Monthly Archives: February 2020

The bioindustry will require more cell and gene therapy plants, says an expert, who says the facilities of the future must be automated, scalable, and flexible.

The number of cell and gene therapies entering clinical development has increased significantly in recent years. According to the Alliance for Regenerative Medicines (ARM) there are 1,066 such therapies in trials at present1, which is a 32% increase on the number of studies in 2014. But the surge in clinical activity has not been matched by an increase in production capacity says Darren Dasburg, a cell and gene therapy-focused consultant.

Hundreds of facilities will be needed to manufacture the treatments that are in play now, he said, adding that if you factor in the plants needed to make viral vectors that could exceed a thousand facilities.

The good news, Dasburg says, is that these facilities are more like labs than traditional large biopharmaceutical plants.

Viral vector capacity is critical to the cell and gene therapy sector. Vectors are hollow viruses used to insert genetic material into cells, both cells used in protein expression and cells used therapeutically. Various organisations have voiced concerns about industry capacity to make vectors. In 2018, for example, the Alliance for Advanced Biomedical Engineering said the scarcity of viral vectors could hamper expansion2. Since then the situation has improved, but it has not been resolved3. While viral vector production capacity in the contract services sector has increased, the expansion is still falling short of demand.

Partly this is because of the complexity of making the vectors, according to Dasburg.

Most viral vectors are produced using adherent manufacturing technologies which are expensive to operate, he explains. A vial of just 20 million cells can cost $2030K because it is so challenging to make.

To bring down costs, vector capacity still needs to increase, continues Dasburg, who predicted that biopharma will continue to rely on CDMOs for the foreseeable future.

Cell and gene therapy manufacturing is still a young industry. Biopharma is still figuring out what the ideal production facility should look like.

Building for flexibility and multipurpose manufacturing is important, Dasburg says, noting that explaining CDMOs and IP holders need to understand they are attacking rare genetic diseases and ailments where the therapy might be a third-line treatment. The numbers are often quite lower, and the treatments can be one and done. All meaning the companies of the future will be attacking many more areas of need.

In terms of technology, all cell and gene therapy facilities should feature sufficient isolator capacity, Dasburg says. Isolators are probably the number one investment to make. Too many people are trying to work five people in full dress in a small room attempting to manufacture in a hands-on traditional way when isolation and automation could help immensely.

Dasburg pointed to benchtop platforms capable of processing a single CAR-T patients treatment as an example of an innovative approach being used. These can be arranged in an array within a single ballroom-like facility providing 100% containment going from leukapheresis bag to treatment bag without any human intervention.

References1. alliancerm.org/wp-content/uploads/2020/02/CBX-Meeting-7-Feb-2020-FINAL.pdf2. aabme.asme.org/posts/virus-shortage-for-cell-therapies-creates-engineering-opportunity3. http://www.genengnews.com/insights/gene-therapy-dollar-is-waiting-on-viral-vector-dime/

More here:
More Cell and Gene Therapy Facilities in the Hundreds are Needed - Genetic Engineering & Biotechnology News

The Food and Drug Administration, facing increased criticism of its regulatory process for gene-edited animals, is mounting a new effort to defend its policies to farmers, researchers and developers, but the industry is backing the Agriculture Department's push to take over some of FDA's oversight role.

FDA regulates as animal drugs any intentional genomic alterations in animals, achieved through gene editing or older genetic engineering technologies,a position roundly criticized by the animal ag and biotechnology industries. The subject has gained more attention recently with statements from FDA defending its oversight role as necessary both for the safety of animals and humans.

We havent announced most of them yet, but were going to have a series of meetings, said Laura Epstein, senior policy adviser in FDAs Center for Veterinary Medicine. FDAs presentations will include case studies examining hypothetical products.

One of the primary goals of the presentations will be to explain the process and FDAs regulatory intentions to farmers, an audience FDA acknowledges it has not communicated with very much, Epstein said.

As a result, theres a lot of confusion and misinformation out there about what we plan on doing, she said. We got word back that farmers seemed to think were going to require them to register them as drug manufacturers. We want to assure them thats absolutely not the case.

One meeting FDA will definitely be attending is the Large Animal Genetic Engineering Summit in Utah in June, said Heather Lombardi, director of FDAs Division of Animal Bioengineering and Cellular Therapies.

FDAs effort follows publication of a commentary in Nature Biotechnology by Steven Solomon, director of FDAs Center for Veterinary Medicine, asserting the importance of regulatory oversight of intentional genomic alterations in animals, even when the intended modification seeks to replicate a naturally occurring mutation.

Solomons piece accompanied an FDA analysis on how the agency was able to detect unintended alterations in genome-edited bulls, Solomon said in a statement on FDAs website.

The biotech and conventional animal ag industries have been pushing for years to get FDA to loosen its regulatory reins, arguing that FDAs development of disease-resistant animals, for example, has been unduly delayed.

Agriculture Secretary Sonny Perdue made that point at USDAs Agricultural Outlook Forum last week, stating at a press conference that USDA is "in the process of working with FDA currently to help divide up the responsibilities, hopefully with an agreeable type of consensual memorandum of understanding with the agency over new breeding techniques. Perdue said FDA could handle oversight of food animal breeding, with FDA handling any other animals.

He pointed to the example of the nearly year-old agreement between USDA and FDA on cell-cultured technology, used to create meat that has been described as clean by supporters and fake by its opponents.

Under that agreement, the agencies said FDA would handle cell collection, cell banks, and cell growth and differentiation, with the Food Safety and Inspection Service overseeing the production and labeling of human food products derived from the cells of livestock and poultry.

Ag Secretary Sonny Perdue and FDA Commissioner Stephen Hahn meet in Perdue's USDA's office.

Without an easier path to commercialization, new breeding techniques are going to go to Argentina, Brazil, Canada, China, or other countries, Perdue said, making the U.S. a follower rather than a leader in the new technologies.

Representatives of both USDA and FDA were reluctant to discuss the interagency communications. A USDA spokesperson said only, We are always in discussion with various FDA officials on a number of issues dealing with American agriculture. FDAsaid the agency "continues to engagewith our federal partners in the regulation of agriculture biotechnology products.

