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Biden Picks Biotech Government to Lead New Biomedical Analysis Company

WASHINGTON — President Biden, who outlined a vision for “bold approaches” to fighting cancer and other diseases, announced Monday that he was recruiting Dr. Renee Wegrzyn, a Boston-based biotech executive with government experience, was selected to serve as director of a new federal agency in pursuit of risky, far-reaching ideas that drive biomedical innovation.

Mr. Biden made the announcement at the John F. Kennedy Presidential Library and Museum in Boston on the 60th anniversary of the former president’s “moonshot” speech, which ushered in an era of space travel. He took the opportunity to reiterate his call to “End Cancer As We Know It” – the slogan for his own “Cancer Moonshot” initiative.

“Imagine the possibilities — vaccines that could prevent cancer, as HPV does,” the president said, referring to the human papillomavirus, which can cause cervical cancer. “Imagine molecular zip codes that could precisely deliver drugs and gene therapies to the right tissues. Imagine simple blood tests during an annual checkup that could detect cancer early.”

Mr. Biden, whose son Beau died of brain cancer in 2015, has a deep personal commitment to advancing cancer research, and the Kennedy Library was a reminder of that. Another Kennedy, former Senator Edward M. Kennedy, whom Mr. Biden described as “one of my dearest friends,” died in 2009 from the same type of cancer — glioblastoma — as Beau Biden.

Mr. Biden helped create the Cancer Moonshot when he was Vice President. His goal, which he described as “quite feasible,” is to reduce cancer death rates by at least 50 percent over the next 25 years while “converting death sentences into chronic diseases.”

With the midterm elections approaching, here stands President Biden.

He proposed the new biomedical research agency earlier this year as part of efforts to revitalize the initiative.

Modeled on the Defense Advanced Research Projects Agency, the new agency is known as the Advanced Research Projects Agency for Health. (In Washington argot, where each agency has an acronym, the Defense Research Agency is called DARPA and the Health Agency is ARPA-H.)

The agency aims to be nimble and flexible — a kind of “shark tank” for biomedical research, populated by “brilliant visionary talents” who will invest in untested approaches, knowing that “a significant proportion of projects are likely to fail,” said Dr . Francis Collins, the former director of the National Institutes of Health who now serves as Mr Biden’s acting scientific adviser and helped find the new director.

dr Wegrzyn is vice president of business development at Ginkgo Bioworks and leads innovation at Concentric by Ginkgo, the company’s initiative to promote coronavirus testing and track the spread of the virus. She also worked at DARPA and its sister agency, the Intelligence Advanced Research Projects Activity.

“Some of the problems we face every day — particularly when it comes to health and disease — are so vast that they can seem insurmountable,” said Dr. Wegrzyn in a White House statement. “I’ve seen firsthand the tremendous expertise and energy the US biomedical and biotechnology company can bring to solve some of the toughest challenges in healthcare.”

Congress has approved $1 billion for ARPA-H, which is housed at the National Institutes of Health but reports directly to Xavier Becerra, Secretary of Health and Human Services – an agreement intended to prevent the new agency too busy with the federal bureaucracy. While its director is not a Senate-approved position, Mr. Biden could be pushed back by Republicans, some of whom have argued that the agency is duplicating the NIH’s efforts.

The agency already has an acting associate director, Adam H. Russell, also a DARPA alumnus, who provided the technical infrastructure and other foundations to get the new agency off the ground. dr Collins said Dr. Wegrzyn will start work on October 1st. Her primary goal will be to hire program managers who will bring bold ideas that the agency wants to pursue, and will spend a limited time, perhaps three years, with the agency, he said.

“They’ll arrive, they’ll do a little due diligence, and then they’ll have to get the idea of ​​Dr. suggest Wegrzyn,” said Dr. Collins. “If she says ‘thumbs up,’ they’ll go off with whatever money they can spend to figure out how to put together the right partners to get the job done.”

The emergence of successful new innovations, he said, will take time. But Steve Brozak, an investment banker whose firm WBB Securities specializes in biotechnology, said if the agency is to be a success, Dr. Wegrzyn acted quickly to differentiate their work from the rest of the federal bureaucracy.

“What she needs to do is get a win on the board right away,” he said. “It doesn’t mean money. This means something that can be seen outside of the current paradigm in promoting health care for all.”

Mr. Biden’s selection was commended by Ellen V. Sigal, chair of Friends of Cancer Research, a nonprofit organization that works with industry and government to advance new therapies. Mrs. Sigal called Dr. Wegrzyn “an inspired choice,” adding that “she is a proven innovator and leader who knows science, knows how to make governments work and understands the urgency for patients across the country.”

In addition to announcing his intention to have Dr. Wegrzyn, Mr. Biden on Monday issued an executive order establishing a biotechnology and biomanufacturing initiative that aims to position the United States as a leader in the field and center drug manufacturing in the country. The coronavirus pandemic has exposed critical vulnerabilities in the supply chain for medicines and life-saving therapies.

