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California Proposed Initiative Enters Circulation: Authorizes Bonds to Continue Funding Stem Cell and Other Medical Research – Sierra Sun Times

December 21st, 2019 5:42 pm

December 19, 2019 - SACRAMENTO, CA- Secretary of State Alex Padilla announced that the proponent of a new initiative was cleared to begin collecting petition signatures.

The Attorney General prepares the legal title and summary that is required to appear on initiative petitions. When the official language is complete, the Attorney General forwards it to the proponent and to the Secretary of State, and the initiative may be circulated for signatures. The Secretary of State then provides calendar deadlines to the proponent and to county elections officials. The Attorney Generals official title and summary for the measure is as follows:

AUTHORIZES BONDS TO CONTINUE FUNDING STEM CELL AND OTHER MEDICAL RESEARCH. INITIATIVE STATUTE.Authorizes $5.5 billion in state general obligation bonds to fund grants from the California Institute of Regenerative Medicine to educational, non-profit, and private entities for: (1) stem cell and other medical research, therapy development, and therapy delivery; (2) medical training; and (3) construction of research facilities. Dedicates $1.5 billion to fund research and therapy for Alzheimers, Parkinsons, stroke, epilepsy, and other brain and central nervous system diseases and conditions. Limits bond issuance to $540 million annually. Appropriates money from General Fund to repay bond debt, but postpones repayment for first five years. Summary of estimate by Legislative Analyst and Director of Finance of fiscal impact on state and local governments:State costs of $7.8 billion to pay off principal ($5.5 billion) and interest ($2.3 billion) on the bonds. Associated average annual debt payments of about $310 million for 25 years. The costs could be higher or lower than these estimates depending on factors such as the interest rate and the period of time over which the bonds are repaid. The state General Fund would pay most of the costs, with a relatively small amount of interest repaid by bond proceeds.(19-0022A1.)

The Secretary of States tracking number for this measure is 1880 and the Attorney General's tracking number is 19-0022.

The proponent of the measure, Robert N. Klein, must collect signatures of 623,212 registered voters (five percent of the total votes cast for Governor in the November 2018 general election) in order to qualify it for the ballot. The proponent has 180 days to circulate petitions for the measure, meaning the signatures must be submitted to county elections officials no later than June 15, 2020*. The proponent can be reached c/o James C. Harrison of Remcho, Johansen & Purcell, LLP at (510) 346-6203. The address for Remcho, Johansen & Purcell, LLP is 1901 Harrison Street, Suite 1550, Oakland, CA 94612.

*Date adjusted for official deadline, which falls on a Sunday (Elec. Code 15)Source: CA. SOS

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SmartTRAK Launches New Website that Speaks Directly to Customer Needs – MarTech Series

December 21st, 2019 5:42 pm

SmartTRAK recently redesigned SmartTRAK.com to prioritize key information for various functional groups as their customer base continues to expand

BioMedGPS, the developer of SmartTRAK Business Intelligence, is excited to announce the launch of their new website, Smarttrak.com. SmartTRAK offers a suite of advisory services for the life sciences industry including real-time online business intelligence and custom consulting.

The new SmartTRAK.com features a clean uncluttered design, improved functionality and enhanced custom content. It allows for medical device professionals to self-identify and learn how SmartTRAKs services, data, and industry insights help meet their specific professional needs. Visitors can learn how SmartTRAK can help streamline their workflow, saving them time while keeping them ahead of the market.

Marketing Technology News: Users Reveal Top Five SMM Vendors of 2019 for User Satisfaction Through SoftwareReviews

The newly launched site also spotlights our industry analysts all who are experts in their fields with years experience working for some of the biggest players in the industry. Visitors can sample articles, analyses and white papers put out by SmartTRAKs team.

Users can also view SmartTRAKs offering by market coverage including orthopedics, wound care, regenerative medicine and neuro therapies. Visitors can quickly pinpoint what coverage they would need and also quickly assess any future needs.

Marketing Technology News: MindTouch Enhances Salesforce Integration for an Improved Customer and Agent Experience

The new site, content and improved functionality speak directly to the needs of our customers. We believe that this new website will allow our visitors to have a very informative experience as we continue to grow, states Sharon OReilly, CEO, and President of BioMedGPS.

Medical device manufacturers who have business intelligence needs are encouraged to reach out to SmartTRAK to learn how SmartTRAK can support their teams.

Marketing Technology News: Ameriprise Financials New Customer Relationship Management System Helps Advisors Deliver Best-in-Class Service

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Can the axolotl teach us to regenerate? – Big Think

December 21st, 2019 5:41 pm

It has long been understood, and by cultures too various to list, that salamanders have something of the supernatural about them.

Their name is thought to derive from an ancient Persian vocable meaning 'fire within', and for at least 2,000 years they were believed to be impervious to flames, or even capable of extinguishing them on contact. Aristotle recorded this exceptional characteristic, as did Leonardo da Vinci. The Talmud advises that smearing salamander blood on your skin will confer inflammability. Not so. But the intuition that salamanders possess fantastical powers is not unfounded.

Like earthbound immortals, salamanders regenerate. If you cut off a salamander's tail, or its arm, or its leg, or portions of any of these, it will not form a stump or a scar but will instead replace the lost appendage with a perfect new one, an intricacy of muscle, nerve, bone and the rest. It will sprout like a sapling. Science has been chopping up salamanders for more than 200 years with the aim of simply understanding the mechanics of their marvels, but more recently with the additional aim of someday replicating those marvels in ourselves. Might salamanders be the great hope of regenerative medicine?

The salamander in which regeneration is most often studied is an odd and endearingly unattractive Mexican species known as the axolotl. In addition to its limbs and extremities, the axolotl is known to regrow its lower jaw, its retinae, ovaries, kidneys, heart, rudimentary lungs, spinal cord, and large chunks of its brain. It heals all sorts of wounds without scarring. The axolotl also integrates the body parts of its fellows as if they were its own, without the usual immune response, and this peculiar trait has facilitated some of the more grotesque disfigurements it's endured in the name of science. In experiments after the Second World War, East German scientists grafted small axolotls crosswise through the backs of larger ones. The animals' circulatory systems came to be linked, and the researchers hailed the conjoined mutants as triumphs of collectivism. While the axolotl can rebound from almost any bodily humiliation, it seems that humankind is proving too much for it: we have all but destroyed its natural habitat, and, outside of laboratory aquaria, it is nearly extinct.

In its most common form, which scientists call the white mutant, the axolotl resembles what the translucid foetus of a cross between an otter and a shortfin eel might look like. On the internet, it is celebrated for its anthropoid smile; in Mexico, where the Aztecs once hailed as it as a godly incarnation, it is an insult to say that someone looks like one. Behind its blunt and flattened head extends a distended torso resolving into a long, ichthyic tail. The axolotl can grow to nearly a foot in length; four tiny legs dangle off its body like evolutionary afterthoughts. It wears a collar of what seem to be red feathers behind each cheek, and these ciliated gill stalks float and tremble and gently splay in the water, like the plumage in a burlesque fan. They grow back if you cut them off, too. Precisely how the animal accomplishes this, or any of its feats of regrowth, is not well understood.

Like the axolotl, our evolutionary forebears seem to have been regenerators, and human children can in fact still regrow the tips of their fingers above the final joint, but that's the only complex regeneration we're known to do. We are, instead, a species that scars. Why our lineage lost its regenerative birthright is unclear. From our present evolutionary vantage point, however, it might be nice to get back what we lost. Amputees could recover their limbs; paralytics could walk; degeneration and decline of all sorts might be reversed.

Last year, after a long effort by an international consortium, the axolotl genome 10 times the length of the human genome was finally sequenced. In early 2019, it was mapped onto chromosomes by a team at the University of Kentucky. (It is, for the moment, the longest genome ever sequenced by far.) Jessica Whited, who heads an axolotl lab at Harvard Medical School, told me that, for those who hope to someday make regeneration available to human medicine, the axolotl is a perfect instruction manual. Its language simply needs decoding.

Regeneration is not, however, the axolotl's only biological extravagance, or prime mystery. Another puzzle of the axolotl concerned what it was. Most salamanders begin their lives as aquatic larvae, like tadpoles, before metamorphosing into terrestrial adults, but the axolotl seems to be a lifelong adolescent, the so-called 'Peter Pan of salamanders', remaining in its larval stage even as it arrives at sexual maturity. This retention of juvenile traits, a phenomenon known as neoteny, perplexed taxonomists, and for decades they debated whether it ought to be considered a species of its own or merely the larval form of the common tiger salamander. Confoundingly, on occasion the axolotl could be goaded (under what conditions remains unclear) into a final transformation, absorbing its gills and fins, and walking out of the water. In biological terms, the scale of this change is akin to a middle-aged human one day broadening her shoulders, lurching forward on her hands and loping off to the jungle to be a gorilla. In France, the Grand Dictionnaire Universel du XIXe sicle (1866) declared the axolotl 'the most imperfect, the most degraded of all the amphibians': a fallen creature, but also one that could accede, as if by grace, to a higher state of being.

Humans are attuned to this sort of qualified possibility. In 1920, the British biologist Julian Huxley found that he could cause axolotls to metamorphose by feeding them bits of sheep thyroid. The Daily Mail declared that Huxley had discovered 'The Elixir of Life'. Huxley's younger brother, the writer Aldous, adopted the axolotl as a metaphor for mankind, its peculiar neoteny an emblem of our incompletion, our frustrated potentiality. A number of his literary contemporaries became neoteny-boosters. Gerald Heard, the philosophising scholar, maintained in 1941 that the survival of mankind would depend upon individuals 'who manage to retain, with full mental stature, the radical originality and freshness of a vigorous child'; John Dewey and Timothy Leary held similar views. More recently, the Mexican sociologist Roger Bartra has proposed the axolotl, in its neotenous indeterminacy, as a symbol of his country's national character.

If the axolotl mirrors us so nicely, it's fitting that we, too, are neotenous. Our flat faces, small noses, hairless bodies and upright postures are all features of infancy in our evolutionary cousins and forebears. We also spend more of our lives in a juvenile state than any other primate. Our brains grow rapidly for a longer period, and are consequently larger; our childhoods are greatly extended, providing occasion for the lengthy training of those brains. We also maintain throughout our lives a 'remarkable persistent juvenile characteristic of investigative curiosity', in the words of the zoologist Konrad Lorenz. 'The constitutive character of man,' Lorenz wrote in 1971, 'is a neotenous phenomenon.'

Some affinity seems to have drawn us to the salamander since well before we fantasised in a serious way of regrowing our bodies how the salamander regrows its own. Perhaps this is what spurred the ancients and the Aztecs to ennoble the animals through mythology. Nowhere has the intuition of kinship been rendered more plainly, though, than in the Argentinian surrealist Julio Cortzar's short story 'Axolotl' (1952). Cortzar writes of one man's quiet obsession with the animals, whom he visits every day at an aquarium. 'After the first minute I knew that we were linked,' the man says, 'that something infinitely lost and distant kept pulling us together.' He watches through the glass tank until, one day, almost imperceptibly, he finds himself suspended in the water beside the creatures, transmuted into one of them, peering out at his former human soma peering in. 'Only one thing was strange: to go on thinking as usual,' the erstwhile man says, 'to know.'

This article was originally published at Aeon and has been republished under Creative Commons. Read the original article.

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Orthopaedic Surgeon, Dr. Jeffrey Carlson, first in Central and Eastern Virginia to implant the M6-C Artificial Cervical Disc – OrthoSpineNews

December 21st, 2019 5:41 pm

NEWPORT NEWS, Va.,Dec. 18, 2019/PRNewswire/ Orthopaedic and Spine Center announced Dr.Jeffrey Carlson, Orthopaedic Spine Surgeon, became the first surgeon in Central andEastern Virginiaarea to implant the M6-Cartificial cervical disc. The outpatient surgery was performed on a 53 year old female at Bon Secours/Mercy Health Mary Immaculate Hospital inNewport News, VirginiaonNovember 20, 2019.

The patient reported symptoms of severe neck pain which radiated to both shoulders after a motor vehicle accident. After she failed to respond to conservative treatment, an MRI was ordered revealing severe spinal stenosis and spinal cord abutment at level C3-4 caused by a herniated disc. In consultation with Dr. Carlson, the patient made the decision to have cervical disc arthroplasty, using the Orthofix M6-C artificial cervical disc.

Ive been waiting for the right patient with the appropriate diagnosis to employ the M6-C disc, said Carlson. The technology used in this procedure facilitates a speedy recovery with minimal limitations and a great outcome, so that my patient can get back to her active life. She just had her two week post-surgical follow-up appointment her recovery is going very well and she feels much relief from the severe pain she once experienced.

The M6-C disc received U.S. Food and Drug Approval in February 2019.It was designed to closely mimic the anatomic structure of a natural disc as well as provide an effective alternative to a spinal fusion. By allowing the spine to move naturally, the M6-C artificial disc potentially minimizes stress to adjacent discs and other vertebral structures.

AboutJeffrey R. Carlson, M.D.Dr.Jeffrey Carlsonhas been a part of Orthopaedic & Spine Center since 1999 and serves as the President and Managing Partner. He is a board-certified, fellowship-trained orthopaedic surgeon who focuses on the treatment of injuries and disorders of the spine.

About Orthopaedic & Spine CenterOrthopaedic & Spine Center (OSC) is staffed by outstanding medical professionals who strive to provide the very best orthopaedic and interventional pain management care available anywhere. Our Center includes a comfortable, state-of-the-art medical facility, pleasant and well-trained personnel, physicians trained in the most advanced orthopaedic treatments, interventional pain management procedures, regenerative medicine, using stem cell and platelet therapies and a dedication to old-fashioned patient care.

