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The Stavros Niarchos Foundation (SNF) Global Center for Child and Adolescent Mental Health at the Child Mind Institute launches its next two-year fellowship for professionals pursuing evidence-based approaches across diverse, underserved global communities
New York, NY—Applications are now open for the 2026 Communicator Fellowship at the Stavros Niarchos Foundation (SNF) Global Center for Child and Adolescent Mental Health at the Child Mind Institute. The fellowship is designed to support a new generation of communicators working to shape child and adolescent mental health care in low- and middle-income countries, in addition to the SNF Global Center’s core country offices in Brazil, Greece, and South Africa. Up to three professionals working in public communications, including journalists, broadcasters, and podcasters, will be selected for the two-year program.
The Communicator Fellowship is part of the SNF Global Center’s broader mission to reduce gaps in data and care, catalyze system-level advancements, and transform child and adolescent mental health care by turning evidence into action, scaling culturally appropriate solutions, and building a global network of experts so young people everywhere can access support when they need it.
The application deadline is June 15, 2026. Fellows will be selected and announced by early August 2026. In addition to financial support of up to $100,000 USD, fellows will receive training, mentorship, and networking opportunities.
At a time when one in five young people are experiencing mental health or learning challenges, with most cases beginning by age 14, effective and accurate communication is urgently needed.
At the Child Mind Institute, we believe that translating research into accessible knowledge that empowers young people, families, and communities is integral to advancing mental health care. The Communicator Fellowship builds on this commitment by supporting professionals who can bring evidence-based mental health information to the public in clear, engaging, and culturally relevant ways.
Vinicius Gaby Vieira Rego, MD, of Brazil, a current Communicator Fellow with the support of the Institute of Psychiatry at the University of São Paulo, exemplifies this mission. Working with youth, Dr. Rego is co-creating a multi-platform literacy hub designed to combat harmful misinformation by empowering Brazil’s young leaders.
“I am deeply grateful for the opportunity to join the SNF Global Center’s network of fellows to support adolescent mental health in Brazil through communication,” said Dr. Rego. “This fellowship will enable a multi-channel communication project aimed at strengthening mental health literacy and peer-support capacity — with young people and for young people — across the country.”
As a fellow, Dr. Rego’s work directly addresses complex mental health challenges faced by young people in Brazil, while contributing to broader global efforts to improve communication about mental health care.
“In the current digital environment, where adolescents are exposed to a high volume of mental health content, the need for evidence-based information that resonates with young people has never been greater,” said Guilherme Polanczyk, MD, PhD, associate professor of Child and Adolescent Psychiatry at the University of São Paulo. “We are proud to endorse a project committed to supporting how young people and their communities understand and reflect on their mental health.”
Other current fellows are leading high-impact projects dispelling misinformation, reducing stigma, and increasing youth engagement — all while bringing critical attention to links among mental health, climate change, and human rights. Through partnerships, these efforts are transforming the future of youth mental health across the globe.
“Vinicius’s project is ambitious, and with the support of the Institute of Psychiatry at the University of São Paulo, we know it will provide young people in Brazil with much-needed resources to support their mental health,” said Peter Raucci, Director of Global Fellowship Strategy of the SNF Global Center at the Child Mind Institute. “What we’re seeing through the Communicator Fellowship is how quickly ideas can move from concept to culturally relevant, real-world impact.”
About the SNF Global Center at the Child Mind Institute The Stavros Niarchos Foundation (SNF) Global Center for Child and Adolescent Mental Health at the Child Mind Institute brings together the Child Mind Institute’s expertise as a leading independent nonprofit in children’s mental health and the Stavros Niarchos Foundation’s deep commitment to supporting collaborative projects to improve access to quality health care worldwide. The center is building partnerships to drive advances in under-researched areas of children and adolescents’ mental health, and expand access to culturally appropriate training, resources, and treatment in low- and middle-income countries. This work is conducted by the Child Mind Institute with support from SNF through its Global Health Initiative (GHI).
About the Child Mind Institute The Child Mind Institute is dedicated to transforming the lives of children and families struggling with mental health and learning disorders by giving them the help they need. We’ve become the leading independent nonprofit in children’s mental health by providing gold-standard, evidence-based care, delivering educational resources to millions of families each year, training educators in underserved communities, and developing tomorrow’s breakthrough treatments.
