Blog Archive - Recon Strategy

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

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

Tory Wolff November 20, 2022

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

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

Marc Herant October 2, 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,

Trends in oncolytic virus therapeutics: then and now

David Kaufmann and Marc Herant September 26, 2022

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

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

Jacob Wiesenthal and Tory Wolff September 19, 2022

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,

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

Alyssa Idusuyi September 12, 2022

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

An auto- or allo- future for cell therapy?

Sarah Dolman and Maggie Pickard August 26, 2022

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

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

Thomas Uhler and Jason Brauner August 19, 2022

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

An excellent July vintage: an opinionated take on NEJM highlights for July 2022

Marc Herant August 1, 2022

Tirzepatide in pole position As previously described in this blog, GLP-1 agonists initially designed to treat glycemia in Type-2 diabetes are emerging as powerful weight loss agents in obesity independent of diabetic status. Recently, tirzepatide (Mounjaro, Lilly, approved May 2022) which combines GLP-1 and GIP activity has shown potential to be best in class, and this is supported by a 72-week study that randomized 2539 obese individuals to 3 different tirzepatide doses or placebo. The results are nothing short of spectacular with ~-21% mean change in weight at the optimal

What’s so special about One Medical in the eyes of Amazon? A few quick thoughts

Tory Wolff and Thomas Uhler July 27, 2022

There isn’t a bricks-and-mortar primary care acquisition out there that is beyond Amazon’s financial reach. While the announcement regarding One Medical has provoked fresh rounds of speculation about what Amazon might do broadly in primary care (e.g., push Pillpack),[1] our interest here is in why Amazon seems to think One Medical specifically is the right move right now. Below are some quick thoughts: Compatible business models One Medical’s legacy commercial business and Amazon (Prime) both operate a fixed annual membership fee plus charge-per-transaction business model. The membership fee provides customers

Looking into the crystal ball – What is in store for the future of gene therapy delivery?

Jason Brauner and Anja Schempf July 18, 2022

Download Here: Troubleshooting GT_Recon Strategy 2022 In the last decade, gene therapies have been a major area of development and interest. What kicked off with the approval of Spark Therapeutics’ Luxturna in 2017 has now blossomed into a robust pipeline including the approval of Zolgensma (Novartis), and a number of cutting-edge therapies in clinical trials (such as Uniqure and CSL Behring’s therapy for hemophilia or Ultragenyx’s therapy for MPS IIIA). However, while the number of gene therapies entering clinical trials has increased, so have the inevitable stumbling blocks in development.

An opinionated take on NEJM highlights for June 2022

Marc Herant July 1, 2022

A cell therapy success against a solid tumor In CAR-T therapies, T-cells are transformed to express an antibody on their surface that allows them to home in on cancer cells and effect killing. This approach has seen remarkable successes in hematological tumors but not so much in solid tumors. However, efforts have been underway to use the intrinsic killing mechanism by T-cells which relies on the native T-cell receptor. The idea is that instead of inserting an antibody construct (i.e., the CAR-T approach), the T-cell receptor is modified to be

An opinionated take on NEJM highlights for May 2022

Marc Herant June 2, 2022

A step forward for kidney xenotransplantation A report on the recent, well-publicized, temporary transplantation of kidneys from genetically modified pigs in two deceased individuals at NYU. The kidneys functioned well and there was no sign of acute rejection, but because these experiments took place over only 54 hours, this is not indicative of longer term compatibility of the transplant of kidneys from this particular strain of pigs. A question in my mind is why there have not been kidney xenotransplants in live patients yet – especially given a recent porcine

Advances in AI for Health in 2021: An Analysis of the Clinicaltrials.gov Registry

Irina Ahmad June 2, 2022

The role of artificial intelligence (AI) and machine learning (ML) in healthcare spans a vast range of potential applications. A view of AI development on clinicaltrials.gov helps to focus this landscape, giving a sense of trends and near-term applications. Following last year’s review of AI development, we have updated our analysis to include registered studies starting in 2021.[1] The analysis revealed continued strong growth of studies across the field, especially in patient engagement and research. Within patient engagement, the tools studied (mostly chatbots) have increased in complexity, tracking with advancements

An opinionated take on NEJM highlights for March-April 2022

Marc Herant May 1, 2022

The opioid crisis and patient abandonment A perspective from a February issue that I originally missed highlighting the plight of patients who have been on a long-term opioid regimen for chronic pain. They are often stable, but it is when their physician retires or leaves that all hell breaks loose because, in this day and age, they cannot find another physician to continue the regimen. For someone who has been taking large doses of opioid for many years, going cold-turkey, or even tapering, is just not an option. These folks

The coming site-of-care shock for infusions

Jacob Wiesenthal and Tory Wolff April 26, 2022

There’s a major disruption looming in how the site-of-care for infusions is managed which will have repercussions for plan competition, delivery system economics, PE hunting for healthcare opportunity and biopharma commercialization strategy. Plans have long been frustrated by the growth of infusion care in expensive hospital outpatient department (HOPD) settings. HOPD infusion services can cost health plans on average 70% more than a physician office for the same infusion. But because patients on infusion therapy are often very sick and the therapies hard to tolerate, plans have historically been reluctant

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