Your Edge In Biotech.
13
Jun
2020

A Conversation About Race: Ted Love on The Long Run

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13 Jun 2020

Today’s guest on The Long Run is Ted Love.

Ted is the president and CEO of Global Blood Therapeutics, or GBT for short. The company is based in South San Francisco. GBT is focused on sickle cell disease. Sickle cell disease affects about 100,000 people in the US, the vast majority of whom are black. About 20 million are thought to be afflicted worldwide. It’s a huge source of pain and suffering.

Ted Love, president and CEO, Global Blood Therapeutics

GBT developed the first innovative, disease-modifying drug purposely developed for this need. GBT secured FDA approval last November. It’s a significant contribution to human health and wellbeing – which is what biotech is about, at its best.  

A few months before that landmark approval, Ted was a guest on The Long Run. You can hear about his upbringing in Alabama, his career path in biotech, and quite a bit about sickle cell and GBT’s drug.

One of the things I admire about Ted is that he’s gotten himself into a position where so many important things are aligned. He’s African American. He’s a physician. He’s an experienced drug developer and company leader. He found a way to combine all of his life experience and values, with his professional skills, and apply them all toward a huge and urgent healthcare need for African Americans.

Ted is someone who thinks about science and society, and the interconnectedness of our communities.

I’m thankful to have him share some wisdom on race today. He talks about some of his personal experiences, the shift that’s occurring in the country, and how individuals and companies can make a positive difference.

This is just one conversation of many we need to have over time. I intend to bring future guests on this show to have constructive conversations about what we can do. To that end, one specific group Ted said he supports is the Equal Justice Initiative, a nonprofit based in Montgomery, Alabama. Bryan Stevenson, a prominent public interest lawyer and author of “Just Mercy” founded and leads this group.

Now, please join me and Ted Love on The Long Run.

11
Jun
2020

AstraZeneca Opens Its Digital Komono

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11 Jun 2020

David Shaywitz

AstraZeneca has emerged with a reputation as one of the industry’s most imaginative pharmas – it was named the “most innovative” global pharma company by IDEA Pharma in November 2019, and was cast as Gallant to GSK’s Goofus in a recent Financial Times piece examining their contrasting trajectories.

In this context, I was especially excited when I saw what looked to be some public discussion of their digital strategy. In an official release on Thursday, several of the company’s digital leaders offered an update on how their digital transformation is going.

As Astounding readers know, “digital transformation” is the ideology sweeping business now, offering, depending on your perspective, either an opportunity for pharma to finally avail itself of the technologies transforming most other industries across the planet, or a sumptuous buffet – a deep trough – where all manner of management and technology consultants may dine.

AstraZeneca offers up three strategic priorities, which correspond (explicitly, it turns out) to the three temporal stages of their “Digital Health R&D Journey” (evidently, iter digitalis est omnis divisa in partes tres…).

The first, or “foundational stage” focuses on transforming processes (“how we work”), the second stage (“advanced”) looks at “redefining digital health,” and the third stage (“future-readiness”) aspires to “reimagine healthcare.”

Understandably, and in parallel to Vas Narasimhan’s experience at Novartis, most of the progress so far seems to be at the level of operations and processes, using digital approaches to introduce efficiencies. They describe a tool, “Merlin” (developed, it appears, with Deloitte) that helps design clinical studies, and another tool (which seems to be Veeva’s Vault Clinical) to “replace legacy trial management systems” with a “cloud-based, single, digitized and connected platform.” (Veeva’s low-key takeover of pharma may be as impressive as Epic’s penetration into academic medical centers.)

There’s also, inevitably, a clinical trial dashboard (for some reason, pharma execs seem particularly obsessed by the size of their dashboards, which, naturally, also have pet names; AZ calls theirs Control Tower; the Novartis version is called “Nerve Live”). 

AZ also highlights digital enhancements of their clinical supply chain that have reportedly yielded significant savings of time and money.

The other two strategic pillars seem, thus far, appreciably more aspirational, although I was struck by what seems like a solid commitment to move aggressively towards “hybrid” trials, where at least some of the data are collected remotely; AZ says up to 70% of trial data in 90 trial protocols they examined could be collected this way, which is obviously easier on patients and presumably could increase enrollment and retention, and would be especially attractive in the context of COVID-19.

Less clear is how the hybrid goal will actually be realized, though it sounds like it will involve a number of partners and a number of devices, which AZ seems to be in the process of vetting.  Beyond the data collection, there’s an aspiration to improve outcomes through digital intervention — though again, beyond the assertion of partnering with “the best in the field” (think “Top. Men.” from Indiana Jones, or “Best of the best of the best. Sir!” from Men In Black), there was really no color provided.

Finally, AZ offers a nod to a future where there’s earlier detection and diagnosis of disease, patients are alerted to risks sooner, symptoms are monitored better, AI picks up on worrisome data, and technology helps patients self-manage.  Relevant top of mind association here, of course, is Steve Martin’s famous “Holiday Wish” on Saturday Night Live. [Readers, trust me, watch this.—LT]

Bottom Line

Most pharmas are now dutifully embarked on a “digital transformation journey” and AZ is no exception; to the extent their approach is especially original or innovative, such creativity is not apparent from what they’ve shared, which feels like what most leading pharmas are doing: leveraging established partners like Deloitte to improve existing processes immediately, aspiring to bring digital to clinical trials soon, and harboring gauzy hopes for more proactive care in a technology-enabled future.

On the other hand, it seems clear that pharmas in general, and AZ specifically, really are serious about bringing more digital tools and capabilities into clinical trials, for highly pragmatic reasons. Emerging companies able to demonstrate excellence in this space are likely to be highly prized.  

11
Jun
2020

Inconvenient Truths and Rays of Light

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11 Jun 2020

Luke Timmerman, founder & editor, Timmerman Report

The information world that we built sometimes has a way of distracting us.

It downplays and marginalizes what’s important.

Not this week.

Let’s start with a few timely, inconvenient truths.

As of this writing on June 11:

  • The US has 113,865 dead from COVID-19 and counting.
  • 2 million+ confirmed cases.
  • 20,000 new cases adding up every day.
  • 21 states are seeing new cases on the rise.
  • We still have no coordinated national system for testing, tracing, and isolation.
  • A heartbreaking 44 million people have filed unemployment claims in 12 weeks.
  • Our 400-year history of systemic racism means blacks are, predictably, suffering from much more health and economic pain in the pandemic than whites.
  • Our state and national leaders don’t seem focused on creating a safe vote-by-mail system in time for the November elections. Voters of color in Georgia, once again, were disenfranchised in this week’s primary election.

But Don’t Despair. There Were Rays of Light

We have done an inexcusable, terrible job as a country fighting the COVID-19 pandemic. The world’s undisputed No. 1 superpower in biomedicine should perform better than this.

I have despaired in these pages about whether we have the guts as a country to reclaim our rights to citizenship and start getting our act together.

But this week, I saw more glimmers of hope that we will.

White Americans are paying more attention to racial injustice. The protests have moved on from the chaotic and destructive early moments to a more focused and constructive set of demands. The energy has been sustained since George Floyd’s death on May 27.

Protests have been forceful, and peaceful.

Citizens — i.e. people who accept responsibility to be informed and active participants in a democracy, rather than mere passive consumers — are holding police accountable in cities around the country. They’re using cell phone cameras capturing video of injustice on an almost daily basis.

Young and old, white and black and Asian and Latinx are locking arms in solidarity against these ongoing, brutal injustices.

The country, with no live sports and entertainment to distract us from the agony all around, can’t look away. Injustice is right there staring everyone in the face.

Powerful organizations can’t escape their past actions and inactions. Everything must be re-assessed from the ground up, and not just viewed through the lens of profit and loss.

Consider the National Football League. With the President in its corner, the NFL shamefully tried to silence black players like Colin Kaepernick and Eric Reid and Malcolm Jenkins. It got upset when these African American players exercised their First Amendment rights to peacefully protest police brutality. Four years too late, the NFL admitted it was wrong.

NASCAR, another powerhouse of cultural influence, banned displays of the Confederate flag at its events. A popular driver, Bubba Wallace, went a step further. He had “Black Lives Matter” painted on his car.

The Boston Red Sox acknowledged that former outfielder Torii Hunter, an African American, was subjected during his career to racist taunts at Fenway Park. It wasn’t just one bad apple here or there. It happens regularly. In liberal New England.

Mitt Romney, Republican Senator from Utah, isn’t living in denial. He marched with protestors.

The TV show “Cops,” after a 33-year run of glamorizing police who push around the “bad boys,”  raking in tons of ad money along the way, was abruptly cancelled.

Amazon said it would no longer provide facial recognition technology to police departments, at least for the next year. Microsoft said it will end sales of facial recognition technology to police.

Our military leadership is resisting the dangerous idea of deploying active-duty troops against American citizens who protest. Police departments around the country aren’t asking for the military to help. They are banning chokeholds. They are de-militarizing. They are getting re-trained in de-escalation tactics. New York repealed its law that shielded police misconduct records from public scrutiny. Portland and Denver got rid of the police in their schools. Police budgets are being looked at with fresh eyes. Funds are being diverted to social services and mental health agencies, which have been terribly underfunded for decades. Cops aren’t supposed to be mental health officers anyway.

What if we hired a new generation of cops who were trained in community policing, and put in the work to get to know members of the community, rather than threaten them with batons and AR-15s?

What if half of police officers were women? They are just as good at law enforcement, and less violent.

We can re-think everything about law enforcement from the ground up, and a whole lot of how our world works or should work, once citizens become active participants in democracy.

Citizens are definitely getting activated.

About three-quarters of Americans now say that George Floyd’s death is a sign of a national underlying problem with systemic racism, according to a recent ABC News poll. That represents an unheard-of 30-percentage point jump from when that question was asked in late 2014 following the death of Michael Brown at the hands of police in Ferguson, Missouri.

Systemic racism isn’t just in the police department. It’s everywhere. The demands for action are spreading, and it’s about time. Close to home, you can see it in #ShutDownSTEM and #ShutDownAcademia.

Feel the frustration, feel the exhaustion from underrepresented communities. Read this essay by Jasmine Roberts at Ohio State University, titled: “White Academia: Do Better.” Then this one, “Stolen Breaths” by Rachel Hardeman and colleagues at the University of Minnesota.

John Lewis, 80, the civil rights legend who marched across the Edmund Pettus Bridge on Bloody Sunday to fight for the Voting Rights Act of 1965, is feeling that youthful energy again.

Lewis told the Washington Post this week he’s feeling “inspired.” (Lewis, by the way, has Stage 4 pancreatic cancer. He’s focused on making the most of his remaining time.)

What can biotech do? A lot of things, like a few specifics suggested by Rob Perez and Uciane Scarlett in these pages.

Then there’s the work of biotech itself. The development of diagnostics, therapeutics, and vaccines for COVID-19 is urgent and important work for all of us, but especially African Americans who are shouldering a disproportionate burden in the pandemic.

Moderna said this week that it will start a 30,000-patient Phase III study in July with its mRNA vaccine candidate with the NIH. It’s an unimaginably fast sprint from when the SARS-CoV-2 DNA sequence was made publicly available on Jan. 11.

This industry can do amazing things.

We all know this industry has tremendous capacity for good. Biotech hasn’t always exercised its muscles for good. It can choose to do so now.

Those of you who are company leaders, here’s one humble suggestion. Make Election Day a company holiday. Give your employees the time and breathing space necessary to exercise their constitutional right to vote at the local, state and national level.

Those of you with real clout – how about pushing for a national biotech industry day off for Election Day? How about leaning on all your CROs and vendors and partners that operate all around the country to take the day off for Election Day? It’s the right thing to do. Business can take the lead.

The changes that need to happen go way beyond biotech, to the fundamentals of how we organize our society, our economy, what we value, and what we don’t. What kinds of behaviors does our economy incentivize, and what behaviors aren’t incentivized?

I’m hungry for thoughtful ideas.

If you have suggestions on how to organize a more humane, a more just, and a more healthy world, let’s talk. These things are all connected.

As Rob Perez recently said, quoting “The Lorax” by Dr. Seuss:

“Unless someone like you cares a whole awful lot, nothing is going to get better. It’s not.”

luke@timmermanreport.com

 

Vaccines

Moderna said it’s on track to start a Phase III study of its mRNA vaccine candidate against COVID-19 in July. The study, in collaboration with the National Institute for Allergy and Infectious Diseases, will enroll 30,000 subjects with the 100-microgram dose – on the low range of what has been evaluated in smaller studies. The primary endpoint, according to a Moderna statement, “will be prevention of symptomatic COVID-19 disease; while key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2, the virus that causes COVID-19.” The company said that it expects to be able to make 500 million to 1 billion doses per year, by 2021, in partnership with its contract manufacturer, Lonza.

Can a COVID-19 vaccine be developed in record time? Read the transcript of an NYT conversation moderated by Columbia University physician-scientist-author Sid Mukherjee.

