Category Archives: Biotechnology

Debate about the security implications of cutting-edge biotechnology is afflicted with a fundamental blind spota lack of attention to growing military interest in the field. This blind spot is evident in discussions about, for example, gene-editing technology (in relation both to gene drives and to human modification). Such debate has tended to focus on the idea that research and technology might be directly misused by the bad guysand has tended to ignore broader questions about how the ongoing militarization of cutting-edge fields in biology might contribute to insecurity.

Last year James Clapper, when he was US director of national intelligence, labelled emerging population-level genetic-modification techniques as potential weapons of mass destruction. A number of states, in the context of the Biological and Toxin Weapons Convention, have in recent years voiced concerns about state investment into biotechnology. Yet ethical reviews of gene editing to date in the United States have barely touched upon concerns about growing military interest in cutting-edge biotechas reflected in their absence from recent reports on both environmental and human modificationbiotechnology. Such omissions are in keeping with broad trends where US discussions about the potential for misusing biotechnology are concerned.

To be sure, the risk that benignly intended innovations might be directly misused by terrorists is a legitimate, if often overblown, security concern. But other issues merit concern as well. One such issue is the risk that military investment in biotechnology will adversely affect research priorities. Another is the possibility that military investment into defensive or public health projects by one state might be misinterpreted by other states as having offensive potential.

In the same vein, the scarcity of publicly available information about military research into biotechnology might fuel public distrust of valuable and well-intended work. It is clear, for example, that research into preventing, identifying, and treating infectious diseases by various militaries around the world will continue to provide broader spin-off benefitsbut publics in some states might be unsure why military rather than public health institutions lead such work.

A path toward addressing these concerns has already been established by the synthetic biology communityespecially in terms of its preemptive engagement with the security concerns that scientists entertain. However, even in this arena there has been a hesitance to address the issue of militarization.

Synthetic biology as a security laboratory. Synthetic biology is a field of scientific and technological development that has greatly extended humankinds abilities to manipulate biological organisms and processes. While genetic modification techniques have existed since the 1970s, synthetic biology is allowing for much more ambitious projectsoffering new ways of getting to grips with the complexity of biology and of developing a wide range of new technologies.

A watershed moment for this field was the First International Meeting of Synthetic Biology (SB 1.0), held at MIT in 2004. Central to the vision of the scientists involved was radically modifying naturally occurring organisms and processes through the application of engineering principles; the undertaking involved the convergence of a range of fields, including genetic engineering and computing. The appeal of the synthetic biology vision was broadand a number of subfields emerged under the synthetic biology banner in both the United States and Europe. Private and public investors committed significant resources to the establishment of research centers and networks, as well as to the development and commercialization of foundational technologies such as gene synthesis. This investment contributed to a number of early successes and landmark initiatives.

The initiatives included the establishment of a digital BioBricks repository, which today contains the genetic sequences of some 20,000 standardized biological parts, such as proteins that are involved in gene-expression within bacteria. This repository was established as a means for scientists to assert discovery rights, while also allowing for the rapid sharing and reuse of these discoveries by others. These biological parts are developed and utilized by the synthetic biology research community and in an annual student competition that showcases both the potential applications of research in the field and the rate at which the technology is advancing. Last years winners included a team based at Imperial College London that developed a tool to help scientists engineer production systems using multiple types of cells, a German team working on biological tissue printing, and a Chinese team that developed a design to detect poisons in traditional medicines.

Since its inception, synthetic biology has been a darling of scientific journalismwhich has made it challenging for civil society and regulators, when thinking through the fields societal implications, to separate hype from reality. Synthetic biology has also become symbolic of deeper questions about the way that science is supported and governed. The issues have included broad transformations in how societies engage with innovation, an increased emphasis on the need to open up the innovation process to public scrutiny, and the need for science to be more responsive to public needs. Security concerns have been a consistent aspect of these broader debates.

In no small part, this is a consequence of synthetic biologys having been established in the United States shortly after the 9/11 and Amerithrax attacks. At the time, regulators and funders in the United States were twitchy about the actual and perceived security concerns surrounding this fledgling field. The National Science Foundation, a major early investor in synthetic biology, set engagement with biosecurity concerns as a prerequisite for funding. The FBI, following through on recommendations by a blue-ribbon biosecurity board on synthetic biology, has also taken a proactive approach to reaching out to the community. The lead agent on this issue, Edward You, was recently profiledby MIT Technology Review as Americas Top Bioterror Cop.

