This month on Blue Steens
Glimpse at the complexity of drug pricing
When we talk about drug prices, what do we actually mean? Is there ONE price? Why do prices differ between countries?
Mindset – Circle of Influence
In the present tumultuous times with things happening beyond our control, reality can weigh heavily on our shoulders. This reminded me of Stephen Covey’s simple framework - the circle of influence.
Next month on Blue Steens
We will explore
... the complex journey of a drug from lab to patient.
Beyond Blue Steens
*** Note that I add references throughout the course of the month. Whilst I try to keep up and replace ‘old news’, the situation is developing so rapidly just now that some articles might be outdated by the time this newsletter is published. ***
Testing capabilities seem to be improving around the globe:
A wee bit of background before you read on. Most diagnostic tests referred to below detect genetic material from the virus in a patient sample (often a swab). Thus, they tell us whether the patient is currently infected, which is important for treatment decisions. Some other tests, however, detect antibodies (usually in blood samples), which tells us whether the patient has ever been infected because antibodies are part of our immune defence and persist even when the virus is gone.
This blood test can tell us how widespread coronavirus really is - This test from the Icahn School of Medicine in New York City detects antibodies. Anyone who has ever caught the virus should test positive even though the virus may have long been defeated by their body. Such a measure would allow epidemiologists to draw a more accurate picture of viral spread and relative death rates. Potentially, this could also be used to treat patients by inducing passive immunity, i.e. passing survivors’ antibodies on to patients.
Thermo Fisher to produce millions of coronavirus diagnostic tests - Thermo Fisher has been granted emergency FDA approval and is aiming to reach the production target of 5 million tests by early April. Another test by Roche has also been approved. Roche’s estimated production capacity sits at 400,000/week. They have started shipping kits.
CE marks (for EEA compliance) have been awarded to diagnostic tests from a whole host of companies including BGI, Co-Diagnostics, Genomica, Novacyt, Gencurix, Bioneer, Solgent, AusDiagnostics, DiaCarta.
U.S. FDA approves first rapid coronavirus test with 45 minutes detection time - Cepheid’s test yields results in 45 minutes. The point-of-care diagnostic does not require special training but only works with Cepheid’s systems.
Coronavirus: device identifies deadly diseases in minutes - The easy-to-use, comparably cheap blood test produced in the UAE can share results with health officials in real-time via Mondialab’s data portal. Apparently the diagnostic immunoassay (in principle comparable to a pregnancy test) only takes 10 minutes and may be used as part of border-crossing checks.
Ahmedabad firm first in India to get licence to make Covid-19 testing kits - The kit has been developed in the USA and will be manufactured in India. The joint venture partners claim that the largely platform-agnostic kit can produce test results within 2.5 hours.
Pune start-up makes affordable, accessible Covid-19 test kit - The Indian start-up reckons that its market-ready fast (2.5 h) detection kit will be up to 60% cheaper than imported alternatives from the US and Europe. Production is to increase from initial 15,000/day to 50,000/day.
As if capacity issues in hospitals weren’t enough… - One of the major COVID-19 testing laboratories in Czech hit by cyberattack - Brno University Hospital in the Czech Republic has been victim of a severe cyberattack that partially collapsed their network forcing a complete IT shut-down. Whilst this article runs under a COVID headline, note that several operations were affected. Patient care was still possible but not data storage.
In terms of treatment…
Researchers Look To Old Drugs For A Possible Coronavirus Treatment - Hydroxychloroquine, an old malaria drug, has shown anti-coronaviral effects in the lab, and there are promising results from a French patient trial. In the USA, Novartis plans to donate 130 million doses of the drug if it gets FDA approval; other pharma companies also offer support. In contrast, India has banned export of hydroxychloroquine.
In relation to hydroxychloroquine, I spotted this interesting thread on Twitter:
FDA approves Roche’s Actemra COVID-19 trial - Sometimes the body ‘overreacts’ with heightened inflammation to an infection causing a so-called cytokine release syndrome, which can be detrimental to the patient’s condition. Actemra is supposed to dampen this excessive response. It has already been approved for other diseases. The COVID-19 phase 3 trial is to begin in April.