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Whats The Real Difference Between Organic And GMO? – Forbes

December 21st, 2019 4:46 am

As the new year approaches, food is front and centerits stocked in our homes for gatherings with friends, offered at office holiday parties and constantly on our minds as we plan menus for family dinners or brainstorm next years healthy eating plan. Its a seasonable time to consider what happens to your food before it hits your plate. And for many consumers, thats something of a puzzle, particularly when it comes to understanding organic versus GMOsor genetically modified organisms.

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Asking questions like Is organic non-GMO? and How do GMOs compare to organic food? can help you make better sense of what youre feeding yourself and your loved ones. Heres a helpful guide to boost your knowledge and inform your nutritional choices all year round.

The World Health Organization (WHO) defines GMOs as organisms whose genetic materialor DNAhas been altered or modified in some way that does not occur naturally. In most cases, genetic engineering works by transferring individual genes from one organism to another. Most commonly found in crops such as soybeans, corn and canola, GMOs are designed to provide a higher nutritional value to food, as well as protect crops against pests.

Organic foods, on the other hand, do not contain any pesticides, fertilizers, solvents or additives. According to the Organic Trade Association (OTA), USDA-certified organic foods are grown and processed according to strict federal guidelines that cover everything from soil quality and pest control to animal raising practices. Similarly, organic livestock raised for meat, eggs and dairy products must be given organic feed, and cannot receive antibiotics, growth hormones or any animal by-products.

Is organic non-GMO?

Theres plenty of debate surrounding GMO and organic food, which can make grocery shopping around the holiday season a harrowing experience. Making a key distinction can go a long way.

For those looking to avoid the use of chemical pesticides, along with the high costs of organic food, non-GMO products are a viable alternative. Thats because non-GMO products dont contain any GMO ingredients. However, that doesnt mean they are grown organically.

Organic isand always has beennon-GMO, says Laura Batcha, CEO and executive director of the OTA. But non-GMO is not always organic.

Understanding the pros and cons of both options can also empower consumers. Heres how industry experts weigh in:

Why GMO?

Why organic?

A critical eye

So what are the shortcomings of GMOs and organic items? Common arguments against GMOs include the consumption of harmful bacteria and toxins, increased risk of allergic reaction and outcrossing, or the mixing of crops from conventional seeds with GM crops, which may have an indirect effect on food safety and food security, reports WHO.

Opponents of organic food argue that its significantly more expensive than GMO or non-GMO foods, has a shorter shelf life compared to GMO foods and may have higher bacteria levels due to limited pesticide and herbicide usage.

How to make the right choice for you and your family

Both categories of foodnon-GMO and organicare subject to strict regulatory guidelines and have gone through rigorous verification programs. That alone may provide consumers with the peace of mind theyre looking for when holiday grocery shopping.

If organic is the way you want to go, Batcha offers these tips to get the best bang for your buck:

Shop smart: Look for specials on organic products, and buy in bulk whenever you can to cut costs.

Prioritize: Think about what your family eats a lot of, and what your healthy eating priorities are.

Comparison shop: Organic fresh produce is sometimes sold at the same price as conventional, so check out organic produce aisles.

Pick and choose carefully: While conventional milk can be cheaper, recent research published by Cambridge University Press suggests that organic milk is free of pesticide and antibiotic residues. If your family drinks milk, its worth the extra cost to buy organic.

A little common sense goes a long way, too. Cookies, cakes and other sugar-laden treats, even if organic, are still not the healthiest option. And if you really want to know what youre eating, try cooking from scratcheven if it means incorporating some DIY cooking hacks. Understanding the differences between organic vs. GMO foods will allow you to provide your loved ones with the right nutritional options.

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Whats The Real Difference Between Organic And GMO? - Forbes

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2020s visions: We’ll get flying cars just before becoming software-based people – CNET

December 21st, 2019 4:46 am

UberAir is planning on taking to the skies over Melbourne by 2020, even if that seems highly ambitious.

In some ways, the future that so much science fiction promised us is already here. We have genetically altered humans, conversations with computers and robots that run around the woods and do backflips.

But the decade beginning in 2020 will take us even further toward a world where far-out ideas like hooking brains up to computers -- and even immortality -- become topics of serious conversation.

Vivek Wadhwa, author of the 2017 book The Driver in the Driverless Car, expects that along the way, several other major advances will be in common use by 2030, including the ever-delayed flying car, medical tricorders, bionic exoskeletons and unlimited clean energy.

"Some technologies will take longer to reach the masses than others, but they will be at hand," he tells me. "The 2020s will be when the incredible promises of technology finally happen."

As 2019, the year in which Blade Runner was set, draws to a close, here's a deeper look at what the next 10 years will bring.

Predicting that George Jetson's or Rick Deckard's favored method of commuting is just around the corner has become the ultimate futurist's faux pas, but here we are again. The barrier to flying around town isn't technology at this point; it's laws and logistics. A number of small companies make flying cars right now, but most require a pilot's license and might cost as much as a helicopter, preventing airborne autos from becoming a replacement for the average driver's Prius anytime soon.

What could happen for the rest of us is a system of flying taxis. Uber hopes to beta-test limited flight-sharing in select cities using small, electric VTOL (vertical takeoff and landing) vehicles as soon as 2023.

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1:18

The driverless future will arrive much sooner. A Tesla can already valet-park itself and take the wheel on the highway -- not completely self-driving, but a start. Several other automakers aim to catch up in the next few years, moving toward fully autonomous driving by the mid-2020s. There's even been a rumor that Apple could create a driverless electric car that adds augmented reality or some sort of smart displays to the concept by 2025.

But engineer, inventor and former BT "futurologist" Ian Pearson sees our self-driving destiny playing out differently.

"I think there's going to be a shock in the 2020s on that one," he says.

Pearson envisions bans on personal cars in city centers in favor of electric "pods" (sometimes called personal rapid transit) that would be inexpensive and basic -- perhaps akin to big, covered golf carts -- running on designated roadways and controlled from riders' phones.

The future of moving around cities could be pods like these in use at London's Heathrow Airport.

If you're looking to go farther than just across town, Elon Musk has promised he'll be ready to ferry us around the globe on super-fast flights via space using the same rockets he hopes will begin carrying humans to the moon and Mars in the 2020s.

Musk has always been a little loose with meeting self-imposed timelines -- SpaceX took several years longer to get its commercial space business off the ground than the founder initially promised -- so it's tough to say how soon regular folks might be catching a ride on his Starship. Other space companies like Virgin Galactic and Blue Origin are closer to ferrying space tourists in the next few years, at least for a quick joyride in the skies.

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The 2020s are opening with millions speaking to digital assistants, and the decade will see the ways we interact with computers evolve and even surpass how we communicate with other humans.

Bill Gates said earlier this year that natural language inputs and AI voice assistants will improve to the point they might be able to fill the role of a human secretary.

"I do think that we'll have executive assistant-type capability in a five- to 10-year period," Gates told MIT Technology Review in the above video.

Pearson thinks that instead of talking to smart speakers or phones, we could soon be conversing with our own eyeballs. He says he first thought up the idea for an "active contact lens" back in 1991. The notion of an augmented reality display floating on your cornea would have been perfect cyborg sci-fi movie fodder back then, but now at least one startup seems to have it just about worked out, with a tiny display that seems just right for embedding in contacts.

We'll soon see if hiding your screen on your eyeball is appealing, but Elon Musk is already thinking one step ahead. His startup Neuralink is just one outfit working on brain-computer interfaces that use our thoughts as input mechanisms rather than taking the time to type, speak or gesture our commands.

Musk hopes to demonstrate the technology with paralyzed patients in 2020, and by 2030 it may become significantly easier to communicate with the digital world than the human sitting next to you.

In 2030, artificial intelligence may be as smart as your biological friends.

"I think that in three to five years you will see a computer system that will be able to autonomously learn how to understand," IBM Watson lead developer David Ferrucci says in 2018's Do You Trust This Computer. "Not unlike the way the human mind works."

Famed futurist Ray Kurzweil has been claiming for years we'll have humanlike AI by 2029. He doesn't see it, though, as the start of the robot apocalypse (as some, including the late Stephen Hawking, have predicted), but rather as a new era of liberation from the limitations of human biology.

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18:31

Kurzweil laid out his vision in his 2005 book The Singularity is Near, and he's doubled down on it over the years. His basic idea is that advanced AI and nanotechnology will perfect our bodies and enhance our brains in such a way that we're not cyborgs, but our best selves: funnier, smarter, sexier and resistant to disease. But that's just the beginning.

All this comes, according to Kurzweil, by 2029, just in time for a new era when we can upload our minds to become fully software-based people, leaving our bodies behind to live forever in the cloud.

But that's predicted for the 2030s. You'll have to check back in a decade for how that pans out.

The genetic engineering genie has been let out of its bottle, with the first children allegedly born from engineered embryos living anonymously somewhere in China today.

Less illicit uses of gene-editing technologies like CRISPR/Cas9 (which acts like a pair of molecular scissors for DNA) will continue to move forward to help tackle disease and force us to wrestle with the ethical questions involved in the inevitable era of "designer babies" who have their genes altered to match the whims and desires of their parents.

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Zoltan Istvan, author and Republican candidate challenging President Trump for the 2020 GOP nomination, says an emerging related technology called in vitro gametogenesis could soon shift how we approach infertility and having children. The process basically allows for sperm or eggs to be created from an individual's stem cells.

"It could change how women approach their lives, since they will no longer be on a timetable. ... They'll be able to have children at any age," he tells me. "This tech can also be used for men, and individuals may not even need partners anymore to have children."

Istvan expects the approach could be tested on humans within two to four years and commercially available by 2027.

In the meantime, look for more medical innovations, like a male birth control pill, chips implanted in the brain to give memory a boost and 3D-printed organs.

It's easy to go down the rabbit hole of optimistic outcomes, but there's also a darker timeline to consider. We may already be witnessing the opening scenes of multiple tragedies that could play out over the next decade. Here are just a few:

SpaceX alone hopes to nearly quintuple the 8,000 satellites launched since the dawn of the space age by middecade. Its competitors aim to launch their own mega-constellations of hundreds or thousands more satellites. Collisions in a congested orbital space over Earth could lead to a worst-case scenario called "Kessler syndrome," in which orbit becomes so full of debris it's no longer safe for astronauts or satellites. We would say goodbye to GPS, satellite communications and space exploration for some time.

This image of a distant galaxy group from Arizona's Lowell Observatory is marred by diagonal lines from the trails of Starlink satellites shortly after their launch in May.

At this point, most experts agree that better robots, artificial intelligence and automation will displace millions of workers in the 2020s. The impact on society and what we do about it may shape the coming years.

Istvan and Democratic presidential candidate Andrew Yang are among the politicians already campaigning on the issue of implementing a universal basic income as a safety net for those who inevitably lose their jobs to tech.

And what about all the potential nightmares we're already navigating online, from deepfakes to concerns over privacy?

"Advances in artificial intelligence will open up new opportunities for mass surveillance and mass-manufactured emotional manipulation," Interchain Foundation President and Tendermint CEO Jae Kwon says. "It will get worse before it gets better."

I've ignored the elephant on the barstool in the corner: a climate and environmental crisis that's already in motion and stirring up deadly extreme weather events with increasing frequency and leaving plastic waste in nearly every nook and cranny of the planet.

To echo Kwon, this also will get worse before it gets better.

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But technology loves nothing more than a big problem to solve, and plenty of possible solutions could take off in the next decade. It may be the long-promised holy grail of clean fusion power, or the notion of replacing all those planet-warming fossil fuels with the very carbon dioxide that they produce (technologies already exist to capture CO2 and convert it into raw materials).

"I also think we'll see some quite advanced materials arriving, like spray-on solar [photovoltaic power] films," Pearson says. "We'll also see water supply being solved in the developing world with desalination and water collection tech."

Author and MIT scientist Andrew McAfee is so confident technology will help us turn around the mass consumption streak weighing so heavily on the environment that he's inviting people to take him up on a bet the US will consume less energy in 2029 than it does in 2019.

So far, no one has taken that bet. Interestingly, Kurzweil has put down money on his own bet that a machine will pass a test of "human-level intelligence" by 2029.

Let's plan to meet back here in a decade to see who's right. Or just look me up in the cloud.

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Viewpoint: Confused about GMOs and pesticides? Here’s a science-based handbook for combating anti-biotech fallacies – Genetic Literacy Project

December 21st, 2019 4:46 am

Junk science is everywhere these days. From scare stories about pesticides to allegations that genetic engineering threatens humanitys future, the internet teems with misinformation about food, farming and biotechnology. A recent (and very disappointing) example comes from the usually reputable Scientific American. In August, the news outlet ran an opinion piece claiming that vegetables today are less nutritious and more toxic than they were in years past:

Why are nutrients in our food declining? Well, for one, we are killing the soil it grows in. Prodigious use of biocides (herbicides, insecticides, fungicides, as well as synthetic chemical fertilizers and antibiotics) kill or disrupt soil microorganisms that allow plants to absorb nutrients. Also, increased atmospheric CO2 is accelerating photosynthesis; plants grow faster but contain fewer nutrients, which is expected to lead to worldwide nutrient deficiencies. Vegetables becoming more like sugary snacks? Not good.

Experts quickly pounced on Scientific American for running an article filled with so many inaccuracies, which was later updated to address some of this criticism. For the record, no, your vegetables arent morphing into sugary snacks, and pesticides arent killing the soil. Theyre a necessary part of any farming systemand becoming more environmentally friendly as time goes on. This story was but one example of the mass of misinformation that proliferates online, poisoning discussions about important technologies and threatening to grind innovation in agriculture to a halt.

With so much on the line, scientists are pushing back against the misinformation onslaught. My colleagues William Kerr and Peter Phillips at the University of Saskatchewan and I are aiding that effort with a new book that takes on a variety of common myths surrounding food production and crop biotechnology: GM Agriculture and Food Security: Fears and Facts.

As academics, the three of us have researched and written about agriculture, biotechnology, food and innovation for more than 20 years, with over 400 publications between us. We certainly dont know everything, but we wanted to share our insights with those interested in separating sound science from media and activist hype.