Referring to USDA and EPA, its other participants in the governments effort to modernize biotech regulations, FDA said each agency has a role to play within its existing statutory structure.

USDAs Flickr account shows Perdue did meet with new FDA Commissioner Stephen Hahn only nine days before his appearance at Ag Outlook, along with Anna Abram, FDAs deputy commissioner for policy, legislation and international affairs, and Frank Yiannas, FDAs deputy commissioner for food policy and response.

The description on the Flickr site doesnt say what they talked about, but one longtime observer and participant in the animal biotech space said, I would be shocked if they had not discussed the issue. The meeting came two days after publication of Solomons commentary and the release of a statement from Hahn touting the potential of gene-editing technology for animals.

It is paramount, however, that as we move forward, we maintain standards of safety and effectiveness, Hahn said.

The Center for Food Safety agrees. The FDA has scientists that better understand genetic engineering of animals given that it has been working for more than 20 years on both GE animals for research purposes and drug testing, and now GE animals for food, CFS Policy Director Jaydee Hanson said.

USDA, he said, has refused to develop regulations for its review of GE animals and insects, despite having agreed to do so in 2011 after a review by its own inspector general.

Perdues suggestion of an MOU was welcome news to the biotech community. Dana OBrien, the Biotechnology Innovation Organizations executive vice president of food and agriculture, called Perdues words encouraging. In an opinion piece posted on Agri-Pulses site Feb. 12, OBrien said BIO had shown the White House how the President could move animal biotechnology oversight to USDA an approach championed by key livestock and scientific stakeholders.

Im all for it, Acceligen CEO Tad Sonstegard saidof Perdues remarks supporting a division of responsibilities. Acceligen is a subsidiary of Recombinetics, which uses gene editing to develop animals for the agriculture and biomedical markets.

I agree with what BIO said, Sonstegard said. We need to get FDA to come to the table.

Jack Bobo, a food industry consultant who is a former vice president at biotech company Intrexon, said Perdues statement may lead to things moving a little more quickly on the animal biotech front. However, he added, Its not clear to me that this is a detailed proposal.

Intrexon owns Aquabounty, developer of genetically engineered salmon that was approved by FDA in 2015 after a 20-year process the only GE animal to be approved thus far. Sold in Canada since 2017, the fish will be available commercially in the U.S. later this, year according to Aquabounty.

Their record stands for itself one approval, Sonstegard said.

But FDA wants to improve its process. It is touting its Veterinary Innovation Program, which Hahn said encourages development and research and supporting an efficient and predictable pathway to approval.

The latest developments on the animal biotech front were triggered by FDAs publication of a paper detailing its discovery of unintended alterations in the progeny of a gene-edited, hornless bull. That paper was published in Nature Biotechnology the same day as the commentary by FDAs Solomon.

The bull was developed by Recombinetics and its calves were monitored by Alison Van Eenennaam, who runs the Animal Genomics and Biotechnology Laboratory at UC-Davis.

Alison Van Eenennaam, UC-Davis

Van Eenennaam responded to the FDA paper and commentary by saying she was "disappointed that the FDA failed to mention that the genome-edited bulls and their offspring were followed for years by researchers at UC Davis and were hornless (polled) and healthy.

The unintended alteration, a plasmid, was not transmitted to half of the offspring, so in one generation there were animals with just the targeted edit, she said, then wondered why her explanation of the project, also published in Nature Biotechnologyback in October, was not referred to in FDAs analysis.

Alexis Norris, a bioinformatician in FDAs Division of Animal Bioengineering and Cellular Therapies, said there was no deliberate attempt to ignore Van Eenennaams paper. FDA submitted its paper to Nature Biotechnology before hers was released, she said. Hers was in revision when ours was submitted to Bio. It was just a timing issue.

Van Eenennaam has been critical of FDAs process. There is nothing fundamentally hazardous about genetic variation in food, and suggesting intentional alterations are equivalent to drugs will frighten consumers who might logically infer the presence of drugs in their food, she wrote on the Nature Research Bioengineering Community blog in a piece entitled Responsible Science Takes Time.

"It's just DNA, man," said Sonstegard.We eat it in every food except vegetable oil.

For more news, go to http://www.Agri-Pulse.com

See the article here:
FDA on mission to explain its animal biotech approval process - Agri-Pulse

The "Gene Therapy Market by Vector Type, Gene Type and Application: Global Opportunity Analysis and Industry Forecast, 2019-2026" report has been added to ResearchAndMarkets.com's offering.

The global gene therapy market was valued at $393.35 million in 2018, and is estimated to reach $6,205.85 million by 2026, registering a CAGR of 34.8% from 2019 to 2026.

Gene therapy is a technique that involves the delivery of nucleic acid polymers into a patient's cells as a drug to treat diseases. It fixes a genetic problem at its source. The process involves modifying the protein either to change the genetic expression or to correct a mutation. The emergence of this technology meets the rise in needs for better diagnostics and targeted therapy tools. For instance, genetic engineering can be used to modify physical appearance, metabolism, physical capabilities, and mental abilities such as memory and intelligence. In addition, it is also used for infertility treatment. Gene therapy offers a ray of hope for patients, who either have no treatment options or show no benefits with drugs currently available. The ongoing success has strongly supported upcoming researches and has carved ways for enhancement of gene therapy.

Recently, a new technique has been developed, where new genes are introduced into the body to help fight against cancer cells. Gene therapies are regarded as a potential revolution in the health sciences and pharmaceutical fields. The number of clinical trials investigating gene therapies is on an increase, despite the limited number of products that have successfully reached the market. In addition, benefits of gene therapy over conventional cancer therapies and increase in government support fuel the growth of the gene therapy market.

The gene therapy market is a widely expanding field in the pharmaceutical industry with new opportunities. This has piqued the interests of venture capitalists to explore this market and its commercial potential. Major factors that drive the growth of this market include high demands for DNA vaccines to treat genetic diseases, targeted drug delivery, and high incidence of genetic disorders. However, the stringent regulatory approval process for gene therapy and the high costs of gene therapy drugs are expected to hinder the growth of the market. On the contrary, increase in the pipeline developments for gene therapy market are expected to provide lucrative opportunity during the forecast period.

