17
Jun
2021

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.

15
Jun
2021

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…

15
Jun
2021

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.

14
Jun
2021

Biotech Pride: 19 Industry Leaders Who Identify as LGBTQ

Scientists have created mRNA vaccines that are saving millions of lives. Better cancer drugs are in the works. Gene editing technologies, and gene therapies, offer potential cures.

Teams of dedicated people are making these things happen, and many of the people on these teams identify as LGBTQ.

As part of Pride Month, I asked TR readers to nominate members of the LGBTQ community who have made, and continue to make, outstanding contributions to the industry.

So many nominations poured in, they can’t all fit in one article.

For today, let’s appreciate some biotech leaders — 19 in all — who publicly identify as LGBTQ and who are using their scientific and business skills to make a difference for human health.

Isabel Aznarez, co-founder, VP of biology, Stoke Therapeutics

Aznarez got her PhD in human molecular genetics from the University of Toronto. In the early 2010s, she was working on antisense oligonucleotides at Cold Spring Harbor Laboratory with Adrian Krainer.

Isabel Aznarez

He had done pioneering work on RNA splicing that contributed to the development of nusinersen (Spinraza). That’s an important medicine for spinal muscular atrophy from Ionis Pharmaceuticals and Biogen.

As that drug progressed in the clinic, Aznarez and Krainer wondered: could antisense oligonucleotides be made not only to silence protein expression in a disease process, but also to upregulate protein expression?

With help from Krainer and Apple Tree Partners in 2013, Aznarez dug in. The company continued to hit milestones, and went public in 2019. Stoke, based in Bedford, Mass., is now in Phase I clinical development with a lead candidate for children with Dravet syndrome.

The company’s market valuation has grown to about $1.4 billion.

Aznarez, like in the early days, continues to oversees discovery.

Coming out as a lesbian in her mid-30s was an essential step, she said. It’s part of what gave Aznarez the confidence to start a company.

“When you’re not at peace or happy with who you are, it’s hard to do anything with confidence,” Aznarez said. “When I stopped pretending, it gave me a huge boost of confidence.”

Carolyn Bertozzi, professor of chemistry, Stanford University

Carolyn Bertozzi is a chemical biologist focused on glycans – the beautiful and complicated sugar molecule structures attached to proteins. These carbohydrates have long been underappreciated by biologists more focused on genes and proteins. But that’s changing.

Carolyn Bertozzi

Bertozzi won a MacArthur “genius” grant early in her career at UC Berkeley, and is a member of the National Academy of Sciences. She’s known for leading teams that developed tools to provide better imagery, better information, about glycan behavior in live action.

Her research has spilled out from academia into a number of startups.

Bertozzi is also savvy on social media, which she uses primarily as a tool for scientific back-and-forth and as a platform to celebrate people and things she appreciates. For more on Bertozzi’s story, listen to her in this Apr. 2019 episode of The Long Run podcast.

Mira Chaurushiya and David Allison, partners, 5AM Ventures

David and Mira are partners at 5AM Ventures, a firm focused on building startups and with $1.5 billion under management.

David Allison

Allison joined 5AM as a principal in 2016 and was promoted to partner in 2018. Before that, he worked as a principal at Versant Ventures, where he was involved in a number of early-stage bets that panned out BlueRock Therapeutics (acquired by Bayer), NeuWave (acquired by J&J), Crinetics (NASDAQ: CRNX), Aprea (NASDAQ: APRE) and BioTie (acquired by Acorda Therapeutics).

Chaurushiya has been on a similar trajectory, starting at 5AM as an associate in 2015 and getting promoted to principal and then partner in 2020. She was previously a postdoctoral fellow at Genentech.

Mira Chaurushiya

In her VC role, she’s an observer or member of the boards of BlueLight Therapeutics, Precision Nanosystems (acquired by Danaher), Purigen Biosystems, Escient Pharmaceuticals, Magnetic Insight, TMRW Life Sciences, and Novome Biotechnologies; and was previously an Observer at Ideaya Biosciences (NASDAQ: IDYA) and NodThera.

Laurent Fischer, CEO, and Leone Patterson, president and CFO, Adverum

Fischer is a veteran biotech executive who joined Redwood City, Calif.-based Adverum Biotechnologies as CEO a year ago.

Laurent Fischer

Patterson joined Adverum as CFO in 2016, and became CEO from 2018 to 2020. She led the organization through early clinical development with its gene therapy for two indications — age-related macular degeneration and diabetic macular edema.

When Fischer was brought in as CEO in June 2020, Patterson agreed to stay on and work with him as president and CFO.

Leone Patterson

Before joining Adverum, Fischer was senior vice president and head of the liver therapeutic area at Allergan. He was chairman and CEO of Tobira Therapeutics, and joined Allergan after that larger company agreed to acquire Tobira for $1.7 billion in 2016. Adverum is Fischer’s fifth stop as a CEO – the other companies he led were Tobira, Jennerex Biotherapeutics, Ocera Therapeutics, and Auxeris Therapeutics.

Patterson worked her way up in the industry at Novartis, Exelixis, Transcept Pharmaceuticals and Diadexus before joining Adverum.

Tim Funnell, new $200m transatlantic venture fund

Funnell, who got his training in pharmacology the University of Oxford, has been active in the early-stage startup world for the past decade. He’s preparing now on a new transatlantic venture fund.

Before, he did stints at Third Rock Ventures, Oxford Sciences Innovation, and Syncona Partners. Those experiences helped him build scientific contacts on both sides of the Atlantic. He’s been part of the founding team at a series of interesting startups.

Tim Funnell

They include:

  • Autolos Therapeutics (T-cell therapies for cancer)
  • Casma Therapeutics (autophagy-based drug discovery)
  • Gyroscope Therapeutics (gene therapy for eye diseases)
  • MiroBio (autoimmune drug discovery)

Funnell also become a founding member of OutBio UK, bringing that sense of community belonging to the UK after seeing how meaningful it was for members of the Boston biotech community.

One reader said of Funnell: “He’s been a great example of US/UK cross fertilisation – he comes back from Third Rock to be an EIR at Oxford Sciences Innovation and shows how to build a competitive international biotech NewCo in Miro with a $34M syndicate including US investors like Samsara.”

Matt Fust, advisor, board member

Fust was nominated by several readers.

Matt Fust

He’s based on the West Coast, and wired in with a number of interesting Bay Area companies, serving on the boards of Arsenal Bio, Atara Biotherapeutics, Crinetics Pharmaceuticals, and Ultragenyx Pharmaceutical.

He’s also a senior advisor to Out Leadership.

Matt plans to moderate a panel discussion on LGBTQ leadership in biotech at the BIO Digital conference this week.

