If you’re ever in a meeting and want to elicit as wide a range of reactions and emotions as possible—think eye-rolling, raised eyebrows, deep sighs, inquisitive looks, furrowed brows, and everything else in between—look no further than the phrase “lab digitalization.” When I speak at conferences, these two words seem to have a magic effect on people, including on their heart rate and blood pressure.

I think this is no surprise. Why, in 2022, is this still a topic for discussion? I’m not aware of any other industry that is still trying to “digitalize” anything. So what exactly is causing the hold-up in pharma? The short answer is that there’s a missing link. The longer answer is that I believe I know what it is, why it went missing in the first place, and what happens to our industry in the coming decade if we’re able to fix it. To begin, let’s look at how things stand right now.

To date, digital tools in the lab environment have been biased toward individual and discrete tasks, especially for things like record-keeping or standalone operational execution. There are the design tools we use before entering the lab, the automation tools we use when we are in the lab, and even more—the eponymous electronic lab notebooks—that we use after the fact to manually record what took place. On top of all of this, we have an entire world of lab hardware, each with its own interfaces and modes of operation.

All of these different systems and tools cover the entirety of the experimental process: the loop we cycle through in designing experiments, running them, analyzing experimental data, and starting all over again. But here’s the problem: there’s no throughline, no thread that links all of these disparate tools together into a unified whole.

At the same time, there are three ideas whose convergence and reliable, lab-based implementation has been stalled because of this fractured landscape:

Next-generation lab automation, or “Lab Automation 2.0”

Artificial intelligence (AI)/machine learning (ML)

Multifactorial experiments are vital in the study of biology because they help us understand the interactions that are fundamental features of all living systems. While DOE will not transform the industry on its own, it allows us to reach far deeper into the complexities of biology than we could otherwise.

Similarly, we’ve had the capacity for high throughput automation for some time now and, while higher throughput is always welcome, there’s only so much value it can drive. The next generation of lab automation has complete traceability, reproducibility, usability, and is capable of handling enormous complexity without code, and with much higher levels of walk-away time.

Finally, the buzz around AI/ML is remarkably strong but we have yet to see the full realization of its potential. The work of biology is difficult to represent in code and the data/metadata that labwork produces is difficult to digitize. If we can’t do it, AI/ML gets stuck as a pipe dream that remains the preserve of “big tech.”

We have already seen the results of a combination of both DOE and next-generation lab automation in some of the 

 made by one of our company’s customers, AstraZeneca, who described how they had begun running “experiments that were previously impossible.”

I believe the missing link is the mental model we use. Much is made of “the lab of the future” as our industry’s solution for success. When we think about the lab of the future, we ask questions like: “will this piece of software make my lab better, or will this new piece of kit?” These don’t feel like they’re good enough.

We create a subtle but profound shift if we instead switch to thinking about 

 This makes us ask different questions. What do I need to change to improve the quality of our experiments? How do I increase the value of our scientific output? What’s missing from thatpicture? When we think of the experiment itself, we stop thinking about the processes, equipment, data, and methodologies as separate problems to be solved in isolation. We begin a journey instead toward a holistic approach that considers the entire picture in a new light. For those like AstraZeneca who have already started that journey, the future looks incredibly bright.

, Chief Scientific Officer and Co-founder, Synthace

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A shift in mindset to the experiment itself could lead the way.

Labs and Computing Power: The Missing Link for a Revolution by 2030

The events of recent years have accelerated the pharmaceutical’s industry’s dedication to speed—more than ever, we’re striving for “innovation at pace.” With the rapid adoption of new technologies, adapted ways of working, and increased expectations for better, more personalized care, as an industry we are focused on delivering breakthrough treatments much faster for patients who are waiting.

“Innovation at pace” could transform the lives of millions of patients facing life-limiting disease but, along with the inherent challenges of drug discovery, development, and delivery, inevitably there will be unexpected hurdles.

Quality is pivotal to addressing these challenges. Not just “quality as a discipline” but as a collective culture of quality across an organization, helping to create the right environment for accelerated innovation. Building confidence and trust, protecting people and data integrity, and overcoming barriers early are fundamentals.

Quality supports brave decisions and intelligent risk-taking

At Astellas, we are evolving operational frameworks that can help to accelerate innovation to deliver at speed without compromising on quality.

We encourage curiosity and diversity of thought because we know that brave ideas will lead to the best health outcomes. But brave ideas require an element of intelligent risk-taking, which must be underpinned by ethical decision-making and solid risk-management principles to truly realize life-changing potential for patients.

A robust quality framework with defined principles gives confidence and empowers rapid decision-making. It’s a model that allows teams to not only identify the biggest risks, but to implement control strategies, such as monitoring systems, and ensure the necessary cross-functional collaboration and communication to recognize and address challenges early. Through our experience, we know issues can and do arise, but our framework allows us to be agile in our response, helping to find problems fast and fix them faster. In our partnership with regulatory agencies, too, our model can inspire confidence and trust in our risk and quality management systems to limit the time-consuming cycles of submission, review, and approval, and ensure rapid access to innovative medicines.

The industry’s response to COVID-19 is a great example of what can be achieved at pace within a quality framework. With unparalleled intent, game-changing COVID vaccines were developed quickly to address the large-scale pandemic challenges. This was only possible through brave decision-making and intelligent risk-taking. If we had relied on our traditional, more conservative approaches, we no doubt would have seen even more devastating illness and loss of life, or we might still be waiting for a path out of lockdowns.

Although it was a unique scenario, we can take valuable lessons from the pandemic—in terms of exceptional risk management, communication, and collaboration, especially between industry and regulatory agencies, establishing how decisions could be made rapidly. The unprecedented speed of development was made possible due to an acute focus on a collective threat, with all eyes and hopes pinned on a solution, but without compromising the expectation of safety and data integrity. Quality standards didn’t change, just the process and speed at which the industry was able to reach our goal.

Quality as a function is quickly adapting to this new reality and expectations for accelerated innovation. Historically, quality was considered “complying with the rules”—an end-stage tick-box exercise. Now, with a much broader scope of responsibility, we are increasingly living the “quality by design” concept, which considers how we control risk in a much more sophisticated way, underpinned by a culture of quality “owned by all.”

