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Re: biopharm post# 332600

Monday, 12/30/2019 8:49:03 AM

Monday, December 30, 2019 8:49:03 AM

Post# of 346029

AVID new website yet no mention that royalties milestones etc from the IP assets ? Did they mention all the ties to Federal Investigations for which the IP assets was central part as PS Targeting etc is at the heart of most all cancer research ...and those puzzle pieces are all going to resurface



Avid Bioservices CDMO, a fast ...very soon to be announced $100M+ revenue due to non disclosed Big Pharma contract news that will make $8 look like breadcrumbs ....had MORE to offer due to the IP assets than most anyone is aware of

From 2012 the NSCLC sabotage at CSM in Fargo ND with Jeanette Bleecker with CEO Gerald Finken to that prior 12 week HepC trial that results "after the 12 weeks" were HIDDEN to much more ....

Once all this sabotage comes forward and MATCHED with market trading fraud right up to John Springs Stafford forcing the breakup of Peregrine Pharmaceuticals

Is it is a coincidence that CEO Steve King seen how the IP assets were sabotaged on multiple levels and now, Steve King plays a major role incorporating blockchain Trustpoint etc etc where video must be used to secure the process of tracking the entire operation and knowing all involved

Avid Bioservices could likely have just been part of Federal Investigations placing the IP assets to Oncologie Inc ...but we shall see soon

The bottom line is what happened to Joel McComb ...what happened to Roger Lias ...what happened to Steve King ....what happened to the late Dr Phil Thorpe that just passes away during the midst of all the controversy? No way

Why would Ampersand Capital not want to fight for the IP assets ...because PS Targeting is required for ANY chance at all in Immunotherapy because Phosphatidylserine exist on every damn stressed cell that leads to many a disease to cancer

Alex Azar knows PS Targeting and he sits close to Eli Lilly where CEO Laura Benjamin from Oncologie Inc was picked ....so why still, all the silence?

Moffitt ties Dmitry Gabrilovich to Soner Altiok CSO of Nilogen to Jenny Kreahlinh to David Noyes to Scott Antonia to....the list goes on and on and all ties to PS Targeting

$8 pps ? Breadcrumbs breadcrumbs breadcrumbs ....no one has heard nothing and below gives a glimpse into the massive fraud of many and all looking for those cherished Biomarkers that were only available AFTER PS Targeting

...just ask the Bavituximab patients in phase III Sunrise that DHHS Alex Azar must know well ...



____


http://ir.avidbio.com/news-releases/news-release-details/peregrine-pharmaceuticals-announces-three-abstracts-accepted-0


April 14, 2015 at 8:00 AM EDT
TUSTIN, Calif., April 14, 2015 (GLOBE NEWSWIRE) -- Peregrine Pharmaceuticals (Nasdaq:PPHM) (Nasdaq:PPHMP) today announced that two preclinical abstracts and one clinical translation abstract are scheduled for poster presentations at the 106th Annual Meeting of the American Association for Cancer Research (AACR), to be held April 18-22, 2015 in Philadelphia, Pennsylvania. Data to be presented include studies investigating the therapeutic potential of Peregrine's phosphatidylserine (PS)-targeting antibodies when administered in combination treatment regimens with approved and developmental cancer immunotherapies and translation data in patients with lung cancer. Peregrine's lead PS-targeting antibody, bavituximab, is in Phase III development for the treatment of second-line non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other
treatment combinations and additional oncology indications.

Abstract details:

Abstract Number: 274

Presentation Title: Bavituximab modulates tumor microenvironment and activates CD8+ tumor infiltrating lymphocytes in a patient-derived 3D ex vivo system of lung cancer
Presentation Time: Sunday, April 19, 2015, 1:00 PM - 5:00 PM Eastern Daylight Time
Location: Section 13
Poster Board Number: 2

Author Block:

Soner Altiok1,
Melanie Mediavilla-Valera2,
Jenny Kreahling2,
David Noyes2,
Tiffany N. Razabdouski2,
Nikoletta L. Kallinteris3,
Joseph Shan3,
Scott Antonia2.

1Nilogen Oncosystems, Tampa, FL;
2Moffitt Cancer Center, Tampa, FL; 3Peregrine Pharmaceuticals, Inc, Tustin, CA


________


Michael Lauer leads the National Institutes of Health’s extramural research program. NATIONAL INSTITUTES OF HEALTH
NIH probe of foreign ties has led to undisclosed firings—and refunds from institutions

By Jeffrey MervisJun. 26, 2019 , 5:10 PM

An aggressive effort by the National Institutes of Health (NIH) to enforce rules requiring its grantees to report foreign ties is still gathering steam. But it has already had a major impact on the U.S. biomedical research community. A senior NIH official tells ScienceInsider that universities have fired more scientists—and refunded more grant money—as a result of the effort than has been publicly known.

