Category Archives: Genetic Engineering

A centurys worth of change is about to be squeezed into a single decade. By 2030, entire industries are likely to be replaced with software code. Whole professions could wake up to find their livelihoods superfluous. Robots may be doing our chores, patrolling our streets, and fighting our wars.

Besides lives and jobs, entire nations could be upended: Digital currencies may destabilize global finance, robotics will likely accelerate the relocation of manufacturing, and the plunging cost of renewable energy will shift power away from petrostates. Nations will compete more fiercely than they have in generations. Whats more, all these changes will occur simultaneously and in ways that promise to be disorderly all around.

Its therefore more urgent than ever that the nations of the world get together to hammer out a shared consensus on a broad range of technologies and their future use. The earthquake will not stop at borders or respect national policieswhats urgently needed is a common understanding on the ethics of whats permitted, what isnt, and how to cooperate globally to make sure that countries, companies, research institutions, and individuals respect these bounds. Yes, we know all the arguments against governments intervening in scientific advances and free market innovation: that they will stifle them or use them only to their own ends. But not to act would be reckless. The giant bulldozer of challenges coming straight at us makes it unavoidable to make important collective decisions.

So far, governments have tried haphazardly to stay in control. Countries have, for example, effectively broken the global internet into a series of national or regional networks under their controlincluding social media, payments, shopping, news, and data storage. But as technology rapidly advances, this quilt of different approaches will no longer work. Each further advance will raise new and fundamental questions of ethics and equity that transcend borders and affect the interests of everyone involved.

Facing different pressures, nations will come to very different conclusions about appropriate uses of technology. Until recently, societies could adapt to new technologies in slow motionthey could study their effects and determine how to regulate them over a span of decades. But the growing speed and breadth of change, powered by the widening availability of powerful yet low-cost new technologies, make regulatory change at such a slow pace untenable.

The battles that Facebook fought with Australia over who should pay forlinkingto news articlespitting a corporation against a major country and its mediawill come to seem quaint as we argue over the deadly anddestabilizingeffects of battlefield killing machines controlled by artificial intelligence. Whether COVID-19 was the result of an accident of nature or a failed lab experiment will be irrelevant as biohackers and governments readily engineer viruses to create pandemics.

We urgently need a consensus between governments that limits the use of a broad range of technologies and institutes a mechanism for reparations by countries liable for their misuse. But before governments can do that, societies need to decide what is acceptable. Laws are codified ethics, after alland ethics are defined by social consensus. Every society approaches each advance with its own cultural, historical, and moral perspective.

These cultural differences were front and center in a series of Exponential Innovation workshops we ran with business executives in more than 30 countries. We put before them a hypothetical dilemma involving the use of CRISPR gene-editing technology, a fast and low-cost method of highly targeted genetic engineering. If their unborn child had a debilitating genetic disorder resulting in a lifetime of suffering, and a doctor had thetechnologyto manipulate the fetuss genes by giving the mother a single injection, what would they decide? As many as one-fifth of participants said they would refuse the novel treatmentbut their reasons differed widely across cultures. In Mexico, Catholic participants worried about Gods will; in Malaysia, the executives discussed the technologys consistency with the teachings of Islam; in Switzerland, many raised the social inequities the technology would create.

The questions and moral dilemmas raised by new technologies are frequently unexpected and difficult to grapple with. There are also no easy answers for how to integrate these technologies into our world safely and responsibly. To keep up with technology, we need our collective ethical governance to keep pace with technology creep. We can achieve that only by building layers of joint understanding and consequent agreement on acceptable limits. Once we find those limits locally, then we have to set them globally. Technology continually expands the boundaries of the possible, but policy and culture are what ultimately determine what we permit.

Finding common cause in such complex areas clearly wont be easy, but the world has risen to the occasion before. Chemical weapons, ozone-depleting chemicals, climate change, marine protection, human rights, and the protection of sites of cultural and natural valuethese are some of the issues on which nations have been able to find broad agreement. International treaties and agreements have set boundaries on whats permissible, created oversight bodies, established pools of capital, and laid down the consequences for failing to abide by the rules.

Unanimous agreement is not necessary for progress. Genetic engineering is a case in point: Although we have been able to clone cattle, sheep, cats, dogs, deer,horses, mules, rabbits, and ratsfor decades, nobody has cloned full human beingsat least as far as we know. Even though there is no formal treatybanningthe practice, instruments of global governance such as theUnited Nations Declaration on Human Cloning of 2005havecreatedpowerful norms and guidelines that have kept the technology in check. Even partial experimentation on humans has received the strongest discouragement across different social and political cultures. When a Chinese researcher, He Jiankui,announcedthat he had created the first gene-edited babies, the consequent global uproar led Chinese authorities to arrest him and later sentence him to three years in prison for unethical conduct, drawing a clear line between what is and what is not acceptableeven if the rebuke only came after the damage had occurred.

In the 1970s, a wave of environmentalism swept much of the globe and gave rise to two decades of global conferences with high ambitions. And it worked: An understanding of resource limits and the ecological fragility of the only planet available to us led to a slew of effective conventions, recommendations, and strategies. That should be our modelexcept we must move faster.

The time has come for us to reach a common understanding of the advancing technologies that stand to remake our world. International institutions and old-fashioned diplomacy may seem like a naive hope and an outdated approach. But in the face of the tremendous and truly unprecedented challenges before us, its the only chance we have. The alternative isnt just technological disruption on a scale the world has never seen but social, economic, and political mayhem.

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The World Must Regulate Tech Before It's Too Late - Foreign Policy

DUBLIN--(BUSINESS WIRE)-- ERS Genomics Limited (ERS), which was formed to provide broad access to the foundational CRISPR/Cas9 intellectual property co-owned by Dr. Emmanuelle Charpentier, today announced the appointment of Jon Kratochvil as Vice-President for Business Development & Licensing for North America.

With over 30 years of experience, Jon becomes a core member of ERS global team. Jon joins ERS from MilliporeSigma where he was Director of Business Development and Licensing, with responsibility for all global development opportunities for the companys gene editing and novel modalities technologies. In his role as Business Development Director for Washington University Jon was pivotal in generating over $70 million in revenue from a portfolio of over 1,000 life science technologies. Prior to this he was a licensing manager and the competitive intelligence analyst for Abbott Laboratories diagnostics division, working on novel detection platforms and pharmacogenetics. He is an inventor on over 40 patents and patent applications, has a BS in Biology from Rutgers University, and received graduate degrees from Northwestern University in Microbiology/Immunology and Loyola University in Chicago in Law.

Jon has a fantastic track record in the industry; we are delighted to welcome him to the team. He will be an asset in our global expansion efforts and pivotal in expanding the use and adoption of CRISPR/Cas9 in North America, said Eric Rhodes, CEO, ERS Genomics.

The team at ERS is making huge progress in its mission to increase global access to the Nobel Prize winning CRISPR/Cas9 system, commented Jon Kratochvil, Vice-President for Business Development & Licensing for North America, ERS Genomics. This powerful technology has led to a revolution in genetic engineering and I look forward to being part of the next phase.

For additional information, please visit http://www.ersgenomics.com

For high resolution images please contact Zyme Communications

View source version on businesswire.com: https://www.businesswire.com/news/home/20210301005374/en/

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ERS Genomics Expands Team With Appointment of Jon Kratochvil as VP Business Development - BioSpace

Introduction

Diabetes mellitus (DM) is one of the most prevalent metabolic disorders globally. It is a highly inflammatory disorder with increased blood concentrations of numerous inflammatory biomarkers.1,2 It is closely related to sedentary life and inappropriate food intake.3 Patients with DM should know about the uses of correct nutritional habits, which is the key in the regulation of blood glucose.4 Dietary strategies are vital to the treatment of DM and risk factors for cardiovascular disease (CVD) development.5

Eating patterns like the Mediterranean style, Dietary Approaches to Stop Hypertension and monitored carbohydrate diet are effective for lowering CVD risk factors and controlling glycemia.6 Mediterranean-style diet is the most comprehensive diet, characterized by olive oil as the chief source of fat and high consumption of vegetables, monounsaturated fatty acids and a low consumption of red or processed meat.7 The American Diabetes Association (ADA) approves a mediterranean-style diet and long-chain omega-3 fatty acids without supplements. Oily fish intake, without supplementation, is recommended in the United Kingdom for DM patients.8 In addition, the national lipid association recommends adults 2 servings of fish/seafood per week.9

CVD is the principal cause of mortality in patients with DM.10 According to some studies omega-3 polyunsaturated fatty acid (O-3 PUFA) therapy helps in the prevention of CVD among DM patients. O-3 PUFAs helps in the improvement of coagulation, lipid profile and inflammatory parameters.11 Moreover, O-3PUFA long-term supplementation helps in the reduction in pulse pressure and blood pressure.12,13

Animal studies revealed the plasma level of O-3 fatty acid is decreased among diabetes.14 The blood levels of O-3fatty acids can differ based on diet habits and geography. For instance, Japanese living in Japan have higher blood o-3fatty acid levels than whites in living in Pennsylvania and Japanese Americans living in Honolulu.15 A low level of O-3 fatty acid promotes inflammation, on the contrary, higher intake of O-3 fatty acid and their high concentration in the erythrocyte membrane is related to a lower risk of inflammation.16

Evidences regarding those issues were relatively deficient with few summarized studies. Hence, in this review, I will provide comprehensive summarized evidence regarding the benefit, types, dietary sources and mechanism of action of O-3PUFA for DM patients using available evidence.

