Category Archives: Transhuman News

GMO has been around for a while now, and it has continued to be the rave. Scientists have long learned to alter the genes of plants to favour the development of some traits in these plants.

When you hear about GMOs for the first time, it is possible that you have questions concerning them. What exactly is GMO? How does it affect the surrounding plants?

Are there plants that are resistant to its effects? Are there any negative effects of growing genetically modified crops? What are the short-term and long-term effects on insects, biodiversity, and the ecological environment?

The answers to these questions would become evident to you as you read on.

GMO stands for Genetically Modified Organisms. GMOs are organisms whose genes and genetic behaviors have been altered with the help of genetic engineering.

In case you were wondering what genetic engineering is, it simply involves modifying the phenotype of an organism by reconstructing its genetic makeup. Most of the time, GMOs come about through mating or the recombination of genes.

Genetic engineering has since pervaded agriculture with crops being genetically modified. The aim of genetic modification of crops is to make the plants more resistant to diseases, pests, chemical treatments, or environmental conditions.

Some other crops are genetically modified to make them more nutritious. A common example of a crop that was genetically modified to increase its nutritional value is golden rice.

The need for genetically modified crops soared when pesticides were deemed incapable to adequately control yield-diminishing pests. Not all insects on a farm are villains.

Some actually have their advantages. The majority of them, however, never have good plans for crops. When you use pesticides on these crops, they kill all insects, including the good and bad ones. Usually, this is not what farmers want.

They want the good insects to remain and the bad ones to go. Also, spraying crops with pesticides could have negative effects on the crops themselves. With these major disadvantages of pesticides, the need for something better increased. Something that would kill the pests but not the good insects. That is how the need for genetically modified crops arose.

It used to be that the genetically modified crops had their protein manufacturing system modified so that a kind of protein that was previously absent in the crops were added. This protein is one that is harmful to select insects.

The genetic engineering of these plants is such that when pests eat crops that contain this harmful protein, it ruptures their stomach and kills them. And while these crops are terminal to pests, they dont affect insects and have some other advantages too.

However, this use of genetically modified crops came under a heavy debate when questions on the effects of these crops on humans popped up.

The solution to that came in the form of RNA modified crops. The genetic modification of crops is such that the crops can produce RNA fragments. These RNA fragments get into pests and target the genes responsible for reproduction or for life in them.

The result is that the pests are either killed or rendered incapable of reproducing. Ralph Bock, a director at a renowned institution in Germany, Max Planck Institute of Molecular Plant Physiology, had something to say about this method.

He said, RNA interference-based pest control can provide protection at essentially no cost because once the variety is developed, the plant can just go on using it instead of needing additional applications of insecticide.

This way, controlling pest infestation becomes a lot more effective.

GMO have delivered the desired effects on both insects and critters. The ones we dont want feeding on our crops are either being killed or being rendered impotent by the genetically modified crops.

Also, genetically modified crops dont affect other insects, animals, and organisms whose presence on our farms is not detrimental. And when humans consume them, they do not exhibit negative developments because of them.

However, this is actively affecting biodiversity and in no time, some insects might go extinct. Given that the RNA fragments target the genes responsible for reproduction or life, before the insects that are responsible for affecting the crops die off, they are unable to reproduce and bring forth another generation.

This also affects the food chain. Some insects depend on feeding on a particular species of insects to survive. If these insects are no longer available or are very scarce, they would have to go some lengths to find food and in due time, they would begin to die off.

Most people might think that these effects are insignificant, however, it could have a huge impact on the ecological environment in general.

The onus is therefore on scientists to discover other ways of pest control that does not involve wiping out an entire species.

Also, rendering the insects impotent is a clear call for extinction. Instead, the spread of these insects can be controlled or the plants can be modified to not seem attractive to the insects anymore.

The effects of GMO can be pretty harsh and they bear long-term effects that most people havent considered and thought through. For instance, some of the good insects on farms are there to consume undesirable ones, and their effect may be two-fold. They prevent the undesirables from destroying the plants and they may aid pollination or some other essential process as well.

These are essential life processes that the use of GMOs may be altering, and the bottom line, maybe GMOs arent as great as most people think.