Key MARKET BENEFITS FOR STAKEHOLDERS

Key Findings of the Gene Therapy Market:

Key Topics Covered:

Chapter 1: Introduction

1.1. Report Description

1.2. Key Benefits

1.3. Key Market Segments

1.4. Research Methodology

Chapter 2: Executive Summary

2.1. CXO Perspective

Chapter 3: Market Overview

3.1. Market Definition And Scope

3.2. Key Findings

3.3. Top Player Positioning, 2018

3.4. Porter's Five Forces Analysis

3.5. Market Dynamics

Chapter 4: Gene Therapy Market, By Vector Type

4.1. Overview

4.2. Viral Vectors

4.3. Non-Viral Techniques

Chapter 5: Gene Therapy Market, By Gene Type

5.1. Overview

5.2. Antigen

5.3. Cytokine

5.4. Tumor Suppressor

5.5. Suicide Gene

5.6. Deficiency

5.7. Growth Factors

5.8. Receptors

5.9. Others

Chapter 6: Gene Therapy Market, By Application

6.1. Overview

6.2. Oncological Disorders

6.3. Rare Diseases

6.4. Cardiovascular Diseases

6.5. Neurological Disorders

6.6. Infectious Diseases

6.7. Other Diseases

Chapter 7: Gene Therapy Market, By Region

7.1. Overview

7.2. North America

7.3. Europe

7.4. Asia-Pacific

7.5. LAMEA

Chapter 8: Company Profile

8.1. Adaptimmune Therapeutics Plc.

8.2. Anchiano Therapeutics Ltd.

8.3. Achieve Life Sciences, Inc.

8.4. Adverum Biotechnologies, Inc.

8.5. Abeona Therapeutics Inc.

8.6. Applied Genetic Technologies Corporation

8.7. Arbutus Biopharma Corporation

8.8. Audentes Therapeutics Inc.

8.9. Avexis Inc.

8.10. Bluebird Bio, Inc.

8.11. Celgene Corporation

8.12. Crispr Therapeutics Ag

8.13. Editas Medicine, Inc.

8.14. Gilead Sciences, Inc.

8.15. Glaxosmithkline Plc

8.16. Intellia Therapeutics Inc.

8.17. Merck & Co., Inc.

8.18. Novartis Ag

8.19. Regenxbio, Inc.

8.20. Spark Therapeutics, Inc.

8.21. Sangamo Therapeutics, Inc.

8.22. Uniqure N. V.

8.23. Voyager Therapeutics, Inc.

For more information about this report visit https://www.researchandmarkets.com/r/yt2y68

View source version on businesswire.com: https://www.businesswire.com/news/home/20200225005742/en/

Contacts

ResearchAndMarkets.comLaura Wood, Senior Press Managerpress@researchandmarkets.com For E.S.T. Office Hours Call 1-917-300-0470For U.S./CAN Toll Free Call 1-800-526-8630For GMT Office Hours Call +353-1-416-8900

Original post:
Global Gene Therapy Market Projected to Grow with a CAGR of 34.8% During the Forecast Period, 2019-2026 - ResearchAndMarkets.com - Yahoo Finance

New pet food companies are springing up to meet what they say is growing demand for plant-based, sustainable alternatives to Fancy Feast and Kibbles N Bits.

By making products from fermented fungus and experimenting with lab-grown food from animal cells and microbes, alternative pet food makers are hoping to carve out a share of the $30 billion U.S. pet food market.

And multibillion-dollar pet food companies, like Mars Petcare and Nestl-owned Purina, are starting to take notice.

Our mission is almost the exact same as Impossible Foods, which is [to] reduce or eliminate factory farming, which has this giant environmental footprint, said Josh Errett, CFO of Because Animals, one of the companies developing new pet foods. I mean, calling it a footprint is too nice, its an environmental disaster.

The other mission is to make a profit. These companies are catering to pet owners who value their ecological footprint and have the income to pay for an alternative product that tends to be more expensive than a can of Pedigree.

Pulling away from factory farming

A UCLA study from 2017 by Professor Gregory Okin estimated that dog and cat food accounts for the release of millions of tons of the greenhouse gases methane and CO2 and constitutes about 25%30% of the environmental impacts from animal production in terms of the use of land, water, fossil fuel, phosphate and biocides.

Like plant-based market leaders Impossible Foods and Beyond Meat, alternative pet food companies say their product will reduce the amount of land and energy used for conventional meat production.

Industrial animal farming, or concentrated animal feed operations, produce large amounts of byproducts and off-cuts like organs and bone meal which are not usually used in human food, but are re-purposed for pet food production.

The goal is to cut factory farming out of the supply chain completely without a market for the unused parts, the meat industry would collapse due to lost revenue, Errett said.

But many large pet food companies defend their use of animal byproducts.

One might argue that this is actually a super sustainable source, because were using materials that most of us wouldnt consume and would be wasted, said Richard Butterwick, global nutrition advisor at the Waltham Petcare Science Institute, a research center for Mars Petcare.

Because Animals along with another company, Wild Earth are using cellular technology to culture real meat from animal cells biopsied from living creatures. The cells are encouraged to proliferate and reproduce in a bioreactor, creating muscle protein without the need to slaughter animals. This process is also being used by more than 30 companies worldwide to develop clean or lab-grown meat for human consumption.

Next year, both Because Animals and Wild Earth hope to release their first cell-grown cat foods, made of cultured mouse meat.

Were getting back to what the cats system was built to digest, Errett said. You dont have to add taurine or anything back, you can make an ancestral diet.

A cat owner himself, Errett wanted to address the ultra-processed nature of a lot of the conventional cat food, or as he calls it biological waste. Cats are obligate carnivores, meaning they need to eat meat to get the 11 essential amino acids they require or they could have serious health problems like blindness or even death.

By culturing animal meat in a lab, these companies can genetically control what nutrients present in the food. They can also eliminate potentially dangerous substances that have made their way into some conventional pet foods. Some popular pet foods companies have had to recall their products in recent years due to toxic levels of Vitamin D and even the euthanasia drug sodium pentobarbital.

Will pet owners buy lab-grown mouse meat for their cats?

Beyond Meat increased its revenues by 250% between 2018 and 2019; consumers are taking an interest in the health and environmental benefits promoted by plant-based foods. Pet owners are showing that they will pay more for luxury and premium pet foods.