A cornerstone of human intelligence is the ability to flexibly adjust our cognition and behavior as our goals change. For instance, achieving some goals requires efficiency, while others require caution. Different goals require us to engage different control processes, such as adjusting how attentive and cautious we are. Here, we show that performance incurs control adjustment costs when people adjust control to meet changing goals. Across four experiments, we provide evidence of these costs and validate a dynamical systems model explaining the source of these costs. Participants performed a single cognitively demanding task under varying performance goals (e.g., being fast or accurate). We modeled control allocation to include a dynamic process of adjusting from one’s current control state to a target state for a given performance goal. By incorporating inertia into this adjustment process, our model accounts for our empirical finding that people undershoot their target control state more (i.e., exhibit larger adjustment costs) when goals switch rather than remain fixed (Study 1). Further validating our model, we show that the magnitude of this cost is increased when: distances between target states are larger (Study 2), there is less time to adjust to the new goal (Study 3), and goal switches are more frequent (Study 4). Our findings characterize the costs of adjusting control to meet changing goals and show that these costs emerge directly from cognitive control dynamics. In so doing, they shed new light on the sources of and constraints on flexibility of goal-directed behavior. (PsycInfo Database Record (c) 2026 APA, all rights reserved)
BackgroundIndividuals with attention deficit hyperactivity disorder (ADHD) are at increased risk of premature mortality, but the mechanisms that underlie this association after young adulthood are unknown. As ADHD is associated with cardiovascular disease, modifiable cardiovascular risk factors could contribute to links between ADHD and premature mortality.AimsThis study aims to investigate whether specific cardiovascular risk factors explain the association between childhood ADHD problems and a higher risk of premature mortality.MethodsWe used the UK 1958 birth cohort, the National Child Development study (NCDS), and linked death register data to examine whether children with ADHD problems at age 7 years were at higher risk of premature mortality by age 58 and if specific modifiable cardiovascular risk factors, measured at midlife (age 44 years), mediated this association using path analysis.ResultsA total of 8,016 individuals completed both the age 7 ADHD assessment and the age 44/45 biomedical assessment. Of these individuals, 231 (3.1%) were grouped as likely having ADHD. The odds ratio (OR) for deaths (n = 251) in the ADHD group versus the non-ADHD group was 1.86 (95% CI 1.08–3.17). The risk was largely explained by cigarette smoking status at midlife and by a higher waist–hip ratio (a measure of obesity).ConclusionsChildhood ADHD problems are associated with a higher risk of premature mortality by age 58. This risk seems to be mainly explained by two potentially modifiable cardiovascular risk factors: obesity and smoking. These risks should be prioritized for preventative interventions to reduce the risk of premature mortality in those with a history of ADHD.
Background: Persisting symptoms affect about one-third of youth following concussion. Mental health history, distress, and coping style are key predictors of prolonged recovery. Early and scalable psychological interventions, such as mindfulness-based intervention (MBI) delivered via smartphones, may improve patients’ ability to regulate their emotions and neurophysiologically recover, reducing overall symptom burden. However, no digital therapeutic (DTx) trials in adolescents experiencing concussion exist. Objective: This study primarily aimed to assess the feasibility of conducting a larger randomized controlled trial (RCT) evaluating the effectiveness of a DTx-MBI in adolescents with a concussion compared with an attention-matched sham intervention. Methods: This was a Health Canada-regulated, parallel-group, blinded, single-crossover feasibility RCT. Adolescents aged 12 to <18 years presenting to a Pediatric Emergency Department or interdisciplinary concussion clinic within 7 days of a physician-diagnosed concussion were approached for participation from November 2022 to June 2024. After providing consent, participants were randomized (1:1), stratified by sex, to either the experimental group (DTx-MBI) or the control group (sham, attention-matched math puzzle game). The DTx-MBI was delivered via the AmDTx platform (Mobio Interactive Pte Ltd, Singapore) as a custom-designed 4-to-8-week program of 8 standardized modules for adolescents with concussion, including audio-recorded guided mindfulness exercises, goal setting, journaling, and psychoeducation. The control intervention, delivered through the