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FDA defends CRISPR-edited animal rules likely to block most uses: Is the agency trying to avoid litigation from anti-GMO groups? – Genetic Literacy…

Posted: February 12, 2020 at 7:43 pm

A heated battle over the future of animal gene-editing in the US has intensified following the publication of dueling articles from the Food and Drug Administration (FDA) and the editorial board of the journal Nature Biotechnology.

In an analysis of genome-edited cattle and an accompanying letter to the editor, the FDA defended its proposal to regulate gene-edited animals as veterinary drugs, arguing the regulation would help prevent unintended consequences that could arise from the use of new breeding techniques such as CRISPR-Cas9. Nature responded in a sharply wordededitorial claiming the agencys proposal is at odds with the evidence, and saying it appears primarily designed to avoid legal battles with litigious anti-GMO groups.

In January 2020, Genetic Literacy Project released its Global gene-editing regulation tracker and index, evaluating nations based on how their laws encourage or hinder innovation. These tools illustrate that the US is a pioneer in agricultural gene-editing research, ranking seventh in the world by maintaining sensible rules that protect public health while developing novel food crops that are addressing important nutritional and environmental challenges.

The one exception in US policy is animal biotechnology. Brazil, Argentina, Japan, Canada and Australia have thus far taken a much more progressive stance on this issue. There are currently no gene-edited animals approved for human consumption in the US.

Under the FDAs oversight, only one genetically engineered animal, the transgenic (GMO) fast-growing AquAdvantage salmon developed by AquaBounty has received regulatory approval, which took roughly 20 years. Because of political wrangling, the salmon is not yet sold in the US, but salmon eggs imported from Canada are being raised at an AquAdvantage fish farm in Indiana. In May 2016, the Canadian Food Inspection Agency approved the sale of the GM fish, and AquaAdvantage salmon fillets became available to customers in Canada.

The FDA is now poised to classify gene-edited animals as veterinary drugs, which would put them in the same regulatory bucket as GMO animals, such as AquaBountys salmon, which is engineered in part using genes from another fish species.

Critics contend this proposed policy would trigger extensive, costly premarket regulatory review that would severely limit the ability of scientists to breed gene-edited animals, though the FDA says it will balance its guidelines to protect public health without hampering innovation. The agencys proposal has been panned by animal biotech scientists, some of whom have moved their breeding programs to countries with less restrictive regulations.

FDA stands its ground

Writing in Nature Biotechnology on February 7, FDA Center for Veterinary Medicine (CVM) Director Steven Solomon explained the rationale guiding the agencys proposal. Citing the examples of a gene-edited bull whose genome was unintentionally altered to contain bacterial DNA and a conventionally bred animal from the 1950s, Solomon argued that:

The intended genome edit sought to introduce the Celtic POLLED allele into Holstein cattle. This allele exists in some other cattle breeds and results in the animals lacking horns (or being polled) . [H]owever, the editing also produced unintended modifications . Unintended alterations can have unexpected and deleterious consequences no matter the size of the alteration or how it was produced . There is a particularly compelling example of the risks of occult genomic alterations in cattle produced by traditional breeding techniques: a high incidence of bovine leukocyte adhesion deficiency (BLAD) syndrome, a lethal autosomal recessive disease, in Holstein calves.

The selection of a particular Holstein bull for superior milk production genetics resulted in wide dissemination of carrier bulls semen for breeding beginning in the 1950s and 1960s. It turned out that the selected bull was a carrier of a naturally occurring single point mutation that causes BLAD when two copies are present. The extensive use of carrier bulls semen led to an eventual 23% BLAD carrier frequency in Holstein calves in the United States. It took a decade to effectively breed the genetic mutation that causes BLAD out of dairy cattle genetics.

. We recognize that there is tremendous excitement over quickly embracing and bringing to market the fruits of genome editing technology, as well as the critical importance of adequately identifying potential risks, efficiently evaluating whether the risks do in fact exist, and determining whether the risks pose an actual safety hazard in a timely manner.

It is the FDAs role to balance these competing imperatives. We want to support the timely development of beneficial products, but not at the expense of abdicating our critical role in protecting consumer and animal health. We have a public health obligation to protect consumer and animal health that we must balance with the potential of this innovative technology to enhance human and animal health and food production.

Experts unconvinced

Nature Biotechnologys editorial board found Solomons case unpersuasive. If anything, they wrote, his examples undermine the justification for strict FDA oversight of gene-edited animals:

BLAD is not a justification for mandatory regulation of all gene-edited animals . [I]t illustrates that conventional breeding might warrant tighter FDA oversight, especially when rapid breeding expansion programs thrust particular genetic profiles to the fore . [I]f the BLAD case history tells us anything, it is that the origin of a DNA arrangement (conventional breeding, recombinant DNA or gene editing) makes little difference to an animal.

While the editorial authors conceded that the presence of extraneous donor plasmid in the gene-edited POLLED Holstein DNA was unexpected and initially missed, they said the unintended edit should be properly contextualized. The genomes of domesticated cattle contain north of 86 million mutationsinsertions, deletions and single nucleotide variantsand none of these changes is linked to negative health outcomes in humans who consume milk or meat from cows. Amidst this background of innocuous variation, how can the presence of one identifiable variant justify the costs and delays of mandatory FDA oversight? the authors asked.

The answer, they continued, has more to do with politics than science. Anti-GMO groups have utilized every tool at their disposal to restrict the progress of agricultural biotechnology. One of their most potent weapons has been a constant stream of litigation aimed at the USDA, FDA and EPA, the three federal agencies tasked with oversight of biotechnology. Activist litigation was a primary factor in the delayed approval of AquaBountys salmon, for example. The groups behind the mass of lawsuits have also successfully stoked consumer concern about the alleged risks of genetically engineered crops and animals. Meanwhile, the relatively small animal biotechnology industry doesnt have anywhere near the same the public relations and legal resources. As the editorial explained:

[T]here are very few companies in this sector to argue the case for genetically engineered (including gene-edited) animals . On the other hand, there is a powerful and litigious anti-GMO/pro-organic lobby that repeatedly challenges the legitimacy of regulatory rulings and attempts to block market access following approval.

Life-saving biotech drugs gain wide support in Washington. But there is little political capital invested in backing gene-edited animals. Food remains plentiful and, if anything, the public mood is shifting to vegetarianism and animal-substitute products. Scientists and breeders want to use new technology in agriculture, but public sentiment nostalgically harks back to Victorian farming practices in a way that it doesnt for Victorian medical practices.

A cautious, process-based regulatory route keeps the FDA out of trouble and lowers litigation risks for CVMs lawyers.

The authors ended with a proposal of their own, urging the FDA to regulate gene-edited animals based on the risks they may pose to human health, not the process that was used to breed them:

Mandatory oversight could be phased out to a system whereby the agency exercises discretion over which gene-edited animals are regulated according to the hazard represented by the introduced trait. This would be consistent with USDA policy and longstanding US regulatory policy. It would give the animal biotech sector a chance to bloom. And it would counter the narrative of fearmongers who would taint all gene-edited animals as hazardous to public health and injurious to animal welfare.

Cameron J. English is the GLPs senior agricultural genetics and special projects editor. He is a science writer and podcast host. BIO. Follow him on Twitter @camjenglish

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Musicians and community coming together in Asbury Park to help Point Pleasant 3-year old – Asbury Park Press

Posted: February 12, 2020 at 7:43 pm

Max Weinberg of the E Street Band plays air drums at a New Jersey Devils inside the Prudential Center in Newark on Feb. 1, 2020. AP Staff

Three-year old Carson Dratch of Point Pleasant has a battle in front of him, but with a communityand a group of steadfast musiciansbehind him, things are looking up.

Musician Matt Witte, his cousin, will lead a benefit for Carson on Saturday, Feb. 8, at the Asbury Park Yacht Club on the boardwalk in Asbury Park.

Carson has Aplastic Anemia, a rare disease that affects bone marrow.

He's a normal little kid afflicted with a terrible disease, Witte said. So far, everything is going well, really good. Everything has been successful but we got a longway to go.