Wild Earth is making dog food from cultured fungi proteins and, according to CEO Ryan Bethencourt, revenue is growing steadily even though production is still relatively small.

This plant-based type of cultured pet food, already on the market, is much more expensive than the conventional options. A 18-pound bag of Wild Earth dog food sells for $49 on its website; whereas the website Chewy sells a 18.5-pound bag of Purina Dog Chow for $11.99.

Bethencourt said the potential for cultured protein could be 10% of the total pet food market within the next 10 years. He is using the success of plant-based proteins for humans as evidence for the market potential of alternative pet foods.

Research backs his point; according to one study from 2019, it is clear that an association exists between the diet a pet owner has chosen to follow and the diet they choose to feed their pet.

Culturing microbes into pet food

Another alternative pet food company, Bond Pet Foods, is taking a slightly different approach to cultured pet food. Bond is experimenting with genetically engineering microbes, like yeast.

Theres a lot more that isnt known about growing mice cells to create meat. Theres just a lot more technical challenges that they have to figure out how to ramp up and replicate that kind of meat production, said Rich Kelleman, CEO of Bond Pet Foods.

Bond is using the same approach to genetic engineering used to synthetically produce rennet for cheese production or insulin for diabetics.

What were doing is isolating a skeletal muscle protein so the building blocks of meat and inserting the DNA from that into a microbe, and then using the machinery of the microbe to produce identical animal proteins that you get on a farm and field, drying it down and then using that in a broader recipe to provide high quality nutrition, Kelleman said.

The major pet food companies are also looking for environmentally friendly, alternative proteins that could be inexpensive to scale up as a replacement for conventionally raised meat.

One area were currently exploring is looking at insects as a potential protein source, said Richard Butterwick at the Waltham Institute. They are potentially much more sustainable than traditional mammalian sources of protein and potentially very nutritious, as well.

Venture capital funds are eyeing the potential of cultured alternatives

Last year, Bond completed a $1.2 million seed round of funding and won a $10,000 innovation award from Purina.

Because Animals won this years innovation award and Wild Earth received a $200,000 investment from Mars Petcare during its 2018 investment round. So far, Wild Earth has raised over $16 million from various venture capital funds to pay for its continued growth.

These are relatively small amounts on the scale of the industry, but there is a sense of momentum.

All the big pet food manufacturers are looking at their supply chain and they see challenges with the growth of the pet food market and the population overall, more people means more pets, Kelleman said. Theyre looking for ways that they could mitigate the risk.

Richard Butterwick said that the main concern is that a pets nutritional needs are understood by their owners. He said consumer trends and the humanization of pets should not compromise pet needs, just because there is a trend towards more sustainable eating for humans.

A 2015 study in the Journal of Animal Science looked at the changing attitudes of pet owners choice in food for their companions. The study said it was paramount that sustainability be weighed against animals nutritional demands.

That means conscientious pet owners need to be wary of compromising a pets health just because eating kogi fungus, cricket treats, or lab-grown meats is trending for humans.

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University of Birmingham Vice-Chancellor Professor Sir David Eastwood with representatives of partner organisations at the signing ceremony in Delhi.

Experts at the University of Birmingham will work with partners in India across education, healthcare, genetic engineering and sports science.

Vice-Chancellor Professor Sir David Eastwood signed a range of Memoranda of Understanding (MoU) with the Universitys partners at a special signing ceremony in Delhi.

The agreements form a key part of the Universitys strategic vision to continue building meaningful education and research partnerships in India.

Professor Sir David Eastwood signed MoUs with:

The University of Birminghams collaborative research output with India partners has almost doubled over the last five years. We currently have over 40 joint research projects of outstanding quality, commented Professor Sir David Eastwood.

We are a global university with a civic heart and a long, illustrious relationship with India. Signing these exciting new agreements with partners in areas such as health, transport and environment gives us a great opportunity to further contribute to Indian society as we continue to forge meaningful research and education partnerships in India.

The University and ICGEB plan to work together on multidisciplinary research including immunity and infection, as well as projects tackling human diseases, compound screening for identifying autophagy modulators, and exchanges of students and staffs across relevant projects.

Working in partnership with CIPLA, University experts will develop healthcare Continuous Professional Development (CPD) programmes.

Researchers at PDPU and Birmingham will continue working on the joint India-H2O project, which is developing, designing and demonstrating high-recovery, low-cost water treatment systems for saline groundwater, as well as domestic and industrial wastewaters. The partners will also identify new research opportunities.

The agreement with Technofin will see the partners working together on a bid to provide rail research and consultancy to the Dedicated Freight Corridor Corporation of India Ltd., to support the establishment of a Heavy Haul Research Institute. They will also develop other infrastructure-related research.

Manipal engineering students will be able to join Birmingham courses in Civil Engineering, Computer Science and Engineering, Electrical and Electronics Engineering, Mechanical Engineering and Mechatronics Engineering - after completing two years of study in India, graduating with degrees from both universities.

University experts will work with Inspire Institute of Sport to develop bespoke distance-learning and blended CPD programmes for the development of the Institutes staff, as well as developing scholarships for postgraduate study in sports science. The MoU is an outcome of the India-UK Sports Alliance set up by the UK Governments Department for International Trade to drive collaboration in sports between the two countries.

Crispin Simon, Her Majestys Trade Commissioner for South Asia, UKs Department of International Trade and British Deputy High Commissioner, Mumbai and West of India, said: I am delighted that the University of Birmingham is strengthening its presence in India across education, healthcare, genetic engineering and sports science. The UK government has played an instrumental role in establishing their partnership with Inspire Institute of Sport, and we will continue to support their work in India.

I am also glad that Professor Tim Cable from the University of Birmingham has made significant contributions to the Indian-UK Sports Alliance organised by the UK government, to bring together influential individuals in both countries to help drive collaboration. I look forward to his continued participation.

Read more from the original source:
University of Birmingham signs up for strategic research vision in India - University of Birmingham

The road into Batlow is littered with the dead.

In the smoky, gray haze of the morning, it's hard to make out exactly what Matt Roberts' camera is capturing. Roberts, a photojournalist with the Australian Broadcasting Corporation, keeps his lens focused on the road as he rolls into the fire-ravaged town 55 miles west of Canberra, Australia's capital. At the asphalt's edge, blackened livestock carcasses lie motionless.

