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Biotech

Squo Solves

$1.05 billion just invested in one company alone- solves the impact

Liginbuhl 15 Martin Luginbühl is professor at Université de Neuchâtel July 02, 2015 US biotech giant to invest one billion francs in Switzerland http://www.s-ge.com/usa/invest/en/blog/us-biotech-giant-invest-one-billion-francs-inswitzerland?utm_source=Sailthru&utm_medium=email&utm_term=*Editors%20Picks&utm_campaign=2015_EditorsPicks_Swiss_Jul6♥Tina

Biogen, one of the global leaders in biotechnology with headquarters in Massachusetts, will open a new plant in the northern part of Switzerland. Biogen specializes in the research, development, and delivery of therapies for the treatment of neurodegenerative, hematologic, and autoimmune diseases to patients worldwide. It is today the third largest biotech company in the world, employing 7,500 people in 30 countries. The organization was originally founded in Geneva in 1978 by a group of prominent biologists, before moving its global headquarters to the US, still keeping a presence in Switzerland. Biogen decided to strengthen its ties with the country and will soon open a new production site in Luterbach, Solothurn. According to the canton’s press release, 1 billion Swiss francs will be invested in the facilities and by 2019, about 400 jobs should have been created. This is the most important settlement in the canton’s history.

Biotech Inevitable

Biotech inevitable- capitalism

Rogers 15 GOODBYE, MEATBAGS The Inherent Inequality of Biohacking WRITTEN BY KALEIGH ROGERS staff writer April 14, 2015 // 09:00 AM EST http://motherboard.vice.com/read/the-inherent-inequality-of-biohacking //♥Tina

“When people find something useful, capitalism reinforces democracy,” Starner told me. “If the doctors and lawyers who are able to pay $10,000 for their cell phone find it useful, then the first thing a company will want to do is find a bigger market. That means you’ve got to get the price down.” Starner has developed and worn wearable computers for decades, and worked as a technical lead to help create Google Glass. Much of his research has focused on augmented memory: being able to store information on an external device, like a wearable computer, but quickly retrieve it in real time. Starner said he believes the transition to wearable and embedded biotechnology is inevitable. “This stuff is going to happen,” he said. “It’s just a question of when.” Starner said a lot of the timing will have to do with cost and whether people have a need and a desire for the technology at hand. He pointed to Simon, IBM’s touchscreen smartphone that debuted in the mid-90s and cost $1,100. Starner said even though the technology was there, the market wasn’t. By the time the iPhone debuted in 2007, the technology was more advanced, the price had dropped, and the market was ready. Less than a decade later, 64 percent of Americans own a smartphone, illustrating the more rapidly closing gaps Starner described.

Biotech inevitable- people want healthy kids, healthy lives, and it’s human nature

Darnovsky 14 Darnovsky, Marcy. "Genetically Modified Babies." The New York Times. Web. 4 Apr. 2014. Marcy Darnovsky, PhD, is an American policy advocate and author who has extensively spoken and written on the politics of human biotechnology, focusing on their feminist, social justice, human rights, health equity, and public-interest implications http://lmaaplang6.blogspot.com/2014/04/opinions.html//♥Tina

Any form of human genetic engineering should only be considered for use in cases such as the treatment of patients who have life-threatening medical conditions. Gene therapy trials in humans have been performed for decades, and some have not been without unintended adverse effects. There are patients who later developed cancers and there were those who died during their therapy studies. Currently, gene therapy is being performed in clinical studies because even with these reported complications and/or deaths, the risks of the engineering techniques still outweigh the overwhelming damage of the disease it is attempting to cure. On the contrary, genetic enhancement that would alter a human being to ensure that highly desirable traits are passed on to offspring should be prohibited, because apart from the risks inherent to genetic engineering, there are ethical issues and societal impacts to consider. Advancements in biotechnology are inevitable, and it is human nature to explore them to see how they may sustain and improve our lives. However, just because they are available does not mean we should use them; the promotion of our health should be of utmost importance.

Biotech is going to happen. Growth, new tech, and demand.