Jesus Gomez-Navarro, Distinguished R&D Fellow, Takeda

Gomez-Navarro, a physician-scientist, joined the biopharma industry in 2000 as Pfizer’s inaugural medical oncologist. He joined Cambridge, Mass.-based Millennium / Takeda in 2009.

Jesus Gomez-Navarro

At Takeda, Gomez-Navarro started as the physician responsible for the first-in-human study and global clinical lead for ixazomib (Ninlaro). It’s the first oral proteasome inhibitor for multiple myeloma that was approved by the FDA in 2015. In 2011, he became the global head of the clinical science function for oncology, a VP-level position he held until 2020.

“He provided both technical and scientific input to numerous development programs and was a major voice across oncology development as the Millennium-Takeda strategy and pipeline evolved,” said Karen Ferrante, the former chief medical officer at Millennium: Takeda. “His enthusiasm for his work is infectious and he has no doubt had major impact in oncology as an authentic leader, and drug hunter and developer.”

Gomez-Navarro has been out since 2000, and has been involved in recent years with Take Pride Takeda Resource Group. It’s Takeda’s employee group in Massachusetts dedicated to people who identify as LGBTQ and their allies.

Paul Hastings, CEO, Nkarta Therapeutics

Hastings is making history this week as the first openly gay man to be elected chairman of BIO, the industry’s international trade association.

Paul Hastings

As the chairman of the BIO, he’s now in a position of industry leadership on important policies such as the industry’s position on drug pricing, patents, support for science, and diversity, equity and inclusion.

He’s passionate about speaking out on a variety of social issues – even when it’s not the popular thing or the politically expedient thing in the moment. See this guest article in TR in January 2021. See also this piece in defense of Asian Americans.

Before any of this, Hastings was a patient. He struggled with Crohn’s disease as a teenager, enduring a couple major surgeries.

Hastings is currently the CEO of South San Francisco-based Nkarta Therapeutics, a company developing engineered Natural Killer cells to fight cancer. Before joining Nkarta, taking it public, and putting it in position to advance the field of NK cell engineering, he endured a pretty big setback. The previous company where he was CEO, OncoMed Pharmaceuticals, the developer of drugs aimed at cancer stem cells, didn’t pan out.

These experiences – as a patient, patient advocate, resilient business leader, and scientific citizen – have shaped who he is. He’ll be introduced as the new chairman at the BIO Digital conference this week.

Moderna Leadership — Melissa Moore, Corinne Le Goff, Eric Huang, Paolo Martini

Cambridge, Mass.-based Moderna accomplished what was considered impossible a year ago. With longtime collaborators at the National Institutes of Health, Moderna created an mRNA vaccine from scratch for the novel coronavirus that was unknown to science until Jan. 10, 2020.

Melissa Moore

The team then drove that vaccine candidate all the way from novel mRNA construct through rigorous Phase III testing in less than one year. They kept pace with a similarly focused and driven team at BioNTech and Pfizer.

It’s an extraordinary scientific achievement that has potential to end this pandemic. It will better prepare humanity for future infectious threats.

Moderna is now scaling up to meet global manufacturing needs, and developing boosters and multi-valent vaccines that may be necessary for variants. It’s further building out its mRNA platform to make other therapeutics.

Paolo Martini

Corinne Le Goff

Everyone has heard of Moderna by this point, but few are aware that some of the major players on this team that’s busy saving the world happen to identify as LGBTQ.

Consider just a few members of the senior leadership team who are part of the LGBTQ community:

  • Melissa Moore, CSO of platform research
  • Corinne Le Goff, chief commercial officer
  • Paolo Martini, CSO of rare diseases, hematology and external R&D
  • Eric Huang, CSO of autoimmunity and exploratory sciences

    Eric Huang

Stephane Bancel, CEO of Moderna, says Le Goff is the executive sponsor of the company’s internal LGBTQ group. Moderna president Stephen Hoge is the sponsor of the Black / African American employee group, and Bancel is the sponsor of the Asian American group.

These groups inside the company exist, and have executive team participation, for a reason.

“Since the beginning, we have had a culture to include everybody,” Bancel writes. “We want the best talent and [to] make sure they are happy and comfortable.”

Jennifer Petter, co-founder and CSO, Arrakis Therapeutics

Petter is a medicinal chemist by training who has worked on many conventional small molecule drug programs over the years. She attended a Gordon conference six years ago that altered the course of her career.

Jennifer Petter

She saw a couple scientific presentations from Matt Disney at Scripps and Kevin Weeks at UNC Chapel Hill that gave her an idea. Might it now be possible to make small molecules against RNA targets that were long thought to be undruggable?

She caught the bug, and got to work as co-founder and chief scientific officer of Waltham, Mass.-based Arrakis Therapeutics. A couple years later, she came out as transgendered, made the gender transition, and changed her name to Jennifer Petter.

It’s quite a story, both scientific and personal. Hear Jennifer talk about it in her own words in this Sept. 2020 episode of The Long Run podcast.

Laura Shawver, CEO, Silverback Therapeutics

Shawver is a true scientific entrepreneur.

Laura Shawver

She got her PhD in pharmacology at the University of Iowa, and built her career in biotech on the West Coast. She started at Sugen (successfully acquired by Pfizer), and in 2002 became CEO of San Diego-based Phenomix (a diabetes drug developer that shut down in 2010).

While running that startup, she was diagnosed with ovarian cancer. Putting her scientific entrepreneurial skills to work, she founded the Clearity Foundation to help women in a similar position navigating treatment options.

She bounced back in her second CEO role with Cleave Therapeutics, and then succeeded in a big way as CEO of San Diego-based Synthorx. That protein engineering company was acquired by Sanofi in 2019 for $2.5 billion. She then joined her current company, Seattle-based Silverback Therapeutics, a cancer drug developer.

Listen to Laura tell her story on The Long Run podcast from July 2019 (when she was CEO of Synthorx).

Martine Rothblatt, CEO, United Therapeutics

Martine Rothblatt is the founder, chairman and CEO of Research Triangle Park, NC and Silver Spring, Maryland-based United Therapeutics. She came out as transgender in 1994, changed her name from Martin to Martine, and started the company two years later.

United has four products on the market, and more than 900 employees. Market value: $8 billion.

The company is unconventional in many respects. But the results are clear. Few biopharma companies grow to this size.

Paul Sekhri, CEO, eGenesis

Sekhri is the CEO of Cambridge, Mass.-based eGenesis, which is seeking to use CRISPR genome engineering tools for xenotransplantation. The concept is to engineer pigs with organs that can be safely transplanted into humans without being rejected by the human immune system.

Paul Sekhri

The hope is that by making xenotransplantation safe and effective, eGenesis will be able to address shortages of organs, tissues and cells for transplant.

Sekhri was previously the CEO of Lycera. Before that, he was EVP of business development and chief strategy officer for Teva Pharmaceutical and an operating partner at TPG Biotech.

eGenesis raised a $125 million Series C financing in March. It plans to advance first-in-human studies for kidney and islet cell transplantation for Type 1 diabetes.

