potentially be practice-changing for breast cancer, and Puma's shares dropped 14% (Aphinity all but confirms Puma's worst nightmare, March 2, 2017).

Roche's trial gave patients Perjeta plus Herceptin for a year versus Herceptin alone. Details, including the extent of Perjeta's benefit, will appear at Asco on June 5.

Other issues for Puma include the severe diarrhea seen with neratinib, questions over neratinib's marginal benefit in Extenet trial, and large numbers of patients being censored.

This week Puma shares took another tumble on the news that its senior vice-president of regulatory affairs, Dr. Robert Charnas, would step down. Speculation that the resignation could be linked with the upcoming panel meeting, rather than the health reasons cited in the company's 8-K, caused shares to fall 16%.

Neratinib sales are forecast to reach $809m by 2022, according to sellside consensus from EvaluatePharma, but just over a year ago these sat at $2bn. Neratinib's PDUFA date is set for July; a strong benefit with Perjeta could be hard for the FDA to ignore.

Lacking options

Emmaus Life Sciences' Endari, in sickle cell disease, will also face the panel on May 24, and has a PDFUA date set for July 7.

The Californian group says that if Endari is approved it will become the first treatment for pediatric patients and the first new therapy in nearly 20 years for adult patients. However, it does not treat the underlying cause of the disease, instead aiming to reduce the frequency of the episodes of pain called sickle cell crises. It has orphan drug designation in the US and EU and US fast-track designation.

Endari is said to work by reducing oxidative damage to red blood cells. It consists of the amino acid L-glutamine as a nutritional supplement - the same active ingredient as the company's Nutrestore nutraceutical, available for short bowel syndrome in combination with recombinant human growth hormone. Endari is filed as a drug under the 505(b)(2) pathway.

The phase III trial was conducted in 230 patients aged five and over. It tested 0.3g/kg of L-glutamine twice daily for 48 weeks, up to a daily limit of 30g. The powder is mixed with water or certain non-heated foods.

The placebo comparator was the food additive maltodextrin, and two thirds of patients were on background hydroxyurea treatment, an established drug used to reduce crises. The company reported a 25% reduction in the median frequency of sickle cell crises, with Endari patients having a median of three over the 48-week trial.

Initially the company reported a p value of 0.063, above the pre-specified p value of 0.045. However, using a different analysis it said the results were "highly statistically significant" at 0.005.

The FDA had raised concerns over the primary endpoint analysis after the data were initially unblinded in 2014. Emmaus provided a report by an independent statistician explaining the significant results using the modified Ridit method, adjusting for varying strata or subgroup size, which in this case was region and hydroxyurea use.

No doubt the panel meeting will pay close attention to the statistical analyses used.

Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. Please be aware of the risks associated with these stocks.

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Bioverativ to Acquire Clinical-Stage Rare Disease Biotechnology … – Business Wire (press release)

WALTHAM, Mass.--(BUSINESS WIRE)--Bioverativ Inc. (NASDAQ: BIVV), a global biotechnology company focused on the discovery, development and commercialization of innovative therapies for hemophilia and other rare blood disorders, today announced that it has entered into a definitive agreement to acquire South San Francisco-based True North Therapeutics, a privately-held, clinical-stage rare disease biotechnology company, for an upfront payment of $400 million plus assumed cash. True North investors are also eligible to receive additional payments of up to $425 million contingent on the achievement of future development, regulatory and sales milestones.

As part of the acquisition, Bioverativ will obtain worldwide rights to True Norths lead candidate, TNT009, a first-in-class monoclonal antibody in development to treat cold agglutinin disease (CAD). CAD is a rare and chronic hemolytic condition that often leads to severe anemia, requiring numerous transfusions, and can result in life-threatening thrombotic events. There are no approved therapies for CAD, which occurs in approximately 16 people per million globally, including an estimated 5,000 people in the United States.

In May 2017, the U.S. Food and Drug Administration (FDA) granted TNT009 breakthrough therapy designation for the treatment of hemolysis in patients with primary CAD, and plans for the full clinical development program, including a registrational program, are underway. Breakthrough therapy designation was created by the FDA to expedite the development and review of medicines that target serious or life-threatening conditions and have shown preliminary evidence of potential clinical benefit.

One of our strategic priorities is to invest thoughtfully in business development with a focus on building our pipeline in areas where we believe we can make a real difference for patients, said John Cox, Chief Executive Officer of Bioverativ. This acquisition of True North is aligned with those goals and with our vision to become the leading rare disease company focused on blood disorders. It strengthens our pipeline with a potential first-in-class therapy to treat CAD, a rare blood disorder with a high unmet patient need.

People living with CAD currently have no approved treatment options and suffer with a significant disease burden including crippling fatigue, frequent transfusions and an increased risk of life-threatening thrombotic events such as pulmonary embolism and stroke, Mr. Cox continued. By combining True Norths industry-leading science in complement biology with Bioverativs expertise in hematology and robust clinical and commercial capabilities, we believe we can bring meaningful progress to CAD patients. In addition, this transaction is consistent with our capital allocation philosophy, and we expect it to create significant value for our shareholders over the long term."

Todays announcement and TNT009s breakthrough therapy designation are testaments to the innovative science underpinning our lead candidate and the strength of the True North team. We are delighted to have progressed our pipeline to this stage, said Nancy Stagliano, PhD, Chief Executive Officer of True North. Bioverativ is well positioned to advance the development and commercialization of TNT009 on behalf of CAD patients who are greatly in need of safe and effective treatments.

The FDA granted TNT009 breakthrough therapy designation based on data from a Phase 1b trial, which showed that TNT009 normalized hemoglobin levels in six of six study participants with primary CAD, increasing hemoglobin by an average of 4g/dL and resolving their anemia. All participants were transfusion free while on treatment. TNT009 was generally well tolerated. As of December 21, 2016, five of six participants (83.3%) with primary CAD experienced at least one adverse event; all were mild to moderate in severity and no adverse event was assessed as related to TNT009 by the investigator.

TNT009 is designed to selectively inhibit the classical complement pathway by targeting C1s and directly impacting the central mechanism of CAD. The only therapy in development that targets C1s, TNT009 has received orphan drug designation from the FDA and the European Medicines Agency. A number of other rare, complement-mediated diseases share the basic underlying pathological mechanism involving C1s that could potentially be addressed by TNT009.

True Norths second molecule, TNT020, is a discovery-stage, follow-on monoclonal antibody that targets activated C1s with the potential for less-frequent dosing and subcutaneous administration.

The acquisition will be financed through a combination of cash on hand and debt. It is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Act of 1976 in the United States, and is expected to close in mid-2017.

Conference Call and Webcast Bioverativ will hold a brief conference call and webcast today at 8:30 a.m. ET to discuss the transaction. The conference call can be accessed through the Investors section of Bioverativs homepage, investors.bioverativ.com, and an audio replay will subsequently be available on the website for at least one month.

About Cold Agglutinin Disease (CAD) CAD is a debilitating autoimmune hemolytic anemia in which autoantibodies target red blood cells, leading to red blood cell destruction via complement activation initiated by the C1 complex, causing chronic anemia, severe fatigue and potentially fatal thrombotic events. CAD occurs in approximately 16 people per million, affecting an estimated 5,000 people in the United States. Typically, symptom onset begins around age 60. There are currently no approved therapies for CAD. Treatment is aimed at normalizing hemoglobin levels through blood transfusions, steroids or off-label immunotoxic therapy; however, current treatment options are often intensive, incomplete or nondurable, leaving patients dependent upon frequent transfusions, which can lead to chronic iron overload.

About TNT009 TNT009 is a first-in-class, humanized, monoclonal antibody that is designed to selectively inhibit the classical complement pathway by targeting C1s, a serine protease within the C1-complex in the complement pathway of the immune system. With a unique mechanism of action and high target specificity, TNT009 is designed to selectively inhibit disease processes in the classical complement pathway while maintaining activity of the alternative complement pathway and lectin complement pathway, which are important for immune surveillance and other functions.

About True North Therapeutics True North Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class product candidates for complement-mediated diseases. The companys lead product candidate, TNT009, is designed to selectively inhibit a target in the classical complement pathway. True Norths antibody drug development is focused on the treatment of certain rare diseases mediated by the complement system. True North Therapeutics is located in South San Francisco, California. For more information, please visit http://www.truenorthrx.com.