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How Does GMO Affect the Insects Around Us? - iharare.com

Releasing mosquitoes into the corridors of apartment complexes might seem like an unusual strategy for a city fighting its worst recorded outbreak of dengue, a painful disease spread between humans by mosquitoes. But the thousands of little insects discharged last week werent your average mosquitoes.

They were bred in a laboratory to carry a substance not commonly found in this type of mosquito: bacteria called Wolbachia. When the bacteria-laden male mosquitoes are released into the open and mate with naturally-born females, the resultant eggs wont hatch.

The outcome is reduced number of dengue cases in the areas where the lab-bred insects were released, according to Singapores government.

Scientists and governments are expanding high-tech solutions like these as the threat from the dengue virus grows. Some are using genetically engineered mosquitoes; others are zapping them with X-ray beams to sterilize them.

The World Health Organization says roughly half the worlds population is at risk of catching dengue, a viral infection that causes an intense flulike illness that is sometimes lethal. Growing urbanization and bulging cities have given mosquitoes vast human populations to feast on. Reported cases of the disease increased from about 500,000 in 2000 to 4.2 million in 2019, with tropical countries such as Brazil, Indonesia and the Philippines especially hard-hit.

Global warming could spread the disease further as both dengue-carrying mosquitoes and the virus itself thrive in warmer climates.

Dengue is transmitted by the female Aedes aegypti mosquito, which also spreads other diseases like Zika, which can cause severe birth defects when pregnant women are infected, and chikungunya, which causes fever and joint pain. Public-health campaigns have traditionally focused on simple solutions, such as encouraging people to empty stagnant water from household objects such as vases, pails and watering cans, where mosquitoes lay eggs. Insecticides are also used in dengue-prone areas.

But mosquitoes have developed immunity against common insecticides and dengue cases are rising globally. That is why scientists turned to altering or modifying the mosquitoes themselves.

In Singaporewhich has long suffered from dengue outbreaksspecialized mosquito-breeding began with mosquito eggs shipped from Michigan. A team led by Zhiyong Xi, a professor at Michigan State Universitys Department of Microbiology and Molecular Genetics used long, thin glass needles to inject Wolbachia into mosquito eggs, resembling tiny grains of dirt, that had been laid 90 minutes before. Upon hatching, the larvae also contained the bacteria.

That first generation passed the Wolbachia bacteria on to its descendants, birthing a new line of bacteria-infused mosquitoes whose eggs were shipped to Singapore to found the city-states colony.

Before the offspring could be released, the females needed to be separated from the males, which dont bite or transmit the dengue virus. Sex-sorting is critical because Singapores program hinges on mating males that contain the bacteria with females that dont. If both sexes carried the bacteria, the mosquitoes would successfully procreate, thwarting the programs goal of reducing the local mosquito population.

A machine developed by Verily, an Alphabet Inc. company focused on life sciences, uses automated mechanical sieves to separate female mosquito pupaewhich are generally largerfrom male ones. This step removes about 95% of females, the company says.

A computer vision system is used to identify any females the sieve may have missed. The system looks for the females distinct proboscis or mouth, antenna and other anatomical clues, flagging it for removal. Verily says substantially fewer than one in a million mosquitoes it releases is female, keeping Wolbachia from being inherited in the wild mosquito population.

Not all Wolbachia mosquitoes released in Singapore are sieved through Alphabets machine. Others are subjected to low-dose X-ray irradiation using a specific methodology Singapore developed in collaboration with the International Atomic Energy Agency. The irradiation sterilizes female mosquitoes, so that any that are inadvertently released will be unable to reproduce and spread Wolbachia to future generations.

Singapores government says that in parts of the city where its males have been released there were 65% to 80% fewer dengue cases compared with areas where the mosquitoes werent released. Mosquitoes are now being discharged in 5% of the citys public housing blocks. The releases are slated to expand to 15% of them by 2022.

Other programs want the Wolbachia to be inherited widely in wild populations. That is because those programs have found that the bacteria has another feature: It strongly reduces the Aedes aegypti mosquitoes ability to transmit dengue to humans.

The World Mosquito Program, a nonprofit active in a dozen countries in Asia, the Pacific and Latin America, released lab-bred bacteria-containing mosquitoesboth male and femalein the city of Yogyakarta in Indonesia. It counted on the fact that female mosquitoes will produce offspring that also have the bacteria, meaning the dengue-blocking feature is passed down.

