Investing at the Nexus of Biology & Technology: Jenny Rooke on The Long Run

Today’s guest on The Long Run is Jenny Rooke.

Jenny is the founder and managing partner of San Francisco-based Genoa Ventures.

Jenny Rooke, founder and managing partner, Genoa Ventures

I’ve been wanting to invite Jenny on the podcast for a while. Back in 2018, I profiled her as one of “Nine VCs Who Matter, But You Never Read About.”

As I wrote then:

VCs take on lots of different types of risk. There’s biology risk (something can’t be reproduced from mice to humans). There’s management risk (sometimes you back bad executives). There’s market risk (maybe the market won’t buy what you’re selling at your preferred price). There’s syndicate risk (your co-investors might run out of money or lose faith, forcing you to prop up portfolio companies if you want to keep them alive to the next milestone).

What you seldom see are VCs who shoulder a more profound type of risk, not just by starting their own firm, but by starting a venture firm with an unproven business model.

She started her firm by building the largest life science syndicate on AngelList, not by going to the usual big pension and endowment funds that typically invest in VC funds as limited partners.”

Here’s how she describes her approach:

“I’m particularly motivated by novel research platforms because part of what surprised me about lab work was how manual, and slow, and low through-put a lot of available tools were for doing science, so when I see companies that are trying to develop new tools that make more and better data for researchers that gets me excited.”

How’s it going so far?

Like any early-stage VC, it takes a while to build a track record.

Two of Jenny’s big investments from the early days of Genoa are emerging – Emeryville, Calif.-based Zymergen, an industrial biotech company, and Berkeley, Calif.-based Caribou Biosciences, a company that uses CRISPR editing for cell therapies.

Zymergen went public in April, and now has a market valuation of $4 billion. Caribou Biosciences recently filed IPO paperwork to raise up to $100 million.

It took a lot of guts and creativity to do what Jenny has done, and continues to do.

Before diving into her story, a word from the sponsor of The Long Run.

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For more information on DNA Script, please visit www.dnascript.com.

Now please join me and Jenny Rooke on The Long Run.


From Delta…to Omega?

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

I hope you are all enjoying your summer break with (finally) being able to see friends and family (and fine food NOT from a delivery service).

You are? Great!

Now let me spoil some of that for you.

  • This pandemic is not over

I understand the inclination to consider the pandemic behind us. In large parts of the US / North America and in (most of) Western Europe, vaccines (largely the very effective mRNA kind, with the UK being a notable exception) have been rolled out quite effectively and have now been administered to large percentages of the elderly and of the “at risk” population.

Cases and deaths have been decreasing for months in the same locations and are now a fraction of the (horrific) numbers we had last winter.

However, the (now infamous) Delta variant (originally discovered in India) is spreading at accelerating rates across the world. This includes (worryingly) countries who previously faced other variants of concern (VoCs), such as Alpha (discovered in the UK) and Beta (discovered in South Africa): it is particularly concerning to notice the exponential spread of Delta in the UK, a country that is now in its summer, had already been ravaged by Alpha last winter, and has fully vaccinated most of its vulnerable population with the adenoviral vector-based AstraZeneca vaccine.

I do understand the impulse to rush to Wembley to watch the home team lose to the Italians, but still. Similarly, South Africa has been facing an exponential growth in cases since June.

I can already hear you: “The increase in the number of cases is not resulting in an increase in hospitalizations and deaths. That link has been broken!”

First of all, and not to repeat myself: increases in cases appear earlier than increases in hospitalizations, which themselves lag behind an increase in deaths, each by 2-3 weeks. We already are noticing meaningful increases in hospitalizations amongst the unvaccinated / younger populations in the UK and US.

It is also true that the young (<50 years old) are at lower (relative) risk of hospitalization and severe disease. That said, the absolute number of people who will now potentially be infected is higher since Delta is super contagious AND vaccination rates are low amongst the young.

Second of all:

  1. it is TRUE that doubly-vaccinated, “healthy” people are strongly protected from severe symptoms and hospitalizations (even from Delta infections); that said, and as eloquently said by Larry Corey in this June 2021 Timmerman Report, there are UP TO 15 MILLION PEOPLE, in the US alone, who are immunocompromised / immunodeficient. These are cancer / HIV / transplant patients, amongst others. Vaccines have not been tested in clinical studies in these populations. There is now a large body of evidence that antibody responses in these groups wanes fairly quickly even after double vaccination. T cell response might last longer than antibody levels and might confer some protection, but we simply do not know how much or for how long: it remains unclear the amount of protection even mRNA vaccines might be able to provide, in the long run, to these patients;
  2. Even in the US and Western Europe, there are significant pockets of vaccine-deniers: refusing to be vaccinated is already resulting (in the US especially) in significant increases in hospitalizations in certain locations. This fall we will have also to contend (again) with more indoor transmission and the re-emergence of other transmissible viruses (flu, RSV, etc.) (FYI: I am NEVER shaking another person’s hand again.

I doubt we will see a repeat of the horrific statistics we saw last winter in the US / Western Europe (vaccination levels were almost nil back then).

However, even now, the US is tracking just below ~300 deaths / day from the pandemic, almost entirely in unvaccinated individuals. And we are in the summer, where opportunity for super-spreader events are much more limited. Without a new surge in vaccinations, and with the Delta variant in wide circulation, we could very well see a corresponding increase in deaths this fall when more people are gathering indoors.

Now, I know this is not a very popular point of view, but let’s try to forget American exceptionalism (for just a minute) and look at what is happening in other countries who do not have the luxury of having access to efficacious vaccines for their population.

Across the world, and in particular in South America, Southeast Asia, and Africa, the conditions are horrific. A lethal combination of insufficient vaccination levels (because of lack of supply), variants spreading (Delta above all, with Lambda being a possible concern in South America) and winter kicking in in the Southern hemisphere, is wreaking havoc on these countries.

Even countries who successfully contained the virus early on (Australia, Japan, Indonesia, Vietnam, etc.) are being forced into repeated lock-downs because of the lack of vaccine supplies and the spread of the Delta variant. South Africa has <3% of its population fully vaccinated, Indonesia <6%: both countries currently report record rises in cases, at levels that are multiple times higher than last January.

  • The increasing risk of more variants of concern

As I mentioned in February, (I am NOT going to change my already tragic first name to Cassandra (thank you very much!): there are no precedents in humanity’s history for a pandemic confronted in similar conditions: 8 billion susceptible individuals, many with co-morbidities (see below), and relatively unfettered, almost instantaneous travel between countries. The Delta variant was sequenced in Dec 2020, and it has since become the most prevalent variant across the world.

Its evolutionary fitness is something to behold. One study earlier in July from Guangdong found that viral loads in patients with the Delta variant were ~1000 times higher than with previous variants on the day the disease was first detected. It also appears people shed viral particles much earlier when infected with Delta. No wonder we’re seeing Delta spread so remarkably fast.

The one, I believe unprecedented factor that absolutely terrifies me, however, is the almost ideal incubation factory for novel, fitter viruses represented by immunocompromised / immunodeficient individuals.

One case from June might highlight this concern: a 36-year-old woman with HIV from South Africa was diagnosed with COVID and followed by her physicians. The virus was found to persist in her (immunodeficient / immunocompromised) body for over 200 days and to accumulate 32 mutations during this period, 13 to the spike protein and 19 others across the viral genome.

That’s a lot of opportunity, in just one individual, for SARS-CoV-2 to find ways to evade the host’s immune reaction. Now consider how many individuals in modern societies are immunocompromised. The virus has a mind-boggling number of opportunities to develop escape mutations, and it’s moving through large populations at exponential speed.

