26
Jun
2020

Leadership, Strategy and Capabilities: How We Are Losing The Fight Against the Virus

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

“The problem with the world is that the intelligent people are full of doubts, while the stupid ones are full of confidence” –Charles Bukowski

The quote above is presented with more than a hint of self-deprecating irony (I did spend some formative years in the UK). Indeed, I am often told I am a little bit too confident in my opinions.

Now, with that disclaimer out of the way…

On May 26, I penned a (quite pessimistic) editorial for Timmerman Report.

I wrote:

“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 are going to revisit the peaks of daily confirmed infections and fatalities we saw in April”.

It turns out I wasn’t pessimistic enough.

As I write again a month later, on June 26, the US just recorded total confirmed cases above 2.5 million (https://www.worldometers.info/coronavirus/country/us/ : please refer to that site for any statistics reported below, unless otherwise stated), as well as over 126,000 deaths. I am not sure this includes the revisions the state of NJ just posted (with an incremental ~2,000 deaths). As discussed in a previous article, fatalities in pandemics are often undercounted.

Nevertheless, this is a tragic situation, and a very different trajectory from other western countries.

COVID-19 in the 10 Most Affected Countries (Confirmed Cases / Day)

Source: Johns Hopkins University Coronavirus Resource Center

Over the past month, the US has seen 800,000 new cases, and 24,000 more deaths. On May 26, US positive tests numbers were ~1.7m and ~102,000 fatalities. For about three weeks, the numbers, while grim, appeared on a daily basis to be trending in the right direction. There was a measurable reduction in overall hospitalizations and fatalities in the US: this was the result of a combination of drastic (and effective) lockdown measures (and citizens compliance with distancing measures) in the hardest / earlier hit regions (NY and New York City above all, and NJ, MA, CT, RI).

Those *inevitable* measures brought temporary, partial control of the pandemic in those regions. Those locations can now, tentatively, and carefully, try to re-open their economies in stages. And be mindful that the virus has not gone away “magically” and that people need to continue to be vigilant and responsible.

However, the uncontrolled spread in the remainder of the country means the proverbial cat is now truly out of the bag. And it is not going to get back in there, either.

Suffice it to say that the 7-day moving average (which smooths out weekend reporting issues) has now reached >34,000 cases/day and it is likely to increase quite a lot in the coming days, now that the trendline is on an inexorable, dramatic upswing (see Florida below). The previous 7-day average peak was ~32,000/day back on April 10. April 29 represented the highest single-day peak of confirmed daily cases until now, with ~39,000 positives (and a very significant decrease in numbers in the following days).

However, yesterday (June 25 for those of you losing track of time) surpassed 40,000 confirmed cases (the highest number of cases in a single day, ever), and almost every day this week has shown confirmed cases above 30,000. I expect today to be much higher. This is not good.

I would like to tackle some commonly heard objections to my message of doom, before reverting to dwelling on the main article topic later on.

OBJECTION No. 1: This is nothing: cases are going up simply because we are testing more! You are such a worrywart! Why do you want to ruin my vacation??

I do not want to ruin your vacation, but, no.

While it is accurate that testing capacity has increased substantially (see www.covidtracking.com for a comprehensive picture on tests, confirmed cases, hospitalizations, and patient outcomes) in the US, to roughly 500k tests performed daily, the percentage of people resulting positive on tests has very substantially increased (we are now roughly at 7-8% positives, vs ~5% only 10 days ago).

So, the percentage of the US population being infected is increasing, and quite rapidly (this should be expected: this is a very contagious virus). It is particularly concerning to see substantial increases in positive rates in populous US states such as California, Texas, Florida (see below in the answer to Objection No. 3).

In the past week alone, Florida’s daily new case count has gone from 3,822 last Friday, to 5,511 on Wednesday, to an astonishing 8,942 today. If you think this is not going to result in a substantial increase in hospitalizations and eventually a massive death toll, I would love to receive a healthy helping of whatever it is that you are smoking.

And, please, before you even ask: we are a long way away from reaching “herd immunity” for the entire population.