At Astellas, we’ve adopted a quality maturity model to assess and improve our quality practices and identify better ways of achieving quality. For example, shifting the emphasis from compliance with memorized rules and procedures, to, instead, leveraging competencies. We’re also looking at the best way to utilize technologies and digitizing transactional work to move our organization to a more mature quality level. This includes investment in an electronic quality management system (eQMS) platform to leverage advanced digital technologies and unlock capabilities in artificial intelligence, including automation and natural language processing, allowing the system to not only process basic work, but also to identify trends. This enables our team to shift away from some of the more routine tasks, freeing up capacity for critical thinking on resolving issues and driving continuous improvement activities.

As with many organizations, the quality maturity model is well established at Astellas—particularly in good manufacturing practice (GMP)—but we are also now implementing it with success across other functions, such as drug development and pharmacovigilance. Although created with manufacturing in mind, by adjusting the language but not the foundational concepts of the quality maturity model, we have been able to identify where meaningful action can be taken by other areas of our organization, to help them advance along the quality maturity continuum. The process has sparked interesting conversation within our functions, helping business partners to consider more deeply what constitutes quality and inspire new ideas to further embed a culture of quality across our organization.

Building quality competencies to drive innovation

To deliver the complex innovations of the future and allow quality management systems to realize their true potential, we must always ensure we do the basics brilliantly. We need robust quality systems focusing on the fundamentals of risk management and strong knowledge management and documentation. That is key to understanding or reconstructing events, enhancing insight, and preventing issues from recurring in the future. At Astellas, we strategically look at our development programs and map the quality pathway to approval, anticipating risks and tailoring our approaches to address scenarios should they arise. The learning is then shared across our programs and built into the new quality strategic plans. Success comes from open dialogue and our collaborative approach ensuring individual programs don’t operate in silos. Instead, teams have visibility of what drives quality success throughout our organization.

Building on our commitment to expand “quality competencies,” however, we’re transitioning away from a typical compliance model, where individuals are trained to follow processes and procedures or focus on fixing what has already occurred. Our Astellas quality competencies emphasize analysis and the ability to influence and interpret data and draw conclusions to help accelerate the new ideas and innovation that will have the greatest impact for patients. Training and procedures remain crucial but as highlighted, new digital tools are increasingly supporting this aspect of our work, allowing our quality experts to focus their energy and skills on critical thinking.

We’re also working to build new quality capabilities through cross-training within our organization, helping to expand team expertise in new modalities or different areas of compliance, and by giving individuals broader opportunities, roles, and visibility in the workplace.

We should all be viewing quality differently, shifting perceptions of the quality function away from the “rule enforcers” and “the people who say no.” Quality is no longer on the sidelines, independent and auditing, pointing out problems and then removing itself from the solution.

Quality is key to the solution and should be considered a core enabler of accelerated innovation—achieved through greater collaboration and partnership across functions; earlier involvement in planning; the sharing of risk-management expertise; and independent perspectives to inspire trust in the work we’re doing.

Instilling confidence, with all stakeholders assured of patient safety and data integrity, really is the pinnacle, and that’s what we’re moving toward. With this, quality will be integral to delivering the life-changing therapies of the future.

, Executive Vice President and Head of Quality Assurance, Astellas Pharma Inc.

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Why enabling a shared culture of quality across an organization is key to maintaining pharma’s recent pace of innovation wins—while inspiring new levels of confidence.

A Culture of Quality: The Catalyst to Accelerate Innovation 

On Sept. 15, a panel of experts convened for a virtual roundtable to discuss the growing field of digital therapeutics in the pharmaceutical industry. Professionals leading digital therapeutic companies, digital health C-suite pharma executives, and leaders of digital health and digital therapeutics organizations, met to share views on new trends in this segment.

The group discussed how life sciences companies are approaching digital therapeutics from a financial standpoint, along with how these tools and devices are part of a growing trend of moving toward “whole-person” healthcare, as opposed to single-point solutions. Other topics included why digital therapeutics still require traditional partnerships, and how these new product-enhancing technologies are changing the ways that payers approach medicine. The following is a recap of the conversation, edited for length and clarity.

Andy Molnar, CEO, Digital Therapeutics Alliance: 

Our first bullet point is what’s top of mind when considering digital therapeutics’ impact on pharma.

Within our membership at the Digital Therapeutics Alliance (DTA) and how pharma is specifically interacting with digital therapeutics and prescription digital therapeutics is in a couple different ways. There are a few pharma companies that really see it as a new line of revenue, almost separate from the pharmaceutical interventions that they’re driving; and then there is a large group of pharma companies who are no longer thinking about point solutions, meaning “here’s a pill that treats something.” They’re looking at the future of healthcare, which is more whole-person care and looking at the patient journey from start to finish.

I see pharma companies caring more about that full journey; it almost feels like a rare disease company with a patient-population [focus] of more than 15 people, but with a patient population of potentially millions of people. How do you take the small cohorts that we see in specialty pharmacy and apply that into the way that large pharma companies treat patients?

Martin Peters, worldwide head, digital health solutions, oncology, Novartis: 

I agree with the assessment that digital health is not going to be a direct line of business for the pharma industry. I think the answer is, nevertheless, more nuanced and depends on two factors.

First, what healthcare market are we talking about, the US geography or ex-US? This has huge implications and there are key differences in the go-to-market [strategy]. Second, what is the therapeutic area that we’re talking about, as we may see a difference in neuroscience and mental health vs. oncology? Ultimately, it is the end-to-end customer journey, and the pain points and moments that matter that will be addressed to make a difference in the patient life. It could be remote monitoring in oncology. It could be using a digital device to perform an ECG, for example, before [issuing] a prescription, if that’s part of the safety label.

Julia Strandberg, chief commercial officer, Pear Therapeutics: 

My first thought about digital therapeutics and their impact is all the macro trends we talk about: chronic disease on the rise, healthcare shortage, long wait times, people are living longer, technology just being super pervasive, and, frankly, having a phone in your pocket is one of the most important things to a person today. It’s not even your wallet; it’s your phone.

What that allows us to do from a care perspective is deliver care where the patients are, not to have to drive the patients to have care be delivered.

