WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca today presented results from the interim analysis of the Phase III ELEVATE TN trial, showing that CALQUENCE (acalabrutinib) combined with obinutuzumab or as monotherapy significantly improved progression-free survival (PFS) compared to chlorambucil plus obinutuzumab, a standard chemo-immunotherapy treatment, in patients with previously untreated chronic lymphocytic leukemia (CLL).

The Independent Review Committee (IRC)-assessed results were presented at the 2019 American Society of Hematology Annual Meeting and Exhibition in Orlando, US. At a median follow-up of 28.3 months, CALQUENCE in combination with obinutuzumab or as a monotherapy significantly reduced the risk of disease progression or death by 90% and 80%, respectively, vs. chlorambucil plus obinutuzumab.

In an exploratory analysis, CALQUENCE in combination or alone demonstrated consistent PFS improvements across most pre-specified subgroups of patients with high-risk disease characteristics, including the unmutated immunoglobulin heavy-chain variable gene (IGHV), del(11q) and complex karyotype. Overall, the safety and tolerability profile of CALQUENCE observed in the ELEVATE TN trial was consistent with its known profile.

Jos Baselga, Executive Vice President, Oncology R&D said: On the heels of approvals in the US, Australia and Canada, these full results provide further evidence that CALQUENCE, as a new treatment option for patients with chronic lymphocytic leukemia, demonstrates remarkable efficacy and a favorable tolerability profile. These results also provide, for the first time, post-hoc analysis data exploring the potential progression-free survival benefit of adding obinutuzumab to a BTK inhibitor versus BTK inhibitor monotherapy in a randomized trial.

Dr. Jeff Sharman, Director of Research at Willamette Valley Cancer Institute, Medical Director of Hematology Research for The US Oncology Network, and a lead author of the ELEVATE TN trial, said: In the detailed results from the ELEVATE TN trial comparing CALQUENCE to a commonly used chemo-immunotherapy treatment regimen, CALQUENCE demonstrated a clinically meaningful improvement in progression-free survival, while maintaining its known tolerability and safety profile. These are encouraging results for a patient population that is known to face multiple comorbidities, and where tolerability is a critical factor in their treatment.

Summary of key efficacy results as assessed by IRC from the ELEVATE TN trial at median follow-up of 28.3 months:

Efficacy measure

CALQUENCE plusobinutuzumab

N = 179

CALQUENCEmonotherapyN = 179

Chlorambucil plusobinutuzumabN = 177

PFS

Number of events (%)

14 (7.8)

26 (14.5)

93 (52.5)

Median (95% CI), months

NR(NE, NE)

NR(34.2, NE)

22.6(20.2, 27.6)

HR (95% CI)

0.10 (0.06, 0.17)

0.20 (0.13, 0.30)

-

p-value

<0.0001

<0.0001

-

Estimated PFS at 24 months, %

93

87

47

ORR

ORR, n (%)(95% CI)

168 (93.9)(89.3, 96.5)

153 (85.5)(79.6, 89.9)

139 (78.5)(71.9, 83.9)

p-value

<0.0001

=0.0763

-

OS

Number of events (%)

9 (5.0)

11 (6.1)

17 (9.6)

Median (95% CI), months

NR (NE, NE)

NR (NE, NE)

NR (NE, NE)

HR (95% CI)

0.47 (0.21, 1.06)

0.60 (0.28, 1.27)

-

p-value

=0.0577

=0.1556

-

CI, Confidence Interval; NR, Not Reached; NE, Not Evaluable; HR, Hazard Ratio; ORR, Overall Response Rate, OS, Overall Survival

Adverse events (AEs) led to treatment discontinuation in 11.2% of patients treated with CALQUENCE in combination with obinutuzumab and 8.9% of patients treated with CALQUENCE monotherapy versus 14.1% of patients treated with chlorambucil plus obinutuzumab.

With over two years of follow-up, 79% of patients in both the CALQUENCE-containing arms remain on CALQUENCE as a monotherapy. In the CALQUENCE combination arm (n=178), the most common AEs of any grade (30%) included headache (39.9%), diarrhea (38.8%) and neutropenia (31.5%). In the CALQUENCE monotherapy arm (n=179), the most common AEs of any grade (30%) included headache (36.9%) and diarrhea (34.6%). In the chlorambucil plus obinutuzumab arm (n=169), the most common AEs of any grade (30%) included neutropenia (45.0%), infusion-related reaction (39.6%) and nausea (31.4%).

Other AEs of clinical interest (%)1

CALQUENCE plusobinutuzumabN = 178

CALQUENCEmonotherapyN = 179

Chlorambucil plusobinutuzumabN = 169

Any

Grade 3

Any

Grade 3

Any

Grade 3

Atrial fibrillation

3.4%

0.6%

3.9%

0%

0.6%

0%

Major bleeding

2.8%

1.7%

1.7%

1.7%

1.2%

0%

Hypertension

7.3%

2.8%

4.5%

2.2%

3.6%

3.0%

Infection

69.1%

20.8%

65.4%

14.0%

43.8%

8.3%

SPM excluding NMSC

Link:
CALQUENCE Significantly Prolonged the Time Patients Lived Without Disease Progression or Death in Previously Untreated Chronic Lymphocytic Leukemia -...

Recommendation and review posted by Bethany Smith

SOUTH JORDAN, Utah--(BUSINESS WIRE)--Rio Tinto has approved a $1.5 billion investment (100 per cent basis) to continue production at its Kennecott copper operation in the United States. The investment over the next six years will extend operations at Kennecott to 2032.

The investment will further extend strip waste rock mining and support additional infrastructure development in the second phase of the South Wall Pushback project, to allow mining to continue into a new area of the ore body and deliver close to one million tonnes1 of refined copper between 2026 and 2032. It is a world class project that will generate attractive returns, and allow further exploration of the deposit and options for mine life extension.

This additional investment will commence in 2020 and is included in our group capital expenditure guidance of $7.0 billion in 2020 and $6.5 billion in both 2021 and 2022 as development capital. With this project, Rio Tinto has invested more than $5.0 billion in modernisation, environmental stewardship and mine-life extension initiatives since it acquired Kennecott in 1989.

Rio Tinto chief executive J-S Jacques said, This is an attractive, high value and low risk investment that will ensure Kennecott produces copper and other critical materials to at least 2032. The outlook for copper is attractive, with strong growth in demand driven by its use in electric vehicles and renewable power technologies, and declining grades and closures at existing mines impacting supply.

Kennecott is uniquely positioned to meet strong demand in the United States and delivers almost 20 per cent of the countrys copper production. North American manufacturers have relied on high quality products from Kennecott for the past century and this investment means it will continue to be a source of essential materials into the next decade.

Earlier this year, Rio Tinto announced that it would cut the carbon footprint associated with operations at Kennecott by permanently closing its coal fired power plant and sourcing renewable energy certificates.

J-S added, Kennecott will be supplying customers across North America with products that are not only produced in the region but responsibly mined with a significantly reduced carbon footprint.

Notes to Editors

The first phase of the South Wall Pushback, which is expected to be complete in 2021, extended production from 2019 to 2026. $0.3 billion remains to be spent of a $0.9 billion investment.

In addition to copper, Kennecott is one of the largest producers of gold, silver, platinum group metals and molybdenum in North America, and a potential source of critical minerals such as rhenium and tellurium.

The complex operates on Rio Tintos privately owned land and hosts one of the most advanced copper and precious metals smelters in the world. It processes concentrate from Kennecott and third parties, and is one of only three smelters in the United States.

Rio Tinto is a member of the US Department of Energys Critical Materials Institute (CMI) and is jointly investigating with CMI experts ways to extract additional critical minerals from the existing refining and smelting process.

_____________________

1 This production target (stated as payable metal) includes 0.9 million tonnes of refined copper from the second phase of South Wall Pushback and 0.1 million tonnes from first phase of the South Wall Pushback. It is underpinned 60 per cent by Proved Ore Reserves and 40 per cent by Probable Ore Reserves for the years 2026-2032, which have been scheduled from current mine designs by Competent Persons in accordance with the requirements of the Australasian Code for Reporting of Exploration Results, Minerals Resources and Ore Reserves, 2012 Edition.

Reserves referenced were released to the market in the 2018 Rio Tinto Annual Report on 2 March 2019. The Competent Person responsible for reporting of those Ore Reserves was Ed Woods (AusIMM). Rio Tinto is not aware of any new information or data that materially affects the above ore reserve or mineral resource estimates as reported in the 2018 Annual Report, and confirms that all material assumptions and technical parameters underpinning these estimates continue to apply and have not materially changed. The form and context in which each Competent Persons findings are presented have not been materially modified.

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Rio Tinto Invests $1.5 Billion to Continue Production at Kennecott Copper To 2032 - Business Wire

Recommendation and review posted by Bethany Smith

December 5, 2019

SBM Offshore is pleased to announce that it has signed contracts for the construction of the Companys fourth and fifth hulls under its purchase program for Fast4Ward new build multi-purpose hulls. The contracts were signed with Shanghai Waigaoqiao Shipbuilding and Offshore Co., Ltd. (SWS) and China Merchants Industry Holdings (CMIH). Both yards are also progressing the construction of SBM Offshores first three hulls which are already allocated to projects.

Bruno Chabas, CEO of SBM Offshore, commented:

We continue to have good visibility on new awards from active client engagements. This has given the Company the comfort to accelerate the program and commit to two additional Fast4Ward hulls. The Company is currently constructing five hulls simultaneously, a fact which underscores the fundamentals of our market and SBM Offshores competitive position. During this period of increasing demand, SBM Offshore remains disciplined and selective with respect to market opportunities.

Corporate Profile

SBM Offshore N.V. is a listed holding company that is headquartered in Amsterdam. It holds direct and indirect interests in other companies that collectively with SBM Offshore N.V. form the SBM Offshore Group (the Company).

SBM Offshore provides floating production solutions to the offshore energy industry, over the full product lifecycle. The Company is market leading in leased floating production systems delivered to date, with multiple units currently in operation and has unrivalled operational experience in this field. The Companys main activities are the design, supply, installation, operation and the life extension of floating production solutions for the offshore energy industry.

As of December 31, 2018, Group companies employ approximately 4,350 people worldwide, including circa 650 contractors, which are spread over offices in key markets, operational shore bases and the offshore fleet of vessels. Group Companies employ a further 400 people, working for the joint ventures with two construction yards. For further information, please visit our website at http://www.sbmoffshore.com.

The companies in which SBM Offshore N.V. directly and indirectly owns investments are separate entities. In this communication SBM Offshore is sometimes used for convenience where references are made to SBM Offshore N.V. and its subsidiaries in general, or where no useful purpose is served by identifying the particular company or companies.

The Management BoardAmsterdam, the Netherlands, December 5, 2019

For further information, please contact:

Investor RelationsBert-Jaap DijkstraDirector Corporate Finance and IR

Media RelationsVincent KempkesGroup Communications Director

Disclaimer

This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation. Some of the statements contained in this release that are not historical facts are statements of future expectations and other forward-looking statements based on managements current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance, or events to differ materially from those in such statements. Such forward-looking statements are subject to various risks and uncertainties, which may cause actual results and performance of the Companys business to differ materially and adversely from the forward-looking statements. Certain such forward-looking statements can be identified by the use of forward-looking terminology such as believes, may, will, should, would be, expects or anticipates or similar expressions, or the negative thereof, or other variations thereof, or comparable terminology, or by discussions of strategy, plans, or intentions. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this release as anticipated, believed, or expected. SBM Offshore NV does not intend, and does not assume any obligation, to update any industry information or forward-looking statements set forth in this release to reflect subsequent events or circumstances. Nothing in this press release shall be deemed an offer to sell, or a solicitation of an offer to buy, any securities.

See more here:
SBM Offshore orders two additional Fast4Ward hulls, bringing the construction program to a total of five hulls - Financialbuzz.com

Recommendation and review posted by Bethany Smith

Following the initial 60,000-metre resource drilling program initialled in June 2019, the company has now completed 28,868 metres with the latest assays comprising 10,000 metres of drilling.

() has received assays for a further 10,000 metres of the 60,000-metre resource definition drilling program at the San Antonio and Roswell prospects to the south of its Tomingley Gold Operations (TGO) in New South Wales.

A total of 28,868 metres has been drilled to date in order to define an initial inferred resource at the Roswell and San Antonio prospects.

The drilling program is part of an extensive regional exploration program designed to provide additional ore feed either at surface or underground to TGO.

Assays received so far have demonstrated the potential for a material project life extension and show that a return to open-pit mining or underground extension is possible with appropriate resource confirmation, landholder agreement and regulatory approvals.

The latest notable intersections at Roswell include:

First phase drilling at Roswell is now complete with samples being prepared and assayed to form part of an initial resource which is expected in December.

San Antonio assays include:

Difficult drilling conditions in the southern portion of the San Antonio prospect has caused early abandonment of some drill holes which means the initial inferred resource is now expected in February.

Drilling continues in other areas while the company awaits the arrival of the collaring and casing tool, including some of the 20 metre infill lines that were scheduled for later in the program.

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Alkane Resources intersects additional broad high-grade gold up to 139.5 g/t at Tomingley in NSW - Proactive Investors Australia

Recommendation and review posted by Bethany Smith

A corrosion monitoring program provides comprehensive monitoring of all critical components of industrial objects, assets, facilities and plants for signs of corrosion. For reliable operation it is important to identify the location, rate, and underlying causes of corrosion. A corrosion monitoring program identifies any non-conforming alloy components, as these are generally susceptible to accelerated corrosion and can give relatively frequent cause for catastrophic failure.

Corrosion Monitoring can provide significant advantages when integrated into both preventative maintenance and the processes inherent to safety management programs. Based on the results of the Corrosion Monitoring program, informed decisions can be made, not only regarding the remaining life of the object affected by corrosion but also regarding life extension strategies, prospective material selection, and cost-effective methods for remedy of corrosion issues and problems.

This reprot focsues on the instrument market.

Access Report Details at: https://www.themarketreports.com/report/global-corrosion-monitoring-instrument-market-research-report

The global Corrosion Monitoring Instrument market is valued at xx million US$ in 2018 is expected to reach xx million US$ by the end of 2025, growing at a CAGR of xx% during 2019-2025.

This report focuses on Corrosion Monitoring Instrument volume and value at global level, regional level and company level. From a global perspective, this report represents overall Corrosion Monitoring Instrument market size by analyzing historical data and future prospect. Regionally, this report focuses on several key regions: North America, Europe, China and Japan.

Key companies profiled in Corrosion Monitoring Instrument Market report are Honeywell, ClampOn, Emerson, Intertek, Buckleys (UVRAL) Ltd, PT Korosi Specindo, Cosasco, Alabama Specialty Products and more in term of company basic information, Product Introduction, Application, Specification, Production, Revenue, Price and Gross Margin (2014-2019), etc.