Do farmers really need pesticides?

Have you ever wondered why farmers use chemicals in their fields? To inform readers about the reasons for farm pesticide use, we discuss how proficiently weeds produce seeds compared to domesticated plants. Weeds frequently produce 1,000 seeds or more every summer. Kochia, a noxious weed in all parts of Canada, is capable of producing 25,000 seeds per year. By comparison, a really good head of wheat produces 40 seeds, but would normally produce 25-35. If farmers didnt use chemicals to control weeds, within a few years, weeds would dominate the entire field, making it difficult to grow a crop.

How GMOs help save our forests

Perhaps youve also pondered how we will sustainably feed 10 billion people, the projected global population by 2050, without cutting down millions of acres of forest. Currently, roughly 800 million people dont get enough to eat on a daily bases, so we felt it was necessary to discuss how innovations in food production have already sustainably increased crop yields around the world, and are poised to continue doing so.

Hawaiis papaya industry was decimated in the 1990s by a disease known as ring-spot virus. Virus-resistant papaya varieties have since allowed Hawaiian farmers to not just save their livelihood but actually increase their production. Likewise, newly developed gene-edited sorghum doubled crop yields of this African staple food in a recent study, fueling expectations that CRISPR is going to have a revolutionary impact on agriculture.

A related question, often asked and answered by organic farming proponents, is whether locally sourced food is capable of meeting the increasing global demand for calories. Many people enjoy the fruits and vegetables they grow in their backyard gardens, so the romantic notion that locally produced food is capable of combating hunger around the world sounds plausible. But we highlight the many reasons why local food self-sufficiency should not be viewed as equivalent to food security.

Food processing is essential to ensure harvest production spikes are leveled out, thus preventing food price spikes months later. Societies that are forced to rely on locally produced crops are more likely to face market disruptions and food insecurity as a result. The discrepancy between popular ideas about sustainable farming and what science says on the topic leads us to another issue worth exploring.

The assault on expertise

400 years ago, Galileo was castigated by the authorities of the day for arguing that the sun, not the Earth, was the center of our universe. We sometimes doubt that much has changed over the last four centuries, as todays experts are often ridiculed for defending scientific facts against attacks from ideological activist groups.

The three of us strongly believe that consumers should know who the experts are: people with degrees who spend their careers conducting original research. This is essential because the discussion around crop biotechnology has become a pitched political battle as anti-GMO activists continue to spin conspiracies to undermine the credibility of academically trained scientists. The work of US Right to Know, an organic industry-funded special interest group, illustrates this point. The anti-GMO outfit has filed freedom of information requests on over 50 university faculty that have published peer-reviewed journal articles that quantify the benefits of GM crops. Two of us belong the group of academics that USRTK has targeted. Our private communications were posted online out of context, and this information has been used to accuse us of shilling for the biotech industry.

To help combat the assault on expertise, we examine the difference between science and opportunistic activism. Science, simply put, is a process that leads to compilations of knowledge. As research methods are agreed to and standardized, carefully conducted experiments expand our understanding of a given scientific topic. Activism, meanwhile, involves cherry picking data that fits a predetermined conclusion. Claims that the weed killer glyphosate cause cancer are often justified with reference to such cherry-picked research.

This isnt to say a new study that contradicts all of the known literature is incorrect, but it should trigger additional research to confirm, or reject, the new findingsbefore activist groups and the press promote any particular conclusion.

What you should know about factory farming

An equally important topic of discussion is so-called industrial agriculture. Many urban consumers that no longer enjoy close connections to agriculture tend to view farms as small, red-barn operations, like the ones our grandparents generation ran. The reality of todays multi-thousand acre, million-dollar-equipment farms is largely incomprehensible to most consumers, which needs to change if society is going to have an informed conversation about the benefits and challenges of modern food production.

While we highlight the economic and environmental benefits from the commercialization of GM crops in various countries, the consolidation within the seed development industry raises legitimate concerns. For example, the increased cost of obtaining regulatory approval for GM crop varieties has become so high that public university researchers are beginning to avoid genetic modification as a plant breeding technology. The regulatory headache and expense are simply not worth it to them.

Meanwhile, much of society is fixated on consolidations at the start of food supply chains, rather than consolidations that have occurred within the food processing and retail sectors. Companies such as Kraft and Walmart have far more influence over the products available in grocery stores than the agricultural firms at the start of the supply chain, yet virtually no attention is given to firms that are closer to consumers.

Mergers and acquisitions within the grocery retail sector can lead to increased market power in the hands of a few large, global firms, which in turn creates the potential for higher prices due to reduced competition. Retail firms have far more power over the price we consumers pay for food than the firms at the start of food supply chains.

Focus on the future

The internet has put limitless amounts of information at our fingertips. Sadly, much of it is misinformationjunk science meant to skew our perception of important topics like food safety and biotechnology. The risk this poses cannot be overstated.

Producing an abundant food supply to economically and sustainably feed a world population of 9+ billion people is a Herculean task. Innovative plant breeding technologies can help us do it, but these advances are being threatened by arduous, unnecessary regulations and deliberate misinformation campaigns led by activist who see mainstream science as a threat to humanity. The only long-term solution is an informed populace that wont be fooled by propaganda.

Stuart J. Smyth is a professor in the Department of Agricultural and Resource Economics and holds the Industry Funded Research Chair in Agri-Food Innovation at the University of Saskatchewan. Follow him on Twitter

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The rise of identity politics is a reminder of Haldane’s worst fears about genetic manipulation – The National

December 21st, 2019 4:46 am

When I first heard about JBS Haldane years ago, I only knew about the final act of his life: that he was a British biologist who moved to India, became a citizen there and died there in 1964. Even that sliver of detail was intriguing. Scientists usually moved from India to the West. What prompted this man to travel in the reverse direction?

Four years ago, I started to examine his life in more detail and grew steadily more fascinated. Here was a man who, as a boy, was often a guinea pig for his scientist father; who wrote his first scientific paper when he was in the trenches during the First World War; who went repeatedly to Spain to help fight Francisco Francos fascist forces; who ruined his body in experiments for Britain's Royal Navy during the Second World War; who got into constant tussles with every kind of authority figure; and who wrote reams of elegant essays on science for the lay reader.

But where Haldane really spoke to me, across the years, was in his astute thinking about how science and politics intersect. Over the past few decades, we have lived in a time when scientific objectivity is often confused for apolitical neutrality. Climate change aside, scientists hardly ever took political stances, or expressed their views on matters of ideology, or occupied the sphere of the public-interest intellectual.

This was not always the case, though. In the first half of the 20th century, during Haldanes time, scientists were vociferous about their politics and their stances on social issues Haldanes own voice the loudest of them all. He decried imperialism and exploitative capitalism. He criticised British and American government policies. He never made a secret of his radical politics and eventually became a card-carrying member of the British Communist Party.

His own scientific field genetics was perhaps the most politicised area of study in his time, and he recognised that. Even while the fundamentals of genetics were being established, the West fretted about their implications. Britain and America worried that the white race was being diluted because the feeble-minded and feeble-bodied were allowed to reproduce, or because immigrants and people of colour were having children with white men and women. The state machinery moved to prevent this. In Britain, about 65,000 people were segregated because they were considered unfit to reproduce. In America, an equal number of people were sterilised.

Haldane lambasted these measures, calling them not only unethical but also unscientific. Similarly, when Nazi Germany formulated racial purity laws and marched towards ethnic cleansing, Haldane excoriated that false science as well. The Nazi doctrine of "blut und boden" blood and soil was rubbish, he wrote witheringly. The only way blood differed was in its basic groups A, B, O and AB so the characteristic of a race is not membership of a particular blood group". And none of the soils of Germany were unique to it, he added. Friesland is not unlike northern Holland, Brandenburg is like western Poland.

Race was not a meaningful category in any sense, Haldane argued. The genes of people can vary more within a so-called race than between two racial groups a fact science has repeatedly confirmed

Like other members of his class and nation, Haldane grew up believing that some races were inferior to others. But as genetics progressed and its implications became clearer, he changed his views. Race was not a meaningful category in any sense, he argued. In fact, the genes of people can vary more within a so-called race than between two racial groups, he wrote a fact that science has repeatedly confirmed.

In his most famous essay, Daedalus, Haldane warned that as humanity refines its skills to manipulate its own genes, it will have to construct a new morality to deal with these powers responsibly. He recognised a fundamental truth: genetics is the science of differences and with such a science, the invasion of politics is inevitable.

Haldanes ideas ring with increased urgency today. All around us, we see the rise of identity politics of an exclusionary politics based on who belongs, or does not belong, to a nation. Who should or should not cross a border. Who should or should not be thought of as a citizen.

In India, Haldanes adopted home, the government has just passed a bill to expedite the citizenship process for refugees fleeing religious persecution from three of its neighbouring countries. Refugees of every faith except Islam have been promised a quick track to citizenship. The signal is loud and clear: Muslims do not belong here.

Around the world, communities and groups have come to believe that they are distinct, or special, or superior, even though science emphasises that this is false

Echoes of this are everywhere. In China, Uighurs are being segregated. In America, the president wants to build a wall to keep out Mexican and South American immigrants and refugees. In Britain, a narrative that the country should turn inward rather than ally itself with a larger union has conclusively won. There is sectarian strife in Lebanon and Iraq, and white nationalism in Europe. Around the world, communities and groups have come to believe that they are distinct, or special, or superior, even though science emphasises that this is false.

Toss genetic engineering into this mix and things only get more incendiary. Haldane was unequivocal in his belief that the social differences of class need to be stripped away. But at the moment, the danger is that if and when scientists figure out how to re-tailor the human genome, the rich will first buy themselves better genes. The inequalities of wealth will be compounded by new inequalities of ability and physiology. If we are not cautious, the gaps in human society will yawn wider and wider.

At a time like this, Haldanes life and work offer us plenty of guidance. He urged his readers and his students to adopt the scientists perspective of sceptical rationality: to question authority, to demand proof for received wisdom, to make decisions based on evidence.

But Haldane was not a proponent of scientism; he did not believe that peace and progress could be delivered exclusively through science.Haldanes university degree was in the classics, not in biology or chemistry or any other scientific discipline, and he always saw his field with the eyes of a humanist who had wandered into it.

He believed, therefore, that we have to consider our societys frailties and foibles, even as we decide what to do with new science and technology. We have to find ways to live with each other before we discover how science can best improve the human condition. And this is an urgent task. The march of science does not wait for us to grow mature enough to know how to use it wisely. He believed, therefore, that we have to consider our societys frailties and foibles, even as we decide what to do with new science and technology.

Haldane was, in his country and in his time, one of the most famous scientists around perhaps even as well-known as Einstein, and certainly the most politically vocal in his profession. Since then, he has sunk somewhat into obscurity. The 21st century, though, is an appropriate time to remember him and through his work, to rediscover lessons for our own age.

Samanth Subramanian is a regular contributor for The National. His latest book is titled A Dominant Character: The Radical Science and Restless Politics of JBS Haldane

Updated: December 21, 2019 11:17 AM

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Meet the Russian geneticist who wants to edit your children – Russia Beyond

December 21st, 2019 4:46 am

CRISPR, a tool used to edit genes, has the power to shape the future of the human genome. The international community is wary of the technology, but a lone Russian scientist says we should already be doing more tests...on human embryos.

Denis Rebrikov would have been following the news with great interest when CRISPR, a method for editing the genes of living organisms, made international headlines last year.

It was reported that a Chinese geneticist named He Jiankui had edited the genomes of twin girls without consulting the global scientific community. Known to the world as Lulu and Nana, the babies had their CCR5 gene altered in the womb in the hope of improving their resistance to HIV. When Hes experiments were made public, the Chinese authorities cracked down on his research, and the resulting international uproar led to further restrictions on human testing using CRISPR.

As it turned out, Rebrikov had already been planning his own tests for quite some time.

A geneticist himself, Rebrikov worked for years in relative obscurity at the Pirogov Russian National Research Medical University that is, until he went public with his intentions last summer to pick up the torch where He left off. When I see a new technology come forward, he says, I want to see how it works and how I can improve it. Where Rebrikovs vision differs from Hes is in whether or not experiments should be conducted openly or not. The Russian scientist believes everything should be done in the public eye, and with the involvement of the state.

Conversations over genome editing are nothing new for Russia. In fact, a public conversation on its national importance has been taking place over the past two years.

A watershed moment came in 2017 when President Vladimir Putin addressed a youth forum in Sochi. In some of his first public comments on the subject, the president described the technologys potential applications, from the medicinal to the military, calling its use (and potential misuse) as fearsome as the atomic bomb. Elsewhere he confirmed it as a technology that will determine the future of the whole world.

Accordingly, Russia has been investing heavily into genetic research. $2 billion was reportedly spent on establishing official research programs in 2017, with an additional $3.3 billion invested this past April. The payoffs when they come will be enormous. Not only may the health of the nation be improved: as with any technology, innovation brings with it a geopolitical edge. Words like biodefense have circulated within the upper echelons of Russian society, and major figures like Mikhail Kovalchuk (director of the Kurchatov Institute, made famous by this years Chernobyl series) have pushed for Russia to become a global leader in genetics.

This kind of environment is encouraging for figures like Rebrikov, who decided to go public in June with his intention to continue working with genes affecting HIV transmission. But there was difficulty in finding parents who were willing to participate in such a study, so Rebrikov changed course and decided to work with genes connected to hearing loss in children. He found five couples who would qualify for the experiment; one of which met with the scientist to discuss potential risks and benefits. The couple as of yet has not decided on whether they want to participate, even in theory.

Rebrikov hadnt gotten as far as He Jiankui before becoming an international sensation, but this was intentional: he may want the scientific community to know there are no secrets in his lab. For him, comparisons to nuclear weapons can be taken in his stride. The situation is completely analogous to developing an atomic bomb, he says. Can bad people use technology for bad purposes? Of course, but did ethical concerns stop the Soviet Union from doing so?