About Bioverativ Bioverativ is a global biotechnology company dedicated to transforming the lives of people with hemophilia and other rare blood disorders through world-class research, development and commercialization of innovative therapies. Launched in 2017 following separation from Biogen Inc., Bioverativ builds upon a strong heritage of scientific innovation and is committed to actively working with the blood disorders community. The companys mission is to create progress for patients where they need it most and its hemophilia therapies when launched represented the first major advancements in hemophilia treatment in more than two decades. For more information, visit http://www.bioverativ.comor follow@bioverativ on Twitter.

Safe Harbor This press release contains forward-looking statements, including statements relating to: the completion of the transaction with True North and timing thereof; the expected benefits of the transaction, including the potential to bring meaningful progress to CAD patients and create shareholder value; and anticipated clinical trials and the timing thereof. These forward-looking statements may be accompanied by such words as anticipate, believe, could, estimate, expect, forecast, intend, may, plan, potential, project, target, will and other words and terms of similar meaning. You should not place undue reliance on these statements.

These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: risks that the transaction will be completed in a timely manner or at all; risks of failure to satisfy the conditions precedent to completion of the transaction, including the ability to secure regulatory approvals in a timely manner or at all; uncertainty of whether Bioverativ can achieve the expected benefits from the transaction and successfully integrate the operations of True North; risks of unexpected costs, liabilities or delays; integration difficulties, including the ability to retain key personnel; risks that Bioverativ will be able to obtain financing on satisfactory terms, if at all; risks relating to the protection of intellectual property; risks and uncertainties relating to product development, clinical trials, regulatory process and approvals, and commercialization that may impact or alter Bioverativs anticipated business plans, strategies and objectives; and other risks and uncertainties described in the Risk Factors section of Bioverativ's quarterly and annual filings with the Securities and Exchange Commission.

These statements are based on our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

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Bioverativ to Acquire Clinical-Stage Rare Disease Biotechnology ... - Business Wire (press release)

TaiGen Biotechnology Announces Submission of New Drug Application for Taigexyn Intravenous Formulation to the … – PR Newswire (press release)

TAIPEI, Taiwan, May 30, 2017 /PRNewswire/ --TaiGen Biotechnology Company, Limited ("TaiGen") today announced that it has submitted a New Drug Application (NDA) for the intravenous formulation of Taigexyn (Nemonoxacin) to the China Food and Drug Administration (CFDA). Taigexyn is a novel non-fluorinated quinolone antibiotic.The NDA submission is supported by a pivotal Phase 3 trial comparing intravenous formulations of Taigexyn 500 mg to levofloxacin 500 mg in 518 patients with moderate to severe community-acquired pneumonia. The clinical success rates were 91.8% for Taigexyn vs. 85.7% for levofloxacin and Taigexyn was shown to be non-inferior to levofloxacin meeting the primary endpoint of the pivotal trial.

About Taigexyn Taigexyn is a novel broad spectrum antibiotic with excellent efficacy against drug-resistant bacteria available in both oral and intravenous formulations. The oral formulation is already approved for marketing and launched in Taiwan and mainland China. In addition, Taigexyn is also partnered in Russia, Commonwealth Independent States, Turkey, Mexico, Brazil and the Latin American territory for a total 32 countries worldwide.

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TaiGen Biotechnology Announces Submission of New Drug Application for Taigexyn Intravenous Formulation to the ... - PR Newswire (press release)

Puma Biotechnology Reports First Quarter 2017 Financial Results – Business Wire (press release)

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced financial results for the first quarter ended March 31, 2017.

Unless otherwise stated, all comparisons are for the first quarter 2017 compared to the first quarter 2016.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss applicable to common stock of $72.9 million, or $1.97 per share, for the first quarter of 2017, compared to a net loss applicable to common stock of $71.0 million, or $2.19 per share, for the first quarter of 2016.

Non-GAAP adjusted net loss was $43.1 million, or $1.16 per share, for the first quarter of 2017, compared to non-GAAP adjusted net loss of $41.5 million, or $1.28 per share, for the first quarter of 2016. Non-GAAP adjusted net loss excludes stock-based compensation expense, which represents a significant portion of overall expense and has no impact on the cash position of the Company. For a reconciliation of GAAP net loss to non-GAAP adjusted net loss and GAAP net loss per share to non-GAAP adjusted net loss per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the first quarter of 2017 was $36.0 million. At March 31, 2017, Puma had cash and cash equivalents of $105.1 million and marketable securities of $88.9 million, compared to cash and cash equivalents of $194.5 million and marketable securities of $35.0 million at December 31, 2016.

We made significant progress with our lead investigational drug, neratinib, during the first quarter of 2017, said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. We look forward to continuing to work with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) as they review our New Drug Application (NDA) and Marketing Authorization Application (MAA)filings, respectively, and we look forward to presenting the data on neratinib at the upcoming FDA Oncologic Drugs Advisory Committee on May 24th.

Data on neratinib was also presented at the 2017 American Association for Cancer Research Annual Meeting in April which included data on the use of antidiarrheal prophylaxis to reduce the diarrhea with neratinib in the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab-based therapy (CONTROL trial). There was also clinical data presented on neratinib in the treatment of patients who have solid tumors with activating HER2 or HER3 mutations (SUMMIT trial). Additional data was also presented on the combination of T-DM1 and neratinib in patients with HER2 positive metastatic breast cancer (MBC) that has previously been treated with pertuzumab and trastuzumab. We look forward to continuing to achieve our objectives and believe that Puma is very well-positioned to build value for our shareholders.

Mr. Auerbach added, During 2017, we anticipate the following key milestones with neratinib: (i) reporting data from the Phase III trial in third-line HER2-positive MBC patients in the second quarter of 2017; (ii) reporting data in the second quarter of 2017 from the TBCRC-022 Phase II trial of neratinib plus capecitabine in HER2-positive MBC patients with brain metastases; (iii) reporting final 5-year disease free survival (DFS) data during the second quarter of 2017 from the ExteNET Phase III trial of neratinib as an extended adjuvant treatment in HER2-positive early stage breast cancer; and (iv) announcing regulatory decisions in the United States and European Union on neratinib for the extended adjuvant treatment of patients with HER2-positive early stage breast cancer in the third quarter of 2017.

Operating Expenses

Operating expenses were $73.2 million for the first quarter of 2017, compared to $71.2 million for the first quarter of 2016.

General and Administrative Expenses:

General and administrative expenses were $18.4 million for the first quarter of 2017, compared to $11.0 million for the first quarter of 2016. The approximately $7.4 million increase resulted primarily from increases of approximately $1.4 million for stock-based compensation, $3.9 million for professional fees, $1.3 million for payroll and related costs, and $0.5 million for facility and equipment costs. These increases reflect overall corporate growth.

Research and Development Expenses:

Research and development (R&D) expenses were $54.8 million for the first quarter of 2017, compared to $60.2 million for the first quarter of 2016. The approximately $5.4 million decrease resulted primarily from decreases of approximately $1.1 million for stock-based compensation and $5.0 million for clinical trial expenses, partially offset by an increase of $0.6 million for consultants and contractors. For our existing clinical trials, we expect R&D expenses to decrease in subsequent quarters as clinical trials wind down.

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 can be found at http://www.pumabiotechnology.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the potential announcement of regulatory decisions in the United States and European Union on neratinib for the extended adjuvant treatment of patients with HER2-positive early stage breast cancer and the Companys clinical trials and the announcement of data relative to these trials. All forward-looking statements included in this press release involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has no product revenue and no products approved for marketing, the Company's dependence on PB272, which is still under development and may never receive regulatory approval, the challenges associated with conducting and enrolling clinical trials, the risk that the results of clinical trials may not support the Company's drug candidate claims, even if approved, the risk that physicians and patients may not accept or use the Company's products, the Company's reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates, the Company's dependence on licensed intellectual property, and the other risk factors disclosed in the periodic and current reports filed by the Company with the Securities and Exchange Commission from time to time, including the Company's Annual Report on Form 10-K for the year ended December 31, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.