same interface, excluded mindfulness content and instead featured the open-source game “2048”. Participants in both groups were encouraged to engage with the app for at least 10 minutes/day, at least 4 days/week. Feasibility criteria to support progression to a full-scale RCT included: eligibility rate >40% of those screened; recruitment rate >50% of eligible participants randomized; intervention credibility >70% scoring above the midpoint on the credibility and expectancy questionnaire (CEQ) at 1 week; retention >75% of randomized participants completing 4-week outcomes; and adherence >70% completing 10 minutes of intervention on at least 4 days/week for 4 weeks. Results: A total of 124 out of 195 (63.6%) screened youth met eligibility criteria. Of these, 99/124 (79.8%) consented and were randomized to either the DTx-MBI group (n=49, median [IQR] age=15.28 [13.66‐16.19] years, 30 [61.2%] female) or the Sham group (n=50, median [IQR] age=14.92 [13.32‐16.71] years, 30 [60.0%] female). Credibility was high, with 62/83 (74.7%) of participants scoring above the credibility midpoint (DTx-MBI: 75.0%; Sham: 74.4%). Retention was strong, with 89/99 (89.9%) of participants completing the 4-week outcomes (DTx-MBI: 89.8%; control: 90.0%). Overall adherence was moderate (54/99 [54.5%]; DTx-MBI: 59.2%; control: 50.0%), and a little higher among outcome assessment completers (53/89 [59.6%]; DTx-MBI: 63.6%; Sham: 55.6%). Feasibility indicators were similar between groups. Conclusions: This feasibility trial supports the implementation of a larger RCT, with modifications to enhance adherence, to rigorously evaluate the clinical efficacy of the DTx-MBI. By targeting modifiable psychological risk factors through a scalable digital platform, DTx-MBI could be a low-burden, cost-effective adjunct to pediatric concussion care. Trial Registration: ClinicalTrial.gov NCT05105802; International Registered Report Identifier (IRRID): RR2-10.2196/57226
Scientists at Columbia University have developed a brain-controlled hearing technology that allows users to amplify the conversation they are focusing on while reducing other voices. Published today in Nature Neuroscience, this study marks the first time this kind of technology has been tested in humans.
“We have developed a system that acts as a neural extension of the user, leveraging the brain’s natural ability to filter through all the sounds in a complex environment to dynamically isolate the specific conversation they wish to hear,” said Nima Mesgarani, PhD, principal investigator at Columbia’s Zuckerman Institute and associate professor of electrical engineering at Columbia’s Fu Foundation School of Engineering and Applied Science. “This science empowers us to think beyond traditional hearing aids, which simply amplify sound, toward a future where technology can restore the sophisticated, selective hearing of the human brain.”
While modern hearing aids can amplify human speech while suppressing background noise, they cannot separate and enhance specific voices when multiple people are speaking. This can make it difficult for users to concentrate on a specific conversation in everyday scenarios such as restaurants, classrooms, busy workplaces, and family gatherings.
The hearing device developed by Mesgarani’s team mimics the way the human brain can naturally identify and focus on a single speaker out of many within a crowd. Previously, the researchers had found a way of identifying which brain signals are linked to a specific conversation, by matching the timing of peaks and valleys of the brain waves to the sounds and silences of that conversation. They also identified distinct patterns of brain activity that indicate which conversation a person is focusing on and which one they are filtering out.
In the current study, the scientists developed a machine learning algorithm that could examine the user’s brainwaves and identify which conversation they are paying attention to in real time, making that voice louder and others quieter to make it easier to listen to. This system was tested on epilepsy patients who already had electrodes implanted in their brains. The electrodes were used to measure the user’s brain activity as they focused on two overlapping conversations played simultaneously, and the algorithm automatically detected which conversation they were trying to focus on.
“The results mark an important step toward a new generation of brain-controlled hearing technologies that align with the listener’s intent, potentially transforming how people navigate noisy, multi-talker environments,” said Vishal Choudhari, PhD, who led the development and evaluation of the system.
More research will be needed before minimally invasive wearable systems can integrate this kind of brain sensing technology with advanced audio processing capabilities, especially to ensure they can accurately decode conversations in real time and in real-world scenarios where multiple voices can be heard.