OBJECTION No. 2: The virus is simply infecting more of us young people: we are not like those old geezers (insert any proclamation of young invincibility of your choice here)! Worse case scenario, I will take generic steroids once I am getting intubated, I heard it works! (exasperated sigh). As George Bernard Shaw eloquently said, “youth is wasted on the young”… Trying, however, to be more constructive (if not altogether convincing to people who are somehow refractory to reason), here are some counterfactuals:

  1. As Sharon Begley (@sxbegle) wrote today in STAT News, and as reported in a huge variety of published scientific literature, COVID-19 attacks a variety of organs, ranging from the (obvious) lungs to kidneys, heart & cardiovascular apparatus, brain / CNS, and others. Let’s please also not forget that this is a new virus, and that we still do not know much about its long-term effects. There are clear and increasing reports showing that even young, apparently asymptomatic / mildly symptomatic people who recovered from the infection have possibly long-term effects such as reduced lung capacity, potential systemic / long lasting inflammation, and increase in diabetes risk. The US population already is relatively unhealthy to start with, so we really can’t afford to have an exceedingly long tail of co-morbidities plaguing us for years after this pandemic… Is that drink at the bar or that pizza really that important? (Note: a good pizza is indeed very important to me, as an Italian, but, you know, priorities).
  2. The virus spreading uncontrolled amongst the population, even if only in the strata that believe themselves “not at risk”, increases dramatically the likelihood of reaching much more at-risk demographics. Especially since we do not have a proper contact tracing and isolation set of protocols in place (or at all, actually) across the country.
  3. It is true (and great news indeed) that some initial hopeful results are emerging from medical research: the publication of the (robust AND randomized) UK RECOVERY trial results (just published on June 22, after topline data announced on June 18), confirms that oral or IV dexamethasone (a cheap, generic steroid) significantly reduced the 28-day mortality rate among hospitalized patients receiving invasive mechanical ventilation or oxygen (but it didn’t provide a benefit to more moderate patients who weren’t receiving respiratory support). So, yes, dexamethasone (and not other steroids, for those of you who buff up at the gym) appears to save the lives of about one out of every three patients being intubated, and about one out of every five patients who need oxygen support for breathing. BUT, that means the rest of the patients still die. Do the math, and wear a mask.

OBJECTION No. 3: The number of US deaths has not gone back up! It was down recently. Why are you worrying? I want to go to the beach bar with my buddies!

First of all, I would like to make the (perhaps silly) argument that, even if we manage to maintain fatalities at the current rough run rate of 3,500-4,200 per week on average, this is still a disaster that should be cause for immense concern. In four short months, this pandemic has already cost the US more fatalities than WWI and Vietnam. And we are a long way from being safe.

I would also like to remind readers (at least those of you with a sense and perspective of history) that the US altered the planet’s geopolitical landscape following a horrific terrorist attack in 2001 that caused ~3,200 casualties: those interventions, performed at immense subsequent cost to the country (in both blood and trillions of dollars of treasure), were never questioned.

Why are we not taking this deadly pandemic as seriously, with a comprehensive strategy and a plan?

That aside, I agree that, SO FAR, fatality rates are not (yet) increasing dramatically across the entire country. However, it is important to remember a few things:

  1. As discussed here in Timmerman Report on Mar. 18, fatality increases lag ~2-4 weeks behind hospitalization increases, which themselves lag ~2-4 weeks behind increases in number of infections. And there are now at least 5 US states reporting substantial increases in hospitalizations. I am particularly concerned about Texas and Florida, since they have some very large / dense cities: as we learned (or should have) from New York (and Milan, Paris, London, and Wuhan before that…), highly populated, dense urban centers are the first and most highly affected, since it is easier for the infection to spread to the most vulnerable population segments there. We are beginning to see alarm bells ringing from hospitals in Houston, the fourth-largest city in the US behind New York, Los Angeles and Chicago.
  2. Current week-on-week growth in fatalities are actually already extremely concerning in Alabama (120% growth), Kansas (100%), South Carolina (57%) and Arizona (56%). I do hope we do not re-enact the tragedy that befell New York, this time across multiple locations across in the country, but we are heading inexorably there without any meaningful course correction. Texas has (I think) decided to stop messing with itself. As I write, Texas Gov. Greg Abbott announced closing of bars and limiting gatherings, in a further rollback of its reopening plans. So, there is hope. But: I cannot but look with regret and sadness to the fact that no lessons were learned here, from other countries and from the lives and livelihoods lost. American Exceptionalism (seen today through an “it can’t happen here” attitude) can sometimes be a very dangerous pre-existing conviction indeed, especially against a virus who only obeys an evolutionary, biological imperative and does not care what you think you know.

Now that those pesky objections are out of the way, let’s look a bit across the pond, again, to the country in Europe that was hit early and hard (yes, of course it is Italy (eyeroll).

How are they doing? Can we apply any additional lessons from there to here?