Another key factor in the synthetic biology communitys continued engagement with security issues has been the commitment of prominent scientists. Stanford University bioengineering professor Drew Endy, who has been involved in numerous reviews of the field, has also been a leading advocate for biosecurity engagement by the next generation of synthetic biologists. Endy established the annual i-GEM competition (the acronym stands for international genetically engineered machine). This team competition for students includes a biosecurity review process providing young scientists an opportunity to consider the potential security implications of their work. Harvard University synthetic biologist George Church has also been a notable contributor on these issues. His public provocations over the years have repeatedly kick-started public debate. In addition, a number of social scientists have formed enduring professional relationships with practitioners of synthetic biologyand much of their work has focused on changing the way that scientists engage with potential risks and with the public.

The synthetic biology community has been central to the most intensive debate about the misuse of civilian biotechnology ever seena debate that has been under way since at least 2003. Engagement by scientists, civil society, funders, and regulators has spurred a raft of technology assessment initiatives and regulatory reviews in both the United States and Europe. In addition, the integration of ethical and security review into I-GEM, the annual undergraduate competition, has sensitized a generation of scientists to questions about their societal roles. Such initiatives have also helped raise the bar for some newer fields. Xenobiology, for exampleoriginally a subfield of synthetic biologyis currently seeking to establish its own disciplinary identity, and security implications are already being discussed as that fields research agenda is set. The security engagement displayed by the synthetic biology community appears to be catching.

At the same time, its important to remember the limitations that such communities face. Scientists envision and design techno-scientific fieldsbut they are subject to the whims of national-level funders and regulators. Its also very difficult for scientists to control how a technology will be used and commodified once the cat is out of the lab. This was illustrated at a recent synthetic biology meeting in Singapore. Endy, in his opening remarks, presented an egalitarian vision for future industrialization of synthetic biology technologies. But Randal J. Kirk, chairman of the biotech firm Intrexon (the main industry sponsor of the conference), delivered a slick presentation that provided a much more corporate vision of the fields future. This was a reminder of the central role that the market will play in synthetic biology investmentand of the role that industry will increasingly play in shaping regulation and public understanding of this area of biotechnology.

Jane Calvert, a University of Edinburgh social scientist who has been working in synthetic biology for over a decade, argued at the Singapore meeting that the field is closing as a creative spacethat the parameters of success are narrowing around what is commercially viable. Military involvement in synthetic biology presents similar dynamicsand discussions of this issue throughout biotechnology need to be promoted and internationalized. Military involvement in technology is not a bad thingand it is also inevitable. Still, legitimate concerns surround the ability of the military sector to skew research priorities. And of course, military involvement could also signal attempts to harness new biotechnology for hostile purposes. In those nations leading the way in terms of innovation, scientists might need to help ensure greater transparency regarding the scope and purposes of military investment in their fields.

Work in synthetic biology has created a community of scientists sensitized to such issues and willing to discuss them. The focus of discussion, however, needs to broaden beyond the national-level security preoccupations that currently dominate. One step in this direction would be to establish international dialogue among scientists specifically on the issue of biotechnology militarization. Such debates should not be limited to the existing preoccupation with pathogens, but rather should cover broader areas of military investment. This sort of dialogue might allow shared principles regarding state investment in biotechnology to be identified and articulatedprinciples that would both guide research priorities and establish hard limits about what is permissible. Such discussions could draw upon relevant principles in international human rights, humanitarian, and arms control lawincluding, but not limited to, treaties specifically dealing with biological, chemical, and environmental warfare. Such an outcome would give scientists a louder voice in conversations about military involvement in biotechnologywhile also reducing the stigma associated with invaluable military research and reinforcing the stigma against the weaponization of biotechnology.

See the article here:
We've got to talk: The militarization of biotechnology - Bulletin of the Atomic Scientists

20th World Congress on Biotechnology and Biotech Industries Meet during March 05-07, 2018 at London, UK with a theme Future prospects for Biotechnology and Economic Growth. Conference Series LLC through its Open Access Initiative is committed to make genuine and reliable contributions to the scientific community.

