Category Archives: Biotechnology

When it comes to getting biotechnology innovations to market, with commercial protection, it can be tough. Around three quarters of patent applications normally fail to cut it. Although biotechnology is recognised as being important for the economy and society, it can also be highly controversial attracting public protests

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

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

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

How much of a focus is the bioeconomy for patents and what are some of the key developments?

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

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

Is the bioeconomy an increasing sector?

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

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

Overall, how complicated is it to obtain a patent, and is it expensive?

I would not say that it is complicated, but it is a difficult process, because we always start from the basis that a patent is an exception to the principle of free trade, free industry, free competition. Globally, for around 20 to 25,000 euros, you can obtain a patent as the EPO. For this amount, 5,000 euros are the EPO fees and the rest is the fees of those who helped to draft a patent and then discuss it with the patent office.

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

By Damon Embling

Read this article:
Biotechnology: navigating a minefield - Cordis News

Dr Vinay Rale shares his thoughts with BioSpectrum on current biotech education and the academia-industry gap

Dr Vinay Rale, Director, Symbiosis School of Biomedical Sciences (SSBS)

Brief recapitulation of genesis of Biotechnology in India A quick recapitulation of the genesis of Biotechnology in India will not be out of place to apprise the lay public. We essentially (and blindly) followed the USA in 1985 in initiating Biotechnology programs at Master's level at six select universities across India. In the 1970s, the ability to modify DNA molecules and the realization of the power of genetic engineering led prominent universities in the US to convince their Government to allocate huge funds to start

Biotechnology' - a term newly coined by them. The Indian model, first at Masters level, to cater to the need for trained manpower for the anticipated boom in the Biotechnology industry was supported by the Department of Biotechnology (DBT). Very soon a large number of institutions both in private and public sector followed suit to attract students. The wildfire spread to undergraduate programs equally rapidly. However, this led to two major disadvantages - the relegation of basic courses in Life Sciences such as Microbiology, Biochemistry, Zoology and Botany and severely inadequate infrastructure and untrained faculty. As a matter of fact, the first Masters programs supported by DBT at six prominent institutions in the country were turned to the advantage of the then faculty expertise, e.g., developmental biology turning a blind eye to the basic essentials that the students have to be proficient in.

A rough estimate of the students enrolled in Biotechnology at undergraduate and postgraduate levels suggests a number exceeding 100,000 at any given time. Also, some institutions offer a bouquet of 8 to 9 allied courses in Biotechnology. Naturally the demand-supply ratio is skewed. The curricula in Biotechnology tries to accommodate' as many subsets as possible with little attention to the fundamentals - especially at the undergraduate levels. Moreover, to overcome the infrastructure deficiency, a good number of students (especially at postgraduate level) are encouraged to bank upon either research institutes or industries to undertake dissertations.

Unfortunately, both categories of organizations take little interest in the welfare of such dissertation research; more so due to the unavailability of mentors from either side. Therefore-, little research done at such levels goes unnoticed. As a consequence-, it is estimated that well over 70 percent of Biotechnology students are considered as unemployable by industries. This is the net result of a large number of factors contributing to the creation of unfit student mass. Reliable sources indicate that industries now prefer to hire students trained in conventional Life Sciences like Microbiology and Biochemistry (also Chemistry) to meet their stringent requirements. The general complaint is that the Biotechnology students lack fundamentals. This is also the observation of this author over the decades.

Considering the seriousness of the Government to increase funding for the DBT and the intiative of the Biotechnology Industry Research Assistance Council (BIRAC) coupled with those of SIDBI and MSME to strengthen research in academia and foster strategic alliances between academia and industry, one can only expect better things to happen. However, like Biotechnology, Microbiology and Biochemistry programs too need nourishment.

Read more from the original source:
Biotechnology Education vs Industry Requirements: Where - BSI bureau (press release)

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

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

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

About ReadCoor

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

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

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/nature-biotechnology-features-readcoor-as-a-2016-leading-spinout-300438536.html

SOURCE ReadCoor, Inc.

http://www.readcoor.com

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

Biotech

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

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

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

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

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

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

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

READ: Kwara International Vocational Centre gets equipment

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

About the Neratinib Expanded Access Program

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

About Puma Biotechnology

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

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

About Caligor

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

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

Read the original post:
Caligor to Support Puma Biotechnology's Expanded Access ... - Yahoo Finance

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

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

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

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

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

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

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

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

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

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

2017 InvestorPlace Media, LLC

Read more from the original source:
Go Long the iShares Nasdaq Biotechnology Index (ETF) (IBB) ETF With Confidence - Investorplace.com

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

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

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

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

Benoit Battistelli -Courtesy of EPO

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

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

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

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

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

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

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

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

See the rest here:
Biotechnology: navigating a minefield - Youris.com

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

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

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

.

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

Macky Sall

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

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

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

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

For more background on the Genetic Literacy Project, read GLP on Wikipedia

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