There are three types of Omega3 fatty acids: Those include; Alphalinoleic acid (ALA), Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA). EPA and DHA are derived predominantly from fish and seafood and ALA is derived from plant sources, such as seeds, particularly flaxseed and leafy greens.17 DHA and EPA are found in predominantly in fish and other seafood, and thus they may be together referred to as marine O3 fatty acids.18

In human diets, ALA is frequently derived from botanical sources such as green leaves, flaxseed, pecans and kiwifruit with chia seed and flax seed being the richest sources. Linseeds and their oil typically contain 4555% of fatty acids as ALA, while rapeseed oil, soybean oil, and walnuts all typically contain ~10% of fatty acids as ALA. There is small ALA from sunflower oil and corn oil.19 The principal food sources of omega-3 fatty acids are oily fish (Table 1). But, it should be noted that the omega-3 content of fish differs by the fishs diet and species. The best sources of omega-3 fatty acids are herring, salmon, anchovies, rainbow trout and sardines.20

Table 1 Summary on the Sources of Omega-3 Polyunsaturated Fatty Acid and Their Concentration

Marine fishes have more O3 PUFAs than farmed ones since most marine fishes feed on phytoplankton and zooplankton that are rich in O3 PUFAs. Similarly, cold-water fishes accumulate much proportions of long-chain O3 PUFAs that aid them to adapt to cold environment than warm water fishes. Omega-3 fatty acid products are available as prescription formulations (icosapent ethyl, omega-3-acid ethyl esters A, omega-3-acid ethyl esters, Omega-3-carboxylic acids) and dietary supplements (predominantly fish oils). Fish, fish oil supplements, and other seafoods primarily account for the DHA and EPA in human diets.21

Once eaten, the body converts ALA to EPA and then to DPA and lastly to DHA, but this conversion is inadequate, with less than 15%. As this conversion is not efficient enough to fulfill health requirements, DHA and EPA are considered essential fatty acid as well and,22 thus consuming them is the only practical way to get them in the body.23 The consumption of O3 PUFAs is usually inadequate because of their limited sources.24 EPA and DHA are also available in O-3 fortified foods, including pastas, breads, cereals, eggs, dairy products, meats, juices, salad dressings, spreads, and oils. Consumption of O-3 fortified foods is a potential option to increase EPA and DHA intake in vegetarians or individuals who dislike fish/seafood.25

T2DM is closely linked with obesity, and adipose tissue produces numerous hormone-like compounds that can raise insulin resistance (IR).26 Adipose tissue is involved in hormone secretion, such as leptin, adiponectin and visfatin, and could stimulate insulin signals. Adiponectin has a role in the modulation of lipid and glucose metabolism together with insulin-sensitive tissues.27

In humans, levels of adiponectin are lower in IR states, as well as in T2DM. Experimental studies revealed supplementation with O-3 PUFA improved insulin sensitization, thru increased levels of adiponectin and reduced inflammation.2830 It raises adiponectin synthesis by inhibiting transient receptor potential canonical calcium ion channels, which can control adiponectin production.31 Besides, in animal model adiponectin prevents T2DM and atherosclerosis.32 Agonism of G-protein coupled receptor 120 (GPR120) which is a receptor for O3 fatty acids, has potent antiinflammatory effects by blocking the signaling of many proinflammatory mediators.33

EPA is metabolized to the thromboxanes, prostaglandins and leukotrienes, which had anti-coagulant and anti-inflammatory effects.28 Besides, the metabolic products of O3 fatty acids, namely protectins, resolvins and maresins are also antiinflammatory in nature and thus counteract inflammatory responses during CVD.34

Generally, proposed mechanisms of O-3PUFAs protection against several diseases including DM, were: (i) They increase the production of anti-inflammatory eicosanoids that can help in phagocytosis and resolution of inflammation; (ii) they can inhibit the production of adhesion molecules (iii) they can limit the activity and production of inflammatory mediators (iv) they can inhibit sterol regulatory element-binding protein 1c nuclear factor which mediates lipid degradation and decreases lipid biosynthesis; and (v) they can improve hypothalamic regulation and glucose uptake.35

Furthermore, O-3 PUFAs can potentially reduce inflammation via many mechanisms, including inhibition of nuclear factor kappa B activation, inhibition of the arachidonic acid pathway, and initiation of anti-inflammatory signaling through GPR120 and decrease C-reactive protein (C-RP) concentration (Figure 1).3638

Figure 1 Summary figure on mechanism of action of O-3PUFA. Arrows going up represent an increase in a specific parameter whereas arrows going down represent a decrease in a specific parameter.

Abbreviations: PG3, prostaglandin E3; TXs, thromboxanes; LTs5, 5-series leukotrienes; TFN-, tumor necrosis factor-; IL-6, interleukin 6; IL-1, interleukin 1; CRP, C-reactive protein; CVD, Cardiovascular disease.

O-3PUFA supplementation was postulated to improve glycaemic control which is the cornerstone of DM management. Possible mechanisms for this include improved hepatic insulin sensitivity through reducing lipogenesis and hepatic fatty acid oxidation39 and modulation of incretin hormones, which are participated in glucose-stimulated insulin secretion.40 Furthermore, in animal studies, supplementation with O-3PUFA improved insulin sensitization, potentially via increased levels of adiponectin, an emerging protective risk factor, and reduced inflammation.33,41

According to some studies O-3 PUFA supplementation had beneficial effect on glucose level, Hb1Ac, reduces pro-inflammatory cytokine levels and improves glycaemia.42,43 A review exploring the impact of PUFA intake on glycaemic control in T2DM populations concluded that PUFA supplementation of 0.425.2 g/day for at least 2months may benefit glycaemic control, particularly in Asian populations.44 DPA supplementation was shown to be effective in reducing blood glucose levels and improving homeostasis model assessment of insulin resistance in a rodent model.45

However, a meta-analysis of 20 randomized controlled trials (RCTs) with T2DM patients reported that there were no significant differences in markers of glycaemic control, including fasting blood glucose, postprandial plasma glucose, fasting insulin and HbA1c with O-3 PUFA supplementation (0.52 to 3.89 g/day EPA and up to 3.69 g/day of DHA, 65 duration ranged 248 weeks) in comparison to control groups.46 Human trials showed that O-3 PUFA supplementation appears to have a negligible effect on insulin sensitivity and markers of glycaemic control including HbA1c and fasting glucose.47,48 Furthermore, one RCT has suggested no benefits of low-dose O-3 PUFAs in dysglycemia.49 Generally, so far there are inadequate studies that recommend the usage of O-3 PUFA for glycaemic control.

CVD is the most common cause of morbidity and mortality in T2DM patients and its risk factors are common in patients with T2DM.50 It has been revealed that O-3 fatty acids can decrease cholesterol and prevent IR.51 They switch off the genes participated in lipid synthesis, diminish the hormones associated with obesity and inhibit omega-6 fatty acids production.52 Furthermore, O-3 PUFA has been widely used for the management of hypertriglyceridemia53,54 and according to recent systematic review of RCTs O-3PUFAs can be recommended for ameliorating CVD risk factors.55

Suggested mechanisms for the protective role of O3 fats against CVDs include: modulating arterial lipoprotein lipase levels; altering the lipid profile, lowering the blood pressure, reducing thrombotic tendency; producing antiinflammatory effects and improving vascular endothelial function.56 Furthermore, it helps against CVD by disrupting the c-Jun N-terminal kinase (JNK) signaling by reducing the expression of tumour necrosis factoralpha.57

A meta-analysis of 5 trials in T2DM revealed that O-3 PUFA supplementation considerably reduced diastolic blood pressure.58 In a similar way, a clinical trial with O-3PUFA supplementation in women with T2DM revealed a major mean reduction in blood pressure.59 Consistent O-3PUFA supplementation may decrease the risks of sudden cardiac death and myocardial infarction (MI). In addition, some evidence proposed that it may improve blood circulation and increase the breakdown of fibrin.60

EPA at a pharmacologic dose can lower fasting triglyceride and interfere with atherosclerosis which causes reduced CVD.61 It has also been reported that O-3PUFA supplementation inhibits platelet aggregation and decreases oxidative stress.62 A meta-analysis demonstrated that O-3 PUFA supplementation improves endothelial dysfunction and arterial stiffness in T2DM patients.63 Furthermore, according to meta-analysis by Wang et al supplementation with long-chain PUFAs significantly improves the endothelial function.64

However, over three months of high-dose O-3 PUFA treatment in very high-risk patients with atherosclerotic CVD and T2DM did not improve the endothelial function indices.65 A recent meta-analysis among type one DM patients indicated that daily high dose bolus of O-3PUFA supplementation for six-months does not improve glucose homeostasis, vascular health or metabolic parameters.66 Furthermore, other study demonstrated that in patients with long-standing, well-controlled T2DM and atherosclerotic disease treatment with a high dose of O-3 PUFAs for three months does not improve coagulation and inflammation.67

According to the result from the ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial, which evaluated the effects of 0.9g/day of O-3 fatty acids ethyl esters on cardiovascular outcomes in patients with DM, found no reductions in deaths from CVD causes.49 Besides, according to ASCEND (A Study of Cardiovascular Events in Diabetes) revealed that among patients with DM but without evidence of CVD at baseline, there was no significant difference in the incidence of serious vascular events between those who received O3 fatty acids and those who received placebo.68

However, Gruppo Italiano per lo Studio della Sopravvivenza nellInfarto Miocardico (GISSI)- -Prevenzion study, showed that the early administration of low-dose (1 g/day) O-3 PUFA reduces total mortality and sudden death by CVD.69 According to JELIS (Japan Eicosapentaenoic Acid Lipid Intervention Study) among patients with hypercholesterolemia received statins alone or in combination with highly purified EPA (1.8 g/day) after 5 years patients receiving the combined treatment experienced a 19% relative reduction in major coronary events.70 Furthermore, based on results from REDUCE-IT (Reduction of Cardiovascular Events with EPA Intervention Trial), the addition of 4 g/d of EPA plus statin resulted in a significantly lower occurrence of CVD events.71 This finding provides a strong rationale for prescribing icosapent ethyl for patients with hypertriglyceridemia who are on a statin.

In general, despite the substantial body of evidence that has investigated O-3PUFA supplementation on CVD risk factors within T2DM populations; the effect of O-3PUFAs on clinical CVD endpoints is not conclusive. Thus, O-3 PUFA supplementation is therefore not recommended by the AHA for the prevention of CVD in patients with T2DM.72

Omega3 fatty acids have a great role to avoid the progression of diabetic retinopathy, because of their antiangiogenic, antiinflammatory and antioxidant properties.73 They reduce the formation of free radicals and inducing the expressions of endogenous antioxidant enzymes. Also, they prevent the initiation of retinal angiogenesis remarkably by down-regulating the expressions of various angiogenic agents such as Matrix metalloproteinases (MMPs), Cyclooxygenase-2 (COX2) and Vascular endothelial growth factor (VEGF).74,75 Furthermore, since they form an vital constituent of cell membranes they control cell membrane fluidity.76

Animal studies revealed that O-3PUFAs inhibit hyperoxia-induced premature retinopathy.77 A prospective observational study among older patients with T2DM who consumed Mediterranean diet and had a dietary O-3 PUFA intake equivalent to at least two weekly servings of oily fish had a significantly lower risk of diabetic retinopathy.78 However, a beneficial effect of omega-3 PUFAs in human retinopathies is unclear, possibly due to the paucity of human studies in the area.