Scope and Importance

Biotech Congress 2018 Conference aims to bring together the Professors, Researchers, scientists, business giants, and technocrats to provide an international forum for the dissemination of original research results, new ideas and practical development and discover advances in the field of biotechnology, management and education in relation to biotechnology as well as a breadth of other topics. The applications of biotechnology include therapeutics, diagnostics, genetically modified crops for agriculture, processed food, bioremediation, waste treatment, and energy production. Biotech Congress 2018 is an excellent opportunity for the delegates from Universities and Institutes to interact with the world class Scientists.

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20th World Congress on Biotechnology and Biotech Industries Meet - Technology Networks

Investors are always looking for stocks that are poised to beat at earnings season and Puma Biotechnology, Inc. (PBYI - Free Report) may be one such company. The firm has earnings coming up pretty soon, and events are shaping up quite nicely for their report.

That is because Puma Biotechnology is seeing favorable earnings estimate revision activity as of late, which is generally a precursor to an earnings beat. After all, analysts raising estimates right before earningswith the most up-to-date information possibleis a pretty good indicator of some favorable trends underneath the surface for PBYI in this report.

In fact, the Most Accurate Estimate for the current quarter is currently at a loss of $2.03 per share for PBYI, compared to a broader Zacks Consensus Estimate of a loss of a $2.10 per share. This suggests that analysts have very recently bumped up their estimates for PBYI, giving the stock a Zacks Earnings ESP of +3.33% heading into earnings season.

Why is this Important?

A positive reading for the Zacks Earnings ESP has proven to be very powerful in producing both positive surprises, and outperforming the market. Our recent 10 year backtest shows that stocks that have a positive Earnings ESP and a Zacks Rank #3 (Hold) or better show a positive surprise nearly 70% of the time, and have returned over 28% on average in annual returns (see more Top Earnings ESP stocks here).

Given that PBYI has a Zacks Rank #3 (Hold) and an ESP in positive territory, investors might want to consider this stock ahead of earnings. You can seethe complete list of todays Zacks #1 Rank (Strong Buy) stocks here.

Clearly, recent earnings estimate revisions suggest that good things are ahead for Puma Biotechnology, and that a beat might be in the cards for the upcoming report.

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Should You Buy Puma Biotechnology (PBYI) Ahead of Earnings? August 04, 2017 - Zacks.com

The August issue of the New Jersey State Bar Association's bi-monthly magazine, New Jersey Lawyer, focuses on the evolving topic of biotechnology, genetics and the law.

"Although a very specialized area, biotechnology law crosses many legal disciplines, including litigation, licensing, intellectual property, patents, agriculture, business, venture capitalism, antitrust, biosecurity and bioethics," said Angela Foster and David Opderbeck, who served as special editors for the issue.

"The use of biotechnology has raised a number of legal, ethical and social issues, including who owns genetically modified organisms (GMOs), whether genetically modified foods are safe to eat, and who controls a person's genetic information. This issue explores contemporary biotechnology issues impacting the legal community."

A dozen articles explore the topic in the award-winning magazine, beginning with a look at whether organs-on-chips are patentable in an article by Douglas Bucklin. Richard Catalina Jr.'s article on the Biologics Price Competition and Innovation Act follows.

Nancy Del Pizzo's article looks at the open source model in biotechnology, while Foster explores the truth and fiction behind genetically modified food. Jonathan Lourie reviews strategic licenses and collaborations.

Reproduction is the topic of two articles, one analyzing assisted reproductive technology, written by Alan Milstein, and one penned by Kimberly Mutcherson on regulating the right to procreate.

Opderbeck's contribution focuses on synthetic biology and biosecurity, while Anjana Patel and Patricia Wagner discuss biotech mergers, acquisitions and antitrust issues and Marina Sigareva and Ryan O'Donnell look at global strategies for protecting biotech inventions.

The edition closes with articles on the Patent Trial and Appeal Board's influence on the biotech and pharma industries, written by Nichole Valeyko and Maegan Fuller, and the privacy implications for biotechnology by Wagner.

The October edition of New Jersey Lawyer will explore pro bono issues.

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NJSBA magazine explores biotechnology and genetics - Yahoo News

Shares in Prana Biotechnology (NADSAQ:PRAN) surged 19% and was earlier higher in New York as it said an article about early data on PBT434 had been accepted in a peer review journal.

The article deals with the fact the compound PBT434 prevents iron-mediated neurodegeneration and alpha-synuclein toxicity in multiple models of Parkinsons disease.