Carson's parents, Doug and Danielle Dratch, reported that Carson has completed his chemotherapy and received his donor's stem cells on Dec.19. The donor's cells have taken to Carsons little body and have been multiplying themselves since day (one), according to the family's Gofundme.com page.

Super Bowl Halftime Show: "Jersey Shore"stars defend Jennifer Lopez, Shakira

Three-year old Carson Dratch of Point Pleasant.(Photo: Courtesy of the Dratch family)

A second medical scare, a brain aneurysm, has been averted and he's home now. He's currently on five medications and is making two trips a week to the hospital. He also needs home nursing.

Funds are needed to help defray costs.

Their hospital bills are out of control, Witte said. They have insurance but it doesn't pay for everything.

Chances are you have come across one of Carson's relatives. Mom Danielle's maiden name is Carr, of the Point Pleasant Beach-based Carr's Driving School family. It's been operated by the Carrs since 1957.

[Subscribe to the Asbury Park Pressand download the app for the latest on the New Jersey music scene. ]

Matt Witte(Photo: Chris Jordan/STAFF PHOTO)

Witte, a former Atlantic Records recording artist, will take the stage with long-time collaborator John Swayne. Old Lady and Disposable are also on the bill. Attendees are asked to make a $10 donation.

Children are our future and we got to help out however we can, said Peter Mantas, entertainment director of the Asbury Park Yacht Club and the adjacent Langosta Lounge.

A fire in downtown Bound Brook on Jan.12 destroyed a pair of buildings under construction and nearly wiped out a block of homes. It looked like a war zone.

Now, out of the ashes has come resiliency.

A We Stand with Bound Brook benefit concert will take place at 4 p.m. Saturday, Feb. 8, at the Brook Arts Center, not far from where the fire took place. Second Wind;Tuesday at Eight with special guest Bill Turner of Bill Haley and the Comets;Anthony Didio;and Rachael Wise and The Guys will play while members of the Serova School of Dance and the Elite Dance Center also will perform.

Proceeds will provide relief to those who have been impacted by the fire via the Fire Relief Fund and the Salvation Army.

We Stand with Bound Brook, 4 p.m. Saturday, Feb. 8, Brook Arts Center, 10 Hamilton St., Bound Brook. $10, free for kids 2 to 13 and first responders. brookarts.org.

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Are you ready for some rattle and roll?

The Michigan Rattlers, who are indeed from Michigan, are coming through the area with shows Tuesday, Feb. 11, at the Wonder Bar in Asbury Park, and Wednesday, Feb. 12, at the Mercury Lounge in New York.

[ Looking for the trusted place to find the best home service providers? Find local pros. ]

Actually, roots rock, or alt-country, might be a better description for the band, who have been touted in everything from Rolling Stone to the Bluegrass Station.

You can expect a good live, energetic, rocking set with meaningful songs and some smiling faces up on the stage having a great time, says the band about the Wonder Bar show. Maybe even a few new songs, too.

They're shaking things up. Brent Cowles is also on the bill.

Michigan Rattlers with Brent Cowles, 7 p.m. Tuesday, Feb. 11, Wonder Bar, Ocean Avenue, Asbury Park. $12 in advance, $15 at the door. wonderbarasburypark.com.

What do you do when youre the real-life drummer on the million-selling hit single that comes on the Drum Cam during the New Jersey Devils game at the Prudential Center in Newark?

You air-drum, of course.

Max Weinberg air drums at the Feb. 1, 2020 New Jersey Devils vs. Dallas Stars hockey game at the Prudential Center in Newark.(Photo: Chris Jordan)

Thats what Mighty Max Weinberg did on Feb. 1 during the Devils game against the Dallas Stars when Dancing in the Dark by Bruce Springsteen and the E Street Band came on the arenas Drum Cam as part of the Ticketmaster Wheel of Cams.

Weinberg air-drummed along, and was introduced to the crowd afterward to a big cheer.

Weinberg, a big Devils fan, was in town with his wife Becky Weinberg and daughterAli Roginto help the 2000 Devils celebrate the 20th anniversary of their Stanley Cup win. Max Weinbergs Jukebox played for the 2000 team at White Eagle Hall in Jersey City on Jan. 31.

More music: Naughty by Nature, up close and personal, at the Grammy Museum Experience in Newark

All the Weinbergs are big hockey fans. Son Jay Weinberg follows the Devils and wanted to be there on Saturday but had another obligation. Hes on tour with his band Slipknot in Europe at the moment.

By the way, the Devils 3-2 lost to the Stars in overtime on Saturday.

Chris Jordan, a Jersey Shore native, covers entertainment and features for the USA Today Network New Jersey. His multiple awards include recognition for stories on both Bruce Springsteen and Jersey Shore. Contact him at @chrisfhjordan; cjordan@app.com.

Who: Matt Witte with John Swayne, Old Lady and Disposable

When: 9 p.m. Saturday, Feb. 8

Where: Asbury Park Yacht Club, Boardwalk, Asbury Park

Tickets: $10 donation requested

Info: apyachtclub.com

Read or Share this story: https://www.app.com/story/entertainment/music/2020/02/06/musicians-and-community-coming-together-asbury-park-help-point-pleasant-3-year-old/4664811002/

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Information on all 50 NH Primary candidates (including the Hartford Whalers guy) – Manchester Ink Link

Posted: February 12, 2020 at 7:41 pm

The front and back of Mark Stewart-Greensteins signs. Photo/Andrew Sylvia

The First in the Nation Primary has finally come and New Hampshire voters will head to the polls with ballots that include 50 total candidates between the two parties (including that guy with the Hartford Whaler signs everywhere)

Heres Manchester Ink Links guide to all 50 of those candidates, 37 Democrats and 13 Republicans, divided between candidates campaigns weve reported on/received letters to the editor on directly and other candidates, with each category sorted in alphabetical order by last name. The names of candidates no longer in the race but on the ballot are italicized.

Links to webpages or Facebook pages can be found on the candidates names where applicable, as well as a brief bit of information about each of the lesser-known candidates we could gather.

Michael Bennet

Joe Biden

Cory Booker

Steve Bullock

Pete Buttigieg

Tulsi Gabbard

Kamala Harris

Amy Klobuchar

Bernie Sanders

Tom Steyer

Elizabeth Warren

Marianne Williamson

Andrew Yang

Mosie Boyd

An attorney hailing from Arkansas, Boyd seeks to rebuild patriotism by uniting Americans around our shared values.

Boyd received 96,000 votes in the 2002 California Democratic Primary for Governor and also runs a PAC that supports female candidates.

She believes that there will be no clear candidate heading into the Democratic National Convention in Milwaukee and can emerge as a dark horse alternative.

Steve Burke

Burke is a cattle rancher and local Democratic party official in New York State. He sees the recent impeachment of Donald Trump as a distraction from issues impacting most Americans such as climate change, unemployment and homelessness.

Julian Castro

Julian Castro was the U.S. Secretary of Housing and Urban Development from 2014 to 2017 and mayor of San Antonio, Texas from 2009 to 2014.

His campaign was suspended on Jan. 2, 2020 after the deadline for removing his name from the ballot.

John Delaney

John Delaney was the Member of the U.S. House of Representatives from Marylands sixth district from 2013 to 2019.

His campaign was suspended on Jan. 31, 2020 after the deadline for removing his name from the ballot.

Jason Evritte Dunlap

Jason Evritte Dunlap of Arizona is a former military intelligence officer fluent in several languages.

Dunlap does not actually want to run for president, but felt compelled to do so after he said repeated attacks by the Trump administration have put himself and fellow intellligence officers in harms way.

Like Boyd, he believes that there will be no clear candidate heading into the Democratic National Convention in Milwaukee and can emerge as a dark horse alternative.

Roque De La Fuente III

Roque De La Fuente III is the son of serial candidate (and 2020 Republican Primary candidate) and is focusing his campaign on global debt relief.

Hes on the ballot in California, Colorado, Idaho, Missouri, Texas and Utah in addition to New Hampshire.