Recent meta-analysis revealed that O-3PUFA supplementation could help improve proteinuria and maintain renal function among T2DM.79,80 The effects of O-3 PUFA supplementation in subjects in DM patients are dependent on the dose of O-3Fatty acid supplementation.81 Other study showed that higher dietary O-3PUFA consumption was related with a lower risk of proteinuria among DM patients.82 For people with T2DM, the European Prospective Investigation of Cancer study showed that consuming at least two servings of fish per week lowered their risk of macro-albuminuria.83 In the CKD population specifically, a 12-week intervention study showed omega-3 PUFA supplementation (3.6 g daily) to reduce triglyceride levels, retard CKD progression, and having the capacity to reduce inflammation and oxidative stress.84

Early rodent models suggest a higher O-3 PUFAs intake, particularly omega-3 PUFAs (from fish oil), to reduce albuminuria in diabetic nephropathy.85 In human trials, however, the effects are far from conclusive, likely owing to the short durations and small sample sizes of current studies.86 Currently, O-3PUFA supplementation should not be advocated for avoiding kidney complications in diabetic nephropathy and existing literature were unable to draw conclusions.

The mechanisms via which O-3 fatty acids diminish proteinuria are not clear up to now. One of the suggested hypotheses is that O-3 fatty acids may decrease urine protein excretion via anti-inflammatory and oxidative stress. As hyperglycemia amongst diabetic sufferers induces podocyte injury as well as endothelial cell and tubulointerstitial harm through the activation of protein kinase C, formation of advanced glycation endproducts, and generation of reactive oxygen species, which performs a pivotal function in initiation and progression of proteinuria and diabetic nephropathy.87

Omega-3 polyunsaturated fatty acids are an increasing number of being used to prevent CVD, along with DM. However, long-term effects of PUFA on development and management of DM remain inconclusive. Some studies suggest that O3fatty acids supplementation was either positively, negatively or insignificantly associated with DM development.88,89 Recent systematic review and meta-analysis suggests that increasing O-3 fatty acids has little or no effect on prevention and management of T2DM.90 A recent meta-analysis of RCTs established that O-3PUFA supplementation has little effect on the prevention of T2DM in humans and evidence for preventing T1DM remains preliminary and limited to animal studies.91

However, a metaanalysis revealed that the appropriate dosage and compositions of omega3, optimized cooking method, and early omega3 supplementation might be beneficial for T2DM prevention.92 Epidemiological studies suggest that inadequate O-3PUFA intake is related with an increased risk of developing both T2DM93 and type 1 DM.16

DHA helps in maintaining membrane fluidity of the brain which is vital for proper neurological and cognitive functions.94 O-3PUFAs are involved in the development and maintenance of healthy nerves. Experimental study revealed in peripheral nerve injury, increased endogenous levels of O-3 PUFAs have been shown to improve sciatic nerve blood flow and speed up the recovery.95 Furthermore, O-3 PUFAs helps in the prevention of heart disease4 and prevent oxidative stress among DM patients.96

Moreover, it has been proposed that O-3 Fatty acid treatment partially blocks the development of experimental diabetic cardiomyopathy by affecting sarcoplasmic reticulum calcium transport activity.97 Supplementation of O-3 FUFAs is also a promising novel nutritional approach to decrease obesity and associated metabolic disorders. They are effective in protecting against obesity by activating brown adipose tissue which aids energy expenditure thru its specialized thermogenic function.98 In general, there is limited clinical evidence which support O-3 PUFA supplement use in DM management and prevention (Table 2).

Table 2 Current State of Evidence for the Effects of Omega-3 PUFA Intake Regarding Diabetes Complications

Dietary intervention is a key factor in the management of DM and the goals of nutrition therapy to adults with diabetes is to promote and support healthful eating patterns, focusing a variety of nutrient dense diet in appropriate portion sizes, to improve overall health (Table 3). Medical Nutrition Therapy for diabetes aims to achieve the following objectives:

Table 3 American Diabetes Association 2016 Recommendations for Diabetes Patients

Evidence does not support recommending O-3PUFA supplements for people with DM for the prevention or treatment of CVD. As recommended for the general public, an increase in foods containing long-chain O-3 fatty acids is recommended for patients with DM due to their beneficial effects on the prevention of heart disease, lipoproteins and associations with positive health outcomes.100 If the triglyceride concentration is not controlled with statins or fibrates O-3 fatty acids (4g/day) EPA can be used in patients with T2DM and in general CVD population.71

So far, there is no similar scientific guideline on the ideal O-3 PUFA intake. Things need to be considered include the issues related to supplement dose, purity, cost of obtaining O-3 PUFAs thru supplementation versus food and possibility of adverse effects. Adverse effects are likely dose-dependent. Due to their structure, O-3 PUFAs are susceptible to oxidation if exposed to excess heat. Improper storage of O-3PUFA supplements may cause their damage and affect their beneficial health effects.

O-3 PUFA supplements are a cost-effective way of attaining therapeutic doses. The common therapeutic dosages range from 14g/day.101 But, due to the beneficial effect of dietary sources in improving diet quality and improve intake of other beneficial nutrients, the food sources have to be prioritized.102

There are limited studies to draw exact suggestions regarding dosage; duration and the interaction of dosage O-3 PUFA intake and the available information are inconsistent. Probably, the consistent their cardiovascular effects might be likely only with doses above 2000 mg daily.103 Currently, dietary recommendations for individuals with and without DM supports increased consumption of foods rich in O-3PUFA but do not recommend supplementation.104 The Global Burden of Disease Study suggests that optimal intake of long-chain O-3 fatty acid is 0.25 g/d.105

The International Diabetes Federation Global Guideline for T2DM recommends that in patients with T2DM who are unable to achieve lipid-lowering targets with or are intolerant of conventional medications should be considered as candidates for other medications for dyslipidemia, including high-dose O-3PUFAs.106 The 2012 Endocrine Society clinical practice guideline on evaluation and treatment of hypertriglyceridemia, though not specific to patients with T2DM, recommends that drug therapies like fibrates, or O-3PUFAs (alone or in combination with statins) be considered for treatment of moderate to severe triglyceride levels.107

According to a systematic review by Brown et al supplemental long-chain O-3 fatty acids would not be encouraged for the prevention or treatment of DM. In case, supplementary long-chain omega-3 fatty acid is used to reduce triglyceride concentrations, or people with or at risk of T2DM choose to take supplementary long-chain O-3, doses below 4.4g/d should be encouraged.90 On the other hand, according to some studies, there is an increased risk of T2DM with the intake of long-chain O-3 fatty acids, particularly with higher intakes (0.20g O-3/d).108 The Food and Drug Administration (FDA) recommends that the intake for consumers not exceeds 3g/day of EPA plus DHA with no more than 2 g/day from dietary supplementation.109

According to recent clinical trial for the general population and those with DM, about 1 g/d of omega-3 fatty acids reduced the risk of from CVD. A higher dose of omega-3 fatty acids (approximately 4 g/d of EPA and likely 4 g/d of EPA+DHA, as well) is also an effective adjunct for cardiovascular treatment in those with high triglycerides who take statins.110 According to one experimental study O-3 fatty acids can be given in conjunction with metformin to decrease triglyceride levels in diabetic dyslipidaemia. Two grams of O-3 fatty acids were more effective than 1 gram of omega-3 fatty acids in decreasing triglyceride levels.111

Based on results from REDUCE-IT, the addition of 4 g/d of EPA should be considered for statin-treated patients who have cardiovascular disease or diabetes and elevated triglycerides. But, the STRENGTH (Statin Residual Risk Reduction with Epanova in High Risk Patients with Hypertriglyceridemia) trial showed no benefit on cardiovascular event rates of a high-dose combination of EPA and DHA and do not support use of this omega-3 fatty acid formulation to reduce major adverse cardiovascular events in high risk patients.112

O-3 PUFA supplementation is not suggested by the American Heart Association (AHA) for the avoidance of CVD in T2DM patients. However, for the secondary prevention of CVD in the general population, the AHA considers O-3 PUFA supplementation reasonable.72 AHA does not recommend supplementation with O-3 PUFAs for individuals with T2DM to prevent coronary artery disease.113,114 Furthermore, the ADA does not recommend O-3PUFA supplements to treat or prevent CVD in patients with DM, even though the consumption of foods containing O-3PUFAs is recommended.115 The AHA recommends supplementation for adults not eating enough oily fish.116

In general, there are limited data on the use of O-3 PUFA supplementation among DM patients. However, for clinical practice, evidence from the most current clinical trials supports the recommendation to consume at least one to two servings of fish/seafood per week, with additional primary prevention benefits conferred by consuming ~1 g/d of DHA and EPA.

Several strategies have been suggested to rise the intake of O3 fatty acids in the body; including; (i) Increased consumption of fatty fish and other O3 PUFAs-rich foods, (ii) Fortification of food products with fish oil or ALA, (iii) Enhancement of O3 PUFAs in animal products by feeding O3 PUFAs-rich diets, and (iv) Fortification of O3 PUFAs in oilseed crops by genetic engineering.117

It has been demonstrated that feeding animals with ALA-rich diet can increase the content of O3PUFA in animal-derived products. However, the magnitude of increase in O3PUFA content appears to be dependent on the type of diet supplementation.24 For instance, two- to five-fold higher DHA and EPA has been recorded in breast and thigh meat of broilers fed with high ALA-rich flaxseed oil for 6 weeks.118 Moreover, O3 PUFAs enriched eggs produced by feeding laying hens with a fish meal or canola/linseed oil are commercially viable as a good source of O3 PUFA.118

FUFAs Metabolically engineered oilseed crops are also beneficial to improve the content of O3 FAs in seed oil. They have certain advantages over conventional sources of PUFAs. For example, pollution of marine ecosystems has resulted in high accumulation of toxic dioxins, polychlorinated biphenyls, heavy metals, and organochlorine pesticides in fish.119 Additionally, low content of n3 PUFAs in farmed fishes and wild fish stock are insufficient in order to satisfy recommended EPA and DHA intake levels. Thus, genetically modified crops can serve as future sources of O3 PUFAs.120

Enhancement of O3 FAs in animal products by feeding O3 FAs rich diets or by genetic engineering fatty acid biosynthetic pathways has revealed potential to improve the content of O3 PUFAs in the diet. However, these strategies need to be fine-tuned. In addition, the releasing and approval of genetically modified crops are challenging due to social concerns.35

Fish oil dietary supplements are widely available and commonly used by consumers; however, there are critical distinctions between these dietary supplements and the FDA-approved O-3PUFA drugs that can be obtained only by prescription. Prescription O-3PUFA products are highly purified, subject to quality control regulations, and required to demonstrate both safety and efficacy in clinical studies to achieve approval by the FDA.

