This month on Blue Steens

Federated learning in healthcare

Federated learning is a machine learning paradigm that allows to train algorithms collaboratively without the need for source data exchange between the parties.

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The winding path from lab to patient

Despite potential short-cuts, drug development is a lengthy and risky process that culminates in marketing approval. However, just because a drug achieves regulatory approval, does not mean that it will be instantly available to those in need.

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Beyond Blue Steens

Coronavirus

⊳ Testing

For a quick explanation of the difference between genetic (PCR) and antibody (serological) tests, check out last month’s COVID-19 Testing section. Note that a newly-infected person does not yet have antibodies but will have genetic virus material. In contrast, a person who has overcome the infection, may not have detectable genetic material anymore but will have antibodies. Hence, timing of these tests is important.

• Antibody tests:

  Overall, these tests are still very unreliable and have been criticised, e.g. here and here. However, the FDA tightens its enforcement.

  Meanwhile:

  • Authorisations: Cellex (US), Biolidics (Singapore), DiaSorin (US, Italy)

  • Hangzhou Biotest Biotech/Premier Biotech’s test was used for screening by the University of Southern California and LA Department of Public Health.

• PCR tests:

  • US saliva tests from Rutgers University, MicroGen DX. Using spit instead of swabs makes sample collection easier.

  • Emergency use authorisation for point-of-care kit that yields positive results in 5 min, negative results in 13 min.

• Inflatable P2 Lab for Emergency Testing

• 🏴󠁧󠁢󠁳󠁣󠁴󠁿 Glasgow University to host new Covid-19 testing facility - The uni lab will be staffed by > 500 volunteers and begin work in mid-April. A few companies, Wellcome Trust and University of Dundee also involved.

⊳ Treatment

• Plasma therapy uses blood plasma from survivors (i.e. the cell-free liquid part of blood containing antibodies) as treatment for patients:

  • Convalescent Plasma to Treat COVID-19: Possibilities and Challenges (academic journal editorial)

  • FDA, EC offer guidance on COVID-19 convalescent plasma

  • Spain's Grifols to test plasma therapy for COVID-19 with U.S. FDA

  • Covid-19: Pakistani doctors get approval for plasma therapy clinical trial

  • Kerala, the first Indian state ready to try Covid-19 plasma therapy has no critically-ill patients for trials

  • Convalescent plasma transfusion shows promise in small Chinese study

• Remdesivir:

  • Noticed that this one escaped me in March: Gilead requested to lose (!) orphan drug designation due to public backlash.

  • Gilead supersizes trials

  • After struggling previously to supply patients (March review), Gilead has promised to donate 1.5M doses.

• (Hydroxy-) Chloroquine:

  • FDA authorisations & FDA warning

  • However, a preliminary meta-analysis casts doubts.

  • Trials announced: Novartis (450 patients planned), GNS561 (Phase 2)

  • Meanwhile, production is being ramped up: W Balkan, Novartis (30M of 130M promised doses shipped), Sanofi

  • India lifted export ban

• Immunosuppressants:

  These drugs aim to prevent a potentially fatal overreaction of the immune system to the infection.

  • InflaRx uses anti-C5a antibodies. [German]

  • Tiziana develops handheld inhaler/nebuliser to be used to deliver anti-IL-6 receptor antibodies directly into patient’s lungs.

• BioCryst launches early-stage study of galidesivir for COVID-19 - Phase 1 trial of broad-spectrum antiviral in Brazil.

• Clinical trial with heartburn drug famotidine

• Collaboration of 15 pharma companies with Gates Foundation includes sharing of proprietary compound libraries.

• Phase 3 trial with diabetes drug, dapagliflozin, to reduce C-19 disease progression and complications.

• 🏴󠁧󠁢󠁳󠁣󠁴󠁿 NovaBiotics’s Nylexa to treat potentially lethal secondary bacterial lung infections in C-19 patients. Trials could start in 2nd half of 2020.