Michael Ellinger

Ellinger is a Ohio resident running on a platform that he calls the Moral Deal. Hes on the ballot in California, Arizona and New Hampshire.

Ben Glieb

Glieb is a comedian that has appeared on CNN, ABC, NPR and other outlets. He dropped out of the race on Dec. 30, 2019.

Henry Hewes

Henry Hewes is from New York and he really, really, really dislikes abortion.

Tom Koos

Koos is the Associate Director for Health and Safety at Stanfords School of Earth, Energy & Environmental Sciences in California.

This is the third time hes put his name in the New Hampshire Democratic Primary, running just days after he turned 35 in 2000 and then again in 2008. Hes unable to put up as much effort this time, but feels that its is civic duty to run again.

He is a son of Eastern European immigrants, he feels a strong need to update the countrys immigration laws and he also feels that climate change is a key issue.

Lorenz Kraus

Kraus is an anti-semite from New York who believes the United States should be broken up into four countries.

Rita Krichevsky

Rita Krichevsky is on the ballot in New Hampshire and Colorado. Repeated calls to Krichevsky went unanswered. According to the Lawrenceville, NJ Town Clerks office, her license to practice medicine was suspended in 2018. No further information was available.

Thomas James Torgesen

Torgesen lives in Saratoga, NY. He has been a Democrat since the 1960s and believes the party has gone too far to the left, but he shouldnt have to leave it. Hes running due to the fact that several current candidates protested the Vietnam War while he served in the Navy.

His primary issues are getting prayer in schools, making sure the Navy has a thousand ships and trade surpluses.

Raymond Moroz

Raymond Moroz hails from New York, his primary focus is strengthening labor unions. He received eight votes in the 2016 New Hampshire Democratic Primary.

Joe Sestak

Sestak is a former Pennsylvania congressman and three-star Navy admiral. He dropped out of the race on Dec. 1, 2019 and endorsed Amy Klobuchar on Feb. 7, 2020.

Sam Sloan

A New York resident, Sloan ran for the Libertarian Presidential Nomination in 2012 as well as running for Governor of New York in 2010 and for New Yorks 15th Congressional District seat in 2014.

In 2016, he ran in the New Hampshire Democratic Primary and he received 15 votes.

Mark Stewart-Greenstein

Anyone driving around the greater Manchester area over the past few months has probably seen his signs (see above), a throwback to his grassroots efforts to return the Hartford Whalers to Connecticut several years ago. In the past, Stewart-Greenstein has run for several offices in Connecticut and received 29 votes in the 2016 New Hampshire Democratic Primary.

He describes himself as a conservatarian, blending philosophies from libertarianism and conservatism, but he also says his views are in line with where the Democratic Party once was before it began to move to the left in the 1960s.

Stewart-Greensteins main goal is not earning the Democratic nomination, but building support for his EPIC (Every Politically Minded Citizen) Party.

David John Thistle

Thistle currently lives in Texas, but originally hails from the Manchester area.

Thistle served in the military and is running for president primarily to reform the Veterans Adminstration, which he says harmed him and has harmed many other veterans.

Thistle received 226 votes in the 2016 New Hampshire Democratic Primary. and

Robby Wells

Wells is the first white football head coach coach of a Historically Black College or University. He also served in the Army National Guard and has a twelve-point plan he calls Eaglenomics that incorporates left-wing and right-wing policies.

He ran for president in 2012 as a member of the Constitution Party and an independent candidate in 2016.

Donald Trump

Bill Weld

Robert Ardini

A moderate Republican from New York, Ardini ran for Congress in 2016 and lost, writing a book entitled Running for Congress in Trumps Backyard about the experience.

His main goal in running is to bring greater awareness to the national debt. However, he also has other unique proposals, such as pushing the age for drivers licenses and other coming of age landmarks to 25 and requiring all Presidents to select at least 20 percent of their cabinet from a party other than their own.

President R. Boddie

Mr. Boddie, a resident of Georgia, legally changed his first name to President after receiving a vision from God in 2018 that he was destined to become President.

Boddies main goal is to merge the United States with Israel and move to capital of the United States to Jerusalem.

Stephen Comley Sr.

Comley, who hails from Massachusetts, is primarily concerned with corruption within the Nuclear Regulatory Commission.

Roque Rocky De La Fuente

Rocky De La Fuente, (not to be confused with his son, who is also running as a Democrat), is not only running for President, but also running for Congress in the 21st District of California.

De La Fuente recieved 96 votes in the 2016 New Hampshire Democratic Primary, and has also tried to run for the nomination of the Reform Party as well as a party he created called the American Delta Party

He ran for the U.S. Senate in Florida in 2016, ran to become the Mayor of New York in 2017 and ran for the U.S. Senate in nine states simultaneously in 2018.

Bob Ely

Bob Ely of Illinois describes himself as having the charisma of a door knob and in previous attempts running in the New Hampshire Democratic Presidential Primary he described himself as a jerk.

Imagine a more boring Vermin Supreme (who is running as a Libertarian this year, so hes not on either ballot in New Hampshire.)

Zoltan Istvan Gyurko

A self-described transhumanist, Gyurko doesnt expect to become president. Instead, he hopes to advance the cause of innovation on the right, which he says has been dominated by the left, not just for the sake of conservatism, but to help America keep track with the innovation of other countries.

Gyurko ran for President in 2016 under the ticket of the Transhumanist Party and ran for Governor of California in 2018 as a Libertarian.

Rick Kraft

Mr. Kraft is a lawyer from New Mexico seeking to unify the country under the principles of Christianity.

Star Locke

Mr. Locke is opposed to abortion, immigration and Islam. Locke received 33 votes as a Democrat in New Hampshire in 2016 and has run for various offices in Texas over the past three decades.

Mary Maxwell

Maxwell, a Concord resident, actually wanted to run for vice president in the Primary, but could not do so. She ran for Congress against Charlie Bass here in New Hampshire in 2006 and ran for the U.S. Senate in Alabama in 2017.

Eric Merrill

Merrill lives in New Boston and ultimately is just running because it was on his bucket list.

He says he has voted Republican in every election since his first vote, which was for Richard Nixon. He generally agrees with mainstream principles of the Republican Party outside of climate change, which he says is a problem, but cannot be addressed with any effectiveness unless China is forced to also reduce its emissions.

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Edited Transcript of NANO earnings conference call or presentation 6-Feb-20 9:30pm GMT – Yahoo Finance

Posted: February 11, 2020 at 8:51 am

MILPITAS Feb 11, 2020 (Thomson StreetEvents) -- Edited Transcript of Onto Innovation Inc earnings conference call or presentation Thursday, February 6, 2020 at 9:30:00pm GMT

Onto Innovation Inc. - Senior Director of IR, Corporate Communications & Marketing Research

* Michael P. Plisinski

Onto Innovation Inc. - CEO & Director

* Steven R. Roth

Onto Innovation Inc. - Senior VP of Finance & Administration, CFO and Secretary

* J. Ho

Stifel, Nicolaus & Company, Incorporated, Research Division - MD of Technology Sector

B. Riley FBR, Inc., Research Division - Associate Analyst

D.A. Davidson & Co., Research Division - MD & Senior Research Analyst

Good day, and welcome to the Onto Innovation Fourth Quarter Earnings Release Conference call. During today's call, there will be a question and answer session. (Operator Instructions) Today's conference is being recorded.

At this time, I would like to turn the conference over to Michael Sheaffer, Investor Relations. Please go ahead, sir.

Michael Sheaffer, Onto Innovation Inc. - Senior Director of IR, Corporate Communications & Marketing Research [2]

Thank you, Karina. Good afternoon, everyone. Onto Innovation issued its 2019 fourth quarter and full year financial results this afternoon, shortly after the market closed. If you have not received a copy of the release, please refer to the company's website at http://www.ontoinnovation.com, where a copy of this release is posted. Joining us on the call today are Michael Plisinski, Chief Executive Officer; and Steven Roth, Chief Financial Officer.