As can be seen in https://www.worldometers.info/coronavirus/country/italy/, Italy seems to have turned the corner: the number of daily new cases seems to have stabilized around 100-200 per day now, from a horrific peak of more than 6,000/day in mid-late March. The number of fatalities has also decreased to low double digit (20-40) / day from a peak of almost 1,000/day at the end of March.

Now, I do not know what you think of my native country, apart from the obvious facts that the food, the art and the people are amazing. But I do hope we did not give you the mistaken impression that we are organizational geniuses with an extremely efficient government and an obedient and compliant population, also excelling in biotech and pharma R&D. Because, and I am sorry to burst your bubble here, nothing could not be further from the truth. Trust me.

However, what the country’s government did realize early on (never too soon, but soon enough) was that the pandemic’s exponential growth rate and high infectivity was the enemy. They locked down initially a few affected villages / small cities in early March, then Lombardy a few days later, and then entire country on March 9 (See Mar. 10 Timmerman Report article).

Even with that, the effects in Lombardy were catastrophic, as we all know.

One thing you might not know, is that there were very, very few cases outside of Lombardy. The lockdown basically pre-empted the spread to the rest of the country. Not fast enough to prevent more than 30,000 deaths. But it could have been a lot worse. And local, regional and national governments ALL ALIGNED in providing clear, simple, unequivocal communication to the population: Stay At Home. (See May 26 Timmerman Report about clear messaging).

There is now an entire comedy art form / meme unwittingly created by the videos of (especially southern Italian) mayors *screaming* to their constituents to take the lock down and social distancing seriously: go to this video and have a laugh. Trust me it is funnier in Italian. But they saved lives by shutting down, *at the same time*, the entire country.

Many grave, in some cases fatal, mistakes were made. Of course,  they did not know better, and human nature is what it is, sadly. Early on, elderly patients were first admitted to hospitals upon suspicion of infection and then brought back to their retirement homes. That unwittingly spread the infection in the most vulnerable demographics.

In late February and early March, industry lobbyists forced the government to wait a few additional days before imposing the lock down, costing many more lives (sound familiar?). Local government officials, in Milano and the Lombardia region, mocked openly the curfews and lockdowns early on, spreading an “insouciant” attitude (sound familiar?). Also, remdesivir was not available, hospitals were severely lacking in PPEs and other essential equipment and instruments, and so on.

This is far from over. As summer arrives, and people relax their precautions and behaviors, as families reunite after months of separation, there is a risk, even a likelihood, that the infection will regain a foothold. My mom in Italy went to the hairdresser the other day, and I almost had an apoplectic fit when I heard.

I hope we in the US avoid what is currently happening in Iran, where cases started to rise again around May 2: fatalities initially did not increase (cue the usual crowd of pundits mentioning “young people are getting infected so nothing bad is going to happen”). However, if you go to https://www.worldometers.info/coronavirus/country/iran/, you will see deaths starting to pick up again ~3 weeks following case increases. But, by starting from a low base, there is the possibility of containing a second wave.

Back to the US: how do we then look forward to the future? What is our strategy to get out of this mess? Is there a strategy??

As J.L. Gaddis discusses (extremely eloquently) in his wonderful book “On Grand Strategy”: strategy is the alignment of aspirations and capabilities. That alignment often requires mastering the arts of logistics, communication, as well as leadership.

If I, the Persian emperor, want to conquer Greece, and invade it with a massive army, I better make sure my supply lines are adequate to the task of feeding my army, and that I have navy captains that know the local waters before engaging enemy fleets (you should really read the book). Otherwise, a not-quite-united country of basically goat herders can wipe out a force 10-20x bigger.

What are our aspirations? That part *should* be easy: going back, safely, as soon as possible and with minimal loss of life, to a “normal” living environment.

What are our capabilities? Well, that part *should* also be very easy. This is, after all, the richest, strongest, most technologically advanced nation on earth. We just sent a new (reusable!) manned rocket to the International Space Station! We have the largest representation of leading biotech and pharmaceutical research, in truly incredible innovation clusters like Boston, NYC, SF, etc. Yet the US has consistently lagged on testing (see chart below).

We should be able to test, trace, isolate infected individuals, make sure our hospitals have plenty of spare capacity and equipment to contain potential surges, and have a corresponding research and manufacturing plan to both develop treatments / vaccines and ensure they can be delivered in the safest way and shortest possible delay to the greatest share of the population.

As also discussed in Gaddis’ book, achieving this alignment does have some essential, mandatory requirements: an earnest and frank assessment of capabilities needed to then achieve your objectives, and a leadership who can then execute and create new capabilities when needed.

And there’s the rub.