Otto et al. 14 Rapid growth in biopharma: Challenges and opportunities Biopharmaceuticals could become the core of the pharmaceutical industry, but not without significant transformation in the laboratory and in strategy, technology, and operations. December 2014 | byRalf Otto, Alberto Santagostino, and Ulf Schrader Mr. Ralf Otto is currently employed at Linklaters, and is a current Director at O&R Oppenhoff & Rädler AG berto Santagostino is an associate principal in the Copenhagen office Ulf Schrader is a partner at McKinsey & Company in Hamburg and co-author of numerous studies on the supply chain in the pharmaceutical and chemical industries. http://www.mckinsey.com/insights/health_systems_and_services/rapid_growth_in_biopharma //♥Tina

The opportunity in biopharmaceuticals is big and growing too rapidly to ignore. Today, biopharmaceuticals generate global revenues of $163 billion, making up about 20 percent of the pharma market. It’s by far the fastest-growing part of the industry: biopharma’s current annual growth rate of more than 8 percent is double that of conventional pharma, and growth is expected to continue at that rate for the foreseeable future. The efficacy and safety of biopharmaceutical products, combined with their ability to address previously untreatable conditions, allows pharma companies to command high prices for innovative drugs. Strong demand has driven significant profits, despite the high cost of goods sold. Biopharmaceuticals have set new standards for blockbuster drugs as well. Blockbusters are traditionally defined as drugs that have $1 billion or more in annual sales; the top 15 biopharma products each enjoy annual revenue of more than $2 billion, with some, such as the antiinflammatory drug Humira, generating sales of more than $10 billion a year. For many players, the biggest challenge has been simply making enough product to sell. It’s no surprise that major pharmaceutical companies around the world are increasingly shifting their R&D and sourcing focus to large-molecule products (Exhibit 2). Investing in biotech R&D has yielded better returns than the pharma-industry average. The current biologics-development pipeline supports an outlook of continued healthy growth. The number of biotech patents applied for every year has been growing at 25 percent annually since 1995. There are currently more than 1,500 biomolecules undergoing clinical trials, and the success rate for biologics has so far been over twice that of small-molecule products, with 13 percent of biopharma products that enter the Phase I trial stage going on to launch. The success of the clinical pipeline will lead to an unprecedented number of new molecule launches, rising from a handful a few years ago to 10 to 15 annually, as biopharma products make up an increasing share of new approvals from the US Food and Drug Administration in the future. A further steep increase is to be expected as multiple players begin to receive approval for the production of biosimilars after 2015. If anything, the emerging long-term picture is even more exciting, with disruptive innovations such as immunotherapies, antibody drug conjugates, and gene and cell therapies all making progress toward commercial launch in the next few years. Biopharma looks poised to transform the industry once more, as increasing understanding of the interaction between drugs and the genetic makeup of patients helps to improve the targeting of therapies. Combined with robust, low-cost genetic profiling, this knowledge will improve treatment outcomes and serve to accelerate and improve the outcomes of clinical trials, helping to reduce the cost of drug development.

GMO Inevitable

GMOs are inevitable- only regulation solves

Barron ’14 founder of Natural health news Jon Barron, March 1^st, 2014, Baseline of Health Foundation, GMO: It May Not Be What You Think, http://jonbarron.org/diet-and-nutrition/gmo-food-safety#.VHNOSYvF_T8 ♥Tina

For Better or Worse GMO Is Inevitable and Here to Stay Genetic engineering is already widespread. Today, despite the Cheerios announcement, around 70 percent of all the processed food that you buy in America contains genetically engineered ingredients, including soft drinks, ketchup, potato chips, cookies, ice cream, and corn flakes. Crops in the US that are now largely GMO include alfalfa, canola, corn, cotton, papaya, soy, sugar beets, and zucchini and yellow summer squash. General Mills merely took advantage of a low cost, low risk option to see if labeling Cheerios non-GMO gave it a meaningful marketing edge over the competition. They most decidedly did not extend that decision to more costly changes such as would be required to make Kix non-GMO. Unlike Cheerios, the first four ingredients in Kix are all GMO: whole grain corn, corn meal, beet sugar, and corn bran. When General Mills announces that Kix is going non-GMO that will actually mean something. But I wouldn't hold my breath. Ultimately, GMO will keep moving forward because it often fills a particular need (resistance to pests, drought, freezing, etc.) or is economically preferable. Look at the European Union (EU), which regulates food stuffs for all its members. The EU has the toughest standards in the world for getting GMO products approved. Nevertheless, as of 2012, they had already approved 48 GMOs, although mostly for animal feed. More to the point, they have indeed approved several GMO food crops for cultivation in the EU including a Bt expressing corn that provides resistance to the European corn borer (fills a particular need) and something called Amflora potato, which was developed by the German company, BASF, that has a higher than normal yield of potato starch (economically preferable). So much for the EU's total resistance to GMO. The other thing to keep in mind, is that genetic modification is now so easy and inexpensive to accomplish, that it is impossible to stop. Stop it in Europe and the US, and it will continue in Africa and Asia. Keep in mind that whereas DNA sequencing once cost millions and millions of dollars and took many months of super computer time, it can now be done for $99--and still turn a profit.3 Trying to stop GMO is a bit like ordering the tide not to come in. Just ask King Canute how well that works.4 The bottom line is that given the inevitability of its coming, we need to figure out better ways to regulate it, label it, and prevent dangerous iterations of it from destroying the environment.

