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Friday, September 22, 2023

Big Pharma bets on AI to speed up clinical trials

 Major drugmakers are using artificial intelligence to find patients for clinical trials quickly, or to reduce the number of people needed to test medicines, both accelerating drug development and potentially saving millions of dollars.

Human studies are the most expensive and time-consuming part of drug development as it can take years to recruit patients and trial new medicines in a process that can cost over a billion dollars from the discovery of a drug to the finishing line.

Pharmaceutical companies have been experimenting with AI for years, hoping machines can discover the next blockbuster drug. A few compounds picked by AI are now in development, but those bets will take years to play out.

Reuters interviews with more than a dozen pharmaceutical company executives, drug regulators, public health experts and AI firms show, however, that the technology is playing a sizeable and growing role in human drug trials.

Companies such as Amgen, Bayer and Novartis are training AI to scan billions of public health records, prescription data, medical insurance claims and their internal data to find trial patients - in some cases halving the time it takes to sign them up.

"I don't think it's pervasive yet," said Jeffrey Morgan, managing director at Deloitte, which advises the life sciences industry. "But I think we're past the experimentation stage."

The U.S. Food and Drug Administration (FDA) said it had received about 300 applications that incorporate AI or machine learning in drug development from 2016 through 2022. Over 90% of those applications came in the past two years and most were for the use of AI at some point in the clinical development stage.

ATOMIC AI

Before AI, Amgen would spend months sending surveys to doctors from Johannesburg to Texas to ask whether a clinic or hospital had patients with relevant clinical and demographic characteristics to participate in a trial.

Anti-affirmative action group, emboldened by US Supreme Court, targets scholarships

 A non-profit group opposing race-based education policies has filed more than a dozen U.S. civil rights complaints this year against universities, challenging the legality of offering minority scholarships, summer study and residency programs to promote racial diversity.

The challenges are part of a growing campaign against diversity initiatives after a U.S. Supreme Court landmark ruling in June outlawed use of race in college admissions, commonly known as affirmative action. Conservative activists say the decision should extend to all educational programs, and some groups have also challenged corporate diversity policies.

The Equal Protection Project of the Legal Insurrection Foundation, headed by Cornell University clinical law professor William Jacobson, filed the complaints with the U.S. Department of Education's civil rights office.

The latest complaint, filed last week, accused Western Kentucky University of violating civil rights law by offering two scholarships – one for undergraduate students and one for graduate students – available only to minority applicants. The university did not respond to a request for comment.

Other targets include a minority scholarship at Kansas State University and a residency program for Black filmmakers at the University of Nebraska-Lincoln.

In an interview, Jacobson said the education department has asked the group for more information but has not indicated whether it will launch formal investigations. A departmental spokesperson said the office for civil rights does not discuss details of its cases.

Jacobson said any program contingent on race is unlawful.

"The typical response is, well, what's wrong with wanting diversity?" he said. "There's nothing wrong with that. But you can't do it through racial discrimination, and the Supreme Court has been very clear about that."

Advocates say race-conscious programs are necessary to combat institutional and societal disadvantages facing minority students, particularly in light of the Supreme Court's decision. Black children are more likely to grow up in low-income households, with less access to high-quality child care and enrichment activities.

Top schools have warned that eliminating race as an admissions factor will result in fewer minority students.

"A student missing $1,000 or having a gap of $800 could mean the difference between being able to graduate or not," said Ameshia Cross, director of communications for the Education Trust, whose website says it works to "dismantle the racial and economic barriers embedded in the American education system."

Cross, who also works as a Democratic strategist, said she would not have been able to attend Belmont University, a private school, without the help of an annual $5,000 minority scholarship.

RESPONSE TO RULING

While the Supreme Court's ruling was limited to admissions, it prompted some schools to re-examine race-based programs.

The University of Missouri system announced it would eliminate race as a factor in awarding scholarships. The state's Republican attorney general sent a letter instructing all colleges in Missouri, including private schools, to adopt race-blind standards for admissions, scholarships, employment and other programs.

Other schools have vowed to pursue alternative avenues toward improving racial diversity, such as increasing recruiting from underprivileged schools.

Evan Caminker, a law professor at the University of Michigan, said it was not yet clear whether the Supreme Court decision would extend beyond admissions to race-conscious programs. He noted that the court emphasized the "zero-sum" nature of admissions - every successful applicant takes away a spot from other potential students.

By contrast, a school might award its scholarships in a race-neutral way, only to then decide which specific scholarships would be assigned to which students, he said.