The only long-term solution for developing countries is to vaccinate their populations as soon as possible: they do not have the luxury of prolonged lock-downs since their governments will not be able to provide the same level of support that Western governments enabled for their workers and economies. Therefore, for the time being, the pandemic will continue to ravage Africa, South America and Southeast Asia with relative impunity.

It is anybody’s guess how long it will take to vaccinate developing countries. We’ve already seen India — the major producer of AstraZeneca’s vaccine for the COVAX facility — halt some of its vaccine exports to better vaccinate its own vulnerable populations. India reportedly made this decision in the aftermath of its tragic Delta-fueled surge this past spring.

A wild guess, but I am thinking it will probably take an additional year / 18 months or so to cover the world with vaccines. And this could be an optimistic scenario, as it assumes a) Western countries avoid falling into more “vaccine nationalism”, as their own populations claim booster shots and b) ALSO that manufacturing has been scaled up.

Add to this timeline the extremely worrying fact that we are still not performing enough sequencing of potential emerging variants (including, and criminally so, in the US), and we might be blindsided again this winter from another variant which might be as infectious as Delta and perhaps better at evading the immune system than Gamma or Beta. I am not sure what the probability of that is. It is far from zero.

By the way, the potential long-term geopolitical repercussions of letting the pandemic ravage uncontrolled in these countries could be absolutely devastating to the current world order. Now, if you want to chat about that, let me know, but I do not want to depress readers any further.

  • Some predictions

I am sure you are, by now, sick of hearing me prophesizing doom and gloom every time that you think you can finally go out on vacation and meet friends. Therefore, before starting my own little break, I am providing below a table describing what might be the short-medium term outlook in different parts of the world.

All this, without being able (of course) to assess the consequences of an “Omega” variant that resists / escapes vaccine-induced immunity. If such a variant emerges, then, as I wrote in my first Timmerman Report on Mar. 10, 2020:  

“May the fates look upon us with mercy”.


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.


Immunocompromised People Are Vulnerable to COVID-19. We Owe Them Some Answers

Larry Corey, MD

As fully vaccinated citizens in our country and around the globe begin to dip their toes in the waters of a post-vaccination world, there are two groups that deserve greater consideration: immunosuppressed or immunocompromised people.

This is not a small group of people.

Estimates are that about 6.2 percent of adults ages 18-64 in the US are living with weakened immune function, along with about 2.6 percent of children, according to the Centers for Disease Control and Prevention.

The prevalence of immunosuppression appears to be on the rise, as many people are living longer with cancer, HIV, organ transplants, or with chronic therapy with biologic medicines that make people more vulnerable to infections.

Fifteen million people is a large community; people who live in all regions and every city in the US. They are your neighbors, your sister’s friend, the person next to you in line at the grocery store; people who are unlikely to mount strong immune response to COVID-19 vaccines.

They need some extra help from all of us to stay safe.

So let’s talk about COVID-19 prevention strategies for this group of vulnerable people among us. Let’s start with patients who have received donor organs (like kidney or liver transplant recipients) and bone marrow transplants who are on medications that suppress their immune systems (to prevent graft rejection), as well as cancer patients whose immune systems have a reduced capacity to respond to vaccines because they’ve received chemotherapies that kill off many of their infection-fighting white blood cells.

The second immunosuppressed population I’ll discuss in a separate piece, are individuals living with HIV infection.

The global COVID-19 vaccine and prevention story, largely narrated by the data generated from the USG COVID Vaccine (formerly Operation Warp Speed) program, did not include immunosuppressed persons in the clinical trials of the COVID-19 vaccines approved under Emergency Use Authorization in the US.

As the architect of these trials, I need to do some explaining here, especially because as a physician and scientist, I have spent almost all of my career working in developing therapies and strategies to reduce infections in these people.

When we started the clinical trials, we had no idea how effective these vaccines would be. Speed and efficiency in trial conduct were necessary. We needed vaccines for the majority of the US adult population.

We knew that historically immunocompromised people are less likely to respond to vaccines than people with competent immune systems. There was also an issue how to discern vaccine side effects from side effects of all the medications immunosuppressed people take, and what other infections the immunocompromised person may have picked up coincidentally would have in relationship to the vaccine.

For this reason, including these patients in the initial efficacy trials would have complicated the interpretation of side effects and hospitalizations. Moreover, when we initiated the trials in summer 2020, we were concerned about the possibility of vaccine-induced COVID-19 disease enhancement, something we would not want in any person, let alone one who was immune compromised.

Fortunately, this is something we now know has not occurred in any of the vaccine trials.

Excluding immunosuppressed patients from the initial Phase III trials was the correct and necessary decision.

Unfortunately, however, we did not initiate concurrent parallel clinical trials in immunocompromised patients. That left trials in these patient populations to the vaccine makers or other philanthropic or government entities to “pick up” and conduct.

While some trials were started, they have been small and limited in scope. Most importantly, none have been large enough to evaluate vaccine efficacy. Unfortunately, the current state of information on vaccination in organ transplant and cancer patients is an anecdotal collection of small studies showing that vaccines seem to be safe, but, as predicted, elicit reduced levels of immune responses.

The data we have on organ transplant patients who have been treated with standard drugs that deplete B cells (e.g., Rituxan) and high-dose chemotherapy all tell us that at best 50% of persons develop detectable antibodies after two doses of mRNA vaccines.

Having detectable antibodies is a good sign, but we have very sensitive tools that can detect very small concentrations of antibodies. Few of these patients are generating the kind of robust concentrations of neutralizing antibodies that immunocompetent persons are typically able to generate, and which are thought to be necessary to protect against moderate to severe COVID-19.

In many populations like these where B-cell depletion occurs, the percentage of persons with detectable levels of neutralizing antibodies is 20 to 25% at best. Little is known of memory T cell responses in immunocompromised persons. This is an important area for further research, as T-cell responses could provide an important clue into whether the vaccines provide protection that lasts for the long term.

The main problem right now is that there are no data to indicate if the level of immunity reduces infection, or more importantly, if these immune responses are good enough to protect these individuals from hospitalization from severe COVID-19.

This is concerning because when immunosuppressed persons get infected with SARS-CoV-2, they frequently get prolonged, persistent infection. Case reports show patients with COVID-19 infection persisting for 200 days. During that time, the virus is replicating inside them, creating ample opportunity for variants to emerge. These variants often have the characteristic mutational changes associated with variants of concern. There is suggestive evidence that both the Alpha and Beta strains initially emanated from immunosuppressed patients.

Like COVID-19 in immunocompetent persons, the spectrum of illness in immunosuppressed patients is wide. The immunosuppressed patient can be asymptomatic—or mildly symptomatic—and transmit to family and friends and then introduce the variant into the community. Or they can have progressive longstanding pneumonia with prolonged shedding of the virus. Thus, we have a twofold difficulty.

It’s not good that we can’t protect the most medically vulnerable from getting COVID-19, and if they do get infected, they are at risk of progressive pneumonia as well as transmitting these variants to their loved ones and communities.

SARS-CoV-2 as a pathogen shows no beneficence or mercy to the vulnerable.

So, we truly need to find solutions here. Can we develop a vaccination regimen that works for immunocompromised people? Should we give them neutralizing antibodies for prevention, to give them some degree of temporary protection while we vaccinate as many people in the wider population as possible?

What about giving them genetically engineered neutralizing antibodies, plus giving them a vaccine to help them mount their own immune response?