Its trial showed a 77% reduction in dengue cases in areas where the mosquitoes were released compared with areas where they werent, the nonprofit said in August.

This method is much simpler than Singapores technique, which involves complex sex-sorting. But some scientists say releasing females with Wolbachia is potentially irreversible. If the Wolbachia turns out to have unintended consequences, it would be very difficult to extract the bacteria from the mosquito population, they say.

One laboratory study found that carrying Wolbachia enhanced the infection rate of West Nile virus in the Culex tarsalis species of mosquito, which is endemic to North America. Its a big black box," said Jason Rasgon, professor of disease epidemiology at Pennsylvania State University, arguing more research should be done on Wolbachias effects on the transmission of other diseases before further large-scale releases.

Cameron Simmons, a director at the World Mosquito Program, said many governments have conducted risk-assessments of its approach. On balance Wolbachia represented a negligible risk compared to doing nothing," he said.

One company is going in a different direction altogether: genetic engineering. Oxitec, a U.S.-owned biotechnology company with research bases in the U.K. and Brazil inserts a new gene in eggs that makes female mosquitoes die shortly after hatching while they are still in the larval stage of development.

Last year, Oxitec conducted a trial of its latest gene-modified version, which it calls OX5034, in Indaiatuba, Brazil, near So Paulo. For the trial, the company produced OX5034 eggs at a factory in Brazil and distributed them at release points around the municipality. When the eggs hatched, the females died before they could become adults capable of flying and biting.

The males, which reached adulthood, mated with local wild females, passing along the female-killing genes, reducing Aedes aegypti mosquito numbers by about 95%, Oxitec said.

The company received U.S. federal approvals in May for pilot releases in Florida, which the company expects to begin next year.

Oxitec says the genes they have added are self-limiting, which means that after a few generationsabout three to four monthsthe female-targeting gene is bred out of the species. Municipalities that wish to continue with the approach would carry on releasing OX5034 eggs to keep the mosquito population in check, it said, and those that dont would still have an off-ramp.

Jeffrey Powell, a biology professor at Yale University, sees drawbacks to the gene-modification approach. He said the need for periodic rereleases would get expensive, and over time wild mosquitoes may adapt to avoid mating with Oxitecs genetically doomed males. There is no evidence it is doing anything bad," he said of the genes Oxitec has introduced into mosquitoes. Its a complete unknown." He said he felt more comfortable with the use of Wolbachia, which is found naturally in many mosquito species.

Oxitec says it has released about one billion mosquitoes in the past decade and has no evidence female mosquitoes selectively mate with non-Oxitec males.

Theres no ecological footprint; theres no persistence," said Kevin Gorman, who heads field operations for Oxitec. Its not going to permanently change the environment at all."

Write to Jon Emont at jonathan.emont@wsj.com

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How to fight the deadly dengue virus? Make your own mosquitoes - Livemint

Precision and personalised medicines are more than products, they are services in their own right. So, how should pharma approach this uncharted territory to ensure targeted therapies work for patients?

Personalised and precision medicines are exciting fields that focus on the development of treatment and prevention strategies for a single patient or patient group. The treatments are developed using cutting- edge technologies such as genomic sequencing and genetic engineering, helping to account for the individual variability in both patient and disease characteristics.

This has gained a lot of attention in recent years due to revolutionary breakthroughs in debilitating chronic diseases such as cancer. Traditionally, cancer patients are treated using one size fits all interventions like chemotherapy, radiotherapy and surgery. These vary in their effectiveness and result in damage to healthy tissues.

Personalised and precision medicine, however, can offer specialised treatments that target the patients unique cancer subtype, its genetic mutations, and the affected tissues.

These therapies involve novel pathways and complex processes to aid and deliver treatment, making each therapy a service in its own right. They depend on many touchpoints, stakeholders, partnerships and interdependencies to treat patients.

As a result, designing suitable services to support patients, caregivers and healthcare providers throughout the treatment pathway is essential. However, doing so successfully depends on understanding how to best approach the design of services in this challenging landscape.

Optimising the service behind the personalised and precision medicine is crucial for turning the treatment into a viable and differentiated option for patients. To make a real difference and ensure the therapy is competitive, we need to adopt a service design approach.