Dr David Stamler, Pranas chief medical officer, said: These findings are important because Parkinsons disease and the related synucleinopathies cause significant disability and diminish the independence of afflicted individuals.

"An agent which slows disease progression could have a great impact on reducing disease burden and improving quality of life. We are eager to begin clinical testing of PBT434.

The publication is the culmination of ten years of research from scientists at the Florey Institute of Neuroscience and Mental Health, (Melbourne, Australia), investigating compounds from Prana Biotechnologys propriety chemical library.

Not only was PBT434 shown to block alpha-synuclein accumulation, but it also prevented loss of nerve cells in the region of the brain primarily affected in Parkinsons disease.

To investigate the therapeutic potential of PBT434 to slow neurodegeneration, the researchers performed extensive animal testing in multiple Parkinsons disease models, including tests in mice that over-expressed the alpha-synuclein protein.

These results showed that PBT434 lowered alpha-synuclein and its toxic effects and simultaneously improved motor performance.

Shares added 19% to $2.73.

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Prana Biotechnology shares surge after journal publication - Proactive Investors UK

Puma Biotechnology, (NYSE:PBYI) is a $3.2 billion market cap company initially focused on developing tyrosine kinase inhibitor neratinib (PB272) for HER2 positive breast cancer. The company has conducted 11 clinical trials for its lead candidate, with over 2,000 patients contributing to a favorable risk-benefit profile, per inflection point clinical trial readouts over the past quarter. Oncologic Drugs Advisory Committee (ODAC) at FDA recently voted for approval of neratinib in HER2 positive extended adjuvant treatment of early stage breast cancer in May 2017. ODAC vote is not binding but carries strong weight in the decision-making process. Given FDA director Gottlieb's new aggressive policies regarding the slow and outdated drug approval process at FDA, this was seen by the market as a "sure thing". The company is advancing neratinib in discussions with EMA for European markets, with validation in August 2016. Other investigations include neratinib in combinatory therapy for metastatic breast cancer and in solid tumors as well.

Neratinib blocks signal cascades of epidermal growth factor receptors or EGFRs, specifically: HER1, HER2, HER3, and HER4. A number of studies are showing nice anti-tumor efficacy. Taken together with ODAC favor, Phase 3 result emphasis for neratinib which met primary endpoints appears to have led to the robust response in the market for high probability of FDA approval. Two-year disease-free survival showed a 2.4% improvement for neratinib versus placebo in ITT population. Five-year disease-free survival showed a 2.5% improvement. In HR+ patients, neratinib adjuvant therapy showed a two-year disease-free survival rate of 95.4% compared to 91.2% in placebo. Five-year disease-free survival conferred a 4.8% benefit. Two-year HR patients' disease-free survival showed a meaningful advantage, but five-year data was not statistically significant.

The company recently presented data June 3 at ASCO 2017 summarizing positive results of its Phase 2 trial in HER2-positive metastatic breast cancer that has metastasized to the brain. Nearly half of the patients in a neratinib plus chemotherapy cohort achieved a central nervous system (CNS) objective response with overall survival data remaining immature at 13.5 months (and counting). CNS progressions remain a huge comorbidity factor in patients with brain metastases. With the ability to cross the blood-brain barrier, and with diarrhea being the number one adverse event, PBYI is well-positioned to advance in this space with neratinib. Studies examining antidiarrheal prophylaxis (Loperamide) to reduce diarrhea severity during neratinib treatment have proven effective. Phase 3 data showed grade 3 diarrhea decreased from ~40% to ~31% with loperamide, to ~23% with loperamide and budesonide, and to 11.5% with loperamide and colestipol. Safety studies examining children and young adults with cancer are also ongoing.

Multiple studies are generating impressive cancer therapy data for neratinib, including clinical data presented at AACR on neratinib in the treatment of patients who have solid tumors with activating HER2 or HER3 mutations. 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. The company has done extensive analysis of breast cancer NSABP FB-7 biomarker during neratinib treatment with a variety of immuno and chemotherapy regimens to qualify its objective tumor response. Mechanistically, phosphoHER2 levels and truncated HER2 mutants (p95HER2) demonstrated statistically significant higher levels in patients who achieved a pCR with neratinib than those treated with trastuzumab or trastuzumab plus neratinib who did not. Moreover, dual pathway suppression (HR/ER+ and EGFR/HER2+) has been seen only in neratinib and not in Herceptin and Tykerb (Novartis (NYSE:NVS)).