As is always the case, I need to remind you of the safe harbor regulations. Any matters today that are not historical facts, particularly comments regarding the company's future plans, objectives, forecasts and expected performance consist of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such estimates, whether expressed or implied are being made based on currently available information and the company's best judgment at this time. Within these is a wide range of assumptions that the company believes to be reasonable. However, it must be recognized that these statements are subject to a range of certainties that can cause the actual results to vary materially. Thus, the company cautions that these statements are no guarantee of future performance. Risk factors that may impact Onto Innovation's results are currently described in both Rudolph Technologies Form 10-K report and Nanometrics Form 10-K report for the year ended December 2018 as well as other filings with the Securities and Exchange Commission. Onto Innovation does not update forward-looking statements and expressly disclaims any obligation to do so. Today's discussion of our financial results will be presented on a non-GAAP financial basis, unless otherwise specified. A detailed reconciliation between GAAP and non-GAAP results can be found in today's earnings release.

And now I'll go ahead and turn the call over to Mike Plisinski. Mike?

Michael P. Plisinski, Onto Innovation Inc. - CEO & Director [3]

--------------------------------------------------------------------------------

Thank you, Mike. Good afternoon, everyone, and welcome to Onto Innovation's fourth quarter earnings call. I'll start with an update on the most exciting event for the fourth quarter, the merger of Nanometrics and Rudolph Technologies, which resulted in the launch of Onto Innovation. Onto Innovation is positioned to benefit from nearly every major technology inflection across the semiconductor value chain from the continued evolution of advanced nodes in both memory and logic fabs to the growth of specialty devices for sensing and communications and the essential advanced packaging that opens the door for greater levels of integration and performance in a smaller form factor. We closed on this transformational merger in late October. And since then, Onto Innovation team has been working diligently to integrate our businesses and form the foundation for future innovation and shareholder value creation. In these past 3 months, we have integrated our talented and customer support teams in order to more efficiently leverage our combined infrastructure, and ultimately, improve our customers' experience with our portfolio solutions. We have identified and implemented $14 million in annualized synergies and we are confident in ending this year with $20 million of annualized cost synergies with additional synergies to follow. Finally, our technology teams have been busy exploring potential revenue synergies to strengthen our core markets and expand our SAM. Of course, it will take time for these benefits to be fully realized, but the effort is progressing very well.

Turning to the specifics of our fourth quarter, the Onto Innovation team delivered solid results with revenue coming in at $120.6 million, which was above the midpoint of our forecasted range. Non-GAAP earnings per share came in at $0.41 at the high end of our guidance. As a reminder, we will be reporting our results in 3 categories. The first category is advanced semiconductor nodes, which includes DRAM, NAND and logic, including foundry. The second category is specialty devices and advanced packaging, which includes those categories in our nascent silicon wafer manufacturing market. And our third category is software and services.

For the fourth quarter, advanced nodes declined slightly overall. Atlas III+ metrology sales doubled over the third quarter, predominantly to support the ramping of 10-, 7- and 5-nanometer logic nodes by 2 of the top 5 semiconductor manufacturers. The Atlas platform's increased throughput and more sensitive broad spectrum optical metrology is well suited to help customers control the increasingly more complex 3D measurements required for yields at the leading edge. The growth in logic mostly offset the decline in memory we projected last quarter after strong demand from NAND customers in the third quarter.

Revenue from our specialty device and packaging -- advanced packaging segment increased 7% from the third quarter. As a reminder, this is generally a unit volume-driven business, where growth is typically through expansions to meet higher chip volume versus technology transitions. As a result, the business is generally more susceptible to the effects of seasonality with Q4 and Q1 typically being the slower quarters. However, revenue in the fourth quarter reflects a growing demand for 5G-enabled devices with advanced packaging revenue increasing 5%.

The Dragonfly inspection system achieved record revenue in the quarter and enjoyed broad adoption across the most demanding advanced packaging applications, including multiple tools shipped to a top 5 memory manufacturer for stack DRAM packaging applications. Other wins included 2D inspection with clarifying technology and 3D bump inspection for top 5 logic and foundry customers in support of their announced 5G and high-performance computing applications. Rounding out the customer wins, several OSAT customers took delivery of their first Dragonfly system for bump inspection to support expansion of their packaging lines for mobility products. Revenue from silicon wafer manufacturers grew by over 50% in the fourth quarter, driven by record shipments of our QS series FTIR metrology systems to substrate manufacturers worldwide. Also contributing to the growth were multiple shipments of NovusEdge in the quarter, including to a new customer. In the last year, NovusEdge has been adopted by 4 of the top 5 silicon wafer manufacturers and our QS series FTIR is positioned on all of the top 5. We believe this will position us well for continued growth in 2020.

Also during the fourth quarter, we delivered and recognized a second JetStep Lithography System for a panel packaging customer who is increasing capacity for 2020. This customer has developed a reputation for high-quality and high-yielding advanced panel processes and has attracted a growing number of customers for devices, such as power management and RF modules, microcontrollers and FPGAs. This customer is also incorporating our Firefly inspection tool to provide feed-forward metrology data to the JetStep Lithography System using our StepFAST software solution as they begin to move toward high-volume manufacturing in mid-2020.

Finally, rounding out the quarter, our software and services business continues to grow as each company had invested in infrastructure and technology to provide more value-enhancing services to our customers. As mentioned at the start of the call, we see opportunities to leverage our broader infrastructure to improve efficiencies and deliver more value-enhancing services.

In summary, over the full year, our new products helped to strengthen our position in core markets and open opportunities in new markets. The Atlas III+ expanded our optical metrology position across the leading-edge logic and memory customers. We have now secured tooler record positions with leaders in logic, 3D NAND and DRAM, resulting in a more balanced foundation from which to grow in 2020. Likewise, we are pleased with the selection of Dragonfly inspection by 15 new customers in 2019 across diverse markets in advanced packaging and across a wide variety of applications such as packaging RF wireless power devices and automotive.

Shipments of our NovusEdge inspection and FTIR metrology product lines more than doubled from 2018 to 2019. We believe this market will continue to grow and be a more meaningful part of our business in 2020. Combined, these new products resulted in over $130 million of revenue in 2019 and provide a strong base to grow from as we look ahead to 2020.

Specific to the first quarter of 2020, we see specialty devices and packaging segment continuing to grow into the first quarter. We see DRAM spending increasing in the first quarter, offsetting a pause in logic and NAND and leading to revenue in the range of $136 million plus or minus 6%. In this revenue range, earnings per share would be $0.23 to $0.41 per share. The midpoint of this revenue range represents an increase of 13% over the reported fourth quarter after being adjusted downward to reflect the projected impact of the coronavirus on the timing of our shipments to China. Absent that adjustment, we expected our midpoint in the upper half of our guidance range. By now, many of you are aware that the rapid spread of the coronavirus has resulted in a mandated extension of the Chinese Lunar New Year holiday to February 10. Strict quarantine of a number of cities and provinces and other travel restrictions across the country. This has delayed some of our planned shipments in February. Our guidance reflects the best information available from our customers as to when they believe travel restrictions will be lifted and shipments to their factories can resume. It's important to note that we do not see any impact on demand at this time. The impact is only on the timing of shipments. And as we manage through this situation and assess timing, our first priority will be to the safety and well-being of our staff and their families.

Looking more broadly at 2020, we see demand for 5G-enabled devices and high-performance computing sparking a broader recovery in the market. Gartner forecasts that worldwide, mobile phones will see a modest increase this year versus a decline in 2019. Driving the majority of that increase are the 5G-enabled handsets, which Gartner predicts will account for 12% of all mobile phone shipments in 2020, increasing to 43% of all mobile phones in 2022. As a result, we expect to see a number of Onto Innovation markets expand in 2020. The most obvious impact of this growth is in our specialty devices and advanced packaging segment. Underscoring this opportunity is our release from earlier in this -- in the month announcing the receipt of orders for 15 inspection systems from 2 customers rapidly expanding advanced packaging capacity to support wafer-level packaging of 5G devices. We see continued growth in these markets in 2020, driven by volume increases as well as additional devices migrating to advanced packaging. We also see 5G and high-performance computing, benefiting our advanced node segments in which leaders, such as SK Hynix, recently forecast 5G smartphones will drive a 25% increase in DRAM content per phone, while NAND will benefit from 20% increase per phone. And TSMC recently cited growing demand for their 5-nanometer process from 5G processors, RF front-end modules and advanced computing. We expect our advanced semiconductor nodes segment to grow modestly with sustained levels of logic foundry spending and a pickup in memory spending starting with DRAM.