Service design is a multidisciplinary art and science that enables us to take a holistic view of the service experience, along with a deep understanding of the target groups, such as patients and healthcare professionals, and the context they operate in. This can include using empathic methodologies, such as in-depth interviews and field studies.

Gaining a comprehensive understanding of the customers needs, how they experience the current service, and how future services address their unmet needs.

Involving different stakeholders throughout the design process to gain a wide range of knowledge and expertise, and to further drive customer-centricity across the business.

Using visual tools such as sketches, maps and prototypes to improve and ease communication and collaboration between the different stakeholders involved in the creative process (surpassing language and knowledge boundaries).

Following a learning-by-doing approach via continuous prototyping and testing to evaluate solutions before investing time and resources on development.

Understanding how the customer experiences the whole service journey and then identifying insight gaps and opportunities for service innovation by looking at the big picture.

Personalised and precision medicines are naturally patient-centred (compared to traditional pharmaceuticals), as the individual patient is central to the product design. Taking this empathic approach throughout the design process provides a deeper understanding of those needs as well as their context.

This means not only adopting collaborative thinking during the design phase but also during production and development.

To deliver these unique therapies to patients, pharmaceutical companies must partner with a wide range of specialised third parties including laboratories, manufacturers, shipping and storing providers.

Looking at the entire service and all of its touchpoints from above is crucial

By engaging with multidisciplinary teams from all levels across the organisation, as well as numerous stakeholders during the co-creation process, you will increase the organisations knowledge and expertise, resulting in better and more fit-for-purpose solutions. Bring this sense of collaboration into the design process to encourage a higher level of consistency, placement and commitment to the patient and ensure they are at the centre of the service philosophy.

Novel therapies require designers to be adaptive. New developments such as changes in the supply chain, shorter genomic sequencing process or the need for an additional quality assurance step, often lead to changes to the envisaged treatment pathway. As a result, it is necessary to have a view of the whole service, in one place, which can be continuously updated.

Visual tools such as customer journey maps and service blueprints are a core part of service design. Journey maps (such as the one featured on p.16) provide an overarching view of the customer experience, along with the pain points, gaps, unmet needs and opportunities for engagement. Service blueprints visualise the process behind the service and the people impacted by it. These tools not only make it easier to understand the service, but they can also help simplify communication and increase alignment between the many individuals engaged in the project.

For personalised and precision medicines, patient journeys and service blueprints can help capture the front-end of the service, which is visible to patients, and the back-end processes, which are used by healthcare professionals. This gives us insights into the interactions, touchpoints and relationships between the patient and various stakeholders, such as the different healthcare professionals, carers and patient groups. Looking at the entire service and all of its touchpoints from above is crucial for making improvements that enrich the customer experience.

CAR-T is a new individualised cancer immunotherapy that has taken precision medicine to a new level. In a nutshell, CAR-T therapy involves extracting T-cells (a type of white blood cells that play a key role in immune response) from the patient, genetically engineering them to target the cancer cells and infusing them back into the patients body.

The CAR-T treatment pathway for a blood cancer involves a uniquely large number of stakeholders, touchpoints and interdependent processes that take place both in the front-end (i.e. visible to the patient) and back-end (i.e. visible to healthcare professionals). Below is a high- level overview of a typical CAR-T journey that can illustrate this complexity:

1. After the patient has identified as a suitable candidate for CAR-T therapy, they are referred by their primary oncologist to a specialised treatment centre to further assess treatment eligibility

2. Once eligibility has been established, the patient undergoes leukapheresis to extract T-cells

3.The samples are sent to a separate facility where they are frozen and prepared for shipping

4. The cells are then sent to a manufacturer where they are genetically engineered to target the patient's cancer cells and multiplied - to create the CAR-T product

5.The product needs to be shipped back to the treatment centre and stored frozen until the patient is ready for infusion

6. The shipping and manufacturing processes can take 34 weeks, during which the patient receives bridging therapy (to slow down disease progression)

7.A few days before the infusion, the patient undergoes lymphodepleting chemotherapy to prepare their body

8. After the infusion, the patient needs to be closely monitored for side effects for 1-3 weeks. Some side effects (e.g. Cytokine Release Syndrome) can require hospitalisation

9. The post-infusion period involves continuous tumour assessment and long-term follow-up

We recently pitched to a pharmaceutical company preparing to launch their new CAR-T therapy to help them design a set of patient-and caregiver-supporting services. We quickly became aware ofthe complicated nature of this therapy and decided to kick off by mapping the treatment pathway and the actors involved.