Since August 2018, Bethesda, Maryland–based NIH has sent roughly 180 letters to more than 60 U.S. institutions about individual scientists it believes have broken NIH rules requiring full disclosure of all sources of research funding. To date, the investigation has led to the well-publicized dismissals of five researchers, all Asian Americans, at MD Anderson Cancer Center in Houston, Texas, and Emory University in Atlanta.

But other major U.S. research universities have also fired faculty in cases that have remained confidential, according to Michael Lauer, head of NIH’s extramural research program. And some have repaid NIH “hundreds of thousands of dollars” in grants as a result of rule violations, he says. “I can understand why [the universities] aren’t talking about it,” Lauer says. “No organization wants to discuss personnel actions in a public forum.”

Lauer suspects some of the cases NIH has uncovered may result in the U.S. government banning certain scientists from receiving federal funds, a process called debarment. NIH has referred at least 18 cases to its parent agency, the Department of Health and Human Services (HHS), for further investigation. “We are still reasonably early on in the process,” Lauer says, “and for a number of cases we don’t know where we’ll end up.”

He also thinks other federal agencies that fund academic research may soon copy NIH’s aggressive approach. “I wouldn’t be surprised if other agencies follow our lead and start doing similar things,” he says.

Connecting the dots
This week, Lauer sat down with ScienceInsider at his office on the NIH campus to talk about how NIH became concerned about foreign influence and what it is doing to defend the process used to spend more than $20 billion annually on outside research projects.

He says the agency’s concerns were initially sparked by reports that scientists were violating the confidentiality of NIH’s peer-review process, in which thousands of volunteer reviewers rate tens of thousands of grant proposals every year. In mid-2016, he says, NIH received a report from the HHS Office of Inspector General that a Federal Bureau of Investigation (FBI) probe had uncovered an MD Anderson researcher sharing proposals he had been asked to review with several other people.

That’s a clear violation of NIH rules intended to ensure the confidentiality of every grant proposal, Lauer says. But few such breaches ever trigger an FBI investigation. “There are people who will download an application and share it with a postdoc or a buddy down the hall and ask a question,” he says. “People are not supposed to do that, but maybe that’s not a hanging offense.”

But this was different. “Grant applications were being sent to multiple people at other institutions” in other nations, Lauer says about the case. “It was quite scary. Initially, we thought it was [the work of] a few rogue scientists, very unfortunate, but probably nothing more than that.”

It turned out, however, that such breaches were just one aspect of what Lauer regards as a much larger assault on the integrity of NIH-funded research. Over the next 2 years, he says, NIH grant managers would find numerous examples of NIH-funded scientists at U.S. universities who were publishing papers that listed a foreign institution—often in China—as their primary affiliation and cited foreign funding sources in the fine print. But the scientists hadn’t reported those affiliations and grants to their institutions or to NIH, as required.

The discovery was serendipitous, Lauer explains, and grew out of the agency’s routine monitoring of progress reports filed by grantees. “We have about 1300 people here, fully trained scientists, who oversee our [extramural] scientific programs,” Lauer says. “They are assigned a set of grants. And each year they look at progress reports to make sure things are OK. And one question we ask is, ‘What have you published?’”

The program managers were looking for exciting new scientific results, Lauer says. But they also found troubling discrepancies between the affiliations and funding that a grantee had reported to NIH and what they wrote in their papers.

“It’s fascinating,” Lauer says. The reporting discrepancy “had been going on for a number of years, apparently, but it took a long time before we noticed it. That’s when we decided there was something going on.”

Initial resistance
NIH’s first step was to notify all grantee institutions that it was launching an investigation. That August 2018 letter, from NIH Director Francis Collins, was followed by inquiries from Lauer about specific researchers.

Many universities pushed back, he says, telling him the agency’s suspicions were misplaced. “What we heard was that there’s nothing going on,” Lauer says. A typical response from a senior university official went like this, according to Lauer: “The faculty member says he’s never been to China, he doesn’t receive any support from the government, and he has no affiliation with any Chinese university. They told us we’re just blowing smoke.”

But Lauer says most university officials changed their tune after NIH showed them evidence that included grant numbers from foreign funders and employment contracts with foreign institutions. “So then what happens is that the university digs a bit deeper and finds that, yes, there is a lot going on,” he says.