In order to provide adequate PUFAs, the level of their fortification into foods needs extensive consideration. At least 0.5 g/d of O-3 PUFAs EPA and DHA are recommended for daily consumption.121 Dietary consumption of O-3 PUFAs via incorporation into foods is ultimately the most effective mechanism of providing them to the average consumer.122

There is considerable evidence indicated that the consumption of O-3 PUFA is associated with substantial health benefits among DM patients. However, despite the promising experimental investigations, currently, the clinical evidence for the usage of omega-3 supplementation for the management of DM and its complications is both conflicting and inconsistent. Hence, further study is required to ascertain the effects of O-3 PUFA supplementation in the management of diabetes.

Diabetes mellitus especially type 2 is a significant health challenge with multiple associated comorbidities. Diet and lifestyle factors are central to its prevention and control. There are three types of Omega3 fatty acids; those include ALA which is derived from plant oils and EPA and DHA which are derived primarily from fish oil.

There is limited clinical evidence that supports O-3 PUFA supplement use in DM management and so far, there is no similar scientific guideline on the ideal O-3 PUFA intake. There are limited studies to draw exact suggestions regarding dosage; duration and the interaction of dosage O-3 PUFA intake and the available information are inconsistent. Several strategies have been suggested to raise the intake of O3 fatty acids and dietary approach to increase omega-3 fatty acid intake is preferable.

The author reports no conflicts of interest for this work.

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[Full text] Purposeful Review to Identify the Benefits, Mechanism of Action and Pr | NDS - Dove Medical Press

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In the winter of 1996, Monsanto and a few other companies first began to sell genetically engineered seeds to commercial growers, and also mounted a massive public relations effort to convince people of their supposed benefits. They hyped their new GMOs as the answer to world hunger, a way to help troubled farmers stay on the land, and as a technology that would bring higher quality, more nutritious food to all. Skeptics in many countries responded swiftly: Greenpeace blockaded shipments and planted symbols in farmers fields, while decentralized networks of activists organized Global Days of Action. Saboteurs in some countries attacked GMO test plots in the dark of night, but in the UK they started doing it out in the open, leading to dramatic acquittals by local courts. Some farmers in India held large, public ceremonies to burn GMO crops. Within a year, the European Union began to require labeling of food products containing GMO ingredients.

Twenty-five years later, genetically engineered crop varieties are grown on roughly 190 million hectares worldwide a relatively constant figure since the early to mid-2010s and the profile of what is being grown and where does not differ very much from the late 1990s. Half the global GMO acreage is in soybeans, with soybeans, corn, cotton and canola representing 99 percent of all genetically engineered crops. Forty percent of all GMO acreage is in the US and 95 percent of the acreage is in just seven countries. Eighty-five percent of GMO crops are engineered to withstand high doses of chemical weed-killers most often Monsanto/Bayers Roundup family of herbicides and more than 40 percent produce a bacterial pesticide aimed to attack various pest species, but with long-documented harms for a host of beneficial insects. (The total exceeds 100 percent due to varieties that contain multiple, or stacked, engineered traits.)

As many readers know, this technology has failed to demonstrate any consistent advantages for crop yields or food quality, but has helped drive an unprecedented consolidation of corporate power in the global seed and agrochemical sectors. Following a mid-2010s cycle of mergers which greatly compounded the impact of the original late-nineties wave of GMO-driven mergers and acquisitions three global agribusiness empires came to control 70 percent of agrochemical production and more than 60 percent of the commercial seed market. The recently merged entities are Bayer-Monsanto, ChemChina-Syngenta and Corteva, a company formed from the merger of Dow and DuPonts agribusiness divisions. Four giant grain-trading and processing companies (ADM, Bunge, Cargill and Louis Dreyfuss) now control 90 percent of crop export markets worldwide.

While much of the world continues to reject GMO crop production, these varieties still dominate global food processing and markets for livestock feed. Farmers in many countries have had an increasingly difficult time obtaining seeds with desired agronomic traits nearly always the result of traditional crop breeding that arent also genetically engineered to resist herbicides and/or produce insecticidal toxins. And while GMO skeptics are occasionally written off as anti-science, researchers around the world continue to document the unintended consequences of GMO products, often in defiance of corporate-driven assaults on their reputations and livelihoods.

While active resistance to GMOs continues in many countries, many people have become complacent about our bifurcated food supply: those who are able to pay more increasingly favor organically grown and GMO-free products, while others are faced with an increasingly synthetic and often toxic food supply. The latest wave of advocacy for state-level GMO labeling in the US was curtailed by an Obama administration-supported bill that purportedly mandated a uniform national labeling rule, but one that is fundamentally misleading, filled with loopholes, and designed to be widely ignored. Still, people in much of the world continue to reject genetically engineered foods and agriculture.

One notable exception to this is Argentina, the third largest GMO producer after the US and Brazil. GMO soybean production has come to increasingly dominate Argentinas agriculture, with only occasional sparks of resistance. Over a decade ago, I met the Argentine sociologist, Amalia Leguizamn, who was then a graduate student in New York City struggling to understand just how that had come to pass. She began to explore the conditions on the ground in the centers of GMO soy production in Argentina, and found that the rare voices of resistance were typically overwhelmed by what appeared to be an unbreakable national consensus. Now a professor at Tulane University in New Orleans, she has produced a meticulously researched and superbly readable volume that tells the story of her investigations and reaches to the core of Argentinas apparent infatuation with GMO soybeans.

Leguizamns book, Seeds of Power: Environmental Injustice and Genetically Modified Soybeans in Argentina (Duke), transports readers into some of the most soy-dependent places in Argentina, spanning the famous pampas grasslands and the forested Chaco region, together encompassing the northeastern third of the country. Fields of herbicide-dependent GMO soybeans have spread as far as the eye can see in many areas, running right into peoples backyards and dominating the roadsides. Many large soy plantations are managed remotely by corporate-tied entrepreneurs and technicians who utilize the latest high-tech tools, and often live in urban and suburban areas many hours away from the farms they operate. They have expanded upon a tradition of large export-oriented farms that goes back to the late-nineteenth century wave of European immigrants, who were recruited by the millions to help turn Argentinas rangelands into el granero del mundo the granary of the world.

But it was only after the arrival of GMOs that the region shifted dramatically from producing wheat, corn, beef, dairy and a variety of other products toward increasingly mechanized monocultures of soybeans. Soybeans now represent half of Argentinas agricultural production, with 80 percent of all farmland in plots larger than 1000 hectares (nearly 2500 acres). Rural dwellers now less than ten percent of the countrys population typically work as contract laborers and their lives are dominated by the decisions of corporate managers and remote farm owners. Yet people in cities and towns still commonly proclaim that we all live off the countryside, as they rely on the relative economic stability the export soy industry can offer. The military dictatorship of the 1970s and eighties largely pacified the rural areas politically, and the neoliberal policies of the 1990s further entrenched patterns of corporate dominance, boosted by hefty seed discounts and relaxed patent rules that made GMO soybeans appear even more desirable for Argentine growers than for their counterparts in the US. The neo-populist administrations of Nestor and Cristina Kirchner supported the expansion of the soy economy and large growers successfully defeated a government attempt to raise export taxes during the global food crisis of the late 2000s, further entrenching their political influence.

Leguizamn did, however, happen upon some pockets of concern and skepticism. In one soy-dependent town, she learned of high rates of cancer, miscarriages and birth defects, but most people insisted they had no idea why this was occurring and voiced a persistent sense of resignation and fatalism, even amidst the ever-present fumigation trucks. While a few more trenchant concerns occasionally slipped through most notably when she found herself in temporarily women-only spaces people typically shut themselves down before their conversations got very far. However in one city, deep in the interior of the country, tacit concerns blossomed into an organized resistance that led to a local ban on crop dusting, a nationally famous lawsuit against a major violator, and eventually the cancellation of plans to build a massive new Monsanto corn seed plant that would have been one of the largest in the world. That community, on the outskirts of the city of Crdoba, became the site of a blockade and encampment that lasted a couple of years and hosted as many as 200 people, including international supporters. Indigenous communities in the northern part of the country, facing widespread deforestation and dislocations, have also made some waves, but have had fewer tangible successes.

Seeds of Power contains insightful reflections throughout on a compelling problem that is rarely closely examined by activist-researchers: how power operates to create acquiescence. What is often characterized as public support for corporate-friendly policies is often just a mere acceptance by those who feel they have little power or agency to raise difficult questions. Constraints of culture, history, enforced traditional gender roles and other such factors play a powerful silencing role. Where people feel disempowered, we know they are often far more susceptible to forms of political and religious demagoguery that may feed their acceptance of the health hazards and economic stresses they experience on a daily basis. Groups of mothers, like those near Crdoba, will sometimes see most clearly through the fog, and are often in the forefront of struggles for environmental justice. Leguizamns insights on the politics of acquiescence also shed light on the realities faced by famers in the US Midwest, where the constant pressure to keep expanding operations just to keep their families on the land often compels acceptance of labor-saving technologies such as herbicide-tolerant GMO crops.

This past year, the coronavirus pandemic and the worldwide race to develop and distribute COVID-19 vaccines has boosted the reputations of companies engaged in medical biotechnology research, and their agribusiness counterparts have mounted a public relations offensive to try to share in the benefits. They systematically obscure the fundamental distinction between the use of advanced genetic methods as research tools and the release of living genetically manipulated organisms into the open environment. While genetically engineered yeasts or bacteria in confined laboratory settings are typically involved in the initial phase of production of new pharmaceuticals such as mRNA vaccines, the purified end products carry far less risk of unintended consequences than whole engineered organisms. The scientific literature on GMO technologies disruption of genetic regulation at the cellular and molecular levels is quite extensive and compelling, despite industry disinformation to the contrary. While biotech approaches to monitoring and analysis have also helped enhance the speed and reliability of plant breeding research, there is a similarly clear distinction between diagnostic methods in a laboratory setting and uncontrolled releases of engineered seeds, plants and even insects. We are told that newer methods of gene editing by methods such as the Nobel-honored CRISPR-Cas9 technology are inherently more precise than conventional genetic engineering methods, but there is also a growing cautionary literature on unintended consequences of those more advanced genetic manipulations.