Non-GAAP Financial Measures

In addition to operating results as calculated in accordance with generally accepted accounting principles, or GAAP, the Company uses certain non-GAAP financial measures when planning, monitoring, and evaluating operational performance. The following table presents the Companys net loss and net loss per share calculated in accordance with GAAP and as adjusted to remove the impact of employee stock-based compensation. For the three months ended March 31, 2017, stock-based compensation represented approximately 40.9% of net loss. Although net loss is important to measure financial performance, the Company currently places an emphasis on cash burn and, more specifically, cash used in operations. Stock-based compensation appears in GAAP net loss but is removed from net loss to arrive at cash used in operations on the statement of cash flows. Due to its noncash nature, the Company believes these non-GAAP measures enhance understanding of financial performance, are more indicative of operational performance and facilitate a better comparison among fiscal periods. These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP reporting measures.

(1)

To reflect a non-cash charge to operating expense for General and Administrative stock-based compensation.

(2)

To reflect a non-cash charge to operating expense for Research and Development stock-based compensation.

(3)

Non-GAAP adjusted net loss per share was calculated based on 36,931,167 and 32,478,408 weighted average common shares outstanding for the three months ended March 31, 2017 and 2016, respectively.

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Puma Biotechnology Reports First Quarter 2017 Financial Results - Business Wire (press release)

Earnings Clues on Puma Biotechnology, Inc. (PBYI), KBR, Inc. (KBR) Analyst’s Predictions – StockNewsJournal


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Earnings Clues on Puma Biotechnology, Inc. (PBYI), KBR, Inc. (KBR) Analyst's Predictions
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Investors who are keeping close eye on the stock of Puma Biotechnology, Inc. (NASDAQ:PBYI) established that the company was able to keep return on investment at -130.59 in the trailing twelve month while Reuters data showed that industry's average ...
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Earnings Clues on Puma Biotechnology, Inc. (PBYI), KBR, Inc. (KBR) Analyst's Predictions - StockNewsJournal

Biotechnology Summer Courses – Reach Cambridge

The Reach Cambridge Biotechnology course introduces students to both the academic study of biotechnology and its exciting practical applications in the real world. This fast-growing area of modern science has the potential to fundamentally alter how we produce food, treat disease and create medicines. Topics covered include genetics, drug resistance, pharmaceutical science, biotechnological devices and drug design. Through lectures by experts in the field and hands-on practical sessions, students will be offered a unique insight into both the study of biotechnology at university and the vocational opportunities in the field beyond higher education.

This exciting and dynamic course will be a rewarding program for all those who have a passionate interest in biotechnology and biological sciences. During the Scholar program, the Biotechnology course is academically intensive and intellectually challenging, focused on the complex scientific problems which the discipline is in the process of tackling.

All Reach Cambridge courses are open to students aged between 14-18 years old.

All courses are taught in English. In order to get the most out of the learning experience, students are advised to have a level of English conducive to understanding sophisticated academic language and to converse with other students and staff in English at all times.

We do offer English as Second Language courses if you, or we, feel that this is more appropriate. Your personal statement will help indicate to us your level of English. We will also ask for a copy of your latest school transcript to help us assess the teaching level of the courses.

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Biotechnology dept to set up tissue culture lab – Millennium Post

The state Biotechnology department has decided to set up a state-of-the-art plant tissue culture laboratory at the Kolkata Biotech Park to enhance production and quality of plants and vegetables.

There will be scientists and research fellows who will carry out various kinds of research on plants and bio-fertilizers and how they can be used to increase the production of vegetables in the state. Various medicinal plants will be conserved in the Biotech Park for research purposes. It has been learnt that the department is in the process of formulating the Biotech Policy for Bengal.

The state government has already taken the initiative to upgrade the infrastructure of Kolkata Biotech Park, apart from setting up new Biotechnology hubs in Burdwan and Kalimpong. The department has been focusing on the modernisation and expansion of the Common Instrument Facility Centre in the Biotech Park in the city. The department of Biotechnology will obtain all the necessary approvals and clearances to secure funding for the augmentation of the 'Bioincubator Facility' in Kolkata.

The department has a plan to conduct research on tissue culture to increase the yield and quality of various products but also to provide germ-free food to the common people. The Biotechnology department will tie up with other departments like Agriculture, Fisheries and Food Processing to strengthen organisational collaboration.

Better co-ordination with other departments will help the Biotechnology department to successfully implement the schemes. The department will help the Agriculture department to improve the quality of various fertilizers. It is also working to increase the production of fishes for the Fisheries department.

Tissue culture will be of immense help in increasing the productivity of land by enhancing crop quality, developing crops resistant to biotic and abiotic stresses, developing bio-fertilizers and bio-pesticides.

Bengal is rich in the biodiversity of crops, vegetables, fruits, flowers and other plant resources. The main objectives of the department are to provide better facilities to the common people and to improve the quality of life. It will also promote the overall development of both traditional and modern biotechnology in the state including various livelihood development programmes. It will also strengthen biotechnology-based aspects that will help in the development of the state economy from the grass-root level.

The Biotechnology department is applying specialised knowledge, skills and management to develop a viable and vibrant biotechnology-based industry in the state. It stresses on equitable and inclusive development through scientific means.

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Biotechnology dept to set up tissue culture lab - Millennium Post

Illinois Biotechnology Innovation Organization Announces First … – Yahoo Finance

CHICAGO--(BUSINESS WIRE)--

The Illinois Biotechnology Innovation Organization (iBIO) today announced the keynote panel for the 2017 iBIO Industry Exposition (iBIO IndEx), held in Rosemont, Illinois, April 24, 2017. The theme of this year's iBIO IndEx, is Converge to Emerge. TheiBIO IndEx 2017 is a place to connect with more than 500 key thought leaders and peers from diverse backgrounds, and gather insight to help drive industry-wide growth and transformation in Illinois. iBIO's signature event is a forum to discuss the latest trends and innovations impacting our community.

We are excited to announce the first keynote panel for the 2017 iBIO IndEx, said Warren Ribley, iBIO president and CEO. We are very fortunate this year to have a strong lineup of industry leaders from our community. Attendees can expect to learn how the biopharma community is focusing on innovative lifesaving medicines while navigating a changing regulatory and political landscape.

The four keynote panelists are:

"Thanks to the tireless work of biopharmaceutical researchers and scientists, we have entered a new era of medicine that is transforming the way we treat and cure diseases, said Stephen Ubl, president and CEO PhRMA . "The iBIO IndEx is an opportunity to convene with other industry stakeholders to discuss ways we can work together to build upon this scientific progress and make our health care system more responsive to the needs of patients."

We are heading into an unprecedented time of growth and collaboration in our industry, said Timothy P. Walbert, president, chairman and chief executive officer of Horizon Pharma plc and chairman of iBIO. The connections we have to each other and the work we do on behalf of patients is at the very core of what makes our community great.

The 2017 iBIO IndEx will also feature the PROPEL Business Plan Competition and Innovation Showcase, a partnership with Illinois major academic research institutions to showcase the next generation of new ventures.

iBIO IndEx program highlights include:

The iBIO IndEx programming would not be possible without the support of our sponsors. AbbVie, Astellas, Horizon Pharma plc, Shire and Takeda are major supporters of the iBIO IndEx. Deloitte, Ernst & Young,McDonnell Boehnen Hulbert & Berghoff, Perkins Coie, PhRMA, and Vetter Development Services provide programming support.

For more information about the iBIO IndEx, visit the conference website: http://index.ibio.org.

About the Illinois Biotechnology Innovation Organization

iBIOs mission is to make Illinois and the surrounding Midwest one of the worlds top life sciences centers: a great place to do business and a great place to grow technology ventures.

iBIO, working on its own and through valued partners

We thereby contribute to the well-being of people worldwide while creating new jobs, attracting firms to the region and generating prosperity.

iBIOs Leadership Sponsors are AbbVie, Astellas, Horizon Pharma plc, Shire and Takeda Pharmaceuticals North America.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170321006017/en/

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Illinois Biotechnology Innovation Organization Announces First ... - Yahoo Finance

Biotechnology 2017 | Biotechnology Congress | Canada …

Allied Academies cordially invites all the participants across the globe from leading universities, clinical research institutions, diagnostic companies and all interested to share their research experiences in the Annual Biotechnology Congress during August 17-18, 2017 in Toronto, Canada with the theme of New Scientific Developments in Biotechnology of Modern Era.

