STAT+: In pancreatic cancer, Patrick Soon-Shiong makes promises he has not kept

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I am entirely enthralled by the World Cup. I am watching a ton of soccer on TV. I love the Tartan Army that has invaded Boston for Scotland’s games at Gillette Stadium. Tiny Cape Verde drawing mighty Spain was incredible. Messi, 39, playing in his sixth (!) World Cup, is still the GOAT. 

And England still hasn’t played but will in a couple of hours, as I get this newsletter finished on Wednesday afternoon. Olé!

Programming note: This newsletter is taking a holiday next week but will be back in your inboxes July 2.

What Soon-Shiong says vs. what he has delivered

I’ve taken a good bit of heat (and hate) from online fans of Patrick Soon-Shiong who view the billionaire physician as a selfless scientist/entrepreneur trying to rid the world of cancer. That’s a laudable goal, of course, except Soon-Shiong’s proclamations are mostly fluff, financially self-serving and have led to FDA wrist-slapping.

A wide gap exists between what Soon-Shiong says his cancer drugs can achieve and what they actually do, based on real clinical evidence.

Pancreatic cancer is an instructive and presently relevant example. Long before Soon-Shiong became rich and famous, he treated diabetic patients with pancreas transplants and performed surgery on patients with pancreatic cancer. A desire to transform the treatment of pancreatic cancer with novel immunotherapies inspired Soon-Shiong’s “Bioshield” mission, according to his own treatise.

Continue to STAT+ to read the full story…

Continuous Production Platform Offers New Gene Therapy Options

A new continuous bioprocessing platform for advanced therapy medicinal products (ATMPs) could help manufacturers increase yields and improve productivity, allowing them to treat larger groups of patients.

The platform, developed by an independent U.K. innovation center, the Cell and Gene Therapy (CGT) Catapult, aims to provide an additional option for manufacturing gene therapies.

“We’re not going to get rid of batch processing, but it is another tool for people to use when developing and manufacturing gene therapies and other ATMPs that could tackle some [existing] bottlenecks,” explains Bilal Ozdoganoglu, an associate senior scientist at the CGT Catapult.

Ozdoganoglu spoke at the Bioprocessing Summit Europe in March about the downstream capture and polishing step of the continuous bioprocessing platform earlier this year.

According to Ozdoganoglu, the platform aims to use continuous bioprocessing to overcome the problems of low yields and productivity, allowing ATMPs to cater to larger groups of patients while taking advantage of economies of scale.

The platform uses perfusion technology in the upstream, followed by, in the downstream, a clarification step and multi-column chromatography.

“Multi-column chromatography is almost bread and butter of more traditional biologics, but it’s relatively new in the gene therapy space,” he says.

“As such, we had quite a few challenges to overcome to allow a system originally built for mAbs to cater for gene therapies.”

For the polishing step, Ozdoganoglu explains that they heavily relied on digital modeling to generate parameters they could take into the laboratory.

According to Ozdoganoglu, the recovery rates and overall performance of the continuous system were slightly better than, or comparable to, traditional batch processing.

The next step, he explains, is to develop the platform further so it becomes an alternative to batch processing.

As such, he says, the CGT Catapult is looking for collaborators, including therapy developers as well as vendors, automation suppliers, and contract development and manufacturing organizations (CDMOs).

The post Continuous Production Platform Offers New Gene Therapy Options appeared first on GEN – Genetic Engineering and Biotechnology News.

The relationship between healthy sleep patterns and the risk of scoliosis: a large prospective cohort study

BackgroundCurrently, prospective evidence on how sleep habits specifically affect scoliosis is nearly nonexistent. We therefore sought to clarify the association between comprehensive sleep behavior patterns and the incidence of this disease.MethodsThis study conducted a prospective cohort study based on the UK Biobank (UKB), including 408,870 participants who did not have scoliosis at baseline. We have constructed a comprehensive sleep scoring system that integrates the following five key indicators: sleep chronotype, sleep duration, insomnia, snoring, and daytime sleepiness. To evaluate the association between healthy sleep patterns and the risk of scoliosis, we conducted a statistical analysis using the Cox proportional hazards regression model.ResultsOver a mean follow-up of 15.82 years, 2,976 incident cases of scoliosis were recorded (0.73%). The 408,870 participants who were free of scoliosis at baseline had a mean age of 56.48 years. Distribution of the healthy sleep score was as follows: 9,939 participants (2.43%) had 0–1 of the five healthy sleep behaviors, 46,175 (11.29%) had 2 behaviors, 115,094 (28.15%) had 3 behaviors, 150,287 (36.76%) had 4 behaviors, and 87,375 (21.37%) had all five. In multivariable models, each 1-point increase in the healthy sleep score was associated with a 10% lower risk of scoliosis [hazard ratio (HR) = 0.90; 95% confidence interval (CI) = 0.87, 0.93]. Compared with the 0–1 score group, the multivariable-adjusted HR (95% CI) for participants with a score of 5 was 0.64 (0.52, 0.80). In subgroup analyses, the inverse association between sleep score and scoliosis risk persisted among participants without diabetes but was absent among those with diabetes (pinteraction < 0.05).ConclusionCohort analysis results confirm that adherence to a healthy sleep-behavior pattern significantly reduces the risk of scoliosis.