Denice Torres, board member, Bluebird, Karuna, Resilience, Glaukos

Denice Torres

Following a long career as an executive in large pharma — Johnson & Johnson and Eli Lilly – Torres has come up with a second act as an entrepreneur focused on mentorship and organizational culture. She’s the founder of two organizations, The Mentoring Place and The Ignited Company.

Torres is also busy serving on boards of a handful of biotech companies with big ambitions – Bluebird Bio (gene therapy), Karuna Therapeutics (treatments for psychiatric conditions), Glaukos (treatments for eye diseases), and Resilience (biotech manufacturing).

10
Jun
2021

T-cell Diagnostic Tests: COVID-19 Pushed Us, and We Can See Where This Leads

Chad Robins, co-founder and CEO, Adaptive Biotechnologies

In late February 2020, when it became clear that COVID-19 was spreading around the world, our senior management team at Adaptive Biotechnologies took a gamble.

We had a hunch that our ability to evaluate T-cell immunity, combined with advanced bioinformatics, could help the scientific community better understand the novel coronavirus.

The entire world, it seemed, was focused on B-cell derived immunity, the antibody response, to SARS-CoV-2. We thought we had something to add. The data we could generate from our immune medicine platform and T-cell technology would capture a more vivid and information-rich picture. 

With one phone call to our partners at Microsoft, the decision was made. The work we did together to build a TCR-Antigen Map for many different diseases supplied the tools and technology to take on this challenge. (TR coverage of Adaptive/Microsoft partnership, Jan. 2018.)

Peter Lee, Corporate Vice President,
Microsoft Research & Incubations

Peter Lee, Corporate Vice President, Research and Incubations, immediately offered us resources, including staffing, and brought in other partners like Providence, a health system with 51 hospitals, to collect patient samples. Deals were being made with phone calls and handshakes. Deals took shape in days, not months. I had never seen anything like it.

From the outset, we agreed with our partners on the importance of data sharing. No one company or institution would be able to make the pandemic disappear. We made the data available freely via an open access portal, ImmuneCODE™.

Rapid Progress Through Collaboration

More than 20 academic and industry collaborators from 7 countries joined us. While many vaccine manufacturers received billions to accelerate research of novel platform technology, we moved forward on our own without government grants or other government support. Organizations from around the world were offering patient samples, including our cancer research partners at Hospital 12 de Octubre, i+12/CNIO in Madrid, Spain, as well as the University of Padua and Ospedale San Raffaele in Italy.

We started with a few basic questions.

First, we wanted to know whether it was possible to detect a past COVID-19 infection from T cells in the blood. Yes or No?

T cells are the first responders of the adaptive immune system and support the antibody response. These cells have specialized receptors which must be extraordinarily diverse to recognize one or a small number of the millions of disease specific antigens to which our bodies are continuously exposed.

When your body encounters a pathogen, T cells arise first and often last longer than antibodies.

Why is this important?

Antibodies tend to surge in the presence of an infection. Their concentrations diminish when the infection passes. That’s normal. We also know that although antibodies may be harder to detect a few months after the initial infection, that doesn’t necessarily mean immunity has been lost. T cells may have been primed, and may still be hanging around in the blood.

It’s up to us to see if the T cells are still there, and if they are still capable of mounting an immune response in case there’s another encounter with SARS-CoV-2.

Testing T-cell levels in response to COVID-19 may therefore be an important complement to antibody testing to identify recent or prior infections. One of our collaborators, a team led by Dan Barouch at the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, looked at blood samples from 20 people vaccinated with the Johnson & Johnson COVID-19 vaccine and found that while antibody concentrations dropped against certain variants of concern in the 71 days after vaccination, the T cell immunity was largely preserved.

This encouraging finding was published June 9 in Nature.

To understand how the immune system responds to a disease like SARS-CoV-2, we need to translate the diverse genetic code of T-cell receptors into data that can be analyzed both at the individual level and across entire populations.

Our partners gather the samples, we generate the sequence data from their diverse T-cell receptors, and the raw data gets uploaded into cloud computing databases. Working with Microsoft, we applied their advanced AI, cloud computing and machine learning technologies to comb through this massive data set, effectively creating a “map” of these immune cells to most diseases.

Our labs were running 24/7 with reduced capacity, taking every precaution to safeguard our employees and samples. The pressure was intense. We needed to keep piling on to that mountain of data continuously, while also figuring out faster and smarter ways to extract meaningful insights to the public health and biopharma communities.

With 5,500 blood samples from Asia, Europe and the U.S. — and only a small team at our central lab in Seattle — we knew we needed more help. It took nearly 8 months to receive all the blood samples. As things started to open up and patients were returning to the clinic for testing, we had to work even harder to process the samples.

We continued to expand our industry collaborations, initially with Labcorp, the biggest diagnostic company in the U.S., and Illumina, the market leader in DNA sequencing.

A New Tool In Our Toolkit / Understanding Immunity and Variants

Fast forward a year to the recent FDA Emergency Use Authorization for T-Detect™ COVID, the first-ever T-cell test for individuals that can detect whether a person has had a recent or past COVID-19 infection. Based on our best understanding of the immunology, we believe this test can tell whether one has been exposed to SARS-CoV-2 months after an original diagnosis.

We can do it with high accuracy, outperforming leading antibody tests in real world studies.

The entire process, including order authorization by a virtual provider, can be completed online except for the blood draw. Samples get collected at a Labcorp facility or by a mobile phlebotomist, shipped to our labs in Seattle, and we provide a report back within 7-10 days. It costs under $300 with a blood draw and virtual provider fee. It isn’t covered by health insurance, but it is covered by healthcare and flexible spending accounts.

At this stage in the pandemic — despite widespread antibody testing and several vaccines — there are still a lot of questions about COVID-19. T cells may hold some of the answers.

For example, they may offer the ability to detect past infections for a much longer period than traditional tests. They may allow us to diagnose Long COVID (patients who have not fully recovered weeks or even months after first experiencing symptoms). It’s theoretically possible for us to draw a quantifiable connection between lingering immune perturbations, potential signs of autoimmunity, and symptoms of Long COVID. That’s something else investigators are looking into.

Patients who use T-Detect COVID have the option to opt-in to ongoing research. This will accelerate our understanding of variants, who is at more risk of getting the virus, who is protected, and the effectiveness of vaccines.

In the future, we may be able to go beyond a yes/no answer. Physicians and patients may be able to identify the source of their immune response either from natural infection or from a vaccine. This is especially important as more of the population gets vaccinated and as new variants appear which may be increasingly capable of escaping natural immunity, or vaccine-induced immunity.