Another thought, which is super popular, is what are we thinking about in the context of contributors to health? Martin, you spoke to geographical differences, the longitudinal view of the patient and the person, but it’s [also] about the contributors of social determinants of health. And that’s where I believe that digital health plays a very significant role.

In 2017, the National Academy cited the World Health Organization (WHO) saying that only 10% to 20% of health outcomes were modifiable by medicine. The remaining 80% to 90% were social determinants of health. So, on reflection, 50% of that remainder were health-related behaviors and clinical care—and that’s about access and quality to clinical care. The sweet spot where digital health and digital therapeutics play a very meaningful role is in the strategic thinking and forethought of pharma, med device, and tech.

As we think about that, Alex and Chris, what would those pharma, medical device, and technology partnerships actually look like to be successful?

Chris Wasden, chief strategy officer, Twill:

 We have been working with pharma companies now for four years, and we’ve seen a dramatic change in the views of what pharma companies expect and want from digital therapeutics. Four years ago, it was common for a pharmaceutical company to believe that digital therapeutics could be a new type of therapy that could be reimbursed, that they could make money on, and could be a new revenue source and a new line of business for them.

We don’t see a lot of that interest anymore. Most pharma companies that we work with are looking at one of three different models. We call them complement, companion, and combination—where they’re looking at different ways of delivering a more holistic solution using digital as a complement, a companion, or a combination to the drug. The commercial part of the organization is driving this because they see it as a way of increasing revenues and scripts and finding new patients.

When we look at our value proposition to pharma companies, it’s about, how many new patients can we deliver to them? How many switches from one drug to another? We look at how we can impact medication adherence in the forms of compliance and persistence and how the digital therapeutic, when used on a regular basis, can educate patients, help them deal with side effects, help them remain on therapy, and provide additional information for them to understand how they’re progressing along the patient journey and with their disease and the management of their condition.

Alex Condoleon, head of digital healthcare, US general medicines, Sanofi: 

The first thing that matters for all parties is that there’s genuine strategic alignment. Whether you’re on the digital side, device, or life science and pharma side, you have to be willing to walk away if there’s any hint that the strategic alignment isn’t there. You can look across our industry and see all the models are being tested. Many of us have had experience with many of them, from joint ventures, equity plays, or trying to get more operational with commercial agreements.

All of them have a place, but I’m hopeful that we’re going to see pharma taking more of an operational role because pharma has to get in the game, understand the market, and learn from the market.

The strategic alignment and the deal structure are going to either set you up for success or cause problems down the path. The incentives in the agreement have to be aligned because tough times are going to come. There’s no question there will be dispute about boundaries, but you’ll survive it if the incentives are driving you to the same goal. The cultural alignment is the glue.

Therefore, you need to figure out what the KPIs (key performance indicators) look like, who’s going to be rewarded, and how does that reward only increase over time so that the glue stays. That’s probably an example of how mindset can make the deal structure something that holds us together in the good and the bad times. My alliance management partners will always say to me that in the good times, they almost don’t need to be involved.

Pharma is going to keep looking outside to complement its capabilities. That makes this idea of partnering key, and there are going to be things that succeed and fail.

It’ll be a game where we all learn together and find a path where we can unlock value for patients, our payer customers, and our investors as well.

McKinsey created a Maslow-like hierarchy chart in early 2021 about inner-connected attributes. I want to highlight the bottom and the top that you spoke of. No. 1 is about culture, talent, and agility. That is when the operating model breaks down. That is what needs to be focused on for your “glue.”

How do you build out that agile but culturally aligned structure that will never exist? Unfortunately, I have a partnership that no longer exists. At the top of the model, how do you create scale? How do you create this viable, sustainable business model to capture value? How do you make sure everything flows from people to value creation and keep that top of mind?

One of the biggest problems we have with pharma clients is that it’s a revolving door for their people. They change companies or jobs within the company every 18 months. We are the source of continuity, but they aren’t because we’re always having to find the new person that we have to work with. We’ve been doing this now with pharma companies for four years, and in all of our oldest relationships we’re dealing with a whole new group of people and bringing them up to speed and trying to maintain the continuity. It’s not easy.

 I agree that it’s pretty much the standard duration, and internally we suffer from that. For me it’s also a reflection that sometimes these partnerships were often not set up for success and we’re unable to measure impact and assess their value.

People internally ask, “What’s the impact of this?” The answer is, “I don’t know.” We track activity and leading indicators, but most digital health companies do not provide lagging or impact metrics.

The ultimate litmus test for a pharma organization is, “What is the impact?” The ones that have demonstrated it, even in this revolving door mentioned earlier, have stuck around and have actually scaled and lived through transition phases. I see the revolving door as a pressure test around [the question of], just how robust is that partnership that we’ve established? That’s not to say that’s always the case, and sometimes, also, good things get killed.

Ed Cox, executive vice president of strategic alliances and global head of digital medicines, Eversana: 

We are in a mature/immature market at the same time. We have the divergence that happens when a market matures, but we are not having the broad-based adoption that normally comes when a market matures.

Julia’s and Chris’s companies are very different companies. They commercialize in different ways, drive value differently, and both of them are 100% exactly what this industry is. We try to put all digital medicine or digital therapeutics into a monolithic way of thinking when, in fact, we are going to have maturing business models and maturing impact.

What is interesting are the evolutionary thoughts that are happening inside of large pharma; but I think, to Martin’s point, the roots are still early and shallow, and a lot of times they’re tied to a couple of core individuals. We definitely see a lot of leadership changeover, as Martin referenced, and the question is will those partnerships survive those leadership changeovers?

But that’s not an indictment on digital medicine. We shouldn’t feel bad that digital medicine is somehow less valid because a there’s a change in leadership, and, therefore, the partnership that was a priority no longer is.

Major, multibillion-dollar acquisitions of pharmaceutical products get deprioritized after their leadership changes. Whole stuff gets acquired, spun out, or never launched. There are huge shifts, and those are within the core business. So it’s critical for us to be aware that those dynamics are true, and we shouldn’t feel self-conscious that just simply because the champion left or the partnership didn’t go forward that it’s somehow a byproduct of digital medicine not yet having arrived.