While international the reaction has not been as heated as it was with He, there have been numerous articles published in major journals like Nature and Science demanding that the international community pressure Rebrikov to stop any future applications of the technology. Some have gone as far as to call him rogue.

In contrast with policies in China and the United States, though, Russias response has been more cautiously optimistic. Whereas other global powers have placed effective moratoriums on embryonic genetic editing (with little chance of these policies changing any time soon), an official panel including leading Russian experts met in July to discuss the question. Figures ranging from Kovalchuk to prominent endocrinologist Maria Vorontsova were invited to speak at the gathering.

Human embryo

The scientist also receives support from the Pirogov Institute. Sergey Lukyanov, Rebrikovs colleague and former PhD advisor, says that his intentions are admirable: [He] is one of those people who takes action towards any imperfection of the universe that can, from his point of view, be corrected. For him, this is an opportunity to bring happiness to parents to have healthy children.

Rebrikov is not without his critics, however. Prominent researchers like Pavel Tishchenko, a bioethicist at the Russian Academy of Sciences (RAS) Institute of Philosophy, have called for increased restrictions. Tishchenko organized an ethics panel in October 2019 to review the case and is concerned that parents might not be aware of all the risks involved, or that ethics and regulatory committees might not be as rigorous as necessary.

One of the main questions that needs answering, Tishchenko has said, is who will bear responsibility for possible complications down the line. The edited genes in the Chinese twins might have effects beyond HIV resilience (especially as the CCR5 gene is linked to memory formation), and he claims that todays scientists are not equipped to make the necessary judgment calls.

The Russian Ministry of Health has since come out with an official statement calling genetic experimentation on humans premature. Interesting enough, however, no concrete regulations have been introduced that would definitively prohibit experiments like the ones Rebrikov suggests. Under the current rules, a grey zone exists that may allow for certain experiments depending on whether or not the embryos were created for research purposes or previously discarded, or on whether the experiments are conducted for research purposes or for a clinical trial.

For now, it seems like Rebrikov has put some of his plans on hold. He has said publicly that he will definitely not transfer an edited embryo without the permission of the regulator, but all the same has expressed frustration with the delays. I want the rules to be set, he said, but nobody is doing this. Moreover, the couple which consulted with him has not yet expressed interested in progressing further, and the global attention paid to his research may make any future missteps into a potential international incident.

But temporary setbacks are no guarantee that the status quo is going to last. The current regulatory limbo, despite the rhetoric from Rebrikovs critics, still allows for dramatic steps to be made in the future. And given the potential for genetic engineering to change the world, it may be that Russia may still allow Rebrikov and his team to develop their research further than any other scientist on the planet.

Only time will tell.

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How Plant Breeding Innovation is Different from GMO and how PBI can improve food security in Africa – THISDAY Newspapers

December 21st, 2019 4:46 am

By Bennett Oghifo

Africa has a big challenge with feeding its large population that is put at 1.3 billion as at 2018. Africas population is 16% of the worlds human population.

Food security in Africa is of global concern, considering its position as the worlds second-largest and second-most populous continent. According to available data, Africas land area is about 30.3 million km, including adjacent islands, and it covers 6% of the Earths total surface area and 20% of its land area.

Africans have been producing their food by tilling the continents vast arable land, using traditional methodsthat are now found to have diminishing returns.

Scientists recommend the use of more modern sustainable methods of food production in Africa. These scientists have narrowed down on two of these systems Genetically Modified Organisms (GMOs), and Plant Breeding Innovation (PBI).

The application of GMOs for food security has raised global controversies among proponents and those who oppose it, because of their belief that organic foods are healthier than inorganic.

Genetically modified foods, also known as genetically engineered foods, or bioengineered foods are foods produced from organisms that have had changes introduced into their DNA using the methods of genetic engineering.

On the other hand, Plant Breeding Innovation (PBI) should be understood in the context of New Breeding Techniques and Precision Breeding Techniques which refer to the tools and methods used to develop new varieties more precisely and rapidly, according to scientists. Precision is just the definition of the accuracy of the technique. It is applicable in both animals and plants. These tools are broad, among which is gene editing. Plant breeding innovations are those specific to plants.

So, PBI is critical for sustainability and food security, and benefits all in the food chain, including farmers and consumers.

Scientists say PBI is not a new concept; breeding has improved over the years. Latest technologies such as GMOs and products of genome editing are an advancement of science and breeding over the years, and are not bad, scientists insist.

They want policy makers to adopt regulatory policies that are science-based, proportionate to risk, and risk/benefit-based, predictable and promote innovations. And that gene editing techniques should not be put into the same category as GMOs.

According to a Scientist, Dr.Joseph Odusanya, the Chief Executive Officer of Biocrops, seed and seedling production company in Abuja, Nigeria,It is pertinent to establish that breeding has always been with us. It is from making positive selection, looking for elite characteristics and multiplying those.

Odusanya said plant breeding is the discipline but that genetic modification, gene transformation or productions of transgenic organisms are just techniques employed in the breeding process.

He said, Many breeding techniques include air layering, grafting, etc that do not change move or transpose or translocate DNA of plants like we do in GMO.Interestingly there is a paper that shows that plants undergo genetic modification on their own naturally. This has been documented. If nature can do it on its own, I wonder why all the hue and cry.

Odusanya stated that plant breeding has been with us for more than a century in various forms with increasing sophistication. GMOs on the other hand are fairly recent dating back only to the 1070s. The GMO technology is by itself getting very sophisticated as well.It has gone beyond introducing bioinsecticides or making plants selective to herbicides, today, we can decide on the amount of starches and the structure of the starches desired.

What we have today is pure designer series of organisms.Designer plants, designer animals and even humans have been engineered. Many ethical issues and probable scientific questions remain unanswered but when we consider the low hanging fruits of either GM technology or breeding as we know it traditionally, we will be doing our works loads of goodness by latching in on them early.

The world, he said was close on genetically modifying microorganisms that would recondition the soil naturally in such a way that degraded soils could be rejuvenated and use of mineral fertilisers will be cut by 95%.

Also discussing the difference between GMO and PBI and why they should not be subjected to the same regulatory policies, an avid Biotechnologist and Business Strategist in Kenya, Doris Wangari said, The creation of GMOs involves inserting genesfrom other speciesinto DNA through modern biotechnology techniques. Genome editing, on the other hand, allows scientists to alter the DNA of an organism without necessarily adding genes from a different organism (usually they use sexually compatible species).

Today, plant breeders can also use genome editing tools to introduce genetic variation. There are different types of genome editing tools such as site-directed nucleases (SDNs) and Oligonucleotide-Directed Mutagenesis (ODM). SDNs currently utilized in plant research include Meganucleases (MN), Zinc Finger Nucleases (ZFNs), Transcription Activator-Like Effector Nucleases (TALENs) and the Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-associated proteins. These Genome editing techniques are precise editing of an existing genome usually by deletion, substitution, silencing.

Wangari said in many instances the Genome edited end-product usually does not have the detectable foreign gene, hence term natural. This becomes hard for the regulators to regulate what they cannot detect. However, some aspects of Genome editing result in formation of GMOs like site-directed nucleases. There is therefore need for regulators to allow for early consultation with the researchers to understand the technique they will be utilising in their work so as to determine whether or not to regulate. This is the approach Kenya is taking.

On how farmers would benefit in terms of cost in ratio to yields, she said the Genome Editing techniques are still very new and that most of the work is still in research an trial phase. I am not sure the cost-benefit analysis has been done in some of the products as this is done in the last stage of research when they compare the performance of the GE product yields to farmers and conventional crops yields to determine the costs.

She said if Africas population is to be fed adequately, then new technologies must come into play. Feeding Africas population is a challenging task. My opinion would be for the various stakeholders to allow for an integrated approach when it comes to food production. We need to embrace new technologies which offer a chance to improve our agricultural systems.All things considered, Africa can no longer depend on traditional methods of agriculture to feed its population and would need all the modern technics of food production to ensure food security, said Professor Ismail Cakmak, Faculty Member, Faculty of Engineering and Natural Sciences, Sabanci University, Istanbul Turkey.

Prof. Cakmak, who was a resource person at a workshop OCP Africa organised in Lagos, Nigeria, in June, this year, believes GMOs or PBI requires sufficient amounts of fertilizers. There is no change in the demand for nutrients by GMO or Breeding. Even if you breed, you need more nutrients because they have higher yield capacity. The higher the yield capacity, the higher the nutrient demands.

OCP Africa is a subsidiary of OCP Group, a Moroccan company and the worlds largest producer and exporter of phosphate and phosphate-based fertilisers. The multinational company drives a bilateral partnership between Nigeria and Morocco on the supply of phosphate to blending plants in several states across Nigeria.

The scientist noted that production of more food in Africa would also be affected byclimate change, which he said had become a major challenge. Extreme weather condition has negative impact on plant grown, on yield capacity of the plant, because of temperature variation, flooding from excessive rainfall. These have huge impact on the yield capacity of the crop. The increase in yield of food crop will be limited in the next 10 years, 20, 30 years because of the increase in the number of environmental problems caused by climate change.

Prof. Cakmak, who had his PhD at Cornell University, Stuttgart Germany, said he was currently working with two professors from the UK and Australia to develop a programme on crop nutrition at theMohammed VI Polytechnic University, Morocco.

He is also working on the HarvestPlus programme to improve the micronutrient content of food crops, stating that HarvestPlus is a breeding programme, adding that there are a lot of breeding programmes in Nigeria by IITA.

There is an ongoing programme to enrich maize, he said, explaining that because HarvestPlus is a plant breeding programme that incorporates an Agronomic programme that uses fertilizer strategy to improve the micronutrient content of staple food crops by using micronutrient content fertilizer.

Prof. Cakmak said his other function is to coordinate the Agronomic Programme under the HarvestPlus Programme, explaining that for instance, they apply it on maize to ensure that it contains zinc, iodine, selenium, adding that the programme will start in Nigeria, Uganda, South Africa, Zambia, Zimbabwe, Mozambique, and Rwanda.

Regulations

It is a fact that Africa needs more food with nutrient content with the application of GM and Gene Editing, but these must be done with safety in mind, scientists say.

John McMurdy, the Director of Emerging Markets at CropLife International, Washington DC, in a presentation, Innovations in plant breeding at crossroads noted the goal of the African Seed Trade Association to promote the use of improved quality seed, wondering how the industry (and the agricultural research community) will take advantage of newer innovations in plant breeding, like gene editing or CRISPR technology.

He said governments worldwide make regulatory decisions on Gene Editing, stating that the transformational ability of gene editing platforms to make precise base pair deletions, edits, and additions makes the potential benefits of the technology quite remarkable.

However,the introduction of gene edited products into global markets has accelerated questions on how they should be considered from a policy standpoint, specifically whether or not some of these products should be assessed and managed under current GMO regulations or whether they should be managed in the same fashion as conventionally developed varieties, he said.

The global seed industry,McMurdysaid, encourages innovation in plant breeding, and advocates government policies that are based on sound scientific principles. Consistent science-based policies regarding products of plant breeding are necessary to ensure timely access to the benefits of products developed through these latest tools.

Inconsistent criteria, standards, and arbitrary categorisation applied to products of gene editing will inevitably impede investment and innovation in agriculture, and limit the realisation of societal and environmental benefits.

McMurdysaid lack of consistent criteria between governments especially trading nations also risks disrupting trade. A rationale solution promoted by the global seed industry is that: Plant varieties developed through the latest breeding methods should not be differentially regulated if they are similar or indistinguishable from varieties that could have been produced through earlier breeding methods.Many countries around the world are in fact adopting progressive policies consistent with aspects of this position, especially in South America (e.g. Argentina, Brazil, Chile and most recently Colombia).

As a primary trade partner, European governments and consumers often ideological view against GMOs has stifled and, in many cases, ground progress to a halt on the African continent, he said.

Outside of South Africa, and a few more recent examples of approvals of insect resistant cotton technology, the vast majority of public and private funded research remains either on the shelf or behind high fences under confined field trial.

While it remains to be seen whether the impasse will be broken on African farmers being afforded the same access to GMOs as farmers in much of the Western Hemisphere, recent decisions by the European court systems have the potential to similarly negatively impact gene editing technology.

In a late July 2018 ruling, the European court of justice ruled that the circa-2001 EU rules for GMOs shall also be applied to newer forms of targeted mutagenesis (including gene editing). This includes all of the onerous provisions that have effectively banned cultivation of GMOs in most of Europe (and, ironically, positioned them collectively as the worlds second largest importer of GMOs).

While the EU Commission now grapples with how to potentially implement these rules for a technology that they were not designed for, this decision shocked much of the EU based public research enterprise, seed industry, and food value chain.

African governments, McMurdy said are at regulatory crossroad, stating that African farmers could benefit significantly from gene edited products, noting ongoing research projects focused on improving disease resistance, pest resistance, drought tolerance and crop composition and nutrition in many indigenous and staple crops to Africa such as cassava, cowpea and banana.

It will be up to African governments and policy makers to set the landscape in which the African seed industry will be able to market and deliver these products, he said.

Some African policy makers, he said are insisting that, following the ECJ ruling,gene edited crops are GMOs for now and/or we need to put in place a system to look more closely at these technologies.

The dilemma, he said would be what policies are put in place, those of much of the world that is working to increasing sustainable production using gene editing and other plant breeding innovations, or policies mirroring the decision of a single 28 member European court on the interpretation of an 18 year-old regulation.

Presenting Genome Editing Applications in Crop Developments, Dr. Rashmi S. Nair of The Nair Continuum LLC said, Based on need to improve Agricultural productivity and increased knowledge of genomics, researchers have developed many new ways for breeding more productive, efficient plants using genome editing.

Regulators around the world have also been developing regulations to approve products developed using various genome editing techniques.