The company has listed other potential tissue types to expand its label for neratinib, including non-small cell lung cancer, colorectal cancer, and solid tumors (any HER2-associated tumors). Roche (OTCQX:RHHBY) annual sales for Herceptin (trastuzumab) approach $5 billion. In contrast, Tykerb has not fared as well due to its unfavorable toxicity profile, with sales in the hundreds of millions. The HER2 positive breast cancer market is estimated to be about $13 billion by 2023. Given this massive market and plenty of room to expand label into other high dollar indications, Puma may still have quite a bit of upside and is generally de-risked. It certainly becomes very attractive on any stock price pullbacks.

Puma reported at end of 1Q 2017 cash and cash equivalents of $105.1 million and marketable securities of $88.9 million, with a 1Q net loss of $72 million. Cash runway is expected to last through mid-2018, with a burn rate of approximately $35 million per quarter. If the company is forced to raise funds, it should be able to do so at a good market value, given the advanced stage of its drug development. Strong Bio recommends a watch list spot for the stock and manageable delays or setbacks as a potential buying opportunity. Moreover, it may be a takeover candidate and could undergo some downward volatility in the standard process of stop-loss triggering. Such swoons will probably not last long as market support should be strong. With market cap of $3 billion and potential market quite a bit larger, there is plenty of room for value position here if sales meet expectations.

Risks for the company to investors are primarily centered around its one-trick pony pipeline. But when the trick is good enough, it's going to bring bank. Its advantage in efficacy will certainly gain a reasonable stake in the market for those that can tolerate the adverse events. In fact, the adverse event of diarrhea is somewhat severe, but luckily, most of that risk was mediated with appropriate prophylaxis regimen. It perhaps would have contraindications for those with extreme inflammatory bowel or related disorders. FDA-related large scale manufacturing risks and regulatory hurdles could prove to add delays and pitfalls to Puma's terrain, and since this is the only revenue-maker in its pipeline, a lot hinges on its expeditious advancement. However, given the aggressive stance at FDA to get life-saving therapies available to patients, most regulatory risks are ameliorated. Partnership decisions will be important inflection points moving forward.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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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Puma Stalks Up - Puma Biotechnology, Inc. (NYSE:PBYI) | Seeking ... - Seeking Alpha

Biotechnology varieties of corn and soybeans make up 95 percent of the 15.5 million acres planted this spring by Nebraska farmers, according to a report from the USDAs National Agricultural Statistics Service on Friday.

According to the report, Nebraska corn growers planted 9.8 million acres, down 1 percent from last year. Biotechnology varieties were used on 96 percent of the area planted, up 1 percentage point from a year ago. Growers expect to harvest 9.5 million acres for grain, which is down 1 percent from last year.

Statewide, soybean planted area is estimated at 5.7 million acres, up 10 percent from last years total and a record high. Of the acres planted, 94 percent were planted with genetically modified, herbicide resistant seed, down 2 percentage points from a year ago. Acres expected to be harvested are 5.65 million, up 10 percent from a year earlier.

Last year, Nebraska ranked sixth in the nation in harvested acres of principal crops at 19,223,000 acres.

Nationwide, the USDA reported that corn planted area for all purposes in 2017 is estimated at 90.9 million acres, down 3 percent from last year. Compared with last year, planted acres are down or unchanged in 38 of the 48 estimating states. Area harvested for grain, at 83.5 million acres, is down 4 percent from last year.

Soybean planted area for 2017, nationwide, is estimated at a record high 89.5 million acres, up 7 percent from last year. Compared with last year, planted acreage intentions are up or unchanged in 24 of the 31 estimating states.

The USDA reported that winter wheat seeded in the fall of 2016 totaled 1.11 million acres, down 19 percent from last year and a record low. Harvested acreage is forecast at 1 million acres, down 24 percent from a year ago.

Along with declining wheat acres, Nebraska wheat farmers are also having to deal with a wheat virus outbreak that has reached epidemic levels and has been damaging fields and yields in the southern Nebraska Panhandle, according to the Associated Press. The Nebraska Wheat Association earlier this month reported that as many as 85 percent of southern Panhandle fields have been affected by the virus.

Nationwide, all wheat planted area for 2017 is estimated at 45.7 million acres, down 9 percent from 2016. This represents the lowest all wheat planted area on record since records began in 1919. The 2017 winter wheat planted area, at 32.8 million acres, is down 9 percent from last year. Of this total, about 23.8 million acres are hard red winter.

