Sarah Dolman, Author at Recon Strategy

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

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

Is the future of US pharma manufacturing domestic?

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?

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 auto- or allo- future for cell therapy?

Sarah Dolman 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

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

Author: Sarah Dolman

Recon takes an analytical look behind select developments in healthcare

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

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

Is the future of US pharma manufacturing domestic?

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

An auto- or allo- future for cell therapy?

The road ahead for genomic testing

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