General agreement among many regulatory agencies is that where no new DNA is introduced, end-product should not be considered genetically modified.

However, the impact of the ruling of the EU Court of Justice to regulate most products developed using genome editing as GMOs is still being evaluated globally.

A Scientist in Nigeria,Dr.RufusEbegba, who is theDirector General,NationalBiosafetyManagement Agency (NBMA), believes Africas population can be fed using, among other methods, biotechnology, which he described as a scientific tool to develop new variety of living organism, whether plant, animal or microbes, and that as it concerns food, it should be looked at from the standpoint of improved crops and animals.

Ebegba said, Modern biotechnology that is being tailored towards safety is the application of biosafety to ensure that the products which are genetically modified are safe. For sure, it is a major step in ensuring food security.

For instance, in Nigeria right now, we have a National Biotechnology Development Agency (NBDA), we also have National Biotechnology Policy, we have agriculture policy that promotes the use of biotechnology, we also have agricultural research institutes and some Universities that are doing genetic engineering with the intent of producing genetically modified objects. All these show that Nigeria has put in place structures to adopt the use of genetically modified organisms.

Also, Nigeria has a law known as National Biosafety Management Act 2015, and this Act gave room for the establishment of the National Biosafety Management Agency.

The governments intention, he said was to ensure that the activities of biotechnology and its products are safe for human consumption and for the environment. In Nigeria, one major thing we also have is the National Biosafety Policy; we have also National Biosafety Regulation and Guidelines for various sectors.

According to him, Risk Assessment is a major step before any genetically modified organism can be used. So, Risk Assessment is very important to determine whether any genetically modified has any risk, if it can be tolerated and risk management strategies are also adopted.

He said food security has a lot of considerations and not just to make the food available, stating that the food must be affordable, have nutrients, and it should be wholesome and safe.

Stating the position of the Nigerian government, he said some permits had been granted for the introduction of some genetically modified crops, like the commercialisation of cotton for which permit has been granted, we also granted permit for the use of genetically modified cowpea, ie, beans also for commercialisation.

He said although these crops have not been fully brought to the market, but that the multiplication of the seeds were ongoing. Then, we have also granted permit to test for the efficacy of the modification of some of the crops like genetically modified cassava for increase in ion content, increase in Vitamin A content. We have also granted some permit to delay harvest deterioration in cassava and to increase the starch content.

There is also permit granted for genetically modified rice for nitrogen use efficient, water use efficient and soil tolerant, adding that these are on-gong processes.

Nigeria, he said has granted permit for genetically modified maize for the production of animal feeds and that the permit for soya beans was basically for the production of vegetable oil. These have been imported into the country, after going through extant laws. The poultry industry needed more grains and the Ministry of Agriculture actually confirmed that the production of maize in the country is not adequate to drive the poultry industry. So, the need for the importation of some of these grains has arisen.

However, he said the genetically modified crops that have been approved have not really reached the farmers but that in respect of the cotton that is insect resistant, some farmers have been selected by the permit holder to set up demonstration plots and to multiply the seeds for commercialisation. Farmers, he said are looking forward to using the seeds.

Also speaking on the use of modern technics in agriculture to ensure food security in Africa, a Nigerian scientist, Dr. Rose Gidado, aDeputy Director, National Biotechnology Development Agency, saidfood security depends on four interrelated factors: quantity of food, which involves increasing agricultural productivity; access to food, which is determined both by income levels and quality of infrastructure; nutrition; and overall stability of the food system, such as resilience to shocks. Genetically-modified (GM) crops/foodscan contribute tofood quality, access to food, nutrition or stability of food systems.She said genetically modified crops already benefit smallholder farmers in several major ways. For example, they help farmers control pests and disease. This leads to higher production and increased income, which in turn provides them with increased ability to consume more nutritious food. Let us take the example of pest-resistant GM cotton. Although GM cotton is not directly consumed, it indirectly contributes to food security by raising household income levels and improving access to more nutritious food.In Nigeria the insect Maruca vitrata destroys nearly US$300m worth of blackeyed peas a major staple crop. It forces farmers to import pesticides worth US$500m annually. To solve the problem, scientists at the Institute for Agricultural Research at Nigerias Ahmadu Bello University have developed a pest-resistant, transgenic black eyed beans variety using insecticide genes from the Bacillus thuringiensis bacterium. These techniques have the potential to address a wide range of agricultural, health, and environmental issues in African countries, leading to increased productivity and therefore contributing to increased food security. The importance of building capacity in biotechnology is reinforced by the rising concern over the impact of climate on agriculture.

Dr. Gidado, who is the Country Coordinator,Open Forum on Agricultural Biotechnology in Africa(OFAB) Nigeria Chapter, noted thatfarmers could benefit in terms of cost to ratio to yields by reduction in production cost per hectare planted with PBR Cowpea, if of the 3 million hectares 1million is planted to PBR Cowpea the savings from reductionThey also benefit in cost of insecticide is sixteen billion and two hundred million naira (N16,200, 000,000.0) annually. A 20% yield increase per hectare translates to forty-eight billion naira (N48,000,000,000.0) annually at N120,000.0 per tonne.Stakeholders should continue to support, promote and encourage the use of appropriate technologies like biotechnology in order to attain Nutrition and food security, she said.

The Nigerian governments position

In September this year, the Nigerian government said it was doing all that was necessary to apply Genetic Engineering and Bio-Technology to ensure food safety and security in the country.Nigerias Minister of Science and Technology, Dr. Ogbonnaya Onu, who inaugurated a training workshop on Basic Laboratory Training on Living Modified Organisms Detection and Identification in Abuja, said the government had recognised the immense importance of Genetic Engineering and Bio-Technology to the progress of the nation, adding that it would boost local production of food and commodities and minimise the need for continuous import.Dr. Onu said, The Federal Ministry of Science and Technology. will continue to support the National Biotechnology Development Agency (NABDA) in carrying out this very important mandate to help our country not only in the area of agriculture but also protecting our environment and in ensuring the desire of our nation to industrialise rapidly is achieved.Nigeria has embraced bio-Technology and genetic engineering, for better improvement in crops and animal production, said the acting Director General/CEO of National Biotechnology Development Agency (NABDA), Prof. Alex U. Akpa.He said, We have made significant investments in modern Bio-Technology to assist in deepening awareness of the Technology and its impact on national growth and development.

Farmers reaction

As these scientists said, Nigerian farmers are eagerly waiting for the genetically modified seeds. We are even waiting for the seeds, said Chief Daniel Okafor, the vice national chairman, All Farmers Association of Nigeria, an umbrella body of farmers in Nigeria with not less than 30 million members, according to Okafor.

He stated that the genetically modified seed trial was done by scientists at the Ahmadu Bello University, Zaria, Nigeria. They brought it to us and it is now being multiplied.

Chief Okafor, who is the national chairman of potato farmers, said this was the ideal thing to do to increase the cultivation of cotton for use in the nations textile industry, as well as for cotton oil. Cotton can generate a lot of revenue and a lot of employment.

He said Nigeria should produce and use biotechnology cotton like other countries do, adding that we are ready to work with any organisation that can make it happen.

He appealed to banks and other lenders to support every farmer that is interested in BT cotton, stating that more research should be done to ensure whatever was produced would be fit for consumption with the right nutritional value and that it should be good for the environment.

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How Plant Breeding Innovation is Different from GMO and how PBI can improve food security in Africa - THISDAY Newspapers

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Drugs, Biologics, and Regenerative Medicine in 2019: A Successful Year Ends with Promise of a More Challenging 2020 – JD Supra

December 21st, 2019 4:44 am

Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA teams second year-end post will provide an overview of 2019 with a focus on the drug, biologic, and regenerative medicine programs at the agency. In many ways, the past year could be called a business as usual year for the FDAs drugs and biologics centers in that they continued to make progress on all of large-scale programs and priorities initiated by former-Commissioner Scott Gottlieb, who left the agency in April. FDA has been under the leadership of an Acting Commissioner since that time, although Texas radiation oncologist Dr. Stephen Hahn will be taking the reins soon following his confirmation by the full Senate in a 72-18 vote on December 12, 2019. (The Senate HELP Committee advanced the nominee on December 3, 2019; see our blog post just prior to that committee vote here.)

At the same time, however, the final months of 2019 have exposed several challenges for various FDA programs that operate under the extensive drug and biologic authorities contained in the Food Drug & Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act), respectively. The agency will be forced to grapple with many of these issues directly and deliberately in 2020as a result of deadlines of the agencys own making as well as external pressures coming from other parts of D.C. and from the rapidly changing nature of the U.S. health care system.

Business as Usual When Getting New Drugs, Generic Drugs, and Biosimilars to Market and Promoting Competition under Various Action Plans But Challenges Are Emerging Related to Accelerated Approval and Breakthrough Products

According to data presented by the Office of New Drugs in early December (see ONDs slides here), FDA had another extremely productive year when it comes to its approval of new molecular entities that address a unique blend of therapeutic areas. The agency approved 45 new molecular entities in FY 2019 (October1, 2018 to September30, 2019), of which 71%, or 32 products, received priority review status and 23 were designated as orphan drugs intended to treat rare diseases. As OND emphasized in the presentation, several of those new product approvals are notable for their uniqueness and therefore, in the agencys view, 2019 reflects not only quantity but [also] quality. The OND presentation also highlights a significant amount of other information on new molecular entity approvals and may be of interest to those readers who want to take a deeper dive into the data.

In addition to advancing important new drugs and biologics to market, former Commissioner Gottlieb is well-known for having spearheaded to development of a Drug Competition Action Plan (DCAP) and a Biosimilars Action Plan (BAP) during his nearly two-year tenure as head of the agency. Some of our prior coverage of the DCAP and BAP is available here. In general terms, the DCAP encourages market competition for generic drugs and helps to bring greater efficiency and transparency to the generic drug review process; the BAP aims to achieve similar goals for biosimilar products as the agency continues its implementation of the 2010 Biologics Price Competition and Innovation Act (BPCIA), including the critical drug-to-biologic transition that will occur by operation of law in March of 2020.

FDA continued to make progress on its various goals under these two initiatives during 2019. Some examples of this progress can be captured with these two data points:

With all of these wins, however, FDA still faces its fair share of challenges related to its expedited drug and biologic programs, especially as it appears to have accelerated its review of products intended for diseases with an unmet need to breakneck speed. Indeed, the OND presentation from early December also added that for FY 2020 and as of November 21, 2019, the agency had already approved 13 such drugs, suggesting that next year could be a record-breaking one in terms of innovative drug product approvals. A recent Bloomberg Law article (available here) used the phrase breakneck speed to describe the agencys actions in this space based on several recent FDA approvals of new molecular entities that have come months in advance of their assigned target dates. The Bloomberg Law article highlights that in response to FDAs speediness in reaching approval decisions on new drugs and biologics for diseases with unmet needs, patient advocates and, increasingly, insurers that have to pay for those treatments are starting to raise concerns that these products lack sufficient safety or effectiveness data.

Relatedly, there has been increasing pressure on FDA to remove certain accelerated approval drugs from the market following a failure by the drug product sponsor to confirm the efficacy or clinical benefits of the product in the required post-marketing confirmatory clinical trial. The most visible example of this regulatory challenge came in October 2019 when FDA convened an advisory committee to recommend whether it should withdraw accelerated approval from hydroxyprogesterone caproate injection (marketed under the brand name Makena for the prevention of preterm birth in pregnant women). FDAs Bone, Reproductive and Urologic Drugs Advisory Committee voted 9-7 to withdraw approval, with the dissenters favoring leaving Makena on the market while requiring the sponsor to conduct a new confirmatory trial. (Notably, no one voted for the option of leaving it on the market without requiring a new confirmatory trial.)Among the concerns of some members who voted to leave the product on the market with a new clinical trial obligation was that the drugs withdrawal would leave no safe treatment options for pregnant women at high risk of preterm birth. FDA will have to make a final decision regarding what to do about Makena in 2020, and it undoubtedly will face intense criticism (and potentially legal challenge) no matter what route it chooses to take for this public health quandary in which it finds itself.

In a similar vein, FDA official Dr. Richard Pazdur participated in a Senate briefing on December 10, 2019, in which he and other speakers defended the Breakthrough Therapy Designation program. FDA insisted again that the designation was intended to let the agency have earlier interactions with drug sponsorsand that it was not meant to be an early rating system for drugs or a signal of how they might do commercially. Given that the Breakthrough program was created in 2012 and is considered to be wildly successful, some speakers at the briefing expressed surprise that there was still any confusion about its purpose and function. Whether Congress picks up any of these emerging areas for consideration as part of FDAs 2022 user fee reauthorization packages remains to be seenas those negotiations will begin in earnest after the New Year, but the issues certainly are complex enough to allow for robust policy discussions to occur.

Finally, there are expected to be bumps in the road with the upcoming March 2020 transition of proteins previously approved under New Drug Applications (NDAs) to Biologics License Applications (BLAs)for which FDA only finalized its guidance for industry last year. The March 2020 transition date was established under the BPCIA and the agency does not have discretion in getting the transition done (only in how it handles the logistical and administrative issues created by transitioning approved products in this way). Check out our prior blog post on the final deemed to be a license transition guidance.

Business as Usual with the Rapid Pace of FDAs Issuance of Agency Guidance But Challenges Are Emerging Related to Judicial Deference to FDA Decision-Making

FDA guidance documents for all regulated product categories continued to be released on a regular basis this year, including several related to areas of agency priorities under the DCAP and BAP including the final biosimilar interchangeability guidance issued in May (see our blog post here) and a draft guidance on insulin interchangeability issued in November 2019. The latter also relates to the March 2020 NDA-to-BLA transition, as insulins are one of the largest class of products that will be transitioning into regulation as biologics, making them open to what is expected to be more efficient competition through the BPCIAs biosimilar pathway than what was possible in the past as insulin NDAs.

