When Cindy Oksanen started out at Pfizer’s Groton, Connecticut research headquarters in 1992, she entered an environment where female Ph.D.s in leadership positions were rare. Starting out as a lab scientist, she developed formulations for new drugs including oral dosage forms like tablets and capsules. “We would develop the dosage forms and then transfer the…
Pharma M&A activity primed for another high-flying year in 2024
Despite challenging interest rates and regulatory environment, pharma M&A activity surged in 2023 with deal volume up more than 30% from the prior year based on a review of more than 200 acquisitions since 2018. The total disclosed deal value in 2023 also more than doubled the prior year’s tally to surpass $100 billion. While…
A J&J veteran highlights listening to address overlooked maternal-fetal needs
With nearly 20 years of experience at Johnson & Johnson, Cynthia Accuosti Jones now spearheads the company’s pioneering maternal-fetal medicine group tackling unmet needs in high-risk pregnancies. As vice president of global commercial strategy for autoantibody and maternal fetal health, she spotlights listening as the driver for patient impact. “You can’t have empathy if you…
ConcertAI acquisition will boost CancerLinQ data capabilities with AI focus
The AI oncology startup ConcertAI recently acquired CancerLinQ, one of the largest oncology real-world data and quality of care technology service entities. Originally developed by the American Society of Clinical Oncology (ASCO) in 2013, CancerLinQ aims to use real-world data and technology to improve cancer care and advance evidence-based research. CancerLinQ has developed one of…
A nurse-turned-pharma-exec strives to advance care for those with an autoimmune liver disease
Now the vice president and head of medical affairs at CymaBay Therapeutics, Mary Standen‘s passion for healthcare was sparked in her high school years when her mother was diagnosed with breast cancer. Though her mother eventually recovered, Standen was galvanized to help provide both emotional support and practical assistance, such as administering weekly injections. The…
How a J&J exec found her calling in autoantibody drug development
Dr. Katie Abouzahr’s career, which began in the wards of the UK’s National Health Service (NHS) before extending into management consulting, paved the way for her leadership of autoantibody and maternal fetal medicine programs at Johnson & Johnson. “It’s not a typical pharma executive’s straight line path,” she acknowledged. “Careers can often be jungle gyms…
AbbVie bets on quality of life approach to gain share in migraine treatment market
In a crowded migraine treatment landscape, AbbVie is aiming to differentiate itself by redefining migraine treatment beyond just counting headache days and other traditional clinical endpoints. At the European Headache Congress (EHC), the company touted its patient-centered approach in evaluating quality of life, daily functioning, rapid relief, and balanced benefit-risk profiles, while aiming to continue…
Two-thirds of pharma companies plan to up IT investments in 2024, survey finds
Two out of three pharma companies (67%) plan to ramp up investment in IT, including AI, over the next 12 months, according to a survey from the cloud vendor Rackspace Technology and Dell/VMware conducted in October 2023. About the same amount, 68%, reported challenges in recruiting and hiring talent skilled in cloud and AI technology.…
LSD shows promise as standalone anxiety treatment in trial
Phase 2b data from MindMed’s LSD-based therapy adds to the mounting evidence that psychedelic-assisted therapies could treat mental health conditions like anxiety, depression and PTSD. In particular, the study found statistically significant dose-dependent improvements in the Hamilton Anxiety rating scale (HAM-A) at the 100 and 200 μg dose levels in the four-week study. Similarly, recent…
Unlocking generative AI requires reshaping culture, operations, and talent dynamics
In drug discovery and development, generative AI and natural-language processing (NLP) tools promise more than incremental productivity gains. For companies that can integrate such tools strategically into their workflows, the tools open the door to a fundamental rethinking of operational processes. For instance, generative AI tools can accelerate drafting of research articles, novel target identification,…
Delix’s psychedelic-inspired DLX-001 appears to pose no safety or hallucinogenic risks in early testing
Biotech startup Delix Therapeutics has unveiled promising interim phase 1 safety data for its lead neuroplasticity drug candidate DLX-001 at a leading neuroscience conference, marking the first clinical validation of its “psychoplastogen” pipeline. In essence, the company is developing psychedelic-inspired therapies that can prompt neuroplasticity without the hallucinogenic, psychotomimetic, or dissociative effects typical with traditional…
MDMA’s potential shift from party drug to PTSD therapy could hinge on strict safety measures
MDMA, the stimulant mood-lifting drug commonly known as ecstasy, could soon transition from party staple to FDA-approved medication — but likely with tight control measures to address its abuse potential and safety risks. On Tuesday, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) filed an application seeking FDA approval of MDMA-assisted therapy for post-traumatic stress…
Zepbound helps people lose 25% of body weight on average 88 weeks, but weight regain is a concern