Testing

Sunnyvale, Calif.-based Cepheid said it is developing a 4-in-1 test for SARS-CoV-2, Flu A and Flu B and RSV virus from a single sample, in time for the upcoming fall flu season. The test will be compatible with its installed base of 25,000 systems around the world, and can be conducted “in as little as 35 minutes.”  

Treatments

Speculation is out there on what Gilead Sciences is going to charge for remdesivir around the world once the initial donated supply runs out. The pharmaceutical industry has done a lot over the years to shoot itself in the foot and destroy its public trust. Approval ratings for the industry were in Big Tobacco territory prior to COVID-19. This is a chance do better. The decision will reverberate across the industry’s reputation, writes John LaMattina in Forbes.

Public Health

Science

  • Enhanced receptor binding of SARS-CoV-2 through networks of hydrogen-bonding and hydrophobic interactions. PNAS. May 27 (Yingjie Wang et al)
  • Effect of Large-Scale Anti-Contagion Policies During the Pandemic. Nature. June 8. (Solomon Hsiang et al)
  • Identifying Airborne Transmission as the Dominant Route for Spread of COVID-19. PNAS. June 11. (Renyi Zhang et al)
  • Analysis of SARS-CoV-2 Viral Load By Patient Age. MedRxiv. June 9. (Terry Jones et al)
  • COVID-19 Coagulopathy: An Evolving Story. The Lancet Hematology.

Science Features

  • Females are Still Routinely Left Out of Biomedical Research and Ignored in Data Analyses. STAT. June 9. (Elizabeth Cooney)
  • Lots of Coronavirus Antibody Therapeutics News. In the Pipeline. June 9. (Derek Lowe)
  • Monster or Machine? Our Enemy, Hidden in Plain Sight. NYT. June 2. (Alan Burdick)
  • COVID-19 Patient Gets Double Lung Transplant, Offering Hope. NYT. June 11. (Denise Grady)

Politics

  • Exceptionalism is Killing Americans. An Insular Political Culture is Failing the Test of the Pandemic. Foreign Affairs. June 8. (Jeremy Konyndyk)

Communications

  • MIT, guided by open access principles, ends Elsevier negotiations. June 11. (MIT Libraries)

Humanity

  • Quarantine Has Changed Us All. And It’s Not All Bad. Vox. June 9. (Sigal Samuel)

Deals

AbbVie agreed to make a $750 million upfront payment to Genmab for the right to collaborate with the Denmark-based company on three bispecific antibody candidates in early development, and to work together on discovery of new drugs.

Novo Nordisk agreed to acquire Corvidia Therapeutics, the developer of an IL-6 directed antibody to reduce cardiovascular disease risk in chronic kidney disease patients. The price was $725 million in upfront cash, and as much as $2.1 billion total if milestones are met.

Sherlock Biosciences, the Cambridge, Mass.-based company developing a cheap and fast CRISPR-based test to detect SARS-CoV-2 in samples, formed a large-scale manufacturing agreement with Integrated DNA Technologies of Coralville, Iowa. The test has received Emergency Use Authorization from the FDA.  

CSL Behring agreed to acquire Vitaeris, the company that took over clazakizumab, an IL-6 inhibitor originally developed by Alder Biopharmaceuticals. The drug is now in Phase III testing for chronic active antibody-mediated rejection (AMR), the leading cause of long-term rejection in kidney transplant recipients.

Some investment banker was probably bored at work, and thought it was a good idea to gin up a megamerger between AstraZeneca and Gilead Sciences, and then float the rumor in the financial press to see if it would get any traction. My guess: this idea is Dead on Arrival.

Paris-based Egle Therapeutics, a spinout from Insitut Curie, formed a collaboration with Takeda Pharmaceutical to advance drugs against targets on T regulatory cells.

New York-based Ovid Therapeutics agreed to collaborate with Wendy Chung, a prominent researcher at Columbia University, on rare neurological diseases.

Auburn, Ala.-based SiO2 Materials secured a $143 million federal contract to produce packaging materials for COVID-19 vaccines and therapies. MIT Institute Professor Bob Langer, an advisor to the company, had the lead paragraph in the press release.

UK-based Evox Therapeutics pocketed a $20 million upfront payment from Eli Lilly as part of a collaboration to develop exosome delivery technology for RNAi therapeutics.

Financings

  • Cambridge, Mass.-based Verve Therapeutics, a company working on gene editing therapies to reduce the risk of coronary heart disease, raised $63 million in a Series A2 round led by GV. The company has now raised $123 million total.
  • San Diego-based Avidity Biosciences raised $259 million in an IPO priced at $18 a share. It’s developing antibody oligonucleotide conjugate drugs.
  • Cambridge, Mass.-based Checkmate Therapeutics raised $85 million to advance its lead drug candidate, CMP-001, which it describes as “a differentiated Toll-like receptor 9 (TLR9) agonist delivered as a biologic virus-like particle utilizing a CpG-A oligonucleotide as a key component.” Longitude Capital and Novo Holdings co-led.
  • Wayne, Penn.-based NFlection Therapeutics raised a $20 million Series A round to develop a gel therapy for neurofibromatosis type 1. VenBio and F-Prime Capital participated.
  • Boston-based CereVasc, the developer of a shunt for hydrocephalus, raised $43.9 million in a Series A financing. Perceptive Xontogeny Venture Fund led.
  • Mountain View, Calif.-based DNAnexus, a cloud-based service provider that manages genomic and other biological data sets for life sciences companies, raised $100 million in financing. Perceptive Advisors and Northpond Ventures led.
  • Cambridge, Mass.-based Vedanta Biosciences, a microbiome-based drug developer, tacked on another $12 million in financing, bringing its Series C financing to $71.1 million.
  • Palo Alto, Calif.-based Autobahn Therapeutics raised a $76 million Series B to develop regenerative medicines for CNS disorders. Arch Ventures and Cowen Healthcare Investments co-led.
  • Sweden-based Calliditas Therapeutics raised $90 million in an IPO to support its work on orphan kidney diseases.
  • South San Francisco-based Applied Molecular Transport raised $154 million in an IPO to advance development of its oral therapies for inflammatory diseases.
  • Dallas-based Lantern Pharma, a cancer drug developer, raised $26 million in an IPO.
  • China-based Legend Biotech completed its IPO fundraising haul with $487 million.
  • Jazz Pharmaceuticals pulled in $850 million through a convertible debt financing.
  • New York-based C2i Genomics raised $12 million in a Series A. It says it’s “dedicated to improving cancer patient lives and outcomes with a breakthrough tumor pattern recognition approach for liquid biopsy.” Casdin Capital led.
  • Boston-based Replimune raised $65 million in a stock offering to support its work on oncolytic virus therapy.
  • San Clemente, Calif.-based Glaukos, a company focused on treatments for glaucoma and other eye diseases, raised $250 million in a convertible debt offering.
  • Boston-based Akouos, the developer of gene therapy for diseases of the ear, issued an S-1 IPO prospectus seeking to raise $100 million.
  • San Diego-based Retrophin, a rare disease drug developer, raised $100.8 million in a stock offering.
  • Boston-based PatientPing, which provides real-time notifications on patient encounters with healthcare providers, raised $60 million in a Series C financing. Andreessen Horowitz, F-Prime Capital, GV, and Transformation Capital participated.
  • South San Francisco-based Kezar Life Sciences raised $45.7 million in a stock offering for its work on autoimmune disease and cancer.
  • Rockville, Maryland-based Cerecor raised $33 million in a stock offering to support its work on rare pediatric diseases.
  • San Francisco-based Twist Bioscience, the DNA synthesis company, raised $107 million in a stock offering.
  • San Diego-based Fate Therapeutics raised $175 million in a stock offering to support its cell therapies for cancer and immune disorders.
  • San Diego-based Cue Health, a health tech company, raised $100 million in a Series C financing that included Decheng Capital, Foresite Capital, Madrone Capital Partners, Johnson & Johnson Innovation, and ACME Capital.
  • South San Francisco-based Alpha Health raised $20 million in a Series A financing to advance its platform for automation in reimbursement. A16Z led.

Personnel File

  • Denmark-based Lundbeck said it will cut 130-160 jobs.
  • South San Francisco-based ORIC Pharmaceuticals, a cancer drug developer, named Lori Kunkel to its board of directors.
  • Legend Biotech added Corazon (Corsee) Dating Sanders, Darren Ji, and Philip Yau to its board of directors.
  • Cambridge, Mass.-based Constellation Pharmaceuticals hired Jeffrey Humphrey as chief medical officer.
  • South San Francisco-based NGM Bio added Carole Ho to its board of directors.
  • Seal Beach, Calif.-based Dendreon hired Jason O’Neill as CEO.
  • Waltham, Mass.-based Affinia Therapeutics, a gene therapy company, named Elliott Sigal to its board of directors.

Regulatory Action

Gaithersburg, Maryland-based Viela Bio secured FDA approval for inebilizumab-cdon (Uplizna) for Neuromyelitis Optica Spectrum Disorder.

San Diego-based Illumina secured an FDA Emergency Use Authorization for a next-gen sequencing test to detect SARS-CoV-2 RNA in respiratory samples.

10
Jun
2020

Fighting COVID-19 & Racism: Andy Plump on The Long Run

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10 Jun 2020

Today’s guest on The Long Run is Andrew Plump.

Andy is the president of research and development, and a member of the board of directors, at Takeda Pharmaceutical. Takeda doesn’t get a lot of attention in the US, but it’s one of the world’s biggest pharmaceutical companies by revenue, ranking a little behind AbbVie and a little ahead of Bristol-Myers Squibb.

Andy Plump, president of R&D, Takeda Pharmaceutical

In this conversation, I asked Andy about the past few months of repositioning the company to fight COVID-19, particularly in its area of strength with plasma-derived therapy. Takeda, like so many companies, had to look in the mirror and ask what it had to offer on the global stage against this unprecedented threat.

Takeda, like many large pharma peers, also moved quickly to a Work-From-Home policy in mid-March, put a bunch of clinical trials on pause, and started collaborating in new ways with its peers.

Toward the end, we talk about the racial reckoning that has followed in wake of this pandemic. Andy, as a white male in a powerful position, reflects on some of the privilege that undoubtedly helped him along the way – whether he fully realized it or not along the way. He discusses some obvious things that pharma can do to right some of the wrongs of history.

Andy is paying careful attention to what the protestors are saying. He’s listening. He endorsed a heartfelt editorial from Ramona Sequeira, an executive colleague at Takeda.

It’s a start.

Like a lot of people, I’ve despaired about this topic in the past. But I’m hopeful now, at least partly because of the openness I’m seeing among white people to stare injustice in the face, and see it for what it is. And to say it must end.

Now, please join me and Andy Plump on The Long Run.

10
Jun
2020

Let’s Turn the Black Nod Into a Collective Nod

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10 Jun 2020

Uciane Scarlett, principal, Oxford Sciences Innovation

I first met Ken Frazier, the CEO of Merck, at the JP Morgan Healthcare Conference in San Francisco in January 2018.

It was my second year as an operator in biotech. I was still getting familiar with the whole bewildering experience of JPM. I was trained as a cancer immunologist at Dartmouth, did a stint in life sci strategy consulting, and had started to realize what I might do with the rest of my career in industry.

At the time, I was the director of business development & strategy for a little-known cancer immunotherapy startup, Compass Therapeutics. I didn’t know a lot of the people swarming around Union Square.

Yet there I was at the rather large Merck reception with several hundred people at the Fairmont Hotel with the CEO of my then company, working the room, making small talk. As would typically be the case, there were maybe 4-5 black people in the room.

When I noticed Ken making the rounds, my CEO had to do a double-take. It can’t be, why would the CEO of Merck attend such a large event with a lot of people likely to hound him with endless unwanted business pitches?

Then Ken saw me and gave me the “black nod.”

For those unfamiliar, this is a nod between black people as a way to say, “I see you; I acknowledge you”.

Then something surprising happened. Ken Frazier, one of the most powerful people in the pharmaceutical industry, and one of the most powerful people in all of Corporate America, came over to our little group. With great enthusiasm, he said he was looking to connect with everyone in the room. He had no idea what I was working on, or whether it might be something of interest to his company. He just made me feel welcome, and asked some questions that showed his curiosity about who I was and what I do.

We never spoke about race. That night I not only saw a black man acknowledging a black woman in a room where we represented <1% of attendees, I also saw a grounded individual with admirable humility.

Last Monday, Ken showed another side of himself during an extensive CNBC interview. He expressed grief and frustration for the killing of George Floyd. He chastised the actions of Minneapolis police officer Derek Chauvin. Importantly, expressed the need to keep the conversation going even after the protests end.

The second part of his 17-minute interview rose to an emotional crescendo as he built on a plea to do more to support African Americans’ participation in society. He spoke of his own opportunity provided by social engineers in Philadelphia which allowed him to be one of nine African Americans to get a rigorous education that set him on a path for success. He emphasized how someone intervened and provided him an opportunity.

Someone essentially said “I see you, I acknowledge your opportunity gap”.

It was poignant. In that instance, I reflected on the numerous images, videos, audio clips that have been in our newsfeeds and social media platforms. I heard the emotions in his voice, I saw it in his face. I was moved to tears.