In conclusion, semiconductor markets are becoming more diverse every year. We see chip innovations and cameras, sensing and communications, enabling new customer products such as smart home, smart grids and wearable health monitors. We see innovations in the advanced nodes for both memory and logic, enabling data centers and AI engines to open up entirely new markets such as medicine, autonomous driving and energy. We see a growing number of customers increasing their focus on advanced packaging technology to unlock the full potential of new chip designs and more tightly integrated and high-performing form factors. Across the spectrum, Onto Innovation is an important partner to our customers. Our merger strengthens our ability to provide value-enhancing services to our customers, increase our pace of product innovation and deliver more comprehensive, integrated solutions to challenges further down our customers' road map. We are only at the very start of this journey, but we are committed to maximizing our potential to the benefit of all of our stakeholders, customers, shareholders and our team.

With that, I'll turn the call over to Steve Roth to review the financial highlights.

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Steven R. Roth, Onto Innovation Inc. - Senior VP of Finance & Administration, CFO and Secretary [4]

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Thanks, Mike. Before I begin my financial remarks today, I want to remind you, as usual, the financial results discussed here will be provided on a non-GAAP basis. And that our non-GAAP presentation for the new merged company no longer excludes stock-based compensation as the former Rudolph financials did. In addition, as detailed in our last conference call, Rudolph was deemed the financial acquirer in the merger. And therefore, the combined financial results presented today represent the results of Rudolph for the full fourth quarter but only the results of former Nanometrics since the closing of the merger on October 25. I recognize that this partial quarter makes comparability of prior period somewhat difficult and I'll try to bridge those differences for comparative purposes to the prior periods.

As Mike mentioned, our reported fourth quarter revenue was $120.6 million, above the midpoint of our guidance. That revenue excludes both $10 million of Nanometrics October shipments and $1.7 million of deferred revenue that would have rolled into the quarter, but was eliminated in the merger accounting. Therefore, on a total quarter basis, as if the merger was completed at the beginning of the quarter, our full quarter revenue would have been $132.3 million. That's a 3% decrease from the $136 million in combined revenue, if you add the 2 separate companies' third quarter reported revenue together.

Breaking the revenue down by market. Revenue from advanced nodes account for 44% of revenue with strength in logic and foundry offset by lower memory business. Specialty devices and advanced packaging customers accounted for 35% of revenue, and the remaining 21% of revenue came from our software and services business. We had 1 customer in the fourth quarter representing 10% or greater sales. As we have discussed, one of the benefits of the merged company is the broad and diverse customer base, with over 150 customers from silicon wafer manufacturers all the way to advanced packaging customers.

Turning to gross margin. Fourth quarter gross margin was 51% and was impacted by the cleanup of inventory items as we prepare to go live with the new ERP system in January, which we did not non-GAAP out. Excluding those inventory adjustments, our Q4 gross margin would have been approximately 52%. As we look forward to our first full combined quarter in Q1, we see the revenue volume per Mike's guidance, or that Mike just provided, and product mix primarily affecting the margin. And therefore, expect our gross margins to be in the range of 50% to 52%.

Fourth quarter operating expenses, as reported, were $40.7 million and excluded $8.7 million of fourth quarter Nanometrics expenses prior to the closing. On a full quarter basis, total operating expenses would have been approximately $49.4 million.

Operating expenses reported by each separate company in the third quarter of 2019, when combined, equaled $51.8 million. Portion of the decrease between the periods is due to the merger synergies, having a partial positive effect on Q4 expenses. Historically, operating expenses increased quarter-over-quarter from Q4 to Q1, as during the first quarter we perform our annual compensation reviews and equity grants and bonus plans and payroll taxes reset for the year. We have also implemented a significant portion of our synergies mainly around business rationalization, streamlining corporate overhead and eliminating duplicative public company costs, which on an annual basis totals $14 million and puts us well on our way to achieving our stated goal of $20 million by the end of 2020. The quarterly benefit of those synergies will partially offset the normal Q1 operating expense increases I just mentioned. And based on that, we are currently forecasting our Q1 operating expenses to be in the range of $49.5 million to $51.5 million. Net income for the fourth quarter was $18.1 million or $0.41 per share and at the higher end of our guidance. That per share amount was based on 43 million diluted shares outstanding due to the deal being closed in the middle of the quarter. For the first quarter, we are estimating a diluted share count of approximately 50.5 million shares in our earnings per share calculations. That share count difference negatively impacts Q1 guidance by approximately $0.04 per share when compared to Q4.

Now turning to cash and investments, which are on a GAAP basis. We ended the year with a cash position of $320.2 million after paying out approximately $25 million in merger expenses. On a 50.5 million diluted share count, that equates to $6.34 per share. As the industry continues to improve and we begin to benefit from the synergies in our operations and improve our working capital metrics, we're targeting cash flow to be approximately 20% of revenue in 2020.

Now I'd like to open the call to questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) We'll take our first question from Patrick Ho with Stifel.

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J. Ho, Stifel, Nicolaus & Company, Incorporated, Research Division - MD of Technology Sector [2]

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Thank you for the color in helping to get the financials in order on a going-forward basis. Mike, first off, in terms of your front-end metrology business, can you give a little bit of color -- one on the NAND flash environment and maybe on the timing of when you believe broader base NAND flash spending will come? And secondly, on the DRAM side, some of the comments you made, I think from the metrology end, obviously, there's been increasing capital intensity trends related to metrology use as layers increase, how do we look at the DRAM market, in -- specifically on the metrology and in terms of capital intensity -- how that plays out?

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Michael P. Plisinski, Onto Innovation Inc. - CEO & Director [3]

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So I'll start with the 3D NAND. So after relatively strong first several quarters of 2019, we had the pause in the fourth quarter. We see 3D NAND picking -- staying or a little bit pause for the first half and picking up more in the second half. And the magnitude of which could determine, obviously, the strength of the year-over-year comparison. But for sure, strengthening in the second half from what we're seeing.

On the DRAM side, we see a little bit of the opposite. We see stronger demand in the first half, starting in the first quarter. And part of that is bringing in equipment for some of the -- I think, it's well publicized, Samsung has announced Beyontec expansion. And going into the second and third quarter, and you know obviously bring in the metrology equipment sooner than the process equipment to help qualify that process equipment, so -- does that...

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J. Ho, Stifel, Nicolaus & Company, Incorporated, Research Division - MD of Technology Sector [4]

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Great. That's helpful. Yes, it does. And maybe, Steve, in terms of OpEx management, actually looks really good in Q1 relative to some of the expectations I have. How do you see that progressing? And what I'm trying to get at is the cost synergies are still going to be put into place. I'm sure you're looking at new investments. How do we look at the trends as 2020 progresses for OpEx management?

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Steven R. Roth, Onto Innovation Inc. - Senior VP of Finance & Administration, CFO and Secretary [5]

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Yes. I mean, I would say you can -- it models down quarter-over-quarter, the way we look at it right now. Obviously, some of the synergies timing come in, like you said, they phase in. But yes, I would say that, right now, the guidance that I gave for Q1 is a high point because, as I said, there's a lot of cost -- some of the costs are not linear. So there's always this uptick in the first quarter. And then I would expect them to trail down from here, Patrick, from that guidance.

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Operator [6]

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And we'll take our next question from Quinn Bolton with Needham.

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Quinn Bolton, Needham & Company, LLC, Research Division - Senior Analyst [7]

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Congratulations on the nice results in the first quarter as a combined company. I wanted to start just kind of with WFE and sort of how you see the profile of spending across the advanced nodes and the specialty side of the business first half versus second half. Certainly, sounds like advanced foundry logic, maybe front-half loaded. You talked about NAND being stronger in the second half, DRAM being a little bit more steady in Q2, Q3. So when you put all that together, how do you see the pattern of revenue on a sequential basis or a half-over-half basis in 2020?