We normally kick off this type of project by conducting primary research with customers (using empathic methodologies) to generate insights that can inform the journey design. However, due to its novelty, it was difficult to access patients who have recently undergone CAR-T therapy. Instead, we carried out in-depth interviews with different types of stakeholders who had considerable experience working on early CAR-T therapies and clinical trials. This gave us insights into the healthcare professionals experience and visibility into the back-end processes.

The insights we gathered allowed us to understand the experience of patients and their caregivers. We could identify their emotional, practical and information-related needs and highlight the pain points that need to be addressed by the future services.

We also created empathy maps, another tool from the service design toolkit, to visually articulate what we know about the customers.

Once we completed the CAR-T patient and caregiver empathy maps, we created the CAR-T journey. The process relied heavily on co-creation by gathering input from key collaborators from the client company, including both medical and commercial personnel.

The continuous consolidation of insights from primary research, secondary research and stakeholder research was highly iterative. This ensured that the journey captured the envisaged treatment pathway in an accurate and comprehensible manner and that we were able to identify insight gaps as they emerged. From there we could then initiate the required steps to address them through additional research.

When executed correctly, a good customer journey is also adaptive and can be re-worked to reflect the changes that naturally occur over time. This is particularly important for journeys that have beencreated pre-launch and need to be revised, post-launch, to align with the emerging reality of the treatment, and for dealing with complicated treatments that are prone to nuanced changes. Both of these scenarios were true in the case of the CAR-T treatment.

The patient journey can also be used in collaborative design workshops with the client and their partners, as it successfully communicates a complicated pathway in a structured, easily digestible visual manner. It acts as a common language that different collaborators from different roles and backgrounds can use to achieve a shared understanding of the envisaged process and the end-to-end customer experience.

Last and perhaps most importantly it can be used to inform and generate new service ideas collaboratively using the journey as a stimulus, by focusing on key pain points and unmet needs.

This type of work is not possible without service design methodologies. These tools enable a diverse group of professionals from different roles and companies to come together and benefit from holistic, visual, customer-centred tools like empathy maps and customers journeys that make iteration and co-creation possible.

To find out how we can help you design a service for a complex medicine, contactsimon.young@fishawack.com

If you would like to request a free, full copy of our CAR-T Service experience map (snippet pictured above) please get in touch withnatasha.cowan@fishawack.com

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In the precision medicine era, the line between products and services is blurred - PMLiVE

Jalna-based Beej Sheetal Research Pvt Ltd will commence the second stage biosafety research trials (BRL-II) for Bt Brinjal from April 2021, said the company chairman Suresh Agarwal.

Beej Sheetal has to carry out trials in at least two of the eight states for which it has received approval by the Genetic Engineering Appraisal Committee (GEAC) recently.

GEAC has approved BRL-II trials for Beej Sheetals two transgenic Bt Brinjal Hybrids called Janak and BSS-793.

Jalna district in central Maharashtra is known as the seed hub of the State because a large number of seed companies are located there. The dry climate of the district is most conducive for seed farming and storage.

Agarwal told BusinessLine that Beej Sheetal along with its sister concern Kalash Seeds Pvt Ltd are privately held and are primarily focussed on vegetable seeds for the last 34 years. Beej Sheetal works on biotech research, while Kalash Seeds looks after production and marketing of the vegetable seeds.

Kalash Seeds had a turnover of 180 crore and 30 crore profit for fiscal 2019-2020. Beej Sheetal being a research-oriented company it had a turnover of 40 crore, he said.

Already about 20 crore has been spent on research and other activities for Bt Brinjal, he said.

Agarwal said Beej Sheetal has been working on Bt Brinjal since 2005, but today after 15 years GEAC has given permissions for field trials. Once the trials are over, the field data will have to be submitted again to GEAC. After that they consider the technology for commercialisation.

He pointed out that for the last 10 years there was a moratorium on GM Brinjal, But recently the company wrote to the Prime Minister Narendra Modi a simple letter saying that the company has worked on Bt technology for Brinjal and it can be a real Make in India product.

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Beej Sheetal to start trials next year - BusinessLine