 DTA held our payer accelerator board recently with representatives from 12 different payers. One said, “I don’t need a digital therapeutic solution for just one indication. I don’t want to do one pilot for one product. I need to know how to implement all of them.”

What do you think about how we build consistency when you see products that are completely different for disease states that are completely different to handle?

 The largest payers in this country are also the largest providers in this country, not provider networks at a third party. They have their own clinicians. UnitedHealthcare is one of the largest healthcare providers in the United States. CVS, the same thing, and it also has retail pharmacy as part of its business.

When you then deconstruct each one of those businesses, what you find is that everyone has a different revenue model with a different necessary value proposition based upon that.

What do they want? What are their goals and objectives? Our first payer customer was Cigna, and they just wanted a wellness product. Then they wanted something more clinical, and then they wanted something for their specialty pharmacy so they could differentiate and have a center of excellence around certain medical conditions that are very high cost.

As you go across a payer organization, there are at least half a dozen different businesses that have different buying-decision processes and different value propositions where digital can play a role.

I think it’s naïve for us to think that there’s this thing called a payer, they all have the same needs, and we just need to solve them once and we’re done. No, it’s a lot more complicated than that.

The other thought that comes to mind is that technology is at a point of maturity where it is reasonable to believe it can have a favorable impact on the health and outcomes of people. But getting adoption, especially where there already is a highly fragmented environment that you’re trying to operate in, is difficult.

What does that mean? For me, this keeps coming back to the idea that the emergent sector is going to find either a protocol, like a backbone technology, or a leading company, that enables workflow to be smooth. Workflow is one of the great barriers that still has to be addressed if we’re going to see wide adoption of these solutions.

I agree with you. I think by 2030 probably one in seven or eight people around the world will be on some form of digital medicine. That means that it’s going to be a major market. We are going to have a couple of backbone players and winners. I think that we’re going to see not consolidation but creation of monolithic solutions, which is really exciting.

If pharma doesn’t act on it, they will lose. They are in the best position to win this and be the stewards of the future of digital therapeutics and digital medicine. There’s going to be a couple of breakout stars. But which industry wins? Is it big tech? Is it big pharma? Is it med device? Or is it an entirely new vector?

 I don’t know if it’s big pharma’s position to lose. I think it’s actually the payers’ position to lose. They have the most to gain and the most to lose to not create an inner-connected system. Even with the different business lines or service lines, they could lose if they do not put a holistic longitudinal, digital solution in place that complements their care coordination or case management or key outcomes. Payers are about managing risk and the actuarial science associated with that monetary value of that risk.

That’s provocative because it says if payers are the eventual owners and winners of this, then pharma had first-move advantage. They were trying to do this five, six, seven years ago. But if all of a sudden this ecosystem is owned by the payers, then this power balance is going to shift.

 I agree with Julia, but let me present a different way of looking at this. About 10 to 12 years ago, I developed a business model called “owning the disease,” which was saying that a pharma company should take one therapeutic area and provide an entire array of products and services around that therapeutic area, so they actually own the disease. For example, in MS (multiple sclerosis), you provide digital therapeutics, a digital front door, access to clinical services, your drug, and so on.

I completely failed convincing pharma companies and med device companies to do this. And the reason was that pharma’s interest in any TA (therapeutic area) is transient because either the drug goes off patent, and they don’t have more in the pipeline for that TA, so they move on, or patients stay on their product for short periods of time. The pharma company really doesn’t have the incentive to own a specific disease.

The payer is looking at the entire patient journey. So for the patient, if drug A doesn’t work, they go to drug B. And if drug B doesn’t, they go to drug C. If Drug C doesn’t work and there’s a device, light therapy for psoriasis, for example, they’ll go to light therapy as a medical device as opposed to the drug.

The payer should have all the risk. However, the payer is transient as well because the employers change contracts every three to five years; the payer only cares about that patient while they have that contract period.

So who is going to provide an ongoing, long-term relationship with a patient that is across their entire disease journey, regardless of time and severity and needs different types of products? Part of the problem is that you don’t have the incentives in the pharma industry for payers to be a long-term, comprehensive player in a disease category.

 For some final thoughts, I think at this time, we are still hungry for more success stories, and the more we have, the more that will fuel the system. If something disruptive [related to digital health] is successful, I guarantee you that pharma will be queuing to be in on it and wanting to do it right. Seeing is believing, and that holds true for pharma more than ever. There are lots of phenomenal examples, including the companies here today. We just need more, and when we show that direct impact and what it does, they will be listening.

Everyone coming from different companies and debating all the different ways it might work is great. However, there’s no one that doesn’t want this to work, and that’s what’s so amazing. Patients want this, pharma partners want this, digital medicine companies want this, and even to some degree, the payers want it. There’s never been a time that health and specifically digital health and pharma have been more at the front of people’s minds.

We just beat back a pandemic because of a confluence of events around the pharmaceutical industry’s innovation, with digital health being able to deliver things. We’re at this moment of great excitement because you do not have an adversary.

And I wish for a world where we don’t call it a digital therapy, we just call it therapy.

is Pharm Exec’s Editor. He can be reached at

Executive Roundtable

Senior leaders focused on the advancement of digital medicine and health meet to discuss the importance of these tools for life sciences companies, payers, and others in harnessing a healthcare future that will be increasingly dominated by holistic treatment and delivery.

Whole-Person Care: Are We Ready? The Intersection of Pharma and Digital Therapeutics

Christi Shaw is no stranger to hard work. The Midwest native who grew up on a working farm in rural Iowa now rolls up her sleeves every day at Kite, a Gilead Company, to develop and commercialize CAR-T cell therapies for oncology patients. As Kite’s CEO, she is thrilled to offer patients hope in a potential cure—something from which she wishes her family could have benefitted. Her unique view on the patient journey and her dedication to helping others continue to drive her efforts to improve these therapies and make them more accessible.

Waking up at the crack of dawn to tend to cattlemight not be how you picture a young biopharma CEO. But Shaw spent her early years fixing fences, baling hay, and pulling rocks out of the field. “Whatever it took to run the farm and the house is what we did,” she says.

