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Recon takes an analytical look behind select developments in healthcare

An opinionated take on NEJM highlights for the first quarter of 2024

Hitting reset for the immune system Every time I get into a new issue of the NEJM, I have a sense of anticipation as in “will this one have an article that blows my mind?” It doesn’t happen very often, perhaps once or twice a year, but when it does, it’s an awesome feeling. From Germany, an application of CAR-T (CD19 directed) therapy to severe autoimmune disease reporting on 15 patients, 8 with severe SLE with renal involvement, 3 with myositis, and 4 with scleroderma, all progressing despite treatments with

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Trends in biotech deals in 2022 and 2023: oncology vs. the rest

Summary After challenging conditions in 2022, deal-driven biotech spending appears to have picked up in 2023. To quantify this trend we have systematically reviewed deals announced during this period and examined differences based on therapeutic areas and stage of development. We find that (1) deal counts shrank in oncology compensated by growth in other TAs; (2) the decrease in number of oncology deals was largely driven by less appetite for earlier phase assets, whereas compensated growth in other TAs came from the same earlier stages of development, (3) across the

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An opinionated take on NEJM highlights for the fourth quarter of 2023

A Chinese study uncovers a new use for an old drug Bleeding in the small intestine is often due to vascular malformations and is difficult to diagnose and manage because 1) the area is hard to reach with a scope and 2) bleeding tends to be intermittent.  Existing approaches are cumbersome and far from satisfactory, which makes a recent blinded RCT study conducted in China exploring thalidomide use in those patients valuable – not only did it show a significant decrease in bleeding episodes after a course of 4 months

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Multi-Cancer Early Detection tests – Will they become part of regular clinical care?

PDF here Summary The idea of a single blood-test to detect many cancers is attractive, but is it practical? Can an MCED enhance, or even replace, current screening tests? This paper delves into these questions by reviewing the effectiveness of current cancer screening methods and identifying areas with the most unmet need. We examine results of Grail’s PATHFINDER2 study on Galleri®, one of the first tools designed to detect many cancers in a single test. However, the test’s adoption will depend on cost-effectiveness, which considers price, cancer detection rate, and

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An opinionated take on NEJM highlights for the third quarter of 2023

How the US taxpayer saved 25M+ people A short piece celebrating the 20th anniversary of PEPFAR, a program that few outside of the field of Global Health are aware of. The world is not always nasty and brutish – it’s a shame it’s not said a bit more often. PEPFAR at 20 — A Game-Changing Impact on HIV in Africa   A hypertension trend? A second study of an investigational antihypertensive drug in the Journal this year; are we back in the 80s or something?  Joking aside, cardiac and vascular

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An opinionated take on NEJM highlights for the second quarter of 2023

Preparing for the next pandemic: don’t waste the value of waste During the Covid-19 pandemic, I got in the habit of checking weekly the Boston sewage report, as a reliable, unbiased way of monitoring trends of infectious activity. There is clearly much more information to extract from waste monitoring and a recent report from the National Academies of Sciences, Engineering, and Medicine makes a number or recommendations. The CDC is implementing some of them, but in the end, exploiting this source of information will depend on 100s of local actors

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TEDxBoston AI in Healthcare

What does Socrates have to do with AI? And what’s the Spooky Mountain and why we need to conquer it to get to an AI enabled future?

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Trends and strategy in oncology development

PDF: Trends and strategy in oncology development Summary We review a sample of oncology programs from the past decade and arrive at the following key findings: The use of expansion cohorts in first-in-human (FIH) studies has grown significantly in the last decade, with an accompanying decrease in separate phase 2 studies Commercial-stage sponsors and early-stage companies backed by established VCs are much more aggressive in discontinuing programs quickly compared to other early-stage companies For drugs that achieve approval, the time from FIH to approval is much shorter for big pharma

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An opinionated take on NEJM highlights for the first quarter of 2023

Hypertension?! Antihypertensive drugs are so 80s and 90s (well, except for pulmonary hypertension) to the point that I cannot recall when I last read research in the NEJM about a new blood pressure drug. One of the reason is that we have so many existing drugs (most of them cheap generics) but despite this, a fraction of hypertensive patients are refractory and cannot get to their blood pressure goal despite using multiple agents. This is where baxdrostat (CinCor Pharma) comes in; it is an oral drug blocking the synthesis of

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Is the future of US pharma manufacturing domestic?

View the PDF here. The supply chain of pharmaceuticals consumed in the US has become reliant on foreign sources of drug products and intermediates over the last two decades. Growth of generics and biosimilars has driven firms to reduce labor costs, which has led to China and India leading much of upstream supply. In response, the White House has announced a series of funded initiatives aimed at improving the US’s domestic market share, creating “good jobs,” and reducing supply chain risk. However, our analysis of the pharmaceutical manufacturing industry suggests

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Can BiTEs take a bite out of CAR-Ts in hematologic cancers?

