Generative AI Finds Its Footing in Drug Development

 Xaira Therapeutics launched April 23 with $1 billion behind it to apply artificial intelligence to drug discovery and development. It was the largest initial commitment from backer ARCH Venture Partners in the biotech-focused fund’s nearly 40-year history, highlighting the flood of interest and investment in harnessing the power and potential of generative AI to advance the biopharma industry.

While AI has been used in biopharma R&D and marketing for years, generative AI is a newer variety that can produce new ideas, words, images, audio and video. The generative AI trend in the industry was precipitated by the November 2022 release of ChatGPT, said Ben Mabey, chief technology officer of AI drug discovery firm Recursion Pharmaceuticals. “[That] triggered the imaginations of execs across the board.”

Some companies are working directly with ChatGPT developer OpenAI. Late last month, for example, Moderna expanded its collaboration with OpenAI to integrate generative AI into all of its business and R&D operations. Other biopharma firms are partnering with life sciences–focused AI services companies or Big Tech companies looking to tap the biopharma market. Still others are developing generative AI technology in house.

“It’s just an exciting time to be in the space now,” Mabey told BioSpace, “because people are finally waking up to the potential here.”

Bryan Hill, VP and chief digital officer for life sciences IT consulting firm Cognizant, agreed that generative AI has grabbed the attention of the biopharma world, “inspiring the art of the possible” since ChatGPT burst onto the scene. “The last 18 months has been filled with ‘educate me,’” Hill said. Now, he added, companies are starting to understand how to apply it.

Figuring Out Generative AI

So far, the biopharma industry at large has mostly been “kicking the tires” on generative AI, Hill said. “A lot of effort has been more geared towards the internal workflows and processes,” such as literature searching and summarization to assist with document writing, he continued, but the potential includes optimization of every stage of pharma R&D, from target discovery to drug development to regulatory approval to commercialization and postmarket pharmacovigilance.

Dane Stout, head of digital transformation at NNIT, the IT and consulting spinoff of Novo Nordisk that largely serves emerging biopharma companies, said he does not believe that anyone fully has their arms around generative AI yet in terms of drug development, but he sees remarkable potential for the technology. While the use of AI in drug discovery is well established, he said, his group at NNIT spends a lot of time working in what he called the “muddied middle” between target discovery and commercialization. That means drug development and clinical trial execution, areas in which companies are just beginning to capitalize on generative AI, Stout said.

In theory, the possibilities are endless, from predicting success of research and stratifying patients in clinical trials to assessing commercialization strategies and executing pharmacovigilance. But it all hinges on feeding the models enough data.

Generative AI, including “large language models” (LLMs), is built on deep learning algorithms trained on huge amounts of data. Mike King, senior director of product and strategy by contract research organization and healthcare analytics giant IQVIA, noted that ChatGPT is based on an LLM called Generative Pre-trained Transformer, now on version 4. “It’s been trained [on] over 30 years’ worth of internet history,” King said. “That dataset is massive.”

But scientific knowledge is constantly changing, so ChatGPT may not be as accurate in life sciences, because information may be out of date and not always considered in context of current biopharma regulation, according to King.

“I think our biggest challenge is helping our customers get their data into the right state,” added Dotmatics’ Alister Campbell, VP and global head of science and technology at the R&D-focused software company. “Scientific software companies have found it very difficult to keep up with how fast science develops, and that’s our task now, to make sure that we stay on top of that.”

A Deeper Connection Between Biopharma and IT

To make the most of the potential opportunity, IT firms are investing in and partnering with life sciences companies.

NVIDIA, for example, has built an AI-focused partnership with Amgen, which has begun applying predictive models to ideas generated by AI. According to Kimberly Powell, the company’s VP of healthcare, this continuous feedback loop has allowed Amgen to shorten antibody design from two years to nine months.

In addition, NVIDIA has invested in and is providing AI support to Recursion Pharmaceuticals and Iambic Therapeutics. Moreover, the high-performance computing giant last year introduced BioNeMo, a cloud service for generative AI in drug discovery. The platform indexes external LLMs and other models that power generative AI, staying current by accessing updates as they are released, according to Powell.