Making the Impossible Possible

One of the unique benefits of Adaptive’s T-cell testing approach is that it can be done at scale, something that was impossible just a few years ago. Historically, to test T cells, you would need a blood sample with live T cells, which have a shelf life of four to six hours. It would be impractical, if not impossible, to test hundreds of thousands of samples in that time frame.

We look at DNA samples taken from hundreds of thousands of T cells in a blood sample to find the unique signature of COVID. The blood samples can be stored at room temperature for up to 5 days or be frozen. The stability of DNA allows us to extract the information needed days or weeks after the sample is collected. This opens the door for the kind of massive T cell data sets that are needed to provide clear answers that go beyond just a few interesting anecdotes.

A Paradigm Shift In Diagnosing a Broad Range of Diseases

One of the exciting things about the T-Detect COVID test is that it provides proof of concept that T-cell testing is effective in diagnosing disease. We can build on this and apply it to many other disease areas, beyond SARS-CoV-2 and infectious diseases.

Imagine if you had a T-cell test that could tell the difference between diseases with similar symptoms like Lyme disease and multiple sclerosis? Or a T-cell test that could detect many different diseases across multiple therapeutic areas with a single vial of blood, eliminating the diagnostic odyssey that many patients face as they spend years trying to get the correct diagnosis for their symptoms?

This represents a paradigm shift in how we diagnose, and ultimately treat, many different illnesses based on how the immune system naturally does this. We call this Immune Medicine.

That is the promise T-cell-based testing holds. We, along with our partners, are up to the challenge. We can say that with even greater confidence today than a year ago because we’ve been compelled to push the limits.

Many more exquisitely informative diagnostics are going to come from this ultimate stress test. It’s something we can look forward to on the other side.

2
Jun
2021

Spatial Biology Coming Into Focus: Brad Gray on The Long Run

Today’s guest on The Long Run is Brad Gray.

Brad is the CEO of Seattle-based NanoString Technologies.

Brad Gray, CEO, NanoString Technologies

NanoString started out in the early 2000s by making digital “bar codes” that allowed it to do multi-plex gene expression – the analysis of multiple genes at once, and the extent to which they were dialled on or off in a given sample.

The technology caught on with a few prominent early adopters in academia. But the company struggled in the early years of selling instruments and consumables to academic labs. Brad was hired in 2010 to be the CEO who could take it to another level in commercialization, and lead an expansion that would take the company into the cancer diagnostics business.

There were some ups and downs. For a while, Nanostring got by with cash from pharmaceutical partners who wanted to evaluate tumors in patients getting immunotherapies. This was a time when many in biopharma was trying to understand what made some tumors ‘hot’ and others ‘cold’, and there was growing interest in why some patients respond and others don’t.

Nanostring in 2019 decided to divest its cancer diagnostics work, and concentrate on a new technology platform – GeoMx. This is the latest tool from Nanostring, and it’s caught on with scientists much faster than the first. These are the early days of spatial biology – in which Nanostring and others are seeking to shed light on what’s going on in cells with fine-grained resolution, but also with more context that can sometimes be lost.

The company’s new ambition — “map the universe of biology.”

As a young person trying to break into biotech, he got some international experience, worked as a consultant, and then got a chance to learn the diagnostics business under Henri Termeer at Genzyme. Brad is one of the many executives who credits Henri with inspiring him and creating an opportunity for him to thrive.

I think you’ll enjoy this conversation with a business leader of a company with an enabling technology.

Please join me and Brad Gray on The Long Run.

1
Jun
2021

The Promise and Challenge of Deriving Meaningful Clinical Insights From Wearables

David Shaywitz

Wearable devices have an ability to capture lots of data, in real-time and over long periods of time, that may reflect aspects of an individual person’s health.

But (and this is a common theme in the application of data science to healthcare), gathering volumes of data is one thing – deriving meaning from these data in a way that significantly improves a person’s health is another.

A recent paper in Nature Medicine paper highlights the delicate balance digital health researchers must maintain as they demonstrate the potential of emerging wearable device technology while taking care not to get ahead of the current state of the science, in terms of what the devices actually can tell us.

The research began in Mike Snyder’s lab at Stanford University, and was co-led by Jessilyn Dunn (a rising star in biomedical engineering now on faculty at Duke University) and Lukasz Kidzinski (now an AI researcher at Stanford and director of AI at Princeton, NJ-based Bioclinica).

Beyond Narciss-ome?

For a decade, Snyder has led the charge on wearables. He has famously used himself as a guinea pig.  So exhaustively has he monitored his own parameters, including genomics, proteomics, and every other -omic, that Baylor College of Medicine researcher Richard Gibbs, tongue-in-cheek, proposed a new term, the “narciss-ome”, to describe this comprehensive assessment.

Mike Snyder, chair, department of genetics, Stanford Medicine

As Snyder’s Stanford colleague Euan Ashley writes in Genome Odyssey (my recent WSJ review here),

“Mike Snyder was on a mission to measure everything about himself, all the time, using every technology possible. And I mean everything. Starting in 2010, shortly after he started at Stanford, Mike would show up to meetings sporting multiple different wearable devices. You would meet him, and there might be one smartwatch on one wrist and a different one on the other. Sometimes, he would wear an armband device the size of a pack of cards that detected airborne toxins in his environment. At one meeting, he showed up with a front-facing camera that took time-lapse pictures of everyone in the room. It freaked everyone out, so he stopped that soon after. Lloyd Minor, the dean of Stanford’s School of Medicine, refers to him as ‘the most studied organism in history.’”

Whether these exhaustive measurement efforts are truly useful has been less than clear; in some ways, like the dancing bear, they seem most remarkable not for quality of the clinical insight generated, but rather because they were conducted at all. Phrased differently, it’s not clear that the burden of such comprehensive data collection is (yet) justified, as I’ve recently discussed (here).

Nevertheless, the promise of rich data collection, particularly using wearables, remains as compelling as it was when Denny Ausiello and I articulated the ambition of digital health nearly a decade ago: we live our lives continuously, yet our medical needs tend to be evaluated episodically, and (hopefully) infrequently. 

Surely, there must be meaningful insight to be obtained from relatively dense, continuous, longitudinal measurements that can’t be gleaned from the occasional clinic visit. 

The challenge has been surfacing this hidden insight, and capturing the implicit value.

From Wearables To Insight?

Which is where the latest paper comes in. Utilizing data from 54 participants in the Stanford iPOP (integrative personal omics profiling) study, researchers examined data extracted from the smart watches the participants wore. The scientists first compared these values to two vital signs (temperature and resting heart rate) obtained in clinic visits using a validated instrument, and then utilized machine learning to see whether they could use either the wearable data or the clinical data to predict the values of routine clinical laboratory tests. 