GMO inevitable- industry pressure and huge investments

Ellis 13 Sean Ellis is an entrepreneur, angel investor, and startup advisor. He is the founder and CEO of Qualaroo. http://www.capitalpress.com/content/SE-GMOWheatSider-061013 September 9, 2013 7:25AM Biotech wheat inevitable, industry says// ♥Tina

"There is a lot of research on transgenic wheat underway, (and) I don't think there's any doubt it will happen," Jacobson said. "It's just a question of when it's going to happen." Doug Jones, executive director of Growers for Biotechnology, agrees with Jacobson's timeline. "I think it's inevitable it will happen," he said. Monsanto began researching transgenic wheat during the late 1990s but stopped in 2005, primarily because of concern by U.S. growers that the Canadian Wheat Board wouldn't support getting GMO wheat approved in that country, according to Steve Mercer, director of communications for U.S. Wheat Associates. The U.S. industry was fighting with Canada for overseas markets at the time and "we felt confident they would try to use it as a competitive advantage," Mercer said. Monsanto, whose research was primarily aimed at developing spring wheat varieties with a Roundup Ready trait, withdrew its application for deregulation in 2005. The U.S. industry supports development of GMO wheat varieties as long as the right approvals can be obtained in the U.S., other major wheat producing countries and key overseas markets, Mercer said. GMO wheat research picked up again after the U.S., Canadian and Australian industries signed a joint statement in 2009 supporting development of genetically modified traits in wheat and moving forward with getting GMO wheat varieties deregulated in those countries. Hundreds of millions of dollars are being spent on GMO wheat research now, and many industry leaders feel its development and commercial introduction are inevitable.

Biotech Bad

Biotech bad for the poor

“If you can start modifying your body not to heal something or to fix a disability but in order to enhance your body, there won’t be any kind of health insurance that’s going to pay,” said Bertolt Meyer, a social psychologist at the Chemnitz University of Technology. Meyer was born an amputee and wears an i-limb on his left arm. Meyer said if we reach a future where technology is developed not to match the capabilities of a healthy human body, but to enhance it, suddenly a new market will emerge. These will be technologies that everyone might want, even those with otherwise healthy bodies. If most people start making modifications, it will change what we think of as an average human body, Meyer said. “If a lot of people are able to afford a device, a technology, or a surgery that enhances their capabilities, the average capability in society shifts upward,” Meyer told me. “That means that something that is normal today will be seen as a shortcoming in the future because a lot of people are ‘better than normal’ in the future.” "This stuff is going to happen. It’s just a question of when.” As an example, Meyer pointed to modern day laser eye surgeries that can enable people to gain 20/10 vision (a person with 20/10 vision can see at 20 feet what a “normal” person can see at 10 feet). If such a procedure became affordable enough that the average person has access to the surgery, perfect 20/20 vision could eventually be considered below-average eyesight. What does that mean for those who have 20/20 vision (or worse) and can’t afford surgery? How might the job market change as the average worker is able to do more? “We’re not talking about a faster car. We’re talking about technology that will be able to enhance human capabilities,” Meyer said. But technology has exacerbated these kinds of economic gulfs in the past, according to Thad Starner, a computing professor at the Georgia Institute of Technology, and society has managed to adapt. A few centuries ago, books and manuscripts were only accessible to the wealthiest sliver of the population. Now, most of the world has access to books and written information, often inexpensively or for free through libraries or the internet. Starner said while it took a long time to close the gap between those who had access to books and those who did not, that process is happening more quickly with modern technology.

No Transhumanism

No transhumanism- people are scared of it.

But he wasn’t as certain as Starner was that this kind of technology is inevitable, suggesting people might balk at the idea of chopping off an otherwise healthy arm to replace it with a bionic limb. Just like the early smartphone, if people aren’t willing to adopt the new technology, it won’t prevail. And as Meyer pointed out, it’s not so hard to imagine the general population feeling hesitant about a transhumanist present. “It’s interesting: whenever you have science fiction that depicts a future where you have people able to enhance the functionality of their bodies with technology, it’s always dystopian. It’s never a good future. It’s always a bad future,” Meyer said. “I wonder why that is.”

No Biotech

Biotech growth is unsustainable- downward cost pressures, manufacturing troubles, and regulatory regimes.