To wrap this up:

  1. I no longer believe the US is going to be able to test, trace and isolate its way back to “normal”, whatever that is. For one, the virus is by now endemic in pretty much every state and very likely in too many communities to be able to “contain it”. The genie is out of the bottle, cat out of the bag, horses / barn door, etc etc. You see my point. Too late for that.  
  2. The government policy of basically abandoning each individual state to its own fate has resulted in a patchwork of inconsistent (and often incoherent) measures: amongst other nefarious consequences, a chunk of the population has therefore seriously underestimated the seriousness of the pandemic. It is now exceedingly difficult to “re-educate” that population to implement healthier behaviors (masks, social distancing, etc.). I will spare any commentary on the absurdity of each state government having to basically figure out from scratch what to communicate, how to fight a pandemic, purchase PPE and diagnostic equipment, hire / consult with experienced virologists / epidemiologists in a time-sensitive crisis, build (again from scratch) a test / trace / isolate infrastructure, etc. etc. Insane does not even begin to describe it. Perhaps NY, MA, CA, WA and a few other large, knowledge-intensive and resource-rich states can do that (but why should they re-invent the wheel every time?). But the Dakotas? Wyoming? Montana? Kansas? The coronavirus task force did its first public briefing today after two months. Do they believe the virus just magically “reappeared” out of thin air? I am not sure my frustration is showing at all here?
  3. We still have a few months (at a minimum) before additional pharmaceutical interventions could show efficacy and then become available in order to make a meaningful difference on severity and fatality: we need that time and those interventions to help us “manage” while we pray for a safe and effective vaccine. We have to limit the damage until then.

So, what are we left with? Not much, without some clear leadership. But, we should try. The alternative is too hard to bear. Some extremely common-sensical suggestions below.

  1. Impose mandatory mask wearing in ALL public spaces. Impose fines for violators. Ban large (or medium-size) gatherings. You might find it shocking, but America led the world during the 1918 flu pandemic (please, do not call it “Spanish” flu, it actually started in Kansas and spread was facilitated by WWI troop deployments…) in imposing mandatory mask wearing with fines and jail terms for people not complying. Forget the debate about individual liberties etc.: your individual “liberty” to not wear a mask should stop when you are threatening the entire community’s welfare.
  2. Keep higher-risk populations as isolated as possible, with particular care for nursing homes, long-term care facilities, prisons, meatpacking plants and other highly-dense populations.
  3. Step up manufacturing of PPE and (for the love of all that is holy), sort out viral testing *at speed* and scale, and serological testing at a sufficient accuracy to make a difference. This is absolutely necessary for the months ahead (see below).
  4. Prepare for the autumn. I am not sure what the fall’s flu season will look like, but we need to be able to differentiate between different respiratory infections so that COVID-19 patients can be screened and isolated. Train an army of contact tracers properly and across the entire country. Employ / train the legions of unemployed in the service, hospitality and airline industry to provide that essential service. Make sure everybody in the country receives a pneumococcal vaccine and a flu vaccine as soon as it becomes available.

I closed my Mar. 10 article with the words: “We have no time to lose. And may the fates look upon us with mercy”.

We lost 16 weeks.

The fates, like the virus, do not seem to care.

It is up to us.

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.

22
Jun
2020

From Heart to Head, Corporations Can Step Up Against Systemic Racism 

Karl Simpson, CEO, Liftstream

The raw, painful emotions emanating from Minneapolis, in the aftermath of George Floyd’s killing by police, have prompted millions of people to stand up in defiance of racism and inequality.

The passionate reaction is right, and long overdue. George Floyd was just the latest in a terrible list of victims of police brutality.

What’s most important is how activists have made clear, and forced the world to listen, to the fact that police brutality is just one of many manifestations of systemic racism that infects so many aspects of the modern world.

The business community has gotten the message. The first step was decrying the grievous act of murder. But very quickly, businesses have been forced to re-think many longstanding systems that serve to perpetuate inequality in so many ways, which usually aren’t caught on cell phone video. Hiring, retention, and promotion are obvious places where companies have control, and a chance to make good on many stated commitments to creating diverse, equitable and inclusive places of work.

Finding your voice in such times can be hard. As a white man in his forties, building leadership teams and consulting on diversity for predominantly white corporate clients in the US and Europe, I am commonly perceived as part of the inequality problem. The fear of vilification for misspeaking, appearing tone-deaf, or doing something perceived as ill-timed in the moment, can be a sufficient deterrent to action.