“The central unanswered question was whether brain-controlled hearing technology could move beyond incremental advances, towards a prototype that could help someone hear better in real time,” said Choudhari. “For the first time, we have shown that such a system that reads brain signals to selectively enhance conversations can provide a clear real-time benefit. This moves brain-controlled hearing from theory toward practical application.”
This is today’s edition of The Download, our weekday newsletter that provides a daily dose of what’s going on in the world of technology.
Here’s what you need to know about the cruise ship hantavirus outbreak
Last week, eight passengers aboard a Dutch-flagged cruise ship contracted a type of hantavirus transmitted by rats. Three have since died. But health experts stress that this situation is nothing like the coronavirus outbreak in 2020.
The Andes virus is known to spread between people, and there are no specific antiviral treatments or vaccines. Yet transmission appears to require a specific form of contact that the cruise ship fostered.
This story is part of MIT Technology Review Explains, our series untangling the complex, messy world of technology to help you understand what’s coming next. You can read more from the series here.
Musk v. Altman week 2: OpenAI fires back, and Shivon Zilis reveals that Musk tried to poach Sam Altman
In the second week of the landmark trial between Elon Musk and OpenAI, Musk’s motivations for bringing the suit came under intense scrutiny.
OpenAI president Greg Brockman testified that Musk had pushed for the company to create a for-profit entity, while Shivon Zilis, a former board member, revealed that the Tesla tycoon had sought to lure Sam Altman to a new AI venture.
The courtroom also heard about Brockman’s private journals, Musk’s abandoned plans for a rival AI lab, and the moment he stormed out of a pivotal meeting carrying a painting of a Tesla.
Michelle Kim, who’s also a lawyer, has been in court on each day of the Musk v. Altman trial. To keep up with her ongoing coverage of their legal showdown, follow @techreview or @michelletomkim on X.
How LLMs could supercharge mass surveillance in the US: 10 Things That Matter in AI Right Now
There are pieces of your life scattered all over the internet, and some of them are for sale. Data brokers collect web searches, financial records, and location data from millions of people and sell them to various clients, including the US government.
While gathering that data has become easier in the smartphone era, making use of it at scale has remained difficult. But researchers are beginning to show that LLM agents can connect anonymized data to real people quickly, cheaply, and at a massive scale.
I’ve combed the internet to find you today’s most fun/important/scary/fascinating stories about technology.
1 Meta’s embrace of AI is making employees miserable Workers feel pressured to use the tech while fearing AI-driven layoffs. (NYT $) + They’re also unhappy about Meta tracking them to train AI. (The Verge) + AI’s rise has been described as “the most joyless tech revolution ever.” (WSJ $) + Gen-Z is particularly fed up with it. (NYT $) + We’ve entered the era of AI malaise. (MIT Technology Review)
2 South Korea’s military wants robots to fill gaps in troop numbers It’s in talks with Hyundai to bring robotics to the front lines. (Bloomberg $) + They could include Boston Dynamics’ Spot and a new exoskeleton. (SCMP) + South Korea’s military has shrunk by 20% over six years. (BBC)
3 OpenAI is being sued over ChatGPT’s alleged role in guiding a mass shooter A lawsuit claims the bot said targeting children would bring more attention. (NBC) + Florida’s AG has opened a criminal investigation into the case. (NPR) + Does AI cause or amplify delusions? (MIT Technology Review)
4 The Canvas hack was the biggest-ever student data privacy disaster It exposes the risks of centralizing the data of millions of students. (404 Media) + While the platform is back online, the hack disrupted university exams. (NPR) + The breach is part of a trend of edtech vulnerabilities. (WP $)
5 Alibaba has joined China’s “chat to buy” shopping craze By integrating AI assistant Qwen into its e-commerce platforms. (Reuters $) + Companies are betting that chat is the future of online shopping. (SCMP) + OpenClaw is a driving force behind the trend. (MIT Technology Review)
6 Cybercrime increasingly comes with threats of physical violence In the US, the physical threats rose more than twofold last year. (BBC)
7 AI’s next phase plays into TSMC’s hands Taiwan’s chip-making giant stands to gain from the supply squeeze. (WSJ $)
8 Europe is confronting life without American tech Dependence on Silicon Valley is a growing geopolitical concern. (FT $)
9 The US, UK, and China top new rankings for AI in life sciences Switzerland and Germany follow in the AI Competitiveness Index. (SCMP)
10 The Pentagon has released a massive trove of declassified UFO files Including newly declassified documents, images and footage. (New Scientist) + The files contain reports of “orbs,” “saucers,” and lunar “flashes.” (Wired $) + Here’s how to spot an alien. (MIT Technology Review)
Quote of the day
“There’s a real sense where ‘safety’ isn’t a bad word anymore.”