The grim scene, widely shared on social media, is emblematic of the impact the 2019-20 bushfire season has had on Australia's animal life. Some estimates suggest "many, many billions" of animals have been killed, populations of endemic insects could be crippled and, as ash washes into riverways, marine life will be severely impacted. The scale of the bushfires is so massive, scientists are unlikely to know the impact on wildlife for many years.

But even before bushfires roared across the country, Australia's unique native animals were in a dire fight for survival. Habitat destruction, invasive species, hunting and climate change have conspired against them. Populations of native fauna are plummeting or disappearing altogether, leaving Australia with an unenviable record: It has the highest rate of mammal extinctions in the world.

A large share of Australia's extinctions have involved marsupials -- the class of mammals that includes the nation's iconic kangaroos, wallabies, koalas and wombats. A century ago, the Tasmanian tiger still padded quietly through Australia's forests. The desert rat-kangaroo hopped across the clay pans of the outback, sheltering from the sun in dug-out nests.

Now they're gone.

Australia's 2019-20 bushfire season has been devastating for wildlife.

In a search for answers to the extinction crisis, researchers are turning to one lesser-known species, small enough to fit in the palm of your hand: the fat-tailed dunnart. The carnivorous mouse-like marsupial, no bigger than a golf ball and about as heavy as a toothbrush, has a tiny snout, dark, bulbous eyes and, unsurprisingly, a fat tail. It's Baby Yoda levels of adorable -- and it may be just as influential.

Mapping the dunnart's genome could help this little animal become the marsupial equivalent of the lab mouse -- a model organism scientists use to better understand biological processes, manipulate genes and test new approaches to treating disease. The ambitious project, driven by marsupial geneticist Andrew Pask and his team at the University of Melbourne over the last two years, will see scientists take advantage of incredible feats of genetic engineering, reprogramming cells at will.

It could even aid the creation of a frozen Noah's Ark of samples: a doomsday vault of marsupial cells, suspended in time, to preserve genetic diversity and help prevent further decline, bringing species back from the brink of extinction.

If that sounds far-fetched, it isn't. In fact, it's already happening.

Creating a reliable marsupial model organism is a long-held dream for Australian geneticists, stretching back to research pioneered by famed statistician Ronald Fisher in the mid-20th century. To understand why the model is so important, we need to look at the lab mouse, a staple of science laboratories for centuries.

"A lot of what we know about how genes work, and how genes work with each other, comes from the mouse," says Jenny Graves, a geneticist at La Trobe University in Victoria, Australia, who has worked with marsupials for five decades.

The mouse is an indispensable model organism that shares many genetic similarities with humans. It has been key in understanding basic human biology, testing new medicines and unraveling the mysteries of how our brains work. Mice form such a critical part of the scientific endeavor because they breed quickly, have large litters, and are cheap to house, feed and maintain.

The lab mouse has been indispensable in understanding physiology, biology and genetics.

In the 1970s, scientists developed a method to insert new genes into mice. After a decade of refinement, these genetically modified mice (known as "transgenic mice") provided novel ways to study how genes function. You could add a gene, turning its expression up to 11, or delete a gene entirely, shutting it off. Scientists had a powerful tool to discover which genes performed the critical work in reproduction, development and maturation.

The same capability does not exist for marsupials. "At the moment, we don't have any way of manipulating genes in a devil or a kangaroo or a possum," says Graves. Without this capability, it's difficult to answer more pointed questions about marsupial genes and how they compare with mammal genes, like those of mice and humans.

So far, two marsupial species -- the Tammar wallaby and the American opossum -- have been front and center of research efforts to create a reliable model organism, but they both pose problems. The wallaby breeds slowly, with only one baby every 18 months, and it requires vast swaths of land to maintain.

The short-tailed opossum might prove an even more complicated case. Pask, the marsupial geneticist, says the small South American marsupial is prone to eating its young, and breeding requires researchers to sift through hours of video footage, looking for who impregnated whom. Pask also makes a patriotic jab ("they're American so we don't like them") and says their differences from Australian marsupials make them less useful for the problems Australian species face.

But the dunnart boasts all the features that make the mouse such an attractive organism for study: It is small and easy to house, breeds well in captivity and has large litters.

"Our little guys are just like having a mouse basically, except they have a pouch," Pask says.

Pask (front) and Frankenberg inspect some of their dunnarts at the University of Melbourne.

A stern warning precedes my first meeting with Pask's colony of fat-tailed dunnarts.

"It smells like shit," he says. "They shit everywhere."

I quickly discover he's right. Upon entering the colony's dwellings on the third floor of the University of Melbourne's utilitarian BioSciences building, you're punched in the face by a musty, fecal smell.

Pask, a laid-back researcher whose face is almost permanently fixed with a smile, and one of his colleagues, researcher Stephen Frankenberg, appear unfazed by the odor. They've adapted to it. Inside the small room that houses the colony, storage-box-cages are stacked three shelves high. They're filled with upturned egg cartons and empty buckets, which work as makeshift nests for the critters to hide in.

Andrew Pask

Frankenberg reaches in without hesitation and plucks one from a cage -- nameless but numbered "29" -- and it hides in his enclosed fist before peeking out of the gap between his thumb and forefinger, snout pulsing. As I watch Frankenberg cradle it, the dunnart seems curious, and Pask warns me it's more than agile enough to manufacture a great escape.

In the wild, fat-tailed dunnarts are just as inquisitive and fleet-footed. Their range extends across most of southern and central Australia, and the most recent assessment of their population numbers shows they aren't suffering population declines in the same way many of Australia's bigger marsupial species are.

Move over, Baby Yoda.

As I watch 29 scamper up Frankenberg's arm, the physical similarities between it and a mouse are obvious. Pask explains that the dunnart's DNA is much more closely related to the Tasmanian devil, an endangered cat-sized carnivore native to Australia, than the mouse. But from a research perspective, Pask notes the similarities between mouse and dunnart run deep -- and that's why it's such an important critter.

"The dunnart is going to be our marsupial workhorse like the mouse is for placental mammals," Pask says.