Despite the accelerated pace of the issuance of Agency guidance, however, FDA is beginning to face more challenges related to its decision-making and the scope of its exercise of agency discretion. In particular, a significant District Court for the District of Columbia ruling issued on December 6, 2019, Genus Medical Technologies, LLC v. FDA, provides hints of a potential shift in judicial deference to certain agency actions. The court vacated FDAs classification of a medical imaging liquid as a drug rather than as a device after determining that FDA did not have discretion to decide how to regulate a product merely because the definitions of drug and device overlap in the FD&C Act.

According to the district court judge, FDA was not interpreting the drug/device definitions in the statute properly, and Congress did not intend to allow the agency unfettered discretion to pick between the two categories. Rather, the court found that the text of the definitions are clear and do not create a gap or any ambiguity for FDA to fill with an exercise of agency discretion. This recently issued decision may indicate a potential shift in how courts are going to apply long-standing precedents related to judicial deference to agency decisions. If FDA decides to appeal the Genus ruling, it may end up at the Supreme Court as one of many expected challenges to the doctrines that established our current framework for judicial deference of an administrative agencys interpretation of an ambiguous statute.

Business as Usual with FDAs Comprehensive Regenerative Medicine Framework and Stepped up Enforcement Against Stem Cell Clinics Offering Unlawful Products But What Happens in November 2020 When the Enforcement Discretion Period Ends?

One of the first FDA press releases for 2019 was co-authored by former Commissioner Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks and was focused on the agencys new policies aiming to advance the development of safe and effective cell and gene therapies. In the press release, the agency leaders predicted that by 2020, FDA would receive more than 200 Investigational New Drug Applications (INDs) for cell and gene therapies each year. The agency has continued to work diligently to increase its staff in CBER to conduct clinical reviews for such INDs and to try to keep pace with the industrys development of these innovative technologies.

As we discussed in our update on FDAs Comprehensive Regenerative Medicine Policy Framework earlier this year, the agency is prioritizing two parallel goals: (1) clarifying the regulatory criteria for product marketing and providing support and guidance to legitimate product developers; and (2) removing unapproved, unproven, and potentially unsafe products from the U.S. market. The second prong of this comprehensive plan for regenerative medicine products was the topic of one of Dr. Gottliebs very last statements as Commissioner before he left the agency, issued on April 3, 2019 in conjunction with CBER Director Dr. Marks, indicating how important this area is to the agencys current public health priorities.

In the April 2019 statement, Drs. Gottlieb and Marks acknowledged FDAs challenges and efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk, citing several Warning Letters issued to manufacturers that violated current good manufacturing practices (CGMPs) for human cells and tissue products. They noted that it was of particular concern given that the industry was nearly halfway through the period during which the FDA intends to exercise enforcement discretion for certain regenerative medicine products with respect to INDs and premarket approval requirements. Now that it is December 2019, that deadline is even closer with less than one year left. November 2020 is the end of the three-year period of enforcement discretion announced by FDA when it first articulated the policies and goals of this comprehensive framework in 2017. See our prior posts on the topic here and here.

Under the Comprehensive Regenerative Medicine Policy Framework, FDA appears to have stepped up the pace of issuing Warning and Untitled Letters to sellers of unapproved stem cell products during the second half of 2019. In conjunction with a Warning Letter issued on December 5, 2019 to two related companies for processing and marketing unapproved umbilical cord blood-derived cellular products, Dr. Marks of CBER reiterated the agencys concerns about safety and reminded the public of the upcoming compliance deadline: As evidenced by the number of actions that the agency has taken this month alone, there are still many companies that have failed to come into compliance with the [FD&C Act] and FDAs regulations.

Dr. Marks was referring to two Untitled Letters that were issued to stem cell product distributors on November 20 and November 25, 2019, respectively. The press release cited above also added that the agency had also recently sent 20 letters to manufacturers and health care providers noting that it has come to [FDAs] attention that they may be offering unapproved stem cell products, reiterating the FDAs compliance and enforcement policy.

FDA also prevailed this year in the U.S. District Court of the Southern District of Florida against a stem cell clinic charged with violating the FD&C Act and the PHS Act. In June 2019, the court held that the defendants adulterated and misbranded a stem cell drug product made from a patients adipose tissue without FDA approval and for significant deviations from CGMPs, issuing a permanent injunction as requested by the Department of Justice on FDAs behalf. The agencys statement on that important court win by the government is available here.

Lastly, on December 6, 2019, FDA issued a Public Safety Notification on Exosome Products. The safety notification informed the public of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes, which came to FDAs attention through the Centers for Disease Control and Prevention, the Nebraska Department of Health and Human Services, and others. There are currently no FDA-approved exosome products and, to be honest, we are not even sure what such a product would be since an exome consists of all the sequenced exons within a single human genome after the introns are removed. (So were the clinics administering complete exomes to patients? that seems unlikely.)But what we found noteworthy about this public safety notice is the forceful and direct language FDA used when describing the unscrupulous conduct of the sellers of these products:

Certain clinics across the country, including some that manufacture or market violative stem cell products, are now also offering exosome products to patients. They deceive patients with unsubstantiated claims about the potential for these products to prevent, treat or cure various diseases or conditions. They may claim that they these products do not fall under the regulatory provisions for drugs and biological products that is simply untrue. As a general matter, exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products under the [PHS Act] and the [FD&C Act] and are subject to premarket review and approval requirements.

The clinics currently offering these products outside of FDAs review process are taking advantage of patients and flouting federal statutes and FDA regulations. This ultimately puts at risk the very patients that these clinics claim to want to help, by either delaying treatment with legitimate and scientifically sound treatment options, or worse, posing harm to patients, as evidenced by these recent reports of adverse events.

As we enter the final year of FDAs enforcement discretion period, perhaps these public notices and Warning/Untitled Letters will become even more frequent and the agency will become even more frustrated by the ongoing violations and medical practitioners who flout federal law. This area will see substantial activity in 2020 and we will be watching closely to see what changes, if anything, about FDAs approach in November when the deadline to come into compliance ends. Will there be widespread FBI raids on stem cell clinics engaged in this kind of bad behavior? Only time will tell.

Final Thoughts: A Few Other Business as Usual Activities in the Therapeutic Product Areas and Prescription Drug Advertising Enforcement

Although we have highlighted what we view as some important challenges for the FDA to address in the coming months, other areas continue to be business as usual without anything very new to report. FDA continues to invest significant resources into improving the quality of compounded drugs and ensuring compliance with Sections 503A and 503B of the FD&C Act. Drug compounding was another topic of one of Dr. Gottliebs very last statements as Commissioner on April 3, 2019, in which he laid out the 2019 compounding priorities that included maintaining quality manufacturing and compliance and regulating compounding from bulk drug substances.

Notwithstanding all the efforts by FDA and State regulators in this area over the past several years, the agency continues to see concerning activity when it comes to compounded drugs, such as problems related to the condition under which compounded sterile medicines are made, which raisesignificant risks to patients. As a result, FDA has made it an intense area of focus to take enforcement actions against compounders who fail to produce sterile drugs in compliance with the law. During the past year, for example, FDA has won at least four permanent injunctions against various compounders after the agency identified behavior that posed a significant risk to public health and safety.

In addition, in 2019 FDA also increased its activities towards reducing and mitigating the impact of drug shortages on the health care system. See our prior blog post on Drug Shortages.

Finally, after a fairly slow year of enforcement in the prescription drug advertising space, the last two months of 2019, at least as of December 12th, have given us three (!) letters two untitled and one warning from the FDAs Office of Prescription Drug Promotion (OPDP). Most interestingly, the Warning Letter issued on December 2, 2019 for omitting warnings about the most serious risks associated with [a medication-assisted treatment] drug from promotional materials was announced to the public via FDA press release, which is not a typical action for normal-course OPDP letters to industry. The drug in question, approved for the prevention of relapse to opioid dependence following opioid detoxification, is associated with several significant risks including potential opioid overdose. Given the countrys public health emergency that is the opioid epidemic, FDA appears to have felt the need to make the deficiencies in the advertisement and those risks more widely publicized. So another thing we will be watching for in the New Year is whether this OPDP action represents the beginning of a new trend by the agency to publicize these Warning Letters more directly, or whether its advertising enforcement activities may be picking up due to industrys evolving approaches to promoting therapeutic products.

If you made it to the end of this post, thank you for reading our tome, and we hope you found it helpful and interesting! Stay tuned next week for our third and final FDA year-end blog post.

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At the centre of eye health – AOP

December 21st, 2019 4:42 am

Every New Year prompts new resolutions. 2020 still makes us think of perfect vision, even if we are metric now. So how do you wish this year to unfold for you and for your patients?

Where and how you practice will to some extent determine the patients you see, but most optometrists will see a cross-section of the population coming through the consulting room in the year. Patients will range from children to the very elderly, and those in the middle who are coming to terms with their changing sight needs with the passing years. Each patient presents their own challenges to optometrists, some greater than others.

It has never been more important for optometrists to be at the centre of eye health and care at every stage in a patients life, and to be recognised as such. Too many members of the public think of the optician as there for the healthy eye, and to detect disease. Not enough people understand the role that optometrists can play in supporting patients in the longer term after a diagnosis, whether with treatment, monitoring or expert prescribing and support for low vision. This view will only change as more and more people experience the full range of what optometrists can offer in primary care.

Not enough people understand the role that optometrists can play in supporting patients in the longer term after a diagnosis, whether with treatment, monitoring or expert prescribing and support for low vision

The commissioning landscape continues to change. There are more pathways and local schemes being set up all the time. Scotland and Wales continue to make the greatest strides that the other nations can learn from. The devolved governments fully understand that optometrists are the untapped resource to relieve pressure on GPs and secondary care. This is being recognised in England too, with its patchy commissioning landscape. The Local Optical Committee Support Unit works hard to increase the number of schemes and pathways, such as the introduction of a pathway for children following problems identified in screening last summer.

If the optometric practice supports patients from youth to old age, in good times and in bad, the AOP does the same for its members. We protect, support and represent our members throughout their careers. This personal and individual understanding of your career is our hallmark.

We recognise how your needs will change at different stages of your career, whatever your mode of practice. Our unrivalled insurance and member defence package is a given in the event of needing assistance with complaints from any source. We have your back.

But we also recognise that the support a locum needs will be different from a business owner, employee, lecturer, hospital optometrist or student, and we recognise the importance of offering the right support at every stage. This is why you can find advice on our website on employment status and tax, government regulation, employee contracts, making accurate claims and dealing with post-payment verification and anything else that might arise for you. It is why we provide CET opportunities for the whole practice team, as well as specialised opportunities for learning at the Hospital Optometrists Annual Conference and Therapeutics London Conference. And it is why the education opportunities we offer cover personal skills and attributes as well as clinical knowledge.

It has never been more important for optometrists to be at the centre of eye healthand to be recognised as such

We also acknowledge career changes in our fee structure, with special rates for newly qualified optometrists, and members taking parental leave or career breaks.

2020 is an auspicious year for all those involved in eye health and care, and we are determined to make it a particularly special one. It begins with an even bigger and better 100% Optical with more CET, more dedicated streams for the whole practice team, more AOP dedicated sessions and the biggest Awards event in the sector, to celebrate outstanding achievement. I look forward to seeing lots of you there and I hope 2020 proves to be one to remember, for all the right reasons.

AOP benefits for membersSee the benefits of being AOP member at different career stages

Image Credit: Getty/sorbetto

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Give the gift of sight by supporting local project – Northglen News

December 21st, 2019 4:42 am

Cathryn Aylett and Carron Strachan from Bright Eyes Centre (BEC) for Visually Impaired Children show off the Plusoptix Vision Screener.

GLENHILLS resident, Cathryn Aylett has urged the north Durban community to give the gift of sight this festive season by sponsoring an eye screening. Aylett who works with the Bright Eyes Centre (BEC) for Visually Impaired Children is actively involved in fundraising for the non profit organisation and to help fund their newest initiative, the Bheka Project.

The project, which launches next year, is a drive to screen 1 000 school children across the province ensuring all grade ones have 20/20 vision in 2020. The initiative is called the Clicks for Christmas campaign which sees a donation of R200 help sponsor an eye screening.

BEC has partnered with Peek A Vu, using a machine Plusoptix Vision Screener, which is used across 98 per cent of pediatric practices in Europe.

The Plusoptix Vision Screener is used across 98 per cent of pediatric practices in Europe.

The reality is that our country doesnt currently have the systems in place to screen the eyes of children under the age of six at their vaccination appointments. On average one in 20 children suffer from an undetected visual disorder. This eye screening is superior as ordinary school vision/acuity tests do not test refractive errors accurately. The sooner visual disorders are detected and treated the greater the probability of successful treatment.More often than not, affected children dont notice their own visual disorders as they are accustomed to seeing the world through their own eyes with no way to compare. Little children who cannot see may be fidgety and have a hard time concentrating. Through the machine we are able to play our part in early detection of visual disorders in children younger than six, Aylett explained.

Speaking on the partnership with Peek A Vu, Aylett said the device allowed them to go into schools and offer eye tests to young children.

The cutting edge technology means we make no physical contact with the the child and the machine uses infrared technology in the form of refraction measurement to determine whether there is an underlying visual impairment. The screening takes seconds and a single click of the device and we have the an immediate pass or refer suit. Most little ones have no idea they have just had their eyes tested. We do not need to rely on verbal feedback from the child. Think of it as taking a photo of your little ones eyes. Click and its done. Early intervention is key.

The cutting edge technology means we make no physical contact with the the child and the machine uses infrared technology in the form of refraction measurement to determine whether there is an underlying visual impairment.

Through the Bheka Project, Aylett said the school would also like to help children from informal settlements who cannot afford eye tests.

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‘Today’: Savannah Guthrie’s Return to Work, Plus the Anchor Parties with Her Show Pals – Showbiz Cheat Sheet

December 21st, 2019 4:42 am

The last four weeks have been rough for Todays Savannah Guthrie.