I moved to the US from Jamaica and started grad school at Dartmouth College in Hanover, New Hampshire in 2006. That year I was the only black student in my class, and one of four black students in the Arts & Science PhD program at Dartmouth. I got my PhD in cancer immunology in 2011 – right around the beginning of the cancer immunotherapy revolution.

Although I’m an American citizen, I won’t write as if I’ve fully experienced what it’s like growing up black in America. The novel “Americanah” by Chimamanda Ngozi Adichie mimics my nuanced experience and reflects many healthy debates I had with classmates of color during grad school.

Still, I am a black woman and until recently – as I moved to the UK last December – fell within the estimated <5% (BIO 2020 report) of the US biotech workforce.

The biotech industry is fairly siloed, but based on meritocracy. It is one of the most diverse in the US relative to other highly specialized sectors, such as Finance (Figure 1). Still, blacks/African Americans represent a grossly underrepresented group in biotech when compared to the overall US population (Figure 2).  

Today, racial justice and diversity, equity, and inclusion are commanding people’s attention in America like never before. The appalling killing of George Floyd by the Minneapolis police, and other recent acts of violence against African Americans, have triggered this awakening. Coupled to the latest economic downturn and psychological pressures of lockdown and social distancing, the societal response and commentary is global.

For the first time in recent history we’re seeing corporate America, including biopharma companies, like Novartis, J&J, and Gilead, show public support with press releases and statements that go beyond the usual rhetoric.

But how do we translate the words, and the expressed values animating the words, into meaningful action? How do we do more? How do we continue to build an industry based on meritocracy, but that is more inclusive? How do we build a path for more underrepresented minorities towards higher education, and ensure we continue to tap into the pool of 3,000+ Black/African American doctoral recipients – 500+ in life science – in 2018?

Ken Frazier started to answer many of these questions during his CNBC interview, but I’ll build on his commentary with a few additional points below:

Start at the level of the individual

Boston is the biotech hub, with $4.8B venture capital investment and employing >70,000 individuals across the industry in 2018. About 10 miles south of the cluster of companies in Kendall Square is Roxbury, a neighbourhood I frequented during my role at Big Sister Boston. I enjoyed connecting with the girls in the program, which was committed to providing opportunities to underrepresented girls, and often drove them around Kendall Square as a way to ignite excitement for science and the biotech community. As humans we make deeper connections with the familiar. To many Americans, minority neighbourhoods are unfamiliar, individuals within these neighbourhoods are unfamiliar. Forming deeper connections with underrepresented groups exposes the unfamiliar, it creates the comfort required to speak openly about racial matters, it creates the foundation necessary to define meaningful actions, and establishes a platform for voices to be heard.        

Go beyond press releases and statements

1. Hire outside of network

When hiring we have natural biases to look within our networks. Oftentimes we look for individuals from select colleges, former colleagues, or members of professional or social groups. Tony Coles, CEO of Cerevel Therapeutics and former CEO of Onyx Pharma reflected on how he achieved 40% people of color on the executive team of Onyx. His marching orders for his head of human resources were simple, find him the best people.

2. Extend patient-specific diagnostic & therapeutic platforms to underserved groups  

In an era of personalized, individualized, and genetic-based therapies, the commercial model predominately supports a European demographic, thus limiting access to underrepresented groups. This is commonly seen in early-stage product development where a company focuses its platform on a major market segment, but often does not expand to minority groups as their platform matures. 23andMe, a genetics service provider who generates reports on health predispositions and traits, recently acknowledged that their product was Euro-centric and recognized they were part of the problem. While admirably forthright, it’s unclear how they intend to address this limitation, but providing underrepresented groups access aligned with potential socioeconomic limitations will be a necessary step forward.

3. Aim for fitting representation of race and ethnic minorities in clinical trials

Blacks and Hispanics are underrepresented in clinical trials for diseases prevalent in these groups. A 2019 AJMC study reported that blacks and Hispanics were enrolled at 22% and 44% respectively of their expected rate of cancer, in contrast to whites and Asians who were enrolled at 98% and 438% respectively. Companies like Pfizer have launched initiatives to recruit participants who are more representative of the patient populations under study, but can they do more? Education is a key limiting factor for clinical trial participation as underrepresented groups often have a misunderstanding of the cost, risk, and benefit of participation. There is also a legacy of mistrust that must be acknowledged and confronted. Coupling targeted education with innovative recruiting platforms, ensures therapies are developed suitably for diseases where minorities are predisposed.

As Chimamanda Ngozi Adichie said:

“the single story creates stereotypes, and the problem with stereotypes is not that they are untrue, but that they are incomplete. They make one story become the only story”.

We’re energized and hungry for change. We’re well-positioned to change the single story. There is so much more that we can all do to create a more equitable world, through our individual actions, and through policies at our companies.

I hope we can all build on the “black nod,” and turn it into the “collective nod.”

 

 

Figure 1: Biotech – survey of 33 biotech company respondents who completed questions on race/ethnicity representation. Tech – survey of 4 tech companies, Google, Apple, Facebook, and Microsoft. Finance – finance & insurance workforce (Sources: BIO – Mix Matters Annual Report, Measuring Diversity in the Biotech Industry, 2020; Wired 2019; US Bureau of Labor Statistics, 2019)

Figure 2: Survey of 98 biotech companies in 2019; showing 33 that completed questions on race/ethnicity representation against US 2019 census demographics (Sources: BIO – Mix Matters Annual Report, Measuring Diversity in the Biotech Industry, 2020; US Census Bureau)

5
Jun
2020

Tech Integration Into Pharma: A Report From The Front Line

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05 Jun 2020

David Shaywitz

Most biopharma companies can talk at some length about embracing data science, and sometimes it’s hard to get beneath the surface of what they’re doing, at least publicly.

But it was my privilege recently to frame and moderate a very insightful recent conversation – recorded for on-demand viewing at this year’s virtual BIO 2020 conference.

This provided an unusual opportunity to get beyond the aspirations and slogans companies tend to use when discussing how to integrate tech and pharma.

For this conversation, we got deep into the sort of issues I tend to encounter in my advisory work, and talked substantively about both the pain points that key players encounter and the specific solutions they are testing as they try to figure out how to make the most of data science in biopharma.

My discussion partners were Ray Deshaies of Amgen, Shahram Ebadollahi of Novartis, Amy Abernethy of the FDA, Chad Robins of Adaptive Biotechnologies, and Peter Lee of Microsoft.

We covered a lot of ground over nearly 90 minutes; rather than summarize, I wanted to share a couple of thematic takeaways that particularly resonated.

Learning From Biological Revolutions In Pharma

It takes a long time for a technology revolution to truly be absorbed by the pharmaceutical industry.  Ray Deshaies, SVP of Global Research at Amgen (and before that, a distinguished biologist at Caltech and a HHMI Investigator) described the lengthy process associated with the adoption of biologics (eg antibodies) by an industry that had been built around the discovery, evaluation and development of small molecules.   

The revolution clearly took. By 2018, eight of the top ten best-selling drugs in the world were biologics.There’s no doubt these products transformed the industry.

The first monoclonal antibody therapy, Deshaies reminded us, was actually a mouse anti-CD3 antibody, OKT3 (Orthoclone), approved by the FDA in 1986.  From there, it took eleven years before the approval of the anti-CD20 antibody rituximab (Rituxan), which would go on to be the first blockbuster drug of this class. 

Deshaies reviewed the ongoing evolution of antibody technology, from mouse antibodies to chimeric (part-mouse DNA/part-human protein sequence) antibodies (like rituximab [Rituxan]) to “humanized” (almost all human) antibodies like pembrolizumab (Keytruda) to “fully human” antibodies like secukinumab (Consentyx).   

This progression, Deshaies pointed out, reflected a considerable amount of deliberate effort, including extensive investment in successive technology platforms, along with the work required to understand each of them, embellish them, and fully understand the issues with each. In the manufacture of biologics, he noted, there are all sorts of less-appreciated complexities that crop up over time, including issues like the impact of cell line and media, which can each significantly impact the performance of the final protein product, despite a constant DNA sequence encoding it.

The rise of biologics gave rise to profound new needs on the talent side, Deshaies added. It created a need to train a new generation of people; for example, the way you think about pharmacokinetics for biologics is very different than how you think about it for small molecules. Additional learning was required, and it took time for all the newly trained people to get in place.

Deshaies also described a second revolution that also required (ongoing) adaptation: human genetics. This became especially important at Amgen once they resolved to pursue targets validated by human genetics, and acquired Icelandic genetics company deCode in 2012. Most lab researchers, Deshaies explained, were trained in mouse genetics, and need to be retrained in human genetics and human physiology. He reports that while Amgen been able to recruit increasing numbers of scientists trained in statistical genetics and human genetics, there’s still a lot of education required for the organization. “It takes repetition,” he said.

These efforts – at Amgen and across the industry – have persuaded most drug hunters of the value of human genetics; such validation significantly increases a compound’s probability of success.  (Of course, a drug may still not work as expected, a tough lesson Amgen itself learned when a genetics-inspired bone drug turned out to cause cardiovascular problems.)

Pursuing human genetics at Amgen, Deshaies added, required more than executive leadership and top-down messaging.  While it’s helpful for top brass to say “we want to do human genetics,” he said, it takes so much more for that message and thinking to permeate the organization, and become part of its fabric; considerable time and persistence seem to be required.

Pharma’s experience with these emerging biological technologies seems like useful context as the industry now contemplates the adoption of digital technologies, highlighting the effort, capital, and patience required to effect durable change in the industry.  While it’s encouraging that pharma constantly seeks out new technology, it’s sobering to appreciate how long it takes for large legacy organizations to fully internalize new ways of thinking.  It’s just not realistic to expect tech adoption to occur overnight in an enterprise this complicated, with this many moving parts.

A Pharma Goes All-In

Novartis is one of those traditional pharma companies that is trying.   With deliberate intentionality, and led by CEO Vas Narasimhan since 2018, Novartis is conspicuously trying to take itself through the revolution it sees happening in digital technology.

There has been no shortage of top-down messaging, starting with Narasimhan himself, who essentially introduced himself to the world by offering a vision of Novartis as a data-driven medicines company. Not unexpectedly, as Narasimhan has subsequently reported, progress has been uneven.

Thus it was especially interesting to listen to Novartis’s Global Head of Data Science and AI, Shahram Ebadollahi, discuss his ambitions and approach. 

What really struck me was that while Ebadollahi offered an example of “AI exploration”- some sexy longshot project in discovery chemistry – he spent a lot more time discussing “AI empowerment.” He described this effort as an attempt to introduce AI and data science tools (many available through a high-profile collaboration with Microsoft) at every step of the work flow; he wants to distill machine learning into “bite size engines,” so employees don’t even realize they’re using ML – it’s just running in the background.  His perspective seemed very aligned with Jim Manzi’s view, using AI to solve unsexy discrete problems.

In addition to the new technology, Ebadollahi described a very deliberate effort to “shift the mindset of people” via constant “multichannel communication.” Basically, if you work at Novartis, it sounds as though you hear about data science relentlessly. There’s an effort to educate current talent through a “data science academy” and other initiatives, and an AI residency program that seeks to embed a recently graduated AI expert within R&D teams. 

Successful cultural change in pharma will require an  elevation of the practice of data science within the industry, Ebadollahi argued. Today, he said, pharma is driven by biologists and physicians, but if a pharmaceutical organization is really to become a data science company, data scientists have to become truly equal partners. 

I imagine most pharma physicians and biologists would reply that this elevation will happen when data scientists demonstrate they can deliver substance and value, not just grandiose promises – which I imagine is why Ebadollahi also highlighted the importance of actually delivering value to programs – of really proving out an approach, not just living in the world of innovation, pilots, and proof-of-concept work. Success, he argued, required putting people with complementary skills in a room and setting them to work.

Learning From Hard-Won Experience

Drawing from her many experiences over her career trying to bring such groups together, Dr. Amy Abernethy, now Principal Deputy Commissioner of the FDA, emphasized not only the importance of integrating health and tech talent, but also the difficulty of pulling it off. The required collaboration is critical but hard, she explained, adding that we need to acknowledge and confront just how hard it is. 

Creating a culture that makes all the collaborators equal is a non-trivial challenge, Abernethy said, but also worth it. She argued that the interesting opportunities happen when we pull together streams of information and talent that generally don’t exist in the same place. Like Ebadollahi, she also emphasized the need to move from idea of collaboration to actually getting stuff done.

Abernethy also highlighted the importance of thinking about the application of technology as a “full stack opportunity” – in other words, it’s not only about how tech can help discover a new drug. We also need to think about how it can help accelerate clinical development, and contribute to clinical trials and through the approval and post-marketing phase as well. 

Abernethy spoke to the particular importance of not neglecting the “last mile” work – to be sure that the relevant information is delivered to the treating physician in a useful fashion. Doctors operate in an increasingly complex environment, she reminded us, with rapidly evolving knowledge, and limited time with patients who are often (and understandably) distraught. As a physician, you need clarity to offer relevant, useful, data driven advice that technology ought to be able to facilitate. 