For that to happen, Pask's team has to perfect an incredible feat of genetic engineering: They have to learn how to reprogram its cells.

To do so, they collect skin cells from the dunnart's ear or footpad and drop them in a flask where scientists can introduce new genes into the skin cell. The introduced genes are able to trick the adult cell, convincing it to become a "younger," specialized cell with almost unlimited potential.

The reprogrammed cells are known as "induced pluripotent stem cells," or iPS cells, and since Japanese scientists unraveled how to perform this incredible feat in 2006, they have proven to be indispensable for researchers because they can become any cell in the body.

"You can grow them in culture and put different sorts of differentiation factors on them and see if they can turn into nerve cells, muscle cells, brain cells, blood vessels," Pask explains. That means these special cells could even be programmed to become a sperm or an egg, in turn allowing embryos to be made.

Implanting the embryo in a surrogate mother could create a whole animal.

It took about 15 minutes to get this dunnart to sit still.

Although such a technological leap has been made in mice, it's still a long way from fruition for marsupials. At present, only the Tasmanian devil has had iPS cells created from skin, and no sperm or egg cells were produced.

Pask's team has been able to dupe the dunnart's cells into reverting to stem cells -- and they've even made some slight genetic tweaks in the lab. But that's just the first step.

He believes there are likely to be small differences between species, but if the methodology remains consistent and reproducible in other marsupials, scientists could begin to create iPS cells from Australia's array of unique fauna. They could even sample skin cells from wild marsupials and reprogram those.

Doing so would be indispensable in the creation of a biobank, where the cells would be frozen down to -196 degrees Celsius (-273F) and stored until they're needed. It would act as a safeguard -- a backup copy of genetic material that could, in some distant future, be used to bring species back from the edge of oblivion, helping repopulate them and restoring their genetic diversity.

Underneath San Diego Zoo's Beckman Center for Conservation Research lies the Frozen Zoo, a repository of test tubes containing the genetic material of over 10,000 species. Stacked in towers and chilled inside giant metal vats, the tubes contain the DNA of threatened species from around the world, suspended in time.

It's the largest wildlife biobank in the world.

"Our goal is to opportunistically collect cells ... on multiple individuals of as many species as we can, to provide a vast genetic resource for research and conservation efforts," explains Marlys Houck, curator at the Frozen Zoo.

The Zoo's efforts to save the northern white rhino from extinction have been well publicized. Other research groups have been able to create a northern white rhino embryo in the lab, combining eggs of the last two remaining females with frozen sperm from departed males. Scientists propose implanting those embryos in a surrogate mother of a closely related species, the southern white rhino, to help drag the species back from the edge of oblivion.

For the better part of a decade, conservationists have been focused on this goal, and now their work is paying off: In the "coming months," the lab-created northern white rhino embryo will be implanted in a surrogate.

Sudan, the last male northern white rhinoceros, was euthanized in 2018.

Marisa Korody, a conservation geneticist at the Frozen Zoo, stresses that this type of intervention was really the last hope for the rhino, a species whose population had already diminished to just eight individuals a decade ago.

"We only turn to these methods when more traditional conservation methods have failed," she says.

In Australia, researchers are telling whoever will listen that traditional conservation methods are failing.

"We've been saying for decades and decades, many of our species are on a slippery slope," says John Rodger, a marsupial conservationist at the University of Newcastle, Australia, and CEO of the Fauna Research Alliance, which has long advocated for the banking of genetic material of species in Australia and New Zealand.

In October, 240 of Australia's top scientists delivered a letter to the government detailing the country's woeful record on protecting species, citing the 1,800 plants and animals in danger of extinction, and the "weak" environmental laws which have been ineffective at keeping Australian fauna alive.

Institutions around Australia, such as Taronga Zoo and Monash University, have been biobanking samples since the '90s, reliant on philanthropic donations to stay online, but researchers say this is not enough. For at least a decade, they've been calling for the establishment of a national biobank to support Australia's threatened species.

John Rodger

"Our real problem in Australia ... is underinvestment," Rodger says. "You've got to accept this is not a short-term investment."

The current government installed a threatened-species commissioner in 2017 and committed $255 million ($171 million in US dollars) in funding to improve the prospects of 20 mammal species by 2020. In the most recent progress report, released in 2019, only eight of those 20 were identified as having an "improved trajectory," meaning populations were either increasing faster or declining slower compared to 2015.

A spokesperson for the commissioner outlined the $50 million investment to support immediate work to protect wildlife following the bushfires, speaking to monitoring programs, establishment of "insurance populations" and feral cat traps. No future strategies regarding biobanking were referenced.

Researchers believe we need to act now to preserve iconic Australian species like the koala.

In the wake of the catastrophic bushfire season and the challenges posed by climate change, Australia's extinction crisis is again in the spotlight. Koalas are plastered over social media with charred noses and bandaged skin. On the front page of newspapers, kangaroos bound in front of towering walls of flame.

Houck notes that San Diego's Frozen Zoo currently stores cell lines "from nearly 30 marsupial species, including koala, Tasmanian devil and kangaroo," but that's only one-tenth of the known marsupial species living in Australia today.

"Nobody in the world is seriously working on marsupials but us," Rodger says. "We've got a huge interest in maintaining these guys for tourism, national icons... you name it."

There's a creeping sense of dread in the researchers I talk to that perhaps we've passed a tipping point, not just in Australia, but across the world. "We are losing species at an alarming rate," says Korody from the Frozen Zoo. "Some species are going extinct before we even know they are there."

With such high stakes, Pask and his dunnarts are in a race against time. Perfecting the techniques to genetically engineer the tiny marsupial's cells will help enable the preservation of all marsupial species for generations to come, future-proofing them against natural disasters, disease, land-clearing and threats we may not even be able to predict right now.

Pask reasons "we owe it" to marsupials to develop these tools and, at the very least, biobank their cells if we can't prevent extinction. "We really should be investing in this stuff now," he says. He's optimistic.

In some distant future, years from now, a bundle of frozen stem cells might just bring the koala or the kangaroo back from the brink of extinction.

And for that, we'll have the dunnart to thank.

Originally published Feb. 18, 5 a.m. PT.