After her young son, Charley, accidentally hit her in the eye with the sharp end of a toy train at the end of November, the anchor suffered an injury to her retina. Its been an up and down journey for her but it looks like things are finally on the upswing for her.

Get the details on the Today party Guthrie got the green light from her doctors to attend, plus find out when shell finally be back on the job.

Once her doctors felt that laser treatments were no longer helping the 47-year-olds situation, they prepped her for surgery on Dec. 11.

Doctors initially had put hope in the laser treatments ability to address Guthries retinal damage. It did look promising the first week of December and the newswoman hoped she could avoid going under the knife.

Five laser treatments later, it was clear the severe injury of her retina was beyond their ability to help. And so, surgery became unavoidable.

It turned out to be kind of serious. They were afraid my retina would detach, Guthrierevealed to Today viewers. They told me to just take it easy and theyve been doing a bunch of laser procedures to avoid having to do the whole surgery.

She added, It was so blurry from not to get too gross but there was so much blood in my eye that it completely blocked my vision.

Post-surgery, the anchor has had to keep her head facedown to be sure the surgery worked. Now she can switch between being facedown and sitting upright.

Its uniquely challenging, this recovery, she says. Your body starts hurting in different places, lying down like that, she told PEOPLE the day after her surgery.

Although shes still recovering from very delicate eye surgery, People reported that the morning show host could not resist the opportunity to make it to the annual holiday party with the Today crew at Catch Steak on Wednesday night this week.

Guthrie documented her big night out on Instagram with a post showing herself, her co-anchor Hoda Kotb, 3rd Hour host Jenna Bush Hager, and executive producer Libby Leist all smiles.

Reunited and it feels so good,she posted. Loving up on my@todayshowgirls at the TODAY holiday party.

Kotb also posted the photo to her Instagram, saying Lookie lookie who is on the mend! @savannahguthriemade it to the@todayshowChristmas party and then everything was right xoxo

Willie Geist quipped that Guthrie said at the party, You all are a sight for sore eye, singular!

USA Today reports that Guthrie is planning her big return for after the holidays.

It will most probably be one more week before her doctor can tell if her eye can hold the retina on its own. Guthrie had hoped to return at the end of this week but thinks itll probably be after the holidays.

Read more: Today Show: What Is Carson Dalys Net Worth and Which Late Night Host Played a Huge Role in His Career?

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What to do if vision deteriorates? – The Saxon

December 21st, 2019 4:42 am

Glasses today the fashion and even become an accessory the youth picks up a massive rim on half of the face. Teaser four-eyes almost gone. Bespectacled become. Just not immediately. After all, children are born with a perfect vision But even the kids get in the hands of the phone or tablet. To stop technical progress is impossible. So what to do?

See also: Read from the screen of the gadget in transport or on the go bad: this is especially dangerous for childrens eyes

If we are talking about young children, then surely we must limit their communication with a phone or a tablet, says the head of the Department of ophthalmology of the National medical Academy of postgraduate education named after P. L. Shupyk Professor Sergey Rykov. The eye is being shaped, with prolonged stress on the eye muscles can form incorrectly. Then already in the first class many children need glasses. We, however, advocate that even congenital problems strabismus, myopia and other repair by the time when the child starts school. So the choice for parents how to save eyesight child.

In adults the eye is already formed. What factors affect vision?

One of the main strain of the eye muscles. If a person for a long time staring at objects up close, muscles tense, and gradually the eye loses its ability to change focus, to switch quickly from near objects to far. The ability to accommodate the inherent nature. If it is not claimed, myopia develops.

But in fact before schoolchildren it started, but the adults have progressed.

Yes, and to slow down the process, we recommend special exercises to relax the eye muscles. Teachers had to replant students on the first Desk, the last. But now the problem is in the gadgets. It concerns both children and adults. The fact that the screen is a Ticker. And when we look at the moving text, the eye muscles tense up to five (!) times stronger. In addition, people blink much less frequently, the cornea badly washed by tears and there is dryness of the eyes. And this is a disease.

Result in the need to pick up points

Or contact lenses. But to do it properly. In most optical stores have special equipment with which the optometrist (a specialist in the selection of points) can accurately determine which glasses or lenses you need. Options there are many bifocal, trifocal, coated, without him.

What if before the eyes of murky veil fly or flies? Who needs to remove cataracts? How long can I wear contact lenses removing?

To these and other questions from our readers on Monday, December 23 from 15:00 to 16:00 during the direct line of FACTS will answer ophthalmologist Professor Sergey Rykov.

Call in edition by phone (044) 503-77-74

Pre-send questions to the email address [email protected]

The material on a straight line read on Thursday, January 9, 2020.

See also: Red eye is a symptom of many diseases requiring serious treatment

Maria Batterburyis a general assignment reporter at the Saxon. She has covered sports, entertainment and many other beats in her journalism career, and has lived in Manhattan for more than 8 years. Vivian has appeared periodically on national television shows and has been published in (among others) NPR, Politico, The Atlantic, Harpers, Wired.com, Vice and Salon.com..

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Scientists Take Stem Cells and Convert Them to Heart Pacemaker Cells – Technology Networks

December 21st, 2019 4:41 am

University of Houston associate professor of pharmacology Bradley McConnell is helping usher in a new age of cardiac pacemakers by using stem cells found in fat, converting them to heart cells, and reprogramming those to act as biologic pacemaker cells. He is reporting his work in theJournal of Molecular and Cellular Cardiology.

The new biologic pacemaker-like cell will be useful as an alternative treatment for conduction system disorders, cardiac repair after a heart attack and to bridge the limitations of the electronic pacemaker.

"We are reprogramming the cardiac progenitor cell and guiding it to become a conducting cell of the heart to conduct electrical current," said McConnell.

McConnell's collaborator, Robert J. Schwartz, Hugh Roy and Lillian Cranz Cullen Distinguished Professor of biology and biochemistry, previously reported work on turning the adipogenic mesenchymal stem cells, that reside in fat cells, into cardiac progenitor cells. Now those same cardiac progenitor cells are being programmed to keep hearts beating as a sinoatrial node (SAN), part of the electrical cardiac conduction system (CCS).

The SAN is the primary pacemaker of the heart, responsible for generating the electric impulse or beat. Native cardiac pacemaker cells are confined within the SAN, a small structure comprised of just a few thousand specialized pacemaker cells. Failure of the SAN or a block at any point in the CCS results in arrhythmias.

More than 600,000 electronic pacemakers are implanted in patients annually to help control abnormal heart rhythms. The small mechanical device is placed in the chest or abdomen and uses electrical pulses to prompt the heart to beat normally. In addition to having the device regularly examined by a physician, over time an electronic pacemaker can stop working properly.

"Batteries will die. Just look at your smartphone," said McConnell. "This biologic pacemaker is better able to adapt to the body and would not have to be maintained by a physician. It is not a foreign object. It would be able to grow with the body and become much more responsive to what the body is doing."

To convert the cardiac progenitor cells, McConnell infused the cells with a unique cocktail of three transcription factors and a plasma membrane channel protein to reprogram the heart cells in vitro.

"In our study, we observed that the SHOX2, HCN2, and TBX5 (SHT5) cocktail of transcription factors and channel protein reprogrammed the cells into pacemaker-like cells. The combination will facilitate the development of cell-based therapies for various cardiac conduction diseases," he reported.

Reference: Raghunathan et al. (2019).Conversion of human cardiac progenitor cells into cardiac pacemaker-like cells. Journal of Molecular and Cellular Cardiology. DOI: https://doi.org/10.1016/j.yjmcc.2019.09.015.

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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BioRestorative Therapies Featured in IEEE Pulse Magazine’s Cover Story About Stem Cell Therapies for Low Back Pain – GlobeNewswire

December 21st, 2019 4:41 am

MELVILLE, N.Y., Dec. 16, 2019 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (BioRestorative or the Company) (OTC: BRTX), a life sciences company focused on stem cell-based therapies, announced today feature coverage in the news outlet, IEEE Pulse, a magazine of the IEEE Engineering in Medicine and Biology Society. According to IEEE, it is the worlds largest technical professional organization for the advancement of technology.

To view the IEEE Pulse Magazines article featuring BioRestorative, click here.

The published cover-story article features commentary from Francisco Silva, Chief Scientist and Vice President of Research and Development for BioRestorative, regarding BRTX-100, the Companys lead therapeutic candidate for chronic lumbar disc disease. Once the U.S. Food and Drug Administration (FDA) authorizes the sale of BRTX-100, we would ship it to your doctor, and with a 30-minute procedure the material would be injected into your disc in a 1.5 ml solution, explains Silva. He elaborates on the product, discussing growing and expanding stem cells from the patients bone marrow under hypoxic conditions that mimic those in the normal intervertebral space. We are enriching the cells to be able to survive in this harsh environment, says Silva.

In addition to BRTX-100, the magazine article also highlights BioRestoratives other research pursuit, its ThermoStem program, utilizing brown adipose (fat) derived stem cells to target treatment of metabolic diseases and disorders, like diabetes, obesity and hypertension.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

Disc/Spine Program (brtxDISC): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders. The BRTX-100 production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat persistent lower back pain due to painful degenerative discs.

Metabolic Program (ThermoStem): We are developing a cell-based therapy to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, whether the Company will be able to consummate the private placement and the satisfaction of closing conditions related to the private placement and those set forth in the Company's Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:Email: ir@biorestorative.com

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This was the best health news over the last decade – USA TODAY

December 21st, 2019 4:41 am

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The 2010s will go down in history as a decade of many newsworthy health-related stories, many of which were not good news -- Ebola, measles, antibiotic resistance. But in the years since 2010 there were also many promising discoveries in medicine, life-saving drugs approved, and great strides taken addressing national health crises. Some of these stories will have lasting effects for generations to come.

24/7 Tempo reviewed multiple news archives and dozens of articles published since 2010 to select 15 of the most positive health news stories that made headlines.

Some of the most talked about stories over the last few years have influenced health guidelines, treatment of serious disease, and even government policy.

Reports of significant research developments in the treatment and prevention of chronic and other conditions gave hope to millions of Americans. Some of the good news broke as recently as just a few months ago these are the 15 biggest health topics of 2019.

Click here for 15 of the best health news over the last decade.

CT scans in high risk patients can reduce overall lung cancer mortality

Year: 2011

Category: Diseases

The tremendous effort by researchers and health institutions to develop a cure for cancer over the decades since the legislation for the War on Cancer was enacted in 1971 will likely continue. Any good news on developments are worth noting. The 2011 National Lung Screening Trial showed a reduction in lung cancer mortality of 20% in high risk patients receiving low-dose CT (LDCT) compared to chest X-ray. The CDC recommends that people at high risk of developing lung cancer -- heavy smokers, people who have smoked as recently as 15 years, and people who are 55 years or older -- undergo annual LDCT scans because of potential risks.

In 2016, there were 218,229 new cases of lung cancer, and 148,869 people died from the disease in the United States, according to the CDC. The American Cancer Society estimates 142,670 deaths from lung cancer in 2019. A major reason for the disease's high mortality rate is that the tumor does not typically cause symptoms until it spreads, making early screening especially crucial to improving survival rates.

Blame SUVs: These 9 cars will be killed in 2020

Pass the ketchup, hold the beef: Americans crave Impossible Burger, Beyond Meat in 2020

Melanoma drug approved

Year: 2011

Category: Treatment

After more than a decade of no new potential drugs for melanoma, the deadliest form of skin cancer, the FDA approved vemurafenib, sold under the brand name Zelboraf, in 2011 for patients with metastatic melanoma with the BRAF(V600E) mutation or for those who have tumors that cannot be surgically removed.

Zelboraf was seen as a major development because it can improve melanoma patients' quality of life -- the drug is a simple pill taken twice a day -- and it may extend survival rate. In a trial, the length of time melanoma patients who received Zelboraf lived without the cancer getting worse was almost double the length of patients who did not take the drug.

Since 2011 several drugs have been approved to treat melanoma, and survival rates of this deadly cancer have improved.

Gene editing is now possible

Year: 2012

Category: Technology

Gene editing is the process of changing an organisms DNA. After decades of research around the world, scientists made a major breakthrough with the discovery of clustered repeats of DNA sequences, known as CRISPR.

First described in 2012, CRISPR, or Clustered Regularly Interspaced Short Palindromic Repeats, is the basis for potentially world-changing gene editing technology, or, as some might say, DNA hacking. It may be used to develop treatments for a range of diseases, including cancer and genetic disorders. In 2015, CRISPR was successfully used for the first time to save a life. Two baby girls, 11-month and a 16-month-old, received gene editing treatment to help them fight leukemia.

While the gene-altering tool is bringing revolutionary change to health fields, it has also raised serious ethical concerns. Misuses and inadvertently harmful uses of CRISPR include those for creating designer babies, and causing environmental ripple effects by eliminating disease-spreading insects.

FDA says trans fat should not be considered 'safe'

Year: 2013

Category: Eating

Trans fats, or partially hydrogenated oils, have been widely used for years, most notably in fast foods. Trans fats can raise the levels of "bad" LDL cholesterol, lower the levels of good-for-you HDL cholesterol, and increase the risk of heart disease, the No. 1 killer in the United States. And now they are on their way out.

In 2013, the FDA officially announced trans fats should not be considered safe in human food. In 2015, the agency gave food manufacturers three years to phase out the use of trans fats in their products. The deadline was June 18, 2018, although the FDA granted a one-year extension in the use of artificial trans fats in some cases. The ban will be fully implemented in Jan. 1, 2020.

HIV prevention pill

Year: 2014

Category: Diseases

About 50,000 Americans are diagnosed with HIV every year, according to the CDC. Despite advancements in treatment and years of research into the infection, HIV does not have a cure. In 2014, the CDC issued new guidelines that recommend a pill to people at high risk of HIV as a prevention method. High risk people include gay or bisexual men, injection drug users, and women with an HIV+ partner.