Abernethy also emphasized that while randomized controlled trials remain the gold standard, the COVID-19 pandemic has highlighted the importance of trying to bring to bear all the data available, and leverage this information to the fullest extent possible, from electronic health record data to claims data to biosensor data. The problem, she explained, is how to bring it all together; everyone thinks there’s a “magic button,” she said, but there’s not, and it’s actually very hard. She hopes that the collaborations driven by the “COVID-19 Evidence Accelerator,” which focuses the community on identifying and then answering a critical set of questions, can help. I hope so too, though my mind kept returning to comments Walmart’s Marcus Osborne made at a recent healthcare conference: the U.S., he said, has no public health infrastructure. That said, if anyone can kluge together something useful from the scattered pieces we have, that person would be Amy Abernethy.

A Startup Integrates Health & Tech From The Outset

The opportunity for emerging tools to potentially add value to established techniques was highlighted by the work of Adaptive Biotechnologies, and their partnership with Microsoft. Adaptive’s focus is sequencing immune receptors – which is probably why their co-founder and CEO, Chad Robins, highlighted the “huge opportunity” in clinical sequencing. 

Like me, your first reaction was probably, “Clinical sequencing?  How quaint!”

But if we’ve learned anything about revolutions in healthcare, it’s that they take awhile, and often require the confluence of just the right technologies. Adaptive’s thesis is essentially that because the immune systems responds to everything adverse we encounter, it harbors in essence a version of our medical record, documenting the many enemies, both foreign (like a virus) and domestic (like a cancer) we may have encountered and mustered a response against. If this record could be understood, if our history could be “read,” the information could be used to diagnose diseases (like Lyme Disease, celiac disease, cancers, and now infectious diseases like COVID-19), as well as to suggest potentially effective antibodies to be tested as a biologic therapy. For example, they are working with Amgen to prioritize potential therapeutic antibodies against SARS-CoV-2 that Amgen could then develop.

Because of the volume and complexity of the sequencing data they intended to study far exceeded the capabilities of a traditional spreadsheet application, Robins said, they needed to develop  their own  software tools that could allow researchers to interpret, analyze and visualize the data.  This required, from the outset, a culture that necessarily integrated bioinformaticians and biologists.

Role Of Big Tech: Cloud Services Supplier

The Adaptive team also realized that even with their own software, they needed access to ever-more computational power, especially as they set their sights on a particularly ambitious goal – matching specific antigens with specific receptor sequences. This turns out, according to Peter Lee, Microsoft’s Corporate Vice President (and former head of the computer science department at Carnegie Mellon University) a difficult but not impossible machine learning problem, on par with language translation, and a perfect opportunity for a partnership, which is  what the two companies announced in 2018, and expanded recently to incorporate work on COVID-19. 

In the foundational agreement, Lee explained, Adaptive gained access to the computational power it required to extract remarkable value (if successful) from the immuno-sequencing data the company generates; Adaptive also received embedded Microsoft talent, and an equity investment from Microsoft as well. In exchange, they were compelled to move all their compute to the Microsoft Cloud (and away from competing clouds like Amazon’s AWS and Google Cloud, for example).

Microsoft’s goal, said Lee, is to develop substantial partnerships that drive value through use of cloud-enabled digital technologies. Microsoft sales teams are compensated based not on whether a client buys Microsoft technology (such as access to their Azure cloud), but rather based on the extent to which the client actually uses it. As Microsoft sees it, this places them in strong alignment with customers; the more valuable the cloud is to the business, the more it will be used, and the more revenue Microsoft will receive.  (This assumes, of course, that customer use of the cloud services actually correlates with the business value the service generates; there’s a parallel here to fee-for-service medicine.) 

Microsoft, in any case, is highly motivated to find ways for the cloud to be useful for customers, as we saw manifest at Novartis as well. (Lee notes the relationship with Novartis is obviously structured very differently than their relationship with Adaptive, which he describes as a model for their relationships with other especially promising startups; however, he notes that even in his relationship with Ebadollahi, Microsoft’s success is “completely indexed” on Novartis’s success.)

Bottom Line

Pharma is highly attuned to technological innovation in a range of domains; the most impactful medicines of today look very different, and were discovered in a very different way, than the medicines of yesterday. Tomorrow’s medicines will look very different than today’s, and are likely to be created, evaluated, and developed in a different fashion as well. 

The promise of digital technologies has appropriately captured pharma’s attention, but figuring out how to effectively engage with and implement these emerging approaches remains a work in progress. Powerful computational tools, combined with rich data, offer potentially transformational opportunities in both diagnostics and therapeutics – often in combination with established technologies such as next-generation sequencing and advanced imaging. More immediately, the application of machine learning to the thousands of intricate processes that underlie pharmaceutical operations are likely to provide the earliest indications of impact. 

Success of the digital revolution in pharma will require a culture that authentically recognizes and equally values the contributions of data scientists, as well as evidence that the promise of data science is translating into tangible pipeline results. We’ll know we’ve arrived when the impact of data science extends from tools used by patients to stay healthy, prevent disease, and discern early signs of trouble, to the discovery, development, and post-market assessment of new medicines to treat patients when they’re sick, through the provision of timely, point-of-care decision support so providers can most effectively guide patients back to health.

It’s an ambitious vision, at once deeply worthy and highly uncertain. Who’s in?

4
Jun
2020

Anger, Pain, and Hope

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04 Jun 2020

Luke Timmerman, founder & editor, Timmerman Report

The emotions this week were especially intense. Anger. Fear. Despair.

But there was also hope. That gets me up in the morning.

In this slice of America, the biotech industry, many people are mission-driven.

People in this industry work every day to improve the human condition by making better medicines.

Not everyone feels the full weight, but many in this part of the scientific problem-solving enterprise didn’t need a news flash that African Americans suffer terrible disparities in things like heart disease, cancer, diabetes, asthma, and now COVID-19.

What I saw this week were glints of new awareness — a growing recognition, let’s say — that the injustice inflicted on African Americans for 400 years is inextricably linked to those health disparities. The mission of biopharma is about improving health. But health is connected to all of those underlying things like housing, education, and criminal justice that are terribly unjust.

If people don’t dig into the root causes to make a better world for everyone, how can we begin to improve health?

The good news is, these protests are starting to move people.

This is a start.

Events move so fast now, it’s easy to lose track of actual progress being made. The police officer that killed George Floyd in Minneapolis had his charge upgraded to second-degree murder. The other three officers — who stood there and didn’t do anything to save him while he cried “I can’t breathe” and begged for his mother — they were charged with aiding and abetting. After days of protestors demanding they be charged.

George Floyd’s family asked for Minnesota Attorney General Keith Ellison to prosecute the case. The attorney general of Minnesota, no less, answered that call.

New investigations into troubling cases of African Americans dying in police custody are being opened up all around the country.

Mayors, Governors, police chiefs, and even some police union leaders all over the country, are speaking out like never before against the horrific acts of the Minneapolis police caught on video. The Republican governor of Maryland called Minneapolis police officer Derek Chauvin a “murderer in a blue uniform.”

Thoughtful executives, like Ken Frazier of Merck, could do the easy thing and say nothing. Or issue a statement with some generic platitudes. Instead Frazier said something real, both about George Floyd’s case and about how his life fortunately went down a different path.

He said it on national TV, on a channel that the powers-that-be actually watch.

This is a start.

If you’re ever going to change laws, change police union contracts, change structures around citizen review boards, and begin to hold cops accountable – you have to start with recognizing there’s a problem and applying pressure.

This is a start.

These things are happening because of the public pressure being brought by protestors.

Young people are demanding action at the local and state level. People in power in Minnesota, and elsewhere, seem to be listening and acting accordingly. They might listen some more, and continue to act accordingly, if the pressure remains relentless.

We need to watch out for the violence and senseless rioting. That’s destructive and wrong. It’s damaging to people’s livelihoods, including livelihoods of African American business owners. It needs to be stopped. Throwing bricks through windows and stealing merchandise? It doesn’t do any good, and we don’t really know who’s doing it and why. Then we watch cops do more abusive things in the heat of the moment, whether it’s because of all-too-human nerves, or because of foolish orders from above.

These past few days have gotten better on these counts. I believe the protestors, as long as they stay peaceful, might just have staying power during this summer of so much pain.

Tremendous acts of community kindness – offerings of water, sunscreen, food and more – are sustaining protestors. See this young woman describe the remarkable generosity she has witnessed in Minneapolis.

Many of us in biopharma are wondering what we can do. It’s easy to surrender to helplessness against a problem this big, this deeply engrained. Where to start? What difference can anyone make? Why bother?

That’s nihilism talking. That’s no way to live.

There are things we can do. Small things, maybe, but things that matter.

Many of you read Rob Perez’s guest article on things biopharma can do to dig deep and fight hard, against injustice. I think people are listening more than in the past.

This is a start.

We can use this moment to teach our children about right and wrong, in terms of racial justice. We can use this surge of energy to vote out dangerous leaders in Washington DC, and vote in a new generation of people willing and able to do the hard work in our communities of dismantling systemic racism – in criminal justice, in housing, in education, in health.

All these things are connected. We need to get our hands dirty, down there at the roots, if we really want to make progress across the board.

Nobody can do this alone. But if everybody digs in – and, crucially, is willing to stick with this long past the end of the news cycle – then we will have accomplished something meaningful.

Politics

The President said he’s pulling the United States out of the World Health Organization in the middle of a pandemic. It will harm people around the world, especially in developing countries. If he follows through with this threat, it will diminish US influence on the world stage. It will create an opening for China and others to seize, gaining more influence over how the pandemic response is run. To say the WHO is perfect would be wrong. It has made serious errors, like not declaring COVID-19 a global pandemic in January. But pulling out of the WHO completely, at this moment, is impetuous and short-sighted and dangerous.

The Pandemic Toll

The pandemic was pushed down in people’s news feeds. But let’s not forget. We have 108,000 deaths in the US, and almost 1.9 million cases. The New York Times reports 17 states where cases were increasing over the past week, and 15 states where cases were decreasing.

Science

  • ‘It Opens Up a Whole New Universe.’ CryoEM Sees Individual Atoms for the First Time. Nature. June 3. (Ewen Callaway)
  • Effect of Convalescent Plasma in Patients with Severe COVID-19. A Randomized Controlled Trial. JAMA. June 3. (Ling Li et al)

Science Features

  • The CDC Waited Its Entire Existence for This Moment. What Went Wrong? NYT. June 3. (Eric Lipton et al)
  • COVID-19 Can Last for Several Months. The Atlantic. (Ed Yong)
  • The Untold Story of the Moderna Coronavirus Vaccine. Boston magazine. June 4. (Catherine Elton)
  • Why Coronavirus Hits Men Harder. Sex Hormones Offer a Clue. Science. June 3. (Meredith Wadman)
  • The Global Race for a Coronavirus Vaccine Could Lead to This Generation’s Sputnik Moment. Washington Post. June 3. (Carolyn Johnson and Eva Dou)
  • Blood Vessel Attack Could Trigger Coronavirus Fatal ‘Second Phase’. Science. June 2. (Catherine Matacic)

Treatments

Gilead Sciences released some Phase III data from a remdesivir study of patients with moderate forms of COVID-19. These results, as many expected, were more encouraging than the earlier results from a study of more severely ill patients. The 5-day course of treatment was also the way to go, which is good news for stretching out manufacturing supplies around the world.

If you’re looking for important, under-covered stories on the pandemic, look at Eli Lilly’s neutralizing antibody candidate for COVID-19. In collaboration with AbCellera and researchers at the National Institute of Allergy and Infectious Disease, the team picked an antibody from the blood of a recovered patient, made recombinant copies as biopharma companies do so well, and now have it in patients in a clinical trial in the span of about three months. Along with Regeneron and VIR Biotechnology, these therapeutic antibodies have a chance to mitigate the pandemic in the interim period before we get a vaccine.

Hydroxychloroquine failed to prevent healthy people from getting COVID-19 in a clinical trial. The study was conducted at the University of Minnesota, and enrolled healthcare workers. See the Washington Post coverage.

Vaccines

  • AstraZeneca Lays Out Plan to Produce 2 Billion Doses of Coronavirus Vaccine. STAT. June 4. (Matthew Herper)
  • GAVI, The Global Vaccine Alliance, Launched $2B Advance Market Commitment to Deliver COVID-19 Vaccines Equitably Through the World. (GAVI statement)
  • Tony Fauci Didn’t Like the Early Data Release on Moderna Vaccine. STAT. June 1. (Helen Branswell)
  • The Five Leading Vaccine Candidates Prioritized by Operation Warp Speed. (See below)

Public Health

  • White House and CDC Remove Coronavirus Warnings About Choirs in Faith Guidance. Washington Post. May 28. (Lena Sun and Josh Dawsey)
  • Tear Gas Is Way More Dangerous Than Police Let On, Especially in a Pandemic. ProPublica. June 4. (Lisa Song)
  • Former CDC Director Says US Led the World Before Becoming a Global Health Laggard. Washington Post. May 29. (Joe Davidson)
  • Evidence for COVID-19 Spread in January and February. May 29. CDC. (Greg Armstrong et al)
  • Will Protests Set of a Second Wave? NYT. June 4. (Roni Caryn Rabin)
  • Zoloft Falls Into Short Supply as Virus Anxiety Strains Supplies. Bloomberg News. June 1. (Anna Edney)

A Big Retraction

The Lancet retracted a widely-read May 22 paper on hydroxychloroquine and chloroquine as treatments for COVID-19. The original article said there was no benefit seen, based on evaluating a registry with records from 96,000 patients. The authors wrote in their retraction, “we can no longer vouch for the veracity of the primary data sources.” Retractions are never good, but especially in a pandemic when we need trustworthy sources of scientific information and guidance. What’s the big takeaway from this? See Ashish Jha below.