University officials insisted it was all news to them, Lauer adds. “Some vice presidents for research and deans have told us that they were surprised, shocked, and horrified when they learned about [these arrangements],” Lauer says. “They said they had no idea some of their employees were spending 4, 6, 8 months away from their institution.”

“We found one person with a $5 million startup package from a Chinese university that wasn’t disclosed to anybody, not to his American university, and not to us,” Lauer asserts. “This is not subtle. It’s not an, ‘Oops, I forgot to list it on a form.’ We’re talking about really, really egregious stuff.”

Those absent without leave scientists were not just stiffing their home institutions, Lauer points out. They were also fleecing NIH and, by extension, U.S. taxpayers. The rip-off became clear, he says, whenever their time commitment to funded research projects exceeded 12 months.

“The American institution thinks it has a 12-month employee who’s working for them,” Lauer explains. “And we give them funding for research that will take 8 months of their time. But they already have 9 months of outside time commitments. So it adds up to 17 months. And that’s not possible.”

Uncovering that faulty math has had financial repercussions, Lauer notes. “Several universities have actually refunded us money for salaries paid during times when, as best they could tell, the faculty member wasn’t at the institution and couldn’t have been working on the NIH grant,” he says. Some of the refunds, Lauer says, are for “hundreds of thousands of dollars.” That is money NIH could have spent on other researchers who are playing by the rules, he adds.

What NIH has learned
Lauer says he hasn’t done a thorough analysis of the 180 cases in which NIH believes scientists have withheld information about their foreign ties. But a few things stand out.

“Most of the scientists are well-funded, meaning they have multiple NIH grants,” he says. “Most are ethnically Chinese, although some of our more serious cases are not ethnically Chinese.” Lauer says the scientists work at institutions all over the United States: “We have examples from the northeast, the southeast, Texas, obviously, the southwest, and elsewhere.”

No particular field seems to have attracted more than its share of bad actors, according to Lauer. “All the people at MD Anderson work on cancer,” he says. “But we’ve also seen [cases involving scientists in] mental health, cardiology, neurology, basic cell biology, and so on.”

Lauer declined to speculate on why these scientists chose not to disclose their foreign ties. But he said NIH has found several cases where the omissions were selective. “We’ve seen scientists who reported other foreign grants and affiliations, but not the Chinese grants and affiliations,” he says.

Among U.S. lawmakers and the media, some of the concern about foreign influence in U.S. research has focused on the role of the Thousand Talents Program, part of China’s decadelong campaign to build ties with scientists outside of China. The program provides distinguished U.S.-based scientists with generous packages to set up and operate labs at a Chinese research institution or university.

Lauer says some of those Thousand Talents awards come with very specific instructions to the researcher, including what they are expected to study and the number of papers they must publish in top-tier journals. But the provisions about what activities should and should not be disclosed are not uniform.

“We have seen contracts that say all the intellectual property that this scientist generates must stay in China and cannot be reported to their American university,” he says. “You can imagine that U.S. universities are not happy when they see that. U.S. universities expect to reap the benefits of research done at their institution, and they are losing that [opportunity].”

Other contracts lean in the opposite direction, Lauer says. “They say every paper a scientist publishes must cite the Chinese university,” he says. “Some have gone so far as to say their university must be cited first.” Lauer says those scientists are also required to cite the Chinese entity funding their research funding, “for the same reason we require people to cite their NIH grants: We want to make sure we get credit for the research we have funded.”

Guilt by association?
Many members of the Asian American community believe that U.S. government agencies have been targeting Asian-born scientists simply for their participation in Thousand Talents and similar Chinese foreign recruitment programs. Lauer says NIH has no problem with U.S. scientists who participate in Thousand Talents so long as they disclose that relationship fully in their grant applications and research progress reports.

“Thousand Talents is not a threat [to the United States],” he says. “It’s not the specific conduct we are focusing on, it’s the failure to disclose it.”

To make his point, Lauer offers an alternative scenario of what he considers to be acceptable behavior. “A U.S. scientist goes to their boss and says, ‘I would like to work in China for 3 months a year, and I managed to secure a part-time employment arrangement. I’ll tell you what I’m working on, and how intellectual property will be handled, and how much they will pay me.’ And then they report all of that in their biosketch.”

That should be the norm, he says. But it’s not. “If that is what was happening,” Lauer says, “you and I would not be sitting here today.”

https://www.sciencemag.org/news/2019/06/nih-probe-foreign-ties-has-led-undisclosed-firings-and-refunds-institutions

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