The book, Seeds of Power, offers important insights on the complex dynamics of power and compliance and how they can play out in a broad national context. It helps us understand how individuals position themselves amidst those dynamics and appreciate the often unconscious personal decisions that can serve to reinforce patterns of social control. It offers an exceptional mix of scholarship and storytelling, and deserves to be widely read by everyone who wants to better understand how the global GMO debate has evolved over these past 25 years.

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25 Years of GMOs, and Some New Insights from Argentina - CounterPunch.org - CounterPunch

Before the pandemic, Anne Leonards friends and family had only a cursory interest in her two decades of work manufacturing pharmaceuticals.

But recently, when her grandmother learned that her work as the director of quality assurance at the Catalent facility in Indiana meant that her granddaughter was helping keep the Johnson & Johnson and Moderna vaccines safe, she was so proud, she told all her friends about her granddaughters efforts to help end the pandemic.

She didnt actually realize how close to the manufacturer of the Covid vaccine I was, said Leonard. She was so tickled by it.

Leonard said even her 9- and 11-year-old kids know that, while she has to work really long days, what she is doing is important work.

I tell them Im doing this for you guys, and for grandma, and for your teachers, Leonard said.

With the US Food and Drug Administrations authorization last week, Johnson & Johnson said about 4 million doses of its coronavirus vaccine would immediately head to states to help meet enormous demand. The company has said it expects to make enough doses to vaccinate 20 million people by the end of March, and has a goal to produce 1 billion doses globally by the end of the year.

But as President Joe Biden said Tuesday, it simply wasnt coming fast enough.

Biden announced that drugmaker Merck will help manufacture the Johnson & Johnson vaccine a decision made after it became clear that J&J would fall short of its manufacturing goals. The planned partnership was first reported by The Washington Post.

The White House said it was utilizing the Defense Production Act to help equip two Merck facilities to manufacture the Johnson & Johnson product, including by bolstering fill-finish capacity, when the doses are placed in vials, and by increasing availability of the components of the vaccines.

There may still be delays, but Biden said Tuesday the United States would have enough Covid-19 vaccine doses for every adult American by the end of May.

Before the J&J vaccine can ever get into someones arm, it must go through a sophisticated and complicated process that involves several companies. It cant happen overnight, but companies say vaccine manufacturing has moved at a speed that has never been seen before in the history of pharmaceutical manufacturing.

J&J said it has been working with urgency to increase production of the vaccine candidate, but it isnt easy.

The production of our vaccine is a highly complex process that requires very particular capabilities and experiences, Dr. Richard Nettles, J&Js vice president of US medical affairs told the subcommittee on Oversight and Investigations for the House Committee on Energy & Commerce last week.

It takes about five or six weeks to genetically engineer and then grow, purify, and finish the vaccine before it can be bottled and sealed and sent on its way to be distributed to vaccine centers.

Put another way, Dr. Paul Stoffels, chief scientific officer for Johnson & Johnson, told CNN, you cant accelerate it by yelling at it.

J&J has looked at 100 potential production sites and found eight that meet its needs so far, Nettles said. Three have produced test batches of the vaccine. It expects to have additional capacity by the second quarter of the year and will be made in the US, Europe, Asia and Africa.

Leonard works at the bustling Catalent facility in Bloomington, Indiana, that sits in a nondescript building tucked away by the indoor pickleball court and the Budweiser distributor. Five shifts of 2,000 employees keep the buzzing production lines going 24 hours a day, seven days a week.

It started production of the J&J vaccine at the end of January and should get the regulatory authority to ship from the plant soon. The doses going out this week come from elsewhere.

Catalent hopes to meet the increasing demands for vaccines to help end the pandemic.

We are going as fast as we can, Leonard said. In such a regulated industry, there are certain steps that you just cant speed up any faster, but I think we are doing amazing things to get the vaccine out as quickly as we have. Everyone at the site feels a great responsibility to do that and were working day and night to get it done.

The plant that, decades ago, made TVs is now helping make the substance that the country is counting on to end its isolation.

The company that actually starts the manufacturing process for J&J is not Catalent, but Baltimore-based Emergent Biosolutions.

Emergent does the work genetically engineering a virus known as adenovirus 26 that causes the common cold in humans. Genes are removed from the virus so it wont replicate and spread in the body. Genetic material is also removed to make room for the genetic instructions for making a piece of the coronavirus spike protein that it uses to attach to cells.

This adenovirus vector is grown in vats of human cells in large reactors. The resulting virus is purified to remove debris. Its a biologic process that takes several weeks before the resulting product can be frozen and shipped hundreds of miles to companies such as Catalent.

For both the J&J and Moderna vaccine, Catalent is one of the companies doing whats known in the industry as the fill/finish part of the manufacturing process.

Catalent will be a part of the effort to scale up J&Js manufacturing. They are a last manufacturing step before it heads out to a distributor and a vaccination site that can get it into someones arm.

What that involves is taking the bulk drug substance, formulating that into its final form, sterile filling it into vials doing 100% visual inspection, packaging, and then the final quality control testing, said Mike Riley, region president, biologics, North America for Catalent. These products need to be completely sterile so that whole process is highly controlled and highly validated.

Manufacturing a vaccine needs to be clean and carefully managed. Workers put on sterile garments before they enter a clean room, where they then reach through gloves that go through glass to get into isolator equipment where the sterile vaccine product goes into the glass containers.

The vaccines are inspected and then fly through high speed manufacturing lines conveyors that pass-through label machines that then get packed up into safe cases that get shipped out from there.

Every step is carefully regulated and every step must be kept under a close watchful eye so nothing else can be introduced into the glass vials beyond the vaccine itself.

Its a complex process, Leonard said.

During the pandemic, Catalent, with manufacturing facilities around the world, has worked with more than 80 Covid-19 related compounds from 60 different companies to make antivirals, other treatments and vaccines. It has done this all while continuing to make hundreds of other critical medications to treat everything from cancer to heart disease.

Knowing the demand, it is continually increasing the rate of its production. The company accelerated the expansion of the Indiana facility by about 10 months so that it could have the capacity to produce the vaccines at the scale that is needed.

Activities that sometimes will take place over the course of two or three years, weve been doing over months, Riley said. Construction partners, subcontractors, you know all of them, weve had a really singular focus on how we can accomplish this and get ourselves out of the pandemic.

Catalent also hired a significant amount of staff in the past year, Riley said, to keep up with it. Leonard, was one of those new hires in August. She had never even set foot into the factory before she took the job. She was hired over Zoom.

I jumped in right at the busiest time here ever, Leonard said. Its been a big challenge but it is also very exciting.

Riley said Catalent has been working and planning with vaccine companies about how they would make these vaccines for almost a year now, long before scientists had figured out what a successful vaccine would look like and got authorization from the US Food and Drug Administration.

When we started work with Johnson and Johnson, with Moderna, with others, we anticipated having to ramp up very substantially our production, said Riley. As such, weve been adding significant staff over the past year just to make sure that we can run 24 hours, seven day production once the vaccine was approved.

Riley said that Catalents employees have been doing extraordinary things during a global pandemic.

Im going to quote our chief operating officer. The impossible is not impossible, it just hasnt been done yet, Riley said. Theres no other choice. As an industry, as a country, weve got to find a way out of this pandemic.

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'The impossible is not impossible': The push to make Covid-19 vaccines at record speed - ABC17NEWS - ABC17News.com

To remind herself that hurried work can have consequences, the anonymous virologist I interviewedkeeps a quote on her office wall from Richard Feynman, the Nobel Prizewinning physicist. As a lesson in drug development, she often tells the story of Feynmans devastating conclusions about the 1986 explosion of the space shuttle Challenger. Its set during an inquiry about the disaster. During a famous line of questioning about the dangerous disconnect between the caution of NASAs engineers and the ambition of the agencys management, Feynman took out an O-ring that engineers had identified prelaunch as a part that could fail catastrophically, especially in freezing temperatures. He dropped it in ice water and the part failed. For a successful technology, reality must take place over public relations, Feynman said. For Mother Nature cant be fooled.

Data is king, the virologist says, echoing Feynman. In my field, a drug is either going to work or its not.

Basically, she thinks that Glanville, who has yet to publish any results from his coronavirus research in a major scientific publication, has oversold the importance of discovering antibodies that can neutralize CoV-2 in a dish or a hamster, even though hes succeeded in doing both. In experiments with hamsters, Glanvilles antibodies reduced viral load by 97 percent in rodents that received the drug as a treatment, andeven more than thatwhen they were given prophylactically. The virologist says this is a good start, but it still doesnt demonstrate the ability to neutralize the virus in people;it doesnt show whether the treatment can cause dangerous side effects;and it doesnt reveal how much to give in a dose, where and how the dose should be administered, whether the antibody actually disperses to the parts of the body that harbor the virus, and whether the drug can even be manufactured.

Thats the problem with biology, says the virologist. It gets more and more complicated the deeper you get into drug development. Between the discovery of an antibody, even a potent one, and the development of an actual drug, there isa gauntlet of manufacturing and safety hurdles that, because of the expertise and moneyneeded to navigate them, giant pharmaceutical companies are better equipped to clear. Although Glanvilles team includes researchers with experience shepherding antibodies from discovery to the marketplace, he is having to learn the bureaucracy of drug approval on the fly. His public optimism, the virologist argues, may be dangerously and even cruelly misleading to those outside the industry.

Glanville is now one in a crowded field of researcherstrying to improve antibodies efficacy against COVID-19.By late 2020, there were at least 21 other monoclonal antibodies in some form of clinical trials, including five knocking on the door of FDA approval in phase three. And after watching the mixed success of the leading antibody drug manufacturer, Glanville decidedto stop trying to emulate the front-runners.Regeneron, the multibillion-dollar company whose antibody-based drug was approved for emergency use by the FDA in late November, took all the right steps, but itsdrug is far from the effective cure ithoped it would be. Before the FDA grantedits final approval, early results suggested it could be hugely successful. Because of this, doctors gave an experimental version of it to President Trump, who claimed that it cured him, despite there being no scientific way to know this, since he received several treatments at once.

What has become clear is that Regenerons cocktail, like Eli Lillys drug bamlanivimab, only works well against milder cases of COVID-19. These drugs arent being widely used by hospitals, because when people fall critically ill, even massive doses of the antibodies delivered intravenously do little to revive them.Antibodies only target the virus, and once an infection is established, there is simply too much virus for the administered antibodies to control, and they can do nothing to tamp down the symptoms that ultimately cause death. This fact, plus issues related to storage and cost, explains why many in the industry no longer pin their hopes of taming COVID-19 on antibodies.