NVIDIA also has an alliance with Cognizant, which itself partners not only with pharma companies including Boehringer Ingelheim and Takeda and radiotherapy giant Accuray, but also Big Tech firms like Microsoft and Google. Google parent firm Alphabet has an AI-driven startup called Isomorphic Laboratories that has been pushing into drug R&D since 2021. NNIT recently announced a global AI initiative, though it is not specific to drug development.

Powell said that LLMs have an important role to play in all stages of pharma processes, including by allowing for rapid trial and error, a sentiment echoed by others who spoke to BioSpace.

Generative AI might influence discovery by generating ideas that humans would not naturally think of. “[It could be] a protein that nature’s never made before, in a way that it actually could be a protein that has therapeutic effects, or a chemical compound that we otherwise haven’t synthesized and does not exist in any database in the world,” Powell explained.

On the back end of drug development, NNIT’s Stout said that generative AI can be helpful in compiling data from thousands of documents to prepare FDA submissions, Stout said. In the same vein, it might have a role in technology transfer by making data more accessible.

“I think people are looking to get away from layers and layers of software tools and stacks,” Stout said, noting that one client asked for a “digital front door” for external partners to collaborate. NNIT ended up deploying what Stout described as an “AI-assisted data ingestion engine.”

“I call it pragmatic AI,” Stout said.

Rachael Brake, the recently hired chief scientific officer at Zephyr AI, sees generative AI moving to support specific areas and processes where it can have the most effect on outcomes, time or cost. Zephyr, which counts Eli Lilly as an investor and NexImmune as a partner, has decided to concentrate on drug response prediction by seeking to extract high-quality data even if a patient cohort is small.

“Making a medicine that doesn’t actually solve for a problem actually is not very valuable to anybody,” Brake said. “Where we can bring value is to uncover the problem and then to be able to direct the biopharma partner in terms of what would need to be the solution.”

https://www.biospace.com/article/generative-ai-finds-its-footing-in-drug-development/

AstraZeneca Withdraws COVID-19 Vaccine Worldwide as Demand Craters

 AstraZeneca is voluntarily withdrawing its COVID-19 vaccine Vaxzevria as global demand for coronavirus products continue to decline and it faces growing competition from newer vaccines, according to several media reports.

The British pharma said that the decision to pull Vaxzevria from the global market was due to the “surplus of available updated vaccines” adapted to newer and emerging variants of COVID-19, Reuters reported Tuesday. “This has led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied,” the company said.

The withdrawal of Vaxzevria also comes more than a week after AstraZeneca admitted in court documents that the vaccine can trigger thrombosis with thrombocytopenia syndrome (TTS), a rare side effect characterized by the presence of blood clots alongside a low platelet count, according to The Telegraph.

AstraZeneca initially contested the claim that Vaxzevria caused the side effect but eventually admitted in a legal document that the vaccine “can, in very rare cases, cause TTS.” The company is facing more than 50 cases in the U.K. and could be on the hook for up to approximately $125 million in damages.

However, AstraZeneca maintains that it is pulling Vaxzevria for purely commercial reasons and the timing regarding the TTS admission is purely coincidental.

“We are incredibly proud of the role Vaxzevria played in ending the global pandemic. According to independent estimates, over 6.5 million lives were saved in the first year of use alone and over three billion doses were supplied globally,” AstraZeneca told The Telegraph in a statement. “Our efforts have been recognized by governments around the world and are widely regarded as being a critical component of ending the global pandemic.”

Vaxzevria’s withdrawal comes as the biopharma industry continues to be hit by a COVID-19 cliff, driven by a steep decline in demand and sales of coronavirus-related products.

Pfizer and BioNTech, beneficiaries of the pandemic boom, continue to suffer from slumping revenues. On Monday, the German biotech reported that its revenue plunged to $202 million during the first quarter of 2024, down from nearly $1.4 billion during the same time period the prior year.

BioNTech attributed the decline directly to “lower commercial revenues” from its COVID-19 vaccine due to “endemic-level demand.”

Pfizer also sustained a 20% year-over-year drop in revenue, which the pharma blamed on the slowdown in COVID-19 demand. Excluding its coronavirus business, Pfizer would have seen an 11% jump in revenues.

https://www.biospace.com/article/astrazeneca-withdraws-covid-19-vaccine-worldwide-as-demand-craters/

China's Xi In Serbia Says 'Never Forget' This Unprecedented US Atrocity

 Chinese leader Xi Jinping has been in France since Sunday where he met with French President Emmanuel Macron to talk about range of topics but especially the Ukraine war and trade between China and the European Union.