The Department of Education's civil rights office is likely to be a frequent battleground. In July, the office confirmed it had opened an investigation into whether Harvard discriminates against minorities by favoring "legacy" applicants with ties to donors or alumni, following a complaint filed by civil rights groups.

On Tuesday, the organization that won the Supreme Court case, Students for Fair Admissions, filed a new lawsuit challenging affirmative action admission practices at the U.S. Military Academy at West Point. The Supreme Court had exempted military academies from its June decision, saying in a footnote that these schools might have "distinct" interests.

https://news.yahoo.com/anti-affirmative-action-group-emboldened-100624922.html

Bankman-Fried's expert witnesses rejected by judge

A U.S. judge on Thursday restricted Sam Bankman-Fried's ability to call expert witnesses to testify at his criminal fraud trial, in a blow to the FTX cryptocurrency exchange founder.

Bankman-Fried wanted to call seven experts on topics such as cryptocurrency markets and English contracts, to convince jurors to acquit him of stealing billions of dollars in FTX customer funds to plug losses at his Alameda Research hedge fund.

But in a written order, U.S. District Judge Lewis Kaplan said three proposed witnesses cannot take the stand, because their testimony was irrelevant or could confuse the jury.

He also said Bankman-Fried may seek to call the remaining four experts, but only to rebut prosecution witnesses.

Among the witnesses Kaplan rejected was Peter Vinella, a consultant who intended to testify about "FTX's use of widely-accepted practices in the financial services industry." Kaplan found the testimony irrelevant.

Bankman-Fried also cannot call English barrister Lawrence Akka to testify about FTX's terms of service, which were governed by English law, because only a judge could tell jurors what the law is, Kaplan said.

Court papers suggest Bankman-Fried may argue that the terms of service did not prevent the use of customer funds to make investments - much as banks use deposits to fund loans - and the practice had been common in the cryptocurrency industry.

Bankman-Fried, a 31-year-old former billionaire, has pleaded not guilty. He has acknowledged inadequate risk management at FTX prior to its November 2022 collapse, but denied stealing funds.

It is common in U.S. criminal trials for prosecutors and defendants to call experts to help jurors understand complex issues.

Prosecutors have said they plan to call three former FTX and Alameda executives, who have all pleaded guilty, to testify at Bankman-Fried's trial, which may last up to six weeks.

https://www.marketscreener.com/news/latest/Bankman-Fried-s-expert-witnesses-rejected-by-judge--44899059/

Merck, Eisai Phase 3 for lung cancer miss primary endpoints

  Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today provided updates on two Phase 3 trials, LEAP-006 and LEAP-008, evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, in patients with certain types of metastatic non-small cell lung cancer.

https://www.biospace.com/article/releases/merck-and-eisai-provide-update-on-two-phase-3-trials-evaluating-keytruda-pembrolizumab-plus-lenvima-lenvatinib-in-patients-with-certain-types-of-metastatic-non-small-cell-lung-cancer/

Positive phase 3 results in breast cancer for Daiichi Sankyo , AstraZeneca datopotamab deruxtecan

 Plans for global regulatory submissions are underway

https://www.biospace.com/article/releases/datopotamab-deruxtecan-demonstrated-statistically-significant-and-clinically-meaningful-progression-free-survival-benefit-in-patients-with-hr-positive-her2-low-or-negative-breast-cancer-in-tropion-breast01-phase-3-trial/

Astellas, SeaGen: Keytruda Combo Improves Survival in Phase 3 for Bladder Cancer

 Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") and Seagen Inc. (Nasdaq: SGEN) today announced positive topline results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) for PADCEV® (enfortumab vedotin-ejfv) in combination with KEYTRUDA® (pembrolizumab) versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC), a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body. The EV-302 trial enrolled patients with previously untreated la/mUC who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status.

https://www.biospace.com/article/releases/padcev-enfortumab-vedotin-ejfv-and-keytruda-pembrolizumab-significantly-improve-overall-survival-and-progression-free-survival-in-patients-with-previously-untreated-advanced-bladder-cancer-in-pivotal-phase-3-ev-302-trial/

Merck Meets Primary Endpoints in Phase 3 in Urothelial Cancer

 First Phase 3 results for the KEYTRUDA® (pembrolizumab) and Padcev® (enfortumab vedotin-ejfv) combination showed a statistically significant and clinically meaningful improvement in OS, PFS and key secondary endpoint of overall response rate versus chemotherapy in these patients, who may or may not be eligible for cisplatin-based chemotherapy

https://finance.yahoo.com/news/merck-announces-phase-3-keynote-100000777.html