Purchase this Premium Report at: https://www.themarketreports.com/report/buy-now/1416380

Table of Content

1 Corrosion Monitoring Instrument Market Overview

2 Global Corrosion Monitoring Instrument Market Competition by Manufacturers

3 Global Corrosion Monitoring Instrument Production Market Share by Regions

4 Global Corrosion Monitoring Instrument Consumption by Regions

5 Global Corrosion Monitoring Instrument Production, Revenue, Price Trend by Type

6 Global Corrosion Monitoring Instrument Market Analysis by Applications

7 Company Profiles and Key Figures in Corrosion Monitoring Instrument Business

8 Corrosion Monitoring Instrument Manufacturing Cost Analysis

9 Marketing Channel, Distributors and Customers

10 Market Dynamics

11 Global Corrosion Monitoring Instrument Market Forecast

12 Research Findings and Conclusion

13 Methodology and Data Source

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Latest Research Report to uncover key Factors of Global Corrosion Monitoring Instrument Market - Market Research Base

Recommendation and review posted by Bethany Smith

Most people would be surprised to hear that the most advanced nuclear-tipped cruise missile ever put into operation was retired from service while its predecessor, a less survivable missile it was supposed to replace, soldiers on in U.S. Air Force service to this very day. This topsy-turvy reality is somewhat metaphorical of General Dynamics' AGM-129 Advanced Cruise Missile (ACM) itself. In fact, the AGM-129 could be considered the second stealth aircraft to ever enter production, because that is what it really was, albeit one that was designed upside down, and for good reason.

The origins of the ACM are fairly straightforward. The AGM-86B Air-Launched Cruise Missile (ALCM) entered service in the early 1980s. When it was being designed, and while the non-production AGM-86A was undergoing initial trials, the best way to deliver a nuclear warhead deep inside Soviet airspace by an air-breathing platform was via low-altitude penetration. The AGM-86 was designed exactly for that, to punch through at treetop level using terrain contour matching, terrain-following radar, and inertial navigation to get close enough to a target that the W80 nuclear warhead onboard could do its job successfully.

USAF

Later on, the AGM-86C and D would integrate GPS to deliver pinpoint conventional strikes. You can read all about the AGM-86C/D's capabilities in this recent piece of ours, but the nuclear-armed version of the era had no such accuracy. Regardless, survivability against quickly evolving Soviet air defenses was the most pressing requirement in the Air Force's air-launched cruise missile portfolio as the 1970s gave way to the 1980s.

USAF

AGM-86 being dropped by a B-52 during tests.

The AGM-86B had a few stealthy characteristics, but it was far from a true low observable design. Just as it came into service, the Air Force realized that the days when being able to beat air defenses via low-flying alone were coming to an end. Airborne early warning and control aircraft and advanced fire control radars with look-down-shoot-down capabilities, like those on Russia's 4th generation fighter and interceptor fleets (Su-27 and MiG-31, specifically), would decrease the effectiveness of nap-of-the-earth flying tactics. Something far more survivable was needed, and fast.

Russia MoD

Out of a handful of DARPA initiatives and studies dubbed TEAL DAWN that explored future cruise missile technologies and long-range bomber strategies, it was concluded thatthe new stealth bomber then in development alone wouldn't be survivable against the densest Soviet air defenses. Long-range and survivable standoff weapons would be needed in part to mitigate those defenses. Two requirements were establishedone stealthy missile that could travel around 1,500 miles or more and another that could travel over 5,000 miles. The latter clearly invalidated much of the need for a stealth bomber in the first place and it was thought that at least a decade would be needed to develop such a long-range weapon. As a result, it was jettisoned to concentrate on the shorter-ranged stealthy cruise missile requirement that could be fielded quickly and equip the Air Force's new stealth bomberat least that's what they hoped. With this in mind, a competition to build such a weapon was quietly launched.

Lockheed, Boeing, and General Dynamics ended up squaring off in secret for this new contract. Lockheed's Skunk Works leveraged their work on the F-117 program, which was just spinning up in a very secretive operational state at the time, to produce its F-117-shaped cruise missile, known under the code name SENIOR PROM. The details surrounding Boeing's design remain unclear. General Dynamics' design was a bit more of a traditional configuration, but one that was clean-sheet and packed with very stealthy features arranged in unique ways to maximize its effectiveness and efficiency. SENIOR PROM, which was a test program before competing for the Advanced Cruise Missile contract, was very stealthy, but it would have been troublesome fitting it into a bomber's weapons bay. By 1983, General Dynamics clenched the contract and the AGM-129A Advanced Cruise Missile was officially born.

Public Domain

Lockheed's SENIOR PROM stealth cruise missile based on its still then very secret F-117 Nighthawk design.

General Dynamics' design, which measured nearly 21 feet long and weighed in at 3,700 pounds, was downright wicked looking. A faceted, stiletto-shaped fuselage with a chined, sharp-tip nose area and forward-swept pop-out wings gave it a sinister, almost Klingon-like look. Not just the wings were backward, all the low observable features were oriented towards defeating detection from above, not below. This resulted in an upside-down-looking airframe of sorts.

The vertical stabilizer-rudder pointed down instead of up. It was made up of composite materials, as were the missile's horizontal forward-swept stabilizers, to remain nearly invisible to the most threatening radar bands. The vertical stabilizer was also offset to the left side of the fuselage's centerline.

Semanticscholar.org/USAF

That gas from the missile's two-dimensional exhaust aperture was blown over a platypus-like defuser structure that shielded its signature from, you guessed it, above, instead of below. The exhaust was also mixed with cold air to help further attenuate its infrared signature. Sovietinfrared search and track (IRST) systems were advancing in capability at the time and included on all of Russia's 4th generation fighter/interceptor designs, so infrared signature reduction was weighted heavily alongside radar cross-section reduction during the competition that led to the AGM-129.

USAF

The AGM-129 seen in stowed configuration during climate testing at Eglin AFB.

The low-observable trapezoidal air inlet sat flush on the bottom of the missile instead of the top of it and fed the engine with air through a serpentine duct, thus eliminating any radar return from the engine fan face. Realizing a flush air inlet on something that flies at transonic speeds comes with major design challenges and it's not like any stealthy air inlet configuration is easy to design or produce, to begin with. Beyond its underlying radar-evading structures, the AGM-129 was also covered with radar absorbent material and coatings and given an olive drab color to blend in with the terrain it would roar over just before sparking off a nuclear apocalypse.

USAF

So, if you think the AGM-129 looks like it is flying inverted, that is by very conscious design. Overall, the missile was designed with a particular weight put on stealth from its upper and forward aspects, where it was most vulnerable. From directly to its side, its radar signature was reduced, but more visible than from other angles. This was deemed a non-issue because the pulse-doppler radars that could threaten it from above are unable to detect low-flying targets hiding in ground clutter while flying at perpendicular angles to the radar antenna as they remain inside the radar's "doppler notch." You can read more about this phenomenon and the tactics associated with it here.

Navigation was also innovative. The AGM-129 introduced a laser doppler velocimeter into its navigational suite, which, like the AGM-86, also included inertial navigation and terrain contour matching. This gave it substantially better accuracy over long distances than the AGM-86B, which was designed less than a decade before it.

It also included laser detection and ranging system (LADAR) to aid in low-altitude flight, which further allowed it to fine-tune its endgame attack run down to as accurate as 90 feet according to stated metrics, although the system likely became even more accurate as it matured. Considering it still packed the same W80 variable yield warhead (5kt-150kt) as the AGM-86B, its better accuracy substantially increased its effectiveness, especially against reinforced targets or those that are partially shielded by terrain.

LADAR, as opposed to radar, also allowed the AGM-129 to remain electromagnetically silent, giving off no radio frequency energy when it was most vulnerable and thus making it even harder to detect. There were some tradeoffs though, LADAR could have trouble receiving data against certain surfaces, such as those that were extremely reflective or highly light absorbent. Still, the system was extremely effective and because the missile was so stealthy, it could fly at higher altitudes and in most cases still survive to make it to its target if need be.

FAS.ORG

Still, the system was not perfect. During one test over Dugway Proving Ground in 1997, an AGM-129 was flying so low it impacted some trailers belonging to an observatory. Nobody was hurt in the incident and the missile had been flying for three and a half hours before the accident. It turns out the mission planners had no idea the trailers were there and how the missile got so low was unclear to begin with.

The missile was fast, traveling at just under the speed of sound, and it also packed a very long range. It used a far more fuel-efficient engine, the Williams International F112-WR-100 turbofan, than the one found on the AGM-86, which gave it significantly greater range while retaining similar dimensions and the same payload. Officially, ACM could reach out 2,000 miles to its target , but it seems clear that its real range was actually significantly further, especially when flying a more efficient flight profile during more benign portions of its trip to its target area. As noted earlier, the missile's high degree of stealth meant that it could climb to more efficient altitudes during certain phases of flight and still have a high chance of surviving to complete its horrific task.

Another interesting component of the AGM-129 was its computer system. From how it has been explained to me it used basically one central processor and computing system to run the vast majority of the missile's functions. For early 1980s military technology, this is an amazing feat. Basically, the computer system and the system designed to used it on the missile was absolutely cutting-edge for its time.

USAF

An incredible gathering of 1990s stealth technology, with the AGM-129 in the foreground and the F-117 and B-2 in the background.

It can't be stressed enough how advanced the ACM was for its time. It had many elements that hadn't yet emerged from the classified manned aircraft realm, but was an autonomous system meant to fly thousands of miles to its target without aid and to be built by the hundreds. It was truly a highly sensitive modern marvel of its era.

The first flight test of an AGM-129 occurred in July of 1985, with the first production missiles being delivered two years later, in 1987. It was that year when the program became public, as well. In that sense, it was the first disclosure of a stealth flying machine ever. Still, the program struggled early in its production run. There were technological issues that popped up in flight testing, but the major problems were with building the advanced missiles themselves. Remember, at the time of its first deliveries, no stealth aircraft had even been acknowledged by the Air Force. This wouldn't occur until two years later when the F-117 was officially disclosed to the public. So, the technologies used in its manufacturing were absolutely cutting-edge in nature.

The missile's very aggressive concurrent testing and production schedule concept and major labor issues with the International Association of Machinists began to cripple the program and it quickly became a pariah on Capitol Hill and in certain parts of the Pentagon. By the end of the decade, the AGM-129 was being declared a fiasco. Things got so bad with quality control issues that production was halted between 1989 and 1991.

FAS.ORG

ACMs being manufactured at the General Dynamics plant.

Of course, the timing of this setback couldn't have been worse. The Cold War was ending and the defense budget was set to snap back hard, especially in terms of strategic weaponry. In addition, the B-2 wouldn't fly until 1989 and still would have a long developmental road ahead of it. The B-1B was also having its own troubles and the missile was never designed to fit in its weapons bays, it was too long, and eventually, the B-1B would lose its nuclear role altogether. So, the weapon that was procured at least in part to be paired with the stealth bomber would be relegated to the B-52.

The confluence of these factors, as well as the START treaty which limited these types of weapons, resulted in a drastic reduction of the programmed buy. The nearly 1,500 missiles needed to replace the AGM-86B in full was slashed down to less than half that, and eventually to a final number of just 460 missiles. Unit cost soared partially as a result of the curtailed order, with each missile costing roughly $4.3 million in 1992 dollars. This is extremely expensive for a cruise missile even by today's standards. A decade earlier, the AGM-86Bs cost around $1.3 million each. The ACM had truly entered a Pentagon budgetary 'death spiral' alongside the plane that was supposed to carry it, the B-2.

FAS.org

President Bush underneath an ACM.

Still, they were the most advanced cruise missiles in the world and the truncated force of 460 missiles soldiered on over the next two decades, exclusively equipping the B-52 force. A single B-52 could carry 20 of the missiles at one time. Six on each wing pylon and eight in the jet's cavernous weapons bay on a rotary launcher.

Two other AGM-129 variants were proposed, but never came to fruition. The AGM-129B was a shadowy initiative to equip a revised design with an axial-flow jet engine, new software, and a different nuclear warhead to take on a specialized role that remains classified. This could have been a GPS-equipped, imaging infrared, or otherwise more precise upgrade of the weapon that would also be equipped with a penetrating nuclear warhead of a lower yield to take on heavily fortified bunkers and more hardened structures. Then again, maybe it was something more exotic, we just don't know for absolute certain.

USAF

ACMs loaded onto a B-52.

The other proposed variant was a conventional land attack model similar to the AGM-86C/D Conventional Air-Launched Cruise Missiles (CALCM), but far more survivable and with a lot longer reach. GPS would have been necessary for this weapon, just like it was for its CALCM progenitor. An imaging infrared seeker with imaging matching could have been injected into the design for even better accuracy. In retrospect, this would have been a relatively amazing weapon.

The ACMs that were built may have received a GPS upgrade sometime during the decade and a half or so that followed their introduction into service in 1990, although it remains unclear if this actually happened. It would have given the missiles pinpoint accuracy, but GPS connectivity would not be assured during a nuclear war and it may have been cost-prohibitive to integrate a GPS antenna onto the ACM's stealth airframe. If the upgrade did happen, it would have likely occurred when the missiles were put through a Service Life Extension Program (SLEP) in the early 2000s that would allow them to serve until 2030 and possibly beyond.

Regardless of this life extension program, in 2007, the 17th year of the AGM-129's operational service, it was decided that the entire ACM force would be drawn down and eliminated from service by the end of 2012. A number of factors contributed to this decision, the first being the post 9/11 focus on counter-insurgency operations instead of preparing for peer state conflicts. The U.S. had two raging wars on its hands that were anything but cheap, and the Russian bear remained largely dormant at the time, while China was just on precipice its economic, geopolitical, and technological rise. The AGM-129 program, with its relatively small fleet made up of super high-tech 1980s technology, meant that sustaining the missiles was far from a cheap or easy task. The AGM-86B, although much less survivable, checked a box for much less money and had commonality with its conventionally armed cousin, the AGM-86C/D, which helped significantly in terms of sustainment scalability.

Beyond fiscal matters, the Strategic Offensive Reductions Treaty (SORT) with Russia also meant more warheads would be pulled off the front lines. So, the Air Force moved forward with not just retiring the AGM-129, but destroying the fleet, a task that was completed as planned by the end of 2012.

During its drawdown period, one highly publicized and unfortunate event occurred with what were historically very shy missiles. On August 30th, 2007 a "Bent Spear" incident occurred with a package of 12 ACMs. A B-52H was set to ferry unarmed ACMs from Minot AFB in North Dakota to Barksdale AFB in Louisiana. The missiles were to be decommissioned at Barksdale, so the mission itself wasn't necessarily out of the ordinary. What was not normal is that six of the missiles were actually carrying their W-80 thermonuclear warheads.

The nuclear-armed B-52 sat overnight without a proper security detail and other precautions until the crew showed up for the mission the next day. During pre-flight checks, the crew did not inspect both pylons loaded with missiles. They only inspected the one that held six unarmed ACMs, but logged that both pylons full of missiles were indeed checked and that they were unarmed. The crews then flew across the Midwest not knowing they were carrying six nuclear warheads.

USAF

A B-52H seen with a 'package' of ACMs pre-loaded on their pylon at Minot AFB.

After arriving at Barksdale, the jet sat for another eight hours without standard precautions associated with nuclear-armed aircraft. It was nearly a day and a half after the Minot AFB personnel blew off normal procedures and loaded the hot ACMs on the B-52 that the fact that the plane was actually carrying live warheads was discovered. The incident was the first of its kind in four decades and sent shockwaves through the Air Force and the Pentagon. A subsequent investigation showed horrible disregard for critical nuclear weapons handling protocols and everyone from four unit commanders down to those directly involved were heavily disciplined or removed from duty. All nuclear weapons handling was suspended at Minot AFB. It also resulted in a new set of procedures that were designed to make sure such a breakdown in procedures doesn't happen again.

It was a sad end to the troubled development and career of the world's first stealth cruise missile.