That Glanvilles competitors havent been huge successes might seem like a good reason for him to abandon his project. So, too, that by midwinter no agencies or private investors had come forward to fund his efforts, despite almost a full year of persistent, exhausting, and ultimately deflating lobbying efforts. By early March, Glanville estimated hed met withalmost a dozen government agencies funding COVID research, from the Army and Navy to Operation Warp Speed. The Gates Foundation turned him down. So did a handful of other big-dollar foundations. He raised only $9 million, barely enough to get his antibodies through animal trials. The challenge seems to have only hardened his resolve. Reality, he says, is driving him forward. Very rarely in the history of pathogens have we vaccinated enough people worldwide to eliminate them, he says (smallpox being the lone example). COVID is here to stay.

When CoV-2 first infected a person somewhere in rural China, the new bug was far stickier to the ACE-2 receptor. For the virus, its hard to imagine a better evolutionary move. For a human, its hard to imagine one that could be worse.

Glanville maintains that his antibody is one answer. His sales pitch is as convincing as ever: an antibody potent enough that doses can be smaller;capable of beingdelivered in a shot rather than an IV;engineered to cause fewer side effects in the immune-system response than his competitors;and, because it targets a part of the virus that hasnt changed even as the human pandemic has spawned new viral mutations in Brazil, South Africa, and England, effective against new variants. True to his Robin Hood style, Glanville also wants his drug to be widely available and relatively cheap. He has mapped out a sort of Walmart distribution method for his drug, a model in which bulk production will keep the price down. Instead of $2,000 a dose, it will be $800, maybe $900, but certainly less than the cost of an iPhone, he says. (Glanville isnt alone in his pharmaceutical goodwill. AstraZeneca is trying to sell itsvaccine for $4 a dose.) Driving the cost savings for Glanville is smaller overhead30 employees versus 30,000 at a company like Eli Lillyand a novel manufacturing approach. Glanville had a team of interns identify more than 500 companies around the world with bioreactors that are capable of brewing his antibodies. Instead of cooking drugs through in-house bioreactors or subcontractors with restrictive terms, as the big companies have done, his plan is for many hands to make light work. By increasing supply, Glanville will fill the need and lower the costs.

The virologist who asked to remainanonymousis unwaveringly skeptical that this will play out as Glanville is willing it to, especially with so many researchers on pace or way out ahead of him. Skeptical is the safe bet, Glanville said of her take. Odds are we fail.

And that looked to be his antibodys fate. But then, in early February, Glanville got a few pieces of good news. He refused to call them unexpected. The first was that Nature Biotechnology, an esteemed journal in his field, agreed to publish his work on the coronavirus. Andin late February, Merck bought Pandion for $1.9 billion. The significance to Glanville was that Pandion used his patented technologies for some of itsdrug-discovery work. The announcement demonstrates thatantibodies he has designed have clinical value.Most exciting for himis that he is finalizing an agreement with a federal entitywhich he wont nameuntil the deal is finalthat will fund his phase-oneresearch.

Whether his antibody becomes a drug or not, entering the race to find a COVID-19 treatment clarified for Glanville why he got into this businessto help people. To that end, in the first week of January, heand his partners sold Distributed Bioto a much larger pharmaceutical company called Charles River Labs for more than $100 million. Hes since founded a new firm called Centivax that will focus solely onmakingtherapeutic drugs and vaccines and getting the ones hes already developed to market. The time is nigh, he says. This work needs the best version of me possible. As such, at 40, he quit drinking and started swimming in the ocean each day. To get just enough of the altered reality he needs to maintain sanity, he smokes three cigars daily on his rooftop office, looking out over the oceanand thinking about wherethe next bad bug might emerge.

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The Antibody Avenger and the Quest for a COVID-19 Cure - Outside

If a two-year-old child living in poverty in India or Bangladesh gets sick with a common bacterial infection, there is more than a 50%chance an antibiotic treatment will fail. Somehow the child has acquired an antibiotic resistant infection even to drugs to which they may never have been exposed. How?

Unfortunately, this child also lives in a place with limited clean water and less waste management, bringing them into frequent contact with faecal matter. This means they are regularly exposed to millions of resistant genes and bacteria, including potentiallyuntreatable superbugs. This sad story is shockingly common, especially in places where pollution is rampant and clean water is limited.

For many years, people believed antibiotic resistance in bacteria was primarily driven by imprudent use of antibiotics in clinical and veterinary settings. Butgrowing evidencesuggests that environmental factors may be of equal or greater importance to the spread ofantibiotic resistance, especially in the developing world.

Here we focus on antibiotic resistant bacteria, but drug resistance also occurs in types of other microorganisms such as resistance in pathogenic viruses, fungi, and protozoa (called antimicrobial resistance or AMR). This means that our ability to treat all sorts of infectious disease is increasingly hampered by resistance, potentially including coronaviruses like SARS-CoV-2, which causes COVID-19.

Overall, use of antibiotics, antivirals, and antifungals clearly must be reduced, but in most of the world, improving water, sanitation, and hygiene practice a practice known as WASH is also critically important. If we can ensure cleaner water and safer food everywhere, the spread of antibiotic resistant bacteria will be reduced across the environment, including within and between people and animals.

Asrecent recommendations on AMRfrom the Food and Agriculture Organization of the United Nations (FAO), the World Organisation for Animal Health (OIE), and World Health Organization (WHO) suggest, to which David contributed, the superbug problem will not be solved by more prudent antibiotic use alone. It also requires global improvements in water quality, sanitation, and hygiene. Otherwise, the next pandemic might be worse than COVID-19.

To understand the problem of resistance, we must go back to basics. What is antibiotic resistance, and why does it develop?

Exposure to antibiotics puts stress on bacteria and, like other living organisms, they defend themselves. Bacteria do this by sharing and acquiring defence genes, often from other bacteria in their environment. This allows them to change quickly, readily obtaining the ability to make proteins and other molecules that block the antibiotics effect.

Thisgene sharing processis natural and is a large part of what drives evolution. However, as we use ever stronger and more diverse antibiotics, new and more powerful bacterial defence options have evolved, rendering some bacteria resistant to almost everything the ultimate outcome being untreatable superbugs.

Antibiotic resistance has existedsince life began, but has recently accelerated due to human use. When you take an antibiotic, it kills a large majority of the target bacteria at the site of infection and so you get better. But antibiotics do not kill all the bacteria some are naturally resistant; others acquire resistance genes from their microbial neighbours, especially in our digestive systems, throat, and on our skin. This means that some resistant bacteria always survive, and can pass to the environment via inadequately treated faecal matter, spreading resistant bacteria and genes wider.

The pharmaceutical industry initially responded to increasing resistance by developing new and stronger antibiotics, but bacteria evolve rapidly, making even new antibiotics lose their effectiveness quickly. As a result, new antibiotic development has almost stopped because it garnerslimited profit. Meanwhile, resistance to existing antibiotics continues to increase, which especially impacts places withpoor water quality and sanitation.

This is because in the developed world you defecate and your poo goes down the toilet, eventually flowing down a sewer to a community wastewater treatment plant. Although treatment plants are not perfect, they typically reduce resistance levels by well over 99%, substantially reducing resistance released to the environment.

In contrast, over70% of the worldhas no community wastewater treatment or even sewers; and most faecal matter, containing resistant genes and bacteria, goes directly into surface and groundwater, often via open drains.

This means that people who live in places without faecal waste management are regularly exposed to antibiotic resistance in many ways. Exposure is even possible of people who may not have taken antibiotics, like our child in South Asia.

Antibiotic resistance is everywhere, but it is not surprising that resistanceis greatestin places with poor sanitation because factors other than use are important. For example, a fragmented civil infrastructure, political corruption, and a lack of centralised healthcare also play key roles.

One might cynically argue that foreign resistance is a local issue, but antibiotic resistance spread knows no boundaries superbugs might develop in one place due to pollution, but then become global due to international travel. Researchers from Denmark compared antibiotic resistance genes in long-haul airplane toilets and foundmajor differences in resistance carriageamong flight paths, suggesting resistance can jump-spread by travel.

The worlds current experience with the spread of SARS-CoV-2 shows just how fast infectious agents can move with human travel. The impact of increasing antibiotic resistance is no different. There are no reliable antiviral agents for SARS-CoV-2 treatment, which is the way things may become for currently treatable diseases if we allow resistance to continue unchecked.

As an example of antibiotic resistance, the superbug gene, blaNDM-1, was first detected inIndiain 2007 (although it was probably present in other regional countries). But soon thereafter, it was found in ahospital patient in Swedenand thenin Germany. It was ultimately detected in 2013 in Svalbard inthe High Arctic. In parallel,variantsof this gene appeared locally, but have evolved as they move. Similar evolution has occurred asthe COVID-19 virushas spread.

Relative to antibiotic resistance, humans are not the only travellers that can carry resistance. Wildlife, such as migratory birds, can also acquire resistant bacteria and genes from contaminated water or soils and then fly great distances carrying resistance in their gut from places with poor water quality to places with good water quality. During travel, they defecate along their path, potentially planting resistance almost anywhere. The global trade of foods also facilitates spread of resistance from country to country and across the globe.

What is tricky is that the spread by resistance by travel is often invisible. In fact, the dominant pathways of international resistance spreadare largely unknownbecause many pathways overlap, and the types and drivers of resistance are diverse.

Resistant bacteria are not the only infectious agents that might be spread by environmental contamination. SARS-CoV-2 has been found in faeces and inactive virus debris found in sewage, but all evidence suggests water isnot a major routeof COVID-19 spread although there are limited data from places with poor sanitation.

So, each case differs. But there are common roots to disease spread pollution, poor water quality, and inadequate hygiene. Using fewer antibiotics is critical to reducing resistance. However, without also providing safer sanitation and improved water quality at global scales, resistance will continue to increase, potentially creating the next pandemic. Such a combined approach is central to the new WHO/FAO/OIE recommendations on AMR.

Industrial wastes, hospitals, farms, and agriculture are also possible sources or drivers of antibiotic resistance.

For example, about ten years ago, one of us (David) studied metal pollution in a Cuban river andfoundthe highest levels of resistant genes were near a leaky solid waste landfill and below where pharmaceutical factory wastes entered the river. The factory releases clearly impacted resistance levels downstream, but it was metals from the landfill that most strongly correlated with resistance gene levels in the river.