Instead of accepting this implicit blame and keeping quiet, I have, since 2004, chosen to put my energy towards developing solutions to the problem. I’ve researched and advocated for improved racial and gender diversity at life science companies at the board level, in the C-suite, and throughout these organizations. I’ve aligned myself with policy and lawmakers and shaped cross-industry actions. Equipped with data, evidence and expertise, I have worked with our clients across the life sciences sector to put together plans, with measurable benchmarks, to introduce diversity and inclusion. 

This experience has taught me to run towards these situations, not away. I have repeatedly had to find my voice and challenge behavior intended to discriminate.  

As a white man, people often reveal to you their racist and sexist views. Whether it is a biotech CEO who plainly refuses to countenance the recruitment of Muslim immigrants, or a male VC who once suggested that “women should be hired where they’ll do the least damage” — you have to confront these attitudes.

By speaking out, I hope to use any advantage that I have to tackle the specific challenges afflicting black people and minorities in our workplaces, as well as encourage others like me to do the same.

White people need to speak up, and be specific about the changes that need to occur, and the things we can do, to create a more equitable world.

The words we use matter. When the atmosphere is this febrile, the comments need to be particularly thoughtful and sensitive, but above all, genuine. Staying silent has implications too, as silence can be deafening, particularly in the ears of those people most expecting us to say something. If you are a company leader and have nothing to say, think about the message that sends.

When events pique our emotions, they guide our actions and our language. But for these passionate words to endure, they must be anchored in intellectual rigor, and a determination to see action follow. Like in any intense situation, the best leaders know how to listen carefully, and act decisively, with poise under pressure.

Company leaders today need to become champions of change.

In tackling gender equality as that movement has gathered momentum in the past few years, men have been crucial champions. Since men hold most of the positions of power, it simply requires men to get on board if we’re going to see real change.

When my company held its first diversity conference in Boston during 2015, of the 200+ executives in the room, only around 10 delegates were men. When we came back the next year, this was nearer 33%. By 2019, men were almost half of the attendees.

This was accomplished largely because we chose to cast a forward-looking narrative that focused on working as a community to address a business problem and that we wanted men included. More widely, women have recognized that to advance their cause, they require those in power to join their fight, which means easing up on the blame and shame game.

Beyond understanding the correlation between diversity and its effects on financial performance, talent acquisition and retention; innovation, access to capital; reduced risk and so much more, men have been motivated to improve the environment for their daughters, partners and friends. Enlightened men now see this as the right thing to do and have dropped many of the legacy values that perpetuated sexism. As gender diversity has taken root, they have witnessed the many advantages besides having truly talented colleagues.

Today though, two in five biotech boards are all-male, showing there is still a long way to go.

For racial equality to achieve the same amplification in the business setting, it too must recruit champions who’ll feel able to speak out and influence. One positive signal of the recent deluge of leader’s statements is that there now appear to be many more people, of all races, who want to be actors in the change process.

A talent imperative

But as corporate leaders join the chorus of the well-intentioned, with a new resolve to level the field, there is a truth to confront.

There’s a lot of work to do.

The life sciences sector has been delinquent in introducing broad diversity and increasing the participation of black and African American people. Sure, progress has been made, particularly on gender, but this has been incremental and slow. This inertia continues to disadvantage racial and ethnic minorities, women, LGBTQ, and others. The industry is simply not including many incredible people – and that is a dereliction of leadership responsibility.

Designing for outcomes

The racial dimension of the inequality problem in life sciences is complex, and its complexity has sometimes led to unhelpful simplification. When analyzing the talent pipeline, it reveals that black and African American employees, on aggregate, occupy a very different place in the pipeline than say people of Indian or Asian desent. Dissect that further and you’ll find variations across functions too. Therefore, prescribing solutions addressing broad classifications, such as “people of color,” can be ineffectual.

Should the representation of black employees need improving, the solution must target the explicit requirements of this group.

For example, a notable issue in growing a diverse workforce is ensuring that contributor-level employees make the transition to management.

Here are a few questions to ask:

  • If black employees are fulfilling early-career roles, how does a company set up the system such that they continue to be fully represented at that next level and don’t lose out relative to their white colleagues?
  • From the moment a black employee enters the company, how is the company allocating project work that will continually stretch and challenge that employee, heightening their chance of advancing?
  • What is the organization doing to build their network and ensure they are having impact within it?
  • What decision frameworks is the company employing to ensure that black employees are delegated decision authority, and that this is not concentrated in places where they’re not represented?