The study utilized an Intel Basis watch, subsequently withdrawn from the market for safety concerns (the device could overheat, causing burns or blisters). The paper was originally submitted for publication in September 2018, but not published until May 2021, perhaps explaining why the Basis was used in this just-reported study.

The Basis could detect four parameters:

  • Heart rate using PPG signals (the approach associated with the shiny green lights on the back of your Apple Watch);
  • Skin temperature;
  • Steps;
  • Electrodermal activity (EDA), a measure of the electrical properties of the skin.

First, the researchers wanted to get a sense of how the measurement of resting heartrate obtained on the smart watch (using PPG) compared to clinic observations. Many devices use PPG to measure heart rate, including the Apple Watch, the Whoop strap, the Oura ring, and the Fitbit tracker, among others. The approach measures absorbance of the shined light, which is proportional to blood volume variation (each pulse transiently increases the volume). 

Challenges of Using PPG Technology To Assess Clinical Endpoints

According to a 2018 review article in the International Journal of Biosensors and Bioelectronics:

“The popularity of the PPG technology as an alternative heart rate monitoring technique has recently increased, mainly due to the simplicity of its operation, the wearing comfort ability for its users, and its cost effectiveness.  However, one of the major difficulties in using PPG-based monitoring techniques is their inaccuracy in tracking the PPG signals during daily routine activities and light physical exercises. This limitation is due to the fact that the PPG signals are very susceptible to Motion Artifacts (MA) caused by hand movements.”

These concerns were further examined in a recent NPJ Digital Medicine paper from Dunn’s current lab at Duke, examining potential sources of PPG wearable variability, compared to an ECG gold standard. While skin tone turned out not to represent a significant source of variability, motion was; moreover, the wearables exhibited different degrees of accuracy, with the Apple Watch generally outperforming competitors.

Jessilynn Dunn, assistant professor of biomedical engineering, Duke University

Dunn’s data accord with my own experience using consumer wearables during exercise; I’ve found the Apple Watch works better than other wearables I’ve tested, but not nearly as well as measurement techniques detecting electrical activity directly, like the Polar chest strap I’ve now adopted. Consumer-facing ECG measurements, like Kardia, and like the Apple Watch measurement obtained when holding the crown for 30 seconds, also utilize electrical detection.

Notably, in Dunn’s recent paper, consumer wearables significantly outperformed several “research-grade” wearables that were also evaluated; research wearables allow investigators access to the underlying waveforms, while consumer wearables function like black boxes from a research perspective, dramatically limiting their use in clinical research and making it prohibitively difficult to utilize more than one wearable in a given clinical trial — a critical interoperability obstacle that Jordan Brayanov, Jen Goldsack, and Bill Byrom elegantly discussed last year in STAT

As the three authors explained,

“You’d think that monitoring heart rate remotely would be easy. But wearables from technology giants like Apple and Samsung measure it in different and proprietary ways. One device may record the number of beats over 10 seconds and multiply by six; another may communicate an ‘instant’ heart rate reported after every single heartbeat. This means the two platforms’ data aren’t consistent and so can’t easily be used simultaneously in clinical trials.”

Resting Heart Rate, Temperature: Wearables Data vs Clinical Data

Back to the original paper: Snyder’s team found that when they considered two weeks’ worth of resting heart rate measurements at the same time of day as the clinic visits, the values were similar, but the variability was significantly less in the wearables groups, compared to the clinical measurement group. 

In other words, you get more consistency measuring resting heart rate over weeks on a wearable than assessing it once in a while in the clinic.

Score one for the wearable!

However, temperature measurement was a different story; here, as the researchers report, “clinically measured oral temperature was a more consistent and stable physiological temperature metric than wearable-measured skin temperature….” 

Translation: compared to clinical measurement, assessment of temperature on wearables was somewhat scattered.

Wearable Data + Feature Engineering + ML = Clinical Lab Predictions?

With these foundational parameters of performance established, here’s where the paper gets interesting. The researchers examined the four basic categories of output from the watch – measurements of heart rate, temperature, electrodermal activity, and steps – and began the alchemy of data science known as “feature engineering.” 

Feature engineering involves selecting attributes from the raw data to use as an input for a machine learning model. It could include a statistical property of the data – average heartrate, say, or a property of the distribution of the heart rate, or it could be the implied activity state of the individual, based on number of steps. 

According to the authors, there were 5,736 possible features they could have considered, from which they selected 153 that seemed the most likely to be altered in a fashion that could conceivably be reflected in a clinical laboratory test.

These 153 features were then fed into several different types of models intended to predict the value of one of 44 different clinical labs that were also obtained from the study participants. The initial work suggested one modeling approach, called random forest, generated predictions that explained up to a fifth of the variability seen in measures of hematocrit, red blood cell count, hemoglobin levels, and platelet count. 

To be clear, the contention isn’t that wearable data predicted these clinical labs with exceptional accuracy, but rather that wearable-derived data seemed to very roughly correlate with these clinical labs, and others. 

When the researchers examined which features were driving the predictions, it turned out that various permutations of electrodermal activity played a critical role in predicting hematocrit, red blood cell count, and hemoglobin levels, while features driving platelet count predictions were all based on heart rate.

The authors then conducted what felt like a bit of a pedantic demonstration exercise, comparing predictions derived from the 153 wearable features with those derived from the two measurements from the clinical visit (heart rate, vital signs), and found that generally, more is better. The authors typically got better predictions when they had more data to consider, even if the source data was only consumer-grade, vs regulatory grade like the clinical measurements.

Warped Perceptions

To read some of the coverage describing this paper, you’d think we could forget about the need for future blood draws, and just rely on data extracted from smart watches. “Your smartwatch can predict blood study results,” one headlined declared. Another: “More than just a step-tracker, smartwatches can predict blood test results and infections, study finds.”

Some of this hyperbole likely stems from the actual title of the paper itself: “Wearable sensors enable personalized predictions of clinical laboratory measurements,” which seems, in the context of the reported data, a bit aspirational.

Co-author Dunn may have expressed the contribution of the paper best in a dialog on LinkedIn, commenting:

“I want to emphasize that this is more about directionality than about exact predictions of clinical labs. The current status of this work is certainly not to the point of replacing clinical labs with wearables, but rather it may indicate which labs are more likely to have changes, which can then be directly and specifically measured (think of it as a pre-screening tool for labs when you have limited time and resources).

This, in my opinion, falls under basic research. We need to establish the principle that these relationships exist before we can iterate over them to improve predictions toward more clinical utility. Agreed that there is much more to do, and I hope in this paper we succeed in making the case that this is a path worth following.”

In a larger sense, this assessment captures the current status of many digital and data technologies that are being brought to bear in biopharma and healthcare these days: neither ready for prime time nor quite living up to the hype, but nevertheless making real progress, which resolute cynics can choose to ignore only at their peril.