USAF/Public Domain

In retrospect, the decision not just to retire, but fully destroy the AGM-129 cadre seems like a very poor one. Today, the Air Force is working on developing a new stealthy long-range nuclear-tipped cruise missile, the Long-Range Stand-Off (LRSO) weapon, a program that will cost tens of billions of dollars and won't produce an operational missile until at least 2030. Raytheon, which owns the AGM-129 design after it bought Hughes Missile Systems, which bought General Dynamics' missile portfolio prior, is competing with Lockheed for the LRSO contract. In the meantime, the AGM-86B is supposed to remain a viable deterrent even in an era of ever more capable highly integrated air defense systems, ones that now rely on look-down-shoot-down sensors more than they did 35 years ago and that are far more advanced in general than what existed when ACM was conceived. This begs the question, is the AGM-86B really a survivable deterrent at all? The true answer, that we will never officially get, is probably less comforting than we may want to hear.

The truth is, the AGM-129 was way ahead of its time. Today, there are numerous stealthy cruise missiles in production or will be in production soon and they are becoming an extremely sought-after item. The USAF can't get enough of Lockheed's JASSM family of missiles, which continues to rapidly grow in capability, while the Navy is procuring the anti-ship LRASM cousin of JASSM, the stealthy Naval Strike Missile, and a powered version of the JSOW. Multiple foreign militaries have their own stealthy cruise missiles, as well. But these are conventionally armed weapons. It will be at least another decade until a nuclear-armed stealth cruise missile hits the USAF's inventory again. That weapon, the LRSO, will be in many ways the son of AGM-129 and from what we are hearing, it will be absolutely loaded with the latest and greatest technology that will allow it to survive in the most inhospitable of combat environments. It is also meant to equip the USAF's new stealth bomber, the B-21 Raider.

Somehow this all sounds eerily familiar, doesn't it?

Contact the author: Tyler@thedrive.com

Link:
The Saga Of The AGM-129 Cruise Missile That Was Basically A Stealth Jet Designed Upside Down - The Drive

Recommendation and review posted by Bethany Smith

The 338 Mira was estabilished on 24th December 1952. All these years, 338 Sqn has consisted and is still continuing to consist the cornerstone of the structure of the Hellenic Air Force , which guarantees the security of Greece and the territorial integrity.The emblem of the Squadron is rapresented by Aris, the god of war, and it well fit with the milestone of the aviations after the 60s, the F-4E Phantom II. In the emblem there is still the quote H TAN H ENI TAS, the phrase that Spartian woman said to their sons when they handed over the shield to them- come back with it (winner) or over it (dead).

The 338 Fighter Bomber squadron was formed at the Elefsis air base equipped with the F-84G, the first jet of the Hellenic Air Force. In April 1953 the Squadron redeployed from Elefsis air base (112 Combat Wing) to Larissa air base (110 Combat Wing), where it stayd until November 1956, when it returned to the 112CW. The next redeployment took place in May 1958 moving to Souda air base, Crete, with the 115 Combat Wing.

In January 1960 the squadron stopped its operations for four years, and in 1964 it was again operative with the new F-84F. At the airport of Souda, the Squadron stayed until 30th June 1974, when it stopped again its operations and become incorporated in the 340 Squadron.

The pause in operation took place in order to be reformed in the airport of Andravida with the new F-4E Phantom II, which were just delivered to Hellenic Air Force. In a very short time, the pilots, trained in the USA, diffused their knowledge to the rest of the Unit, yielding a fully operational Squadron in May 1975.

In 1981 the Mobile Training Unit of USAF partecipated in the training of the Squadron on new tactics and advanced aerobatic maneuvers. On 1st February 1984, the new Basic Order 3-1/1984 was applied concerning the increase of fighting capability.

Particularly, all the pilots were trained and certified in low apex attacks, low night navigation and advanced maneuvers. There were also carried out a lot of missions for the familiarization of the pilots with the operational environment of the Aegean Sea.

The next milestone in the history of 338 Squadron happened on 5th August 1991, when the replacement of Peace Icarus I and II aircraft by F-4E SRA took places. Since 12th October, flights of the new aircraft were carried out for their operational development. On 18th December 2002, the aircraft, which equipped the squadron since 1st July 1974, returned, having been upgraded structurally as well as electronically, making them the best Phantoms ever flown.

Until today, after 60 years, 338 squadron continues to contribute to the missions of the Hellenic Air Force, having highly trained crew, that in cooperation with an upgraded legendary aircraft, is able to defend the rights and interests of the Hellenic Nation both in Greece as in Cyprus.

Apart from many exercises and training missions outside Hellenic Airspace, Ares Sqn. partecipated in all range of HAF missions like air to ground attacks, interception, Close Air Support, Interdiction, Air to Surface attacks and Electronic Warfare, but the main role of the Squadron is OCA (Offensive Counter Air) and CAS missions.

The training of the pilots is continuous and includes many release of live ordnance such as AIM-9, AGM-65 Maverick, Laser-guided bomb GBU-12, GBU-16 and GBU-24 and Mk 82 and Mk 84. Squadron sorties are also used to train other HAF pilots with JEWCS jamming pods which fit the F-4E and also with releasing flare targets for A/A live ordnance shots.

Due to its primary role in air-to-ground missions, the 338 Sqn was always present and ready to take action for attacking ground or naval targets during all the tensions in the Aegean Sea such as Ocanographic Chora crisis in 1987 or Imia island tensions during 1996. 338M being the last squadron of Polemiki Aeroporia using the Phantom, is even responsable for the training of new pilots assigned to the Phantom.

Actually the Group is training four pilots are complating the basic training to the F-4E, and after aproximately 70 missions, they are ready to be a aircraft leader, and to continue the big History and career of F-4E in Hellenic Air Force. The Squadron keep two aircraft armed with air to ground weapons ready for QRA.

On 11st August 1997, when the contract was signed with the German EADS for the Peace Icarus 2000 upgrade, also known as the Avionics Upgrade Program (AUP), the most important milestone was put for the History of 338 Mira. It was decided to upgrade the initial F-4s in Hellenic service (Peace Icarus I and II) and to apply a service life extension program to the entire F-4E and RF-4E fleet.

The AUP was an ambitious and challenging piece of work carried out to enhance the capabilities of the Phantom and to maintain the effectiveness of the weapon system into the 21st century. The AUP was complex and resulted in an all-new avionic system featuring a core MIL standard 1553 Databus with integration of improved AN/APG 65 GY radar, mission computer, armament central system, navigation system including GPS and INS, communication system, TCAN, radar altimeter (RADALT), data transfer and video recording system, the CPU-143/A central air data computer, Modular Multi-Role Computer (MMRC), laser gyro inertial navigation system with embedded GPS, AN/APX-113 Advanced Identification Friend or Foe (AIFF) and multi-function colour displays.

A comprehensive upgrade of the associated equipment and mission software ensured that the introduction of this all-new avionic suite brought an increased workload for pilots. In order to ease the transition and ensure that the Phantom cockpit become a more ergonomic and logical working environment a redesigned Human Machine Interface was introduced, featuring Hands on Throttle and Stick (HOTAS), multi function colour display, improved Head Up Display and an enhanced audio warning system.

The AUP upgrade allow the Hellenic Phantom to enhance its operative life. Nowadays the date for its retirement is not clear, probably the Phantom will fly in the Hellenic sky for other 5 years, until the budget for a new aircraft will be available. And, until now, it is not known if the new jet will be the F-16V or the new F-35.

Text and images: Andrea Avian

Original post:
Hellenic Air Force 338 Mira "Ares": the last Phantom over the Aegean - Aviation Report

Recommendation and review posted by Bethany Smith

In November 2018, He Jiankui, a researcher in Shenzhen, China, claimed he utilized CRISPR-Cas9 gene editing to alter the DNA of embryos for seven couples. A set of twins, whose names are Lula and Nana, were born. The research was met by global condemnation and calls for a moratorium on this type of gene editing.

However, aside from the public presentations and the resulting controversy and government crackdown on He Jiankui in China, the actual technical results have not been published. This week, the MIT Technology Review announced they had received a copy of Hes unpublished manuscript titled Birth of Twins After Genome Editing for HIV Resistance. They also received a second manuscript that discussed laboratory research on human and animal embryos. The research was apparently reviewed earlier by Nature and JAMA but is as yet unpublished. The MIT group had the papers reviewed by four experts, a legal expert, an IVF physician, an embryologist, and a gene-editing specialist.

MIT Technology Review writes, Their views were damning. Among them: key claims that He and his team made are not supported by the data; the babies parents may have been under pressure to agree to join the experiment; the supposed medical benefits are dubious at best; and the researchers moved forward with creating living human beings before they fully understood the effects of the edits they had made.

The analysis found 13 key problems, but one of the most relevant is that the stated purpose of the researchwhich is also under attackdid not occur. That is to say, He Jiankui and the authors of the research claim that the goal was to modify the CCR5 gene to make the children resistant to HIV. Not only did that not appear to have happened, but its questionable if it was the real reasonthe real, less scientific reason being to be the first scientists to modify human embryos using CRISPR gene that are then born.

One of the reviewers, Fyodor Urnov, a genome-editing specialist at the University of California Berkeley, said, The claim they have reproduced the prevalent CCR5 variant is a blatant misrepresentation of the actual data and can only be described by one term: a deliberate falsehood. The study shows that the research team instead failed to reproduce the prevalent CCR5 variant.

Another of the reviewers, Rita Vassena, scientific direct or the Eugin Group in Spain, noted, Approaching this document, I was hoping to see a reflective and mindful approach to gene editing in human embryos. Unfortunately, it reads more like an experiment in search of a purpose, an attempt to find a defensible reason to use CRISPR/Cas9 technology in human embryos at all costs, rather than a conscientious, carefully thought through, stepwise approach to editing the human genome for generations to come.

Vassena goes on to say, The idea that editing-derived embryos may one day be able to control the HIV epidemic, as the authors claim, is preposterous.

Hank Greely, professor of law at Stanford University, agreed with that assessment, calling it ludicrous. He also noted, We have no, or almost no, independent evidence for anything reported in this paper. Although I believe that the babies probably were DNA-edited and were born, theres very little evidence for that. Given the circumstances of this case, I am not willing to grant He Jiankui the usual presumption of honesty.

There is also significant doubt as to whether the parents involved in the study understood the procedures and the lack of necessity for having it performed. The father was HIV seropositive and it was under control using anti-retroviral therapy. There was little or no risk of HIV being transferred to the children under a normal in vitro fertilization treatment.

Jeanne OBrien, reproductive endocrinologist with Shady Grove Fertility in Atlanta, said, Being HIV-positive in China carries a significant social stigma. In spite of intense familial and societal obligations to have a child, HIV-positive patients have no access to treatment for infertility. The social context in which the clinical study was carried out is problematic and it targeted a vulnerable patient group. Did the study provide a genetic treatment for a social problem? Was this couple free from undue coercion?

Another problem, one of many, is that the gene edits performed were not the same as the mutations that are known to confer natural HIV resistance. The researchers indicated in the papers that they expect the edits to confer HIV resistance, because they are similar but not identical to CCR5 delta 32, the natural mutation that confers resistance. One of the babies only had edits to one of the CCR5 genes, which at best would only provide partial HIV resistance.

Greely said, Successfully is iffy here. None of the embryos got the 32-base-pair deletion to CCR5 that is known in millions of humans. Instead, the embryos/eventual babies got novel variations, whose effects are not clear. As well, what does partial resistance to HIV mean? How partial? And was that enough to justify transferring the embryo, with a CCR5 gene never before seen in humans, to a uterus for possible birth?

There is also significant concern, as there often is with CRISPR, of possible off-target edits. Urnov called it an egregious misrepresentation of the actual data that can, again, only be described as a blatant falsehood. It is technically impossible to determine whether an edited embryo did not show any off-target mutations without destroying that embryo by inspecting every one of its cells. This is a key problem for the entirety of the embryo-editing field, one that the authors sweep under the rug here.

In short, review of He Jiankuis research finds it deeply flawed in terms of rationale, procedures and results, with what can only be described as serious ethical problems and what appears to be a deliberate misrepresentation of the facts.

Originally posted here:
Reviewers of Chinese CRISPR Research: "Ludicrous" and "Dubious At Best" - BioSpace

Recommendation and review posted by Bethany Smith

DUBLIN--(BUSINESS WIRE)--The "Global CRISPR Technology Market 2019-2025" report has been added to ResearchAndMarkets.com's offering.

The global CRISPR technology market is expected to witness a significant growth rate during the forecast period. CRISPR technology enables the alteration of DNA sequences and modifies the gene function. CRISPR technology can be used for various applications such as treatment of diseases, correcting gene, crop modification, bio-fuel manufacturing and many more. Industry giants are working in CRISPR technology development and are investing in the R&D of the technology. Such investments are expected to create an opportunity for the growth of the market in the near future.

The global CRISPR technology market is segmented on the basis of application and end-user. Based on the application, the market is segmented into biomedical applications, agricultural applications, and industrial applications. In fruit crops, CRISPR technology has numerous applications as it improves the important agronomic traits such as biotic and abiotic stress tolerance and fruit quality. Further, on the basis of end-user, the market is segmented into pharmaceutical & biopharmaceutical companies, and academic & research institutes. CRISPR being a really new technology seeks the interest of everyone from doctors to academic & research institutes. CRISPR holds a lot of hidden potentials to cure many rare and incurable diseases that are still to be discovered and is driving the academic & research institutes as an end-user segment to grow with a significant rate in the market.

Geographically, the market is segmented into four major regions: North America, Europe, Asia-Pacific and Rest of the world (RoW). Among these, North America is expected to hold a prominent position in the global CRISPR technology market. The presence of major pharma companies in the region tends to enhance the growth of the global CRISPR market. Further, the report covers the analysis of several players operating in the market.

Some of the players include Thermo Fisher Scientific Inc., Merck KGaA, GenScript Biotech Corp., Horizon Discovery Group PLC, CRISPR Therapeutics AG, and others.