As Shaw’s hard-working parents operated the farm as a side business, she looked up to them as role models. Off the farm, her father worked in corporate America. Her stay-at-home mother, who grew up on a farm like her, was always busy giving to family, neighbors, the church, and schools and later started a business of her own.

But it was two high-school teachers who nurtured Shaw’s interest in biology and chemistry. Combining her love of science with the examples of running a business and giving back to others from her parents, she felt like pharma could be a natural fit. While in high school and as the first person in her family to go to college, she worked as a pharmacy technician in order to gain practical experience. Upon graduation, Shaw was recruited by Eli Lilly and landed a job on the commercial side as a product detail representative based out of Oshkosh, Wisc. Lilly also helped her obtain her MBA from the University of Wisconsin.

After working as a detail rep, Shaw moved on to more senior positions at Lilly, Johnson & Johnson (J&J), and Novartis before she joined Kite. Though she’s been in oncology for almost 13 years, she has crossed at least 12 different therapeutic areas in a variety of functions. This diverse experience has given her unique perspectives as a leader.

“Back when I was in the field, we were called product detail reps and you were the only person in that territory,” she says. “You answered medical questions, commercial questions, reimbursement questions. There weren’t all these pieces to the pharmaceutical industry. It was really a one-stop point person for physicians, the community, and pharmacists. So my entree was [more] broad-based and cross-functional in nature than how we have a sales rep role today.”

In addition to commercial and clinical development, Shaw was able to dip her toes into legal, compliance, human resources, finance, and even medical devices over the years. “When people go up through the function and [then want to] be the CEO, it tends to be very difficult if you haven’t seen how the other eight functions work beyond your own,” she says. “[Seeking multidiscipline experience] is one of the things I highly recommend.”

As part of her cross-functional journey, Shaw sometimes had to make lateral moves to break into new areas, but she always kept the big picture in mind. For example, during a consolidation at J&J, she volunteered to take a lateral staff assignment focusing on commercial analytics, research, and business development—areas she hadn’t worked in before—rather than remain vice president of the newly combined commercial business. “That got me a lot more breadth of experience,” she says.

While she had always been demanding of these functions, Shaw now was able to experience the demands placed on her. Knowing people’s individual functions also helped her to understand and appreciate their diverse perspectives. Though she may have once questioned some of their decisions, once she crossed over, she was able to gain empathy for their insights. “I could take a step back, and when I asked questions, seek to understand a lot more,” she says.

Shaw’s first foray into cell therapy was at Novartis, where she led the North America Oncology business.

Her real education, however, came in a much more personal way. Shaw’s older sister was diagnosed with multiple myeloma in 2013. In May 2016, her sister had exhausted all the therapies that were approved commercially. At the time, Shaw was US country head and president at Novartis, based in New Jersey. She was able to direct her sister to the people who had access to clinical trials. Her sister eventually found a Phase 1 trial for CAR-T therapy at the University of Pennsylvania in Philadelphia and enrolled.

Despite being at the top of her professional game, Shaw made the bold move to step back from her position at Novartis to care for her sister. “Having lost my mom to breast cancer, I wanted to do everything I could to try to make sure my sister lived as long a quality of life as possible,” she says. “I had so many regrets [about my mother]: Why didn’t I do something? Why didn’t I get her somewhere else besides rural Iowa? It seemed like I was so courageous [stepping down to care for my sister], but in fact, I had learned from my mistakes.”

For two months, Shaw stayed with her sister at the American Cancer Society’s Hope Lodge in Philadelphia. She was able to see firsthand what patients and their care providers go through. She herself was drained from the flurry of questions that needed to be answered and paperwork that needed to be completed. She witnessed the difficult task of managing medicines, when her sister received a pill one day that came in a different color, causing confusion. The experience took Shaw’s dedication to patients to a new level.

“It’s just so hard for patients to navigate when they’re so sick already,” she says. “After going through that, it just never leaves you to think, what undue burdens are we placing on patients and their caregivers and families? And how does not just our therapy but what we do connect to the whole system? How are we helping or hurting patients on their journey?”

Eventually, Shaw’s sister’s disease progressed, and she decided to seek a donor transplant. While Shaw wasn’t a match, her younger sister was. It was time to step back yet again and let her other sister take over.

With the word circulating through professional networks that Shaw was available to return to pharma, she received a phone call from Lilly. She welcomed the opportunity to rejoin her former company in Indianapolis, which was close to both her sisters in Chicago and St. Louis. As senior vice president and president of Lilly Bio-Medicines, Shaw oversaw nine different disease states, thousands of employees, and one of the largest business units at the company. The position also offered a span of Phase II through commercialization responsibilities instead of just individual functions.

“It is hard to go back to an individual function when you’re used to having the breadth of teamwork, so that intrigued me,” she says. “I had a dual motivation of going back to running a big business in a team environment and being near my sisters.”

Shaw felt she would stay at Lilly until she retired, but then she received a call from Gilead, Kite’s parent company, to come aboard as CEO in 2019 after her sister passed away the previous year. She welcomed the opportunity to find a way to get the company’s promising CAR-T therapy treatments to patients. “When you know what your passion is and what you want to do, the fact that I could potentially help bring cell therapy and cures for cancer to the world was really compelling to me,” she says.

Kite’s currently approved therapies, Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel), have shown potential for a cure for some lymphoma patients, with five years of durability data. In April, FDA approved Yescarta as the first CAR-T therapy for initial treatment of relapsed or refractory large B-cell lymphoma (LBCL)—the first improvement on standard of care in nearly 30 years. (Last month, Yescarta was approved in Europe for use in second-line diffuse large B-cell lymphoma and high-grade B-cell lymphoma.)

Tecartus was approved in July 2020 as the first and only approved CAR-T therapy for relapsed or refractory mantle cell lymphoma (MCL), and in October 2021 for relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The one-time treatments involve extracting a patient’s cells, re-engineering them, and infusing them back into the patient. About half the time, the body cures itself.

“We literally have two-thirds of our 3,500 employees in our manufacturing labs taking people’s lives in their own hands,” says Shaw. “Most people—even within our own company—thought there’s no way to bring this to the world. It’s too labor intensive. Patients are located too far and wide. Yet here we are three years later.”