—Nathan Calvin, general counsel at Encode, a nonprofit AI advocacy group, tells the Washington Post that Anthropic’s Mythos has forced a White House reset on AI safety.
One More Thing
This computer-generated image of Mars was built with laser altimeter data from NASA’s Mars Global Surveyor, which operated for nine years in orbit around the planet.
NASA/JPL-CALTECH
Inside NASA’s bid to make spacecraft as small as possible
As NASA’s InSight lander descended to Mars in November 2018, two tiny spacecraft tracked its progress. InSight had touched down, they reported, and survived its treacherous journey.
The mission offered a pathway to cheaper space exploration, with small, low-cost probes launching far more often than multibillion-dollar flagship missions. But there’s a catch: miniaturization can only go so far before it collides with the hard limits of physics.
NASA still hopes small sats could transform planetary exploration. But first, scientists and engineers have to figure out what these tiny spacecraft can realistically do.
IntroductionTheta-band transcranial alternating current stimulation (tACS) has been proposed to enhance working memory (WM) by entraining endogenous oscillations, yet the haemodynamic signatures accompanying theta-tACS–related WM gains remain unclear. We investigated whether 6 Hz tACS modulates prefrontal task-evoked haemodynamic responses during WM and whether such changes relate to behavioral improvement.MethodsIn a randomized, single-blind, sham-controlled design, healthy adults (18–30 years) were allocated to 6 Hz tACS or sham (initially n = 25 per group). Stimulation (1mA peak-to-peak, 20min, 30-sramp-up/down) was delivered bilaterally over the dorsolateral prefrontal cortex (DLPFC; F3/F4). Participants completed the Digit Span Test and N-back tasks (1-, 2-, 3-back) before and after stimulation. During N-back performance, fNIRS recorded bilateral DLPFC signals. Task-evoked oxygenated hemoglobin (HbO) β coefficients were estimated using a general linear model. Group differences in pre–post changes were tested using within-/between-group analyses and ANCOVA, with brain–behavior coupling assessed via Spearman correlation.ResultsAfter fNIRS quality control, 44 participants were included in the final analysis; six participants were excluded because more than 30% of channels were identified as low quality. Relative to sham, 6 Hz tACS produced greater improvements in backward Digit Span and total Digit Span. In the N-back task, accuracy improved selectively under the high-load 3-back condition (between-group change: [F(1.40) = 12.29, p_adj = 0.0034, η2p = 0.24)], whereas reaction time showed no significant between-group differences. fNIRS revealed post-stimulation increases in left DLPFC HbO-β during 3-back, with a significant between-group β-change at one channel [(F(1.40) = 10.69, p_adj = 0.035)]. Within the 6 Hz group, 3-back accuracy gains correlated positively with β-change in the left DLPFC (ρ = 0.44, p_adj = 0.039).ConclusionBilateral 6 Hz tACS selectively enhances high-load WM accuracy and is accompanied by increased task-evoked haemodynamic activation in the left DLPFC. The observed brain–behavior coupling suggests that theta-frequency neuromodulation may facilitate executive control under high cognitive demand via strengthened prefrontal neurovascular responses.
For decades, physicians and scientists have thought that metformin, a biguanide drug that is prescribed for millions of people worldwide for type 2 diabetes (T2D), mainly targets the liver to suppress glucose production. A Northwestern University-led study in mice has now found that this “wonder drug” instead acts primarily on the gut, and prevents glucose levels from rising in the blood by driving glucose utilization inside cells lining the intestine.
The research found that metformin slows mitochondrial energy production in gut cells by inhibiting mitochondrial complex I in the intestinal epithelium. This then “co-opts” the intestines to function as a glucose sink, forcing the intestine to metabolize extra sugar. The study also found that another biguanide drug, phenformin, and the structurally unrelated supplement berberine, which is known as “nature’s Ozempic,” appear to engage the same pathway in the gut as does metformin.