Another paper that depended on Surgisphere for raw data collection appeared suspicious enough to generate an “Expression of Concern” in the New England Journal of Medicine. That was for a paper titled “Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19.” Strangely, the authors of that paper “all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor.” Maybe this is just naïvete, but aren’t authors of a scientific paper supposed to have access to raw data so they can properly analyze and summarize? This doesn’t smell right.

Deals

Cambridge, Mass.-based Intellia Therapeutics pocketed $100 million upfront ($70 million cash and $30 million equity investment at $32.42 a share) as part of a collaboration with Regeneron Pharmaceuticals to develop CRISPR-based treatments for hemophilia A and B. The companies have experience working together already, and this is an expansion of the prior collaboration.

Berkeley, Calif.-based Aduro Biotech merged with privately-held Vancouver BC and Seattle-based Chinook Therapeutics. The new company, called Chinook Therapeutics, will be led by Chinook CEO Eric Dobmeier. Chinook now will get a Nasdaq listing, will have $200 million of cash in the bank, and the runway to pursue its precision medicine approach to kidney disease.

Lexington, Mass.-based Accent Therapeutics, the developer of cancer drugs that target RNA-modifying enzymes, secured a $55 million upfront payment as part of a collaboration with AstraZeneca.

Data That Mattered

Waltham, Mass.-based Minerva Neuroscience said its drug candidate for schizophrenia failed in a placebo-controlled Phase III trial of 515 patients. The stock collapsed, down 70 percent.

Gilead Sciences released updated safety data from more than 4,500 patient years of experience with filgotinib, the oral JAK1 inhibitor for rheumatoid arthritis, at the European League Against Rheumatism conference. The drug is part of the collaboration with Galapagos NV of Belgium.

Regulatory Action

AbbVie won FDA clearance to market elagolix estradiol, and norethindrone acetate (Oriahnn) capsules as a treatment for heavy menstrual bleeding due to uterine fibroids. It’s the first oral treatment of its kind.

Eli Lilly won FDA approval for its IL-17 alpha inhibitor, ixekizumab (Taltz) for non-radiographic Axial Spondyloarthritis, including ankylosing spondylitis.

Personnel File

Mark Genovese was hired as senior vice president of inflammation at Gilead Sciences. He was on the faculty at Stanford University for 21 years.

Admiral Brett Giroir, who has been leading coronavirus testing efforts for the federal task force, said he’s being “demobilized” from that effort, and going back to his regular role at the Department of Health and Human Services, according to NPR.

Sanofi Ventures hired Jim Trenkle as head of investments. He was previously with Pivotal Bioventures. Cris de Luca also joined as global head of digital investments. He was previously with Johnson & Johnson Innovation and JLABS.

Financings

  • South San Francisco-based Pliant Therapeutics, a developer of treatments for fibrosis, raised $144 million in an IPO priced at $16 a share. See my coverage from its startup days in Forbes ( 2016).
  • Cambridge, UK, Seattle and Lexington, Mass.-based NodThera, a developer of anti-inflammatory drugs, received $55 million in a Series B financing. Novo Ventures led.
  • Cambridge, Mass.-based Intellia Therapeutics, the CRISPR drug developer, raised $100 million in a stock offering after the positive news of its expanded collaboration with Regeneron.
  • Shanghai-based Everest Medicines raised $310 million in a Series C financing.
  • Seattle-based Athira Pharma, an Alzheimer’s drug developer, raised $85 million in a Series B. Perceptive Advisors led.

On Grace

Tony Dungy, the Hall of Fame football coach, is a man of deep religious faith. I have respected him for years. He offered some wisdom — that rarest and most valuable of things — on a sports radio call-in show.

Dungy spoke his calm, empathetic words in the middle of the outraged, frenetic aftermath of what New Orleans Saints quarterback Drew Brees said about protests. Brees, a man with some great African American teammates, said something that was clueless and insensitive and self-centered. He later apologized.

We’ve seen this kind of foot-in-mouth moment a million times. In 400 years, we’ve never had an adult conversation about race in the US in which everyone sits and truly listens. If we’re going to take a deep breath and have that necessary conversation, the kind that’s incredibly painful but builds bridges of awareness needed to make things right, then our best bet is to look to community leaders like Dungy.

He’s giving people some space. Allowing them some room to say dumb things. Things that are awkward or tone deaf. Notice, Dungy didn’t excuse what Brees said and didn’t apologize for him. But he’s creating some room where people can listen to each other, and begin to understand why what the great quarterback said was so hurtful to so many of our fellow citizens.

People need to be given the room to make mistakes, and to see the error of their own ways. To begin to realize that perhaps they have blind spots. If people don’t feel they can be open and honest, and let their ignorance and clumsiness be forgiven, then they’ll crawl back into a shell, clam up, or stay in denial.

The worst among us will lash out in performative defensiveness and cash in off their perceived “victimhood.”

If that happens, we’ll stay right where we are, stuck in a rut, with terrible injustice happening all around us every day. With the majority of the country blind to the horror.

I want this terrible racism to end with our generation, and for our kids to grow up in a more humane and empathetic world.

Those of us — like me — who are privileged and don’t walk down the street afraid of police, need to stand shoulder-to-shoulder with those who do. We need to insist on this change, and be relentless about that change, right there with our black brothers and sisters.

It’s our job to have the awkward, painful, tearful conversations with our family members and friends who aren’t yet all the way there with us on this journey.

As Martin Luther King said: “Injustice anywhere is a threat to justice everywhere.”

As Frederick Douglass said: “Power concedes nothing without a demand.”

As John Legend wrote: “Justice for All Ain’t Specific Enough.”

The injustice is so pervasive, and so deep. We need to demand it end. Then we roll up our own sleeves. It’s not someone else’s job. For us to rip out the roots of this enduring injustice, we need to get comfortable with being uncomfortable.

Do everything Rob Perez wrote about this week. When you’ve done all that, think about doing more.

Do it with empathy, with patience. The conversations we need to have to change people’s hearts will happen in unusual places, unusual settings. Not just from a podium or a pulpit.

If you listen to Tony Dungy talking with a sports talk radio host — a young white guy — then you’ll get a feel for the words, the tone, the setting. This is what it’s about. Watch the empathy and respect he has for his conversation partner.

This is change in action.

2
Jun
2020

Digital Natives and Skilled Operators: Weaving Data Science Into Pharma R&D

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02 Jun 2020

David Shaywitz

An abiding challenge at the intersection of technology and pharma R&D is the need to bring together two historically disparate cultures. 

Tech companies tend to be led by engineers. Pharma R&D is generally run by chemists and biologists in the early stages, and by physicians further on in development.

Each of these domains has its own distinct language, culture and norms that don’t all neatly overlap on a Venn diagram.

It’s clear by this point that effective integration across these disciplines is both required and difficult. 

Data science is likely to make an impact on R&D when it’s perceived not as an exotic, novel capability, but rather when it becomes woven into the way medical researchers go about their daily work.   

This is how science progresses. In the 1980s, molecular biology was exotic, and clinician-scientists famously abandoned physiology to embrace it, as Brown and Goldstein classically described.  Today, molecular biology is a given, a standard part of the researcher’s toolbox, and the leaders of pharma R&D are all fluent with the standard tools and techniques.

I suspect data science today is where molecular biology was 40 years ago. It is now widely recognized as an incredibly powerful emerging tool, and many young physicians and medical scientists are eager to embrace it. 

Talent at intersection of medical research and data science is rare, and in high demand.  I think of people like Dr. Alvin Rajkomar, formerly of UCSF and now at Google; Dr. Krishna Yeshwant, at GV; Dr. Taha Kass-Hout, formerly of the FDA and now at Amazon; Dr. Andrew Trister, formerly at Apple, now leading the Innovative Technology Solutions team at the Gates Foundation; and Imran Haque, trained in computer science at Stanford and now at Recursion; among others. 

In what I suspect may be an early indication of where the puck is heading, Genentech recently announced what I believe is the first example of a “digitally native” researcher to lead a major pharma R&D group. The distinguished biotech drug discovery company recruited highly regarded computational biologist and systems biologist, Aviv Regev from the Broad Institute to run gRED (Genentech Research and Early Development). Her predecessor, Michael Varney, trained as an organic chemist. Varney’s predecessor in that high-powered, priority-setting role, Richard Scheller, was a molecular neurobiologist.  

To be sure, there are plenty of strong data scientists in pharma, but generally within data science-specific functions; at Genentech, Regev is responsible for all of early R&D. She isn’t being charged with running a science project, an innovation initiative, or some novel effort to link up disparate databases and see what happens. Her department must deliver actual drug candidates that move forward in development, and eventually become products that help patients.

Regev, known for her work in single-cell sequencing at high volumes, generating data that can be placed in a larger biological context, is the rare kind of individual who is equally comfortable at a computer science and molecular biology symposium. She inhabits several domains that seem critical for pharma’s future.

Digital natives like Regev remain extremely rare, though I suspect they will increasingly come to populate top pharma and medical research leadership roles – if data science is perceived to deliver on its promise (not a given). 

But “digital nativist” isn’t the only path to success. A second route is the “skilled orchestrator” – leaders who are knowledgeable, curious, and have a particular knack for effectively aligning health and tech talent against an objective. There’s a high degree of emotional intelligence that seems to be required, as well as an intuitive feel for both domains. A few role models spring to mind: Dr. Amy Abernethy (currently Deputy Commissioner of the FDA) and her leadership at Flatiron is one; Chris Gibson, the founder and CEO of Recursion seems like another.

Successful orchestration requires a common sense of mission; this is a much higher bar than most appreciate, requiring more than simply putting an engineer and a biologist in a room, say, or appending a data scientist onto a pharma product team. But a skilled orchestrator who can pull this off has the opportunity to leverage comparatively large pools of specialized tech and pharma talent, and doesn’t require all the competencies to reside in a single, remarkable person.

Whether through digital natives or skill orchestrators, it’s exciting to see pharma embrace the challenge of bringing data science to bear. The proof, however, will be in the pipeline.

31
May
2020

Adtech Data For Health: Time To Get Past The ‘Ick’ Factor

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31 May 2020

David Shaywitz

If you were responsible for the health of a large population, and could access just one of the following types of data, what would you choose (assuming all were acquired legally and responsibly)?

(a) Genetics and other –omics data;

(b) EHR data;

(c)  Consumer/adtech data.

For at least the last 20 years, we’ve been obsessively focused on the first two categories, as proponents of precision medicine were enthralled with the possibilities of what we could learn from genomics and other types of -omics data. Advocates for a learning healthcare system, meanwhile, tended to emphasize the value of medical record data. These efforts have yielded important progress. 

At the same time, if we’re being honest, we must acknowledge that these approaches haven’t (yet) delivered anything close to the envisioned healthcare transformation originally promised. Perhaps, we just need to be more patient.

While some academic groups have begun looking at consumer/adtech data, this information has remained largely off-limits for serious healthcare companies and researchers — mostly because it’s just too fraught, enmeshed as it is with ethical and legal landmines. The very existence of the copious amounts of data on consumer buying patterns and expressed affinities is viewed by some as intrinsically problematic. Many worry about the ecosystem in which these data were generated, concerned about the increasing pervasiveness of what sometimes called “surveillance capitalism.” 

According to some critics, these data shouldn’t even exist. Given the reality of their enduring presence, many believe we should do all we can to minimize their impact.

Similarly, I suspect some medical researchers viscerally view adtech data the same way they (and I) view the results of historically unethical experiments, like (to pick a deliberately extreme example, and risk invoking Godwin’s Law) Nazi doctor Josef Mengele’s notorious twin studies. The repugnant method in which Mengele’s data were obtained are generally felt to outweigh any potential utility; the results are not typically considered part of the scientific canon.

While Mengele analogy may be over the top, the discomfort towards this information is real, and consequently, most everyone in healthcare steers clear – well clear – of adtech data. Medical systems, to the extent they are even aware such data exist, are unlikely to go anywhere near them; it would risk reducing patient trust, with no apparent upside. (I’m sure the marketing department of medical systems are well-aware of these data, but have no interest in connecting this information with traditional health data.) 

Tech companies like Google and Amazon are keenly aware of consumer and adtech data; their business models and staggering valuations are built on these data. Yet, most large tech companies seem to have decided that they want to become trusted partners to healthcare. The business opportunity they see in this space doesn’t involve their traditional model of harvesting consumer data; rather, they hope to sell cloud computing and related services (like AI) to hospitals, drugmakers, health insurers and others. 