Key Topics Covered:

1. Report Summary

1.1. Research Methods and Tools

1.2. Market Breakdown

1.2.1. By Segments

1.2.2. By Geography

2. Market Overview and Insights

2.1. Scope of the Report

2.2. Analyst Insight & Current Market Trends

2.2.1. Key Findings

2.2.2. Recommendations

2.2.3. Conclusion

2.3. Rules & Regulations

3. Competitive Landscape

3.1. Company Share Analysis

3.2. Key Strategy Analysis

3.3. Key Company Analysis

3.3.1. Thermo Fisher Scientific, Inc.

3.3.1.1. Overview

3.3.1.2. Financial Analysis

3.3.1.3. SWOT Analysis

3.3.1.4. Recent Developments

3.3.2. Merck KGaA

3.3.2.1. Overview

3.3.2.2. Financial Analysis

3.3.2.3. SWOT Analysis

3.3.2.4. Recent Developments

3.3.3. GenScript Biotech Corp.

3.3.3.1. Overview

3.3.3.2. Financial Analysis

3.3.3.3. SWOT Analysis

3.3.3.4. Recent Developments

3.3.4. Horizon Discovery Group PLC

3.3.4.1. Overview

3.3.4.2. Financial Analysis

3.3.4.3. SWOT Analysis

3.3.4.4. Recent Developments

3.3.5. CRISPR Therapeutics AG

3.3.5.1. Overview

3.3.5.2. Financial Analysis

3.3.5.3. SWOT Analysis

3.3.5.4. Recent Developments

4. Market Determinants

4.1. Motivators

4.2. Restraints

4.3. Opportunities

5. Market Segmentation

5.1. CRISPR Technology Market by Application

5.1.1. Biomedical Applications

5.1.2. Agricultural Applications

5.1.3. Industrial Applications

5.2. Global CRISPR Technology Market by End-User

5.2.1. Pharmaceutical and Biopharmaceutical Companies

5.2.2. Academic & Research Institutes

6. Regional Analysis

6.1. North America

6.1.1. United States

6.1.2. Canada

6.2. Europe

6.2.1. UK

6.2.2. Germany

6.2.3. Italy

6.2.4. Spain

6.2.5. France

6.2.6. Rest of Europe

6.3. Asia-Pacific

6.3.1. China

6.3.2. India

6.3.3. Japan

6.3.4. Rest of Asia-Pacific

6.4. Rest of the World

7. Company Profiles

7.1. AstraZeneca PLC

7.2. BASF SE

7.3. Beam Therapeutics Inc.

7.4. Bio-Rad Laboratories, Inc.

7.5. Caribou Bioscience Inc.

7.6. Cellectics SA

7.7. Cibus, Ltd.

7.8. CRISPR Therapeutics AG

7.9. Danaher Corp.

7.10. Editas Medicine

7.11. GeneCopoeia inc.

7.12. GenScript Biotech Corp.

7.13. Horizon Discovery Group PLC

7.14. Intellia Therapeutics Inc.

7.15. Lonza Group Ltd.

7.16. Merck KGaA

7.17. New England Biolabs, Inc.

7.18. Origene Technologies, Inc.

7.19. Pairwise Plants

7.20. Precision Bioscience, Inc.

7.21. Sangamo Therapeutics Inc.

7.22. Thermo Fisher Scientific, Inc.

7.23. Transposagen Biopharmaceuticals, Inc.

See the original post here:
Global CRISPR Technology Market Report 2019-2025 with Analysis of Key Companies - Thermo Fisher Scientific, Merck KGaA, GenScript Biotech, Horizon...

Recommendation and review posted by Bethany Smith

Chinese scientist He Jiankui shocked the world by claiming he had helped make the first gene-edited babies. One year later, mystery surrounds his fate as well as theirs.

He has not been seen publicly since January, his work has not been published and nothing is known about the health of the babies.

Thats the story its all cloaked in secrecy, which is not productive for the advance of understanding, said Stanford bioethicist Dr. William Hurlbut.

..

The report said the twins and people involved in a second pregnancy using a gene-edited embryo would be monitored by government health departments. Nothing has been revealed about the third baby, which should have been born from that second pregnancy in late summer.

Chinese officials have seized the remaining edited embryos and Hes lab records.

A moratorium is no longer strong enough, and regulation is needed, CRISPR pioneer Jennifer Doudna of the University of California, Berkeley recently wrote in acommentaryin the journal Science.

She noted that the World Health Organization has asked regulators in all countries not to allow such experiments, and that a Russian scientist recently proposed one.

Read full, original post: 1 year later, mystery surrounds Chinas gene-edited babies

See more here:
There's still a lot we don't know about China's controversial CRISPR babies, including their health status - Genetic Literacy Project

Recommendation and review posted by Bethany Smith

When Ben Campbell started out with The New York Produce Show and Conference, he was a professor at the University of Connecticut. During the event, Ben and his students participated in ourUniversity Interchangeprogram, which provides a forum for university professors to share cutting-edge research with the trade and thus help fulfill their mission to disseminate knowledge, while also providing an educational and mentorship program for students. He found the program so valuable, that when he moved on to the University of Georgia he asked if we would expand the program. Which we did.

Professor Campbell has presented on a number of important topics, including these:

Setting Producers Free Production Agriculture And The Regulatory Burden:Can States Help Northeast Production Thrive?Are They Inclined To Do So?

Perceptions And Misperceptions: Consumer Attitudes On Organic And Local University Of Connecticut Study To Be Unveiled At New York Produce Show and Conference

Connecticut Professor Ben Campbell Comes Back To The New York Produce Show With Seminal Work On Consumer Reaction To The Marketing Of Locally Grown Produce

We asked Pundit Investigator and Special Projects editor Mira Slott to see what the good professor has in store for attendees this year:

Ben CampbellAssistant Professor,Department of Agricultural andApplied Economics,University of Georgia

New York Produce Show attendees await your thought-provoking consumer research, measuring how different variables influence and impact produce shoppers perceptions and purchasing decisions.

In 2018, you delved into the multitude of ways consumers can access information to understand how various generations are getting information about produce, while also analyzing how these methods are impacting purchasing. You also have presented on organic and local. What do you have planned for this year?

A: This year, my research examines how giving consumers information about GMOs,CRISPR, organic and pesticides impacts their likelihood of purchasing different products.

Q: Thats a hot topic with the new federal and state labeling laws, increased pesticide restrictions, and the influence on retail buying

A: The emphasis is very much the new labeling laws coming into place with GMOs, and new technologies, and a lot of retail policies banning particular production methods. For instance, you seeneonicotinoidsbeing banned in Maryland, and these pollinators being phased out in Home Depot and Lowes of a lot or all of their plant stock. There are new pesticide bans in homes in Ontario, and within school grounds in Connecticut and New York. When looking at produce, there are issues with GMOs and pesticides in the production process as well.

We see bans of products in different areas, and a lot of misinformation about products. People often dont understand GMOs, but they are very much not in favor of them. So, youre against something but you dont know what it is. You see this phenomenon across the board in relation to different chemicals and pesticides too. And even with organic, misinformation abounds. Theres strong lobbying against something or for it and mixed messaging.

Q: How do you set out to understand the impacts of that cacophonous messaging?

A: I was interested in discovering if we gave people fact-based information about what these production methods are, how would that effect their perceptions or influence their potential purchase of these foods, plants and turf, which use these production practices.

Can information impact the role of production practices on the decision to purchase, and more specifically the type of message and source of message.

One of our objectives was the premise that consumer sentiment drives policy changes at the federal, state and local levels, and at retail, and how these decisions could translate into policy implications.

Q: Could you describe the study methodology. What types of production practices were included and what products? What information did you provide participants?

A: We gave participants different treatments and defined the technology of each, looking at three segments: food, plants and turf. The production practices included insecticides, fungicides, herbicides, CRISPR, GMO and organic. Heres the meaning of what this is and the information on how this production practice works.

Q: Were these scientific definitions? How detailed or complex were the descriptions? Were they consumer-friendly?

A: We purposefully adhered to scientific information for the different treatments, though at a level that non-scientists can understand.

Editors note: here are the definitions provided to participants:

*CRISPR:a new biotechnology that allows scientists to directly edit an organisms genetic material (DNA). This does not require transferring DNA from one organism to another.

*Genetically-Modified Organism (GMO):an organism in which the genetic material (DNA) has been altered through the use of modern biotechnologies. The alteration typically involves transferring DNA from one organism to another.

*Insecticide:a pesticide that is used to eliminate or repel insects.

*Fungicide:a pesticide that is used to eliminate or prevent the growth of fungi, molds, and their spores.

*Herbicide:a pesticide that is used to eliminate or prevent the growth of plants

*Organic:the application of a set of cultural, biological, and mechanical practices that support the cycling of on-farm-resources, promote ecological balance, and conserve biodiversity. These include maintaining or enhancing soil and water quality, conserving wetlands, woodlands, and wildlife and forbidding use of synthetic fertilizers, sewage sludge, irradiation and genetic engineering.

Q: These scientific definitions arent really that appealing when talking about food! Did people understand these terms, or want further explanation or context on usage? The GMO and CRISPR definitions dont seem likely to allay a consumers pre-disposed concern about the effect these technologies could have on a food item. Although, I could see the draw of wanting to purchase produce void of insects, fungi and mold

A: Some people got it. Some people didnt. Most people have never heard of CRISPR. We divvied people into groups to determine how likely they would be to buy the product based on the information we provided them on the production practices of that product.

Q: How were the groups formed?

A: Respondents were randomly divided into the treatment groups. After being randomly placed into a treatment group, they were given the information treatment associated with that treatment group.

We had a control group that didnt receive any information, we just said CRISPR or GMO

Q: Who participated in the study, the numbers, demographics, how did you glean peoples preferences, etc.

A: We did an online survey of 2,500 respondents in the spring/summer of 2019. It included Southeastern US residents in nine states with 10-20 percent of participants per state. The average age was 44 and the average income was $50,000. We had 64 percent female and 71 percent Caucasian.

Q: Did you assess the participants knowledge, or perceived knowledge, of each practice going into the study for a relative comparison? Did you break down the sample further to determine, for example, if some consumers were more prone to buy organic

A: Not exactly in that way, but we asked about knowledge level, how knowledgeable are you about organicand I will show the effects of that in our model.

Q: So, this is the knowledge level that is perceived by the participant, not necessarily the correct knowledge?

A: Yes, thats an important point. We know the odds are that consumers are not correct in their knowledge of the production practices, but perception is the reality. We wanted to find out their perceived knowledge of the different production practices. With 0 = No Knowledge; 50 = Somewhat Knowledgeable; and 100 = Extremely Knowledgeable.

Organic was the highest rated. People said they had the most knowledge of it at 64 for food, 62 for plants, and 60 for turf. Organic stood out relative to all the other practices, where there was much less fluctuation. This compared to both GMO and CRISPR at 44 for food, 44 for plants, and 45 for turf. Insecticides 42 for food, 47 for plants and 48 for turf; herbicide 45 for food, 47 for plants, and 48 for turf; and fungicide, 43 for food, 45 for plants and 48 for turf.

Q: What can be learned from this?

A: Interestingly, people indicated they were more knowledgeable about pesticides as they are applied to turf but less knowledgeable as they are applied to their food, though we see moves to eliminate pesticides on food even though people say they are not that knowledgeable. From a produce standpoint, this is informative, first because consumers are not knowledgeable, and second because consumers who are not knowledgeable are making demands on produce production methods or are not able to knowledgably engage with activists in the discussion.

Q: Since youll be presenting this information to executives in the fresh produce industry, what was included in the food category? Did you distinguish between fresh produce and processed items?

A: In looking at the food category as a whole, by and large its going to be an ingredient, a GMO or CRISPR is going to be applied at the production level, so its not directly targeting produce.

Q: The reason I ask,Brad Rickard of Cornell, a veteran like you at our New York Produce Shows, has presented fascinating research related to this topic.In one studyhe conducted, consumer acceptance of GMOs changed based on the food category (grain crop, fruit or beef) and the level of processing. For instance, consumers showed more willingness to buy the GM processed products relative to their GM fresh versions.

A: In our study, were focused on the impact of messaging. So, in this case, if youre more accepting of a treatment in processed food, would knowledge of the treatment push you to be more accepting? Similarly, if youre less accepting of a treatment in fresh produce, will knowledge make you more accepting. Conversely, will more information about insecticides, herbicides, and fungicide usage on conventional produce increase acceptance, and could that lessen acceptance of organic, which restricts that use?

Q: So, the scale of acceptance might change on processedversusfresh, but thats not what youre measuring in this study

A: Were interested to see if our messaging is going to nudge a consumers acceptance and willingness to purchase one way or the other; thats what were focused on in this study.

Q: Thats interesting, because now youre looking at a domino effect of how knowledge of one type of production practice could change acceptance of products in several categories

A: What we found, in fact, is if we showed participants information about pesticides the message that pesticides are used to eliminate insects or fungicides and the growth of fungi, molds, and their spores or herbicides to get rid of the problem plant if you got that message, you rated organic lower.

If its an apple or a processed apple, I dont think the differences will be that big. The result is still moving in the same direction. Receiving the information on pesticides nudges the participants on likeliness to purchase conventional over organic.

Q: How are you defining nudge? Could there be a noticeable change in purchasing choices if consumers received such messaging?

A: Messaging can have marginal impacts. The lesson here is around the messaging and consumer knowledge actually, perceived knowledge. If I think I know more about CRISPR, Im more accepting of buying that product. So, this is about getting the information out there. That information impacts how we view these things.

If someone views pesticides as bad, providing an explanation negates some of the mysteries of pesticides I understand why theyre using it, and Im less likely to buy organic and more likely to buy something produced with insecticides. We see this movement here. This messaging can impact the perceived value of different products, and the effects on each other.

Q: Doesnt it get complicated, though, since there are so many different types of pesticides, and regulations, safe levels of use, etc., and sometimes frightening media reports can lump them all together?

A: Organic is often viewed as less risky for that reason.

Q: If someone is a diehard organic shopper, they might not be as flexible to change

A: Youre not changing people on the endpoints, youre changing people in the middle. Were looking at the average person, not those on the extremes. Youre not changing the person who is diehard organic, or diehard anti-organic. Their minds are set. Youre shifting perceptions of those in the middle.

Q: How important is pricing in this equation? Did you consider this? For example, isnt there a correlation of organic produce purchases increasing when the pricing is more on par with the conventional counterpart?

A: Yes, pricing certainly could have an impact. For this study, we wanted everything else to be constant, to control for what the message was when consumers were considering acceptance of the different treatments. If an herbicide is used or an insecticide is used, what is the effect of that on consumer purchase decisions?

We chose to give participants a scientific definition instead of doing something more general. The reason we did this is, in the marketplace you see a lot of different labels, and best practice claims, both good and bad. We wanted to see if we gave consumers fact-based information, might that affect their views on these foods that have these different characteristics?

Q: Did you consider homing in on particular products, such as an Arctic apple, where the genetically engineered practice prevents browning, and how that quality might change a consumers likelihood of purchasing it? Also, what if you used a more consumer-friendly description of the production process with clever marketing as can be found on theArctic apple website?

A: These variables certainly could play a role We intentionally kept the definitions scientific to alleviate the positive and negative biases.

Q: You note the broad scope of labeling, certifications and product claims vying for consumer attention. Youve done other studies analyzing consumer acceptance and perceptions or misperceptions of these various labels (environmental labeling, local, organic, natural, bee-friendly, etc.). For instance, I remember in one study, you found that some consumers thought that local and organic were interchangeable. Are you taking these types of influences into account when youre conducting your analysis?

A: We touch on them, and will discuss them in our presentation, but by and large, were going to stick with the production processes and focus on the ones coming under threat, like GMO, and CRISPR. Local is not one of those, because its here to stay. With respect to environmentally friendly labels, those are out there, but we can see that insecticides, fungicides, herbicides, GMO, and CRISPR are the ones really on the forefront now of consumer protests and where people have strong opinions.

Q: Based on your study parameters and methodology, what did you learn? What is most illuminating for produce executives?

A: I can give you some examples from the charts Ill be presenting

With no information, the likeliness to purchase organic was 60, but when given information about pesticides, your score for organic went down to 57. Thats a 3 percent drop in your likeliness to purchase a product, so thats what were seeing.

We see that giving consumers information about pesticides had a small effect on their likeliness to purchase organic. When you hear messaging now, you hear that organic is better because no pesticides are used. But we know that consumers indicate they are not knowledgeable about pesticides. When we give them minimal information about pesticides, they move slightly away from organics.

That example was for turf. For food, it went from 64 to 62.

Q: Is that statistically relevant?

A: A two percent shift doesnt sound like a lot, but were seeing these differences here, which could move people in the middle. Though it sounds marginal, we know that for many consumers, production method makes up a small part of their purchasing decision. If you weaken the case for organic, then it will decrease the likelihood of paying a higher price for organic and thereby lower the probability of purchasing organic.

Q: What movement occurs when you introduce CRISPR and GMO information?