Similarly, the “double jeopardy” of intersectionality demands exploration. Each organization must understand the change it wants to affect and the outcome it seeks. To do that, it must identify the particular problems affecting each racial group and use evidence-based approaches to address the representation at each level of the corporate ladder. There is a balance for leaders to strike between discussion and action.

Although, leaders would be advised not to be too contemplative.

It doesn’t require a lot of in-depth thought or committee meetings to decide to pull the plug on the Aunt Jemima brand. Or if you’re Microsoft and Amazon, you don’t need to think very hard about stopping sales of facial recognition technology to police departments. Big pharma companies, for their part, shouldn’t need a lot of convincing to re-double efforts to recruit representative populations into their clinical trials, ever mindful of the trust they need to foster with these communities.

Many valid recommendations have been in public circulation for years, and they could be swiftly implemented as a visible sign of meaningful improvement. Inaction on some obvious steps to advance racial equity in corporations – such as the board of directors defining a clear diversity policy in their governance charter or publicly stating goals and targets for diversity – is bound to attract scrutiny from those asking what’s taking so long.

Impatience is growing.

Fix the system

When a manufacturing plant has a contamination problem, or there is a logistics issue in the supply chain, businesses typically act swiftly to implement new processes and systems that rectify the problem.

But when companies see a need to change the recruiting, retention, promotion and management of the human beings that work in a business, there’s not the same urgency to act.

The academic research, the experts, and even collective wisdom have pointed out that the systems and processes used to identify, hire, develop and retain talent are producing outcomes which repeatedly and negatively impact black people, and other people representative of diversity.

For example, if you’re a college admissions department, and you know that your university says it wants a diverse student body, but it continues to use standardized tests that favor students who can pay for expensive test prep classes, and who have been raised in school systems designed to prepare them to ace the test, then why stubbornly stick to the standardized tests for evaluating applications?

This was true until recent days, when universities around the US, after years of pressure from activists, finally said it was time to get rid of the standardized tests and find other ways to evaluate promising students.

Systems like this exist everywhere in our world, often operating below the radar of most people. Yet instead of dismantling the failed systems and replacing them with others capable of delivering more balanced representation across racial and ethnic groups, companies continue to merely tweak existing structures.

Companies commonly default to redefining company values, writing policies and handbooks, or switching emphasis to talent identification. Some will put emphasis on restructuring the interview process based on a hypothetical model of fairness, or they’ll add minorities to the team of interviewers, or they’ll scrutinize the supply chain. None of these things are likely to shift the dial.

The substantive overhaul required to correct systemic faults is then declined in favor of introducing actions designed to change individual behaviors.

It is not my wish to discourage supporting individuals, because that too is part of the solution. But no amount of training, mentoring, coaching or sponsorship is going to re-balance the opportunity scale for people of color if the underlying system is unchanged.

And fixing the system does not mean fighting inequality with other kinds of inequality. The desire for accelerated progress can lead us to seductive practices, many of which eventually disadvantage other people.

If a business wants more black employees, drawing up hiring shortlists of only black candidates, or handing out promotions to only black employees, directly discriminates against and is harmful to others. While this contortion of processes may bring short-term results, it stores up considerable problems for the future, is damaging to company culture, and should be avoided.

Better Measurement

Many CEO statements about racial inequality are prefaced with some general metric about the percentage of minorities they employ. I understand why leaders do this, but they should resist. Presenting aggregated workforce composition data often belies the real situation, and creates the perception that a company is doing better on diversity and equality than it actually is.

Alternatively, CEOs should offer accurate data that show where they employ black people in the company, at what level, and in which function. Reveal data highlighting how black and African American people are moving up through the company relative to the employee base. And report on how many racial minority candidates are being interviewed, hired and rejected in recruiting processes.

Data is needed to confirm that racial minorities are included in the decision-making fabric of the company and to introduce accountability. 

The time for data transparency has unquestionably arrived. Although complicated, it can and should be done.

Legitimate Intent

When racial minorities enter a hiring process, often their lived experience is divergent from that of a comparable white candidate.

Ultimately, many minority candidates that aspire to great jobs are met with rejection, like so many times before.

This repeated rejection compounds over time and begins to infect the way minorities see the process and alters their personal actions. The sense of not belonging, of being an outsider, of being invisible, becomes a determinant of whether they continue to engage in such competition for opportunities, knowing that being their best is unlikely to change the outcome. Where race intersects with other social categorizations, then this perception of unequal treatment is even more profound.