But on Tuesday he traveled to Serbia, and importantly the trip falls precisely on the 25th anniversary of the bombing of the Chinese Embassy in Belgrade, which came in the midst of NATO’s bombing of the Serbs of Yugoslavia during the 1999 Kosovo war.

Just ahead of arriving in the Serbian capital, Xi wrote a letter which has been published by the Serbian outlet Politika. In it he lambasted NATO and by extension United States for its historic war crime..

"Twenty-five years ago today, NATO flagrantly bombed the Chinese Embassy in Yugoslavia, killing three Chinese journalists," Xi's words introduced.

It happened on May 7, 1999 during US-NATO 78-day bombing campaign over Yugoslavia. That's when five US Joint Direct Attack Munition guided bombs hit scored a direct hit on the Chinese embassy in Belgrade, killing the journalists.

The US was adamant that it was inadvertent and unintentional, and eventually then President Clinton issued a formal apology to the Chinese government. It had marked the first time in all of modern history that a sovereign government's military attacked another country's embassy. It had not even happened once during World Wars I and II.

"This we should never forget. The Chinese people cherish peace, but we will never allow such tragic history to repeat itself," Xi wrote.

"The Chinese-Serbian friendship, forged with the blood of our compatriots, will stay in the shared memory of the Chinese and Serbian peoples," he continued.

His emphasis on the line "never forget" is interesting given it is a common line used by Americans when it comes to remembering the 9/11 terror attacks, as well as in the West when it comes to Holocaust remembrance days.

To review of what we've featured in a previous post called "America's Benevolent Bombing of Serbia," President Bill Clinton commenced bombing Belgrade in the name of human rights, justice, and ethnic tolerance. Approximately 1,500 Serb civilians were killed by NATO bombing in one of the biggest sham morality plays of the modern era. 

As British professor Philip Hammond has noted, the 78-day bombing campaign “was not a purely military operation: NATO also destroyed what it called ‘dual-use’ targets, such as factories, city bridges, and even the main television building in downtown Belgrade, in an attempt to terrorise the country into surrender.”

NATO bombing of Yugoslavia

Clinton’s unprovoked attack on Serbia, intended to help ethnic Albanians seize control of Kosovo, set a precedent for “humanitarian” warring that was invoked by supporters of George W. Bush’s unprovoked attack on Iraq, Barack Obama’s bombing of Libya, and Donald Trump’s bombing of Syria.

https://www.zerohedge.com/geopolitical/chinas-xi-serbia-says-never-forget-unprecedented-us-atrocity

Bio-Rad Laboratories reiterates 2024 revenue growth outlook; shares slip

 Diagnostics firm Bio Rad Laboratories reiterated its 2024 sales growth forecast on Tuesday, weighed by persistently weak spending by biotech companies and sluggish demand in China.

The supplier of laboratory apparatus and instruments for drug manufacturers and biotech companies continues to see adjusted revenue growth for the full-year between 1% and 2.5% on a currency-neutral basis.

Large rival Thermo Fisher Scientific slightly bumped up its annual profit forecast in April while Waters Corp left its outlook for the year unchanged as it remains cautious about a recovery in its key markets.

Subdued spending in the biotech sector as well as sluggish demand in the key China market has hit Bio-Rad's life sciences segment sales, offset by an increase in demand for its clinical diagnostics products.

The Hercules, California-based company continues to be cautiously optimistic about a gradual recovery in the biopharma market in the second half of the year. Sales from its life sciences unit, which makes products for biotech, pharmaceutical and food testing clients, fell 25.3% to $241.7 million. On an adjusted basis, Bio-Rad recorded a per-share profit of $2.29 for the quarter ended March 31, marginally above analysts' estimate of $2.15.

https://www.yahoo.com/news/bio-rad-laboratories-reiterates-2024-221051519.html

TikTok, ByteDance sue to block US law seeking sale or ban of app

 TikTok and its Chinese parent company ByteDance sued in U.S. federal court on Tuesday seeking to block a law signed by President Joe Biden that would force the divestiture of the short video app used by 170 million Americans or ban it.