27
May
2021

From Fitness To Flourish: Expanding the Scope of Digital Exercise

David Shaywitz

Sometimes the most relevant digital health companies have the least elaborate technology.

More than a decade ago, I discussed UpToDate, a fairly basic medicine e-textbook, served through a web-based app. It was then, and still remains, a go-to site for timely, high-quality medical information relevant to clinicians.

There’s nothing fancy about it, it just works.

Recently, I discovered a similar resource, PrecisionNutrition, that’s focused on coaching coaches to help their clients adopt consistent healthy behaviors. What’s interesting is how PN fosters a holistic, multidimensional view of health. The company stands out against a field of competitors that tend to have a myopic emphasis on a particular aspect of physical health like weight loss or physical training. 

Their stated goal is to teach the coaches they train to “transform” clients’ health, and help clients “thrive,” in the broadest sense. 

Physical health, PN tells fitness coaches, is just a small percentage of “what determines your clients’ success.”

Instead, PN emphasizes a focus on a multi-dimensional view of well-being, arguing that they are all interrelated, and to improve any one of them, coaches need to consider the many components of well-being. 

Not only will coaches attuned to the many components of well-being find themselves able to support their clients’ immediate goals (such as losing weight or gaining muscle), PN astutely argues, but an initial focus on fitness, say, may provide an opportunity, an on-ramp, to improve their clients’ well-being more generally, across multiple dimensions.

To me, this second part – fitness as an on-ramp to a broader opportunity to enhance well-being and to help people flourish more fully – is the profound health opportunity lurking in the consumer space.

It’s the opportunity that so many digital fitness companies, in their singular focus on driving athletic performance, may be missing.

Well-Being

At best, most of us probably think of “well-being” in an informal or casual sense; many probably share the perspective of one initial skeptic, who told Yale psychologist Laurie Santos he originally assumed, before taking her course on the subject, that it was “hippy California well-being crap.” (I can totally relate.)

Well-being, it turns out, has become a subject of serious scientific study, and represents a prominent area of focus for academic researchers and well as health organizations including the CDC and the WHO. There are treatises on the measurement of well-being, and academic centers focused on the cultivation of “human flourishing,” such as the Human Flourishing Program at Harvard, the Center for the Study of Human Flourishing at Kings’ College in New York, and the Stanford Flourishing Project

Flourishing itself turns out to be key concept within a burgeoning academic area called “positive psychology,” which focuses on what makes us happy or fulfilled. The term was said to have been coined by Abraham Maslow (of “hierarchy of needs” fame), and popularized by Martin Seligman of University of Pennsylvania (previously best known for studies of depression, and the concept of “learned helplessness”).

Some of today’s most popular academic psychologists are associated with this school of thought, including Daniel Gilbert at Harvard (though he apparently rejects the label), and Santos at Yale (who hosts the wonderful and highly recommended “Happiness Lab” podcast).

The key premise around positive psychology, and flourishing, is the idea that thriving isn’t just about reducing misery, as critical as this obviously is. Rather, the goal of positive psychology, as Seligman puts it, is to “supplement its venerable goal” of misery mitigation with a new aim: “exploring what makes life worth living and building the enabling conditions of a life worth living.” 

The question of what it means to be well, and to live a good life, is both ancient and elemental.  Researchers tend to consider two formulations: a hedonic approach, focused on the idea that we’re driven primarily to make life pleasant and pleasurable, and a eudaimonic approach, which recognizes a greater range of motives, such as self-actualizing and pursuit of meaning.  

From these approaches, frameworks have emerged that emphasize different aspects.

Notes for figure:
  • Ryff – Chapter 4 from Measuring Well Being, 2021
  • Deep Health from PrecisionNutrition.com, link.
  • WHO (WHOQOL) from WHO.org, link.
  • WBT (Well-Being Theory) from Seligman, 2011, which describes PERMA; subsequent iterations of this framework (PERMA+, PERMA-V) include vitality.

 

While well-being – definitionally – represents a valued end in itself, there are also data linking attributes often associated with well-being to traditional endpoints such as mortality. 

A 2019 review by Trudel-Fitzgerald and colleagues at the Harvard T. H. Chan School of Public Health found that several dimensions of well-being “are associated with a reduced risk of premature all-cause mortality among the general population, with small to medium effects,” associations that, critically, held up even after adjusting for confounders. 

The attributes with the strongest evidence, according to this review?

“Purpose in life, optimism, and ikigai (a Japanese term that translates into happiness, worth, and benefit of being alive, and apparently capturing both eudaimonic features like purpose and hedonic features like pleasure). 

According to the authors, there’s also somewhat less robust evidence linking other dimensions such as life satisfaction, positive affect, mastery, and sense of coherence to reduction in mortality. Studies examining the relationship between happiness, personal growth, and autonomy with mortality reductions “suggested no effect or were too limited to draw firm conclusions.”

Vicious vs Virtuous Cycles

In medicine, we’re all too familiar with the vicious cycles leading to the rapid downward spiral of health: an injury might impede exercise, leading to weight gain and making exercise even more difficult. The fragility of life, so easily taken for granted, can be tragically revealed by even the slightest setback, and the cascade of challenges it can produce.

How encouraging, then, to encounter a publication (thoughtfully discussed by Gretchen Reynolds in the New York Times, here) describing a rare virtuous cycle – the reinforcing findings from a longitudinal study of aging American adults that people who have a greater sense of purpose are subsequently more likely to exercise, and people who are more likely to exercise are subsequently likely to describe having a greater sense of purpose.

The study utilized an approach called a “cross-lagged panel model” in effort to reduce confounding. The bidirectional effects observed were small but statistically robust, according to the authors.

Fitness as an on-ramp to a broader opportunity to enhance well-being and to help people flourish more fully is the profound health opportunity lurking in the consumer space

The very appeal of the conclusion should remind us to keep our enthusiasm in check, and as always, seek replication and additional data.

But this study, and others like it, speak to a broader point: we need to look at physical activity from a perspective less reductive than either athletic performance – the focus of digital fitness companies (“improve your position on the leaderboard!”) – or mortality reduction – the focus of many clinicians (“exercise more if you don’t want to die sooner”). 

Exercise offers a range of benefits, in many domains, perhaps including an enhancement of our sense of purpose. Similarly, attention to these other domains, as PN advises coaches, can help motivate greater physical activity. 

Both physicians and connected fitness companies need to reframe how they conceptualize exercise; the opportunity is to see it not only as a path to improved cardiovascular health and performance, but as tangible starting point for greater well-being

Entrepreneurs leading the digital exercise movement may be missing an opportunity if they don’t profoundly enlarge their ambitions, and take, as their job-to-be-done, not the need to get people fit, but rather the opportunity to help people flourish.