AbbVie gives up patent rights to HIV med Kaletra amid COVID-19 tests: report - Previously, AbbVie had already made its HIV treatment Kaletra available to the Chinese government for testing as COVID-19 treatment. So far, experimental results are not overwhelming. However, to help prevent potential shortages, AbbVie will not enforce its patent rights allowing generics manufacturers to support potentially increased demand. This incredible move is very considerate seeing how Gilead has struggled to supply patients with its antiviral drug remdesivir in a compassionate use programme. In a somewhat unusual move, the FDA has just granted remdesivir orphan drug status, which is generally reserved for rare disease drugs. This bestows increased IP protection on the manufacturer to stave off competition and could cause a bottleneck if the drug made it to market. Clinical trials are ongoing.
WHO to launch multinational trial to jumpstart search for coronavirus drugs - The trial willl test 4 treatments that have already been approved for other conditions:  remdesivir,  Kaletra,  Kaletra/interferon beta combination,  chloroquine or hydroxychloroquine.
Stem cell therapy has shown success as antiviral treatment in COVID-19 and HIV infections. If this approach ever made it beyond the experimental stage, I would imagine this to be a treatment of last resort.
RingMD offering telemedicine platform for free to help support and improve industry-wide responsiveness to global COVID-19 pandemic - Treatment also means looking after suspected or mild cases and keeping them away from hospitals in addition to looking after other conditions that are treatable remotely and keeping them separated from diagnosed COVID-19 patients.
On a lighter note (well, kind of…):
In terms of vaccination…
CureVac focuses on the development of mRNA-based coronavirus vaccine to protect people worldwide - Some reassurance by the German company CureVac after getting caught up in a media storm. Commercialisation of science is complex enough. Politicising is not helpful here. CureVac collaborates with the Coalition for Epidemic Preparedness Innovations (CEPI) to develop a rapid-response vaccine platform. The deal provides initial CEPI-funding of up to $8.3 million.
Fosun, Pfizer to help BioNTech join the mRNA race for a coronavirus vaccine - German BioNTech is looking to commercialise its vaccine with the help of Fosun Pharma in China and possibly with Pfizer elsewhere. Human trials are to start in April.
China's CanSino pushes coronavirus vaccine into clinical testing as Moderna kicks off trial - CanSino Biologics’ phase 1 trial will launch in Wuhan after promising results from animal tests. In contrast, the FDA has granted Moderna permission to start human testing without animal data. Moderna’s phase 1 trial has already started.
Korean company starts animal trial of coronavirus vaccine - SK Bioscience and Celltrion are looking to begin human vaccine trials in September and July, respectively.
A neural network can help spot Covid-19 in chest x-rays - The convolutional neural network COVID-Net has been trained to recognise COVID-19 signs in chest x-rays. The tool and underlying data have been released to the public to crowdsource a solution, as the tool is currently not ready for deployment.
Researchers identify two coronavirus strains as China cases dwindle - Preliminary results suggest that 70% of cases have been caused by the more aggressive ‘original’ (Wuhan) strain and 30% by a less aggressive strain. Overall, the disease spread in China has slowed down significantly, whilst it has increased elsewhere.
Not healthtech, but great joint effort: COVID-19: Digital service delivery for charities - Third Sector Lab and SCVO Digital created an open source document to collate best practice and guidance specific to delivering charity services online.
New TB drug regimen controls resistant disease in 9 of 10 cases: study - The success of this 3-drug combination is “probably one of the biggest advances in TB therapeutics since the 1970s”.
Argentinian Scientists Develop Kit That Diagnoses Dengue in Just 10 Minutes - The simple and fast test strip for Dengue Type 1 detects antibodies against the virus in a small blood sample. With ca. 40% of the world population living in risk areas, a cheap commercial kit could massively improve healthcare management.
Individualized Therapies: CBER Director Discusses Challenges, Regulatory Approach - The FDA acknowledges that costs of individualised therapies are a tremendous obstacle and that the traditional phased drug development route is not suitable. Alternative development approaches are needed. The article doesn’t address alternative financing ideas but made me think of healthcare derivatives.
Seed-Financing for iATROS [German] - Effectively, the company aims to create a virtual cardiovascular clinic by leveraging manufacturer-independent data analysis from smart wearables. Physicians’ advice will be supported by AI.
ConsenSys Announces Healthcare Spin-Off—ConsenSys Health - The healthcare-focused spin-off will maintain access to ConsenSys’ core products to develop blockchain- and machine learning-based solutions that aim to introduce increased efficiency into healthcare research and administration.
Out and about
Aberdeen Data Meetup, 10 Mar 2020could be worth billions to Scottish economy. 1st talk 2n8 by at data . surprised to hear that isn't leading the way here. 🏴 Much more going on South of the border by the sound of it. @ONECoPsmBHSn