The companies filed their lawsuit in the U.S. Court of Appeals for the District of Columbia Circuit, arguing that the law violates the U.S. Constitution on a number of grounds including running afoul of First Amendment free speech protections. The law, signed by Biden on April 24, gives ByteDance until Jan. 19 to sell TikTok or face a ban.

"For the first time in history, Congress has enacted a law that subjects a single, named speech platform to a permanent, nationwide ban," the companies said in the lawsuit.

The lawsuit said the divestiture "is simply not possible: not commercially, not technologically, not legally. ... There is no question: the Act (law) will force a shutdown of TikTok by January 19, 2025, silencing the 170 million Americans who use the platform to communicate in ways that cannot be replicated elsewhere."

The White House has said it wants to see Chinese-based ownership ended on national security grounds but not a ban on TikTok. The White House and Justice Department declined to comment on the lawsuit.

The lawsuit is the latest move by TikTok to keep ahead of efforts to shut it down in the United States as companies such as Snap and Meta look to capitalize on TikTok's political uncertainty to take away advertising dollars from their rival.

Driven by worries among U.S. lawmakers that China could access data on Americans or spy on them with the app, the measure was passed overwhelmingly in Congress just weeks after being introduced. TikTok has denied that it has or ever would share U.S. user data, accusing American lawmakers in the lawsuit of advancing "speculative" concerns.

Representative Raja Krishnamoorthi, top Democrat on a House committee on China, said the legislation is "the only way to address the national security threat posed by ByteDance’s ownership of apps like TikTok."

"Instead of continuing its deceptive tactics, it’s time for ByteDance to start the divestment process," he said.

The law prohibits app stores like Apple and Alphabet's Google from offering TikTok and bars internet hosting services from supporting TikTok unless ByteDance divests TikTok by Jan. 19.

The suit said the Chinese government "has made clear that it would not permit a divestment of the recommendation engine that is a key to the success of TikTok in the United States." The companies asked the D.C. Circuit to block U.S. Attorney General Merrick Garland from enforcing the law and says "prospective injunctive relief" is warranted.

According to the suit, 58% of ByteDance is owned by global institutional investors including BlackRock, General Atlantic and Susquehanna International Group, 21% owned by the company's Chinese founder and 21% owned by employees - including about 7,000 Americans.

TENSIONS OVER INTERNET AND TECHNOLOGY

The four-year battle over TikTok is a significant front in the ongoing conflict over the internet and technology between the United States and China. In April, Apple said China had ordered it to remove Meta Platforms' WhatsApp and Threads from its App Store in China over Chinese national security concerns.

TikTok has spent $2 billion to implement measures to protect the data of U.S. users and made additional commitments in a 90-page draft National Security Agreement developed through negotiations with the Committee on Foreign Investment in the United States (CFIUS), according to the lawsuit.

That pact included TikTok agreeing to a "shut-down option" that would give the U.S. government the authority to suspend TikTok in the United States if it violates some obligations, according to the suit.

In August 2022, according to the lawsuit, CFIUS stopped engaging in meaningful discussions about the agreement, and in March 2023 CFIUS "insisted that ByteDance would be required to divest the U.S. TikTok business." CFIUS is an interagency committee, chaired by the U.S. Treasury Department, that reviews foreign investments in American businesses and real estate that implicate national security concerns.

In 2020, then-President Donald Trump was blocked by the courts in his bid to ban TikTok and Chinese-owned WeChat, a unit of Tencent, in the United States. Trump, the Republican candidate challenging the Democrat Biden in the Nov. 5 U.S. election, has since reversed course, saying he does not support a ban but that security concerns need to be addressed.

Biden could extend the Jan. 19 deadline by three months if he determines ByteDance is making progress. The suit said the fact that Biden's presidential campaign continues to use TikTok "undermines the claim that the platform poses an actual threat to Americans." Trump's campaign does not use TikTok.

Many experts have questioned whether any potential buyer possesses the financial resources to buy TikTok and if China and U.S. government agencies would approve a sale.