Track 1:Biochemistry & Molecular Biotechnology

Molecular biotechnology is the use of laboratory techniques to study and modify nucleic acids and proteins for applications in areas such as human and animal health, agriculture, and the environment. Molecular biotechnology results from the convergence of many areas of research, such as molecular biology, microbiology, biochemistry, immunology, genetics, and cell biology. It is an exciting field fueled by the ability to transfer genetic information between organisms with the goal of understanding important biological processes or creating a useful product.

The key drivers for molecular biology enzymes, kits and reagents market are the rising R&D expenditure by the pharmaceutical and biotech companies, and increasing public funding for life science research. The World Health Organization estimates that the total aged population may rise from 605 million in 2000 (11% of the global population) to 2 billion by 2050, accounting for 22% of the global population.

Track 2:Animal biotechnology

It improves the food we eat - meat, milk and eggs. Biotechnology can improve an animals impact on the environment. Animal biotechnology is the use of science and engineering to modify living organisms. The goal is to make products, to improve animals and to develop microorganisms for specific agricultural uses. It enhances the ability to detect, treat and prevent diseases, include creating transgenic animals (animals with one or more genes introduced by human intervention), using gene knock out technology to make animals with a specific inactivated gene and producing nearly identical animals by somatic cell nuclear transfer (or cloning).

Track 3:Biomedicine Engineering

Medicine is by means of biotechnology techniques so much in diagnosing and treating dissimilar diseases. It also gives opportunity for the population to defend themselves from hazardous diseases. The pasture of biotechnology, genetic engineering, has introduced techniques like gene therapy, recombinant DNA technology and polymerase chain retort which employ genes and DNA molecules to make a diagnosis diseases and put in new and strong genes in the body which put back the injured cells. There are some applications of biotechnology which are live their part in the turf of medicine and giving good results.

This field seeks to close the gap between engineering and medicine. It combines the design and problem solving skills of engineering with medical and biological sciences to advance health care treatment, including diagnosis, monitoring and therapy. Prominent biomedical engineering applications include the development of biocompatibleprostheses, various diagnostic and therapeutic medical devices ranging from clinical equipment to micro-implants, common imaging equipment such as MRIs and EEGs, regenerative tissue growth, pharmaceutical drugs and therapeutic biological.

Track 4:Agricultural Biotechnology

Biotechnology is being used to address problems in all areas of agricultural production and processing. This includes plant breeding to raise and stabilize yields; to improve resistance to pests, diseases and abiotic stresses such as drought and cold; and to enhance the nutritional content of foods. Modern agricultural biotechnology improves crops in more targeted ways. The best known technique is genetic modification, but the term agricultural biotechnology (or green biotechnology) also covers such techniques as Marker Assisted Breeding, which increases the effectiveness of conventional breeding.

Track 5:Food Processing & Technology

Food processing is a process by which non-palatable and easily perishable raw materials are converted to edible and potable foods and beverages, which have a longer shelf life. Biotechnology helps in improving the edibility, texture, and storage of the food; in preventing the attack of the food, mainly dairy, by the virus like bacteriophage producing antimicrobial effect to destroy the unwanted microorganisms in food that cause toxicity to prevent the formation and degradation of other toxins and anti-nutritional elements present naturally in food.

Track 6:Industrial Biotechnology

Industrial biotechnology is the application of biotechnology for industrial purposes, including industrial fermentation. The practice of using cells such as micro-organisms, or components of cells like enzymes, to generate industrially useful products in sectors such as chemicals, food and feed, detergents, paper and pulp, textiles and biofuels. Industrial Biotechnologyoffers a premier forum bridging basic research and R&D with later-stage commercialization for sustainable bio based industrial and environmental applications.

Track 7: Pharmaceutical Biotechnology

Pharmaceutical Biotechnology is the science that covers all technologies required for producing, manufacturing and registration of biological drugs.Pharmaceutical Biotechnologyis an increasingly important area of science and technology. It contributes in design and delivery of new therapeutic drugs,diagnosticagents for medical tests, and in gene therapy for correcting the medical symptoms of hereditary diseases. The Pharmaceutical Biotechnology is widely spread, ranging from many ethical issues to changes inhealthcarepractices and a significant contribution to the development of national economy.Biopharmaceuticalsconsists of large biological molecules which areproteins. They target the underlying mechanisms and pathways of a disease or ailment; it is a relatively young industry. They can deal with targets in humans that are not accessible with traditional medicines.

Track 8:Environmental biotechnology

Biotechnology is applied and used to study the natural environment. Environmental biotechnology could also imply that one tries to harness biological process for commercial uses and exploitation. The development, use and regulation of biological systems for remediation of contaminated environments and for environment-friendly processes (green manufacturing technologies and sustainable development). Environmental biotechnology can simply be described as "the optimal use of nature, in the form of plants, animals, bacteria, fungi and algae, to produce renewable energy, food, and nutrients in a synergistically integrated cycle of profit making processes where the waste of each process becomes the feedstock for another process".

Track 9:Genetic & Tissue Engineering

One kind of biotechnology is gene technology, sometimes called 'genetic engineering' or 'genetic modification', where the genetic material of living things is deliberately altered to enhance or remove a particular trait and allow the organism to perform new functions. Genes within a species can be modified, or genes can be moved from one species to another.

Tissue engineering is emerging as a significant potential alternative or complementary solution, whereby tissue and organ failure is addressed by implanting natural, synthetic, or semisynthetic tissue and organ mimics that are fully functional from the start or that grow into the required functionality. Initial efforts have focused on skin equivalents for treating burns, but an increasing number of tissue types are now being engineered, as well as biomaterials and scaffolds used as delivery systems. A variety of approaches are used to coax differentiated or undifferentiated cells, such as stem cells, into the desired cell type. Notable results include tissue-engineered bone, blood vessels, liver, muscle, and even nerve conduits. As a result of the medical and market potential, there is significant academic and corporate interest in this technology.

Track 10:Nano Biotechnology

Nano biotechnology, bio nanotechnology, and Nano biology are terms that refer to the intersection of nanotechnology and biology. Bio nanotechnology and Nano biotechnology serve as blanket terms for various related technologies. The most important objectives that are frequently found in Nano biology involve applying Nano tools to relevant medical/biological problems and refining these applications. Developing new tools, such as peptide Nano sheets, for medical and biological purposes is another primary objective in nanotechnology.

Track 11:Bioinformatics

Bioinformatics is the application of computer technology to the management of biological information. Computers are used to gather, store, analyze and integrate biological and genetic information which can then be applied to gene-based drug discovery and development. The science of Bioinformatics, which is the melding of molecular biology with computer science, is essential to the use of genomic information in understanding human diseases and in the identification of new molecular targets for drug discovery.

Track 12:Biotechnology investments and Biotechnology Grants

Every new business needs some startup capital, for research, product development and production, permits and licensing and other overhead costs, in addition to what is needed to pay your staff, if you have any.Biotechnology products arise from successful biotech companies. These companies are built by talented individuals in possession of a scientific breakthrough that is translated into a product or service idea, which is ultimately brought into commercialization. At the heart of this effort is the biotech entrepreneur, who forms the company with a vision they believe will benefit the lives and health of countless individuals. Entrepreneurs start biotechnology companies for various reasons, but creating revolutionary products and tools that impact the lives of potentially millions of people are one of the fundamental reasons why all entrepreneurs start biotechnology companies.

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Biotechnology 2017 | Biotechnology Congress | Canada ...

Assessing biotechnology in the age of cloud computing – Cloud Tech

In order to ensure that patient outcomes are constantly being improved upon it is important that the speed of change within the biotechnology sector occurs at an exponential rate. However, this continued drive for innovation puts immense pressure on IT departments to develop new technologies at speed, while also making sure that they do this cost effectively.

Add to this the fact that, more so than other industries, biotech firms are extremely tightly regulated. As a result, IT groups within this industry are often reluctant to introduce more complexity into what is already a very complex environment. To them, expanding a data centre can often feel a whole lot easier than navigating the regulations of the cloud. Despite this, growth in the demand for cloud computing in life sciences research and development is escalating due to the benefits it brings to the industry benefits like exceeding regulatory requirements, for example.

