Validation Lead

Sibylla names ex-Novartis cell and gene therapy head Usman Azam CEO. 13 October 2026 Italy's Sibylla Biotech, an oncology firm developing small-molecule protein degraders that interfere with protein folding, has appointed Usman Azam as chief executive and Gianluca Fuggetta as chief financial officer, as it prepares to take its lead program into first-in-human studies. Lidia Pieri, a co-founder and Sibylla's previous chief executive, becomes chief operating officer, and Elena Ardini is promoted from vice president of research and development to chief scientific officer. The company said the changes reflect progress in validating its folding-interference technology and its plan to move its lead program, a degrader targeting cyclin D1, into the clinic. This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here. Try before you buy Free. 7 day trial access * All the news that moves the needle in pharma and biotech * Exclusive features, podcasts, interviews, data analyses and commentary from its global network of life sciences reporters. * Receive The Pharma Letter daily news bulletin, free forever. Become a subscriber £820. Or £77 per month * Unfettered access to industry-leading news, commentary and analysis in pharma and biotech. * Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results. * Daily roundup of key events in pharma and biotech. * Monthly in-depth briefings on Boardroom appointments and M&A news. * Choose from a cost-effective annual package or a flexible monthly subscription The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It's part of the key information for keeping me informed Chairman, Sanofi Aventis UK More on this story... 8 May 2025 12 October 2026 14 March 2024 Companies featured in this story. Sign up to receive email updates Join industry leaders for a daily roundup of biotech & pharma news Today's issue. 13 October 2026 Company spotlight. An RNA therapeutics platform company enabling discovery and development of modular and programmable RNA medicines. More features in biotechnology. 13 October 2026

INVESTOR ALERT: Pomerantz law Firm investigates claims on behalf of investors of Novartis AG - NVS. Oct 08, 2026, 10:00 ET NEW YORK, Oct. 8, 2026 /PRNewswire/ - Pomerantz LLP is investigating claims on behalf of investors of Novartis AG ("Novartis" or the "Company") (NYSE: NVS). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980. The investigation concerns whether Novartis and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. On September 8, 2026, Novartis issued a press release "announc[ing] that the global Phase III HARBOR study evaluating del-desiran in people living with myotonic dystrophy type 1 (DM1) did not demonstrate statistically significant improvement versus placebo on the primary endpoint of video hand opening time (vHOT), a novel measure of hand myotonia." On this news, Novartis's American Depositary Share ("ADS") price fell $22.29 per ADS, or 13.93%, to close at $137.70 per ADS on September 8, 2026. Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com. Attorney advertising. Prior results do not guarantee similar outcomes. SOURCE Pomerantz LLP