Otto et al. 14 Rapid growth in biopharma: Challenges and opportunities Biopharmaceuticals could become the core of the pharmaceutical industry, but not without significant transformation in the laboratory and in strategy, technology, and operations. December 2014 | byRalf Otto, Alberto Santagostino, and Ulf Schrader Mr. Ralf Otto is currently employed at Linklaters, and is a current Director at O&R Oppenhoff & Rädler AG berto Santagostino is an associate principal in the Copenhagen office Ulf Schrader is a partner at McKinsey & Company in Hamburg and co-author of numerous studies on the supply chain in the pharmaceutical and chemical industries. http://www.mckinsey.com/insights/health_systems_and_services/rapid_growth_in_biopharma //♥Tina

Downward cost pressure will intensify as healthcare systems struggle to balance rising demand with flat or declining budgets. In this environment, payors may find it difficult to justify the annual treatment costs of $50,000 to $100,000 that some biopharma products currently demand. It is hard to imagine that these price premiums will be sustainable for any but the most innovative drugs. Furthermore, governments in emerging markets understand the critical role that biopharma will play in boosting healthcare outcomes, and they are aggressively supporting alternative ways to fulfill demand for these products. The result of these pressures will be the inevitable development of the biosimilars industry. The availability of biosimilar versions of human-growth hormones and interferons has already opened access to these products to a far larger number of patients. As patent protection on more complex biopharmaceuticals expires, biosimilars will surely follow the same path. Early regulatory and customer concern is already being overcome. In June 2013, for example, the European Union approved Remsima, Celltrion’s biosimilar version of the monoclonal antibody Remicade. In emerging markets, where consumers are able to access products only if they are available at considerably lower prices, enthusiasm for biosimilars is likely to be even stronger. The biosimilars industry has the potential to change the commercial landscape as profoundly as generics players have done in conventional pharma. Pressure from biosimilars will force the innovators to accelerate the search for better products and will increase pressure on the industry as a whole to reduce its cost of goods sold. Complexity of biopharma supply chain and operations As the number of products rises and new process technologies such as continuous manufacturing are introduced, the complexity of biopharma operations and the biopharma supply chain will increase. Evidence indicates that current production programs are already stretching the industry, with several players failing to deliver to the market. This challenge will only increase as sites move from the current “one line, one product” setup toward nimble and flexible multiple-product operations and are required to manage both current and future technologies under one roof. The high premium on biopharmaceutical products and the relatively smaller share of revenues they have historically accounted for in big pharmaceutical companies have led to industry-wide challenges in the supply chain. Complexity, cost, and service levels are far from small-molecule best practices, even considering the additional complexity of cold-chain requirements. New manufacturing technology platforms The new classes of molecules discussed above, from drug conjugates to the cell and gene therapies arriving in the next five years, will each require its own novel manufacturing, supply, and quality-assurance approaches. Today, many companies that are insourcing these products in the late clinical or early commercialization phase are struggling to set up the novel technologies and processes required to produce them. Making the right decision about how to set up operations for an autologous cell therapy is not an obvious exercise, and there will naturally be many suboptimal solutions before sufficient experience is built. Quality compliance and regulatory scrutiny Quality functions are struggling to keep up with the rising demands of regulators, primarily the US Food and Drug Administration. The industry has received an unprecedented number of warning letters and remediation programs in the last five years, and scrutiny is unlikely to decrease. Furthermore, the increasing relevance of global markets (beyond the United States, European Union, and Japan) is adding the complexity of multiple quality standards and regulatory regimes. Compliance, robustness of processes, and efficiency will need to be squared in one equation.

No biotech- cost, expertise, time, and tech challenges

Yet there are operational and technological challenges. Reproducing large molecules reliably at an industrial scale requires manufacturing capabilities of a previously unknown sophistication. Consider this: a molecule of aspirin consists of 21 atoms. A biopharmaceutical molecule might contain anything from 2,000 to 25,000 atoms (Exhibit 1). The “machines” that produce recombinant therapeutics are genetically modified living cells that must be frozen for storage, thawed without damage, and made to thrive in the unusual environment of a reaction vessel. The molecules must then be separated from the cells that made them and the media in which they were produced, all without destroying their complex, fragile structures. This sophistication comes at great cost. Large-scale biotech-manufacturing facilities require $200 million to $500 million or more to build, compared with similar-scale small-molecule facilities that may cost just $30 million to $100 million, and they can take four to five years to build. These facilities are costly to run, too, with long process durations, low yields, expensive raw materials, and, not least, the need for a team of highly skilled experts to operate them. There are myriad reasons the rapid growth and increasing importance of the industry is producing new challenges and opportunities. To keep pace, biopharma players must revisit and fundamentally reassess many of the strategies, technologies, and operational approaches they currently use.

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