At iland, we have worked with many companies in the healthcare, life sciences and biotech industries. Therefore, we know from experience that the implementation of cloud computing in biotechnology empowers organisations with the control and flexibility needed to lead the way in both the research world as well as the businesses world. For example, we recently worked with a US based biotechnology organisation on their backup and disaster recovery (DR) strategy, and were able to drive global data centre consolidation with host-based replication to the iland cloud. As a result, their DR testing and auditing processes were greatly simplified and streamlined which drove significant cost savings as well as compliance assurance.

If you still need convincing here are three key benefits that we believe cloud brings to biotech organisations:

When the Human Genome Project began it was one of the most extensive research projects in the field to date costing billions of pounds and lasting over a decade. These days, thanks largely to cloud technology, it can bedone in just 26 hours. Things such as drug R&D, clinical research as well as a whole host of other areas have benefited just as much from the rapid growth of computational power. The better your technology is at crunching huge sets of data, the quicker you can innovate.

Cloud computing within the biotech sector can take big data analysis to the next level by means of performance, connectivity, on-demand infrastructure and flexible provisioning. Labs can also benefit from immense computing power without the cost and complexity of running big onsite server rooms. They can also scale up at will in order to make use of new research and ideas almost instantly.

Concerns have been voiced that so called scientific computing in the cloud may make results less reproducible. One concern is that cloud computing will be a computing 'black box' that obscures details needed to accurately interpret the results of computational analyses. In actual fact, by leveraging the application program interfaces (APIs) in the iland cloud, biotech customers are able to integrate cloud data back into on-premises IT systems to ensure that data analyses done in the cloud can be easily shared and consumed by other applications. Essentially, cloud computing services bring more players to the table to solve the giant puzzle. Its a win-win situation from an economic and patient standpoint, and several big name companies are jumping on the biotech cloud bandwagon.

Biotech companies need to maintain strong access and authentication controls, while also being able to collaborate easily.For this reason audit trails and other measures are often required to verify that information has not been improperly altered, and that good experimental and manufacturing procedures have been followed. At the same time biotechnologists need to be able to access and share data across multiple departments or even multiple companies.

Cloud computing in biotechnology makes this all possible. Theiland cloud, for instance, centralises data, ensuring security and data sovereignty while facilitating collaboration. It supports extensive user and role based access control, two-factor authentication and integrity monitoring to prevent improper access and changes. In addition to data encryption, vulnerability scanning and intrusion detection, these measures facilitate security and compliance, without disrupting the internal workflow.

Complex regulatory requirements and logistics combined with niche markets make efficiency paramount within biotechnology. Even minor mistakes as a result of sloppy process management can easily result in major issues. Real-time operational reporting dramatically improves efficiency, quality control and decision making, allowing organisations to react instantly to challenges and opportunities, both internal and external.

As well as enhanced billing visibility and resource management functions, the release of our latest Secure Cloud Services means that the iland cloud now includes on-demand security and compliance reports. This advanced cloud management functionality is designed to foster strategic, self-sufficient control of a cloud environment, optimising overall cloud usage and costs to drive business initiatives and growth.

Without a shadow of a doubt, cloud technology can help biotechnology companies build the future.From research and development to marketing, computing affects everything your organisation does. With rich experience in the biotech, healthcare and life sciences sector, you should talk to iland today to find out how our cloud hosting services can give you the power to develop at the speed of thought, not the speed of compliance or processing.

Read more: Why the cloud could hold the cure to diseases

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Biodiversity, Biotechnology and Intellectual Property: their relevance for the development of Colombia – Lexology (registration)

Biotechnology has emerged as one of the most forward-looking fields of science in recent decades, and a large number of nations have set their sights on it as a long-term development pillar, given its wide range of applications and the leapfrogging of current information technology, which allows to further exploit its potential.

Biotechnology has already proven to be an option for growth in multiple economic sectors, finding applications of high importance in sectors such as pharmaceuticals, food, veterinary, cosmetic, environmental, agricultural, energy, among others, which make it an opportunity for those developing countries in search of a boost for the progress of their economies.

It is then in biotechnology that a country like Colombia, which occupies the second place after Brazil in world biodiversity, with around 10% of the fauna and flora of the planet, can find possibilities of great impact for its economic growth and technological development. However, it is not a simple challenge if one takes into account the little investment that, unfortunately, is destined for R&D in the country. For example, according to World Bank data for the year 2014, Colombia allocated about 0.2% of GDP for this purpose, an amount significantly lower than the world average of about 2%, and much lower than the number one country in this regard, South Korea, which investment in R&D is above 4% of GDP.

In this manner, the government, academics and companies must work together to transform this enormous biodiversity into a factory of knowledge and innovation that translates into solutions to both local and global problems, which in the long term will allow to narrow the economic-technological gap between Colombia and the most developed countries in the world.

Thus, in the commitment to research in general as a driving force for development, and in particular concerning the emerging biotechnology, intellectual property plays a decisive role for its progress; this is due to the fact that tools for the protection of inventions, such as patents, greatly influence the decision of companies to invest or not their capital in a particular sector, and even more in biotechnology, which is undoubtedly one of those with highest cost in both R&D and product development and process design.

Hence, it is possible to evidence in different countries a closely related upward trend between R&D spending and the filing of patent applications, making them a clear indicator of a country's innovation and inventive step. By way of example, this is clearly visible when comparing the number of patent applications filed in Colombia and South Korea, using data provided by the World Bank in this regard for the same year mentioned above. In Colombia, in 2014, 260 patent applications were filed by residents and 1898 by non-residents; values much lower than those in South Korea where the numbers amount to 164073 patent applications filed by residents and 46219 by non-residents for the same year.

Therefore, it is necessary a vision change from the government of Colombia that promotes the injection of public and private capital in R&D, which is supported by an intellectual property system that provides adequate legal protection to the inventions and compensates the economic efforts made in innovation. Taking into account the characteristics of the country, Colombia has the potential to establish, as one of the pillars of its economy, its own biodiversity together with biotechnology; however, to this day, this latter is greatly underestimated.

In this sense, the challenge for Colombia in the coming years is to recognize and take advantage of the immense potential for scientific research that it possesses, especially in terms of biotechnology, in order to have in the future the ability to offer products and services with high standards of quality and added value, derived from a sustainable exploitation of its natural resources that goes hand in hand with policies ensuring the technical, legal and economic conditions conducive to its realization.

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Biodiversity, Biotechnology and Intellectual Property: their relevance for the development of Colombia - Lexology (registration)

Puma Biotechnology Inc (PBYI) Plunges 9.45% on March 21 – Equities.com

Market Summary Follow

Puma Biotechnology Inc is a A biopharmaceutical company

PBYI - Market Data & News

PBYI - Stock Valuation Report

Puma Biotechnology Inc (PBYI) had a rough trading day for Tuesday March 21 as shares tumbled 9.45%, or a loss of $-4.2 per share, to close at $40.25. After opening the day at $44.75, shares of Puma Biotechnology Inc traded as high as $44.85 and as low as $39.80. Volume was 947,068 shares over 8,315 trades, against an average daily volume of 991,915 shares and a total float of 36.95 million.

As a result of the decline, Puma Biotechnology Inc now has a market cap of $1.49 billion. In the last year, shares of Puma Biotechnology Inc have traded between a range of $73.27 and $19.74, and its 50-day SMA is currently $36.22 and 200-day SMA is $42.55.

For a complete fundamental analysis of Puma Biotechnology Inc, check out Equities.coms Stock Valuation Analysis report for PBYI.

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Puma Biotechnology Inc is a biopharmaceutical company. It is engaged in the acquisition, development and commercialization of products to enhance cancer care.

Puma Biotechnology Inc is based out of Los Angeles, CA and has some 160 employees. Its CEO is Alan H. Auerbach.

Puma Biotechnology Inc is a component of the Russell 2000. The Russell 2000 is one of the leading indices tracking small-cap companies in the United States. It's maintained by Russell Investments, an industry leader in creating and maintaining indices, and consists of the smallest 2000 stocks from the broader Russell 3000 index.