A: For CRISPR and GMO, showing CRISPR info moved the rating from 44 (no info) to 46 (CRISPR info); for GMO: 44 (no info) to 42 (CRSPR info); GMO: 44 (no info) to 41 (GMO info). This indicates that providing GMO info hurts GMO purchasing; GMO: 44 ( no info) to 46 (all info) this implies when looking at all the different methods, GMO is not seen as bad; CRISPR: 44 (no info) to 46 (CRISPR info) -providing CRISPR info helps with purchasing; CRISPR: 44 (no info) to 40 (GMO info) GMO info causes a negative reaction to CRISPR.

Q: If you add in other variables of shopping in a grocery store, the changes could be much more significant

A: Thats right. Two years ago, we examined price premiums and how pricing could impact the market. Once you start adding or subtracting premiums or discounts, that makes a difference. Even if youre at a higher price, I can generate or negate that price premium, through messaging impacts.

We had five percent of the group that would not purchase food with insecticides. These were diehards on the endpoints. And when we gave the group the information on insecticides, that 5 percent of diehards dropped to 2 percent that would not purchase the product. We are talking a 3 percent swing, or getting them from, Im not buying, to being open to buying now.

Q: Did you break down the results by demographics?

A: There are things going on demographic-wise. We see with GMOs, older people are less likely to buy GMOs. People in rural areas didnt like GMOs as much, but by and large, the big thing is, the more people perceive they know about these production practices, the more likely they are to consider buying these products with these practices.

Q: But you cant really control peoples perceptions, or whether they grasped the scientific definition you provided The type of information and the way its communicated seems to be very important.

A: Yes. It depends on what you want to do. If youre selling organic, you dont want to give people the scientific information on pesticides. If youre selling something traditional, non-organic, providing information about production practices and why youre doing it can be a way to counter organics.

Its the same with CRISPR and GMO, in terms of how consumers perceive your product, and in turn other products in a different way.

Q: This goes back to all the information out there that is not always scientific and scares people Some of that information can be quite impressionable. One of the issues magnified by vocal GMO opponents is the unknowns, or the long-term potential negative effects of consumption of GMOs Your definition of CRISPR and GMO outlines scientifically how the practice works, but doesnt address the impacts these alterations could have, either positive or negative. For instance, there is no mention of the positive attributes of the Arctic apple non-browning trait.

A: The key is the information you give will be a nudge to the average consumer, more so than those on the endpoints. The information you give can be powerful. It can have a meaningful effect on those people in the middle who may have strong opinions but can be influenced.

Q: To clarify, you just asked consumers about food, in general, without segmenting food categories, like fruits and vegetables, and you didnt give them examples?

A: No, we didnt. The problem is there are so many examples and categories. If the notion is your likeliness to buy a GMO apple is less than a GMO Pop Tart, the nudge to change that likeliness is what were interested in measuring based on receiving information on the production practice of GMO. Youll see that nudge going in the same direction with either one. I can spin it toward produce or food, in general, but the message stays the same; its just the starting point differs, as Brad Rickard showed in his study that you referenced earlier. Could we ask about produce directly, yes, but then you lose the process we set for this study.

Q: Miguel Gmez of Cornell will be revealing his latest peer-reviewed research, which will be hot off the press, at the NYPS, related to potential impacts of new GMO labeling requirements and non-GMO labeling counter-plays. It specifically targets strawberries, potatoes and apples. [Editors note, a sneak preview Q&A piece is here].

A: Im looking forward to seeing his presentation. I have a study, now in review, looking at tomatoes and tomato plants with GMO and non-GMO labels, and no labels, and those differences, and as a plant or as the product you buy at the supermarket to eat. The differences of how consumers perceive these things is there.

Labeling and how you message matters how you message can impact how consumers feel about your products and others products. So, if youre giving people good information about pesticide usage, it could have a positive impact on peoples views of your product if youre using those practices, and a detrimental impact on organic purchases. If you provide information de-mystifying GMO or CRISPR, it could have a negative effect on purchases of non-GMO, or non-CRISPR products. Thats the point Im trying to get across.

This messaging is interdependent. If you put a GMO label on one thing, it could have a detrimental impact on something else.

Q: Are you interested in extending this study in anyway? For instance, taking it from surveys to an actual supermarket setting, or as youve done in other instances, arrange scenarios where youre interviewing consumers in person and presenting them with actual products

A: Thats always the ideal, but its challenging to conduct studies like that. The problem is getting access to stores to do it. Retailers sometimes dont like you telling consumers about the products in the stores and giving them different messages about pesticides, GMOs, and CRISPR. That can be tricky, so a lot of times we stick to the online surveys or conducting our research outside of stores. I would love to go into stores and change prices of organic products and see how demand changes

Where we go from here the next step Im working on a study looking at plants and the media message, whats the source of the information, and how that impacts consumer perceptions. I would love to understand if the information is from a producer versus a retailer versus an association, versus a mass media outlet. What would happen if each of these players told you the same message, how would that influence the different choices? If an ag group told you about GMOs versus a retailer telling you about GMOs, would that impact the message and your purchasing decision?

Q: That research sounds fascinating

A: My hypothesis would be if the information was coming from an activist group, the consumer would take the information more seriously generally people trust universities; they dont trust the government that much. They trust activists, they dont trust retailers as much; they dont trust industry associations as much. You have these different groups that are vying for power and influence, in respect to getting information out.

Q: Its an interesting hypothesis to test. Will consumers be more accepting of a scientific-based, academic study debunking theEWG Dirty Dozenclaims than if they are warned to stay away from produce on the Dirty Dozen list on the Today Show or Dr. Oz? Further, if the messenger of that scientific-based study is theAlliance for Food and Farming, an industry organization, will that influence the consumers perception of its accuracy?Weve been reporting on these issues for many years.

A: At the NYPS, Ill talk about the production-practices messaging study we did, and the next steps

If you put a government GMO label on a product, it may have a detrimental impact on the consumers desire to purchase that product. But what we found in this study was if the GMO label also comes with good information describing what it is, the consumers could be nudged toward that GM product, and affect how they view other products. In the same way, pesticides are not all bad when you tell consumers what they are, and why theyre used. They may move incrementally toward the pesticide group, especially with plants, and away from the organic alternative. When people understand what it is, they are less likely to fear it and thereby say they are more likely to buy it.

Q: Did any of the results surprise you?

A: I expected if you provided pesticide information, it was only going to have an impact on pesticide products. I wasnt expecting to see so much cross effect on the other products, in respect to pesticides impacting organic, and GMOs impacting CRISPR and organic.

Read more here:
The Science of Product Messaging: How Unbiased Information on Pesticides, Fungicides, Herbicides, Organics, GMO and CRISPR Can Affect Consumer Buying...

Recommendation and review posted by Bethany Smith

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Global and Regional CRISPR And CRISPR-Associated (Cas) Genes Market 2019 by Manufacturers, Regions, Type and Application, Forecast to 2025 - Breakaway...

Recommendation and review posted by Bethany Smith

In the summer, a mother in Nashville with a seemingly incurable genetic disorder finally found an end to her suffering -- by editing her genome.

Victoria Gray's recovery from sickle cell disease, which had caused her painful seizures, came in a year of breakthroughs in one of the hottest areas of medical research -- gene therapy.

"I have hoped for a cure since I was about 11," the 34-year-old told AFP in an email.

"Since I received the new cells, I have been able to enjoy more time with my family without worrying about pain or an out-of-the-blue emergency."

Over several weeks, Gray's blood was drawn so doctors could get to the cause of her illness -- stem cells from her bone marrow that were making deformed red blood cells.

The stem cells were sent to a Scottish laboratory, where their DNA was modified using Crispr/Cas9 -- pronounced "Crisper" -- a new tool informally known as molecular "scissors."

The genetically edited cells were transfused back into Gray's veins and bone marrow. A month later, she was producing normal blood cells.

Medics warn that caution is necessary but, theoretically, she has been cured.

"This is one patient. This is early results. We need to see how it works out in other patients," said her doctor, Haydar Frangoul, at the Sarah Cannon Research Institute in Nashville.

"But these results are really exciting."

In Germany, a 19-year-old woman was treated with a similar method for a different blood disease, beta thalassemia. She had previously needed 16 blood transfusions per year.

Nine months later, she is completely free of that burden.

For decades, the DNA of living organisms such as corn and salmon has been modified.

But Crispr, invented in 2012, made gene editing more widely accessible. It is much simpler than preceding technology, cheaper and easy to use in small labs.

The technique has given new impetus to the perennial debate over the wisdom of humanity manipulating life itself.

"It's all developing very quickly," said French geneticist Emmanuelle Charpentier, one of Crispr's inventors and the cofounder of Crispr Therapeutics, the biotech company conducting the clinical trials involving Gray and the German patient.

Crispr is the latest breakthrough in a year of great strides in gene therapy, a medical adventure started three decades ago, when the first TV telethons were raising money for children with muscular dystrophy.

Scientists practising the technique insert a normal gene into cells containing a defective gene.

It does the work the original could not -- such as making normal red blood cells, in Victoria's case, or making tumor-killing super white blood cells for a cancer patient.

Crispr goes even further: instead of adding a gene, the tool edits the genome itself.

After decades of research and clinical trials on a genetic fix to genetic disorders, 2019 saw a historic milestone: approval to bring to market the first gene therapies for a neuromuscular disease in the US and a blood disease in the European Union.

They join several other gene therapies -- bringing the total to eight -- approved in recent years to treat certain cancers and an inherited blindness.

Serge Braun, the scientific director of the French Muscular Dystrophy Association, sees 2019 as a turning point that will lead to a medical revolution.

"Twenty-five, 30 years, that's the time it had to take," he told AFP from Paris.

"It took a generation for gene therapy to become a reality. Now, it's only going to go faster."

Just outside Washington, at the National Institutes of Health (NIH), researchers are also celebrating a "breakthrough period."

"We have hit an inflection point," said Carrie Wolinetz, NIH's associate director for science policy.

These therapies are exorbitantly expensive, however, costing up to $2 million -- meaning patients face grueling negotiations with their insurance companies.

They also involve a complex regimen of procedures that are only available in wealthy countries.

Gray spent months in hospital getting blood drawn, undergoing chemotherapy, having edited stem cells reintroduced via transfusion -- and fighting a general infection.

"You cannot do this in a community hospital close to home," said her doctor.

However, the number of approved gene therapies will increase to about 40 by 2022, according to MIT researchers.

They will mostly target cancers and diseases that affect muscles, the eyes and the nervous system.

Another problem with Crispr is that its relative simplicity has triggered the imaginations of rogue practitioners who don't necessarily share the medical ethics of Western medicine.

Last year in China, scientist He Jiankui triggered an international scandal -- and his excommunication from the scientific community -- when he used Crispr to create what he called the first gene-edited humans.

The biophysicist said he had altered the DNA of human embryos that became twin girls Lulu and Nana.

His goal was to create a mutation that would prevent the girls from contracting HIV, even though there was no specific reason to put them through the process.

"That technology is not safe," said Kiran Musunuru, a genetics professor at the University of Pennsylvania, explaining that the Crispr "scissors" often cut next to the targeted gene, causing unexpected mutations.

"It's very easy to do if you don't care about the consequences," Musunuru added.

Despite the ethical pitfalls, restraint seems mainly to have prevailed so far.

The community is keeping a close eye on Russia, where biologist Denis Rebrikov has said he wants to use Crispr to help deaf parents have children without the disability.

There is also the temptation to genetically edit entire animal species -- malaria-causing mosquitoes in Burkina Faso or mice hosting ticks that carry Lyme disease in the US.

The researchers in charge of those projects are advancing carefully, however, fully aware of the unpredictability of chain reactions on the ecosystem.

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Charpentier doesn't believe in the more dystopian scenarios predicted for gene therapy, including American "biohackers" injecting themselves with Crispr technology bought online.

"Not everyone is a biologist or scientist," she said.

And the possibility of military hijacking to create soldier-killing viruses or bacteria that would ravage enemies' crops?

Charpentier thinks that technology generally tends to be used for the better.

"I'm a bacteriologist -- we've been talking about bioterrorism for years," she said. "Nothing has ever happened."

Link:
A #ReUp of 2019: The year when gene therapy, DNA modifications came of age & saved lives - Economic Times

Recommendation and review posted by Bethany Smith

Its said that nothing is certain except death and taxes. But doubt has been cast over the former since the 1970s, when scientists picked at the seams of one of the fundamental mysteries of biology: the molecular reasons we get old and die.

The loose thread they pulled had to do with telomeresmolecular timepieces on the ends of chromosomes that shorten each time a cell divides, in effect giving it a fixed life span. Some tissues (such as the gut lining) renew almost constantly, and it was found that these have high levels of an enzyme called telomerase, which works to rebuild and extend the telomeres so cells can keep dividing.

That was enough to win Elizabeth Blackburn, Carol Greider, and Jack Szostak a Nobel Prize in 2009. The obvious question, then, was whether telomerase could protect any cell from agingand maybe extend the life of entire organisms, too.

While telomere-extending treatments in mice have yielded intriguing results, nobody has demonstrated that tweaking the molecular clocks has benefits for humans. That isnt stopping one US startup from advertising a telomere-boosting genetic therapyat a price.

Libella Gene Therapeutics, based in Manhattan, Kansas, claims it is now offering a gene therapy to repair telomeres at a clinic in Colombia for $1 million a dose. The company announced on November 21 that it was recruiting patients into what it termed a pay-to-play clinical trial.

Buyer beware, though: this trial is for an unproven, untested treatment that might even be harmful to your health.

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The company proposes to inject patients with viruses carrying the genetic instructions cells need to manufacture telomerase reverse transcriptase, a molecule involved in extending the length of telomeres.

The dangers are enormous, says Jerry Shay, a world expert on aging and cancer at the University of Texas Southwestern Medical Center. Theres a risk of activating a pre-cancerous cell thats got all the alterations except telomerase, especially in people 65 and over.

For years now, people involved in the company have made shifting claims about the study, raising uncertainty about who is involved, when it might start, and even where it would occur. Trial listings posted in October to clinicaltrials.gov currently show plans for three linked experiments, each with five patients, targeting critical limb ischemia, Alzheimers, and aging, respectively.

Jeff Mathis, president of Libella, told MIT Technology Review that two patients have already paid the enormous fee to take part in the study: a 90-year-old-woman and a 79-year-old man, both US citizens. He said they could receive the gene therapy by the second week of January 2020.

The decision to charge patients a fortune to participate in the study of an experimental treatment is a red flag, say ethics experts. Whats the moral justification for charging individuals with Alzheimers? asks Leigh Turner, at the University of Minnesotas Center for Bioethics. Why charge those bearing all the risk?

The telomere study is occurring outside the US because it has not been approved by the Food and Drug Administration. Details posted to clincaltrials.gov indicate that the injections would be carried out at the IPS Arcasalud SAS medical clinic in Zipaquir, Colombia, 40 kilometers (25 miles) north of Bogot.

It takes a lot longer, is a lot more expensive, to get anything done in the US in a timely fashion, Mathis says of Libellas choice to go offshore.

To some promoters of anti-aging cures, urgency is justified. Heres the ethical dilemma: Do you run fast and run the risk of low credibility, or move slowly and have more credibility and global acceptancebut meanwhile people have died? says Mike Fossel, the president of Telocyte, a company planning to run a study of telomerase gene therapy in the US if it can win FDA signoff.

