Category: Biopharma

Recon takes an analytical look behind select developments in healthcare

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

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.

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The coming site-of-care shock for infusions

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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The growth of small molecule drug classes over time

Modern drug discovery is largely based on the identification and validation of a biochemical target, and then screening and optimizing molecules that engage that target. Over time, this has given rise to an extensive set of small molecule drugs approved for human use with activity at specific biological targets. We wanted to answer the question of how many different targets are addressed by existing agents, and how the rate of addition of newly addressed-target has varied over time. To do this, we reviewed every small molecule drug approved since 1970

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The road ahead for genomic testing

New molecular diagnostics, especially tests based on next-generation sequencing and gene-panels, could revolutionize how diseases are evaluated. But experience shows that insurers won’t cover these tests just because they’re available – they need to improve clinical care. Here, we explore how researchers and test developers can prove value, and improve their chances at broad clinical uptake. Outside the niche realm of self-pay (where buyers have very different expectations[1]), the business opportunity of new molecular tests is driven by payer-coverage and reimbursement. Payers are beginning to manage[2] high-cost (>$1,000) lab tests

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The Puzzling Future of Healthcare

This post is from a talk at the 2021 Link Ventures CEO summit. Original talk: Transcript: The practice of medicine has always been an information problem. Clinicians seek to diagnose an ailment and to prescribe a cure based on an incomplete understanding of what’s happening in a patient’s body as it relates to an incomplete set of knowledge about diagnoses and treatments.  This aspect of medicine has remained the same for centuries even as our collective understanding of medicine has gone through three major phases.  Until the 18th century, much

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An ADC renaissance: a resurgence of antibody drug conjugates for cancer

PDF:  An ADC renaissance: a resurgence of antibody drug conjugates for cancer Summary: Antibody-drug conjugates (ADCs) have seen a record number of approvals in 2020. This comes after a first era of intense activity in the early 2000s followed by a period of relative quiescence from the late 2000s to mid-2010s. To understand how the nature of the ADC pipeline has changed over time, we have reviewed all 88 ADC oncology programs that have reached phase 2 development and beyond from 1997 onward. We found that, currently, the main contributor

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AI in healthcare III: COVID-19 applications and implications

COVID-19 has accelerated the adoption of AI in healthcare. AI based tools and solutions can work quickly, be deployed at scale, and respond to the dynamic nature of the crisis. Use-cases span all facets of responding to the pandemic, from diagnosis and triage, to treatment and combating new transmission. A wide range of players—including startups, established companies, universities, and more—are bringing their capabilities and perspectives to the table. Startups like Current Health, a UK-based remote-monitoring company supporting Mayo Clinic and Baptist Health with their COVID-19 response, are benefitting the industry’s

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Strategy in the Time of Covid

Preamble A recent post from Recon Strategy outlined the longer-term strategic implications of Covid-19 on 12 healthcare sectors. This post highlights the opportunity to redeploy corporate strategy assets to focus on the most important short-term strategy imperatives to not only ensure organizational resilience but to set up for success coming out of this crisis. Corporate strategy teams have tremendous analytical, creative, and operationally savvy resources that are accustomed to jumping into new situations, getting quickly up-to-speed, and delivering value. Leaders should proactively point these resources towards these areas of greatest

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The day after: Implications for hospitals, payers, biotech and more…

Even as our priority today is dealing with the Covid crisis, healthcare organizations would do well to start thinking about the longer-term implications for their strategies. In some instances the marketplace will revert to the prior dynamic, but in many others the changes wrought during this crisis are likely to persist in a way that will call for new strategy or will produce unpredictable outcomes that will require scenario planning. Sectors will be impacted in very different ways and there will be winners and losers in each. In this short

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Disease as an information defect

One way to think about disease[1] is as a loss of information[2] from the operating blueprint for human physiology.  Broadly speaking, there are three main possible types of informational defects depending on the nature of the informational encoding that is compromised. The first is genetic through loss of information due to corruption of the genetic (and sometime epigenetic) code, for instance in congenital disease or in cancer. The second is spatial through loss of architectural information due to cumulative changes away from a structural template. This prevents turnover of tissue

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Will the coming wave of gene therapies have a Sovaldi-like impact?

The first approval of a gene therapy for congenital disease in the US (Luxturna) inaugurates a new – though long anticipated – era for therapeutics. Along with questions around durability of response and long-term safety, pricing and reimbursement is a particular challenge. At $850,000, the price of Luxturna is nominally higher than other high-cost specialty medicines. However, as a one-time cost with a multi-year benefit, the cost per year of efficacy is far lower. This is not a new challenge for the industry: Hepatitis C antiviral therapies such as Sovaldi

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A golden age for gene therapy: an opinionated take on NEJM highlights for December 2017

Successes in gene therapy for hemophilia B and A Hemophilia A and B are X-linked genetic diseases which prevents the formation of functional coagulant factors VII and IX respectively and cause a propensity to bleeding in about 20,000 people in just the US. The standard of care of intravenous administration of recombinant factors is effective but also burdensome, expensive, and does not fully prevent the disabling sequellae of the disease caused by repeated bleeding in the joints. A possible cure is to deliver a functional copy of the defective gene

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A population health approach to value-based drug pricing

Working Paper   Summary Drug companies are naturally incentivized to price their drugs under assumptions of optimal clinical value, i.e. as high as possible.  Payers react to this by setting stringent conditions for patient eligibility for coverage of those therapies. As a consequence, patients who do not meet these conditions do not receive those drugs even though they could derive benefit, albeit not of a magnitude that would justify the cost.  Here we lay out a population health based scheme by which payers and drug companies can design a system

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