Russell's indices differ from traditional indices like the Dow Jones Industrial Average (DJIA) or S&P 500, whose members are selected by committee, because they base membership entirely on an objective, rules based methodology. The 3,000 largest companies by market cap make up the Russell 3000, with the 2,000 smaller companies making up the Russell 2000. It's a simple approach that gives a broad, unbiased look at the small-cap market as a whole.

To get more information on Puma Biotechnology Inc and to follow the companys latest updates, you can visit the companys profile page here: PBYIs Profile. For more news on the financial markets and emerging growth companies, be sure to visit Equities.coms Newsdesk. Also, dont forget to sign-up for our daily email newsletter to ensure you dont miss out on any of our best stories.

All data provided by QuoteMedia and was accurate as of 4:30PM ET.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer

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Puma Biotechnology Inc (PBYI) Plunges 9.45% on March 21 - Equities.com

What Will Eventually Wobble Puma Biotechnology (PBYI), IMAX Corporation (IMAX) – US Post News

The recent performance of Puma Biotechnology (NASDAQ:PBYI) stock in the market spoke loud and clear to investors as PBYI saw more than 2.07M shares in trading volumes in the last trading session, way higher than the average trading volume of 2.07M shares by far recorded in the movement of Puma Biotechnology (PBYI). At the time the stock opened at the value of $7.90, making it a high for the given period, the value of the stock jumped by 3.11%. After the increase, PBYI touched a low price of $6.62, calling it a day with a closing price of $7.39, which means that the price of PBYI went 7.62 below the opening price on the mentioned day.

Given the most recent momentum in the market in the price movement of PBYI stock, some strong opinions on the matter of investing in the companys stock started to take shape, which is how analysts are predicting an estimated price of $12.63 for PBYI within consensus. The estimated price would demand a set of gains in total of 22.75%, which goes higher than the most recent closing price, indicating that the stock is in for bullish trends. Other indicators are hinting that the stock could reach an outstanding figure in the market share, which is currently set at 34.75M in the public float and 375.67M US dollars in market capitalization.

When it comes to the technical analysis of PBYI stock, there are more than several important indicators on the companys success in the market, one of those being the Relative Strength Indicator (RSI), which can show, just as Stochastic measures, what is going on with the value of the stock beneath the data. This value may also indicate that the stock will go sideways rather than up or down, also indicating that the price could stay where it is for quite some time. When it comes to Stochastic reading, PBYI stock are showing 10.95% in results, indicating that the stock is neither overbought or oversold at the moment, providing it with a neutral within Stochastic reading as well. Additionally, PBYI with the present state of 200 MA appear to be indicating bearish trends within the movement of the stock in the market. While other metrics within the technical analysis are due to provide an outline into the value of PBYI, the general sentiment in the market is inclined toward negative trends.

With the previous 100-day trading volume average of 602215 shares, IMAX Corporation (IMAX) recorded a trading volume of 1.95 million shares, as the stock started the trading session at the value of $10.85, in the end touching the price of $11.10 after jumping by 2.30%.

IMAX stock seem to be going ahead the lowest price in the last 52 weeks with the latest change of 3.06%.Then price of IMAX also went backward in oppose to its average movements recorded in the previous 20 days. The price volatility of IMAX stock during the period of the last months recorded 6.88%, whilst it changed for the week, now showing 12.63% of volatility in the last seven days. The trading distance for this period is set at -29.31% and is presently away from its moving average by -36.70% in the last 50 days. During the period of the last 5 days, IMAX stock lost around -26.15% of its value, now recording a dip by -45.14% reaching an average $20.18 in the period of the last 200 days.During the period of the last 12 months, IMAX Corporation (IMAX) dropped by -45.67%.

According to the Barcharts scale, the companys consensus rating was unchanged to 4.86 from 4.86, showing an overall improvement during the course of a single month. Based on the latest results, analysts are suggesting that the target price for IMAX stock should be $11.10 per share in the course of the next 12 months. To achieve the target price as suggested by analysts, IMAX should have a spike by 0% in oppose to its present value in the market. Additionally, the current price showcases a discount of 58.89% when compared to the high consensus price target predicted by analysts.

IMAX shares recorded a trading volume of 2.55 million shares, compared to the volume of 804.68K shares before the last close, presented as its trading average. With the approaching 12.63% during the last seven days, the volatility of IMAX stock remained at 6.88%. During the last trading session, the lost value that IMAX stock recorded was set at the price of $11.10, while the lowest value in the last 52 weeks was set at $10.77. The recovery of the stock in the market has notably added 3.06% of gains since its low value, also recording -37.54% in the period of the last 1 month.

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What Will Eventually Wobble Puma Biotechnology (PBYI), IMAX Corporation (IMAX) - US Post News

National Academies Report Finds Future Biotechnology Products May Overwhelm Agencies – The National Law Review

On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine (National Academies) published a report entitled Preparing for Future Products of Biotechnology, prepared by the Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System (Committee). The Committee was asked to describe the possible future products of biotechnology that will arise over the next five to ten years, as well as provide some insights that can help shape the capabilities within the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) as they move forward. According to the Committee, agencies may be overwhelmed by the number and diversity of new biotechnology products. The Committee states that the agencies should increase their scientific capabilities, tools, and expertise in key areas of expected growth. The report reflects the Committees deliberations regarding the future products of biotechnology that are likely to appear on the horizon, the challenges that the regulatory agencies might face, and the opportunities for enhancing the regulatory system to prepare for what might be coming. The Committee reached consensus on conclusions and recommendations that are based on extensive information gathering, Committee discussions, and input from a wide variety of communities interested in biotechnology. A copy of the slides used during a National Academies webinar on the report can be found on the National Academies website.

On July 2, 2015, the White House Office of Science and Technology Policy, the Office of Management and Budget, the U.S. Trade Representative, and the Council on Environmental Quality issued a memorandum, Modernizing the Regulatory System for Biotechnology Products, directing EPA, FDA, and USDA to update the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework). The Obama Administration asked the agencies to accomplish three tasks:

Clarify the current roles and responsibilities of the EPA, FDA, and USDA in the regulatory process;

Develop a long-term strategy to ensure that the federal regulatory system is equipped to assess efficiently the risks, if any, of the future products of biotechnology; and

Commission an expert analysis of the future landscape of biotechnology products.

As reported previously, on January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and responsibilities of EPA, FDA, and USDA with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the 2017 Update offers a complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology. Within that regulatory structure, the federal agencies maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices. More information is available in the White House blog item, Increasing the Transparency, Coordination, and Predictability of the Biotechnology Regulatory System.

The July 2, 2015, memorandum called for the commission of an external, independent analysis of the future landscape of biotechnology products. EPA, FDA, and USDA commissioned the National Academies to prepare an analysis to identify potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood. This analysis is presented in the report prepared by the Committee that was released on March 9, 2017.

The Committee was tasked to:

Describe the major advances and the potential new types of biotechnology products likely to emerge over the next five to ten years;

Describe the existing risk-analysis system for biotechnology products including, but perhaps not limited to, risk analyses developed and used by EPA, USDA, and FDA, and describe each agencys authorities as they pertain to the products of biotechnology;

Determine whether potential future products could pose different types of risks relative to existing products and organisms. Where appropriate, identify areas in which the risks or lack of risks relating to the products of biotechnology are well understood; and

Indicate what scientific capabilities, tools, and expertise may be useful to the regulatory agencies to support oversight of potential future products of biotechnology.

Human drugs and medical devices were not included in the purview of the study.

To address its statement of task, the Committee gathered information from a number of sources, and heard from over 70 speakers over the course of three in-person meetings and eight webinars. The Committee received responses to a request for information from a dozen federal agencies, and solicited statements and written comments from members for the public. According to the report, the Committee defined biotechnology products as products developed through genetic engineering or genome engineering (including products where the engineered DNA molecule is itself the product, as in an engineered molecule used as a DNA information-storage medium) or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes. The term also covers some products produced by such plants, animals, microbes, and cell-free systems or products derived from all of the above.