How about trying vaccination first and if that doesn’t work, use long-acting monoclonal antibodies for those patients for whom vaccination has failed?

Vaccinating patients’ loved ones and households certainly is important. And hospitals that care for immunosuppressed persons need to make sure their employees are vaccinated to reduce variant spread.

Yes, in this author’s opinion, there should be mandatory vaccination for hospital employees.

These studies I’m proposing not only need to be about the immune responses to the vaccines as we’ve conducted in other studies, but also about studies of immunosuppressed persons globally where we can evaluate not only clinical efficacy but breakthrough shedding.

Does vaccination eliminate the virus from the nose? If so, then how do new variants emerge? These studies will be a bit more onerous to run than the original Phase III trials, as we’ll need to collect nasal samples on a daily basis to answer this question about viral transmission from the nose. Today, we are vaccinating cancer and organ transplant patients, but without any assurance that they are well protected.

Do we know that two-dose inoculation will afford them the same amount of protection as the rest of their families and communities? The answer is no.

Can vaccinated immunocompromised persons, like the rest of the vaccinated population, take off their masks in most public spaces and move freely throughout their days with greater peace of mind? The answer is, we’re not sure.

These are all questions we need to answer for a population that is not trivial—either in significance or in number. In the US, there are 16 million people living with cancer and at least 1 million organ/bone marrow transplant patients. These are real issues to many US and global citizens, their families, and communities.

We in the medical and scientific community owe them real answers.

Dr. Larry Corey is the leader of the COVID-19 Prevention Network (CoVPN ) Operations Center, which was formed by the National Institute of Allergy and Infectious Diseases at the U.S. National Institutes of Health to respond to the global pandemic and the Chair of the ACTIV COVID-19 Vaccine Clinical Trials Working Group. He is a Professor of Medicine and Virology at University of Washington and a Professor in the Vaccine and Infectious Disease Division and past President and Director of Fred Hutchinson Cancer Research Center.


The Other Half: Decentralized Research is The Path to All-Inclusive Medicine 

Sanskriti Thakur, chief growth officer, Medable

More than half of the U.S. population is projected to be “other than non-Hispanic white” by 2045.

If the current clinical research process doesn’t adapt to these changing population demographics, the life sciences industry will continue developing drugs and devices that are only shown to work for a select few, leaving out the “other half.”

Despite efforts, including those from the U.S. FDA and the Revitalization Act of 1993, which required that clinical trials funded by the National Institutes of Health include women and minority participants, diversity in clinical trials has not substantially improved. At least 83% of research participants are white even as they make up about 67% of the U.S. population. African Americans make up 13.4% of the U.S. population, but only 5% of the people who participate in trials. Hispanics represent 18% of the population but less than 1% of those enrolled in trials.

Participants in clinical trials should reflect the diversity of the population, and not just for altruistic reasons. A lack of representation from minority groups in research has resulted in interventions that have not translated well in the real world. This can even prove harmful in different populations.

For example, 5-Flurouracil, a commonly used cancer chemotherapeutic drug, often exhibits differences in drug response among different populations. A major side effect associated with the drug is the occurrence of hematologic toxicities, including leukopenia and anemia. These toxicities are often found in higher rates in underrepresented populations. Not surprisingly, this fact wasn’t discovered in clinical trials. 5-Flurouracil’s clinical trials were overrepresented with white participants, missing the opportunity to assess the adverse effects in minority groups.

Unexpected safety issues are one of the main drivers of failure in R&D. When data from diverse populations is lacking, additional post-marketing studies are often recommended, adding costs. Yet drugs are still sold, and the cycle repeats.

About 2 million serious adverse events occur each year in the US, and SAEs are responsible for about 100,000 deaths a year, according to the FDA’s Center for Drug Evaluation and Research. We could reduce this toll of suffering and death by more thoroughly testing drug candidates in a representative study population. Instead, we are making drugs for one population. The rest are often not even aware of potentially life-saving clinical research opportunities. Misinformation, politics, money, distance, fear are all contributors to why medicines remain suboptimal. It must change.

Finally, fortunately, the foundation has been laid to make clinical research more accessible with better outcomes. Decentralized clinical trials, hybrid trials, remote clinical trials, adaptive clinical trials – these boundaryless research models are possible now thanks to technology and a patient base eager to use it.

Here are three reasons why an inclusive, adaptive, decentralized model for research is the future: 

1) Patients demand more. For the first time, the masses experienced remote treatment during the pandemic, and they will continue to expect it. In one survey, up to 98% of patients reported satisfaction with telemedicine. In another, 72% of physicians reported similar or better experiences with remote engagement compared with in-person visits. Indeed, patient-centric healthcare is possible with technologies built of human-centered design principles. 

2) The efficiencies are irresistible. The $2.6B+ cost per product for developing drugs is still growing especially where personalization and cell and gene therapies challenge the system. Decentralization breaks from the traditional model to drive costs down by reducing time to market, improving trial efficiency, and enabling better outcomes for a more diverse population. Leveraging hybrid and remote technologies, scientists can test new therapies at pace in smaller but more representative populations without investing in as much brick-and-mortar infrastructure. For instance, community pharmacies and local urgent care centers can become cost-efficient, convenient site locations for certain therapeutics while telemedicine reduces travel and cost burden for patients as well as sponsors.

3) Precision medicine is becoming mainstream. Targeted therapies accounted for just 5% of new molecular entities approved by the U.S. FDA in 2005 but accounted for more than 40% in 2018. That’s great news, but it also makes finding the right patients to fill those niche research opportunities difficult. With advanced technologies now available to include smaller cohorts of patients in these trials, there is an  opportunity to dismantle the current paradigm of clinical research.

Today, three-fourth of companies say they are running “some decentralized trials”, the U.S. FDA is expected to offer new guidance for operating decentralized trials, and 100 industry leaders make up the newly formed Decentralized Trials & Research Alliance (DTRA). Additionally, the continued rise of precision medicine and gene therapies means that diversity in clinical trials is now more crucial than ever to obtain a complete picture of a drug’s safety-efficacy profile. 

The industry is at a critical inflection point. Do we continue to make drugs that treat just half of the population? Or do we adopt new clinical research models that enable better outcomes? We are now able to move science from product to platform, creating technological access to medicine for everyone.

It’s an imperative for health equity. Without it, medicine is not made for everyone.

Sanskriti (“Sans”) Thakur is Medable’s Chief Growth Officer. She most recently served as global life sciences research lead for Accenture. sans.thakur@medable.com.


Biopharma’s Racial Justice Work is a Start. But More Needs to Happen

Stewart Lyman, biotech consultant

Stewart Lyman

Biopharma leaders have pledged to make their companies more diverse and inclusive. MassBio created an open letter on culture, recruitment, development, sustainability and accountability that has been signed by presidents and CEOs of more than 200 member companies.

Large and small companies have described some of their specific efforts in public. Bristol-Myers Squibb aims to double the number of executive roles for Black and Latinx employees; Biogen has said it will be increasing minority participation in clinical trials, and Sutro Biopharma is working hard to increase diversity within company ranks.

The work to fight racism is showing up in clinical medicine as well. American Society of Clinical Oncology President Dr. Lori Pierce has made “Equity: Every Patient. Every Day. Everywhere” the theme of her Presidency. The American Medical Association has released a plan for ending structural racism not just within medicine, but also within the organization itself.

A pledge won’t transform an industry where BIPOC and Latinx employees are historically underrepresented, but it’s a start. We’re living in a time when many people, especially young people, expect corporations to do more than just maximize the bottom line.