There is a logic to this because toxic metals can stress bacteria, which makes the bacteria stronger, incidentally making them more resistant to anything, including antibiotics. We saw the same thing with metals inChinese landfillswhere resistance gene levels in the landfill drains strongly correlated with metals, not antibiotics.

In fact, pollution of almost any sort can promote antibiotic resistance, including metals, biocides, pesticides, and other chemicals entering the environment. Many pollutants can promote resistance in bacteria, so reducing pollution in general will help reduce antibiotic resistance an example of which is reducing metal pollution.

Hospitals are also important, being both reservoirs and incubators for many varieties of antibiotic resistance, including well known resistant bacteria such as Vancomycin-resistant Enterococcus (VRE) and Methicillin-resistant Staphylococcus aureus (MRSA). While resistant bacteria are not necessarily acquired in hospitals (most are brought in from the community), resistant bacteria can be enriched in hospitals because they are where people are very sick, cared for in close proximity, and often provided last resort antibiotics. Such conditions allow the spread of resistant bacteria easier, especially superbug strains because of the types of antibiotics that are used.

Wastewater releases from hospitals also may be a concern.Recent datashowed that typical bacteria in hospital sewage carry five to ten times more resistant genes per cell than community sources, especially genes more readily shared between bacteria. This is problematic because such bacteria are sometimes superbug strains, such as those resistant tocarbapenem antibiotics. Hospital wastes are a particular concern in places without effective community wastewater treatment.

Another critical source of antibiotic resistance is agriculture and aquaculture. Drugs used in veterinary care can be very similar (sometimes identical) to the antibiotics used in human medicine. And so resistant bacteria and genesare foundin animal manure, soils, and drainage water. This is potentially significant given that animals producefour times morefaeces than humans at a global scale.

Wastes from agricultural activity also can be especially problematic because waste management is usually less sophisticated. Additionally, agricultural operations are often at very large scales and less containable due to greater exposure to wildlife. Finally, antibiotic resistance can spread from farm animals to farmers to food workers, which has been seen inrecent European studies, meaning this can be important at local scales.

These examples show that pollution in general increases the spread of resistance. But the examples also show that dominant drivers will differ based on where you are. In one place, resistance spread might be fuelled by human faecal contaminated water; whereas, in another, it might be industrial pollution or agricultural activity. So local conditions are key to reducing the spread of antibiotic resistance, and optimal solutions will differ from place to place single solutions do not fit all.

Locally driven national action plans are therefore essential which the newWHO/FAO/OIE guidancestrongly recommends. In some places, actions might focus on healthcare systems; whereas, in many places, promoting cleaner water and safer food also is critical.

It is clear we must use a holistic approach (what is now called One Health) to reduce the spread of resistance across people, animals, and the environment. But how do we do this in a world that is so unequal? It is now accepted that clean water is a human right embedded in the UNs 2030Agenda for Sustainable Development. But how can we achieve affordable clean water for all in a world where geopolitics often outweigh local needs and realities?

Global improvements in sanitation and hygiene should bring the worldcloser to solving the problem of antibiotic resistance. But such improvements should only be the start. Once improved sanitation and hygiene exist at global scales, our reliance on antibiotics will decline due to more equitable access to clean water. In theory, clean water coupled with decreased use of antibiotics will drive a downward spiral in resistance.

This is not impossible. We know of a village in Kenya where they simply moved their water supply up a small hill above rather than near their latrines. Hand washing with soap and water was also mandated. A year later, antibiotic use in the village was negligible because so few villagers were unwell. This success is partly due to the remote location of the village and very proactive villagers. But it shows that clean water and improved hygiene can directly translate into reduced antibiotic use and resistance.

This story from Kenya further shows how simple actions can be a critical first step in reducing global resistance. But such actions must be done everywhere and at multiple levels to solve the global problem. This is not cost-free and requires international cooperation including focused apolitical policy, planning, and infrastructure and management practices.

Some well intended groups have attempted to come up with novel solutions, but those solutions are often too technological. And western off-the-shelf water and wastewater technologies are rarely optimal for use in developing countries. They are often too complex and costly, but also require maintenance, spare parts, operating skill, and cultural buy-in to be sustainable. For example, building an advanced activated sludge wastewater treatment plant in a place where 90% of the population does not have sewer connections makes no sense.

Simple is more sustainable. As an obvious example, we need to reduce open defecation in a cheap and socially acceptable manner. This is the best immediate solution in places with limited or unused sanitation infrastructure, such asrural India. Innovation is without doubt important, but it needs to be tailored to local realities to stand a chance of being sustained into the future.

Strong leadership and governance is also critical. Antibiotic resistance ismuch lowerin places with less corruption and strong governance. Resistance also is lower in places with greater public health expenditure, which implies social policy, community action, and local leadership can be as important as technical infrastructure.

While solutions to antibiotic resistance exist, integrated cooperation between science and engineering, medicine, social action, and governance is lacking. While many international organisations acknowledge the scale of the problem, unified global action is not happening fast enough.

There are various reasons for this. Researchers in healthcare, the sciences, and engineering are rarely on the same page, and expertsoften disagreeover what should be prioritised to prevent antibiotic resistance this muddles guidance. Unfortunately, many antibiotic resistance researchers also sometimes sensationalise their results, only reporting bad news or exaggerating results.

Science continues to reveal probable causes of antibiotic resistance, which shows no single factor drives resistance evolution and spread. As such, a strategy incorporating medicine, environment, sanitation, and public health is needed to provide the best solutions. Governments throughout the world must act in unison to meet targets for sanitation and hygiene in accordance with the UN Sustainable Development Goals.

Richer countries must work with poorer ones. But, actions against resistance should focus on local needs and plans because each country is different. We need to remember that resistance is everyones problem and all countries have a role in solving the problem. This is evident from the COVID-19 pandemic, where some countries have displayedcommendable cooperation. Richer countries should invest in helping to provide locally suitable waste management options for poorer ones ones that can be maintained and sustained. This would have a more immediate impact than any toilet of the future technology.

And its key to remember that the global antibiotic resistance crisis does not exist in isolation. Other global crises overlap resistance; such as climate change. If the climate becomes warmer and dryer in parts of the world with limited sanitation infrastructure, greater antibiotic resistance might ensue due to higher exposure concentrations. In contrast, if greater flooding occurs in other places, an increased risk of untreated faecal and other wastes spreading across whole landscapes will occur, increasing antibiotic resistance exposures in an unbounded manner.

Antibiotic resistance will also impact on the fight against COVID-19. As an example, secondary bacterial infections are common in seriously ill patients with COVID-19, especially when admitted to an ICU. So if such pathogens are resistant to critical antibiotic therapies, they will not work and resultin higher death rates.

Regardless of context, improved water, sanitation, and hygiene must be the backbone ofstemming the spread of AMR, including antibiotic resistance, to avoid the next pandemic. Some progress is being made in terms of global cooperation, but efforts are still too fragmented. Some countries are making progress, whereas others are not.

Resistance needs to be seen in a similar light to other global challenges something that threatens human existence and the planet. As with addressing climate change, protecting biodiversity, or COVID-19, global cooperation is needed to reduce the evolution and spread of resistance. Cleaner water and improved hygiene are the key. If we do not work together now, we all will pay an even greater price in the future.

David W. Graham is a Professor of Ecosystems Engineering at Newcastle University. Davids work combines methods from engineering, theoretical ecology, mathematics, biochemistry, and molecular biology to solve problems in environmental engineering at a fundamental level.

Peter Collignon is a Professor of Infectious Diseases and Microbiology at the Australian National University. Particular interests are antibiotic resistance (especially in Staph), hospital acquired infections (especially blood stream and intravascular catheter infections) and resistance that develops through the use of antibiotics in animals. Peter can be found on Twitter @CollignonPeter

A version of this article was originally published at the Conversation and has been republished here with permission. The Conversation can be found on Twitter @ConversationUS

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Fighting the next pandemic: Antibiotic resistance - Genetic Literacy Project

SOUTH SAN FRANCISCO, Calif. & BOULDER, Colo.--(BUSINESS WIRE)--Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, and Watchmaker Genomics today announced a broad partnership to enable innovative research across a wide range of high throughput sequencing applications including oncology and tumor profiling, inherited disease detection, liquid biopsy assays, and minimal residual disease monitoring.

In their first product offering together, Twist will leverage Watchmakers expertise in enzyme engineering by incorporating the companys high-fidelity library amplification master mix into Twists enzymatic library preparation kit, providing a superior solution that can be accessed from Twist as a single source.

With our eye squarely on working in service of our customers, this partnership brings together two teams relentlessly focused on innovation and execution to provide superior products, said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. By pairing superior enzymes with best-in-class DNA, we expect to offer differentiated products that simplify and streamline workflows before putting samples on the sequencer.

This is the first in what we believe will be a series of joint product development opportunities between Twist and Watchmaker aimed at driving continued improvement in performance and data quality for high-resolution genomic applications including NGS-based cfDNA and ctDNA studies, single-cell work, low allele somatic variant detection and tumor mutation burden, said Trey Foskett, co-founder of Watchmaker. In addition, we look forward to bringing our protein engineering technologies into the product mix to fuel new avenues of research across many disease areas.

About Watchmaker Genomics

Watchmaker Genomics applies advanced enzymology to enable breakthrough applications for the reading, writing, and editing of DNA and RNA. The company combines deep domain expertise in protein engineering with large-scale enzyme manufacturing to address the demanding quality, performance, and scale requirements of high-growth genomics applications.

Watchmakers product portfolio includes enzymes and kits for next-generation sequencing library preparation, synthetic biology, and molecular diagnostics. Based in Boulder, Colorado, Watchmaker Genomics is co-founded by Trey Foskett, Brian Kudlow, and Stephen Picone. The team brings decades of collective experience building successful life science companies, commercializing novel technologies, and advancing clinical genomics applications. Watchmaker partners directly with innovative life science companies, commercial sequencing providers, and pioneering research labs. For more information, visit http://www.watchmakergenomics.com

About Twist Bioscience Corporation

Twist Bioscience is a leading and rapidly growing synthetic biology and genomics company that has developed a disruptive DNA synthesis platform to industrialize the engineering of biology. The core of the platform is a proprietary technology that pioneers a new method of manufacturing synthetic DNA by writing DNA on a silicon chip. Twist is leveraging its unique technology to manufacture a broad range of synthetic DNA-based products, including synthetic genes, tools for next-generation sequencing (NGS) preparation, and antibody libraries for drug discovery and development. Twist is also pursuing longer-term opportunities in digital data storage in DNA and biologics drug discovery. Twist makes products for use across many industries including healthcare, industrial chemicals, agriculture and academic research.