Entrepreneurs in Nairobi make the case for going solar

globe icon with Nairobi indicated
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THE PLACE
Nairobi, Kenya

Most of Kenya’s power grid runs on renewables. But with 25% of communities lacking centralized electricity, the nation is looking to off-grid solar to hit its goal of delivering universal electricity access by 2030 without driving up emissions. The ever-­improving economics of solar technology have helped. A couple of years ago, a panel cost about $3 a watt; now it’s down to cents. 

On the margins of a bustling Nairobi, we wind past a mix of high-rises and hardware shops interspersed with small plots growing corn or potatoes. After a few minutes, we arrive at a street-side stall run by the bespectacled Milcah Wanjiru. She sells plenty of half-liter packets of milk, loaves of bread, and matches, but Wanjiru’s core business is a service: She mills corn flour for local residents, which they most often use in ugali—a common Kenyan dish that is similar to polenta, albeit less creamy. 

In the middle of her small shop, a milling machine stands on three adjustable legs. “Whenever customers came to mill their grain, they asked for other goods,” says Wanjiru, “and this is how I got to stock these other items.” 

Shops with a grain mill are common here in rural areas and most neighborhoods, especially low-income ones—even in the city. But most of these mills burn diesel fuel. Hers? It runs on either solar energy or electricity from the grid. 

Matt Carr, the CEO and cofounder of Agsol, the company that designed Wanjiru’s mill, is here with me, visiting to get her feedback on his product. One issue bothers her. “It can be slow,” Wanjiru tells Carr, explaining that grains can get stuck in the front chamber where they feed into the machine. Sometimes, the whole thing jams. 

Carr says the mill automatically reduces its speed if the grain is at all damp, so that the pulverizing hammers within can squeeze out as much flour as possible. That process can unfortunately lead to the problem she’s describing. 

Overall, Wanjiru seems happy with the machine, which she’s been using since December 2025. It makes running her business cheaper. About 40% of what shop owners who use diesel-powered mills charge customers goes toward paying for fuel, according to Carr, whereas operating Agsol’s solar-powered machine can be up to 80% more profitable once the initial cost (about $1,300) is paid off, which takes between six and 12 months. Wanjiru also likes the fact that—unlike diesel-burning models—her mill can handle very small amounts of grain, which has brought a few new customers her way.  

Carr launched the first Agsol product in 2018 in Kenya and has raised over $4 million of investment—much of that via a UK government program that supports clean energy projects in the region. Last year, Agsol sold 530 units. The company, which is based just outside Nairobi, has received orders from as far as Mozambique and Angola.

As we say goodbye to Wanjiru, she turns and bends over burlap sacks half full of peanuts, mung beans, rice, and millet, arranged neatly on wooden pallets on the cement floor. She lifts a scoopful from one of the sacks and dumps its contents on a scale. A customer waits to be served. 

Geoffrey Kamadi is an award-winning freelance journalist based in Nairobi, focusing on science, climate change, environment, technology, and development. 

Six Takeaways from the Danaher Bioprocessing Summit

The Danaher Bioprocessing Summit, “The Next Era of Bioprocessing: From Promise to Patient Impact,” took place in London earlier this month. The event brought together officials from Danaher companies (Cytiva, Pall, Beckman Coulter Life Sciences, IDBS, and Leica Microsystems), along with biopharma manufacturers and researchers to discuss how the industry can accelerate the transition from scientific breakthroughs to commercial therapies.

Key themes included:

  • AI-driven bioprocess development and manufacturing
  • Intensified and continuous bioprocessing
  • Digitalization and connected data ecosystems
  • Improving productivity and reducing cost of goods
  • Cell and gene therapy manufacturing challenges
  • Scaling production of high-demand biologics, including GLP-1 therapies
  • Advanced analytics and process control
  • Sustainability in biomanufacturing

The conference emphasized that future competitive advantage in biomanufacturing will come less from building additional capacity and more from increasing productivity, speed, and process intelligence across the development-to-manufacturing workflow.