As a remedy, it is sorely tempting to encourage more racial minorities to put their hands up and their resumes forward to compete for positions. Cramming the funnel with candidates, unless they have a legitimate and equal chance of being hired, perpetuates false hope and exacerbates their compounded perception of bias when rejected. Instead, companies must test and trial the recruitment process to make it just and fair, as well as create that vital sense of belonging. It must deliver feedback constructively and systematically, as to negate any personal discrimination.

We have reached a moment of potentially momentous change. It’s a terrible shame it took a horrific police murder on video to compel people to get off the sidelines. But there’s a clear opportunity now to enact change and tackle the pernicious racism and inequality that weakens our organizations. History fuels our skepticism, but the millions of people marching the streets, for weeks on end, in sustained opposition to this insidious malady fills me with hope.

And it is the actions of individuals, en masse, working for change; speaking out, displaying their humanity; that will lead us to an equitable future.

 

Resources:

Karl Simpson is CEO of Liftstream, an executive search and leadership consulting practice that exclusively serves clients in the life sciences industry by supporting board and executive appointments, and consulting on diversity and governance. He is also co-founder of BioDirector, a diverse international network of board directors which is improving corporate governance and diversity in the boardrooms of innovative healthcare companies. 

13
Jun
2020

A Conversation About Race: Ted Love on The Long Run

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

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

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

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

Making Drugs at the Edge of Reason

Vicki Sato, chair of Denali Therapeutics and VIR Biotechnology

Editor’s Note: This essay is excerpted from “Biotechnology in the Time of COVID-19” edited by Dr. Jeremy M. Levin. It is printed with permission from RosettaBooks. The book is available exclusively on Amazon.

A few days ago, I Zoomed with a Hollywood Squares display of faces on my laptop: the top 60 leaders of VIR Biotechnology, a young company founded with the intent to arm the world against infectious disease. Not a popular vision in 2017, as far as investment was concerned.

But on this day, these employees were working across nine time zones to identify new treatments for COVID-19; working from home, working in labs in San Francisco and Bellinzona, Switzerland, to identify and isolate human antibodies that might treat this new pandemic disease.

I am the chair and a co-founder of VIR, and George Scangos, our CEO, had invited me to answer questions from these smart, committed, and stressed leaders.

Early on, someone asked if I had experienced anything like this before.

I answered somewhat reflexively.

“No, there hasn’t been anything of this scope or speed; it’s a unique time.”

Then some older neurons kicked in. I practically struck my forehead in self-reproach. How could I have forgotten about HIV and AIDS?

Today, a generation is unaware of the terror of HIV infection; it is a disease that is “managed” because of medicines that were created in the 1990s and beyond.

What lessons did we learn in creating that medical advance?

In 1984 I joined Biogen as a lab rat, an immunologist fussing about interferon and IL-2, but also cognizant of a puzzling and deadly disease — Acquired Immunodeficiency Syndrome — because of my recent academic days reviewing grant applications on a profound immunodeficiency affecting primarily homosexual men. This condition was a tornado, obliterating the immune systems of healthy, young men and killing them within months of diagnosis with opportunistic infections that ravaged their bodies. We didn’t know where it came from and we didn’t know where it would take us.

We had just learned that this havoc was caused by a new virus, likely from Africa, that infected and killed T lymphocytes, destroying the very physiology designed to protect us from lethal pathogens. Could we imagine anything more diabolical, more deadly, more obscene?

Oh…and it was a retrovirus, one of the first described with an affinity for human cells, not monkey or chicken, or mouse. Viruses of this type can uniquely embed themselves permanently into the DNA of the host. They can do this because they have an enzyme, reverse transcriptase, that converts the genetic information of the virus, which is RNA, into DNA, the double-stranded form that comprises our own genetic material. They could drive the normal biochemistry of “DNA makes RNA” backward, from RNA to DNA, hence retroviruses.

It all seemed rather daunting, and the speed of postgenomic analytical techniques and computer-accelerated modeling, which we take for granted today, were still in our future.

But at Biogen, working on a strategy for a virus-receptor blockade, and later at Vertex working on HIV protease inhibitors, I was able to be part of the scientific anschlag that took on the challenge of treating this disease. They were experiences that shaped my outlook on the drama and melodrama of infection.

What did I learn?

Your drug is only as good as your assay

At Biogen, we worked to develop a soluble version of the CD4 receptor, the initial portal for HIV. The idea was to create a decoy that would lure virus away from cells. This engineered molecule worked remarkably well in the in vitro replication assays that measured viral p24 antigen, the gold standard at the time. It did not work so well in patients, though, in part because those early assays employed strains of virus that had adapted to laboratory conditions—strains whose molecular mechanisms had drifted in critical ways from the actual strains infecting people. In addition, we learned that HIV also had co-receptors that figured significantly in viral tropism and entry. Our assays, the most current at the time, had misled us.