To move the TikTok source code to the United States "would take years for an entirely new set of engineers to gain sufficient familiarity," according to the lawsuit.

https://finance.yahoo.com/news/tiktok-bytedance-sue-block-us-160112179.html

Bankrupt Steward Health puts its hospitals up for sale, discloses $9 bln in debt

 Bankrupt Steward Health Care has put all of its 31 U.S. hospitals up for sale, hoping to finalize transactions by the end of the summer to address its $9 billion in total liabilities, its attorneys said at a Tuesday court hearing in Houston.

Steward, which filed for bankruptcy protection on Monday, hopes to keep all of its hospitals open over the long term, Steward attorney Ray Schrock told U.S. Bankruptcy Judge Chris Lopez, who is overseeing the Chapter 11 proceedings.

"Our goal remains that there are zero hospitals closed on our watch," Schrock said. "There's going to be a change in ownership in many hospitals, we recognize that. But we don't want to see any of these communities fail to be served."

The privately-owned company closed a hospital in Massachusetts earlier this year, and officials in that state have criticized Steward's management and its former private equity owners for making short-sighted financial decisions that undermined patients' care. Massachusetts officials in particular criticized a series of transactions that sold off the company's real estate and saddled it with long-term rent costs at its hospitals.

In court documents filed before the hearing, Steward said it had over $9 billion in total liabilities, including $1.2 billion in loans, $6.6 billion in long-term rent obligations, nearly $1 billion in unpaid bills from medical vendors and suppliers, and $290 million in unpaid employee wages and benefits.

Schrock said Steward has real value, despite carrying a $9 billion debt load. The company had $6 billion in annual revenue before filing for bankruptcy, and it has been pursuing a sale of its physician group, Stewardship Health Care, to UnitedHealth subsidiary Optum Care for an amount that would repay the company's loans and allow it to pay some of its vendors, Schrock said.

Steward had hoped to use the proceeds of that sale to avoid bankruptcy. But stalled regulatory approvals forced the company to seek short-term emergency financing that did not give Steward enough cash to continue operations for long, Schrock said.

"It never really stabilized the company," Schrock said. "The company was always very close to running out of cash."

At Tuesday's hearing, Lopez allowed Steward to borrow $75 million from Medical Properties Trust, which owns the real estate where Steward's hospitals are located and is owed $6.6 billion on leases that run until 2041. Steward hopes to borrow an additional $225 million from Medical Properties Trust later in its bankruptcy.

Steward is putting all of its hospitals up for sale. It intends to hold auctions on June 28 auction for its hospitals outside of Florida and July 30 for its nine hospitals in Florida. Schrock said those timelines were negotiated as part of the new $75 million bankruptcy loan, and that Steward would seek more time to sell its hospitals if necessary.

"What we don't want to do is have a fire sale of the assets," Schrock said. "There is a lot of value here." 

https://finance.yahoo.com/news/bankrupt-steward-health-puts-hospitals-201114957.html

FBI File On Jeff Bezos' Grandfather, A DARPA Co-Founder, Has Been Destroyed

 What's not widely known is that Amazon founder Jeff Bezos' grandfather, Lawrence Preston Gise, helped form the Pentagon's supersecret Advanced Research Projects Agency (ARPA—renamed DARPA) in 1958. Years later, DARPA developed the internet and spurred breakthroughs in high-speed networking, voice recognition, and internet search. 

One year before Gise died in 1995, Bezos founded Amazon in the garage of his Bellevue, Washington home.

Or so we're told... 

John Greenewald Jr., who operates The Black Vault, a website dedicated to revealing declassified government documents through obtaining Freedom of Information Act requests, posted on X that he went after Gise's "FBI file, but found out if there was one, it has been destroyed." 

News website Leading Report's Patrick Webb commented on Greenewald's findings, saying, "There has long been speculation that DARPA has been involved in the creation of many popular big tech companies, using "frontmen" for the allusion of a startup led by outsiders." 

With the contents of Gise's FBI file unlikely to ever be unearthed and likely never destroyed, just inaccessible to FOIA requests or the public, other X users commented on Webb's and Greenewald's posts, pointing out how DARPA possibly created other big tech firms: 

Questions swirl about DARPA's involvement in creating Amazon, given Bezos' grandfather's connection to the secret agency. 

https://www.zerohedge.com/technology/fbi-file-jeff-bezos-grandfather-darpa-co-founder-has-been-destroyed