I’m hopeful that these companies and organizations follow through on their words. But the industry could do one thing above all to attack racial disparities in healthcare.

It could make drugs more affordable. Especially for members of the BIPOC community.

As discussed here by Patients for Affordable Drugs Now, a patient advocacy group, the high price of prescription drugs helps to perpetuate systemic racism.

I want to applaud the industry for stepping up and taking pledges to do better to address racial inequities in hiring, career development, and representation in clinical trials. This is important work. But it’s simply not enough.

What’s going to have more impact: doubling the percentage of BIPOC employees at your company from three to six percent, or helping tens of millions of BIPOC people obtain the drugs you make?

Let’s not dream small. Why isn’t it possible to do both of these things?

BIPOC Communities are Marginalized by Biomedicine

There are many ways that Black people and other minority groups have been marginalized by the biomedical industry.

Here’s just a partial list of the disparities exposed and amplified by COVID-19 in the past year:

  1. Black people ages 35 to 44 were dying at nine times the rate of white people the same age from COVID-19.
  2. Neighborhoods that have higher COVID-19 hospitalization rates should have higher rates of COVID-19 testing, but if they’re majority Black neighborhoods, they don’t.
  3. Life expectancy in the U.S. fell in 2020 by the largest amount measured since WWII. Life expectancy for white people fell by a full year; for Black Americans it fell by 2.7 years.
  4. Racial bias was found in a major health care risk algorithm that is used for determining patient needs.
  5. Pulse oximeters used to measure blood oxygen levels, a quick and easy test to determine the severity of disease for a given patient, don’t work as accurately for many Black people.
  6. The number of kids being diagnosed with SARS-CoV-2 induced Multisystem Inflammatory Syndrome in Children (MIS-C) is growing in the U.S. Though MIS-C is rare, the majority of kids who get it are Black or Latino.
  7. In Palm Beach, Florida, COVID-19 vaccines intended for rural Black communities were instead given to wealthy white Floridians, and in general Blacks and other minority groups lag whites in getting the COVID-19 vaccine.
  8. In emergency departments at children’s hospitals in the U.S. from 2016-2019, Black children were 18% less likely and Hispanic children were 13% less likely than white children to receive X-rays, ultrasounds, CT scans, or MRIs.
Unfortunately, We’ve Seen This Movie Before

Some of the racial problems in healthcare are outside the control of the biopharma industry. But when the issue turns to race in biopharma, the industry tends to fall back on knee-jerk defenses that do nothing to solve longstanding racial inequities.

Biopharma has some movies I’ve had to watch far too many times. Three examples with comments:

  • Patients testifying in public that they can’t afford their drugs, or how unaffordability led to the death of a loved one.

The unaffordable price of drugs has been raised as an issue at least as far back as the Eisenhower administration and the Kefauver-Harris hearings that transformed the FDA in 1962. The industry managed to avoid price controls back then, and it’s beaten back every similar effort since. Our former President promised many times to lower drug prices. He broke that promise.

  • Drug prices can’t be cut because that would remove the incentive for innovation.

Venture capitalists are quick to point out that cutting prices would slow the development of new drugs. All of us would love to see a continuous stream of new and truly useful medicines. But what good are medicines, old or new, if patients can’t get them?

  • Listening to the CEOs of biopharma companies, healthcare insurers, and pharmacy benefit managers explain why they bear no responsibility for high drug prices, and why it’s always “the other guy’s fault.”

People are tired of these finger-pointing, blame-shifting exercises. Each of these special interest groups is there to protect itself, and each controls a small army of highly effective, well-paid lobbyists. Their combined forces would make a worthy opponent to those rampaging legions of Orcs in the Lord of the Rings movies.

The connections between these three industries are deliberately constructed to be opaque and hard for those on the outside to review and understand. For example, “rebate walls” have been set up between drug companies and PBMs. This term refers to contractual arrangements that control the placement of certain drugs on formularies that are used by most healthcare plans. Drug makers can offer higher rebates to the PBMs for any given medicine, or bundles of different medicines. This allows them to “wall off” other drug makers from getting favorable formulary placements for their drugs.

All of these groups should spend a lot less time offloading blame and focus instead on solving the problems of increasing access to medicines, reducing healthcare costs, and improving health outcomes. Mud slinging just promotes the growth of a swampy ecosystem of missed opportunities and wasted money. Everyone’s reputation gets bogged down in the muck and mire.

Reputation Resuscitated?

Life-saving COVID-19 vaccines were produced in record time, along with new and repurposed drugs for combating the pandemic. Many people are grateful for this work. Polls have shown that biopharma’s reputation is trending upward. That’s good news for the industry. Whether this will be sustained is an open question.

This positive movement in favor of biopharma is being counterbalanced in real-time by anti-vaccine forces, most of which are anti-pharma and anti-science. The anti-intellectualism and misinformation promulgated by these groups lingers like a bad cough, even as biomedicine successes continue to pile up.

Biopharma scandals continue, with large fines levied for all manner of offenses. Purdue Pharma is on the hook for $8B for driving the opioid crisis. Novartis agreed to pay $678M for making improper payments to doctors (i.e. kickbacks). Even after admitting this, Novartis was forced to walk back comments made by its chairman, who inaccurately insisted that the company had done no such thing.

Gaslighting is never a good look for an industry leader. Congressional testimony about drug pricing from the CEOs of AbbVie and Amgen was embarrassingly bad, wilting under the tough questioning of Rep. Katie Porter with her “whiteboard of truth.” This confirmed what many in the public already suspect, and which helps drive the anti-vaccine movement: the industry can’t be trusted.

Just as coal, oil, and gas companies need to change their business models because of the threat of global climate change, biopharma companies need to work much harder to ensure their medicines will be available to all those who need them.

It’s a reasonable request for an industry that continues to oppose state drug pricing boards, Canadian drug imports, and Medicare negotiations on drug prices.

The industry’s stance on those issues hasn’t changed in the past decade. But the industry can and must change.

The shifting position on racial diversity, equity, and inclusion is a sign that industry can do better. We need to hold it accountable. Let’s make sure the industry follows through on its promise by doing everything in its power to ensure that the poor, the disadvantaged, and BIPOC and Latinx folks gain access to the treatments and medicines that will enrich and prolong lives.

Stewart Lyman is a biopharma consultant based in Seattle.


On Juneteenth, Honoring 22 Black Biotech Leaders

A few Black people have risen to prominence in biopharma. Ken Frazier, Tony Coles, Rob Perez and Ted Love are among the most visible.

But there are many other Black leaders in the industry who are making important contributions to the science and business of human health.

Today, let’s recognize the Juneteenth holiday coming up June 19. It’s a celebration of emancipation. No one taught this in school when I was a kid, but on June 19, 1865 — long after the Emancipation Proclamation of Jan. 1, 1863 — the last remaining slaves in Texas were informed they were free.

This is a moment to celebrate freedom and progress and human potential.

For the biotech industry, I sought out some of the up-and-coming leaders who are Black. The focus here is on people who have made, and continue to make, an impact in science and entrepreneurship.

Karen Akinsanya, chief biomedical scientist, head of discovery R&D, Schrodinger

Akinsanya is the chief biomedical scientist at New York-based Schrodinger. She joined this fast-emerging $5.3 billion computational drug discovery company in 2018. She arrived with a wealth of experience in biology (PhD in endocrine biology from Imperial College London) and drug discovery (11 years in roles of increasing responsibility at Merck).