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Michael P. Plisinski, Onto Innovation Inc. - CEO & Director [8]

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You're speaking specifically about us, correct? So we're seeing...

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Quinn Bolton, Needham & Company, LLC, Research Division - Senior Analyst [9]

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Correct.

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Michael P. Plisinski, Onto Innovation Inc. - CEO & Director [10]

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Yes. And that will depend, obviously, on customer mix, application strength, market share, et cetera. So from our perspective, we're seeing logic -- so we'll start with logic foundry to give you a kind of a complete picture. Logic foundry has maintained relatively high levels, and we see that continuing into 2020. And then the DRAM we see picking up rather nicely into 2020. And then 3D NAND is really the -- I'd say the wild card a little bit. That's -- certainly, we see a pickup in the second half over the first half and the magnitude of which we'll determine is it going to grow over -- year-over-year or is it going to stay a little bit depressed?

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Quinn Bolton, Needham & Company, LLC, Research Division - Senior Analyst [11]

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Okay, great. And then second question, you mentioned that without the coronavirus you would have probably guided closer to the middle or upper middle part of the first quarter revenue range. Wondering on that coronavirus effect whether you're seeing delays in the tool deliveries to one of the larger NAND players in China. Is that a specific risk? Or are you just sort of generally trying to be conservative with the March quarter guidance, given everything that's going on with the outbreak?

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Michael P. Plisinski, Onto Innovation Inc. - CEO & Director [12]

--------------------------------------------------------------------------------

No, that's a specific risk. That's -- I mean, they're, obviously, right in the center of ground zero. So clearly, we've had a lot of detailed discussions there. And we're working with the customers to, obviously, balance the demands that they still have with the realities of the situation on the ground.

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Quinn Bolton, Needham & Company, LLC, Research Division - Senior Analyst [13]

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Great. And then last one for me, just as we come through the year. So it sounds like gross margin in the first quarter at 50% to 52%, it sounds like there's some mix or some sort of quarter-specific factors. How do you see that gross margin trending beyond the first quarter?

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Steven R. Roth, Onto Innovation Inc. - Senior VP of Finance & Administration, CFO and Secretary [14]

--------------------------------------------------------------------------------

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Kanazawa University Research: Combined Drug Treatment for Lung Cancer and Secondary Tumors – Yahoo Finance

Posted: February 11, 2020 at 8:51 am

KANAZAWA, Japan, Feb. 10, 2020 /PRNewswire/ -- Researchers at Kanazawa University report in the Journal of Thoracic Oncology a promising novel approach for a combined treatment of the most common type of lung cancer and associated secondary cancers in the central nervous system. The approach lies in combining two cancer drugs, with one compensating for a resistance side effect of the other.

In 20 40% of patients with cancer, metastasis (the development of secondary tumors) in the central nervous system (CNS) occurs. CNS metastatis impacts negatively on a patient's quality of life, and is associated with a poor health prognosis. In a form of cancer known as ALK-rearranged non-small-cell lung cancer (NSCLC), CNS metastatis is known to persist when drugs targeting primary tumors are used.Now, Seiji Yano from Kanazawa University and colleagues have investigated the origins for the resistence to such drugs, and tested a new therapeutic strategy on a mouse model.

The researchers looked at the drug alectinib.Although used in standard treatments for advanced ALK-rearranged NSCLC, approximately 20 30% of patients treated with alectinib develop CNS metastatis, which is attributed to acquired resistance to the drug.

By treating mice first injected with tumor cells with alectinib daily for 16 weeks, the scientists obtained a mouse model displaying alectinib resistance.By biochemical analyses of the mouse brains, Yano and colleagues were able to link the resistance to the activation of a protein known as epidermal growth factor receptor (EGFR).This activation is, in turn, a result of an increase in production of amphiregulin (AREG), a protein that binds to EGFR and in doing so 'activates' it.

Based on this insight, the researchers tested the effect of administering drugs used for inhibiting the action of EGFR in combination with alectinib treatment.The experiments showed that a combination treatment of alctinib with either erlotinib or osimertinib two existing EGFR-inibiting drugs prevented the progression of CNS metastasis, controlling the condition for over 30 days.

The scientists conclude that the combined use of alectinib and EGFR-inhibitors could overcome alectinib resistance in the mouse model of leptomeningeal carcinomatosis (LMC), a particular type of CNS metastasis.Quoting Yano and colleagues: "Our findings may provide rationale for clinical trials to investigate the effects of novel therapies dual-targeting ALK and EGFR in ALK-rearranged NSCLC with alectinib-resistant LMC."

Background

Non-small-cell lung cancer

Non-small-cell lung carcinoma (NSCLC) and small-cell lung carcinoma (SCLC) are the two types of lung cancer. 85% of all lung cancers are of the NSCLC type. NSCLCs are less sensitive to chemotherapy than SCLCs, making drug treatment of the highest importance.

Alectinib is a drug used for treating NSCLC, with good efficiency. However, 20-30% of patients taking the drug develop secondary cancer in the central nervous system (CNS), which is associated with an acquired resistance to alectinib.Seiji Yano from Kanazawa University and colleagues have now made progress towards a novel therapy against this resistance: a combination of alectinib with other drugs.

Epidermal growth factor receptor inhibitors

The drugs that Yano and colleagues tested in combination with alectinib on a mouse model were of a type known as epidermal growth factor receptor (EGFR) inhibitors, including osimertinib and erlotinib. Both are being used as medication for treating NSCLC.The former was approved in 2017 as cancer treatment by the U.S. Food and Drug Administration and the European Commission.Yano and colleagues obtained results showing that EGFR inhibitors counteract resistance to alectinib and have therefore potential in novel therapies for NSCLC and secondary cancers in the CNS.

Reference

Sachiko Arai, Shinji Takeuchi, Koji Fukuda, Hirokazu Taniguchi, Akihiro Nishiyama, Azusa Tanimoto, Miyako Satouchi, Kaname Yamashita, Koshiro Ohtsubo, Shigeki Nanjo, Toru Kumagai, Ryohei Katayama, Makoto Nishio, Mei-mei Zheng, Yi-Long Wu, Hiroshi Nishihara, Takushi Yamamoto, Mitsutoshi Nakada, and Seiji Yano. Osimertinib overcomes alectinib resistance caused by amphiregulin in a leptomeningeal carcinomatosis model of ALK-rearranged lung cancer, Journal of Thoracic Oncology, published online on January 21, 2020.

Story continues

DOI: 10.1016/j.jtho.2020.01.001

URL: https://www.sciencedirect.com/science/article/pii/S1556086420300228

About Nano Life Science Institute (WPI-NanoLSI)

https://nanolsi.kanazawa-u.ac.jp/en/

Nano Life Science Institute (NanoLSI), Kanazawa University is a research center established in 2017 as part of the World Premier International Research Center Initiative of the Ministry of Education, Culture, Sports, Science and Technology. The objective of this initiative is to form world-tier research centers. NanoLSI combines the foremost knowledge of bio-scanning probe microscopy to establish 'nano-endoscopic techniques' to directly image, analyze, and manipulate biomolecules for insights into mechanisms governing life phenomena such as diseases.

About Kanazawa University

http://www.kanazawa-u.ac.jp/e/

As the leading comprehensive university on the Sea of Japan coast, Kanazawa University has contributed greatly to higher education and academic research in Japan since it was founded in 1949. The University has three colleges and 17 schools offering courses in subjects that include medicine, computer engineering, and humanities.

The University is located on the coast of the Sea of Japan in Kanazawa a city rich in history and culture. The city of Kanazawa has a highly respected intellectual profile since the time of the fiefdom (1598-1867). Kanazawa University is divided into two main campuses: Kakuma and Takaramachi for its approximately 10,200 students including 600 from overseas.