Today, Kite operates in the US, Europe, Australia, China, Japan, Canada, Brazil, Singapore, and Saudi Arabia. The company has treated 15 times more patients than it did before Shaw’s arrival. There are now over 10,000 people who have been treated. “There are just so many people that have been affected positively by the therapy,” says Shaw. “Before I came here, everybody thought this was science fiction. But it is reality now.”

Looking toward the future of cell therapy, Shaw highlights the need for improvement in three key areas: communication, science, and global access. Even where people are eligible, only two out of 10 currently receive it. To grow this number, Kite is educating community physicians and patients directly that this therapy could be a potential cure. By continuing to advance the science behind CAR-T, Shaw hopes to improve the efficacy rate and understand why certain people experience side effects. Future research efforts to increase patient accessibility and speed include looking at “off-the-shelf” CAR-T using donor cells.

Recent journal articles touting the success of cell therapy in disease states beyond cancer is also hopeful. “Being able to harness someone’s own immune system to treat their own diseases, across multiple diseases, is the way that we’re going to help cure some of the diseases we have,” says Shaw.

One of the key learnings Shaw and her sisters experienced during their journey was that not everybody has the ability to connect to clinical trials like they were able to. The cost of travel to the care center, lodging, meals, and transportation to and from the treatment site can be expensive. To ameliorate this issue, Shaw and her younger sister started More Moments More Memories. The foundation provides a travel, lodging, and meals program to help patients who don’t have the financial means to access clinical trials.

“We always talk about how many more moments we can give patients for lasting memories,” says Shaw. “I thought we’d give them one more special event or maybe a few more months of life. To my surprise and happiness, it’s been five years and two-thirds of the patients are still alive. That’s been extremely rewarding.”

In addition to managing the foundation, she and her younger sister travel back to Iowa periodically to check in on the family farm that is now partly rented to local farmers and partly in conservation. Overseeing the operations keeps her grounded. “We go back a couple times a year,” she says. “Sometimes we have to tear down a shed, sometimes we have to do things to upkeep the farm, like cutting brush, and sometimes we just take time to enjoy the area. We’re always brought back to our humble roots.”

Whether in Iowa or her current home of Southern California, Shaw makes sure to leave time for family. When she has the chance, she enjoys golfing with her husband and 14-year-old son, who is currently trying to join the junior PGA.

“Going through these experiences [with my family] has made me think about where I can best spend my time each day,” she says. “I wouldn’t say my job defines me; it’s a piece of who I am. I just happen to be very lucky that my job is part of my true north and part of my life.”

Each day, Shaw prioritizes her most important responsibilities, which could be her son’s sporting event over her job. “COVID has taught us that your job isn’t 8 a.m. to 5 p.m. anymore,” she says. “I may need to pick up my son at 3 p.m. and go to his sporting event. But I’ll be back online in a few hours. It’s never balanced, but it’s being at the right place at the right time where you feel like you’re most needed, wanted, and you would have no regrets.”

 is a freelance content specialist based in New Jersey. She was formerly Editor-in-Chief of Pharmaceutical Executive.

Executive Profile

Christi Shaw, CEO of Kite, is working hard to bring cell therapy to the masses, fueled by her family’s personal experiences with cancer.

A Mission of the Heart

A near-record number of emerging biotech companies are trading at negative enterprise values and by year end, if nothing changes, nearly 40% will have less than 12 months of cash.

This is despite the fact that in 2021, emerging biotechs raised more than $80 billion in follow-on financing, venture funding, and initial public offerings (IPOs), second only to the record amount of $90 billion raised in 2020.

During that time, biotechs didn’t need their cash-rich upperclassmen to validate or fund programs, money flowed in with force and urgency to advance innovation renaissance.

This bull market for biotechs made it tough for large-cap biopharmas to do deals without paying massive premiums, which drove the trend toward collaborations and strategic partnerships.

But rotation into value with the economic recovery ushered in the longest and deepest decline in the XBI biotech index since its inception in 2016. This was punctuated over the greatest surge in interest rates in a seven-month period in history. Biotech valuations plunged and access to capital dried up. The market for follow-on offerings is highly selective to companies generating positive data, and often painfully dilutive. The IPO market has been effectively shut, and is likely to remain so throughout next year.

Restructurings, consolidation, reverse mergers, and liquidations are all being pursued across the sector to extend cash runways.

Emerging biotechs now find themselves with few options for access to capital and in many cases, large-cap biopharma partners may be among the most attractive among them.

This comes at a time when the M&A firepower among the biopharma industry’s largest players has reached a nearly $1.2 trillion for the first time since 2014, according to EY.

So, the tables have turned. Marry that with several known facts:

M&A and business development has always been a key pillar of growth strategies for the industry’s leading companies.

Bleeding edge and new modalities, such as cell and gene therapies, antibody drug conjugates, and RNA- and DNA-based medicines are widely expected to represent the majority of industry revenues in the next decade, and while leading biopharmas have made a push to bring such capabilities in-house, research suggests that they are only a small minority of current pipelines, and their efforts are far behind the more nimble small innovative biotechs. To quote EY, “To stay competitive, bigger biopharma companies need to aggressively pursue external innovation. Simply put, they need to transact if they want to transform their businesses.”

Further, if we examine the history of the large biopharma industry pipeline, the data reveals that the 70% of breakthrough innovations were generated outside of large biopharma—a share that is likely to be sustained given what’s required in investments in the biotech sector. Half of the top 20 blockbusters launched by large biopharma between 2011–2021 were sourced externally, and they correspond to 60% of the cumulative industry peak-year sales.

Beginning in 2025, the larger biopharma companies will face losses of exclusivity for products with revenues exceeding $225 billion, a substantial growth gap to overcome. This also underpins the need for decisive M&A and business development efforts in the short term.

To quote Rob Davis, CEO of Merck, on the company’s just- reported third-quarter 2022 earnings call, “Our focus, our urgency on business development has not changed. We do see a list of potential places to play. Our priorities have not changed. In fact, maybe we’re even a little bit more bullish and eager to do something.”