In their interactions with healthcare systems, Google, Amazon, and Microsoft each seem to go out of the way to emphasize the robust firewall between patient data and consumer data. At a recent healthcare conference, senior physician-executives at Microsoft and Google, for example, repeatedly emphasized the importance of trust and equity in all discussions of technology. These tech giants want healthcare data from clinical care and pharmaceutical research to be managed and analyzed on their respective cloud services. 

The tech companies evince little interest in “crossing the streams,” and somehow connecting adtech data and healthcare data. The goal is to be trusted stewards of the health industry’s sensitive data, and to help healthcare customers use analytical tools to extract greater value from this information. 

Apple, for its part, has never been particularly interested in monetizing individual data, but rather seems focused on providing a secure data ecosystem, so it can sell the devices that collect (Apple Watch) and integrate (iPhone) this information. 

Facebook, meanwhile, was exploring the possibility of integrating user and health data back in 2018. This work was happening largely out of public view for more than a year. As described by Sidney Fussell in The Atlantic in January 2020, Facebook had sent cardiologist Freddy Abnousi (current head of health technology at Facebook) on a mission:

“He was to get the Stanford University School of Medicine and the American College of Cardiology on board with a new project that would combine Facebook user information with hospital-patient data in order to influence patient outcomes. Facebook hoped it could leverage the cache of data users already give it – about their education, relationships, habits, spoken languages, employment status, and more, all of which have an enormous impact on health outcomes – to create a sort of subclinical health-care system, warning providers if, for example, a user recovering from surgery had a small support group.

Then came the Cambridge Analytica debacle, and with it a cascade of highly public inquires and privacy revelations that resulted in the cessation [of these efforts].”

The Cambridge Analytica scandal, in which Facebook user data was harvested without consent and ultimately used to inform political campaigns brought new scrutiny on many aspects of the social network’s business. In response, Fussell reports, Facebook opted to roll out a dramatically scaled-down version, “Facebook Preventive Health.” The capability is offered as an (opt-in) feature in the Facebook mobile app, and uses only two user data points: age and gender. 

Just a few months after The Atlantic report, Facebook still seems to be pursuing an ambitious health vision. Facebook’s Abnousi is currently hiring a Head of Health Tech Research, seeking “a world leader in outcomes research to develop and execute a digital health tech research agenda that is aimed at improving morbidity, mortality, cost, and inequity in health outcomes” (you can apply here).  This suggests that although Facebook told The Atlantic that the Preventive Health effort is unrelated to the original data sharing proposal, the underlying goal outlined in talks with Stanford and the American College of Cardiology has endured.

Without question, there’s a creepy, icky aspect to adtech data, information that speaks to our habits and predilections, and are collected every time we Like something on Facebook, purchase something on Amazon, or search for something on Google. 

Responsible health researchers typically seek to understand patients based on parameters like genetic sequence or physician notes or claim records – each of which could be exceptionally useful.  But meanwhile, reams of data describing our actual, real-world behaviors are now the exclusive provenance of advertisers seeking to hawk soda and politicians. Health scientists and hospital administrators, for the most part, seem to have a knee-jerk reaction against touching these data; concerned about the risks and anxious about the many uncertainties. But the inconvenient truth remains: our behavior and choices play an outsized role in determining our health – and adtech data may offer the most relevant window into this critical parameter.

From the perspective of a startup, the ickiness of the data, and its existence in a grey area, may represent an opportunity, since established healthcare companies and tech giants are likely to give these data wide berth, creating an opportunity for a startup in the model of Uber or PayPal willing to embrace and intelligently navigate the risk, as VC Josh Kopelman has described. 

A startup that could leverage adtech data and generate relevant health insights for traditional stakeholders could be an intriguing proposition. Think of all the research that seeks to elucidate the genetic basis for extreme phenotypes, including exceptional responders; imagine if there was a way to identify characteristics of patients most likely to maintain weight loss, or patients most likely to respond to treatment A vs treatment B.

Intriguing as these research questions are, figuring out the right business model for a startup in this space remains a critically important challenge.  

As a leading data guru told me:

“The main issue is what do you do with this information … that’s what I don’t think anyone has figured out. Let’s say you can figure out that [some factor] is correlated with a particular health outcomes, etc. — how does that actually change the course of care, or what pharma companies/payers/providers do?”

This feels to me like a solvable problem – and a worthy challenge. The risks can be responsibly managed. To the extent that we remain awash in ultra-granular, legally-obtained behavioral data, it seems a shame not to gainfully leverage this information for the improvement of human health.

28
May
2020

The Infodemic Summer

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28 May 2020

Luke Timmerman, founder & editor, Timmerman Report

The US death toll from COVID-19 exceeded 100,000 this week.

Another 40 million people are unemployed. 

We’ve been on this terrible trajectory for what seems like forever, with 20,000 new cases a day and 1,500 or so deaths every day. The New York Times lists 18 states where new cases are increasing and 19 states where cases are decreasing.

Memorial Day weekend came and went. People are stressed and fatigued and antsy and lonely and depressed. We’re all seeking social contact. Some are gathering outside in large groups without masks. Images of crowds were everywhere from the Georgia coast to the lakes of Missouri to the Montlake cut in Seattle.

Knowing what we know about how the virus transmits, and everything we’ve seen this spring, we can expect an increase of cases in 2-3 weeks. (See Otello Stampacchia’s May 26 analysis).

Will there be just a “blip” in new cases, in the optimistic scenario outlined by Tony Fauci, or will we see a Second Wave surge?

We don’t know yet. But we do know that a pharmaceutical intervention will not be riding to the rescue this summer. If we want to reduce the toll of suffering and death, we will have to get by with non-pharmaceutical interventions that have caused so much pain since March.

Another thing we do know is that our country is at war with itself. Many people can’t even speak to members of their own families. Many can’t speak to old friends across the partisan divide. Many, inhaling toxic fumes from our 24/7 online networks and extremists on cable TV, suspect bad faith and fraud and conspiracy everywhere. It strikes some people as hard to believe that anyone might mean well, make a mistake, and then try to fix it.

All of the bitterness and resentment and suspicion of other people’s motives makes it incredibly hard to mount the kind of consistent, disciplined, collective action response we need.

The consequences of the infodemic are here, staring us in the face.

This is a good time to re-think what kind of information commons we want to have in the 2020s and beyond. One place to start is by re-reading the late Neil Postman’s “Amusing Ourselves to Death: Public Discourse in the Age of Show Business.” It was written in 1985, when TV was king, and social media didn’t exist. It’s a brilliant, biting work of media criticism. But it doesn’t let us off the hook as citizens. It asks an uncomfortable question: are we willing to do the work of being citizens, or are we just empty consumers of entertainment and advertisements?

Even though Postman didn’t predict the nightmare of the entertainer-in-chief — that was too preposterous for the time — he correctly saw the conditions that made that rise possible.

I’d like to think we can reclaim what it means to be citizens. What are the responsibilities that come with that? What sort of work does this demand of us? What do we owe our fellow citizens? It means more than just showing up to vote once every four years.

Right now, a lot of people are wrestling with deep questions like this. In my more optimistic moments, I imagine that people will come out of this terrible time dedicated to others and to issues larger than themselves.  

Communication in the 21st Century

Headline: “Zuckerberg Says Twitter is Wrong to Fact-Check Trump.” Newsweek. May 27. (Daniel Villarreal).

Early in the pandemic, a reporter asked the President of the United States about the diagnostic testing failures and delays.

He replied: “I don’t take any responsibility at all.”

He’s not the only powerful man shirking his responsibility. So is the man in control of the most powerful information distribution network in human history.

Mark Zuckerberg, the Facebook founder and CEO, built an empire that siphoned away most of the revenue from advertising that used to support local news publishers all over the United States.

While Zuckerberg was demolishing the local news gathering engines that hold local officials accountable and build community tensile strength, he did nothing to fill the civic void. Zuckerberg, for years, has insisted Facebook is just a platform, and doesn’t really have to shoulder any responsibility of being a publisher. Grudgingly, the company has instituted a few bare-minimum policies to take down the worst kind of posts that incite imminent harm. These are expensive and tedious and difficult things that come with a publisher’s responsibility. It’s a big responsibility. Like making sure the things you publish are rooted in fact. Like adhering to basic standards of fairness. Like correcting your mistakes. Like giving a damn about serving your community with the kind of quality journalism that people need to make informed decisions in a democracy.

Instead of owning up to his role in hollowing out local media and doing something meaningful about it, Zuckerberg has spent years in a defensive crouch. This week, he threw some shade at Twitter. Twitter, like Facebook, is under pressure to behave like a responsible publisher. So Twitter started pointing out the baselessness of certain tweets by the President. That provoked Mr. Zuckerberg. Maybe he’s afraid that if citizens demand accountability from Twitter, they might also demand it of Facebook?

Zuckerberg went on offense. He told FOX News that “Facebook shouldn’t be the arbiter of truth of everything that people say online.”

I agree. It shouldn’t be the arbiter. No Internet company should be that big, and that unaccountable to the public. While we are free to speak out and consume on Mr. Zuckerberg’s propaganda-drenched social network, we’re also free to ignore it — even though persuasive design and algorithm enhancements make that psychologically very difficult. We’re also free to demand that Zuckerberg take responsibility as a publisher, or force him to do so through legislation.

It will take tenacity and discipline, but we can do that.

That won’t happen anytime in 2020, as lawmakers have other things to do. But if you want to do something positive right now to reverse the catastrophic degradation to our information system, I suggest permanently deleting your Facebook account and purchasing a subscription to your local newspaper.

Headline: “Sorry, No Mask Allowed. Some Businesses Pledge to Keep Out Customers Who Cover Their Faces.” Washington Post. May 28. (Teo Armus).

Some people don’t like being told to wear masks. But as things get more extreme, we now have businesses banning people from setting foot in their establishment if they choose to wear masks.

This can only happen in a society that cares little about others. Wearing a mask isn’t much to ask. We have got to take a deep breath as a people, and find a way to talk to each other, listen to each other, and help each other adopt the collective behaviors necessary to reduce the risks of the pandemic.

Headline: “Why Scientists Are Changing Their Minds and Disagreeing in the Pandemic.” CNBC. May 23. (Chrissy Farr).

With distrust on the rise, a fair bit is directed at scientists. Scientists need to be aware, and communicate with care.

Glancing at the headline above, you might say “duh, that’s how science works.” Of course, good scientists change their minds when presented with new evidence, or evidence that contradicts guidelines based on prior studies that have been overturned. But not everyone knows that. Scientists, and journalists, should take great care to communicate with humility and caution about what’s known and what’s not, and what’s the best course of action for the time being. Readers and viewers should know things could change if new evidence emerges, and it probably will with a virus that’s brand new to science.

Headline: “He Experienced a Severe Reaction to Moderna’s Covid-19 Vaccine Candidate. He’s Still a Believer.” STAT. May 26. (Matthew Herper)

Say what you want about reporting on an anecdotal adverse event in the midst of an ongoing clinical trial of global significance. I would rather wait to see the text and data tables from a mature analysis in the New England Journal of Medicine. When anecdotes dribble out in the middle of a trial, it injects bias for both investigators and participants. Then it can spread like cynicism wildfire.

See this young man’s succinct summary of what happened after this article ran about his experience on the Moderna vaccine.   

 

Merck on the Case

The big drugmaker company hasn’t been the loudest voice in the pharmaceutical world this spring, but it announced a series of aggressive moves after Memorial Day. The company:

  • Acquired Themis, a preclinical, private vaccine developer that has a partnership with the Institut Pasteur and the Center for Vaccine Research at the University of Pittsburgh. Merck said it plans to drive that SARS-CoV-2 vaccine candidate into clinical testing in 2020.
  • Agreed to collaborate with IAVI on a vaccine candidate that uses the same underlying technology platform that Merck used to make the first and only Ebola virus vaccine.
  • Obtained from Ridgeback Biotherapeutics the exclusive worldwide right to develop and commercialize EIDD-2801, an orally-available ribonucleoside analog drug that inhibits the replication of multiple RNA viruses including SARS-CoV-2.
  • Sought to pooh-pooh the ambitious expectations on vaccine development timelines.

Scientific Articles of Note

  • Remdesivir for the Treatment of COVID-19. Preliminary Report. New England Journal of Medicine. May 22. (John Beigel et al)
  • Deep Sequencing of B cell Receptor Repertoires from COVID-19 Patients Reveals Strong Convergent Immune Signatures. BioRxiv. May 20. (Jacob Galson et al)
  • Targets of T cell responses to SARS-CoV-2 coronavirus in humans with COVID-19 disease and unexposed individuals. May 7. Cell. (Alba Grifoni et al)
  • Key residues of the receptor binding motif in the spike protein of SARS-CoV-2 that interact with ACE2 and neutralizing antibodies. May 15. Cellular & Molecular Immunology. (Chunyan Yi et al)
  • The Emergence of SARS-CoV-2 in Europe and the US. BioRxiv. May 23. (Michael Worobey et al)
  • Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis. The Lancet. May 22. (Mandep Mehra et al)
  • Preventing Cytokine Storm May Ease Severe COVID-19 Symptoms. May 20. HHMI News. (Meghan Rosen, quoting Bert Vogelstein)
  • A National Open Genomics Consortium for COVID-19 Response. Centers for Disease Control and Prevention.