Based on the formal presentations, roundtable discussion groups, and conversations among speakers, panelists, and attendees, six key takeaway ideas emerged.

The old manufacturing playbook no longer fits

Biomanufacturing was built for large batches of standardized therapies. The next generation of medicines—cell and gene therapies, targeted and complex biologics, N-of-1 treatments—doesn’t fit that mold. As molecular diversity increases, the field is shifting toward smaller, parallel and distributed systems that can flex to meet the complexity of individualized medicine. This means faster decision-making, new investment models, and process designs that are data-driven and purpose-built from the start rather than adapted from previous playbooks.

Manufacturing can no longer be treated as a downstream problem. It has to be part of the scientific conversation from day one.

Automation and AI are making personalized scale possible

For years, the promise of personalized medicine ran into a hard wall: you can’t manufacture one patient’s therapy the same way you manufacture a million doses of a traditional drug. Integrating automation, AI and high-throughput experimentation is changing that equation.

These tools are enabling a shift from large-batch production to small-batch and even patient-specific manufacturing while improving efficiency, regulatory consistency, and access to advanced therapies. AI and digital tools are also compressing process development timelines, making it possible to design more tailored, adaptive manufacturing approaches without sacrificing rigor.

Prediction is becoming a competitive advantage

The organizations gaining ground are not merely reacting to problems faster but actually anticipating them. Digital twins powered by integrated data are helping teams model outcomes before committing resources, accelerating timelines and reducing risk. And real-time, molecular and submolecular-level data—shared across interoperable systems—are enabling more precise, proactive decision-making at every stage of development and manufacturing. Investing in this area with critical infrastructure is essential.

Breakthroughs require collaboration across the whole ecosystem

It turned out that the most consistent theme across both days of the Summit was this: no single organization can accomplish what’s needed alone. Partnerships across academia, industry, and regulators are accelerating how all kinds of therapies, especially gene therapies, move from discovery to approved treatment. Earlier alignment between developers, manufacturers, and regulators is reducing friction and compressing timelines.

A central theme surfaced throughout the conference: the science is not the problem. The bioindustry already possesses powerful technologies and therapeutic capabilities. Future success depends on rapidly implementing them through manufacturing, regulatory alignment, supplier collaboration, and partnerships. Organizations that execute most effectively will shape the next decade of medicine. [Danaher]
A central theme surfaced throughout the conference: the science is not the problem. The bioindustry already possesses powerful technologies and therapeutic capabilities. Future success depends on rapidly implementing them through manufacturing, regulatory alignment, supplier collaboration, and partnerships. Organizations that execute most effectively will shape the next decade of medicine. [Danaher]

What makes these partnerships work is not goodwill alone but transparency, shared incentives, and data-driven collaboration that keeps everyone oriented around the same outcomes. The organizations making the most progress are those treating collaboration as a core capability.

 

Regulatory models are evolving with the science, and sustainability is now a procurement requirement, not a values statement 

 

Most of the frameworks that currently govern drug development were built for an earlier era of medicine. As therapies grow more complex and more personalized, those frameworks must change. Early engagement and risk-based approaches are helping bring complex therapies to patients faster without compromising scientific rigor. For rare diseases, which collectively affect an estimated 300 million people worldwide, tailored regulatory pathways are becoming essential.

Summit speakers agreed that regulators are not the obstacle they’re sometimes assumed to be. They want to move faster too, and building the right collaborative infrastructure makes that possible.

Environmental and social criteria are moving from corporate commitments into day-to-day supplier decisions. Organizations are integrating sustainability standards into procurement frameworks, requiring verified supplier commitments and shared performance targets as part of doing business.

Far from being separate from operational strategy, this is part of building supply chains resilient enough to support long-term innovation at scale. Progress toward net-zero goals, Summit participants agreed, accelerates when sustainability is wired into commercial relationships rather than managed alongside them.

Across two days and numerous conversations, one key point kept surfacing: the science is not the problem. The biopharma industry has the tools, the knowledge, and the therapeutic advances to transform how medicine is made and delivered. What it lacks is the collective will to operationalize them at speed. The next phase of progress will be won in manufacturing facilities, regulatory negotiations, supplier contracts, and partnerships that connect all of them.

The final conclusion: organizations that close the gap first will define what the next decade of medicine looks like.

To watch recorded keynote presentations, panel discussions, and fireside chats from the Danaher Summit on Bioprocessing, click here.

The post Six Takeaways from the Danaher Bioprocessing Summit appeared first on GEN – Genetic Engineering and Biotechnology News.