Further information

Hiroe Yoneda Vice Director of Public Affairs WPI Nano Life Science Institute (WPI-NanoLSI) Kanazawa University Kakuma-machi, Kanazawa 920-1192, Japan Email: nanolsi-office@adm.kanazawa-u.ac.jpTel: +81-(76)-234-4550

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Immix Doses First Patient in USA in its Phase 1b/2a Trial in Patients with Advanced Solid Tumors – BioSpace

Posted: February 11, 2020 at 8:51 am

LOS ANGELES, Feb. 4, 2020 /PRNewswire/ --Immix Biopharma, Incannounced today that the first patient in the USA was dosed successfully in its flagship phase 1b/2a clinical trial testing Imx-110 in patients with refractory solid tumors.To-date, the trial has accrued patients across tumor types. The expansion of the study to the US builds upon Immix' results from Australia, wherein six cohorts were dosed with no treatment-related serious adverse events observed and dose escalation is continuing.

The first US patient was dosed at Sarcoma Oncology Research Center in Santa Monica, California - led by Dr. Sant Chawla, a world renowned expert in sarcoma treatment and clinical research. Based on his extensive experience with anthracycline-based experimental therapies for sarcoma, including CytRx' Aldoxorubicin, Dr. Chawla shared his optimism for Imx-110 as an investigational candidate both from the standpoint of superior efficacy and a lower risk of cardiac complications associated with older formulations of doxorubicin.Dr. Chawla's colleague, Dr. Erlinda Gordon is the Principal Investigator leading the study at Sarcoma Oncology Research Center in Santa Monica.

Dr. Gordon is a Diplomate of the American Board of Pediatric Hematology/Oncology and previously a Tenured Associate Professor for 24 years at USC and currently a Professor Emeritus at the USC Keck School of Medicine, Los Angeles, California. She is a co-inventor of more than 150 patents in biomedical research, and patented the first targeted gene delivery system for cancer in the USA, Europe and the Philippines. She has authored more than 100 original peer-reviewed articles and served as Editor-in-Chief of the International Journal of Pediatric Hematology-Oncology, Director of the Red Cell Defects Program and the NIH-funded Comprehensive Hemophilia Center at Children's Hospital of Los Angeles and the NIH-funded Children's Oncology Group. Dr. Gordon was co-founder of two biotechnology companies and is a pioneer in the development of targeted gene therapy products.

For more information on the Imx-110 study, please visit clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT03382340.

Immix also has an open call for investigator initiated studies where the company will provide Imx-110 at no charge.

About Imx-110Imx-110 is a first-in-class combination therapy designed to inhibit cancer resistance and evolvability while inducing apoptosis. Imx-110 contains NF-kB/Stat3/pan-kinase inhibitor curcumin combined with a small amount of doxorubicin encased in a nano-sized delivery system for optimal tumor penetration. The nanoparticle is tunable in that it can be bound to various targeting moieties, allowing it to deliver even more payload to tumors or other cell populations of interest, if needed. Imx-110 showed preclinical efficacy in glioblastoma, multiple myeloma, triple-negative breast, colorectal, ovarian, and pancreatic tumor models with the mechanism of action being a 5x increase in cancer cell apoptosis compared to doxorubicin alone, and a wholesale shift in the tumor microenvironment post administration.

About the CompanyImmix Biopharma, Inc. is a privately-held, biopharmaceutical firm focused on developing safe and effective therapies for cancer patients. The company was founded by Vladimir Torchilin, Ph.D., D.Sc., Director of the Center for Pharmaceutical Biotechnology and Nanomedicine at Northeastern University; physician-scientist and clinical researcher Ilya Rachman, MD, PhD, MBA; and Sean D. Senn, JD, MSc., MBA, a senior biotechnology patent attorney. Immix's founding investor is a family office focused on harnessing scientific advances in order to engineer transformative and effective cancer treatments. For more information visit http://www.immixbio.com.

Media ContactRyan Witt+1 (888) 958-1084info@immixbio.com

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Stem Cell therapy Middletown Delaware 19709

Posted: February 10, 2020 at 2:46 pm

Stem Cell Therapy Middletown DE 19709

Stem cell treatment has become a popular dispute in the worldwide medical scene. This extremely controversial therapy has gotten blended viewpoints from various stakeholders in the health care market and has actually also brought in the interest of politicians, spiritual leaders and the general population at large. Stem cell therapy is thought about a revolutionary treatment for individuals experiencing a wide range of degenerative conditions. Some common questions regarding this therapy are addressed below.

Are you a stem cell therapy specialist close to Middletown DE 19709?Contact us for more information.

Stem cells can be referred to as blank state or non-specialized cells that have the ability to become specialized cells in the body such as bone, muscle, nerve or organ cells. This indicates that these special cells can be used to regrow or establish a wide range of broken cells and tissues in the body. Stem cell therapy is therefore a treatment that aims at accomplishing tissue regrowth and can be utilized to treat health conditions and illnesses such as osteoarthritis, degenerative disc illness, spine injury, muscular degeneration, motor neuron disease, ALS, Parkinsons, heart disease and much more.

Being a treatment that is still under research study, stem cell treatment has actually not been completely accepted as a feasible treatment alternative for the above discussed health conditions and health problems. A lot of studio is currently being carried out by scientists and medical experts in various parts of the world to make this treatment viable and efficient. There are however numerous restrictions enforced by federal governments on research involving embryonic stem cells.

Currently, there have not been numerous case studies performed for this kind of treatment. Nevertheless, with the few case studies that have been conducted, one of the major issues that has actually been raised is the boost in a patients threat of developing cancer. Cancer is brought on by the quick reproduction of cells that have a tendency not to pass away so easily. Stem cells have actually been associated with comparable growth factors that may result in formation of growths and other malignant cells in clients.

Contact us for more information about stem cell doctor in Middletown DE 19709

Stem cells can be extracted from a young embryo after conception. These stem cells are frequently referred to as embryonic stem cells. After the stem cells are extracted from the embryo, the embryo is ended. This is generally among the significant causes of debate in the field of stem cell research study. Many people suggest that termination of an embryo is unethical and inappropriate.

New research has nevertheless shown pledge as scientists aim at establishing stem cells that do not form into growths in later treatment phases. These stem cells can therefore successfully change into other kinds of specialized cells. This treatment is therefore worth researching into as lots of clients can benefit from this innovative treatment.

Stem cells can still be gotten through other means as they can be discovered in the blood, bone marrow and umbilical cords of adult human beings. Typical body cells can likewise be reverse-engineered to become stem cells that have actually limited capabilities.

stem cell doctor in Middletown DE 19709

Stem cell therapy has actually become a popular dispute in the global medical scene. This highly controversial treatment has actually gotten combined opinions from different stakeholders in the health care market and has likewise drawn in the interest of political leaders, spiritual leaders and the basic population at large. Stem cell treatment is thought about a revolutionary treatment for people struggling with a wide variety of degenerative conditions. Some common concerns concerning this treatment are addressed listed below.

4.96

Main address:Middletown, Delaware, 19709

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First CAR-T cell cancer therapy patient in Delaware – Dover Post

Posted: February 10, 2020 at 2:46 pm

'This is the beginning of my new life'

I thought my cancer diagnosis was a death sentence, said Lynnette Williams-Briggs, 60, of Seaford, Delaware, who was diagnosed with advanced B-cell lymphoma in 2018.

Briggs cancer is now in complete remission thanks to successful chimeric antigen receptor CAR-T cell therapy she received in August atChristianaCaresHelen F. Graham Cancer Center & Research InstitutesBone Marrow and Stem Cell Transplant Program.

I can breathe again. This is the beginning of my new life, Williams-Briggs said following the treatment that restored her hope for a second chance at life.

She was the first patient to receive CAR-T cell therapy in Delaware. A second patient was treated in December 2019, and doctors are preparing several more patients for CAR-T cell transplants in coming weeks.

The U.S. Food and Drug Administration has approved CAR-T cell therapy to treat patients like Williams-Briggs with highly resistant, B-cell blood cancers, for whom other available options have failed.