⊳ Vaccination

• Pharma collaborations:

  • BioNTech & Pfizer [German] - Phase-1/2 trial OK in Germany

  • Pfizer collaborating within healthcare ecosystem

  • NIH & 16 drug companies (treatments & vaccines)

  • Sanofi & GSK - Clinical trials expected in 2nd half of 2020.

  • VBI Vaccines & National Research Council of Canada - Aiming to develop a vaccine against various coronaviruses to induce wider immunity.

• China approves two experimental vaccines to enter clinical trials

• Novavax fast-tracks phase 1 testing - Start by mid-May.

• Johnson & Johnson identifies a lead COVID-19 vaccine candidate - Human trials expected by Sep 2020. J&J intend to provide it on a not-for-profit basis.

• University of Pittsburgh found potential vaccine - Animal results promising. FDA application for clinical trials underway.

⊳ Other news

• Number and severity of COVID-19 mutations: NextStrain (at least 8 strains), Zhejiang University (at least 30 mutations, medRxiv source)

• Virological assessment of hospitalized patients with COVID-19 - Analysis of 9 patients with mild symptoms. Some key takeaways: patients highly contagious in 1st week and still potentially contagious after symptoms have gone; antibodies detectable after 7-14 days.

Biotech

• Scientists have created a new type of robot that is literally alive - The so-called xenobots are part living cells, part machine. They are programmable to take on different forms, self-heal and complete tasks. Their life span is about 1 week. Let’s hope bioethics catch up quickly with the tech evolution.

• Flagship raises $1.1B to create biotechs for post-pandemic world - Whilst loads of funding is currently pouring into finding solutions for the COVID-19 crisis, Flagship Pioneering is thinking about opportunities in the 3 years after this crisis and is ready to fund a “new generation of companies”. A significant focus area is disease prevention.

Medtech

• Storing medical information below the skin’s surface - Applying near-infrared dye (quantum dots) alongside vaccine as proof of vaccination.

• Korean Regulator OKs 1st AI-based cancer diagnosis software (prostate cancer)

Out and about

More like ‘in and about’ these days…

• CARES, FEMA, COVID19: What healthcare providers, entities need to know (EY), 30 Mar 2020

  Request on-demand recoding here.

• Blockchain for Medical Research - Book Release, 31 Mar 2020

  Virtual book release. Here’s an article about the book & excerpts from Chapter 15.

• Stop COVID-19 Hackathon, 13 Apr-11 May 2020

• EY Global Blockchain Summit, 21-23 Apr 2020

  Chris @blue_steens

  "Transparency is going to be a licence to operate." Rodrigo Santibanez, panelist at @EYnews global #blockchain summit. #Pharmaceuticals #innovation #pharmaindustry #biotech @pbrody

  April 21st 2020

  Chris @blue_steens

  Blockchain is not just about improving efficiency & transparency but also about creating new revenue streams for biz. - Chen Zur, panelist at @EYnews global #blockchain summit. #supplychainmanagement #supplychain #foodindustry #trackandtrace #sustainabledevelopment

  April 21st 2020

  Chris @blue_steens

  "Move fast and break things won't work here. We have to understand the risks." - Robert Bench at @EYnews global #blockchain summit. #FederalReserve #fintech #Governance #riskmanagement

  April 22nd 2020

  1 Like

• STM and Center for Open Science: US Workshop – April 2020, 27 Apr 2020

• MediLedger Webinar #2: Contracts & Chargebacks (Chronicled), 28 Apr 2020

  Chris @blue_steens

  Legacy systems can be hooked up by the sound of it. Design w/ user in mind. "There is a reason biz do biz the way they do." Transition rather than disruption. #innovation #blockchaintechnology #pharmaindustry @ChronicledInc

  Chris @blue_steens

  Interesting @mediledger Webinar #2 just kicked off. It's about managing #Pharmaceuticals Contracts & Chargebacks thru #blockchain by putting as little (!) info as necessary on-chain. #lifesciences #supplychain #healthcare #procurement #distribution

  April 28th 2020

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In this newsletter I share personal views and observations only. For more information and the privacy policy visit Blue Steens.