Our reporting revealed a number of unanswered questions about the trial. According to the listings, the principal investigatorwhich is to say the doctor in charge--is Jorge Ulloa, a vascular surgeon rather than an expert in gene transfer. I dont see someone with relevant scientific expertise, says Turner.

Furthermore, Bill Andrews, who is listed as Libellas chief scientific officer, says he does not know who Ulloa is, even though on Libellas website, the mens photos appear together on the list of team members. He said he believed that different doctors were leading the trial.

Turner also expressed concerns about the proposed 10-day observation period described in the posting for the overseas study: If someone pays, shows up, has treatment, and doesnt stick around very long, how are follow-up questions taking place? Where are they taking place?

Companies seeking to try the telomere approach often point to the work of Maria Blasco, a Spanish scientist who reported that telomere-lengthening gene therapy benefited mice and did not cause cancer. Blasco, director of the Spanish National Centre for Cancer Research, says she believes many more studies should be done before trying such a gene experiment on a person.

This isnt the first time Libella has announced that its trial would begin imminently. It claimed in late 2017 that human trials of the telomerase therapy would begin in the next few weeks. In 2016, Andrews (then partnered with biotech startup BioViva) claimed that construction of an age reversal clinic on the island nation of Fiji would be complete before the end of the year. Neither came to pass.

Similar questions surround Libellas most recent claims that it has two paying clients. Pedro Fabian Davalos Berdugo, manager of Arcasalud, said three patients were awaiting treatment in December. But Bioaccess, a Colombian contract research organization facilitating the Libella trial, said that no patients had yet been enrolled.

Also unclear is where Libella is obtaining the viruses needed for the treatment. Virovek, a California biotech company identified by several sources as Libellas manufacturer, did not answer questions about whether any treatment had been produced.

See more here:
Buyer beware of this $1 million gene therapy for aging - MIT Technology Review

Recommendation and review posted by Bethany Smith

The transgender pride flag.

A Russian court has sentenced a 53-year-old trans woman to three years in prison, on bogus distribution of pornography depicting minors charges for sharing nude anime drawings on social media.

The case began in the summer of 2018, when Michelle was informed she was under criminal investigation for posts of hentai sexually charged drawings featuring naked characters from Japanese cartoons in 2013 and 2014.

Prior to the trial, which took place in November, the investigators ordered an expert evaluation of the images from the Center for Socio-Cultural Expertise, an organization known to provide damning conclusions in politically motivated criminal cases, including the case of Pussy Riot, the child pornography case against human rights defender Yury Dmitriev, and dozens of extremism cases against Russias Jehovas Witnesses. Their evaluation of the drawings concluded that they included characters younger than 14 years of age. Authorities took Michelle into custody from the courtroom, immediately after the judge handed down the verdict. She remains in a solitary cell in jail pending an appeals hearing in her case.

Michelle, a survivor of bladder cancer who worked as an epidemiologist at a local clinic before she was fired because of the criminal case, has been on hormone therapy for transitioning for about two years. But she is legally recognized as male. She will therefore be forced to serve her sentence in a mens penal colony. Such a blatant disregard for her gender identity leaves Michelle extremely vulnerable to abuse by both male detainees and guards.

Moreover, Maria Chaschilova, a lawyer at the Moscow LGBT Community Center, who was in contact with Michelle before her trial, says Michelle does not have access to hormone therapy in prison and will not have it in penal colony. The World Professional Association for Transgender Health warns that for trans people in detention the consequences of abrupt withdrawal of hormones include a high likelihood of negative outcomes such as surgical self-treatment by autocastration, depressed mood, dysphoria, and/or suicidality.

Michelle is appealing her conviction and sentence, but so long as this case persists Michelles rights to health, identity, expression, liberty, and even to life hang in the balance.

Read the original here:
Russian Trans Woman Sentenced to Three Years in Men's Prison on Bogus Pornography Charges - Human Rights Watch

Recommendation and review posted by Bethany Smith

This press release was orginally distributed by SBWire

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Aviva Woman Is Providing Bio-Identical Hormone Therapy and Botox Treatment in Salt Lake City - Press Release - Digital Journal

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A Nov. 26 letter cites failed entrapment videos by the so-called Center for Medical Progress group of anti-abortion activists (not to be confused with a research program of the same name at the conservative Manhattan Institute for Policy Research) to perpetuate long-debunked myths about Planned Parenthood and abortion.

The record needs to be set straight once again concerning these fake journalists and their deliberately deceptive videos.

CMP founder David Daleiden and other group members were recently found civilly liable in federal court of several conspiracy charges and other federal and state violations. Meanwhile, every one of 13 states that have investigated Planned Parenthood in the matter has fully cleared that organization of any wrongdoing.

The letter implies that federal funds to Planned Parenthood are used for abortion. In fact, public tax dollars to Planned Parenthood pay for much-needed medical services such as STD testing and treatment, birth control, well-woman exams, cancer screening and prevention, hormone therapy, infertility services, and general health care for people who otherwise couldnt afford such services.

Moreover, the Hyde Amendment bars all use of federal funds to pay for abortion, except to save the life of the woman or where pregnancy arises from incest or rape.

The grotesque stories spread in this hateful letter are backed by zero credible sources. Meanwhile, there are numerous confirmed threats of violence against clinic patients and staff tied to this kind of disinformation, including the 2017 attempted bombing of Womens Health Practice in Champaign.

JENNY LOKSHIN

Champaign

Originally posted here:
Letter to the Editor | Critics' charges are totally false - Champaign/Urbana News-Gazette

Recommendation and review posted by Bethany Smith

In terms of fitness and bodybuilding, protein is undoubtedly the much-appraised hero for all fitness and health enthusiasts. And it is for good reason as protein definitely one of the main contributing factors towards a fit and healthy body.

The two main types of protein powders commonly used by people are whey protein and casein, out of which whey protein is the most sought after one. According to Mordor Intelligence, the global whey protein industry as a whole generated a revenue of $6.1 billion in just the last year.

This surge in demand and popularity of whey protein can be attributed to an increased awareness of the benefits of protein powders in general and also to the availability of more varieties of protein products in the market.

However, of late the pace at which the industry is booming has slowed down. In fact, growth literally took a detour in the last couple of years when some of the protein products were alleged to be loaded with harmful chemicals and sweeteners. Put together with other hypoallergenic reactions specific to individuals such as lactose intolerance, consumers are found to have started looking for other alternatives to whey protein.

Now the focus is on plant-based protein sources, which are slowly gaining popularity according to a report published by 1010 data.

While the whole world is increasingly looking for effective plant-based and vegan protein powders like Sunwarrior Canada, which is also completely gluten-free and sold by a Canadian online retailer called Yes Wellness, here are some more reasons why it is best to switch from dairy to plant-based protein.

For starters, plant-based protein powders are rich in antioxidants and other essential vitamins. This further depends on the composition of the powder, which again is increasingly diverse. From brown rice to hemp to peas, there is a wide variety of plant-based protein sources for powders and better yet, most of them are created as a blend of all these powerhouses. Suffice it to say, a single jar of plant-based protein powder will get you an array of essential nutrients derived from all of these sources, along with sufficient fiber and of course protein.

It is like packing a punch to go with their daily cardio and workout routines for fitness enthusiasts.

Another reason why you need to switch to plant from dairy is because of the glaring digestion issues reported by many people all over the world.

Generally, plant-based powders are easier for the digestive system to process and break down. And this is not only for people who are lactose intolerant. For everyone in general, dairy products are definitely a lot more complex to handle than plant-based products and for the same reason, a lot of them are reported to have experienced some form of uneasiness and discomfort from consuming dairy, even if they didnt have a history of lactose intolerance.

This kind of discomfort can be mainly caused by the presence of a high level of sugar and also because of the protein derived from whey. In the long run, a regular supply of complex dairy-based protein can prove to be harmful to the digestive system, kidneys and the entire health of a person in general.

Thirdly, dairy-based protein powders are often highly acidic in nature. This is largely due to the presence of sulfur-based amino acids. This can become a serious risk when combined with diets that are rich in supplementary acidic substances and compounds. On regular consumption, an aggravated acidic environment may be created within the body, which can lead to problems like calcium loss and in turn osteoporosis, weakening of bones and increased risk of kidney malfunctions.

Plant-based proteins, on the other hand, are alkaline in nature as such and hence contribute towards a more alkaline effect within the body. This is in addition to the many nutrients and antioxidants it provides for bodily functions.

Needless to say, plant-based products are always preferred worldwide these days because of their less environmental implications. At a time when Mother Nature is crying for help, there is an increased need to switch to more natural and clean products, free from chemicals.

Last but not least, plant-based proteins are rich in fiber content as well. This ensures smoother digestion, bowel movements and better absorption of essential nutrients.

Evidently, plant-based proteins act as a catalyst for fitness enthusiasts to reach their goals effectively by providing a natural and reliable means of daily protein consumption.

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PCOD Treatment Through Cupping Therapy - The Hear UP

Recommendation and review posted by Bethany Smith

captionEighty percent of miscarriages happen in the first trimester.sourceGetty

Miscarriages are common, and nobody is immune. An estimated 10% to 20% of pregnancies end in miscarriage. But, some experts think that the percentage is probably even higher since some miscarriages occur before someone even knows theyre pregnant.

You can have a miscarriage as soon as you become pregnant, says UCLA OB-GYN Leena S. Nathan, MD. Sometimes we see people who have a miscarriage very early on. We usually call that a chemical pregnancy because the pregnancy hormone hCG goes up, but we never actually see anything in the uterus.

While there is no foolproof way to prevent miscarriage, there are some lifestyle changes you can make before and during pregnancy to lower your risk.

Heres what you can do before getting pregnant to reduce your risk of miscarrying:

Heres what you can do during pregnancy to reduce your risk of miscarrying:

Its most common to miscarry in the first trimester, which is up to 13 weeks, says Nathan. In fact, about 80% of miscarriages happen within the first trimester. After this, your chance of miscarrying drops.

However, you can miscarry as late as 20 weeks. Beyond that, if the pregnancy isnt successful its no longer called a miscarriage, its a stillbirth.

There are plenty of reasons a miscarriage can happen, and unfortunately, some types of miscarriages simply cant be prevented.

Most times [the cause is] something genetic, which is unpreventable, meaning there is something wrong with the chromosomes and either the egg or the sperm that came together, Nathan says.

Other causes could be related to the mothers health. For instance, if the mother has a blood clotting issue, if the mother carries any sort of genetic mutations, health and lifestyle issues can cause miscarriages as well as smoking, diabetes, and obesity.

Then, theres always the possibility that you do everything right and still miscarry.

When I see a patient whos had a miscarriage, I reassure them that its nothing they did or didnt do because theres a lot of guilt that comes with having a miscarriage, but most of the time, its unpreventable, says Nathan.

Read this article:
You cannot prevent a miscarriage but there are steps you can take to reduce your risk - Business Insider

Recommendation and review posted by Bethany Smith

From the HumanCharger which shines light into your ear to give you energy to deprivation tanks and screaming sessions, weird wellness trends have become commonplace in 2019. But even so, when wellness influencerMetaphysical Meagan shared a picture of herself on her back, legs akimbo, sunning her perineum (AKA butthole), people, understandably, took notice.

And nowDiplo has got in on the action. Yesterday, the DJposted a picture of himself on a cliff overlooking the sea, ankles in hand, ass to the sun. Accompanying this enduring image is the caption presenting my peace offering to climate change. Diplos famous friends had some things to say about his pose. Chrissy Teigen had a rare moment of speechlessness, writing been thinking about a comment for a long time, while basketball player Liz Cambage commented, I feel like this isnt your first time in this position.Megan Thee Stallion summed up all our feelings, meanwhile, with her comment: dude.

Discussion around butthole tanning first started last month when Metaphysical Meagan, who, according to her Instagram bio is also a healer, teacher, Tantrika, and Embodied Mermaid, first posted the image of herself alongside a caption explaining why she has recently begun to include sunning her bum and yoni in her daily rising routine. 30 seconds of sunlight on your butthole is the equivalent of a full day of sunlight with your clothes on! she writes, before going on to say she has noticed better sleep, better connection to her Sexual energy & control of my Life Force and so much creativity flowing through my life!! since implementing the practice.

Meagans post was then shared on Twitter with the caption, "People out here butt-chugging sunlight," and it (obviously) went viral. In response to peoples many questions about what she was doing, Meagan then posted a second time expanding on the origins and benefits of the practice. Perineum sunning is an ancient Taoist practice that originated in the Far East, she writes. In Taoism, the perineum or Hui Yin is called the Gate of Life and Death. This is a gateway where energy enters & exits the body.

While there are many who swear by the practice including Shailene Woodley who told Into the Gloss Another thing I like to do is give my vagina a little vitamin D If youre feeling depleted, go in the sun for an hour and see how much energy you get, Western doctors remain unconvinced. There is absolutely no proven scientific evidence to suggest any health benefit to sunning your perineum or bottom, Dr Stephanie Ooi from MyHealthcare Clinic in London told Insider. This is a classic example of social media medical misinformation which in some cases can be damaging or dangerous.

Here is the original post:
Diplo joins the weird new wellness craze of butthole tanning - Dazed

Recommendation and review posted by Bethany Smith

DESPERATELY taping her eye open, Allana Prosser was determined she would prove doctors wrong and see out of her right eye again.

The teen's eye had clamped shut after a devastating operation to remove a deadly brain tumour - months after it was misdiagnosed by medics as a cheese allergy.

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But Allana, from Warwickshire, wasn't going to let her ordeal set her back - and has since taught herself to see out of her right eye again.

Now in recovery, Allana is sharing her story to raise awareness and give hope to those in a similar situation.

She said: "I count myself as one of the lucky ones. I survived and have been given the chance to live my life."

Allanas nightmare ordeal begun in 2009, aged 11, when she started having headaches while she was at primary school.

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She said: "I had them every day and took two paracetamol every four hours like clockwork to even touch the pain and I also felt sick every morning."

Allana's symptoms continued to worsen until she was barely struggling to stay awake at school or go out with her friends.

"All I wanted to do was sleep," she said.

"From the moment I walked into the house from school, I just flaked out - eventually, I lost all my friends as I was so tired I didnt want to go out.

"I also had very blurry eyesight and couldnt see the whiteboard at school, but I went to the optician for an eye test and it was fine."

While other teenagers were having fun with their friends, Allanas life was put on hold - making her feel completely "isolated".

From 13 onwards, she begun waking up in the middle of the night feeling sick, only to collapse at the bottom of her mum and step-dad's bed.

She said: "They called 999 several times and I was taken to hospital and put on a drip.

"Despite my constant headaches and sickness, no one ever suggested I should have a brain scan."

Despite my constant headaches and sickness, no one ever suggested I should have a brain scan

Things continued to deteriorate and by14, Allana hadnt started her periods and also had delayed growth.

She said: "I was at least a head-and-half shorter than my classmates and didnt get my periods like the other girls.

"We went to the GP who just said to come back the following year or when I was over 18.

"Like most teenagers I wanted to fit in, but I felt different."

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Allana also developed a raging thirst" - which meant she was drinking up to ten litres of water a day.

Doctors once again dismissed her symptoms, and told Allana's mum she was just "thirsty".

Allana kept going back and forth to the GPs who repeatedly turned her away - even though she also had balance problems and, every few months, episodes of vomiting and blacking out.

In fact, one doctor even claimed her concerning symptoms were down to a cheese allergy.

"He asked me to keep a food and drink diary for two weeks," Allana said.