The Committee grouped future products into three major classes:

Open-release products: The open-release products that the Committee saw on the horizon include plants, animals, microbes, and synthetic organisms that have been engineered for deliberate release in an open environment. According to the report, the ability to sustain existence in the environment with little or no human intervention is a key change between existing products of biotechnology and some of the future ones anticipated in this class. The report states that the Committee thought that future open-release products would be developed for familiar uses, such as agricultural crops, but would also likely be developed for uses such as cleaning up contaminated sites with engineered microbes, replacing animal-derived meat with meat cultured from animal cells, and controlling invasive species through gene drives;

Contained products: The Committee concluded that future biotechnology products that are produced in contained environments are more likely to be microbial based or synthetically based rather than based on an animal or plant host. According to the report, organisms of many genera are used in fermenters to produce commodity chemicals, fuels, specialty chemicals or intermediates, enzymes, polymers, food additives, and flavors. When considering the laboratory as a contained environment, the report states that many examples of transgenic animals from vendors are widely used today for research and development. Because performing biotechnology in contained environments allows higher control over the choice of host organism, systems with advanced molecular toolboxes are already in high use; and

Platforms: Biotechnology platforms are tools that are used in the creation of other biotechnology products, according to the report, including products that are traditionally characterized as wet lab, such as DNA/RNA, enzymes, vectors, cloning kits, cells, library prep kits, and sequencing prep kits, and products that are dry lab, such as vector drawing software, computer-aided design software, primer calculation software, and informatics tools. The report states that these two categories continue to meld as newer approaches are published or commercialized.

The report notes that there are a variety of technical, economic, and social trends that drive and will continue to drive the types of biotechnology products developed in the next decade. Technical and economic trends in the biological sciences and biological engineering are accelerating the rate at which new product ideas are formulated and the number of actors who are involved in product development. The report states that with regard to social trends, it was evident to the Committee that there are many competing interests, risks, and benefits regarding future biotechnology products. According to the report, it was clear that the U.S. and international regulatory systems will need to achieve a balance among these competing aspects when considering how to manage the development and use of new biotechnology products.

The Committee found that the Coordinated Framework appears to have considerable flexibility in statutory authority to cover a wide range of biotechnology products. The jurisdictions of EPA, FDA, and USDA are defined in ways that may leave gaps or redundancies in regulatory oversight, however. According to the report, even when jurisdiction exists, the available legal authorities may not be ideally tailored to new and emerging biotechnology products. Other agencies will likely have responsibilities to regulate some future biotechnology products, and their roles are not well specified in the Coordinated Framework.

The report states that the Committee found that the complexity of the existing biotechnology regulatory system, which could appear fragmented, results in a system that is difficult for product developers -- including individuals, nontraditional organizations, and small enterprises, as well as consumers, product users, and interested members of the public to navigate. The complexity can cause uncertainty and a lack of predictability for developers of future biotechnology products and creates the potential for loss of public confidence in oversight of future biotechnology products.

According to the report, the increased rate of new product ideas means that the types and number of biotechnology products in the next five to ten years may be significantly larger than the current rate of product introduction. The report cautions EPA, FDA, USDA, and other relevant agencies to prepare for this potential increase, including finding effective means of evaluation that maintains public safety, protects the environment, and satisfies the statutory requirements appropriate for each agency. The increased number of actors involved in product development means that the regulatory agencies will need to be prepared to provide information regarding the regulatory process to groups that may have little familiarity with the Coordinated Framework.

According to the report, advances in biotechnology are leading to products that involve the transformation of less familiar host organisms, have multiple engineered pathways, are comprised of DNA from multiple organisms, or are made from entirely synthetic DNA. Such products may have few or no comparators to existing nonbiotechnology products, which function as the baseline of comparison in current regulatory risk assessments of biotechnology products.

For future biotechnology products in all degrees of complexity and novelty, the Committee considered the risk assessment endpoints related to human health or environmental outcomes, such as illness, injury, death, or loss of ecosystems function. The Committee concluded that these endpoints are not new, but the intermediate steps along the path to those endpoints may be more complex, more ambiguous, and less well characterized than those for existing biotechnology products. According to the report, the scope, scale, complexity, and tempo of biotechnology products likely to enter the regulatory system in the next five to ten years have the potential to critically stress EPA, FDA, and USDA, both in terms of capacity and expertise.

At a high level, the Committee found that there are existing frameworks, tools, and processes for risk analyses and public engagement that can be used to address the issues likely to arise in future biotechnology products in a way that balances competing issues and concerns. Given the profusion of biotechnology products that are on the horizon, however, there is a risk that the capacity of the regulatory agencies may not be able to provide efficiently the quantity and quality of risk assessments that will be needed. The report states that an important approach for dealing with the increase in the products will be the increased use of stratified approaches to regulation, where new and potentially more complex risk analysis methods will need to be developed for some products, while established risk analysis methods can be applied or modified to address products that are familiar or that require less complex risk analysis. To help articulate what capabilities, tools, and expertise might be useful to meet these objectives, the Committee created a conceptual map for decision-making aimed to assess and manage product risk, streamline regulation requirements, and increase transparency.

The Committee identified the following broad themes regarding future opportunities for enhancement of the U.S. biotechnology regulatory system:

The bioeconomy is growing rapidly and the U.S. regulatory system needs to provide a balanced approach for consideration of the many competing interests in the face of this expansion;

The profusion of biotechnology products over the next five to ten years has the potential to overwhelm the U.S. regulatory system, which may be exacerbated by a disconnect between research in regulatory science and expected uses of future biotechnology products;

Regulators will face difficult challenges as they grapple with a broad array of new types of biotechnology products -- for example, cosmetics, toys, pets, and office supplies -- that go beyond contained industrial uses and traditional environmental release (for example, Bacillus thuringiensis (Bt) or herbicide-resistant crops);

The safe use of new biotechnology products requires rigorous, predictable, and transparent risk-analysis processes whose comprehensiveness, depth, and throughput mirror the scope, scale, complexity, and tempo of future biotechnology applications; and

In addition to the conclusions and recommendations from this report, EPA, FDA, USDA, and other agencies involved in regulation of future biotechnology products would benefit from adopting recommendations made by previous National Academies committees related to future products of biotechnology that are consistent with the findings and recommendations in this report.

On the basis of its conclusions, the Committee developed a number of detailed recommendations regarding actions that can be taken to enhance the capabilities of the biotechnology regulatory system to be prepared for anticipated future products of biotechnology.

EPA, FDA, USDA, and other agencies involved in regulation of future biotechnology products should increase scientific capabilities, tools, expertise, and horizon scanning in key areas of expected growth of biotechnology, including natural, regulatory, and social sciences;

EPA, FDA, and USDA should increase their use of pilot projects to advance understanding and use of ecological risk assessments and benefit analyses for future biotechnology products that are unfamiliar and complex and to prototype new approaches for iterative risk analyses that incorporate external peer review and public participation; and

The National Science Foundation, the Department of Defense, the Department of Energy, the National Institute of Standards and Technology, and other agencies that fund biotechnology research with the potential to lead to new biotechnology products should increase their investments in regulatory science and link research and education activities to regulatory-science activities.

The report is well written and contains a significant amount of new and valuable information on the types of new biotechnology products being innovated and coming into commerce, trends of note regarding future products, and regulatory gaps and redundancies that need to be addressed. This background information is clearly presented and supports well the conclusions that are essential to understand, and the recommendations that are in urgent need of response.

That the federal agencies tasked with regulating biotechnology products need increased funding and organizational retooling to address the challenges eloquently and convincingly described in the report are truths beyond dispute. In this political climate, and under this Administration, meeting these needs will be challenging. Shareholders of all sorts in the biotechnology area -- businesses, innovators, environmental and public health activists -- are urged to weigh in and express support for the allocation of resources needed to fulfill the reports recommendations. Future generations of biotechnology products are on the line and at risk if these recommendations fall on deaf ears.

2017 Bergeson & Campbell, P.C.

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National Academies Report Finds Future Biotechnology Products May Overwhelm Agencies - The National Law Review

Where Does CLVS Stock Rank in the Biotechnology Industry? – InvestorsObserver

Clovis Oncology Inc (CLVS) is near the top in its industry group according to InvestorsObserver. CLVS gets an overall rating of 50. That means it scores higher than 50 percent of stocks. Clovis Oncology Inc gets a 67 rank in the Biotechnology industry. Biotechnology is number 99 out of 148 industries.