Karen Akinsanya

She was eager to learn and grow with the computational tools for drug discovery. Listen to her describe her journey on The Long Run podcast in January 2019 (before Schrodinger’s IPO).

Akinsanya, 53, recently joined the board of trustees at The Rockefeller University, and serves as a member of the scientific advisory board for Thermo Fisher Scientific and Seattle-based Variant Bio. She also volunteers in the New York area to inspire kids in grades K-12 to learn about science.

Andrew Farnum, CEO of Variant Bio, said Akinsanya went above and beyond in her role as an SAB member, recommending the person he ultimately hired as head of R&D. “She has experience on the genetics side, on the drug discovery side, her strategic thinking is incredible, and she’s a joy to work with,” Farnum says.

Terry-Ann Burrell, chief financial officer, Beam Therapeutics

Terry-Ann Burrell

Cambridge, Mass.-based Beam Therapeutics has captivated the imagination of investors with precise base editing technology. It’s another step in the CRISPR revolution, and showing promise through a partnership with Verve Therapeutics to edit PCSK9 as a one-shot treatment for cardiovascular disease.

Burrell, 44, is one of the leaders at Beam responsible for strategy, and telling the story of CRISPR base editing to investors.

She joined Beam after an 11-year run at JP Morgan. Her last job there was as managing director in the healthcare investment banking group. She worked on a lot of hot biotech IPOs of the past decade. “We were going to hire her to do our IPO at Beam but ended up hiring her as our CFO,” said Beam CEO John Evans. 

Burrell joined the company in August 2019.

Evans added:

“She is a top executive at Beam driving our strategy and culture. She drove our IPO, a secondary financing, and a PIPE — three different financings in under a year, all successful, all in response to changing market dynamics. She’s incredibly well connected and respected in the field, recently joining the Board of Recursion where they also had a very successful IPO. And above all that, she’s an exceptional, warm human being with high integrity and a truly talented leader who inspires people.”

Abraham Ceesay, president, Cerevel Therapeutics

Ceesay didn’t go to medical school or get a PhD like many biotech executives. He didn’t know what he wanted to do after college. He was coaching football, while taking classes through an MBA program at Suffolk University. That’s where he discovered biotech, in the early 2000s.

Abe Ceesay

He set his sights on Genzyme, and worked his tail off to land an internship.

He loved it. Ceesay took on increasing roles of responsibility in more than 8 years at that pioneering biotech company. After that, he took on new commercial and operating challenges at smaller companies around Boston. From 2019 until earlier this year, he was CEO of Cambridge, Mass.-based Tiburio Therapeutics, a rare disease startup backed by NEA.

Last month, he took a new job as president of Cambridge, Mass.-based Cerevel Therapeutics, a developer of treatments for the brain founded through a partnership with Pfizer and Bain Capital. In this job, Ceesay is working closely with CEO Tony Coles on drug candidates for Parkinson’s, epilepsy, and schizophrenia.

“Abe brings exactly the broad leadership capabilities and operating experience that we need at Cerevel as we continue on our journey to become the premier neuroscience company,” Coles said in a statement. “I think the world of him,” he added.

Listen to Abe Ceesay describe his career path on The Long Run podcast from July 2020.

Kelly Chibale, professor, organic chemistry, University of Cape Town; founding director, H3D

Chibale is the founder and director of H3D, at the University of Cape Town in South Africa. It was started in 2010 as the first integrated drug discovery center in Africa.

Kelly Chibale

In 2018, H3D formed a five-year partnership with Germany-based Merck KGaA and Medicines for Malaria Venture to work on malaria drug discovery.

Colin Wilson, also a South African and medicinal chemist by training who worked for Chibale for almost six years, raves about how his former boss grew the organization from a handful of people to about 80 over a six-year period.

The team delivered results with the first two clinical candidates discovered and developed on the African continent for the treatment of malaria.

Wilson wrote:

“One of his main goals is to create long term opportunities for scientists on the African continent. His aspiration is to catalyze a bioscience industry in South Africa with his research to help fight Africa’s “brain drain”. He is also an advocate for more equitable and representative clinical trials and speaks out against what he calls “afro-pessimism”, the pessimistic view that the western world has over Africa and its scientists.”

Chibale was featured in Fortune in 2018 as one of the World’s 50 Greatest Leaders.

Kizzmekia Corbett, assistant professor, department of immunology and infectious diseases, Harvard T.H. Chan School of Public Health

Corbett is one of the scientific heroes of the pandemic.

Kizzmekia Corbett

After getting her PhD in microbiology and immunology from the University of North Carolina-Chapel Hill, she went to the Vaccine Research Center at the National Institute for Allergy and Infectious Disease (NIAID) in Bethesda, Maryland.

There, working in collaboration with Moderna, she was involved in developing the mRNA-1273 vaccine directed at the spike protein. That vaccine is one of the two mRNA vaccines that delivered 95 percent vaccine efficacy against the novel coronavirus in randomized Phase III clinical trials conducted in less than 12 months.

Not only was Corbett one of the key contributors to this extraordinary accomplishment, she spent much of the past year dedicated to fact-based, contextual science communication on social media. She took on extra work to do targeted community outreach to build vaccine confidence.

She will now get to write the next chapters of her career as an assistant professor in the department of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health.

Howard E. Davis, COO at stealth startup

Davis is working on a stealth startup, which I’m hearing is backed by Atlas Venture.

Howard E. Davis

Davis comes to this challenge with a mix of science and business experience. He got his bachelor’s in chemical engineering at Yale University, and a PhD in biomedical engineering at MIT in 2002.

His first large pharma job was at Novartis, where he worked on commercial efforts on therapies for multiple sclerosis and age-related macular degeneration. He then took on increasing roles of responsibility, including a couple of vice president roles at Biogen. He made the leap into the startup world in 2018, initially at Flagship Pioneering.

Peter Emtage, venture partner, Versant Ventures

Emtage’s career has taken off the past few years.

Emtage got his PhD in molecular virology, immunology and inflammation at McMaster University in Ontario, Canada. He did a couple stops in academia at the National Cancer Institute and Harvard Medical School.

Peter Emtage

The big leap in industry came about five years ago. In 2016, he joined Cell Design Labs as chief scientific officer. It was a startup focused on T-cell engineering from Wendell Lim’s lab at UCSF (see my Forbes coverage at the time). This was before the first couple of CAR-T therapies for cancer were approved by the FDA – a watershed moment for cell therapy.

A few months after Gilead acquired Kite Pharma in 2017, it followed up by also acquiring Kite’s little partner, Cell Design Labs, for $567 million. Emtage stuck around at the big merged company for a couple more years as global head of cell therapy research for Gilead / Kite.

In October 2020, he left to join Versant Ventures as an entrepreneur-in-residence. Six months later at Versant, He was promoted to venture partner about six months later.

Jackie Grant, principal, Abingworth

Grant was moved last July in the wake of America’s racial reckoning over the killing of George Floyd, and the inequities exposed by pandemic.

She looked into the numbers of fellow partners and investment decision-makers at top-tier biotech venture firms to see how many were Black women, like her.

Jackie Grant

She found none.

That finding may not have been a surprise, but it does matter. As Grant wrote in Nature Biotechnology:

“Although venture capitalists comprise a small segment of the life science industry by numbers, they hold outsized influence and power over the sector: the power to invest millions of dollars into innovation and to incubate new companies; the power to offer senior positions in startups and to shape companies through board positions; the power to create wealth.

Today, that power sits outside of the hands of under-represented racial minorities.”

Grant is building her career, seeking to become one of the people who changes things.