26
May
2021

11 Asian-American Executives Shaping the Future of Biopharma

Jingyi Liu is a physician and MBA candidate at the Wharton School of Business

The biopharma industry was pressured to get faster and more innovative to respond to the urgent global health challenge of the past year.

Asian-American executives have played a key role in leading this charge, although they often aren’t in front of the cameras and microphones.

As part of Asian American and Pacific Islander Heritage Month, we wanted to stop and think about who some of the AAPI leaders are in our sector, and honor their contributions. They inspire us.

While there is overall strong representation of Asian-Americans in the biopharma sector, there remains significant underrepresentation of Asian-Americans in positions of executive leadership. Asian-Americans make up 22 percent of employees, but only 3 percent of CEOs, according to BIO’s first report on diversity.

Eric Dai is a PhD candidate in bioengineering at the University of Pennsylvania

How did we arrive at our list of high-impact executive leaders? Our selection criteria were as follows: commitment to solving critical health problems, a track record of leading high-integrity and scientifically innovative organizations, and dedication to patients and the next generation of innovators.

As biopharma companies continue to improve in hiring leaders and employees representative of the patient populations they serve, we look forward to seeing this list grow in breadth and depth.

Here are our top 11:

David Chang. CEO, Allogene Therapeutics

David Chang, M.D., Ph.D., is the co-founder and CEO of South San Francisco-based Allogene Therapeutics, a biotechnology company developing allogeneic CAR-T therapies for blood cancers and solid tumors. David also serves as a venture partner at Vida Ventures.

David Chang

David is perhaps best known for his work at Kite Pharma, where he was the head of R&D and chief medical officer who oversaw the team that developed one of the first two chimeric antigen receptor-modified T-cell therapies (CAR-T) for cancer. That personalized cancer immunotherapy, Yescarta, was a historic milestone for the field, developed around the same time as Novartis’ Kymriah.

Prior to Kite, David held senior leadership roles at Amgen, where he played key roles in development of Vectibix, Blincyto and Imlygic. Before entering the biopharma industry, David was Associate Professor of Microbiology, Immunology and Molecular Genetics at the David Geffen School of Medicine at UCLA.

Pearl Huang. CEO, Cygnal Therapeutics

Pearl S. Huang, Ph.D. joined Cambridge, Mass.-based Cygnal Therapeutics in January 2019 as President and CEO. She is also a Venture Partner at Flagship Pioneering and a member of the boards of Cygnal, KSQ Therapeutics, and Waters Corporation.

Pearl Huang

Prior to Cygnal, Pearl served as Senior Vice President and Global Head of Therapeutic Modalities at Roche where she oversaw the discovery of biologics, small molecule, and nucleic acid-based therapies.

Prior to Roche, Pearl was the co-founder and Chief Scientific Officer of BeiGene, and before that, she was the Vice President, Oncology Integrator of Discovery and Early Development at Merck where she led 14 early development teams and conducted seven first-in-human trials in one year. Before joining Merck, Pearl led oncology discovery at GSK where she initiated the programs that delivered trametinib and dabrafenib to patients.

Pearl received her undergraduate degree in life sciences from MIT and a Ph.D. in molecular biology from Princeton University. (Listen to Pearl describe her career arc, and her recent work on cancer drugs based on new learnings about the peripheral nervous system, on The Long Run podcast).

Angela Hwang. President, Pfizer Biopharmaceuticals Group

Angela Hwang is a member of Pfizer’s Executive Team and Group President of the Pfizer Biopharmaceuticals Group, which comprises the entire commercial organization of Pfizer. Her organization of 26,000 colleagues across 125 countries is responsible for bringing over 600 innovative medicines and products to patients.

Angela Hwang

Angela is a member of the Board of Directors of UPS, the global leader in supply chain logistics and package delivery, EFPIA (European Federation of Pharmaceutical Industries and Associations), as well as the Pfizer Foundation, a charitable organization that addresses global health challenges. She has also been active in industry groups such as BIO, where she previously co-chaired the Vaccines Policy Committee.

In 2019, Angela launched Diverse Perspectives, a podcast series where she hosts global thought leaders pioneering change across a variety of industries.

Angela received her Bachelor of Science in Microbiology and Biochemistry from the University of Cape Town and M.B.A. from Cornell University. She is a wife and proud mom to a teenage son and daughter, and a strong advocate for women’s leadership and sustainable global health equity.

Sek Kathiresan. CEO, Verve Therapeutics

Sekar Kathiresan, M.D. is a co-founder and the Chief Executive Officer of Cambridge, Mass.-based Verve Therapeutics, a biotechnology company developing gene-edited medicines for cardiovascular diseases.

Sek Kathiresan

Sek has dedicated his career to researching the genetic mechanisms underlying cardiovascular disease and using these insights to improve preventive cardiac care. Prior to co-founding Verve, Sek served as director of the Massachusetts General Hospital (MGH) Center for Genomic Medicine and was the Ofer and Shelly Nemirovsky MGH Research Scholar. He also served as director of the Cardiovascular Disease Initiative at the Broad Institute and was professor of medicine at Harvard Medical School.

Among his scientific contributions, Sek helped highlight new biological mechanisms underlying heart attack, discovered mutations that protect against heart attack risk, and developed a genetic test for personalized heart attack prevention.

Sek led the team at Verve that demonstrated CRISPR base editing could be used to edit PCSK9, and substantially and durably bring down LDL cholesterol in non-human primates with a single infusion. That pioneering work was published last week in Nature.

For more on Sek’s life story, and the concept behind CRISPR base editing for cardiovascular disease, listen to this episode of The Long Run podcast.

Reshma Kewalramani. CEO, Vertex Pharmaceuticals

Reshma Kewalramani, M.D., is the CEO at Vertex and the first female CEO of a large US biotechnology company.

Reshma Kewalramani

Reshma first joined Vertex in 2017 as the Chief Medical Officer. During her time as CMO, Vertex approved SYMDEKO/SYMKEVI and TRIKAFTA for Cystic Fibrosis and also advanced multiple clinical programs outside of CF including alpha-1 antitrypsin deficiency, APOL1-mediated kidney diseases, sickle cell disease and beta-thalassemia.

Prior to Vertex, Reshma spent more than 12 years at Amgen and held various positions of leadership including as Vice President, Global Clinical Development, Nephrology & Metabolic Therapeutic Area and Vice President, U.S. Medical Organization.

Reshma is passionate about developing and supporting the next generation of scientists and giving back to her community. She is a member of the board of directors of the Biomedical Science Careers Program, and RIZE Massachusetts.

Reshma completed her medical training in Internal Medicine and Nephrology at the Massachusetts General Hospital and is a graduate of the Boston University School of Medicine and Harvard Business School.

Samarth Kulkarni. CEO, CRISPR Therapeutics

Samarth Kulkarni, Ph.D., has been the CEO of Switzerland and Cambridge, Mass.-based CRISPR Therapeutics since 2017.