For other Nebraska crops, the USDA reported that:

Alfalfa hay acreage to be cut for dry hay is at 770 thousand acres, up 3 percent from 2016. Other hay acreage to be cut for dry hay is 1.70 million acres, unchanged from last year.

Sorghum acreage planted and to be planted, at 140 thousand acres, is down 30 percent from a year ago. The area to be harvested for grain, at 110 thousand acres, is down 37 percent from last year.

Oats planted area is estimated at 115 thousand acres, down 15 percent from the previous year. Area to be harvested for grain, at 25 thousand acres, is unchanged from a year ago.

Dry edible bean planted acreage is estimated at 150 thousand acres, up 9 percent from last year. Harvested acres are estimated at 139 thousand acres, up 14 percent from the previous year.

Proso millet plantings of 130 thousand acres are up 37 percent from a year ago.

Sugarbeet planted acres, at 49.7 thousand, are up 4 percent from last year.

Oil sunflower acres planted are estimated at 55 thousand, up 90 percent from last year. Non-oil sunflower planted acreage is estimated at 6 thousand acres, down 52 percent from a year ago and a record low.

Dry edible pea estimated planted acres are 45 thousand acres, down 18 percent from last year. Harvested acres are estimated at 42 thousand, down 19 percent from the previous year.

See more here:
Biotechnology crops dominate Nebraska crop fields - Grand Island Independent

Is there an easy way to assess the value of a biotech or pharmaceutical company based on its potential, cash, and asset position while adjusting for potential risk?

Are there any easy ways to enter an investment at a stage in which a company has passed a key FDA approval level for one of its drugs?

Biotech investors must recognize these issues. Weighing up the risk, and whether or not the company stock is over or undervalued, is a basic investment concern but one that can be hard to navigate in the Biotech industry. Various websites do provide information which makes the task easier, though.

Historical and Current Sector P/E

As reported in Forbes.com, biotech company values can achieve an extraordinary high P/E ratio when they're successful, and sentiment favors this sector. In 2015, on the most recent biotech stock 'highs', Zero Hedge reported that about 75% of biotech companies were not creating any profit despite high valuations. Perhaps this led many investors to assume the biotech industry was in a bubble. Investing in biotech isn't comparable with any other form of technology. Biotech companies acquire significant levels of venture capital to fund very long-term and extremely expensive new drugs and rely on high share price valuations to achieve this.

According to Investopedia:

Pharmaceutical stocks typically trade at a large discount to biotech stocks. The historical mean forward P/E multiple is 16x from 1976 through March 2013 for pharmaceuticals as compared to the high 20x to 30x or more for biotech.

Market Realist.com summarizes valuation factors:

A biotechnology company's (NASDAQ:IBB) value is comprised of two main factors: assets in place and growth assets. Assets in place, or drugs currently being sold in the market, are indicators of the present cash generation capacity of the biotechnology company. Growth assets involve drugs in a company's research and development (or R&D) pipeline as well as future licenses and collaborations with other pharmaceutical and biotechnology companies.

Many biotechnology companies carry substantial debt on their balance sheets. EV-to-EBITDA value can be used to determine the attractiveness of a mature biotechnology company. Low EV-to-EBITDA ratios may signal that the market is undervaluing the stock.

Since a large portion of a biotechnology company's value is derived from its R&D assets, discounted cash flow valuation (or DCF) proves to be a more effective valuation technique. However, this method is extremely sensitive to inputs related to future riskiness and returns of the company. So, wrong inputs can lead DCF in returning erroneous company values.

The problem is, of course, discounting for risk.

It can take 10 years or more to take basic experiments to a commercially viable product, and each stage requires extensive funding. There's a lot of risk involved, especially at the early stages, but investors in those companies which succeed are often generously rewarded. Weighing up risk is as crucial as buying at the right price; the two go together.

'Techinvest Daily' has a valuation suggestion. Here are some additional ideas, too, on where to source useful info, how to buy into a company which has just reached an FDA approval, reducing at least one level of risk.

FDA Approval Is A Lengthy, Costly, and Risky Business

Unlike P/E valuations (which are based on earnings, so exclude many small biotech companies) and 'DCF' (which is based on a cash flow measurement, a biotech valuation needs to account for reduced risk, as well as a product which is becoming increasingly viable as it successfully clears each of the three main hurdles needed for approval of each drug.