She joined Abingworth in 2018. Before that, she worked in business development at Genentech. She got her PhD in neuroscience at Stanford School of Medicine, and an MBA from the Stanford School of Business.

She’s interested in gene therapy, and oversaw Abingworth’s Series A investment in Durham, NC-based Atsena Therapeutics. It’s doing AAV-based gene therapy with novel capsids to enable intravitreal delivery to the eye for ocular diseases. The hope is this will provide a better safety profile, and higher rate of gene transduction into key cell types, Grant said last December.

“Jackie is a super savvy investor and really an emerging leader in the venture community. I have a ton of respect for her passion and expertise in neuroscience,” Abe Ceesay wrote.

Yvonne Greenstreet, president and COO, Alnylam Pharmaceuticals

Greenstreet came to Alnylam with a long track record in management at Pfizer and GlaxoSmithKline. In her last job at Pfizer, she was the senior vice president and head of medicines development, a member of the executive team for the specialty business.

Yvonne Greenstreet

She joined Alnylam as chief operating officer in 2016 and was promoted to president and COO in October 2020.

During her time at the company, Alnylam has grown. The company has become more commercial, more international, bigger and more complex. It introduced its first marketed RNA-interference medicine in 2018, and now has three products on the market – Onpattro, Givlaari and Oxlumo. Net product revenues almost doubled in the first quarter of 2021.

“Yvonne is a remarkable leader — in my view one of the strongest in biopharma today — who understands the intersection of science, medicine, and business and how these combine to maximize impact for patients and value creation for shareholders,” said Alnylam CEO John Maraganore. “As our president, she makes bold decisions, provides exceptional leadership, and exemplifies our core values.”

Colin Hill, co-founder and CEO, GNS Healthcare

Hill co-founded Somerville, Mass.-based GNS Healthcare in 2000, and has served as chairman and CEO from the start.

Colin Hill

Obviously, he’s seen a lot of change in healthcare and information technology. Surely, it has taken some grit to endure cycles of hype and the thicket of organizational atherosclerosis, perverse incentives, and confusing policies that have made healthcare and biopharma such challenging domains for healthtech entrepreneurs.

GNS has adapted at many junctures. The latest thing at GNS is what it calls an “in silico patient” that uses AI to simulate drug treatment in an individual before that individual gets the drug. The company has developed tools for various cancers, including prostate cancer and multiple myeloma. It’s also attempting to predict which patients will respond to checkpoint inhibitor therapy for cancer.

GNS said in January 2020 that it raised $66 million in a Series D financing that included Merck Global Health Innovation fund, Amgen, BMS, Cigna, and Horizon Blue Cross of NJ among others.

William Hobbs, VP of hematology, Vertex Pharmaceuticals

Hobbs, a physician who got his MD at the University of Pittsburgh School of Medicine, is now the VP of clinical development for hematology for Vertex Pharmaceuticals.

William Hobbs

That means he’s in a key leadership position for the CTX-001 program in partnership with CRISPR Therapeutics – the gene editing program that is showing remarkable results – potentially curative data – for the treatment of sickle cell disease.

If these data hold up, it will be one of the biotech great achievements. It would also mean a lot for people with a terrible disease that has been neglected too long.

Enoch Kariuki, former CFO, VelosBio and SVP of corporate development, Synthorx

Kariuki was the chief financial officer of San Diego-based VelosBio when it was acquired by Merck for $2.75 billion in cash in November 2020. Merck is now developing its antibody-drug conjugate aimed at ROR1 for hematologic malignancies and solid tumors.

Enoch Kariuki

Before VelosBio, Kariuki worked as senior vice president of corporate development with San Diego-based Synthorx. That protein engineering company, starting with its engineered version of IL-2 for cancer, was acquired by Sanofi for $2.5 billion in December 2019.

“Enoch is a wonderful person. He is about to have his first CEO role. I’m sure the first of many,” said Laura Shawver, who worked with him when she was CEO of Synthorx.

Darrin Miles, chief commercial officer, Agios Pharmaceuticals

Miles has been with Agios for about six years, advancing in management as the Cambridge, Mass.-based company developed its first FDA approved treatments. The company sold its cancer business to Servier in December for up to $2 billion.

Darrin Miles

That means Agios is now focused on treatments for genetically defined rare diseases that include pyruvate kinase, or PK, deficiency, thalassemia and sickle cell disease.

Prior to joining Agios, Miles had a long run on the commercial side at Genentech.

Paul Mola, founder, president and CEO, Roswell Biotechnologies

San Diego-based Roswell Biotechnologies has a big ambition for DNA sequencing — to sequence whole genomes for $100 in about one hour. Its vision to get there is through molecular electronics.

Paul Mola

Mola and Roswell chief scientific officer Barry Merriman have a long history of working together on sequencing technologies. They were at Life Technologies when that company acquired Ion Torrent Systems, an early mover in semiconductor-based sequencing, for $725 million.

Roswell raised $32 million in a Series A financing in early 2019. Read more about its concept in this TR piece on novel sequencing technologies from June 2020.

Mola recently joined the board of Biocom California, an industry trade association.

James Mutamba, VP, business and corporate development, Pyxis Oncology

Mutamba got his PhD in biological engineering from MIT. He went to work in 2012 at Boston-based Puretech Health, getting exposed to a lot of entrepreneurial ideas and teams.

James Mutamba

From there, he went to Longwood Fund, where he became an investment principal and served on a few boards. Longwood founded Pyxis Oncology, and in early 2020, Mutamba went to work there as VP of business and corporate development.

In March, Pyxis said it in-licensed a pair of antibody-drug conjugates from Pfizer, along with a license to Pfizer’s ADC technology. One of the new Pyxis candidates aims to be a first-in-class non-internalizing ADC that targets a tumor-restricted antigen that is overexpressed in several solid tumor types to selectively kill tumor cells while also enhancing an anti-cancer immune response.

A couple weeks after the Pfizer transaction, Pyxis announced it raised a $152 million Series B financing.

Daphne Zohar, founder and CEO of Puretech, said, “James is determined and charismatic. One of the qualities I admire about him is his open mind when it comes to ideas that are off the beaten path and the related creativity that leads to.”

David Steinberg, general partner at Longwood Fund and the former CEO of Pyxis, added: “James is a skilled and creative leader, innovator and business development professional with a keen eye for translating technologies into medicines. He has founded or co-founded multiple important companies and led major transactions underpinning critical products and development programs. I look forward to collaborating with James for years to come.”

Jen Nwankwo, founder and CEO, 1910 Genetics

Nwankwo got her PhD in pharmacology at Tufts University School of Medicine in 2016, where she did her dissertation on sickle cell disease – a traditionally understudied area of biology that disproportionately affects Black people. After some time as a consultant, she got to work on Cambridge, Mass.-based 1910 Genetics.

Jen Nwankwo

In March, the company came out of stealth mode, announcing $26 million in seed and Series A capital. The plan is to bring together the tools of biological automation, computation, and AI for platforms to advance small and large molecule drug discovery. Her syndicate of backers include M12 – Microsoft’s Venture Fund, Playground Global, Sam Altman’s Apollo Projects, Y Combinator, FoundersX Ventures, and Scientia Ventures.

“Jen Nwankwo is future superstar in our industry,” said Rob Perez, operating partner at General Atlantic. Abe Ceesay concurs. “A phenomenal talent,” he said.

Peter Olagunju, SVP of technical operations, FerGene

Olagunju has gained valuable experience over the past two decades of growth in gene and cell therapy.