Download a PDF of this article here. Hematologic cancers account for ~10% of annual new cancer diagnoses and continue to have some of the poorest overall outcomes, particularly for older adults.[1] However, the last decade has seen major clinical improvements, led by drugs from two new modalities: cell therapy[2] and bispecifics. Here, we discuss the looming competition between these two drug-classes for hematological cancer indications. With recent approvals, and multiple late-stage assets for the same indication, the success of future launches will depend on how treatment paradigms shift, or do

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An opinionated take on NEJM highlights for December 2022

An unusual article on road safety Motor vehicle accidents are a major share of morbidity and mortality in the young, and as such prevention has long been considered a medically adjacent area (e.g. with pediatricians asking about infant car seats etc.).  Still it was a surprise to see an article on an intervention specifically designed to improve road safety in the NEJM, but it applies specifically to teens with an ADHD diagnosis, for whom distraction while driving is a significant risk factor. In the study, 152 teen drivers with ADHD

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Hearts and souls: An opinionated take on NEJM highlights for October and November 2022

A psychedelic for refractory depression While major depression is awful, treatment-resistant depression (as defined not responding to at least two different courses of therapy) is worse with sufferers stuck in a long dark tunnel of anguish without a light at the end of it. Since psilocybin (the psychedelic agent in so-called magic mushrooms) has shown some effectiveness in depression, it seemed reasonable to test its differentiated mechanism of action in this high need patient population.  In this study that was mostly Europe-based but included sites in the US (finally), patients

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Amazon becomes a shopping facilitator for healthcare services (finally…)

Back in 2018, I offered a speculation about what Amazon might do in healthcare as part of its now defunct joint venture with JPMorgan and Berkshire Hathaway.   The focus was on doing what Amazon is remarkably good at: creating simple, consumer-friendly, transparent and highly liquid markets.   Here was my suggested Step 1: “[T]here are several classes of healthcare that many patients are ready to shop for (and payers have been trying to get them to shop for): minor acute care (sniffles and coughs to simple fractures), basic diagnostic

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Some very disappointing failures: An opinionated take on NEJM highlights for August and September 2022

Is Parkinson’s α-synuclein going to be as elusive a target as β-amyloid has been for Alzheimer’s? Alpha-synuclein aggregates are characteristic of Parkinson’s disease and genetic variants of this protein clearly lead to familial forms of Parkinson’s; it was therefore reasonable to target alpha-synuclein with antibodies in the hope of modifying disease progression. Sadly, two well designed placebo-controlled studies have now crushed this hope. Both showed absolutely no impact on the progression of patients with early Parkinson’s over times that extended to 1.5 year of follow-up. If there is silver lining,

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Trends in oncolytic virus therapeutics: then and now

PDF: Trends in oncolytic virus therapeutics: then and now The idea of using pathogens to treat disease is not new; ranging from phage therapy to malariotherapy (resulting in the only Nobel in medicine to a psychiatrist – in 1927), but it was really only with the onset of the biotech revolution in the 1990s that an old concept of using viruses as tumor killing agents started to come into its own.  As the ability to characterize viruses at the genetic level grew, it was followed by the techniques to genetically modify

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Are some of Kaiser’s regional ambitions starting to pay off?

PDF: Are some of Kaiser’s regional ambitions starting to pay off? We have produced a new study evaluating developments in Kaiser’s regions (outside of California). The report provides an explanation for recent improvements in performance as well as leadership and governance changes. Further, we identify several implications for the future of Kaiser strategy. The Kaiser Permanente model has a heavy infrastructure, and so it requires a lot of local market share and operating scale to deliver a positive net underwriting margin (we roughly size how much using statistical analysis). Yet,

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What should school nurses do (and not do)? A call for further research

About the author: Alyssa Idusuyi is currently a high school senior attending Miss Porter’s School (Connecticut). She spent the summer of 2022 with Recon Strategy as a paid intern assigned a project to research the evolving role of school nurses in student health. Alyssa plans to attend college next year, and is considering a career in healthcare.   School nurses do more than just give students band aids and Tylenol. Since the rise of the COVID-19 pandemic, school nurses have been front and center in taking care of students and

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An auto- or allo- future for cell therapy?

Download a PDF of this article here. Ex vivo gene-therapies have been a game-changer for aggressive hematologic cancers. These products can effectively cure patients who otherwise had very low chance of survival beyond 5 -years.  However, making these products is exceptionally complex and the drugs are priced accordingly (from $370,000 to over $2.5M). While few patients receive these treatments today, clinical development could lead to a much broader population. If 1 in 20 newly diagnosed cancers were optimally treated with these high-price therapies, the cost to health-payers could become untenable

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An innovative sales strategy for a pivotal drug; Novartis trailblazes with Leqvio

After the $9.7B acquisition of The Medicines Company two and a half years ago, Novartis is eager to demonstrate value with a successful launch of the primary target of the deal, Leqvio. This launch is also a key catalyst for new revenue generation at Novartis, due to a $9B patent cliff by 2026. Given the high-stakes nature of Leqvio’s launch, the decision of the Swiss pharma to employ a non-traditional sales strategy in several key countries, including US and England, is noteworthy.   Novartis paves an innovative commercial path for

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