Science Features

Thoughts on Evidence in a Pandemic (Debate in Boston Review)

Humanity

  • Is It Safe for Me to Go Back to Work? Risk Stratification for Workers. New England Journal of Medicine. May 26. (Marc Larochelle)
  • Medical Residents Are Stressed to the Breaking Point. USA Today. May 26. (Ashely Alker)
  • AIDS Activist Larry Kramer Dies at 84. The Guardian. May 27. (Joanna Walters) See Also, “He Was a Force of Nature” a Set of Remembrances from Tony Fauci, Tom Frieden, Gregg Gonsalves, Harold Varmus and Rick Berke in STAT.

Testing

Wuhan, China, the original epicenter of the SARS-CoV-2 outbreak, reportedly ran 9 diagnostic tests in 10 days as it sought to gain clarity on where the virus is, so it can be isolated and give people the confidence necessary to resume activities of normal living. (WSJ coverage).

Treatments

Roche / Genentech said it has initiated a Phase III trial of its IL-6 inhibitor tocilizumab (Actemra) in combination with Gilead Sciences’ remdesivir as combo therapy for hospitalized patients with severe COVID-19 pneumonia. This would combine the Gilead drug’s antiviral effect with the antibody that suppresses cytokine storms which are known to cause major complications. Enrollment is expected to start in June, with 450 patients globally. Separately, Genentech said it’s close to completing enrollment in the Phase III Covacta study, and expects results this summer, to see how the IL-6 inhibitor alone performs for hospitalized COVID-19 patients.

Vaccines

GSK said it plans to scale up production to make 1 billion doses of vaccine adjuvants in 2021. These are the compounds that can boost the potency of vaccines to elicit robust immune responses, and which could be used to reduce the actual dose of vaccine protein per dose, thereby stretching out potentially limited supplies to a larger swath of Earth’s population. GSK said it believes more than one vaccine will be necessary, and that it’s working with partners to make adjuvants that will complement more than one vaccine candidate.

Gaithersburg, Maryland-based Novavax said it began enrolling 130 healthy adult volunteers in a randomized Phase 1/2 clinical trial of its SARS-CoV-2 vaccine candidate. The protein-based vaccine comes in a standard version, and with another version that includes a proprietary adjuvant designed to boost higher levels of neutralizing antibodies. A low and high dose are being evaluated, with and without the adjuvant. The study is being run at two sites in Australia. The program is funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

Reuters had a detailed piece on the US plan to enroll 100,000 volunteers in COVID-19 vaccine studies in the hopes of hitting the extraordinary deadline of delivering a vaccine by the end of 2020. Dr. Larry Corey, principal investigator of the HIV Vaccine Trials Network based at Fred Hutch, was quoted in the story as one of experts designing trials. (Listen to Dr. Corey on this recent episode of The Long Run podcast).

US Healthcare Dysfunction

Read this piece by Dr. Sachin Jain and nod along about all the entrenched interests and how they stymie positive change in healthcare. To summarize, quoting Upton Sinclair: “It’s hard to get a man to understand something if the man’s salary depends on not understanding it.”

Financings

  • Sanofi said it intends to sell 23 million shares it holds in its longtime partner, Regeneron Pharmaceuticals. That deal will fetch a cool $13 billion. Regeneron will repurchase $5 billion of the shares, and Sanofi will keep about 400,000 shares, less than a 1 percent ownership stake in the company.
  • Vancouver, BC-based Abcellera, an antibody discovery company, raised $105 million in a Series B financing led by OrbiMed.
  • San Francisco-based Insitro, a company using machine learning to aid with drug discovery, raised $143 million in a Series B financing. Andreesen Horowitz led.
  • Seattle-based Variant Bio raised $16 million in a Series A financing led by Lux Capital. Andrew Farnum, who previously ran the $2 billion strategic investment fund at the Bill & Melinda Gates Foundation, joined as CEO. The company is working to develop drugs by studying the genes of people from understudied populations who are outliers for medically relevant traits. The company has projects focused on the Maori, in the Faroe Islands, in Pakistan, and with the Sherpa people who live at high-altitude in Nepal.
  • Boston-based Ginkgo Bioworks, a synthetic biology company, raised $70 million to develop tests for COVID-19.
  • Emeryville, Calif.-based Octant, a synthetic biology company developing small molecules for large numbers of GPCRs, raised $30 million in a Series A deal led by Andreesen Horowitz.
  • Seattle-based Good Therapeutics raised another $11 million to complete a $22 million Series A round, to advance its work on developing protein drugs that activate only in certain biological contexts. Roche Venture Fund and Rivervest Venture Partners participated.
  • Seattle-based Nautilus Biotechnology raised $76 million in a Series B financing. The company is developing a low-cost platform for analyzing the human proteome for drug discovery. Vulcan Capital, the investment company founded by the late Paul Allen, led.
  • Cambridge, Mass.-based Q32 Bio announced it has raised $46 million in a Series A financing to pursue biologic drugs for autoimmune diseases, starting with an IL-7 receptor inhibitor. Atlas Venture led the round, and was joined by OrbiMed Advisors, Abingworth and Sanofi Ventures. Michael Broxton was named CEO, and co-founder Shelia Violette is CSO and president of research.
  • San Francisco-based Syapse raised $30 million to work on real-world evidence for cancer trials.
  • Wayne, Penn.-based Palvella Therapeutics, a rare genetic disease drug developer, raised $45 million in a Series C.
  • San Diego-based Arena Pharmaceuticals raised $275 million in a stock offering priced at $50 a share.
  • Research Triangle Park, NC-based Biocryst Pharmaceuticals raised $100 million in a stock offering.
  • San Carlos, Calif.-based Iovance Biotherapeutics, a cancer immunotherapy company, announced plans to raise $500 million in a stock offering.
  • Deerfield Management committed as much as $130 million to support research at the University of Michigan.
  • Gaithersburg, MD-based Viela Bio raised $169 million in a stock offering for its autoimmune disease drug programs.
  • Alameda, Calif.-based Penumbra, a drug developer, raised $100 million in a stock offering.
  • Menlo Park, Calif.-based Geron raised $140 million in a stock offering.

Data That Mattered

Netherlands-based Argenx passed a Phase III clinical trial with its drug candidate efgartigimod for myasthenia gravis, a rare autoimmune disease that causes debilitating muscle weakness. About two-thirds of patients on the drug met the primary endpoint of improvement in activities of daily living, compared with about one-third of those on placebo. The company said it plans to submit an application for FDA approval by the end of 2020. Two days later, the company seized on the momentum in its share price to haul in $750 million through a stock offering.

South San Francisco-based Atara Biotherapeutics reported on Phase I results for an experimental T-cell therapy against the progressive form of multiple sclerosis, which is notoriously hard to treat. Results were from a Phase I trial of ATA188, an off-the-shelf T cell therapy candidate, designed to target B cells that carry the Epstein-Barr Virus, and which become a troublesome cell type attacking neuronal sheaths, causing the pain and misery of multiple sclerosis. It was a small study of 25 patients in four dose cohorts, but the company reported that the treatment was safe and patients saw improvements on disability out to 12 months of follow-up. Atara immediately sought to cash in on the data, raising $175.5 million in a stock offering a day later.

Roche/Genentech said it passed a Phase III clinical trial with a next-generation permanent refillable implant to deliver the VEGF inhibitor ranibizumab to the eyes of patients with the vascularized form of age-related macular degeneration. The new implant, about the size of a grain of rice, can be refilled with drug after a period of months. In this study, it was refilled after six months, and delivered similar results as the standard form that requires frequent injections of ranibizumab (Lucentis).

Merck said it passed a Phase III trial, in which its single-agent PD-1 inhibitor pembrolizumab (Keytruda) was found superior to standard chemotherapy in patients with microsatellite-instability high or mismatch repair deficient forms of metastatic colorectal cancer. The drug showed a 40 percent improvement on Progression Free Survival.

Deals

Hayward, Calif.-based Arcus Biosciences collected $175 million upfront from Gilead Sciences as part of a 10-year collaboration to work on Arcus’ treatments based on how tumors evade the immune system. Arcus, like so many other companies in this bull market biotech spring, followed up that news by announcing plans to raise more money from Wall Street.

Cambridge, Mass. and Montreal-based Repare Therapeutics collected a $65 million upfront payment from Bristol-Myers Squibb as part of a collaboration to work on the small company’s CRISPR-enabled synthetic lethal cancer drug discovery platform.

Chi-Med and Beigene announced a partnership to test combinations of a couple VEGF receptor inhibitors with Beigene’s PD-1 inhibitor for solid tumor cancers.

Roche acquired Stratos Genomics to advance its development of a nanopore-based DNA sequencer. Terms weren’t disclosed.

Moderna struck a deal with Luxembourg-based CordenPharma to provide lipid excipients for delivery of its SARS-CoV-2 vaccine candidate. Corden, a supplier to Moderna since 2016, said it will provide “large scale volumes.”

Regulatory Action

Regeneron Pharmaceuticals won clearance from the FDA to expand the label for its IL-4 and IL-13 inhibitor dupilumab (Dupixent) as a treatment for kids ages 6-11 with moderate to severe atopic dermatitis.

The FDA cleared Takeda’s brigatinib (Alunbrig) as a treatment for ALK-positive forms of metastatic non-small cell lung cancer.

Worth a Listen

Epidemiologist Marc Lipsitch on Whether We’re Winning or Losing Against COVID-19. 80,000 Hours Podcast

26
May
2020

Finding a Path in Biotech Venture Capital: Nina Kjellson on The Long Run

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26 May 2020

Today’s guest on The Long Run is Nina Kjellson.

Nina Kjellson, general partner, Canaan Partners

Nina is a general partner with Canaan Partners on the West Coast.

Her investing style leans toward high science, which you can see in portfolio companies like PACT Pharma, a company developing neoantigen targeted T cell therapies for cancer, Tizona Therapeutics, a targeted antibody developer for cancer, and Vineti, a software platform to help cell and gene therapy companies manage their supply chains and scale up with these intricate medicines.  

Nina is also a powerful advocate for helping women advance in biotech. She has developed her own platform with a podcast called Women who Venture, or WoVen, to amplify voices of strong women leaders. She organizes meetings for help women executives extend their networks.

As a successful VC who sits on a lot of company boards, she’s in a position to open doors and uplift people. She takes that role seriously.

I saw Nina do this at close range, when she joined me last summer on a trip to climb the highest peak in Africa, Mt. Kilimanjaro, as part of a group fundraiser for the Fred Hutchinson Cancer Research Center.

It was very important to me as the team captain to assemble a diverse, gender balanced group. Nina played a key role in helping make that happen.

Now before we start, this interview was recorded in early March. I was already sheltered in place, and a bit anxious, but we didn’t talk about the pandemic. I’ve held onto this conversation for a couple months to squeeze in more timely news-oriented episodes of The Long Run. This episode is more in the typical format of this show, which runs longer and discusses the guest’s personal journey.

I know everyone’s busy, but I think we need to have these kinds of deeply humanizing conversations to understand each other better as people, not just one-dimensional professionals who do X or Y.

I hope you enjoy the conversation. 

Now, please join me and Nina Kjellson on The Long Run.

26
May
2020

Miscommunications, Misapplied Policy & Misunderstood Liberty: Why the US Pandemic Response is in Trouble

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26 May 2020

Otello Stampacchia, founder, Omega Funds (illustration by Praveen Tipirneni)

On April 17 — seemingly a long time ago — I wrote about what steps would have to be taken in order to (cautiously) “reopen” US states from their various lock-downs and stay-at-home advisories.

The piece tried to focus on the “how”, versus the “when”.

By the early days of May, most states had begun re-opening, and now all 50 states are well along in the process. So how are we doing in terms of following through on the actions that we know can mitigate the spread? What can we expect in the next few months? How should we behave?

This follow-up piece will be divided in the following sections (I have been told I try to cram too much into everything I write, with excessively long sentences, such as this one: I am hoping making this a bit more structured might make easier to follow my writing. Fingers crossed.):  

  1. “Second wave” concerns.
  2. The importance of communication, compliance and behavior modifications in beating the pandemic.
  3. Public Service Announcement.
“Second Wave” Concerns

Medical Definition of “Second wave”: A phenomenon of infections that can develop during a pandemic: the disease infects one group of people first. Infections appear to decrease. And then, infections increase in a different part of the population, resulting in a second wave of infections.

Public health officials and policymakers are concerned about a “second wave” of the pandemic hitting, potentially with even greater force than the first. Most are focused on a timeline towards the fall / end of the year. Some of the (justified) concerns are centered about a renewed surge of COVID infections coinciding with a flu season of unknown severity, taxing healthcare systems even further. That would be bad news for sure.

Yogi Berra: “It’s tough to make predictions, especially about the future.”