That said, “The volatility actually doesn’t help for a conducive M&A environment right now because you have sellers, potential sellers holding on to 52-week highs or all-time highs, which, quite frankly, aren’t too distant in the rearview mirror,” added Davis.

We share the view that some biotech CEOs and board members may have their eyes stuck in the rearview mirror, but the new reality is setting in, or will have to very soon. We expect the deal calendar to heat up, large and small. Wait for it.

is Founder, Barbara Ryan Advisors, and a member of Pharm Exec’s Editorial Advisory Board.

Finance

Focus is on cash: who’s got it, who doesn’t, and what will it mean?

The New Reality for Industry Dealmaking May be Setting In

A backlash against ESG investing fills the headlines of 

and certain other business publications. The harshest critics characterize ESG-informed investing and corporate ESG programs as great destroyers of shareholder value, undertaken for political reasons, and without resulting in any benefit to society. The ESG movement has been condemned by some state attorneys general as being rife with “destructive, illegal business practices” that politicize financial decisions. One recent editorial characterized ESG stakeholder engagement as a “protection racket.” Given the hyperbole, a serious look at the at these charges is warranted.

Certainly, the ESG movement has suffered growing pains. Those include persistent challenges, such as the difficulty and expense of measuring progress on ESG goals, and the incoherent multiplicity of disclosure frameworks, raters, and rankers in the space. Some of the backlash is also a reaction to bad behavior: greenwashing, ESG marketing ploys, and activist pressure on narrow issues unrelated to a company’s business. 

But a protection racket involves pressure on businesses to pay for something they are already entitled to receive. Pressure to disclose ESG data is different. No company is entitled to quiet investors single-mindedly focused on the next quarter’s financial results. No company is entitled to consumer confidence or stakeholder trust. Spending corporate resources to build the trust of those stakeholders is hardly an anti-capitalistic strategy. Fundamentally, I believe in the efficiencies of the marketplace, including the marketplace of ideas. And ESG is winning in the market.

ESG investment has gone mainstream. One recent study from Bloomberg Intelligence projects more than one-third of all globally managed assets could carry explicit ESG labels by 2025. Given the scale of the movement of assets into ESG-screened funds, the suggestions that ESG is all about politics seems far-fetched. Investor perceptions of risk and potential return and the preferences of their own clients deserve respect. A preference for investments in firms deemed socially responsible companies is no less valid or inherently political than a preference around a firm’s R&D strategy. Is it really credible that many of the largest and most sophisticated investment managers in the world have been pressured into pursuing strategies at odds with their clients’ interests?

Investors have also spoken with their votes. During the 2022 proxy season, companies were presented with no shortage of “anti-ESG” shareholder proposals. The average level of shareholder support was just 3%. That kind of consensus is a powerful signal.

But if many investors truly value sustainability, and if companies have an economic incentive to demonstrate social responsibility, then why does ESG arouse such passion? One answer is information—or more precisely, the lack of good data. Transparency is the foundation of any serious ESG strategy, but much ESG data is expensive to discover and provide. ESG is also complicated. Jumbling E, S and G performance scores into one consolidated rating of a company’s social responsibility is nearly meaningless—which may explain why different raters so rarely agree on the top companies. In addition, there is simply no political consensus around strategies to address environmental sustainability, gender and racial equity, and other issues. And most politicians are notoriously short-term oriented. Especially in areas where hard trade-offs must be made, is it any wonder that they would be frustrated by long-term investing strategies that drive changes unaligned to their own priorities? The furor over ESG reflects the divisions that already exist in our society.

The controversy surrounding ESG does not mean that it is time for the government to step in. Regulators properly insist that company disclosures are truthful, but there is little reason for them to dictate what investors and customers want to know. ESG factors are too numerous, complex, and variable across industries for a one-size-fits-all disclosure scheme. Voluntary disclosure can be better tailored to companies’ circumstances and the interests of their shareholders.

The growing noise around ESG is evidence of its increasing maturity and entry into the mainstream. Especially in a highly regulated and publicly sensitive sector like healthcare, leaders should welcome the scrutiny of ESG critics, but they should also resist any urge to take comfort in it or step back from well-considered ESG initiatives. On the contrary, we should instead redouble efforts to ensure that ESG factors are incorporated into corporate decision-making in a way that is truly aligned with the long-term sustainability of the firm.

, head of external affairs and ESG at Organon and author of Bone by Bone. In this role, she focuses on guiding and shaping how the company interacts with key stakeholders and the environment.

The validity of ESG-driven investment and reporting in healthcare.

Is ESG a ‘Protection Racket’ or Long-Term Value Contributor?

The life sciences industry continues to embrace artificial intelligence (AI), algorithms, and machine-based learning in its pursuits to collect and analyze important pharmaceutical and healthcare data. I recently had two conversations with people using these tools to improve the ways that Alzheimer’s disease and amyotrophic lateral sclerosis (ALS), respectively, are diagnosed and, ultimately, improve patients’ chances of mitigating the symptoms and living longer.

David Bates, PhD, co-founder and CEO of Linus Health, discussed work his company is doing to boost the Alzheimer’s detection process. AI and machine learning (ML) are at the core of his technology, which focuses on identifying and recognizing digital biomarkers for the disease.

“We built a digital platform that can deconstruct some human behavior into discrete signals,” he says. “We have integrated what’s known as the Boston Process Approach, which was developed several decades ago. The process involves observing the subject’s process of completing the test. That provides as much information as the results of the test itself.”

Unlike traditional diagnosis methods, digital biomarkers don’t rely on measuring how the patient feels. Instead, they track physiological and behavioral data points.

According to Bates, the algorithms require a large number of data points before the platform can start recognizing trends that signify that something might be wrong.

This is especially important for Alzheimer’s diagnosis. As Bates explains, by the time a patient is showing symptoms, the disease has likely progressed for about a decade. Patients may notice memory loss or disorientation, but by that point, they’ve already suffered from a loss of neurons, which can’t be recovered.

Obviously, using digital biomarkers for early detection of disease is helpful for patients. It may enable them to start taking medication or adjust their lifestyle to slow down or stave off the effects of the disease. There’s another important benefit for integrating these biomarkers, however. Testing new therapies for Alzheimer’s has long been an arduous and expensive process, due to the difficulty of diagnosing the condition and finding proper candidates for the testing and control groups in clinical trials. Identifying digital biomarkers can make it easier for researchers to identify and target patients who may have the disease but haven’t started showing noticeable symptoms yet.