Samarth Kulkarni

Sam oversaw the strategic collaboration of CRISPR with Vertex Pharmaceuticals to develop gene-edited therapies for hemoglobinopathies. This collaboration recently culminated in data released at the American Society of Hematology 2020 meeting, where 10 patients with sickle cell or transfusion-dependent beta thalassemia were effectively cured after a one-time treatment with CTX001. See the paper describing that achievement in the New England Journal of Medicine.

Sam also oversaw strategic collaborations with ViaCyte to develop regenerative medicines for diabetes, with Nkarta Therapeutics to develop gene-edited cell therapies for cancer and the formation of Casebia Therapeutics, a joint subsidiary formed by CRISPR and Bayer.

Prior to CRISPR, Sam spent a decade at McKinsey & Company, where as a Partner, he co-led the biotech practice, focusing on strategy and operations and leading initiatives in areas such as personalized medicine and immunotherapy.

Sam received a Ph.D. in Bioengineering and Nanotechnology from the University of Washington and a B.Tech. from the Indian Institute of Technology.

Neil Kumar. CEO, BridgeBio

Neil Kumar, Ph.D. is a co-founder and CEO of BridgeBio, a biotechnology company focused on developing medicines for rare genetic diseases.

Neil Kumar

At BridgeBio, Neil built a hub and spoke model of company structure, with BridgeBio as the umbrella company with an $8.8 billion market valuation driven by a network of subsidiaries that includes Eidos Therapeutics, QED Therapeutics and Navire Pharmaceuticals.

Prior to BridgeBio, Neil worked as interim vice president of business development at MyoKardia, and prior to that, he was a principal at Third Rock Ventures. Before that, Neil worked as an associate principal at McKinsey & Company.

Neil is passionate about building an organization that is patient-first. The cornerstone of the BridgeBio mission is commitment to patients and their families.

Neil received his B.S. and M.S. degrees in chemical engineering from Stanford University and received his Ph.D. in chemical engineering from MIT.

Dean Li. EVP and President, Merck Research Labs

Dean Li, M.D., Ph.D., took over one of the biggest biopharma industry R&D jobs on Jan. 1, 2021 when he became Executive Vice President and President of Merck Research Laboratories.

Dean Li

From this position, Dean leads the company’s worldwide human vaccines and therapeutics R&D organization. In just a few months, Dean has already overseen several transformative deals at Merck including the acquisition of Pandion Therapeutics and collaboration agreements with Artiva Biotherapeutics and Amathus Therapeutics. (See TR insider coverage of the Pandion/Merck deal by Vikas Goyal).

Prior to joining Merck in 2017, Dean was in academic medicine at the University of Utah. He was a professor of cardiology, and chief scientific officer and vice dean at the University of Utah Health System.

While in academia, Dean co-founded several biotechnology companies based on research conducted in his lab, including Recursion Pharmaceuticals, Hydra Biosciences and Navigen Pharmaceuticals. (See TR coverage of Recursion’s AI drug discovery partnership with Bayer, Sept. 2020).

Dean mentored the next generation of physician-scientists through his roles as the primary investigator of the University’s Cardiovascular Research Training Program and as Director for the School of Medicine’s M.D./Ph.D. programs.  

Vas Narasimhan. CEO, Novartis

Vas Narasimhan, M.D., has been CEO of Novartis since 2018. Since joining Novartis in 2005, Dr. Narasimhan has served as Global Head of Development for Novartis Vaccines, Global Head of Drug Development and Chief Medical Officer.

Vas Narasimhan

He has overseen the licensing of over 30 novel medicines, including cell and gene therapies and vaccines. He is a champion of access and global health priorities, including through a commitment by Novartis to expand access to innovative medicines in low- and middle-income countries by at least 200% by 2025.

Vas is dedicated to unleashing the creativity of Novartis’ employees and making culture a driver of innovation, reputation and performance. Drawing inspiration from ancient philosophical texts and from leading thinkers today, he is committed to developing “unbossed” leaders who inspire and empower their teams to solve problems.

Vas received his bachelor’s degree in biological sciences from the University of Chicago, his M.D. from Harvard Medical School, and his M.P.P. from Harvard’s Kennedy School of Government.

Vicki Sato. Chairman, Vir Biotechnology and Denali Therapeutics

Vicki Sato, Ph.D., serves as chairman of the board of directors at Vir Biotechnology and Denali Therapeutics, and as Venture Partner at Arch Venture Partners.

Vicki Sato

Vicki has a long history of distinguished work in research, teaching, and leadership. She served as Professor of Management Practice at Harvard Business School and as Professor of the Practice, Molecular and Cell Biology, on the Harvard Faculty of Arts and Sciences.

Before joining the Harvard Business School faculty, she worked as President of Vertex Pharmaceuticals from 2000-2005, and prior to that, she was Chief Scientific Officer, Senior Vice President of Research and Development and chair of the Scientific Advisory Board. Before joining Vertex, Vicki was vice president of research at Biogen, where she led research programs in the areas of inflammation, thrombosis, and HIV disease, and where she participated in the executive management of the company.

Vicki received her A.B. from Radcliffe College, her A.M. and Ph.D. degrees from Harvard University and pursued post-doctoral work at the University of California Berkeley and Stanford Medical Center. (Listen to Vicki describe her career path on The Long Run podcast, July 2018). [Editor’s Note: Vicki also serves as an advisor to Timmerman Report.]

Tachi Yamada. Venture Partner, Frazier Healthcare Partners

Tachi Yamada, M.D., is currently a Venture Partner at Frazier Healthcare Partners. Before this, he was Chief Medical and Scientific Officer at Takeda Pharmaceuticals.

Tachi Yamada

Prior to Takeda, Tachi was President of the Bill & Melinda Gates Foundation Global Health Program, where he oversaw over $9 billion in grants for applying technologies to address major health challenges of the developing world. Before joining the Gates Foundation, Tachi was Chairman of Research and Development at GlaxoSmithKline and member of the board of directors.

Earlier in his career, Tachi was the Chief of the Division of Gastroenterology and the Chair of the Department of Internal Medicine at the University of Michigan.

Tachi received his M.D. from New York University School of Medicine and a B.A. in History from Stanford University.

 
About the Authors:

Jingyi Liu is a physician and an MBA candidate at the Wharton School of Business, where she is a William and Patricia Jewett Fellow. She is passionate about diversity and creating healthier and more equitable futures for patients around the world. Jingyi trained in internal medicine at Stanford Healthcare and received her MD from Harvard Medical School.

Eric Dai is a PhD Candidate in Bioengineering at the University of Pennsylvania. Outside of his research, Eric has served as an investor at Alix Ventures and helped lead Alix’s community and content platform, BIOS Community. Eric is passionate about the intersection of biotech, business, sustainability and social impact.