Click Here to get the full Stock Score Report on Clovis Oncology Inc (CLVS) Stock.

Analyzing stocks can be hard. There are tons of numbers and ratios, and it can be hard to remember what they all mean and what counts as good for a given value. InvestorsObserver ranks stocks on eight different metrics. We percentile rank most of our scores to make it easy for investors to understand. A score of 50 means the stock is more attractive than 50 percent of stocks.

Our proprietary scoring system captures technical factors, fundamental analysis and the opinions of analysts on Wall Street. This makes InvestorsObservers overall rating a great way to get started, regardless of your investing style. Percentile-ranked scores are also easy to understand. A score of 100 is the top and a 0 is the bottom. Theres no need to try to remember what is good for a bunch of complicated ratios, just pay attention to which numbers are the highest.

Clovis Oncology Inc (CLVS) stock is trading at $5.51 as of 1:00 PM on Tuesday, Nov 12, an increase of $0.13, or 2.32% from the previous closing price of $5.38. The stock has traded between $5.25 and $5.91 so far today. Volume today is 4,592,272 compared to average volume of 5,433,499.

To screen for more stocks like CLVS click here.

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Where Does CLVS Stock Rank in the Biotechnology Industry? - InvestorsObserver

Agricultural biotechnology: Gene Editing versus Gene Modification – The Indian Express

Written by Venkata Sresty Tavva, Shaibal Dasgupta | New Delhi | Updated: January 30, 2020 5:04:50 am

Increased agricultural production and sustainable food security is of paramount importance for a growing population, both globally and in India. Rice is one of the major staple food crops, on which over half of the worlds population and 80% of Asians are dependent for meeting their daily energy needs. India is the second largest consumer (around 100 million tonnes) as well as producer (115 million tonnes) of milled rice after China.

Rice, like other crops, is exposed to various biotic and abiotic stresses during its life cycle. Several diseases such as bacterial leaf blight and blast, and insect pests like the brown plant hopper, cause significant damage that result in devastating yield reductions. The crop losses from some of these biotic stresses can be as high as 50% and even reach 90% in epidemic conditions. In addition, rice accounts for more than half of the fresh water used in agriculture. Water availability for agriculture in general is becoming a significant constraint now, due to ever-increasing domestic, urban and industrial consumption requirements. The situation will become more complex with decreased arable land availability as well, not to speak of the impact of climate change on crop productivity.

Successful development of rice lines, incorporating important biotic and abiotic stress resistant traits, can provide solutions for minimising yield losses that affect consumers (from reduced availability) and producers (from lower incomes) alike. This may, however, require adoption of innovative technologies, as the existing breeding techniques based on physical crossing of parental plants may not be enough. One such approach is targeted genome editing of crop plants, which could yield varieties with desired traits within a short period of time compared to traditional breeding methods. For this, we must first identify rice varieties that are already being grown extensively in a selected geography and develop strategies for improving traits such as disease and pest resistance, drought tolerance, etc.

In the last six years, targeted genome editing using CRISPR/Cas9 has captivated the attention of the research community. The applications of this technology an acronym for clustered regularly interspaced short palindromic repeats/CRISPR-associated protein 9 have gained significant traction in various fields of science, including agriculture.

CRISPR/Cas9 was originally identified and adapted from a naturally-occurring immunity mechanism in bacteria, which is employed against invading viruses. The bacteria basically capture snippets of DNA from the viruses and use them to create CRISPR arrays. These DNA segments allow the bacteria to remember the viruses. In the event of the viruses attacking, the bacteria produce RNA (messenger that carries genetic information from the DNA) from the CRISPR arrays. The bacteria then uses Cas9 enzyme, which acts as a pair of molecular scissors, to cut the DNA apart and disabling the virus.

The same system has been engineered by researchers to produce RNA complementary to a specific target DNA sequence in the genome of an organism. This guide RNA binds itself only to that target sequence and no other regions of the genome. The Cas9 enzyme will, in turn, follow the guide RNA and cut the two strands of DNA at the targeted location. At this stage, the cell knows that the DNA is damaged and tries to repair it. The researchers can now use the natural DNA repair machinery to introduce changes, including by adding or deleting genetic material.

Such genome editing using CRISPR/Cas9 is possible through three different approaches: Site-Directed Nuclease (SDN) 1, 2 and 3. SDN1 produces a double-stranded break in the genome of a plant and modifies an existing trait without undertaking insertion of any foreign DNA or even editing at the site of interest. SDN2 modifies the trait of interest by producing a double-stranded break and, while that is being repaired by the cell, editing a small sequence at the target site. SDN3 uses site-specific insertion of a large, foreign DNA fragment to introduce a new trait of interest.

In the case of SDN1 and SDN2 approaches, the CRISPR components used to edit the selected native genes for a desirable trait can easily be removed by segregation of the plant progeny in the next and subsequent generations. In this way, one can produce transgene-free edited plants (in other words, non genetically-modified or non-GMOs) that are indistinguishable from conventional breeding material. But this method is faster and cheaper than traditional crossing, which results in a host of unwanted traits also getting transferred and, hence, requires several more breeding cycles in order for the offspring to have only the desired traits. The use of CRISPR/Cas9 technology has been successfully demonstrated, for instance, in developing rice lines that are resistant to blast (by knocking-out genes that suppress immunity to the fungus) and bacterial leaf blight (by editing the binding sites of the disease-causing genes).

Globally, regulatory policies for genome edited crops, as opposed to transgenic or GMOs, are in different stages of implementation. Countries with available regulatory processes for genome edited lines include the United States, Canada, Argentina, Israel, Chile, Brazil, Australia and Japan. Regulatory agencies in India are still deliberating over the extent of regulation required for crop plants developed through gene editing, which does not involve addition of DNA from totally unrelated species.

When it comes to new gene editing technologies, we need rational analyses of the risks and benefits that the technology offers in each scenario; we need to strengthen our research efforts in scientific technologies that offer the most benefit to society through strategic funding, collaborations or even public-private partnerships; and we need clear regulatory frameworks for the application of these technologies. Every step we take could help reduce hunger and improve the quality of life for ourselves and future generations.

The writers are Group Leaders at Tata Institute for Genetics and Society, Bengaluru

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Agricultural biotechnology: Gene Editing versus Gene Modification - The Indian Express

Vir Biotechnology, Inc. (VIR) distance from 20-day Simple moving Average is 76.19% : What to Expect? – The InvestChronicle

At the end of the latest market close, Vir Biotechnology, Inc. (VIR) was valued at $40.97. In that particular session, Stock kicked-off at the price of $42 while reaching the peak value of $47.47 and lowest value recorded on the day was $41.71. The stock current value is $44.90.

Price records that include history of low and high prices in the period of 52 weeks can tell a lot about the stocks existing status and the future performance. Presently, Vir Biotechnology, Inc. shares are logging -40.13% during the 52-week period from high price, and 285.39% higher than the lowest price point for the same timeframe. The stocks price range for the 52-week period managed to maintain the performance between $11.65 and $75.00.

The companys shares, operating in the sector of healthcare managed to top a trading volume set approximately around 1.07 million for the day, which was evidently lower, when compared to the average daily volumes of the shares.

When it comes to the year-to-date metrics, the Vir Biotechnology, Inc. (VIR) recorded performance in the market was 257.06%, having the revenues showcasing 240.15% on a quarterly basis in comparison with the same period year before. At the time of this writing, the total market value of the company is set at 6.38B, as it employees total of 217 workers.

Raw Stochastic average of Vir Biotechnology, Inc. in the period of last 50 days is set at 52.22%. The result represents improvement in oppose to Raw Stochastic average for the period of the last 20 days, recording 48.91%. In the last 20 days, the companys Stochastic %K was 46.74% and its Stochastic %D was recorded 50.97%.

If we look into the earlier routines of Vir Biotechnology, Inc., multiple moving trends are noted. Year-to-date Price performance of the companys stock appears to be pessimistic, given the fact the metric is recording 257.06%. The shares increased approximately by 1.54% in the 7-day charts and went down by 28.38% in the period of the last 30 days. Common stock shares were driven by 240.15% during last recorded quarter.

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Vir Biotechnology, Inc. (VIR) distance from 20-day Simple moving Average is 76.19% : What to Expect? - The InvestChronicle