Peter Olagunju

He started out in quality assurance roles, and worked his way up at three important Seattle biotech companies – Targeted Genetics (gene therapy), ZymoGenetics (protein drug developer acquired by BMS), and Dendreon (developer of Provenge cell therapy for prostate cancer).

Besides those valuable experiences in different aspects of science, Olagunju gained management experience, and got an MBA at the University of Washington.

Olagunju moved to Boston and went to work at Bluebird Bio in a variety of technical operations roles during the company’s growth phase from 2015 to 2020. He left there a little over a year ago as VP of technical operations to become senior vice president of technical operations for FerGene.

The Cambridge, Mass.-based company raised $570 million in November 2019 from Blackstone Life Sciences and Ferring Pharmaceuticals to develop a gene therapy for bladder cancer that isn’t responsive to BCG treatment.

Cameron Pitt, chief business officer, Quanta Therapeutics

Pitt got his PhD in biomedical sciences from UCSF, focusing on cancer, particularly the RAS pathway and how its various mutations drive malignancy.

Cameron Pitt

After graduate school, he went to work in venture capital, first at Versant Ventures and then at Sofinnova Investments.

Quanta, founded in 2018, is a Sofinnova Investments portfolio company working on allosteric modulators to target driver oncogenes – something relevant to Pitt’s earlier experience in the lab.

Derrell Porter, founder and CEO, Cellevolve Bio

Porter got his MD and MBA from the University of Pennsylvania before entering industry. He did a stint as a consultant at McKinsey, and later gained a wide range of US and international experiences in strategy and business development at AbbVie and Amgen. He was a vice president at Gilead Sciences from 2013 to 2017 before joining Atara Biotherapeutics as global head of commercial.

Derrell Porter

A couple years ago, he saw a market opportunity to help many cell therapy startup companies.

While staying focused on the science and early development, they also need to lay the groundwork for commercialization while relatively early in development. Porter set out to start a new company, Cellevolve Bio, in 2020, to help companies do this. Porter tells me he’s secured the first license for Cellevolve, and expects to close a seed financing this month.

Last month, Porter joined the board of Philadelphia-based Passage Bio, a publicly traded company working on rare CNS diseases.

Uciane Scarlett, principal, Oxford Sciences Innovation

First, her name is pronounced “YOU-shuh-knee” Scarlett.

Uciane Scarlett

Uciane is originally from Jamaica. She came to the US to get her PhD in cancer immunology at Dartmouth Medical School.

She went to work as a consultant (Clarion), at a startup company (Compass Therapeutics), and in venture capital (Atlas Venture). She moved to the UK in 2019 to join Oxford Sciences Innovation, to build on her knowledge of cancer biology, startups, and her network in the Boston biotech community.

Uciane was a member of my Kilimanjaro Climb to Fight Cancer team that raised $1.6 million for the Fred Hutchinson Cancer Research Center and summited the highest mountain in Africa in 2019. I know how hard she worked. She has also written a few excellent guest articles for TR about adaptive trials, SPACs, and on “turning the black nod into a collective nod.”

It was about a brief, but meaningful moment at the JP Morgan Healthcare conference one year when Ken Frazier showed her a little support.

Uciane’s portfolio at Oxford is still in the early days, but reflects her interests in a number of hot scientific areas — T-cell therapies for cancer, autoimmunity and infectious disease, neuromuscular diseases, antibody therapies for autoimmunity, and gene modifiers for cancer and rare disease.

RA Session II, founder, president and CEO, Taysha Gene Therapies

Session, 42, has worked his way up the business side, gaining experience in business development, finance, and corporate strategy prior to becoming CEO of Dallas, Tex.-based Taysha Gene Therapies. He focused on rare diseases at BridgeBio, AveXis (the developer of Zolgensma, the AAV9-vector based gene therapy for spinal muscular atrophy type 1, acquired by Novartis), and PTC Therapeutics.

R.A. Session II

Before starting Taysha, Session was an entrepreneur-in-residence at UT Southwestern Medical Center. Relationships there proved important.

Session structured a broad collaboration in which UT Southwestern leverages its expertise in AAV9 vectors for gene therapy. The academic side does discovery and preclinical work, leaving Taysha responsible for clinical development, strategy, regulatory filings, and commercial manufacturing.

While getting that deal in place as the foundation for the company, Session recruited the executive team, built a 120-person company, and led a successful IPO in September 2020 that raised $157 million at $20 a share.

That’s a whirlwind for a company that’s less than two years old. The pace appears to be continuing. Taysha has said it plans to have four gene therapies in the clinic by the end of 2021.

R. Nolan Townsend, CEO, Lexeo Therapeutics

Townsend, a former president of Pfizer’s rare disease division in North America, took the entrepreneurial plunge earlier this year.

R. Nolan Townsend

He’s now the CEO of New York-based Lexeo Therapeutics, a clinical-stage gene therapy company that raised an $85 million Series A financing in January, co-led by Longitude Capital and Omega Funds.

The company has programs in the works on an IV-administered therapy for cardiomyopathy associated with Friedreich’s ataxia, a CNS-administered therapy for CLN2 Batten disease and a CNS-administered therapy for APOE4-associated Alzheimer’s disease.


After Devastating New Study, Is There A Future For Workplace Wellness – And Has Peloton Figured It Out?

David Shaywitz

This is a story about the tension between what we desperately want to believe and what the data suggest we should believe, and — surprise! — this isn’t about the contentious recent approval of the Biogen drug aducanumab for Alzheimer’s Disease.

Rather, it’s about a powerful and important study just published in Health Affairs, examining the outcomes of a workplace wellness program in a randomized clinical trial (RCT). The study was led by Zirui Song of Massachusetts General Hospital and Katherine Baicker, the dean of the Harris School of Public Policy at the University of Chicago.

While corporate wellness programs may harbor a range of ambitions, they are often sold by vendors based on the promise of improving employee performance while making them healthier. Healthier employees, vendors argue, save companies money by avoiding preventable medical expenditures. 

It’s an appealing idea – focusing on prevention rather than treatment, “well care” rather than sick care.  Many academics have long championed the promise, while a large industry has developed of wellness vendors aggressively hawking workplace wellness solutions.

And now, a robust RCT. Drum roll please.

The key result: after three years, employees who received a “multicomponent” wellness program (which included modules on nutrition, physical activity, and stress reduction) reported improved health behaviors, such as active weight management. However – and this is the punchline – “no significant differences” were found in:

  • Self-reported health;
  • Clinical markers of health;
  • Healthcare spending or use;
  • Absenteeism;
  • Tenure;
  • Job performance.

In short: an epic fail. 

As the authors conclude with tart academic understatement:

“To the extent that these results are representative of other wellness programs, they temper expectations of substantial improvements in health outcomes or financial returns on investment from wellness programs up to a three year horizon.”

Others were less circumspect.

Al Lewis, a long-time critic of mandatory corporate wellness programs, embraced these RCT results as sweet vindication. 

“Ding, dong the wellness witch is dead,” he crowed on LinkedIn. 

In a somewhat more expansive blog post, he noted that the study had particular credibility because the authors had played a critical role in highlighting the promise of workplace wellness, most famously (Lewis would say infamously) in a 2010 Health Affairs publication, “Workplace Wellness Programs Can Generate Savings,” reporting data from a meta-analysis on the topic. 

The new RCT, Lewis says, “kills wellness dead.” 