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Building a 'doomsday vault' to save the kangaroo and koala from extinction - CNET

Agriculture is responsible for the production of a quarter of the total human-generated greenhouse gases. Growing food also uses about 70 percent of the water available to us. Moreover, agriculture (especially meat production) is the single most significant driver of deforestation and biodiversity loss. Food production is detrimental to the health of the planetbut it doesnt end there. Once the food reaches plates, poor-quality diets cause malnutrition, claiming more lives than tobacco, drug and alcohol combined.

Search for malnutrition online and you will see pictures of frail and sick children. But along with stunting, wasting, vitamin and mineral deficiency, malnutrition also includes overweight, obesity and other diet-related illnesses. Yes, 1 in 9 people around the world go to sleep hungry, but nearly 2 billion adults are also overweight or obese. As such, more than one-third of the world population suffers from at least one form of malnutrition.

With the climate and biodiversity crises, and the global public-health crisis in the form of malnutrition, we must find a healthy and environmentally sustainable diet to feed the growing population. In 2019, the EAT-Lancet Commission brought together leading experts in nutrition, health, sustainability and policy to recommend ways to transform the global food system to achieve a healthy and sustainable diet.

The EAT-Lancet report recommends that planetary health diets to feed 10 billion people by 2050 requires cutting down meat consumption by half and eating twice as much as fruits, vegetables, beans and nuts. Despite recognizing the need to make healthy food affordable for the poor, the EAT-Lancet Commission didnt review the cost and affordability of the ideal diet. Therefore, in a recent global study, scientists reviewed prices for nearly 750 food items to calculate the value of healthy and sustainable diets in 159 countries.

The research, published in Lancet Global Health, shows that many people in low and lower-middle-income countries are too poor to afford EAT-Lancets ideal diet. EAT-Lancet says that we would need to eat twice as much as many fruits and vegetables, and get more protein and fats from plant-source foods. However, the new study found that fruits, vegetables, beans and nuts are the most expensive items of the ideal diet accounting for half of its total price.

Shifting foodsystems

A key challenge of the 21st-century is to change our food system to produce a healthy diet that is both economically and environmentally sustainable. As EAT-Lancets ideal diet isnt affordable for much of the worlds low-income population, authorities must make several parallel interventions to tackle global food inequality.

Lower food prices and higher earnings would give poor people more purchasing power. We must also find cheaper, nutritious food alternatives that are affordable and accessible to people living in low-income areas. I believe that biotechnology has the power to lower the cost of locally and globally grown food, making the ideal diet economically viable to those that need it the most.

One problem is the lack of available, affordable options, which partly stems from decreasing agrobiodiversity. Just three crops (rice, wheat and corn) provide over half of the plant-derived calories worldwide. Shifting calories away from the starchy staple foods towards more nutritious fruits, vegetables and other protein-sourced food remains a significant challenge in meeting EAT-Lancet targets. Grand challenges require great technological solutions, and genetic engineering technology is among the most powerful tools at our disposal.

Power of biotechnology

Biotechnology can improve agrobiodiversity and provide more locally-grown food options for people in low-income areas. One way to do this would be to make inedible plants into a good source of nutrition and calories. Take cottonseed, for example, which has the potential to be a cheaper alternative to nuts. Cottonseeds are highly nutritious, containing oils and proteins in abundance, but many low-income cotton farmers cant eat cottonseeds because they produce toxins called gossypol.

Now, scientists have engineered cotton plants to remove the toxin, making cottonseeds safe for us to eat. And recently, the U.S. Food and Drug Administration approved genetically modified (GM) cottonseed for human consumption. Biotech cottonseed can act as an excellent alternative dietary source in low-income regions, where people struggle to meet the costs of the ideal diet recommended by EAT-Lancet.

Genetic engineering can also enable widespread cultivation of local plants. The groundcherry plant in its native form has a wild, sprawling growth habit which causes its fruits to drop to the ground while still small. Difficulties in cultivating the wildcherry mean its an orphan plant. However, scientists used genetic engineering to improve wildcherrys undesirable traits, including the plants weedy shape, flower production and fruit size. Now there are hopes for large-scale cultivation of genetically engineered groundcherry, which is native to Central and South America.

Millions of children and adults around the world suffer from micronutrient deficiencies, and biotechnology can also help fortify current crops to improve their vitamin and micronutrient contents. For example, scientists have recently developed biofortified cassava, which has higher zinc and iron contents than regular cassava. The biofortified cassava may one day prevent illnesses related to iron and zinc deficiencies.

Golden Rice is perhaps the prime example of a biofortified cropconventional rice that is genetically engineered to produce the vitamin A precursor beta-carotene. Golden Rice, acting as a source of vitamin A, can address vitamin A deficiency that blinds and kills hundreds of thousands of children every year. After a rigorous biosafety assessment in the Philippines, the Department of Agriculture-Bureau of Plant Industry found Golden Rice to be safe as conventional rice. Golden Rice regulation application is under review in Bangladesh, as well. This biofortified crop can provide much-needed micronutrients, taking the everyday staple food further to meet peoples dietary requirements in the poorest regions of the world.

Economic benefits

Improved agrobiodiversity and availability of local food varieties, enabled by biotechnology, will bring down the cost of the ideal diet, reducing food inequality. But GM technology also has the power to lift people out of poverty and increase the spending power of the low-income communities in developing regions.

Higher farm productivity, especially in low-income areas, can lower food prices. A meta-analysis of studies published after 1995 found that adopting GM technology has widespread benefits, including economic gains for farmers that grow GM crops. The meta-analysis found that GM technology increases crop yields by 21 percent. Some GM crops are engineered to be more resistant to pest damage, which helps achieve higher yields, for example.

The meta-study also found that GM crops require 37 percent less pesticide, which reduces pesticide costs by 39 percent and helps spare the environment. Even though GM seeds are more expensive than non-GM seeds, savings in pest control and pesticide use mean that farmers adopting GM crops enjoy 68 percent more profit. Therefore, GM crops can increase farmers spending power, which is excellent news for the quarter of the worlds working population employed in agriculture . More importantly, the yield and profit from GM crops are higher in developing countries than in developed countries.

If adopted widely, genetic engineering technology will bring us closer to meeting the EAT-Lancet dietary targets, which will help us protect the environment, public health, and reduce inequality.