Lilly’s hot weight loss drug Zepbound (tirzepatide) may be one of the most effective drug therapies for weight loss. In an open-label 36-week study, participants lost an average of 20.9% of their body weight in 36 weeks. With an average weight of 107.3 kg (236.5 lbs), that equates to about 22.4 kg (49.4 lbs) on average.…
Pfizer hemophilia drug marstacimab accepted for FDA, EU review
U.S. and European regulators have accepted applications for Pfizer’s marstacimab, an investigational treatment for hemophilia A and B. The FDA set a decision date in late 2024 while the EMA set the stage for a possible approval in early 2025. The applications are based on positive data from the phase 3 BASIS trial, presented over…
Government patent seizures could curb costs but could have unintended consequences
The Biden administration has announced a new framework to enforce the government’s “march-in” rights to seize patents on drugs developed with taxpayer funding if it deems that their prices are unreasonably high. While the government has had these rights for decades thanks to the 1980 Bayh-Dole Act, it has not used them previously. Before the…
Kristofer Mussar on VectorBuilder’s ethical imperative in gene delivery
As genetic technologies unlock new possibilities, companies like VectorBuilder aim to navigate progress responsibly, guided by a strong moral compass. “Ethics to me is the one thing that really is so, so important,” said Kristofer Mussar, managing director of VectorBuilder GmbH. “I have such a high ethical threshold I make decisions that are sometimes not…
Unicorn gene-delivery firm VectorBuilder eyes future breakthroughs
Genetic tools are growing more powerful by the day and hold immense medical promise. Kristofer Mussar, managing director of VectorBuilder GmbH who holds a Ph.D. in molecular genetics and epigenetics, noted that in the wake of the pandemic, genetic research requires increased awareness and ethical stewardship to responsibly tap into its power. While the current…
EDC fading in prominence as AI and cloud gain ground
In a year or two, the clinical trial industry may move beyond electronic data capture (EDC), a technology that has been the cornerstone of clinical data management for decades, projects Raj Indupuri, CEO of eClinical Solutions. Given the potential of electronic medical records (EMR) to feed directly into data infrastructure, the need for EDC may…
Insilico Medicine’s latest AI-engineered drug ISM5411 could provide a novel approach for treating IBD
Capping off a busy 2023, Insilico Medicine has announced a potentially first-in-class oral PHD inhibitor for the treatment of inflammatory bowel disease (IBD). ISM5411 is the fifth AI-backed drug candidate from Insilico Medicine to reach clinical stages. ISM5411 targets prolyl hydroxylase domain (PHD) enzymes via modulation of the hypoxia-inducible factor (HIF) pathway, which is involved…
AWS-NVIDIA gen-AI alliance epitomizes Big Tech’s growing interest in drug discovery
The allure of healthcare has long captivated Big Tech giants. Over the past fifteen years or so, several prominent companies in the sector have ventured into the life sciences sector with ambitious projects, only to often find themselves retreating. The dynamic appears to be changing, particularly in drug discovery, thanks in part to burgeoning data…
At AWS re:Invent, Pfizer exec frames digital as a core business strategy
In the midst of a global pandemic, Pfizer, under the leadership of its chief digital and technology officer Lidia Fonseca, achieved what was once thought impossible. The company, with the partnership of BioNTech, developed a COVID-19 vaccine in only 269 days, a process that traditionally would have taken 8 to 10 years. While prior research…
2024 forecast: Navigating new frontiers in pharma with AI, synthetic data, and strategic partnerships
In late 2022, we published a series of predictions, which, among other things, projected that 2023 would be a “massive showcase” for machine learning (ML) in drug discovery and development. And in many ways, 2023 was a pivotal year for AI in pharma. This evolution in AI and ML applications in pharma built upon the…
Genmab’s data-driven strategies speed up drug commercialization
Genmab’s senior vice president, global head of data science and AI, Hisham Hamadeh, describes the company’s journey to becoming “a data-driven decision-making company.” In one sense, there is little choice but to do so. “We’re swimming in data like never before. We’ve seen the volumes of data, the ability to compute on that data, and…
How Accenture and AWS are upgrading Merck’s IT and drug discovery R&D engine
Historically, the pharma sector has exhibited a degree of caution in adopting emerging technologies such as cloud computing and AI, given the sector’s stringent regulatory requirements, data security concerns, and the complexities involved in integrating new systems into legacy processes. The situation is beginning to shift considerably with the COVID-19 pandemic, in particular, acting as…
Eversana’s AWS alliance aims to cut red tape in pharma regulatory paperwork
In July, the life sciences services company Eversana revealed it was partnering with AWS to tap generative AI (gen AI) for pharma and other life science customers. It aimed to “pharmatize” gen AI, as the company put it then. Now, the company has revealed the first technology from that partnership – a regulatory review automation…