The preclinical findings could help to explain several gut-related clinical effects in people who take metformin and suggest that modulating mitochondrial metabolism in the gut may represent an effective strategy for controlling blood sugar. “Metformin essentially helps the intestine suck the glucose out of the bloodstream, which further highlights that the gut plays a major role in regulating blood sugar levels,” said corresponding author Navdeep Chandel, PhD, professor of biochemistry and molecular genetics at Northwestern University Feinberg School of Medicine.
Chandel is senior and co-corresponding author of the researchers’ published paper in Nature Metabolism, titled “Metformin inhibits mitochondrial complex I in intestinal epithelium to promote glycaemic control.” Chandel is also the David W. Cugell, MD, Professor of Medicine (Pulmonology and Critical Care), Biochemistry and Molecular Genetics, and an investigator with the Chan Zuckerberg Initiative. The study’s first author is Zach Sebo, PhD, a postdoctoral fellow in the Chandel lab who will soon start his own research group at the University of Kansas School of Medicine.
Metformin is the most widely prescribed medication for type 2 diabetes and the biguanide class drug approved by the FDA, the authors wrote. However, they noted, “Despite its extensive use, the mechanisms underlying its clinical effects, including attenuated postprandial glucose excursions and elevated intestinal glucose uptake, remain unclear.”
The body relies on glucose as a fast and versatile fuel, but too much glucose can lead to insulin resistance and ultimately damage blood vessels and organs. The newly reported study builds on findings from previous work in Chandel’s lab, which found that metformin lowers blood sugar by blocking a specific part of the cell’s energy-making machinery, mitochondrial complex I, a key enzyme in cellular respiration. The research reported in Nature Metabolism extends that work by pinpointing the specific tissue targeted by metformin.
The study used a mouse model genetically engineered to express a yeast enzyme (NDI1) that mimics mitochondrial complex I but is resistant to inhibition by metformin. By expressing NDI1 specifically in intestinal cells, those gut cells resisted metformin’s effects. In these mice, the drug’s ability to lower blood glucose was significantly reduced, demonstrating that inhibition of mitochondrial complex I in the gut is a key driver of its therapeutic action. “In this study, we show how metformin exerts multiple clinical effects through selective inhibition of mitochondrial complex I in the intestinal epithelium,” they wrote.
Corresponding author Navdeep Chandel, PhD, in his lab in Chicago. [Kristin Samuelson, Northwestern University]
Metformin is currently the only FDA-approved biguanide drug, but the team found that another biguanide, phenformin, which had previously been used to control blood glucose but was then withdrawn, also lowered blood glucose through the same mechanism. The findings suggest that directing drugs or supplements to the gut could be an effective strategy for controlling blood sugar, Chandel said. Sebo added, “Our study suggests that revisiting assumptions about metformin’s mechanism may offer a more detailed understanding of how it works.”
The study revealed unexpected parallels with berberine, a popular plant-derived OTC supplement that is often used to control blood sugar. Berberine has recently gained attention on social media as “nature’s Ozempic,” though experts caution that evidence is still limited, and it should not be used as a substitute for approved medications. The study by Chanel and colleagues has now found that berberine appears to engage the same pathway as metformin in the intestine. “Thus, we identify mitochondrial complex I in intestinal epithelium as a shared and essential therapeutic target for metformin, phenformin, and berberine,” the authors stated.
“Metformin has decades of clinical evidence behind it, whereas supplements like berberine are far less rigorously tested,” Chandel said. “If you’re going to use berberine, you may as well use the real deal.”
The study results may help to explain clinical observations among people who take metformin. According to Chandel, individuals who take metformin tend to have lower blood sugar after meals, and the study suggests that metformin turns the gut into a “sponge” that soaks up extra sugar. Individuals taking metformin also tend to have lower levels of circulating citrulline, which is made only by mitochondria in small intestine cells. If metformin inhibits mitochondria, citrulline production drops. Taking metformin also increases levels of GDF15, a hormone linked to reduced appetite and weight loss. The gut senses energy stress and sends out GDF15, which tells the brain to eat less and adjust metabolism.