CAR-T cell therapy is only available at select cancer centers with specialized expertise in cellular therapies that are recognized for quality by the Foundation for the Accreditation of Cellular Therapy.

The Graham Cancer Centers Bone Marrow and Stem Cell Transplant Program is the only one in Delaware that is certified to treat adult patients with advanced B-cell lymphomas and children and young adults (to age 25) with acute lymphoblastic leukemia, using an FDA-approved drug.

CAR-T cell therapy is highly personalized medicine that attempts to use the bodys natural defenses to fight against cancer. The transplant team extracts millions of T cells, from the patients bloodstream, using a specialized blood filtration process called leukapheresis. The collected T cells are flash-frozen and sent to a lab for reprogramming, and then later infused back into the patient using a process similar to a blood transfusion.

The therapy is considered a living drug with potential benefits that could last for years.

When we first met Ms. Williams-Briggs, her cancer had progressed rapidly despite a third round of chemotherapy, so we knew we had to move quickly, said Graham Cancer Center Hematologist Peter Abdelmessieh, D.O. He worked closely with the bone marrow/stem cell transplant team and Graham Cancer Center leadership over the course of just eight months to develop the CAR-T cell therapy program.

It was truly a team effort to bring CAR-T cell therapy to our community so quickly, Dr. Abdelmessieh said.

CAR-T cell therapy has been extremely effective for many patients like Williams-Briggs, whose PET scan at 90 days confirmed her remission.

The supercharged T cells Williams-Briggs received were genetically modified in the lab to sprout new surface tools that improve their ability to recognize, latch onto and destroy other cells (including cancer cells) that express a specific antigen called CD19. These reprogrammed cells continue to multiply in the body after treatment, remaining on guard to seek and destroy any new cancers that might develop.

With continued success in increasing numbers of patients, it is conceivable that in the not too distant future, CAR-T cell therapy could become the new standard of care, replacing chemotherapy and stem cell transplants for many cancers, Dr. Abdelmessieh said.

The extended recovery period for CAR-T cell therapy is generally two to three months. After the infusion, patients may spend up to three weeks in the hospital to monitor treatment response and any side effects.

During the first 30 days after leaving the hospital, patients are required to remain close to the treatment center for regular follow-up care.

The ability to offer potentially life-saving CAR-T cell therapy is one more reason our patients need not travel further than the Graham Cancer Center for state-of-the-science cancer treatment, said Nicholas J. Petrelli, M.D., Bank of America medical director of the Helen F. Graham Cancer Center & Research Institute.

The Bone Marrow and Stem Cell Transplant Program is an outstanding example of how well our clinical teams work together to drive innovation in patient care.

Although patients normally do not experience the side effects associated with chemotherapy, such as nausea, vomiting or hair loss, CAR-T cell therapy is not without risks. A common side effect, which Williams-Briggs also experienced, is cytokine release syndrome. This is an inflammatory condition that causes flu-like symptoms that may be mild or severe.

The transplant team responded quickly to manage her symptoms while she received expert care on the Bone Marrow Transplant and Oncology unit at Christiana Hospital.

From the moment I first met with my transplant team, I felt like I was part of one big loving family that extended beyond my own loved ones, Williams-Briggs said.

Dr. Abdelmessieh and my ChristianaCare family gave me hope to keep fighting when I really didnt think I would make it. I would have driven anywhere to get life-saving treatment, but I am thankful that I did not have to. I found my miracle closer to home.

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First CAR-T cell cancer therapy patient in Delaware - Dover Post

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Why your heart needs extra love and care during menopause – WLTX.com

Posted: February 10, 2020 at 2:45 pm

COLUMBIA, S.C. Theres no mystery. The risk of developing heart disease increases for everyone as they age. This is no different for women and yet many people still believe it is a mans disease.

The American Heart Association (AHA) says it is the leading killer in women. In fact, one in three adult women, thats over 30 percent of the adult female population, have some form of cardiovascular disease.

Midlife is not just a period where women have hot flashes and experience other menopausal symptoms. For women, the risk of developing cardiovascular disease goes up about 10 years after menopause.

Remember, menopause is not a disease, it is a natural part of aging and does not cause cardiovascular disease, however hormone fluctuations in midlife may play a part.

What are midlife women at risk for heart disease?

Estrogen, the primary female sex hormone, has a positive effect on your blood pressure and cholesterol, and both are beneficial when it comes to heart disease.

Heart doctors believe healthy levels of the natural hormone estrogen keep blood vessels flexible. That means the blood vessels can relax and expand to accommodate healthy blood flow. When estrogen decreases during menopause, blood vessels tend to get stiff. Women no longer have their natural protection against heart disease and stroke. Doctors believe this is the reason why women tend to develop heart disease ten years later than men.

According to a research team led by scientists at the University of Pittsburgh Graduate School of Public Healththere is also evidence suggesting the changes that affect the heart may occur earlier in black women than white women.

How can women decrease their heart disease risk?

Less estrogen is not the only reason women are at risk. Estrogen does help protect the body but there can be other changes that happen during menopause.

Blood pressure and cholesterol tend to increase as well. Combine those changes with other lifetime bad habits like smoking cigarettes and vaping, a diet high in fat and cholesterol, or a family history of heart disease and there can be trouble ahead.

Despite the benefits of natural estrogen, The American Heart Association does not recommend postmenopausal hormone replacement therapy (HRT). Heart doctors say there is not enough proof HRT helps reduce the risk of heart disease. Instead they say the opposite has been shown. HRT could increase your risk of blood clots and cancer.

The American Heart Association does say it is reasonable to appreciate the benefits of estrogen and recommend helping your heart be healthy. The ticket to that includes behavior that can contribute to overall good health and delay the onset of menopause. Quitting smoking, getting regular exercise and eating a nutritious diet are all steps that are proven to significantly reduce the risk of heart attack.

The American Heart Association does recommend establishing a plan of action with your health care provider.

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Why your heart needs extra love and care during menopause - WLTX.com

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Dr. Fulton – Providing a High-Quality of Care for His Patients for Over 20 Years -Simpatra.Health – PR.com

Posted: February 10, 2020 at 2:45 pm

Dr. Fulton is dedicated to providing all of his patients with a superb level of care.

Dr. Fulton is dedicated to providing all of his patients with a superb level of care. He emphasizes using the most effective health techniques to ensure that his patients are in the best position to resolve their health issues. Dr. Fulton is also very accomplished in several medical fields. He is a Diplomate of the American Academy of Anti-Aging Medicine and the American Board of Phlebology and board-certified in Emergency Medicine.

Speaking upon his work, Dr. Fulton stated, I have a passion for exploring new ways to help people feel better. Thats what originally drew me to becoming a doctor and continues to drive me. He also stated that My mission is to deliver the best care using the most advanced technology and techniques to give every client the best possible outcome.

Since adding Simpatra's BHRT and technology services to his practice, Dr. Fulton has been able to provide his patients with more options to relieve their health issues. The addition of Simpatras Technology suite to his practice allows Dr. Fulton to go the extra mile to ensure that his patients are receiving the highest quality of care. His practice SKINovative located in Gilbert, Arizona provides hormone replacement therapy for both men and women.

Doctor Contact:William Fulton, MD2557 South Val Vista Drive, Gilbert, AZ 85295https://simpatra.health/listing/william-fulton-md-hormone-replacement-therapy/

About Simpatra.Health:

Providers investing in Patients with Simpatra.Health

Simpatra.Health, working hand in hand with your provider to enhance every aspect of your patient journey. The goal is to use unique technologies to elevate patient outcomes and to improve patient outreach. Ranging from complex algorithms used during procedures, simple emails informing you of your appointment, or aftercare articles to make you feel more comfortable about the treatment you just received. Whatever your visit might entail, we are firmly committed with your provider in ensuring that every patient has a consistent medical experience and receives the highest quality of care.

Contact:Simpatra.Health15210 N. Scottsdale Rd. - Suite 210pr@simpatra.com480-682-4850https://www.simpatra.health

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Dr. Fulton - Providing a High-Quality of Care for His Patients for Over 20 Years -Simpatra.Health - PR.com

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