Here is the really bad news: in my opinion (and being mindful of the quote above), we are going to see a continuous, substantial increase of infections and fatalities in the US starting (very, very roughly) early / late July, if not sooner. Quite likely, by August / September we might revisit the peaks of daily confirmed infections and fatalities we saw in April.

What am I basing such a pessimistic forecast on?

This bears repeating: this is a very infectious, new virus that spreads at an exponential rate. Please re-read my previous Timmerman Report articles discussing R0 and the rapid spread of the virus. I am still absorbing the visual shock of the historical New York Times front page for Sunday May 24, which listed names of roughly 1% of the dead across the US, in a stunning display covering several pages. I spent hours on its interactive version on the website. Scrolling through it, I was reminded that the total US death toll from COVID-19 was about 100 on Mar. 17. We are now on track to exceed 100,000 deaths by early next week, just as we are “re-opening”. It is easy to forget that.

Let that sink in for a second: 100,000 fatalities in two months.

Let’s also keep in mind that, as of right now, only / roughly a few percentage points, if that, of the US population has been exposed to the virus. Exposure rates appear to vary greatly from state to state, of course (with NY likely being the most exposed): that said, I would be personally shocked if it turns out that more than 3-5% of the US has been exposed as of right now. The problem is we will not know that for sure for a while yet.

For those of you who think this virus will stop circulating altogether over the summer: I would like to point you towards the rapidly escalating pandemic in South America, particularly in Brazil. Rio de Janeiro has had temperatures in the 60s-70s degrees Fahrenheit for a while and cases have spread very fast there for weeks now. Yes, we should expect some R0 reduction (driven by higher humidity, sunlight, etc.), but again it will not magically disappear.  

Another important statistic: back in March, two-thirds of US newly-confirmed cases were concentrated in just five states: NY, NJ, MA, CA, IL. The rest was mostly in MI and WA, which were also hit early (and very hard in the case of MI). Those states reacted early and with the strongest distancing guidelines and measures. At great economic cost, for sure. But they saved lives.

Last week, two-thirds of newly confirmed cases came from the other 45 US states: the virus has continued to spread widely across the country during those two months.

It’s not “just a New York thing” because the city is dense and has subways. It is accurate that highly dense urban areas were hit first and (so far) hardest, and that high population density “weaponizes” the virus. But other, less dense and even rural areas of the country are not “immune”. There is no existing immunity. The virus will keep spreading.

If we do not beat this virus everywhere, we won’t beat it anywhere.

Also an important contributor to my pessimism: since the virus started spreading in Jan / Feb in the US, we did not ramp up PCR (nucleic acid) or serological (antibody) testing to a sufficient scale to identify early on asymptomatic / symptomatic infection spreaders and thus limit the reach of the virus. There is an understandable supply scarcity of reagents needed to perform the tests at a scale that few previously imagined. In addition, a number of antibody tests have been faulty (to the point of being useless).

That said, a country with the technological prowess of the US should have figured this out months ago. We did not.

The importance of communication, compliance and behavior modifications (non-pharmaceutical interventions) in beating the pandemic

A final component leading me to my pessimistic predictions: there is no way we can beat this pandemic without clear, transparent, coherent communication by authorities, followed by the citizenship’s broad compliance with behavior modifications to reduce transmission. Assistance from drugs and (hopefully, one day) safe and effective vaccines will come, but we need to limit the damage and survive before the cavalry arrives.

Needless to say, almost all of those components are missing or confusing at the very least. The sacrifices of so many healthcare and other essential workers and the many people sheltering at home away from their families are potentially being squandered when a minority of the population refuses to comply. When enough come together in close proximity indoors, the math clearly shows that it increases the risk of “super spreader” events like the choir practice group in Skagit County, Washington.

As I am sure you have seen on the news from Memorial Day weekend, multitudes of people have celebrated the “end” of the lock-down and the long weekend by frolicking in large assemblies in swimming pools, beach town sidewalks, across the US. No masks to be seen. Social distancing nonexistent. This is unconscionable.

I want to express just how important those non-pharmacological interventions are by discussing briefly the Japanese experience and making a “compare & contrast” exercise between theirs and other countries’ response to the pandemic.

Japan has surprisingly managed to avoid a catastrophic outbreak, contrarily to most pundits’ predictions. It has the oldest population in the world, with very densely populated cities, and large public transportation networks used by most citizens. It also has very extensive travel links to China, so it is impossible to think that it was not seeded early in the pandemic.

Japan did not perform mass testing of its citizenship, like South Korea, nor did it impose restrictive lockdowns (hairdressers and restaurants have been kept open: for those who know me, I do care way more about the latter than the former, but not everybody is as follicularly challenged as I am). According to Worldometer’s dashboard, Japan has had only ~800 fatalities to date due to the virus. This is a miracle that cannot be overstated and that everybody is quite puzzled by.

Very early on (in late January), Japan activated its public health centers, which are heavily staffed with nurses trained in contact tracing. So, no fancy contact tracing app like Korea or Singapore, but old-fashioned shoe-leather epidemiology performed by an army of well-trained individuals. People with suspected symptoms, or in contact with people with suspected viral infections, were first screened for other respiratory viruses (influenza, RSV, etc.) and only if tested negative, were then tested for COVID, maximizing the use of scarce COVID test resources. Quarantines of infectious clusters were also sensibly put in place, like in Korea.

A huge emphasis was also put on behavior modification of the entire population to minimize infection spread: preventing one cluster of patients from creating another cluster.

To that extent, government and health authorities spread early, broadly and effectively a very simple message: “avoid the three Cs!”: 1) Closed spaces (with poor ventilation), 2) Crowded places (with many people nearby) and 3) Close-contact settings (such as close-range conversations).

Those recommendations are so sensible — and easy for people to remember — that there is no need, hopefully, to elaborate further. That said, they were given very prominently, very early, and very clearly, by the entire government apparatus as a single voice.

Finally, and essentially, the population broadly complied. Everybody wears masks at all times when walking outside. Nobody speaks loudly (or at all, actually) on their phones on subways / other means of public transportation / while walking down the street (yes, that was already the case in Japan even before the pandemic: I am hoping to sneak in some permanent behavioral modifications also in the US for after the pandemic).

There are probably other factors helping protect Japan from the worst. The population has arguably the lowest rate of obesity and diabetes in the developed world, but again that should be counter-balanced by the demographic skew towards elderly citizens. Who knows. But I am sure there are lessons to be learned here. And that you, non-mask-wearing runners in downtown residential Boston, should learn (that is where I live).

To summarize:

  1. Testing at scale would be very useful to contain the pandemic: in the US, we do not have large volumes of tests available yet;
  2. We could compensate for the lack of large-scale testing with a skilled contact-tracing infrastructure, thus reducing the spreading from one infected cluster to the other: in the US, we lack enough trained people; a tech-based solution is not available yet and might run into privacy and implementation concerns;
  3. We could have tried / try now to compensate with the issues in 1) and 2) above by implementing a sensible communication policy. Communication of the risks / benefits associated with each behavior, if implemented early, clearly and spread widely to ensure compliance, has shown benefits. It is clear to me that the communication effort in the US should probably be characterized as late, lackadaisical, and lacking in consistency and clarity across the various branches of government and public health policy agencies. There are now many instances, across a number of US states, of mistaken statistics provided to the public, concerning both testing volumes (confluence of PCR and serological testing) and undercounting of cases. Ruth Etzioni had another great piece in Timmerman Report about this recently.
Public Service Announcement (Part I)

First, a preamble: this gets into some cultural aspects that might be controversial. You might want to skip this next section if you find it disagreeable and go to PSA (Part II) with some more concrete suggestions. Those should be objectively useful, I hope.

According to the CDC, 45% of the US population has pre-existing conditions (diabetes, hypertension, obesity) that appear to increase severity and fatality outcomes when infected with the virus. This will certainly worsen the already dismal count of blood and treasure (or lives and livelihoods) that the country will have to disburse to get on the other side of this pandemic.

What I would like to discuss, and I am on very thin ice here, as I am a guest in this amazing country, is the role of pre-existing convictions in increasing infection spreading. A number of people in the US reflexively dismissed, early on, warnings coming from science journalists and healthcare / government about the virus. Some of that, certainly early on, might be based on partisan positioning, some of that might be due to a narrow / misguided interpretation of the “American exceptionalism” that seemed to think “it can’t happen here, because nothing like this has in anyone’s living memory.” (I want to state for the record that I do truly believe that this is indeed an incredible country). It might be also hard for people to truly understand the implications of a tragedy that has not yet affected them / their region. However, the virus does not care. It follows a biological imperative to reproduce and spread itself.

Equally, we need to face this pandemic as a challenge for us as a species, not as something to face as a jigsaw of disparate strata of society (or regions) with different socio-economic status, education, access to healthcare, etc. Again, the virus does not care. You should. Your behavior affects others. They might be more or less privileged than you, might be younger or older, it does not matter.

Let me briefly introduce Ayn Rand, celebrated author of “The Fountainhead” and “Atlas Shrugged.” Rand was the founder of a philosophical system named Objectivism (which I am not going to get into, but let’s say succinctly she was not the biggest champion of socialized medicine or collectivism, and she’s become a kind of hero to modern libertarians in the US).

Even Rand, skeptical of the role of government and a champion of individual rights as she was, discussed pandemics as situations where society (as a whole) needs to respond together for the benefit of the herd versus the narrow benefit of the individual. According to Rand, knowingly or negligently subjecting another person to infection with a deadly pathogen falls under the category of the initiation of physical force (like dumping toxic waste on another person’s property).

She makes the illustrative example of “Typhoid Mary,” an asymptomatic carrier of a typhoid fever. She was released from quarantine in 1910, but repeatedly broke her promise to stop working as a cook and ended up spreading the disease further. She eventually returned to quarantine (and spent decades there on an isolated island). It appears to me this is a case that pretty clearly falls under the governmental function of protecting individual rights (not to be infected by others).

This pandemic needs to be tackled as a societal response instead of an individualistic response. With a science-driven, probabilistic approach and using statistics instead of basing ourselves on pre-existing positions and convictions based on whatever politics we might belong to.

Public Service Announcement (Part II)

You will find below some suggestions for behaviors that might help identify different susceptibility risks and factors this summer as things re-open. These guidelines are not perfect, and, to quote Harvard Business School, “it depends” on your circumstances which of them are more relevant to you. The corollary to that, is that the trick is to know what it depends on. The important part is to understand that this is not a set of binary recommendations. Risk is on a sliding scale and different factors have different importance depending on your personal situation.

You are probably familiar with the known individual risk factors: age and pre-existing conditions are still the single largest contributors, as far as we know. I personally believe a medical history of inflammatory disorders (asthma, etc) also increases risk, but it is hard to quantify that or to find hard data on that. It stands to reason, though, since the single largest driver of fatalities appear to be driven by a hyperactive response of the immune system to the virus.

It is also very, very important to consider the sheer volume of virus (size of the viral “inoculum”) you are potentially exposing yourself to with your behavior: time spent in enclosed spaces, with a lot of people for long-term interactions, are very, very risky, obviously, especially if containing younger individuals who might have had promiscuous contacts with a large number of people beforehand, and might well be asymptomatic.

However, even open spaces are risky if in close physical contacts (handshakes, hugs, etc) with multiple parties. For example, we are learning from parts of developing world, like India and Brazil, that even belonging to a younger demographic does not protect individuals from severe prognosis and possibly fatality: so population density / inoculum size could outweigh young age / lack of pre-existing conditions.

Even the amount of physical distancing is relative. Say the person running / biking across from you happens to be a super-spreader, breathing heavily, with a tailwind at his back and close to you? It is impossible to calculate the risk. It is probably not 100%, but it is not 0% either. If you are young, vigorous, with an impeccable immune system (Are you? Really? How do you know?), and avoid touching your face and wash your hands when you are back at home after the run, your immune system is likely to beat this since you are probably not going to be exposed to too many copies of the virus. But you still could become an asymptomatic spreader and nobody would be able to check that.  

So, it’s great to walk outside and exercise, but unless you live in a desert with nobody around for miles, always carry a mask (and wear it in case you come across other individuals / groups), stay as far apart from other people as possible, avoid physical interactions unless you have isolated with these individuals for weeks, and don’t talk loudly on the phone without a mask while walking (or, ideally, ever).

This pains me personally as a Southern Italian, but again there are some lessons here from the Japanese: no touching, no hugging / kissing on the cheeks, no handshakes, no buffets, we should think of individually-wrapping snacks and cookies. All those behaviors limit infectious disease spreading. Civilizations in the Middle East and elsewhere have developed religious precepts prohibiting the consumptions of certain foods, mainly to avoid diseases.

The whole world is going through this tragedy like us: we should all learn from other experiences. The only thing that might move faster than this virus is information. And we all have a lot of things to learn.

Follow Otello Stampacchia on Twitter: @OtelloVC

This article expresses the personal views and perspectives of the author. The views and perspectives expressed here do not necessarily represent the views or perspectives of Omega Fund Management, LLC or any officer, director, partner, member, manager or employee of Omega Fund Management, LLC or any of its affiliated entities.

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