Blog Archive - Recon Strategy

AI for Pipeline Discovery and Beyond

Sarah Dolman October 9, 2024

“media attention [is] on lead identification, probably because it sells headlines” – Greg Meyers, Chief Digital and Technology Officer, BMS[1] The biopharma industry is known for its high risk and potential high reward, but R&D costs have skyrocketed over the past century, delivering diminishing returns on investment. Despite breakthroughs, success rates remain low, and bringing a drug to market takes years. To combat this, the industry has continually adopted new tools, including crystallography, bioinformatics, robotics and high-throughput screening, all aimed at improving early-research efficiency and success rates. The latest tool generating

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

Marc Herant October 2, 2024

The new Humira? It’s not that often that you see industry-sponsored head-to-head studies of one biologic vs. another, but Abbvie took the plunge comparing risankizumab (Skyrizi) to ustekinumab (Stelara, J&J) a leading therapeutic for Crohn’s disease, a notoriously hard indication because of its unpredictable manifestations. The risk paid off for Abbvie: a significant advantage was seen for risankizumab which provided clinical remission in 60.8% of patients. Abbvie probably had no choice: ustekinumab biosimilars are expected on the market by 2025; absent a clinical advantage, most payers would have demanded patients

Can doulas help with our maternal health crisis? Promises and obstacles to impact

Phiona Nabagereka and Lilian Zhang September 18, 2024

About the author: Phiona Nabagereka is currently a high school senior attending the Noble and Greenough School. She spent the summer of 2024 with Recon Strategy as a paid intern assigned a project to research doula integration into clinical care teams. Phiona plans to study biology and statistics in college next year, and is considering a career in healthcare. Significant inequalities in US maternal health today Maternal death rates in the US have more than doubled in the past two decades. Notably, women of color are very overrepresented in

A Kaplan-Meier view of oncology development

Lilian Zhang, Jason Brauner, and Marc Herant August 8, 2024

We refresh a prior analysis of two cohorts of oncology development programs: one with first-in-human (FIH) in 2012, and the other with FIH in 2017H2. We use a Kaplan-Meier approach to track whether programs have reached either of two final outcomes: a first approval from FDA, or a discontinuation of development. We find again that programs from commercial pharma reach final outcomes much faster than those from early-stage biotechs, which likely reflects a mix of a higher operational resourcing and efficiency, and more portfolio prioritization rigor. Beyond other specific findings,

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

Marc Herant July 1, 2024

The quest for solid tumor CAR-T For all their success in hematological cancers, the track record of CAR-Ts against solid tumors has been disappointing (though see here for an exception). One key obstacle has been access by CAR-Ts to the tumor site. Here, a Mass General team reports on their experience treating 3 patients afflicted with glioblastoma multiforme (GBM, a nearly always fatal brain malignancy) positive for a variant of the EGFR receptor. In each case they prepared (autologous) CAR-Ts against the EGFR variant, and delivered them directly into the

Walmart Health didn’t test the opportunity in rural underserved markets

Harry Sultan and Tory Wolff June 20, 2024

What lessons can be drawn from Walmart’s precipitous shut down of its attempt to launch primary care, dental and behavioral health services? The Walmart Health management team (after some mid-stream ‘dialing in’) was composed of savvy healthcare insiders; the team could tap into learnings from Walmart’s four prior attempts to launch clinics inside supercenters; and Walmart invested quite a bit of money in the effort. Collectively, however, these assets were not enough for success. We think Walmart Health’s key mistake was to target markets with high disposable income, which, unfortunately

Beyond drug supply: BIOSECURE and early-stage drug R&D

Sarah Dolman June 10, 2024

A PDF version can be downloaded here. One of the major aims of the proposed BIOSECURE ACT[1] is to reduce supply-chain risks for pharmaceuticals, by penalizing firms that contract with China-based “biotechnology companies of concern” — specifically naming WuXi AppTec and WuXi Biologics. Nearly all discussion in the media has focused on the impact to drug-manufacturing; yet the contribution of these firms to innovation may be even greater. The industry must plan ahead — to future-proof not just supply chains, but also product-pipelines and diversity of CDMO partners. Here, we

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

Marc Herant April 2, 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

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

David Kaufmann, Marc Herant, Jason Brauner February 7, 2024

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

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

Marc Herant January 3, 2024

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

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

Sarah Dolman December 21, 2023

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

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

Marc Herant October 2, 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

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

Marc Herant July 3, 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

TEDxBoston AI in Healthcare

Nikhil Bhojwani June 1, 2023

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?

Trends and strategy in oncology development

Lilian Zhang, Jason Brauner, and Marc Herant May 15, 2023

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

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

Marc Herant April 20, 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

Is the future of US pharma manufacturing domestic?

Jacob Wiesenthal and Sarah Dolman February 10, 2023

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

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

Maggie Pickard and Sarah Dolman January 6, 2023

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

An opinionated take on NEJM highlights for December 2022

Marc Herant January 4, 2023

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

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

Marc Herant December 4, 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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