“In addition to enhanced intestinal glucose utilization and blood glucose clearance, this mechanism accounts for metformin-induced citrulline depletion, improved postprandial glycaemia, and elevated lactoyl-phenylalanine (Lac-Phe) and growth differentiation factor 15 (GDF15) levels—all of which are definitive clinical outcomes caused by metformin treatment,” the authors wrote in summary.
“People have always wondered how one drug can do 10 things,” Chandel said. “Well, it can do that if the drug is hitting a big node in a cell, and hitting mitochondria in a cell is a big node. So, if you can get into those cells and inhibit mitochondria, it’s going to have huge effects.”
The rapid growth of cell and gene therapies is exposing structural limitations in how traditional biopharmaceutical systems were designed. Unlike batch-based manufacturing models, these therapies are patient-specific, requiring tightly coordinated execution across clinical, manufacturing, and quality domains.
In this environment, maintaining chain-of-identity and chain-of-custody is not simply a regulatory requirement, but a foundational design constraint. As programs move from early clinical development into global commercialization, gaps in system-level orchestration can translate directly into compliance and operational risk.
These pressures are driving renewed attention toward how digital infrastructure is architected in regulated life sciences, particularly around validation, traceability, and cross-system integration.
Monika Birdi, global product strategy leader for SAP’s Cell and Gene Therapy Orchestration (CGTO) platform, has spent more than two decades working on regulated enterprise systems across industries, with a recent focus on advanced therapy manufacturing and supply chains. In this interview with GEN, Birdi discusses SAP CGTO’s architecture, regulatory design in SAP Batch Release Hub (BRH) and Intelligent Clinical Supply Management (ICSM), and digital frameworks for inspection readiness, jurisdictional control, and chain-of-identity enforcement. She also shares insights on balancing innovation with GxP validation and building digital infrastructure for global commercialization of patient-specific therapies.
GEN: What foundational lessons about compliance architecture, data integrity, and large-scale system design most influenced your transition into life sciences and cell and gene therapy?
MB: The biggest shift I experienced after moving to life sciences was in perspective and significance. During the many years I worked building large-scale regulated systems in diverse industries, a failure of data integrity meant financial loss or reputational damage. However, when I moved into the pharma and biotech life science sectors, I realized that in this domain, there was zero margin for error. If the chain-identity breaks anywhere in that journey, there is no fallback.
Monika Birdi
This reality puts compliance at the heart of architecture. Controls need to be built from the start and cannot be retrofitted later. We must stop treating compliance and scalability as competing priorities, because when you architect them together, one enables the other.
GEN: When you began working in advanced therapies, what operational or digital fragilities did you observe in early-stage programs that signaled a structural gap in how regulated supply chains were being architected?
MB: The first thing we need to understand is that advanced therapies are completely different from traditional small molecule manufacturing. Hence, for organizations that have been in the pharma business, shifting to manufacture advanced therapies is different from both scientific and architectural perspectives. The same tools that worked for small molecules will not serve the end-to-end business for advanced therapies.
The common structural gaps I observed were around chain of identity and chain of custody tracking. Since these are typically not part of the native system design, every single process runs via piles of papers that are difficult to organize and trace. In these cases, there was no orchestration layer and all the systems—such as clinical, manufacturing, quality—were running in silos.
GEN: You have led the design and commercialization of SAP CGTO. What operational failures or regulatory risks did you observe in early-stage CGT programs that convinced you digital orchestration had to be architected differently from traditional pharma systems?
MB: Traditional pharma systems are built around batch manufacturing, where thousands of units are manufactured in one batch. Even if one batch fails the compliance, the next batch can be used by discarding the non-compliant batch. Chain-of-identity is being maintained through a combination of spreadsheets. This is what convinced me to rethink orchestration. You can’t take a traditional batch management system and configure your way into CGT compliance.
The right therapy needs to reach the right patient. So, with CGTO, the design question was never “how do we adapt existing functionality” to make a compliant solution. Our approach was to ask, “if we are building this from scratch for one patient and one batch, what should the process actually look like?”
GEN: Autologous cell and gene therapy manufacturing is patient-specific and tightly synchronized. How did you architect SAP CGTO to enforce chain-of-identity and chain-of-custody controls at every transition point rather than relying on retrospective reconciliation?