“Any vendor of so-called ‘pry, poke and prod programs,’ like most recently Virgin Pulse,” Lewis told me, “is lying through their teeth if they claim significant savings, or if they claim any savings at all after fees. Anyone who has read my book or the current series that the Validation Institute posted on outcomes evaluation can easily spot the way they are fabricating their savings.”

Is Wellness Dead?

So where does this leave employers and wellness?

On the one hand, my own experiences in management consulting more than a decade ago led me to share much of Lewis’s skepticism about many of the industry’s claims. I also thought Lewis was directionally right in his 2012 book, Why Nobody Believes the Numbers, explaining how vendors often torture the data (or worse) to generate their claims around health and financial impact.

At the same time, however, I’m not prepared to toss out the concept of wellness, nor dismiss efforts to enhance well-being. 

To the contrary, I’ve been increasingly impressed by the data emerging from positive psychology originating with the pioneering work of University of Pennsylvania professor Martin Seligman. This line of investigation has found increased global expression through a range of academic initiatives aimed at promoting “human flourishing.” 

This begs the question: how to reconcile these two views – an emerging evidence base, primarily from the positive psychology literature, suggesting that well-being can be improved, and a growing number of RCTs pointing to the failure of implemented workplace wellness programs to deliver on their consistently overhyped promise.

When I asked Katherine Baicker, the lead author of the new Health Affairs study, about this, she diplomatically responded, “I’m not sure that it’s so easily answered.”

Seligman, posed the same question, told me “The outcome can only be as good as what is taught,” adding that the substance of the wellness intervention in the recent Health Affairs study “Looks like just the content that many groups run as placebo controls. I would have expected little or no gains from these topics.”

Martin Seligman, Zellerbach Family Professor of Psychology, University of Pennsylvania; Founding Director, Positive Psychology Center

In essence, GIGO (garbage in, garbage out) for behavioral interventions. 

In contrast, Seligman pointed to encouraging conclusions from several reviews and meta-analyses, including a particularly robust, 2020 systematic review and meta-analysis by a team at University College, Dublin, examining positive psychology interventions (PPIs). 

The Dublin authors reported statistically significant “small to medium” improvement effects on parameters such as well-being, strengths, quality of life, depression, anxiety and stress both immediately following the intervention and after three months. After seven months, however, gains “began to ‘wash out.’”

To be sure, the explicit point of PPIs, and positive psychology in general, isn’t to remediate disease, but rather to help fortify various dimensions of well-being – the PERMA-V model I’ve recently discussed, encompassing positive emotion, engagement, relationships, meaning, achievement, and vitality). Nevertheless, as Harvard’s Trudel-Fitzgerald reviewed in 2019, “psychological well-being is associated with lower disease and mortality risk, and may be enhanced with relatively low-cost interventions.”

Thus, it’s (still) not unreasonable to imagine that a program of select evidence-based wellness interventions could reduce healthcare costs, and improve employee performance. Such benefits, however, are clearly not the inevitable outcome of all wellness initiatives.

Lewis, for his part, is more of a wellness agnostic than a wellness atheist. He certainly isn’t against personal wellness initiatives – just “forced corporate wellness,” telling me, “companies should facilitate personal wellness initiatives and there are many ways to do that.” (One approach, he points out, involves Quizzify, a company he founded that aims to educate employees about health and facilitate improved decision-making.)

Adds Lewis, “I am not at all opposed to wellness done for employees. Just wellness done to employees.  The way to tell the difference is whether there is a ton of money on the line.” 

I remain enthusiastic about the promise of evidence-based interventions that leverage positive psychology principles, and I am especially hopeful about approaches that include a vitality component involving activity/fitness/movement. 

Existing data point to a real, if limited, impact of positive psychology interventions to date. Even so, this established foothold should enable the iterative, incremental innovation that so often drives substantial progress (see hereherehere).

The free market champion in me would much prefer to see employers offer workers the ability to opt in to their choice of promising, personally-resonant well-being programs — or none at all — rather than mandate participation in a single “wellness” offering, touting a level of benefit not supported by rigorous science.

Is Peloton The Future of Workplace Wellness?

If you had to bet on one company in the wellness space right now, you’d have to take a serious look at Peloton (yes, Peloton). In previous TR columns, I’ve discussed both the value of immersive experiences and the appeal of exercise as an on-ramp to wellness. Now, according to fascinating recent article by journalist Courtney Rubin in The Hollywood Reporter, Peloton is implementing something very close to this exact vision.

Founded as stationary bike company for busy cycling enthusiasts who struggled to make it to in-studio classes, Peloton is developing an increasingly broad range of offerings, including strength training, dance cardio and barre. 

Classes, delivered by compelling instructors (as I’ve written in TR here, here) are revealed by Rubin to be meticulously developed and often highly scripted. They’re also associated with exceedingly high production value and accompanied by music from top artists. The effort reflects CEO John Foley’s stated ambition to be a “media company,” regarding exercise equipment as “a portal for experiences.”

Reports Rubin:

“The company is also experimenting with ‘how far we can go as a media company,’ says [Peloton’s chief content officer, Jennifer] Cotter — meaning how far beyond straight-up fitness content. This includes videos the company produces for YouTube and Instagram, such as a nearly seven-minute one about [pregnant instructor Robin] Arzón’s prenatal journey. Explains Cotter, ‘The idea that we’re pivoting from great fitness classes to, well, are we the Netflix of wellness? Can we tell stories outside of class? I mean, those things are happening now, and they’ll be a part of our future.’”

Moreover, Peloton clearly harbors ambitions to move into corporate wellness, aggressively pursuing talent in this space.

Would providing employees with access to Peloton equipment and programming actually save companies money, through reduced health expenditures and more productive workers? I’m highly skeptical. But Peloton, particularly given the direction it’s evolving, could well represent a powerful tool to help individuals who are drawn to it (and can afford it) flourish in the Seligman sense, and live better lives. The promise is palpable.

But proof must still await robust RCTs. Paging Drs Song and Baicker…


Mentoring Young Scientists: Jay Bradner and Andy Plump on The Long Run

This episode of The Long Run is a little different.

I invited a couple previous guests on The Long Run to discuss a specific issue: How the industry can do a better job of mentoring young scientists, and creating on-ramps to careers in the biopharma industry for people from underrepresented groups.

Jay Bradner, president, Novartis Institutes for Biomedical Research

Jay Bradner, the president of the Novartis Institutes for Biomedical Research, and Andy Plump, the president of R&D at Takeda Pharmaceuticals are a couple of powerful R&D leaders. They are in positions of influence, and can make meaningful changes in their organizations in certain situations.

For background, listen to this Long Run podcast with Jay in May 2019, and this with Andy in June 2020.

In this more recent conversation, these two pharma R&D leaders shared a few revealing anecdotes that said a lot to me about how their thinking has evolved on inequities over the year, and what things they can do to make positive changes in their workplaces.

Andy Plump, president of R&D, Takeda Pharmaceutical

I’m thankful they accepted my invitation to discuss this issue, which they didn’t have to do.

This conversation was recorded April 15 on Clubhouse. If you’re not familiar, it’s the relatively new audio-only social network. This recording was specifically hosted on Biotech Clubhouse, a specific part of Clubhouse on the app for biotech conversations. Thanks to Chris Garabedian and Brad Loncar for inviting me to guest host this session in their particular ‘clubhouse’.

I asked these guys a lot of questions in the first part of the episode, and then opened it up to audience Q&A in the second half. It’s a little like old-school call-in radio shows, which provides a sense of spontaneity.

Please enjoy this conversation on mentoring young scientists with Andy Plump and Jay Bradner on The Long Run.