“The United States has relied heavily on foreign materials for biomanufacturing for too long,” the White House said in a statement, “and our past outsourcing of critical industries, including biotechnology, poses a threat to our ability to access key materials such as including the active pharmaceutical ingredients for life-saving medicines.”

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California Biotech Govt Is Responsible in $77 Million Blood-Testing Scheme

A biotech executive in California was convicted Thursday of orchestrating a $77 million scheme of making false and fraudulent claims for Covid-19 and allergy testing, federal prosecutors said.

CEO, Mark Schena, 59, served as president of Arrayit Corporation, a biomedical company that claims to have invented technology to test for any disease by pricking just a drop of blood on your finger. According to Arrayit’s website, its “microarray” technology could test for ovarian cancer, Parkinson’s disease, colon cancer and male fertility, among others.

Mr. Schena was found guilty on a total of nine federal charges, including conspiracy to commit wire fraud and healthcare fraud and three counts of securities fraud. He faces up to 20 years in prison for conspiracy to commit healthcare fraud and conspiracy to commit wire fraud, and 20 years for each count of securities fraud.

Beginning in 2018, Mr. Schena paid kickbacks and bribes to recruiters and doctors to perform allergy testing for 120 different allergens, including hornet stings, shrimp, peanuts, dairy and Bermuda grass, regardless of medical necessity, federal prosecutors said.

The US Department of Justice said he then developed “a misleading marketing plan” that falsely promoted the test’s accuracy “when in reality it was not a diagnostic test.”

According to the department, Mr. Schena filed fraudulent claims with Medicare and private insurance companies for unnecessary allergy testing. The company billed Medicare more per patient for blood-based allergy testing than any other lab in the United States, the Justice Department said. Some commercial insurers have been billed more than $10,000 per test.

When Arrayit’s allergy testing business collapsed during the coronavirus pandemic, the company turned its attention to Covid-19 testing, claiming to have developed a blood-based test using its alleged technology.

Because Arrayit falsely claimed its Covid test was more accurate than a PCR test, the US Food and Drug Administration had told Mr Schena that Arrayit’s test was not accurate enough to receive an emergency use authorization. Mr. Schena kept this rejection secret from the investors.

Mr. Schena referred to investors as the “father of microarray technology” and falsely stated that he was shortlisted for the Nobel Prize, the Justice Department said.

A phone number listed for the company was disconnected. An attorney for Mr Schena, Todd A. Pickles, declined to comment Friday.

Arrayit compared itself at least once to Theranos, the failed blood testing startup, on its Facebook page, writing that its technology could use drops of blood “that are 250,000 times smaller than the volume of the Theranos nanotainer,” according to the First Complaint of the Department of Justice in 2020.

Elizabeth Holmes, the founder of Theranos, who once promised to revolutionize healthcare through a simple blood test, and Ramesh Balwani, a former top executive at the company, have been accused of exaggerating the capabilities of its blood-testing devices to appeal to investors and customers.

In January, Ms Holmes was convicted of four counts of fraud and in July Mr Balwani was found guilty of 12 counts of fraud.

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Hong Kong biotech start-up Prenetics plans $1.three billion SPAC merger

Signage for Prenetics, a Hong Kong-based biotechnology company, at the company’s laboratory in Hong Kong, China, on Jan. 26, 2018.

Anthony Kwan| Bloomberg | Getty Images

Hong Kong biotech company Prenetics is set to merge with Artisan Acquisition, a special purpose acquisition company, in a deal that will value the new entity at $1.3 billion or more, according to a source close to the deal.

The transaction is expected to close by the end of this year. The SPAC is already traded on the Nasdaq under the ticker ARTU.

SPACs are shell companies set up to raise money through an initial public offering — their sole purpose is to merge with or acquire an existing private company and to take it public. They bypass Wall Street’s traditional IPO process.

Artisan Acquisition is backed by Adrian Cheng, the CEO and Executive Vice Chairman of Hong Kong-listed New World Development, a conglomerate with $88 billion in assets.

Prenetics is a diagnostic and genetic testing company with significant operations in Hong Kong and the U.K. It was founded by serial entrepreneur Danny Yeung and will become the first billion-dollar start-up in Hong Kong to go public.

A technician handles a sample at a Prenetics laboratory in Hong Kong, China, on Jan. 26, 2018.

Anthony Kwan | Bloomberg | Getty Images

UBS, Citi, Credit Suisse and CICC are financial advisors on the potential de-SPAC transaction.

Artisan raised $339 million in the SPAC, and has signed a further $60 million forward purchase agreements with investment firm Aspex and PAG, a private asset manager for institutional investors, according to the source who requested anonymity as that person was not allowed to discuss the information publicly.

Talks with additional pipe investors are said to be ongoing, with strong initial demand, the source said.

The company has grown significantly since its founding in 2014, and 2021 revenue is projected to surpass $200 million. That would mark 400% growth over the year prior, according to the source.

Annual revenue is expected to reach $600 million by 2025, said the source.