MB: Personalized advanced therapies operate under a unique manufacturing cycle, which makes conventional post-production reconciliation processes ineffective. We needed an architecture that shifts the control point from “detect and correct” to “prevent and confirm” for every transaction.
With SAP CGTO, every transition point, from receipt at the plant, disposition, manufacturing start, and allocation to final shipment, is within an order and includes validations to make sure the right patient gets the right therapy. The system won’t let you proceed with a mismatched identity. These validations ensure that the process is stopped immediately, instead of alerting the user at a later point in time.
GEN: In your work on SAP BRH, you focused on jurisdiction control and regulatory components. How do digital release architectures need to evolve to support multi-country regulatory environments while preserving data integrity and inspection readiness?
MB: Most organizations use local Standard Operating Procedures (SOPs) and spreadsheets, utilized by people who have been around long enough to manage the regulatory requirements. This system will likely fail if a critical employee leaves, or if you are entering a new market under pressure, or when an inspector asks you to reconstruct a release decision from two years ago.
Jurisdictional controls should be part of the solution. Once validations are embedded directly into workflows, compliance becomes part of the business process. The audit trails are thus automatically created as a natural result of doing the job.
GEN: You believe designing infrastructure before scale exposes operational gaps. What are the most common digital fragilities you see when sponsors defer enterprise architecture decisions until Phase III or Phase IV?
MB: In cell and gene therapy, many sponsors treat digital infrastructure like office furniture: something to worry about later. The largest problems tend to be in two areas: traceability and coordination.
Credit: Metamorworks/Getty Images
In terms of traceability, it’s common for programs to track materials in whatever way is convenient at that time, such as spreadsheets, half-set-up software, or systems that don’t talk to one another. But for a hundred patients across many sites, it becomes nearly impossible to track it all correctly, especially when the FDA starts asking questions.
But as trials get bigger, it becomes difficult to manage all of it through those means—and in fact, it can become dangerous. Then, as the trial advances, scale your investment in alignment with emerging trial results.
GEN: Across CGTO, BRH, and ICSM, you have helped define regulatory-ready digital architectures for emerging therapy models. What measurable operational or compliance outcomes have resulted from these implementations, and how do they demonstrate advancement in the field’s digital maturity?
MB: The actual benefit of digitalization in advanced therapies shows up in audits and inspections. By ensuring that digital systems are properly implemented from the beginning and integrated with quality and batch record systems, decisions regarding the release of batches are much faster and more accurate.
In the area of clinical trials, integrated systems enable teams to predict and prevent problems rather than simply reacting to them. This results in fewer delays, and the benefits are easy to demonstrate and prove to the authorities.
GEN: What principles guide your approach to building compliant cloud-native platforms that remain modular, secure, and extensible?
MB: I believe modularity itself is a compliance strategy. Highly integrated platforms introduce hidden risk, because every regulatory change or market requirement can trigger system‑wide retesting.
I design security and extensibility together, with clear separation between what is validated, configurable, and subject to formal change control. That clarity allows teams to move faster without compromising compliance.
Commercialization teaches you that adoption depends on validation of reality. A platform can be technically strong, but if it is difficult to validate and operate in a regulated environment, it will not be scaled. The most successful products do not transfer the customer’s validation burden.
GEN: As advanced therapy pipelines expand and manufacturing networks become more geographically distributed, which architectural capabilities will determine whether organizations can sustain compliant commercialization without repeated remediation cycles?
MB: We need to start building compliance as the core of architecture instead of treating it as per each unique market need. Once the foundation has been set, market regulations can be adjusted accordingly. A few capabilities in which I would invest early include real-time chain-of-identity enforcement, jurisdictional logic embedded in workflows rather than documented beside them, and audit structures that generate inspection-ready data as a natural output, as opposed to a reconstruction exercise. What really matters most is the flexibility of architecture. Regulations evolve, new markets pop up, and manufacturing networks constantly adapt and relocate. This requires organizations to build adaptable and modular architecture that can evolve with growth.
![Corresponding author Navdeep Chandel in his lab in Chicago. [Kristin Samuelson, Northwestern University]](https://www.genengnews.com/wp-content/uploads/2026/05/Low-Res_Navdeep-Chandel-1-225x300.jpeg)
