Biopharma Archives - Recon Strategy

Working paper: Incentivizing progress, even if small and incremental, in therapies for Alzheimer’s disease should be a priority

Martha Deja and Marc Herant October 22, 2024

Summary: Over the coming decades, Alzheimer’s disease threatens to become a huge drag on national well-being. To put things in perspective, by 2040, the US may be allocating more resources to the care of Alzheimer’s patients than care and education of children. Unfortunately, we are not likely to find a therapeutic “silver bullet”; progress will most probably take place in incremental steps as is the case with the latest A-beta directed therapies. Because of the potential modest benefit of new individual therapies, one could reasonably argue to place stringent limits

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

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,

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

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

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

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

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

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

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.

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

The growth of small molecule drug classes over time

Marc Herant April 8, 2022

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

The road ahead for genomic testing

Sarah Dolman December 24, 2021

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

The Puzzling Future of Healthcare

Nikhil Bhojwani October 10, 2021

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

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

Marc Herant and Anja Schempf October 21, 2020

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

AI in healthcare III: COVID-19 applications and implications

Sophie Ranen and Nikhil Bhojwani June 5, 2020

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

Strategy in the Time of Covid

Nikhil Bhojwani April 15, 2020

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

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

Nikhil Bhojwani April 6, 2020

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

Category: Biopharma

Recon takes an analytical look behind select developments in healthcare