"When I went back, he flicked through the first few pages and read that I ate cheese sandwiches for lunch at school and loved pizza and lasagne.

"He said my headaches were triggered by a cheese allergy and suggested I stopped eating it.

"But I didnt stop because I knew there was something far more seriously wrong with me - you know your own body.

"My parents were worried sick but no one was listening to us."

Despite her struggles, Allana passed all her GCSEs in 2014 and got an apprenticeship at a wedding shop.

But at 16, her confidence was shattered when she became incontinent.

"It was so embarrassing," she said.

"I had to give up my apprenticeship and was soon scared to go out in public at all.

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"Other people my age were going out partying and there I was at 16, scared to wear white clothes and rocking a Tena lady not a great look!"

She was put on incontinence medication and when she developed a twitch in her right eye, doctors told her it was a side effect.

Allana was finally diagnosed in May 2015 when she went to the optician again about her headaches and twitchy eye.

She said: "I went to Specsavers and the optician said there was pressure behind my eyes.

"She sent me to the emergency eye clinic at my local hospital, but they said they couldnt see anything.

"As we walked out, my mum broke down and I was really embarrassed but her meltdown saved my life.

"When a doctor saw what state she was in and asked her what was wrong, he arranged a CT scan."

Other people my age were going out partying and there I was at 16, scared to wear white clothes and rocking a Tena lady not a great look

Doctors said they could see something on Allanas brain and that she needed a more detailed MRI scan.

"I was so nervous and Mum came in with me," she said.

"As I Iooked at the screen, it went from body scan to head scan and I saw my mums face change.

"What is it? What can you see? I asked

"She was trying to smile but she had tears in her eyes."

Then a doctor broke the news that Allana had an orange-sized brain tumour formed from embryonic tissue, which she had been born with.

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The tumour was on her pituitary gland and pushing against the optic nerve on her right eye, which explained her delayed periods, growth, uncontrollable thirst and headaches.

Allana said: "Doctors told me that I was a week away from death due to a build-up of fluid on my brain.

"But I didnt show any reaction - I felt frozen.

"I sat there in silence while my mum was an emotional wreck.

"By that point, I felt so ill, part of me was just relieved they finally knew what it was."

The next morning, Allana was forced to have a life-saving five-hour operation at Coventry University Hospital to drain fluid on her brain.

A week later, she underwent a 10-hour craniotomy and surgeons removed most of the tumour.

Biopsy tests confirmed it was a slow-growing, low-grade craniopharnigioma, formed from embryonic tissue.

"It felt weird that Id probably been born with it and that Id walking around for years with this thing inside in my head which nearly killed me," she said.

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Allana, who has dubbed her tumour Gemima as shes a Gemini, was in intensive care for a week and hospital another four weeks.

She recovered well from the surgery but was told her right eye would never open again.

Desperate not to wear an eye patch, she started taping her eye open.

Allana said: "There was no way I wanted to wear an eye patch."

"Every day for a couple of months, I put masking tape over my eye for a few hours to stimulate the eye muscles.

"God knows how I came up with the idea, but it worked."

Doctors told me that I was a week away from death due to a build-up of fluid on my brain. But I didnt show any reaction - I felt frozen

In February 2016, Allana went to Jacksonville, Florida for three months to have proton beam therapy to shrink what was left of the tumour.

A few months after her treatment, Allana was referred to a fertility clinic as it was feared she may not be able to conceive.

"At 16, it felt surreal to talk about freezing my eggs," she said.

"After tests, though, I was told that I should be able to become pregnant so didnt have them frozen."

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But last year she had devastating news at a check-up - where she was told her fertility had been affected after all as the tumour had stopped her brain from sending hormone signals to the rest of her body.

She said: "It was a shock which Im still struggling to process.

"Its a conversation Ill have to have with a partner one day if we decide we want a family.

"But hopefully well have treatment options."

Now, Allana has scans every six months and her tumour has remained stable.

How to spot brain tumour symptoms in young people

The most typical symptoms of brain tumours in children and young people include:

At 4ft 11ins, she still suffers long- term effects including diabetes insipidus and osteoporosis.

However, she has continued to remain positive and begunstudying counselling at the University of Coventry so she can eventually work with children.

She is also a Young Ambassador for The Brain Tumour Charity and is backing the HeadSmart campaign, which raises awareness of children and teenagers brain tumour symptoms to reduce diagnosis time.

Allana said: "It helps hugely talking to other people who understand.

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"And I want to share my story to help others if one person gets an earlier diagnosis and one life is saved, its worth it.

"It means so much to me to support other young people who are struggling with the impact of their brain tumours."

Thanks to Allana, about 20 GP surgeries across Warwickshire are stocked with HeadSmart symptom cards.

Allana has vowed to make the most of her life.

"I am still living with Gemima but I feel truly blessed with love and support," she said.

And I'm determined to make the most of every minute because I'll never forget that I am one of the lucky ones."

Sarah Lindsell, The Brain Tumour Charitys chief executive, said: "We are so grateful to Allana for sharing her story to help us raise awareness about brain tumour symptoms and how crucial early diagnosis is.

"And we are inspired by how she is turning her horrendous experience into a positive by backing our HeadSmart campaign.

SICK LEAVE My fear of vomiting made me too scared to leave the house & left me in hospital

CHILLING DIAGNOSIS Dad, 49, who went to GP with runny nose diagnosed with terminal cancer

SEXUAL HEALING I lost 10st because being fat meant I could only do one sex position

GAME ON Playing Xbox helped me lose 10st after getting so big I could barely walk

COLD TRUTH Needing to pee more when its cold can be sign of deadly condition, docs warn

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I had to tape my eye open after op to remove brain tumour which docs dismissed as cheese allergy - The Sun

Recommendation and review posted by Bethany Smith

What happened

Shares of CRISPR Therapeutics (NASDAQ:CRSP) gained over 42% last month, according to data provided by S&P Global Market Intelligence. The company provided the first glimpse of CTX001, a therapy based on CRISPR gene editing, in sickle cell disease and transfusion-dependent beta-thalassemia (TDT). While the preliminary results were from only two patients -- one in each indication -- they demonstrated promising potential for the approach.

Investors cheered the update, which was the first from any company developing CRISPR-based tools. The news sent several gene-editing stocks higher. Shares of Editas Medicine and Intellia Therapeutics rose as well, although super-early success for CTX001 means next to nothing for industry peers. More meaningful might be the implications for Vertex Pharmaceuticals (NASDAQ:VRTX), the collaboration partner of CRISPR Therapeutics for CTX001, which could be handsomely rewarded for its early bet on the gene-editing technique.

Image source: Getty Images.

CRISPR Therapeutics reported that after one dose of CTX001, the individual with TDT was transfusion independent through the nine-month mark. The patient had averaged 16.5 blood transfusions per year in the two years prior to the clinical trial.

Similarly, after one dose of CTX001, the individual with sickle cell disease was free of vaso-occlusive crises (painful blockages of small blood vessels caused by abnormally shaped blood cells) at the four-month mark. The patient had averaged seven such events in the two years prior to the study. Both patients achieved promising results for an important biomarker as well.

How excited are investors? Well, CRISPR Therapeutics announced a public stock offering days after providing the clinical update, but after briefly tumbling, shares actually shook off the dilution concerns and continued ascending through the end of the month. The business ended September with over $629 million in cash and raised up to $315 million from the November offering.

Simply put, the early update from CTX001 is about as good as investors could have hoped for, although the results are obviously very preliminary. The studies are designed to enroll dozens of patients and track them for two years. Will the results prove durable? Will adverse events or other safety issues crop up as the studies mature? Investors will have to remain patient, but CRISPR Therapeutics remains the top gene-editing stock.

Read more:
Here's Why CRISPR Therapeutics Jumped 42.2% in November - The Motley Fool

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Earlier this year a source sent us a copy of an unpublished manuscript describing the creation of the first gene-edited babies, born last year in China. Today, we are making excerpts of that manuscript public for the first time.

Titled Birth of Twins After Genome Editing for HIV Resistance, and 4,699 words long, the still unpublished paper was authored by He Jiankui, the Chinese biophysicist who created the edited twin girls. A second manuscript we also received discusses laboratory research on human and animal embryos.

The metadata in the files we were sent indicate that the two draft papers were edited by He in late November 2018 and appear to be what he initially submitted for publication. Other versions, including a combined manuscript, may also exist. After consideration by at least two prestigious journals, Nature and JAMA, his research remains unpublished.

The text of the twins paper is replete with expansive claims of a medical breakthrough that can control the HIV epidemic. It claims successa word used more than oncein using a novel therapy to render the girls resistant to HIV. Yet surprisingly, it makes little attempt to prove that the twins really are resistant to the virus. And the text largely ignores data elsewhere in the paper suggesting that the editing went wrong.

We shared the unpublished manuscripts with four expertsa legal scholar, an IVF doctor, an embryologist, and a gene-editing specialistand asked them for their reactions. Their views were damning. Among them: key claims that He and his team made are not supported by the data; the babies parents may have been under pressure to agree to join the experiment; the supposed medical benefits are dubious at best; and the researchers moved forward with creating living human beings before they fully understood the effects of the edits they had made.

Because these documents relate to one of the most important public interest issues of all timethe ability to change human heredity using technologywe here present excerpts from the twins manuscript, together with some of the experts comments, and explain the questions they raise. The excerpts are in the order in which they appear in the paper.

To understand why the manuscripts have remained unpublished up to now, read the accompanying article on He's attempts to get them into scientific journals. For the case for making their content public, read the op-ed by Kiran Musunuru, a gene-editing specialist at the University of Pennsylvania, who argues the Chinese data shows that gene-editing for reproduction is unsafe and premature.

1. Why arent the doctors among the papers authors?

The manuscript begins with a list of the authors10 of them, mostly from He Jiankuis lab at the Southern University of Science and Technology, but also including Hua Bai, director of an AIDS support network, who helped recruit couples, and Michael Deem, an American biophysicist whose role is under review by Rice University.

Its a small number of people for such a significant project, and one reason is that some names are missingnotably, the fertility doctors who treated the patients and the obstetrician who delivered the babies. Concealing them may be an attempt to obscure the identities of the patients. However, it also leaves unclear whether or not these doctors understood they were helping to create the first gene-edited babies.

To some, the question of whether the manuscript is trustworthy arises immediately.

Hank Greely, professor of law, Stanford University: We have no, or almost no, independent evidence for anything reported in this paper. Although I believe that the babies probably were DNA-edited and were born, theres very little evidence for that. Given the circumstances of this case, I am not willing to grant He Jiankui the usual presumption of honesty.

2. The researchers own data dont support their main claims

The abstract, or summary, lays out the aim of the projectto generate humans resistant to HIVand the main results. It states that the team was successfully able to reproduce a known mutation in a gene called CCR5. The small percentage of people born naturally with this mutation, known as CCR5 delta 32, can be immune to infection by HIV.

But the summary goes well beyond what the data in the paper can back up. Specifically, as well see later, the team didnt actually reproduce the known mutation. Rather, they created new mutations, which might lead to HIV resistance but might not. They never checked to see, according to the paper.

Fyodor Urnov, genome-editing scientist, Innovative Genomics Institute, University of California, Berkeley: The claim they have reproduced the prevalent CCR5 variant is a blatant misrepresentation of the actual data and can only be described by one term: a deliberate falsehood. The study shows that the research team instead failed to reproduce the prevalent CCR5 variant. The statement that embryo editing will help millions is equal parts delusional and outrageous, and is akin to saying that the 1969 moonwalk brings hopes to millions of human beings seeking to live on the moon.

Rita Vassena, scientific director, Eugin Group: Approaching this document, I was hoping to see a reflective and mindful approach to gene editing in human embryos. Unfortunately, it reads more like an experiment in search of a purpose, an attempt to find a defensible reason to use CRISPR/Cas9 technology in human embryos at all costs, rather than a conscientious, carefully thought through, stepwise approach to editing the human genome for generations to come. As the current scientific consensus indicates, the use of CRISPR/Cas9 in human embryos destined to give rise to a pregnancy is, at this stage, unjustified and unnecessary, and should not be pursued.

3. Gene-editing embryos wont bring HIV under control, especially in the worst-affected countries

The end of the abstract and beginning of the main text is where the authors justify their research. They suggest that gene-editing babies could save millions of people from HIV infection. Our commenters call this claim preposterous and ludicrous, and point out that even if the CRISPR method works to create people who are HIV resistant, its unlikely to be practical in places where HIV is rampant, such as in the southern part of Africa.

Rita Vassena: This work offers little justification for the editing and subsequent transfer of human embryos to generate a pregnancy. The idea that editing-derived embryos may one day be able to control the HIV epidemic, as the authors claim, is preposterous. Public health initiatives, education, and widespread access to antiviral drugs have been shown to control the HIV epidemic.

Hank Greely: That this is a plausible way to control the HIV epidemic seems ludicrous. If every baby in the world were given this variation (beyond unlikely), it would begin to affect HIV infection substantially in 20 to 30 years, by which time we should have much better methods of stemming the epidemicas well as existing methods that have substantially, if not yet sufficiently, slowed it. The 64% increase in infections in China (if true) is from a very low base. China has a substantially lower rate of HIV infection than Western countries. The situation in some developing countries remains more serious. But that this high-tech response is likely to be helpful in those countries is not plausible.

4. The parents might have wanted to take part for the wrong reasons

Contrary to some interpretations, the point of using CRISPR on the babies DNA wasnt to prevent them from catching HIV from their father, who was infected. As the paper describes, this was achieved by sperm washing, a well-established technique. Instead, the purpose of the editing was to give the children immunity to HIV later in life. Thus, the experiment didnt provide clear, immediate medical benefits to either the parents or the children. Why did the couple agree? One reason may have been to access fertility treatment at all.

Rita Vassena: I find it worrying that the husband in the couple offered this experimental genome editing was positive to HIV infection, as one can imagine the unnecessary emotional pressure on the couple to consent to a procedure offering no improvement to the patient and their childrens health, but carrying a potential risk of negative consequences. It is worth remembering that HIV infection is not passed on through generations like a genetic disease; the embryo needs to catch the infection. For this reason, preventive measures such as controlling the viral load of the patient with appropriate drugs, and careful handling of the gametes during IVF, can avoid contagion very efficiently. Current assisted reproductive techniques ensure safe procreation for HIV-positive men and women, avoiding both horizontal (between partners) and vertical (between parent and embryo/fetus) transmission, making the editing of embryos in these cases unnecessary. In fact, the couple in the experiment did undergo such ART procedures, consisting in this case of an extended wash of semen to remove all seminal fluid, which may harbor HIV. Extended sperm washing has been used for almost two decades in IVF laboratories worldwide and in thousands of patients; in ours and others experience, it is safe for both parents and their future children and does not entail invasive manipulation of embryos.

Jeanne OBrien, reproductive endocrinologist, Shady Grove Fertility: Being HIV-positive in China carries a significant social stigma. In spite of intense familial and societal obligations to have a child, HIV-positive patients have no access to treatment for infertility. The social context in which the clinical study was carried out is problematic and it targeted a vulnerable patient group. Did the study provide a genetic treatment for a social problem? Was this couple free from undue coercion?

5. The gene edits werent the same as the mutations that confer natural HIV resistance

Here, the researchers describe the changes CRISPR actually made to the twins. They removed a few cells from the IVF embryos to look at their DNA, and found that edits intended to disable the CCR5 gene had indeed taken hold.