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Legal Notice Regarding Forward-Looking StatementsThis press release contains forward-looking statements. All statements other than statements of historical facts contained herein, including Twist and Watchmaker entering into a definitive agreement with respect to the partnership and the ability of the partnership to offer differentiated products that simplify and streamline workflows, to improve performance and data quality for genomic applications and to fuel new avenues of research across many disease areas, are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause Twist Biosciences actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties of the ability to attract new customers and retain and grow sales from existing customers; risks and uncertainties of rapidly changing technologies and extensive competition in synthetic biology could make the products Twist Bioscience is developing obsolete or non-competitive; uncertainties of the retention of a significant customer; risks of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Twist Biosciences patents or proprietary rights; and the risk that Twist Biosciences proprietary rights may be insufficient to protect its technologies. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Twist Biosciences business in general, see Twist Biosciences risk factors set forth in Twist Biosciences Quarterly Report Form 10-Q filed with the Securities and Exchange Commission on February 9, 2021 and subsequent filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Twist Bioscience specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

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Twist Bioscience and Watchmaker Genomics Announce Partnership to Drive New Applications of High-throughput Genetic Sequencing - Business Wire

This article is by Featured BloggerJos Morey from hisblogpage.Republished with the authors permission.

December 31, 2019 is a day that will live in infamy. On this day, a pneumonia of unknown origin in the Hubei province of China was reported to the World Health Organization (WHO). We did not know it then, but this would be the day that the world would change. At the time of writing this article, there have beenmore than 4 million confirmed casesand nearly 300,000 confirmed deaths worldwide.

This global enemy, which we have learned to call COVID-19, has ravaged lives, regardless of age, creed or socioeconomic status. It has causedeconomic turmoiland hasdisrupted the livesof almost every human across the globe.

The impact that an entity approximately120 nanometers in diameter-- approximately 1/100th the diameter of a human hair -- can have on the world is remarkable. But as indelible a mark as the virus has had, so too has been the call to arms by the scientific community. Every generation tends to be called to rise to a great challenge, and the response of this generation of scientists, technologists, engineers and mathematicians will shape the future of humanity and health more than SARS-CoV-2 itself.

As mentioned in a recentarticleon Forbes, the mobilization of biotechnology is similar to the allies storming the beaches on D-Day. Just like that fateful day, the attack on coronavirus is multipronged. There are new-generation vaccine methods, such as synthetic peptide-based vaccines and nucleic acid-based vaccines, that are genetically engineered.Retrovirals, diabetic medications, immunologic drugs, antibiotics and even anticoagulants have all been proposed to combat the pandemic. By the last count,over 250 medicationsare being evaluated at various stages.

Before the Defense Research Advanced Projects Agency's (DARPA) support of this work in 2011, the concept of engineering vaccines into DNA strands was at the edge of science. This allows the immune system to generate proteins directly. Prior to this, conventional vaccines were created by inducing an immune response by introducing antigens into the body. Now, many of the vaccines that are being evaluated are using the more novel approach, includingModernasvaccine, the first to enter phase one human trials, andInoviosvaccine, scheduled to enter trials this summer.

But newer, even more audacious biotechnological solutions are currently underway by DARPA in a project they're callingCOVID-19 Shield,as part of the Pandemic Protection Platform. The cutting-edge concept is to harvest B cells from survivors of the disease and replicate and mass produce them via genetic engineering. This concept, if successful, could potentially mitigate any future potential pandemic in a matter of weeks and allow time for a vaccine to be developed while maintaining a flat infection curve.

However, DARPA is not the only group actively seeking solutions. There are myriad others, including the Biomedical Advanced Research and Development Authority (BARDA), which is seeking both low and high technology readiness level (TRL) solutions through a broad agency announcement (BAA). This includes a large vaccinecontract with J&Jworth over $1 billion andfast-tracking an IL-6 inhibitor by Actemra that could mitigate the lung manifestations of COVID-19.

This joins several other immune-mediated drug therapies to attempt to ameliorate the suspect cytokine storm cascade that occurs in more severe cases. BARDA is also reviewing advances from the pinnacle of bioengineering by exploring the use ofextremophiles for drug therapies.

Then there is theCOVID-19 Open Research Dataset (CORD-19),a multi-institutional initiative that includes The White House Office of Science and Technology Policy, Allen Institute for AI, Chan Zuckerberg Initiative (CZI), Georgetown Universitys Center for Security and Emerging Technology (CSET), Microsoft, and the National Library of Medicine (NLM) at the National Institutes of Health (NIH).

The goal of this initiative is to create new natural language processing and machine learning algorithms to scour scientific and medical literature to help researchers prioritize potential therapies to evaluate for further study. AI is also being used toautomate screeningat checkpoints byevaluating temperaturevia thermal cameras, as well as modulations in sweat and skin discoloration. What's more, AI-powered robots have even been used to monitor and treat patients. In Wuhan, the original epicenter of the pandemic, an entire field hospital was transitioned into a smart hospital fully staffed by AI robotics.

Any time of great challenge is a time of great change. The waves of technological innovation that are occurring now will echo throughout eternity. Science, technology, engineering and mathematics are experiencing a call to mobilization that will forever alter the fabric of discovery in the fields of bioengineering, biomimicry and artificial intelligence. The promise of tomorrow will be perpetuated by the pangs of today. It is the symbiosis of all these fields that will power future innovations.

December 31, 2019 is a day that will always be remembered. Currently, the day is known as the beginning of a disruption to our lives that few -- if any -- have ever experienced, but none shall ever forget. However, as time passes and life begins anew, I believe it will be remembered for a different reason. It will be remembered as the day science and technology went to war. A day in which humanity united to unleash the full capacity of scientific innovation on anenemy that was indiscriminate to race, religion or creed. And on that fateful day, in our darkest hour, science shined brightest. And in science we trust.

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Technology In A Time Of Crisis: How DARPA And AI Are Shaping The Future - Straight Talk

Transitional shelters have proven to be cost-effective over time if implemented correctly

Strengthening resilience to climate-related hazards is an urgent target of Goal 13 of the United Nations-mandated Sustainable Development Goals (SDG).

Stocking emergency supplies or preparing a family evacuation plan can substantially minimise loss and damages from natural hazards. However, the level of preparedness among households is often low even in disaster-prone areas.

Studies have shown that human suffering and other damage do not end with the event itself. Therefore, there is a need to focus on the complicated process of recovery and reconstruction in the months and years following a disaster.

Amid the pandemic

Cyclone Amphan, which caused massive destruction in West Bengal and adjacent areas, intensified rapidly on May 17, 2020 to become a super cyclonic storm of category 5. It, however, weakened to category 3 before making a landfall on May 20.

The devastating cyclone came at a time when people were struggling with surging cases of the novel coronavirus disease (COVID-19). Lockdowns and travel restrictions during the COVID-19 pandemic complicated the response and evacuation process during the disaster.

The challenge was to protect the vulnerable people within the emergency shelters from Cyclone Amphan as well as COVID-19. Most of them were craving for their basic rights of food, shelter and clothing.

Implementation of shelter and toilet rebuilding programme is an immediate need to let them survive.

The process of building resilience requires systematic methods which can be implemented through community interactions to understand the context of their living conditions. Awareness campaigns to understand the purpose of each individual and sensible living facility like eco-friendly shelters and toilets can facilitate the return to normalcy.

Long-term solutions from temporary shelters

Transitional shelters, built for survivors of natural disasters, are unable to hold up against intensifying calamities and the advanced construction technologies are yet to penetrate the population living in acute poverty in West Bengal.

Over the years, use of concrete materials and better technologies in transitional shelters, has made these dwellings stronger against cyclones. The concept, however, is taking time to get widely accepted.

The adaptation of transitional shelters can provide an important insight into cyclone preparedness and resilience and can help develop a community-based approach for disaster management.

Transitional shelter, being an incremental process rather than a multi-phased approach, needs acceptance. Such rapid, post-disaster shelters are made from materials that can be upgraded or re-used in more permanent structures, or can be relocated from temporary sites to permanent locations.

Transitional shelters have proven to be cost-effective over time if implemented correctlyand provide good opportunities for scaling-up by using common, local and regional materials. With building transitional shelters comes in meaningful engagement with affected communities /individuals. This ensures design and implementation is context-appropriate and the needs of marginalised and vulnerable groups are considered.

However, knowledge of good, safe building practices is inculcatedso thathouses incorporate disaster risk reduction measures. Pressure should not be taken off permanent housing reconstruction effort. The integration of other sectors or issues such as livelihoods, Water, Sanitation and Hygiene (WASH) and transport, is important for the success of the transition.

There are several ways to boost infrastructure resilience. Hazards can be addressed partially through the widespread deployment of green infrastructure, while preventing the development of grey infrastructure.

Energy resilience can be enhanced through the development of distributed renewable power such as rooftop solar installations. The primary need is avoiding water pollution.

The practice of setting up toilets right beside ponds can be replaced with ecological sanitation toilets. Manure collected from these units can also help the local community in irrigation.

Community engagement for effective recovery

Delivering shelter-recovery programmes is complex and often subject to significant competing interests and obstacles. The needs of women, girls, men and boys and that of different households can vary significantly.

A one-size-fits-all shelter design has limited flexibility to meet these needs. Governments and non-governmental organisations should greatly strengthen their approaches to community engagement in shelter projects, with the aim to improve community ownership of projects and individual ownership of shelters.

Future programmes should aim to empower people to take charge of their own shelter recovery, including giving them meaningful control and choices over shelter design and construction, hence leading to improved outcomes overall.

To do so, developing a communal understanding of the different risks disaster-affected people face and ensuring they have the knowledge to make choices about these risks is required. This will require strong community engagement and technical support capacity.

Any future climate adaptation strategy needs to account for material needs of the most vulnerable communities, prioritising the building of a social safety net that will enable them to resume their livelihoods and continue to live with dignity.

Moreover, among the various stakeholders that build and carry community resilience are government, grassroots organisations and volunteer networks. These stakeholders are those who understand the local community and show up in solidarity at the hour of need, as disasters around the world have shown time and again.

Yezdani Rahman is the chief of programmes,Sustainable Environment and Ecological Development Society(SEEDS).

Views expressed are the authors own and dont necessarily reflect those of Down To Earth.

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Cyclone Amphan: Building back with resilient infrastructure and community engagement - Down To Earth Magazine