The case for regeneration over slowing decline. Novartis' President of Biomedical Research, Fiona Marshall, on what it would take for big pharma to go all in on longevity. When the person who runs research for one of the world's largest drug companies turns up at a longevity meeting, people notice. Fiona Marshall oversees around 5,500 scientists across nine Novartis research sites, and she sits on the company's Executive Committee. As one pharma attendee put it to me, why is someone like Fiona Marshall at a conference like this, rather than at a 10,000-delegate cancer congress? Longevity Ltd. sat down at the ARDD 2026 conference to find out why and explore where Novartis sees the real opportunities in the biology of aging, and the hurdles that stand between the field and an approved 'antiaging' drug. Aging as the root cause. Marshall, a Cambridge-trained neuroscientist who co-founded structure-based drug design company Heptares before senior roles at Merck & Co, says her interest in aging goes back more than a decade - and it comes straight out of the day job. "As head of research, we need to start with the understanding of the disease, and then from there, what are the best treatments," she says. "More and more over time, I keep seeing how aging is in fact the major cause of disease at the end of the day. Probably the most important cause." Decades of focus on genetic risk, she explains, have delivered some very effective therapies - but have also shown that genetics is only one factor interacting with environment and lifestyle. "When you think about what these other factors are that genetics interacts with, aging is one of the main ones," she says. Large data sets now make that link to disease - and the way factors like exercise modify it - "very much more mainstream science." That thinking runs through Novartis' Diseases of Aging and Regenerative Medicine (DARe) research area, which targets three fundamental aging processes - mitochondrial dysfunction, declining DNA repair and extracellular matrix alterations - supported by a data-driven 'Regeneration Engine'. Marshall points to a long Novartis heritage in aging biology, from mTOR and rapamycin to cardiovascular prevention and, more recently, musculoskeletal work in sarcopenia and osteoarthritis. "That led to thinking about regenerative medicine," she says. "Instead of just trying to slow the decline, is there a way you can regenerate healthy tissue?" Inflammaging - and not everyone ages the same way. Asked which aging pathways excite her most, Marshall goes straight to inflammation. She cites Novartis' CANTOS study of the IL-1β antibody canakinumab, which was designed to lower cardiovascular risk but also produced signals that "lowering inflammation actually had a beneficial effect on cancer outcomes." Even after Novo's ZEUS trial of IL-6 inhibitor ziltivekimab missed its cardiovascular endpoint this summer, she says interest in IL-6 biology remains. The real question is patient selection - and here she outlines what may be one of the most important ideas in the field. "Probably some people do have more inflammation-driven aging. Other people may have more metabolic-driven aging," she says. "Some may be more prone to DNA mutations - maybe they have lower DNA repair enzyme activity." Proteomic signatures are beginning to reveal these different pathways. "The next stage, I think, is to look at what we call aging endotypes," she explains - stratifying people by their dominant driver and matching them with different therapeutic approaches. Healthspan first, not lifespan. Does that mean Novartis is preparing to take a pan-aging drug to regulators? Not yet. "We're still very much focused on our core diseases, which are nearly all diseases of aging - cardiovascular disease, neurodegenerative disease, and even cancer," Marshall says. And she is clear about the goal. "Our aim is not to increase lifespan. It actually is to increase healthspan. My concern about going for lifespan until we've addressed healthspan is you are actually going to just increase disease burden, not reduce it - particularly neurodegenerative disease." Nor is prevention necessarily the industry's first move. As cardiovascular care improves, prevention trials get longer, larger and harder. Developers therefore target the highest-risk groups - often people who have already had an event. Going earlier is the ideal, she says, "except then you need a much safer drug, because you're treating a healthy person for the rest of their life." GLP-1 drugs, she notes, benefited from a decade of use in diabetes before moving into broader populations. Why regeneration could be the cheaper bet. This is where regeneration becomes so attractive. Many current treatments for diseases of aging, such as Alzheimer's drugs, slow progression - measurable in a trial, but patients "don't feel any better." Counterintuitively, Marshall argues that a regenerative drug could be less expensive to develop, not more. "It's easier to measure an improvement than a reduction in a decline," she says. It is also a far easier case to make to payers and prescribers than saying a patient has "had a six-month less decline over three years." Novartis has historically pursued regeneration with small molecules from phenotypic screening, but the toolkit has widened: oligonucleotides, siRNA, mRNA, gene therapy and cell therapy can now all be brought to bear. Partial cellular reprogramming is "an area that we're very interested in" and "quite compelling" in preclinical models, but still early. Cell targeting is technically difficult, and whole-body approaches carry safety risk - so she expects the first clinical steps to come in focused, contained systems such as a single organ. As for how Novartis would access such technologies: build, partner or acquire - "we will go where the best opportunity is, and quite often, if it's a new technology, we do it with a partner." Mining exercise biology with BioAge. One such partnership is with BioAge Labs. Novartis is particularly interested in exercise as "profoundly beneficial as an antiaging mechanism," and the collaboration combines BioAge's longitudinal, multi-omic human data sets with Novartis' exercise expertise. The aim is to find targets that both decline with aging and are increased by exercise - the interface where an exercise mimetic could ultimately emerge. Regulators, endpoints and the consortium question. On the panel earlier that day, Marshall was the first to say Novartis would join a collaborative effort to move the field forward. Pressed on what would bring big pharma in, her answer was unequivocal: "If the FDA came up with a roadmap for how to develop an antiaging drug, we would be right in there. That would be one of the major barriers to entry." But the roadmap has to be achievable. She recalls a former FDA official once floating the idea of a 100,000-person trial with survival endpoints across multiple diseases - a study that, Marshall says, could take decades and cost billions, and would be impracticable to take forward. The obstacle, in other words, is the arithmetic of survival endpoints; at that scale and over that timespan, few sponsors could realistically see such a trial through. Instead, she sees a composite endpoint: biochemical biomarkers such as organ clocks as they become better validated, combined with AI-enabled imaging of muscle, bone, joints, the heart and the brain. "If you had a composite measure of those types of endpoints, those could be more tractable than survival." Agreeing those endpoints, she argues, needs a pan-system consortium rather than an industry club - academia, hospitals, regulators, small biotechs and large pharma, typically with government co-funding. She points to the EU's Innovative Health Initiative as a model, with companies contributing data and know-how rather than cash. IP is not the obstacle: "These are things we all need to agree with the FDA. It's really pre-competitive, and it's for the benefit of everyone." The catch is time - such efforts outlast a single government term and need long-term commitment, building on population resources such as the US All of Us program and the UK's Its Future Health. The next ten years. So where will the field be in a decade? Marshall expects a far deeper mechanistic understanding of how aging drives the major diseases - the causal biology that reveals druggable targets. "In less than ten years, hopefully, you would be seeing drugs that have actually come out of this causal biology, at the interface of aging and existing diseases," she says. Those drugs, she suggests, could act as a proxy for understanding aging's contribution to disease - "that ultimately could then lead to potentially antiaging drugs." Coming from the head of research at one of the world's biggest pharma companies, that is a measured but significant signal: the door is open - and a credible regulatory roadmap could be the key that unlocks it. Read more of its on-the-spot coverage of ARDD 2026 - CLICK HERE.