The agency said that the pill, sold under the brand name Truvada, may lower the risk by as much as 90% when taken consistently. Truvada has been used to treat HIV since 2012 when the FDA approved the drug. Truvada contains tenofovir and emtricitabine, which when used in combination with other antiviral medication may keep the HIV virus from establishing a permanent infection.

A new way to treat cavities

Year: 2015

Category: Treatment

In 2015, the FDA approved a painless new way to treat tooth decay called silver diamine fluoride (SDF). It's a liquid that is applied directly to cavities to stop the decay. The FDA gave it a "breakthrough therapy designation" two years later.

As a non-invasive and fairly cheap method (it costs about $20-$25 per tooth), SDF treatment, which must be prescribed by a dentist, can save people a lot of money. About 91% of American adults have dental decay, and about 27% have untreated tooth decay, according to the CDC. Tooth decay is common among kids as well -- it's the most common chronic disease in children between 6 and 11 years of age.

3D printing of human organs

Year: 2015

Category: Technology

3D printing technology has improved considerably over the past few years. (Today, low-budget 3D printers are available for anyone who can spare $100.) The technology has advanced so much that producing fully functional replacement organs from a person's own cells seems like a not-so-distant possibility. Scientists at Harvard's Wyss Institute have grown a heart tissue that beats just like a normal human heart.

Production for treatment is still years away, however. The technique, called sacrificial writing into functional tissue (SWIFT), has not even been tested on mice yet. But if it works, it can be used to print other organs, too, potentially saving the lives of thousands of people who are waiting for an organ transplant.

Immunotherapy and cancer

Year: 2016

Category: Treatment

Cancer immunotherapy was named the 2016 Advance of the Year by the American Society of Clinical Oncology. The therapy is designed to support and boost the immune systems response to cancer cells, rather than targeting the cancer itself. One of the most successful immunotherapies so far is the checkpoint inhibition. It makes the immune response stronger by keeping immune cells activated, which does not normally happen when a person has cancer.

It may take decades until immunotherapy could replace the current standards in cancer treatment of surgery, chemotherapy, and radiation, but currently hundreds of immunotherapy drugs are being tested in clinical trials on people.

Some benefits of immunotherapy include fewer side effects than radiation or chemotherapy, lower risk of relapse, and making other cancer treatments more effective.

Opioid crisis recognized as national public health emergency

Year: 2017

Category: Public health

Every day over 130 people in the United States die from opioid overdose, including pain medication, heroin, and synthetic opioids such as fentanyl, according to the National Institutes of Health. In 2017, President Donald Trump declared the opioid crisis a national public health emergency, giving hope that the federal government's involvement could help fight the worst drug crisis in U.S. history.

The official designation removed certain administrative requirements for accessing federal funds to fight the epidemic, including the use of taxpayers' money to make addiction treatments and naloxone, a life-saving medication that can reverse an opioid overdose, drug, more accessible.

The Department of Health and Human Services has renewed the opioid crisis' status as a national emergency several times since 2017. Money has been used to speed up a survey on whether and how often doctors prescribe opioids and help launch anti-addiction programs quicker, according to the a 2018 report by the Government Accountability Office.

Early-stage Alzheimer's treatment

Year: 2019

Category: Diseases

Currently, there is no treatment for Alzheimer's disease, the sixth leading cause of death in the United States. Pharmaceutical companies and universities have tried to tackle different aspects of the neurodegenerative disorder, but to no avail. Until just a few months ago.

Biogen, a biotechnology company, announced in October 2019 it would ask the FDA to approve its Aducanumab drug as first treatment for early Alzheimer's disease. The company said that patients in the early stages of the disease who were treated with a high dose of the drug experienced significant improvements in memory, orientation, and language. If Aducanumab is approved, it will be one of a handful of drugs approved to treat the disease.

Smoking rates at all-time low

Year: 2018

Category: Habits

The short and long-term health problems smoking causes have been well-documented for decades. Today cigarette smoking among U.S. adults is at an all-time low -- 13.7% in 2018, according to the CDC.

While smoking regular cigarettes is down, smoking e-cigarettes is on the rise. About 37% of 12th graders reported vaping in 2018, compared with 28% in 2017. A recent Gallup survey found that 20% of 18- to 29-year-olds vape regularly, more than twice the national average for all age groups.

There has been a recent outbreak of lung injury associated with the use of e-cigarettes. At least 47 deaths and 2,290 lung injuries have been confirmed by the CDC as a result of vaping as of Nov. 20, 2019. The agency has identified vitamin E acetate, an additive in some THC-containing e-cigarettes, as the likely cause for the lung injuries.

Cystic fibrosis treatment approved by FDA

Year: 2019

Category: Treatment

About 30,000 Americans live with cystic fibrosis, a fairly common genetic disease that affects the lungs and other organs, limiting one's ability to breathe as the disease progresses. About 1,000 new cases are diagnosed every year.

The FDA approved in 2019 what it called a "new breakthrough" therapy to treat the condition. The medication, sold under the name Trikafta, is available to patients who are 12 years or older and have the F508del mutation, the most common cystic fibrosis mutation. It is found in 90% of the people living with the disease. The treatment can increase the life expectancy of patients, which is now around 44 years.

Second HIV patient goes into remission

Year: 2019

Category: Diseases

A second person since HIV was identified in the 1980s has been said to be in sustained remission. The patient, who was treated in London, has not been given antiretroviral therapy for 18 months, and the virus has remained undetectable. The good news comes more than a decade after the Berlin patient, known as the first person to have been cured from the infection. Both patients received a stem cell transplant.

HIV, the virus that causes AIDS, is one of the most serious global health challenges. Almost 38 million people live with HIV worldwide, according to the World Health Organization. Just over 60% are receiving treatment.

Blood test detects breast cancer 5 years early

Year: 2019

Category: Diagnoses

Even though deaths from breast cancer have declined, the disease remains the second leading cause of cancer death among women in the United States, according to the CDC. More than 40,000 women die from it a year.

Improved rates of early detection have helped drive up survival rates. A recent British study offers hope that the condition could now be detected five years before there are any clinical signs of it. The new method is a blood test that identifies the body's immune response to antigens produced by tumor cells. The test may be available in clinics in about five years.

Finding a cure for arthritis

Year: 2019

Category: Treatment

2019 has been an exciting year in the field of health technology and scientific research. In addition to such technological developments as organ printing and gene editing, recent research has shown promise for a cure for arthritis. Millions of people suffering from joint inflammation -- from osteoarthritis, for example, which is the most common form of arthritis -- may be helped.

A recent study published in the Science Advances journal has found that "cartilage in human joints can repair itself [...] to regenerate limbs." The body was previously believed to be unable to do so. People have a molecule that helps with joint tissue repair, and that molecule is more active in ankles and less active in knees and hips. The findings can help develop treatments that may prevent, slow, or even reverse arthritis.

24/7 Wall Street is a USA TODAY content partner offering financial news and commentary. Its content is produced independently of USA TODAY.

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Manufacturing: the next breakthrough in gene therapy – STAT – STAT

December 19th, 2019 7:49 pm

I never thought Id see the day when words like process, scale, and automation would make news in the biopharma industry. Yet as the race heats up to bring more first-of-their-kind gene therapies to market, breakthroughs in manufacturing are often the key or break down the barrier to delivering these therapies to patients.

In my career, which has largely focused on drug manufacturing, Ive been lucky to be directly involved in the approval of six new medicines. My current work, as head of technical operations at Spark Therapeutics, is offering the biggest challenge: bringing Luxturna, the first gene therapy for a genetic disease, to patients and families in the U.S. Getting here has been no small task.

With no precedent to guide us, we had to forge new clinical, regulatory, and manufacturing pathways. Working through the unknown meant developing a robust set of assays to test various aspects of the gene therapy product just so we could better understand it. We also built, from scratch, the only in-house manufacturing facility for a licensed gene therapy that is approved by both the U.S. Food and Drug Administration and the European Medicines Agency. This facility is located on the 13th floor of a high-rise in West Philadelphia.

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Gene therapy, as others in this space know, is not a one-size-fits-all approach. That means there isnt a gene therapy manufacturing playbook yet to guide the development of gene therapies, as there is for well-established therapeutic categories. And at least for now, every gene therapy is different. Each relies on a different delivery mechanism (vector) to transport functional copies of a gene into the patient.

Even if one day we have a platform that is flexible enough to accommodate multiple vector types, well still need to consider the fact that individual therapies require different dosing and modes of administration, both dependent on the patients cells and disease. While we certainly seek to standardize processes through enhanced analytics, automation, and even artificial intelligence, manufacturing each therapy will still require custom processes.

And time is of the essence, because patients and their families are waiting for these therapies. Given that many of these diseases have limited or no treatment options, regulatory authorities are rightly granting expedited approval pathways for investigational gene therapies. The tight timelines in these pathways narrow the window for manufacturing teams to plan and implement strategies to create gene therapies at scale for commercial use.

Here are three aspects I see as unique to the gene therapy manufacturing process:

Get comfortable with the uncomfortable. Given the shortened clinical development timelines and limited precedent to guide them, gene therapy manufacturers must make decisions about investing in Phase 3 manufacturing processes far in advance of knowing the clinical outcome of their therapy. Its important to trust your expertise and invest in well informed good risk. We saw the success of this at Spark with the first gene therapy, which is helping create a clearer road map for future ones.

Develop capability for capacity. Manufacturing a gene therapy is only half the battle. The other half is making enough of it, doing that as efficiently as possible, and getting it to the patients who need it. These challenges become even more urgent to tackle as the industry shifts to the next chapter in gene therapy development, from treatments made in small batches for small patient populations to bigger volumes for larger rare-disease populations and commercial scale.

Spark, for example, is optimizing the way it produces viral vectors, shifting from adherent cell lines, which attach cells to the sides of roller bottles, to a suspension process that is more efficient and scalable. In this process, bioreactors grow cells unattached, in a liquid or suspended environment. This alternate way of manufacturing uses well-established unit operations commonly employed in the biotechnology industry, making efficiency at scale more easily achievable. Less manual manipulation provides for more process consistency and higher success rates. Each of these elements aids in our ability to scale more easily.

Dont let perfection be the enemy of progress. Versions of this phrase have been attributed to Voltaire, Shakespeare, and Winston Churchill, among others, but the point here is that when it comes to manufacturing, the process is never perfect and can always be better. Our gene therapy manufacturing processes are constantly evolving based on what we learn from them and from new best practices. What matters most today is that we can manufacture gene therapies safely and effectively. The speed will continue to improve.

Manufacturers are accustomed to setting up highly repeatable processes for making and delivering medicines. But when it comes to gene therapies, we understand that the ingenuity for manufacturing needs to be as unique and cutting-edge as the therapies themselves.

While its exciting to see gene therapy manufacturing in the limelight today, I hope that the progress we are making will soon make these challenges old news.

Diane Blumenthal is the head of technical operations at Spark Therapeutics, where her responsibilities include manufacturing, quality control, and more.

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Ring Therapeutics Launches to Expand Gene Therapy Viral Vector Options – Xconomy

December 19th, 2019 7:49 pm

XconomyBoston

Ring Therapeutics, a Flagship Pioneering spinout, launched Thursday with ambitious plans to expand the universe of vectors available for gene therapy delivery.

Gene therapy, treatments intended to treat disease by inserting a gene instead of using drugs or surgery, has had a banner year, with the second ever such therapy approved this year in the US.

Ring want to use itsresearch into viruses that exist in the human body without apparent negative effects to provide more and better options to fuel the rise of gene therapy treatments.

For the past two years, Flagship Pioneering partner and Rings founding CEO Avak Kahvejian says the company has been exploring the human commensal viromebasically, a group of viruses that exist within humans without negative effectsfor its potential to address limitations of the vectors currently used.

The sector relies heavily on adeno-associated viruses (AAVs), which naturally infect humans but arent known to cause disease, to deliver the DNA. Previous exposure, however, can spark an immune response.

A lot of the workhouses in gene therapy have either been pathogenic viruses or viruses that have been taken from other species or viruses that are highly immunogenic, or all of the above, Kahvejian tells Xconomy. That leads to a certain number of limitations, despite the successes and advances weve made to date.

A number of issues stymie widespread use of AAVs, Kahvejian says, including the fact that 10 percent to 20 percent of people have at one time or another been infected with such a virus, thereby building up an immune response to it. Another concern is where such gene therapies end up, because viruses tend to gravitate toward certain types of tissues, and to go elsewhere, require special tweaking.

The Cambridge, MA-based startup believes the viruses it has found are unlikely to cause an immune response or prove pathogenic, given their ubiquity in the body.

Like extrachromosomal DNAa new discovery at least one company is exploring for its potential as a target in cancer treatmentsthe viral sequencing Ring is studying are circular pieces of DNA that exist outside the 23 chromosomes of the human genome.

Ring says it has found thousands of these viruses that coexist with our immune system. It aims to use those to develop vectors that can facilitate gene replacement throughout the bodymultiple times, if necessary. While gene therapy is thought of as a one-time fix, cell turnover means whatever the fix engendered by the inserted gene could falter over time, necessitating a re-up.

Kahvejian wouldnt share a timeline for Rings plan to develop re-dosable, tissue-targeted treatments.

Were looking at the unique features and activities of these viruses in different tissues to establish the various vectors were going to pursue, he said.

Flagship, which pursues scientific questions in-house and builds and funds companies around the answershas put $50 million toward Ring, which has about 30 employees.

Rings president is Rahul Singhvi, an operating partner at Flagship. Most recently he was chief operating officer of Takedas global vaccine business unit. Its head of R&D is Roger Hajjar, who has led gene therapy trials in patients with heart failure.

Ring is the second startup Flagship has spun out this month. Cellarity launched last week.

Sarah de Crescenzo is an Xconomy editor based in San Diego. You can reach her at sdecrescenzo@xconomy.com.

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