Rupesh Paudyal holds a PhD in plant science and covers agriculture and the environment as a freelance writer. Visit his website and follow him on Twitter @TalkPlant

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Viewpoint: We can sustainably feed 10 billion people. Here's how CRISPR and GMO crops can help - Genetic Literacy Project

To create a scope of networking among young biotechnologists and engage them into biotech related activities outside of structured curriculum, Network of Young Biotechnologists of Bangladesh (NYBB) organised National Young Biotechnologists Congress for the fifth time. This year, the event was held on February 22 in the Nabab Nawab Ali Chowdhury Senate building of University of Dhaka. The Department of Genetic Engineering and Biotechnology of University of Dhaka hosted the congress. 744 participants from 34 different universities and institutions took part in the event.

The inaugral session started with the welcome address of Md Arif Khan, Chief Executive Officer of NYBB and Lecturer of University of Development Alternative, where he stated the limitations of job opportunities for biotechnologists. To solve this issue, he drew the attention of Dr Kazi Shahidullah, Chairman of University Grants Commission. The special guests, Independence award winner, Dr Haseena Khan, Chairman and Professor of Biochemistry & Molecular Biology, Department of University of Dhaka, Dr Zeba Islam Seraj, Director General of National Institute of Biotechnology, Dr Md Salimullah expressed their thoughts on this initiative of NYBB and appreciated young biotechnologists for their active participation. The chief guest of the event, Dr Kazi Shahidullah shared his views on biotechnology and its need in our country. Dr Nazmul Ahsan, Chairman and Professor of Genetic Engineering and Biotechnology Department of University of Dhaka, chaired the inaugral session. After his thoughtful and encouraging speech, this session ended with the vote of thanks from Mahmuda Kabir, Chief Operation Officer of NYBB.

The first Plenary Lecture titled "Professor Ahmed Shamsul Islam Biotechnology Speech 2020" was from Sir Walter Bodmer, renowned human geneticist and cancer researcher of University of Oxford. More than 500 students and professionals were present at the event.

After this session, a panel discussion on the topic, "Challenges and Opportunities in Biotechnology as a Career" took place, where the panelists Dr Zeba Islam Seraj, Professor Genetic Engineering and Biotechnology Department of University of Dhaka, Dr Anwarul Azim Akhand, Founder Chairman and Professor of Genetic Engineering and Biotechnology Department of University of Chittagong, Dr Mohammad Al Forkan, Executive Director of Laal Teer Livestock Development Ltd, Dr Kazi Emdadul Haque and Head of Grameenphone Accelerator, Minhaz Anwar discussed how the students should prepare themselves for their desired career path and what are the expectations of the job authorities or industrial sponsors. This session was moderated by Dr Mustak Ibn Ayub, a member of the Board of Directors of NYBB and Assistant Professor of Genetic Engineering and Biotechnology Department of University of Dhaka.

At this stage, Esco Lifescience Private Ltd presented "10 Minutes on Biosafety" after which the competitions began. The first contest was an oral presentation, in which 13 selected works were presented among 80 submitted abstracts. The champion, first runner up and second runner up of this competition were Lecturer Afrin Sultana from Noakhali Science and Technology University, Afroza Akter from University of Chittagong and Rakib Wazed Nayon from Shahjalal Science and Technology University, respectively.

150 abstracts were submitted in the research and Idea-based poster presentation competition, from which 80 were selected for the showcase. The champion of this competition was Md Sadek Bachu. The first place was occupied by both Topu Rayhan & Anti Islam and the second prize winner of the competition was Anjasu Paul.

Student combined their skills of photography and understanding of biotechnology in the Biotech Photography Contest. In this competition, 'The First Triumph', a picture taken by Md Thosif Reza, 'Microtuber formation in cell culture of Solanum tuberosum', a picture taken by Sheikh Sanjid Ahmed from University of Dhaka and 'Fungus for my Valentine', a picture taken by Rocktim Barua from University of Chittagong won the first, second and third prizes, respectively.

In 3 Minute Biotech Contest, students got the opportunity to explain their research work in Bangla. With 15 contestants, the semifinal took place on February `9 in Star Labs, from which 6 were selected for the final presentation in the congress. With the votes of audiences, the people's choice award was won by Drishty Badhon Sarker from University of Dhaka. The champion and runner up of this competition were Anti Islam from Khulna University and Md Thosif Reza from University of Chittagong.

After that, a biotechnology hackathon, the first of its kind in Bangladesh, was arranged. Team Super Bug 2.0 of Chittagong University, Team Sanryu of Dhaka University and Team Biotech of Khulna University won the first, second and third prizes at the event. The judges were: Iqbal Bahar Chowdhury (President, E-Commerce Association of Bangladesh), Reza Chowdhury (Radiant Pharmaceuticals) and Dr S M Mahbubur Rashid (DU).

Dr Senjuti Saha, Microbiologist of Child Health Research Foundation presented the speech, titled "Bill and Melinda Gates Foundation Heroes of the field 2020" on her journey in the field of science. 22nd L'Oral-Unesco For Women in Science Award winner Dr Firdausi Qadri, Emeritus Scientist of icddr,b and Founder of ideSHi gave the speech, "Professor Naiyyum Chowdhury Memorial Speech 2020", which inspired the young biotechnology students.

Professor of University of Dhaka Dr Sharif Akhteruzzaman guided students on how to succeed in the path of their biotech careers in his speech, "Research Excellence in Biotechnology: Obstacles to Overcome".

At the last stage of the event, Dr Md Tofazzol Islam, Professor and Director of Institute of Biotechnology and Genetic Engineering, Bangabandhu Sheikh Mujibur Rahman Agricultural University, spoke about biotechnology. Dr Md Abul Kalam Azad, Professor of Shahjalal Science and Technology University and Dr Abdul Haque, Assistant General Manager and Head (Biotech plant) of Aristopharma Ltd, shared their views on research opportunities in biotechnology in their respective speeches.

The event ended with a speech from Dr Md Adnan Mannan, Member of Board of Directors of NYBB and Professor of University of Chittagong. He conveyed his best wishes to young biotechnologists.

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Fifth National Young Biotechnologists Congress 2020 held at Dhaka University - The Daily Star