Assessing The Value Of The Pipeline and Third Party Resources

For example, a company has four products developing in its pipeline. We can assess a top value for each drug by multiplying its projected market share by its potential value, "assuming approval".

We can then risk adjust, the possibility of not passing regulations, by multiplying the value of each drug by the likelihood of its approval (the three hurdle assessment). This delivers a 'Risk Adjusted Value' or RAV which can be added together for the total company pipeline.

It would be difficult for investors to decide on the likelihood of approval in advance. There are websites which specialize in biotech company information like Biospace. The BioMedTracker Drug Intelligence Platform tracks company pipelines and drug catalysts, but otherwise, risk has to be assessed based on what's happened to other products trying to achieve similar results. Information is available from the FDA itself. Some sites which flag which products are waiting on approval include Biopharmcatalyst.com.

The Value of The Market Opportunity

Potential revenue numbers are usually provided by specialist biotech market intelligence companies, anticipating the potential for a company to acquire a share of a particular drug market. It doesn't account for potential profit. 30% of revenue or more can be lost to a drug distribution channel and profit influenced by costs like:

Other substantial costs can include sales and marketing (which can be significant to create national cover), as well as patent, office, and administration fees.

Risk Valuation Example

E.g. Company X

Maximum potential of $1 billion. RAV value, $500m (after adjusting for market share and the one-third level risk and likelihood of achieving that, the pipeline is worth $500m at the particular stage the products are at, plus cash, less debt).

Share value is (RAV + cash - debt/shares outstanding)

So, if company X were to have $50m in cash and $30m in debt, the calculation would look like:

$500m + $50m - $30m/50 million outstanding shares

or $520m/50 million shares means the stock is a good buy, trading under $10.20 relative to its risk.

Risk adjusted Value (RAV) = product valuation * market share * likelihood of approval

Risk Avoidance Measures

It's possible to avoid the individual company risk issues (while sacrificing some of the stock appreciation performance) by investing in one of the ETFs which track the biotech industry, like IBB. Service fees can accumulate for regular trading, though.

Armed with some specialist advise and having compared other companies developing similar products and their outcomes, an investor is able to make an improved risk judgement using the methods suggested. An investor can then decide whether buying into the stock is worth the risk involved in the pipeline. Further risk is reduced on buying a stock immediately following FDA approval of individual products, and potentially most advantageous following stage three approval.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

The rest is here:
Value A Biotech Company Against Risk - Seeking Alpha

Biotechnology Separation Systems Market

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Biotechnology Separation Systems Market: Research methodology

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Market Research Store is a single destination for all the industry, company and country reports. We feature large repository of latest industry reports, leading and niche company profiles, and market statistics released by reputed private publishers and public organizations. Market Research Store is the comprehensive collection of market intelligence products and services available on air. We have market research reports from number of leading publishers and update our collection daily to provide our clients with the instant online access to our database. With access to this database, our clients will be able to benefit from expert insights on global industries, products, and market trends.

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The Economic and Financial Crimes Commission, EFCC, says it has arrested Lucy Ogbadu, the Director-General of National Biotechnology Development Agency (NABDA), over alleged N23 million fraud.

The spokesperson of the commission, Wilson Uwujaren, disclosed this in a statement he issued on Thursday.

Mr. Uwujaren said Ms. Ogbadu was picked up by EFCC operatives in Port Harcourt on Wednesday, following her alleged link with the Bayelsa State Director of Bio-resources Development Centre, Josiah Habu.

Mr. Habu, according to him, is being investigated by the anti-graft agency in a case of fraudulent diversion of N75 million.

He said investigations by the EFCC revealed that Ms. Ogbadu allegedly received N23 million through a bank account belonging to the wife of Mr. Habu, Esther Habu.

The EFCC spokesperson stated that Ms. Ogbadu admitted the transaction in a voluntary statement made to the commissions investigators.

Further investigations also revealed that Mrs Habu is one of the contractors with Bio-resources Development Centre, Odi, Bayelsa State.

A total of N603 million has been traced to her in different deals involving over 20 directors of the centre across the country.

Ogbadus involvement is being investigated. She has been duly served with bail conditions while investigations continue, Mr. Uwujaren added.

Ms. Ogbadu, a professor of microbiology, was appointed NABDA director-general in November 2013.

(NAN)

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