Successful and persistent pathogenic viruses are complex

They have evolved efficient genomes to subvert the workings of host cells in ways that enhance their own replication and survival. Single silver bullets rarely work. At Vertex, we worked hard to develop a potent, highly selective inhibitor of the viral protease, an enzyme that controlled one essential step in viral replication. It was a powerful drug, but it wasn’t enough. Over time, mutational drift and selection created new strains resistant to the drug. Combination strategies, incorporating drugs that targeted multiple steps in viral pathogenesis, were needed to ensure a durable and sustainable response. Inhibitors of viral protease, when added to inhibitors of reverse transcriptase, another protein essential for the virus to multiply, finally tipped the balance toward more durable responses. The combinations were game changers; the individual components were the essential and encouraging steps along the way.

Patients need to be heard and respected

The first generation of drugs were poorly tolerated; the treatment was potentially as bad as the disease, with debilitating side effects and an upside of only weeks to months of prolonged life.

Was this enough?

Doctors and scientists fretted about doing more careful studies, more innovative studies, before approving the drugs for use. Patients clamored for a voice in that decision, pointing out that their lives were the ones at stake; their lives the ones complicated by handfuls of drugs that caused disfiguring lipid growths, or commandeered their lifestyles with difficult-to-manage, often-contradictory dosing schedules. Maybe weeks or months of life were enough for the moment, if even more effective treatments could emerge in that interval. Patients wanted a seat at the table at the FDA, a seat at the table inside of drug companies, offering insights to teams of scientists.

What impressed me so much about this patient engagement was the diligence and sense of community that sustained this effort. Patients who hadn’t taken a science class since high school made themselves experts at immune regulation; journalists used to covering crime beats or Broadway shows or financial markets were writing newsletters to keep fellow patients and families informed of the latest discoveries. Patient-activists chained themselves to fences at pharmaceutical companies to demand better access and better medicines. Gay physicians opened neighborhood clinics where patients could find information, advice, and treatments as they emerged, because not all hospitals or physician practices would take on patients infected with HIV.

It all made a difference.

Lots of other lessons were learned as well, but these all came rushing back after the figurative forehead slap in front of those leaders at VIR that morning. I believe the lessons are important to us today: know what your assays are telling you and keep making them better. Don’t expect a silver bullet cure, but build on steady victories. Be engaged with the breadth of patients affected.

During the time of HIV and AIDS, the biotech industry was in its infancy. It is startling to look back. The only drugs approved from our companies in 1987 were recombinant human insulin, somatotropin, and alpha interferon. Our viability as a set of businesses, let alone as an industry, remained a determined dream for the founders but a “show me” for the rest of the world. We hadn’t flexed our muscles yet.

For COVID-19, we aren’t newbies anymore. Our industry delivers the majority of game-changing drugs to patients. The speed at which young companies and old have joined hands to test older drugs for rapid efficacy, to launch vaccine trials using a technology only invented a half-dozen years ago, and to map the changing face of this complex virus is breathtaking. We are showing we can do the science and drive the medicine, and that we can invent even as we discover and learn new things about the virus and the multifaceted disease it causes.

But with our maturity comes a heightened responsibility for social equity and responsibility: we must ensure not only that our science is sound but that our medicines are accessible to everyone who needs them. Society is already predicting that we will engage in price gouging, exclusivity, and competition for “credit,” the attributes that make our industry one of the least respected globally. Some of our remarkable medicines in other disease areas are better known for their prices than their medical impact.

As we continue to “science the hell” out of this pandemic, let us match our scientific prowess with humility and a commitment to the patients we pride ourselves on serving.

Plagues, it has been noted, have a way of leveling the playing field. Medicines should do that, too.

Vicki L. Sato, PhD, is chair of Denali Therapeutics and VIR Biotechnology. She has spent many years in leadership roles within the biotechnology industry. More recently, she has served on the faculties of Harvard University and Harvard Business School. Sato is also a director of Bristol-Myers Squibb, Akouos, and BorgWarner Corporation.

This essay is excerpted from BIOTECHNOLOGY IN THE TIME OF COVID-19 edited by Dr. Jeremy M. Levin and is printed with permission from RosettaBooks. The book is available exclusively on Amazon:  https://www.amazon.com/dp/B089JGDZNC    

 

10
Jun
2020

Let’s Turn the Black Nod Into a Collective Nod

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)

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