But while they expect these edits to confer HIV resistance by nullifying the activity of the gene, they cant know for sure, because the edits are similar but not identical to CCR5 delta 32, the mutation that occurs in nature. Moreover, only one of the embryos had edits to both copies of the CCR5 gene (one from each parent); the other had only one edited, giving partial HIV resistance at best.

Hank Greely: Successfully is iffy here. None of the embryos got the 32-base-pair deletion to CCR5 that is known in millions of humans. Instead, the embryos/eventual babies got novel variations, whose effects are not clear. As well, what does partial resistance to HIV mean? How partial? And was that enough to justify transferring the embryo, with a CCR5 gene never before seen in humans, to a uterus for possible birth?

6. There could have been other, unwanted CRISPR edits

CRISPR isnt a perfect tool. Trying to edit one gene can sometimes create other, unintended changes elsewhere in the genome. Here the team discusses their search for such unwanted edits, called off-target mutations, and say they found just one.

The search was incomplete, however, and the manuscript also glosses over a key point: any cells the researchers took from the early-stage embryos to test didnt, therefore, actually contribute to the twins bodies. The remaining cells, the ones that would multiply and grow to become the twins, could have harbored off-target effects too, but there would have been no way to know that in advance of starting the pregnancy.

Fyodor Urnov: An egregious misrepresentation of the actual data that can, again, only be described as a blatant falsehood. It is technically impossible to determine whether an edited embryo did not show any off-target mutations without destroying that embryo by inspecting every one of its cells. This is a key problem for the entirety of the embryo-editing field, one that the authors sweep under the rug here.

7. The doctors treating the couple may not have known what was going on

Reporting by a variety of news outlets, including the Wall Street Journal, has charged that Hes team tricked doctors by switching blood samples and that not all of them knew they were involved in creating gene-edited children. If true, thats a problem, since its the duty of doctors to do what is in the best interest of the patient.

Jeanne OBrien: The IVF procedure described follows the same steps and time line whether or not CRISPR is used for genome editing. The Chinese physicians who performed the IVF may have been unaware of the fathers HIV status or that the embryos were genetically modified. He Jiankui would have only needed a willing embryologist to inject CRISPR at the time of insemination. Hes comments make it appear as if the physicians who performed the IVF were not involved in the subsequent decision regarding which embryos to select for transfer. This is a wake-up call to physicians involved in IVF: the science and technology will continue to progress, and desperate couples with infertility may overlook the unknowns or believe the technology is proven safe. Once we, the infertility physicians, knowingly transfer an embryo with germline editing, we are in essence confirming the safety of the modification to the parents and the future child. Is it ever possible to know that?

8. The manuscript misrepresents when the babies were born

By now, several media reports and people familiar with the research have established that the twins were born in October, not November. Why did Hes team include a false date? It may have been to protect the anonymity of the patients and their twins. In a country the size of China, there could be more than ten thousand sets of twins born each month. The falsified date may have been an attempt to make their reidentification even more difficult.

9. Its not clear if there was a proper ethics review

The paper includes an exceptionally brief discussion of ethics. It says the research plan was registered with the China Clinical Trial Registry, but in fact the public registration occurred only after the twins were born.

Hank Greely: Registered when? The answer is on November 8, 2018, after the births and very shortly before they were announced, and probably in order to increase publication potential. This was not a normal registration. Maybe there was an ethics approvalthough that hospital has denied it. Who is telling the truth? Not sure well ever know. The phrase we were told about a comprehensive ethics review is not very powerful evidence. The article also does not discuss the Chinese ban on assisted reproductive services for HIV-positive parents. It has been reported that He had other men pretend to be the intended fathers for purpose of the required HIV tests. The article doesnt say this. It seems to me likely to be trueand damning. If true, it means He defrauded the Chinese regulatory process.

10. The researchers didnt test whether the HIV immunity worked before creating living human beings

Here the Chinese team outlines their plan to collect blood from the twins to see if their edited cells really resist HIV. That is something they could have tried to learn ahead of time, before creating the girls. Before transferring the embryos, they could have kept them frozen while they made identical edits in laboratory cells and tested the effects of HIV on those cells.

Fyodor Urnov: This statement proves that the research team placed their interests above those of the couple who donated the embryos and of their prospective children. There is zero evidence in the manuscript supporting the essential expectation that the new forms of CCR5 would be HIV-protective. It was essential to have determined that before the embryos were implanted. They could have done so using a known assay: introduce the same edits into immune system cells in the laboratory and then infect them with HIV. Only the cells that have HIV-protective variants of CCR5 survive. The research team chose not to do that assay. Instead, they made children out of embryos that had forms of CCR5 of entirely uncertain functional impact. Were the researchers in a rush? Did they simply not care? Whatever the explanation, this egregious violation of elementary norms of ethics and of research borders on the criminal.

11. An American Nobelist may have helped He justify his experiment

The articles conclusion contains an unexpected digression that puts forth an entirely new justification for the research, one that connects the project to the heart of the HIV epidemic in Africa. Its that many uninfected children of African mothers with HIV suffer a syndrome called HEU that makes them more susceptible to a variety of childhood illnesses. The authors say genome editing could be a novel strategy against HEU.

There isnt any evidence for this idea, but there are some clues about where He got it. In an email he sent on November 22 to Craig Mello, a biologist at the University of Massachusetts who at the time was an advisor to one of his companies, He thanked Mello for suggestions on the topic and enclosed in his email the same paragraph above.

Does that mean Mello, a winner of the 2006 Nobel Prize for medicine, contributed a key idea to the paper? Mello was told about the twins project early on but, through a spokesman, says he never gave He advice on how to write the paper. According to Hes email, however, any such interaction was meant to remain unacknowledged. Again, I wont tell people you know what is happening here, he wrote to Mello.

12. The project had other supporters, but some key information is missing

The manuscript concludes by thanking a list of people who, according to He, gave him direct feedback on draft versions of the text or other advice. In an acknowledgement for editing the text, he names Mark Dewitt, a researcher at the University of California. Dewitt didnt reply to emails but earlier gave a description of his role, saying he had warned against the project. William Hurlbut, an ethicist at Stanford, says he gave ethics advice to He but didnt know that the Chinese scientist had created children.

He also thanks W.R. Twink Allen, an equine reproduction specialist in the United Kingdom, and Allens onetime student Jin Zhang, also known as John Zhang, who is now head of New Hope Fertility Center in New York, one of the largest in the US. According to reports, Zhang was planning with He late last year to open a medical tourism business for gene-edited babies.

Of these names, only Allens has not previously been cited in connection with the CRISPR-baby research. Allen did not reply to attempts to contact him by email. Zhang, who has not been forthcoming about his role, told us he was not familiar with the manuscript. I have never seen it, he told us in October.

The version of the twins manuscript we have is missing two critically important disclosures usually present in scientific papers. First, it gives no information about who funded the project or what financial interests the authors have in the outcome. Also missing is a section in which each authors scientific contribution is detailed. This means the text does not explicitly describe the role of the single non-Chinese author, Michael Deem of Rice University in Texas. The nature of Deems roleparticularly any hands-on involvement with the patientscould determine penalties that Deem, or his university, could face. Deems lawyers did not answer questions, including a request for copies of his past statements, which sought to minimize his role in the research. Rice says its investigation is ongoing.

13. The researchers ignored evidence that the gene edits werent uniform

In data attached to the paper, in the so-called supplementary material, are tables that He previously showed publicly. It shows chromatograms, or the readout of the DNA sequences found in the embryos and birth tissues of the twins (the umbilical cord and placenta) when his team tried to measure what editing had happened to the CCR5 gene.

Some observers, including Musunuru in our accompanying op-ed, say these data show clearly that the embryos are mosaic, meaning that different cells in the embryo were edited differently. He says presence of multiple edits is visible in the chromatograms, where several distinct readings are registered in overlapping signals at a given DNA position.

The implication of the data is that the twins bodies could be composites of cells edited in different ways, or not at all. That, Musunuru points out, means only some of their cells might have the HIV-resistant gene edit; it also means some might have undetected "off-target" edits, which could potentially cause health problems. The problem of mosaicism was well known to He from his experiments on animal embryos. One of the mysteries of the research project is why He chose to proceed with embryos if they were flawed in this way.

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In his manuscript, He doesnt resolve the mystery. It says only, The CCR5 gene was deep sequenced for all samples to examine the mosaicism of gene editing. Theres no interpretation of what was found, and no acknowledgement that the data seem to show mosaicism or that its a problem.

Fyodor Urnov: They should have worked and worked and worked until they reduced mosaicism to as close to zero as possible. This failed completely. They forged ahead anyway.

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Chinas CRISPR babies: Read exclusive excerpts from the unseen original research - MIT Technology Review

Recommendation and review posted by Bethany Smith

Cyrus Biotechnology has teamed up with the Broad Institute to optimize CRISPR for use in humans. Feng Zhang, who had a hand in developing CRISPR, will serve as the Broads principal investigator for the collaboration.

One concern with using CRISPR-Cas9 to perform in vivo genome editing stems from the risk that the body will mount an immune response against the system. Those concerns have grown as researchers have shown that many people have antibodies against Cas9, reflecting the fact that the homologs of the protein used in genome editing systems are derived from bacteria that commonly infect people.

Cyrus, which lists Johnson & Johnson among its customers, thinks its technology can mitigate the risk of an immune reaction. That confidence reflects Cyrus experience of using software to identify and work around the epitopes in protein therapeutics that cause immunogenicity.

How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDC

CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management.

We have validated our computational deimmunization platform in a variety of systems, and now seek to apply it where it can make a major impact. Given the extensive therapeutic possibilities of CRISPR systems, and the leading position the Broad Institute and Dr. Zhang hold, we are very excited to work in partnership with them to make these molecules more amenable for use in humans with maximal efficacy and minimal side effects, Cyrus CEO Dr. Lucas Nivn said in a statement.

Partnering with the Broad will allow Cyrus to combine its experience of deimmunization with the skills of researchers who helped put CRISPR on the map. Zhang, the Broads lead on the project, was at the forefront of efforts to optimize Cas9 for use in human cells.

The partners plan to publish their research and make the fruits of their collaboration available to the nonprofit and academic research community for free.

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Cyrus, the Broad team up to make in vivo CRISPR use safer - FierceBiotech

Recommendation and review posted by Bethany Smith

Its been a year since He Jiankui announced that hed made the worlds first gene-edited human babies, twin girls with the pseudonyms Lulu and Nana. Widespread condemnation of his actions followed the announcement. But the facts of the case remain unclear, because he has not been transparent about his work.

In his single public appearance following his announcement, at the Second International Summit on Human Genome Editing in Hong Kong in November 2018, He presented his work by racing through about 60 slides in just 20 minutes. Although he showed data about what he had done to the twins genes, it was blink-and-youll-miss-it, and not enough to convince anyone of his claim that hed safely edited the genomes of the human IVF embryos that became Lulu and Nana.

At the summit, He did say hed just submitted a manuscript describing this work to a scientific journal. Twelve months later, however, the manuscript has remained unpublished and its contents mysterious.

He was asked at the summit why he hadnt posted his manuscript to a preprint server such as bioRxiv or on a public websitesomething scientists frequently do to invite feedback on early drafts. He claimed that hed intended to do so, but colleagues had advised him to allow the manuscript to go through peer review by other scientists before posting it. (Normally, formal peer review takes place only when an academic journal is considering publishing a paper.)

By deciding not to release his manuscript right away, He has made it difficult for other scientists to figure out exactly what he did and how he did it. We already know that there were profound ethical problems with Hes work in germline gene editing, which refers to genetic alterations to embryosor to egg or sperm cellsthat can be passed down through the generations. But its scientific merit, and especially its safety, have remained in question.

When I first had the opportunity to look through a complete manuscript from He last November, I immediately realized there were problems.

The most serious was rampant mosaicism. This means that the gene edits He made to the embryos didnt take effect uniformly: different cells showed different changes. Evidence of mosaicism is present in both Lulus and Nanas embryos, as well as in Lulus placenta, making it likely the twins themselves are mosaic. Some parts of their bodies may contain the specific edits He said he made, other parts may contain other edits he didnt highlight, and yet other parts may contain no edits at all. This would mean that the purported benefit of Hes editing HIV resistancemay not extend to the twins entire bodies, and they could still be fully vulnerable to HIV.

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When judging whether the embryos had edits, He took a few cells from the 200 to 300 present in an IVF embryo and analyzed their DNA. But it was the remaining cells went on to multiply to make up the full body. So it is possible that some parts of the twins bodies have edits that He didnt intend to make (off-target edits) and never had a chance to see. Such off-target edits could cause problems such as cancer and heart disease, and could be passed on to Lulus and Nanas future children.

He apparently didnt realize that his own data revealed extensive mosaicism in the embryos, since he made no note of it in the manuscript I saw. Some have wondered if the CRISPR twins were actually a hoax, but to me, the flaws evident in the data make it clear that they werent. Rather, Hes work was a graphic demonstration of attempted gene editing gone awry. Two living human beings, and potentially their descendants too, will bear the consequences.

You shouldnt have to take my word for any of this. You should be able to judge for yourself, or at least hear what other scientists have to say about it.

However, it seems increasingly unlikely that He will be publishing in a peer-reviewed journal. For one thing, I doubt that any respectable journal would seriously consider publishing research with such ethical problems. And even if one did, and sent the manuscript for peer review, He would be in no position to respond to any technical criticisms with further experimental work. He has been under house arrest, and his laboratory was shut down shortly after his announcement about the twins last year.

The only reason to continue keeping Hes work under wraps would be to preserve his ability to publish it someday in a peer-reviewed journal and earn the imprimatur of scientific quality. The community is under no obligation to grant him this privilege. Indeed, it owes him no professional courtesy at all, any more than it would have owed such courtesy to the doctors responsible for the medical experiments in Nazi Germany or the American scientists in charge of the Tuskegee syphilis study.

Rather, in light of the egregious scientific and ethical lapses inherent in Hes cavalier and secretive efforts to make the worlds first gene-edited babies, it is he who owes all of us a full accounting of his actions. Since he has shirked his responsibility to make his work public, its up to others to step in.

Why must the information be public? Its because Hes work reveals serious, unresolved safety concerns. Its not clear that any effort to directly edit human embryos, even if done ethically and with full social approval, can reliably avoid these problems.

International committees convened by the World Health Organization, the US National Academies of Medicine and Sciences, and the Royal Society are currently working to propose regulatory frameworks for doing clinical germline gene editing safely, if it is to be done at all. How can the committees properly do their work without fully understanding all the scientific problems with the single real-world application of clinical germline gene editing thats been attempted to date?

Most worrying is that scientists like Denis Rebrikov in Russia aspire to follow in Hes footsteps. Rebrikov has said hell be able to edit the human germline safely. But how can Rebrikov credibly claim to be able to do better than He if the nature of the problems with Hes work arent widely known? How can the Russian authorities properly evaluate the safety of his proposals without being able to refer to Hes work for guidance?

Its time for the scientific community to fully understand what happened with Lulu and Nana, and to avoid stumbling down a path toward further ill-starred experiments with clinical germline gene editing.

Kiran Musunuru is an associate professor of cardiovascular medicine and genetics at the Perelman School of Medicine at the University of Pennsylvania and the author of The CRISPR Generation, a book about the history of gene editing and the Chinese twins.

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Opinion: We need to know what happened to CRISPR twins Lulu and Nana - MIT Technology Review

Recommendation and review posted by Bethany Smith