“We take over 100 biomarkers in a test alone, and it’s an assembly of them that lead you to conclude that this person is likely suffering from Alzheimer’s disease,” says Bates. “It’s been shown that you can differentiate between someone who has Alzheimer’s and someone who has vascular dementia, or Parkinson’s[, for example]. “The relative deviation from norm of those biomarkers give insight into not only if they are impaired, but also what kind of impairment they’re suffering from. This is important for clinical trials because it helps you reduce the heterogeneity of the population, so you’re not lumping everyone into one bucket.”

 about her work toward improving the diagnosis process. With a technology background and holding master’s degrees in computer science and electrical engineering, Navar was on the founding team of what is today known as WebMD. She also founded Everything ALS, a non-profit that uses AI, remote patient monitoring, and propriety algorithms to identify key markers in diagnosis. Navar’s husband tragically passed away from ALS in 2019. He was 49 when he showed the first symptom, foot drop, but it took two-and-a-half years to be formally diagnosed, Navar says.

“The goal is to bring technology innovations to ALS, and if we crack ALS, these methods would be applicable to other neurological diseases,” she says. “We keep thinking that we understand more science and biology, but we all know that if you don’t know how to measure it properly, it’s really hard to prove something. Again and again, ALS patients are put into trials who are in the equivalent stages of the disease to Stage 4 cancer and hope that a miracle will happen.”

According to Navar, one of the goals in ALS is to move away from self-reported data, which can be inaccurate due to patients not understanding the scales properly. Digital biomarkers, however, provide consistent and accurate data points that can be measured and compared without relying on patients understanding the difference between a two or a three on a five-point scale of discomfort.

Technology

AI drives new signal-detection efforts in Alzheimer’s and ALS.

Digital Biomarkers Could Reshape CNS Diagnosis, Treatment

In normal circumstances, journalists deliver tomorrow’s news today. But these are not normal circumstances in European drug regulation. Since 2019 the European Commission has been preparing changes to a once-in-a-generation revision of its comprehensive pharmaceutical rules. It was due to unveil its proposals for change next month, December, just in time for Christmas, so that the package could be slotted neatly into the EU’s legislative machinery for an early start on processing. However, things have not gone to plan.

A senior legislative scrutiny committee within the Commission has rejected the draft proposals—virtually on their way to the printers—and the process has come to a grinding halt. So instead of bringing you tomorrow’s news, this column can only offer information on yesterday’s news—a quick look at what the Commission officials had in mind—and offer some warnings about what this could mean for the future of European drug regulations.

The commission officials responsible for drafting the proposals have understandably been playing down this reversal. They have been insisting that the internal objections raised are merely technicalities—while being reticent about exactly how their draft has offended their superiors. And they have been offering reassurances that planning is still on for everything to go ahead “in the coming months.” But the coming months is proving to be as long as a piece of string. And the necessary rewrite to overcome the supposedly technical objections appears to be taking so long that the talk of publication has now stretched beyond January, beyond February, and into March—in other words, perhaps just in time for Easter.

The current rules that the revision is supposed to update go back as far as 2000, so an optimist could argue that a few more months here or there will not matter very much. But the optimists may be reckoning without the complex timetable for European legislation. Publishing the proposals is only a step in the formal legislative process, and a step that leads into a long and challenging corridor in which the formal proposals come in for lengthy evaluation and discussion in the European Parliament and in the Council, where member states’ ministers regularly meet. Typically, it takes one or maybe two years for the legislation to progress down this corridor while MEPs and ministers establish their own positions on the proposals, and a new law emerges into the light only after the two groups agree with one another on a compromise that they can both live with. And this legislation is hardly typical. It is complex, it is voluminous, and it is politically highly sensitive.

That is because the envisioned update of the legislation is going to be tackling issues as divisive as unmet medical need, affordability of medicines and patient access, and modernizing medicine development pathways. One of the most sensitive topics covered by the draft is the incentivization of innovation, particularly to restock the pipeline of antibacterials, and to promote treatments designed specifically for rare diseases and for children. This is a real hot potato in Europe, where advocates of research are in a continual face-off with critics alleging price-gouging by abusive monopolies. Controversially, the draft proposal toys with options for cutting back on the current EU incentives or for attaching onerous conditions to them, and offers calculations—admittedly uncertain—of the impact of each option, economically and in terms of product innovation. It is widely believed that questions over these calculations contributed to the rejection of the draft. The atmosphere is made all the more tense by widespread demands for drugmakers to come clean over how far public-funded research has benefited their products, and to cut their prices accordingly.

The discussions on the proposals—when they eventually appear—are likely, therefore, to be long and contentious. And a clock is ticking ominously. The European Parliament’s current five-year term ends in mid-2024, which makes the chances more remote of reaching even a preliminary agreement among MEPs every time the publication date of the proposals slips back. The next European Parliament—and its new intake of MEPs—is under no obligation to pick up unfinished business where its predecessor left off, so the proposals could just fade into oblivion, and an entirely new legislative procedure would be necessary.

That will be small comfort to the patients hoping for faster authorization of better medicines, or to healthcare payers anxious to cut back on excessive rewards for new drugs, or to drug firms—and investors—looking for greater clarity over the operating context in Europe. They will all be hoping, as 2022 turns into 2023, that yesterday is not going to be the pattern for tomorrow.

is Pharmaceutical Executive’s correspondent in Brussels.

Europe Report

Making sense of surprise rejection of draft proposals.

Long-Sought Reforms To EU Drug Rules Hit A Snag—What Now?

Held for the first time in person the second week of October, Reuters Pharma 2022 in Nice, France brought a lot of energy and excitement back to this staple European event, previously produced by eyeforpharma and held annually in Barcelona. The 

 will make a return to Barcelona, and back to its traditional spring schedule next year.

What makes this conference a must is the ex-US pharma factor, and the whole reason for pharma’s need for global presence and expertise in market access, patient centricity, and healthcare professional (HCP) approaches.

Executives share insights at recent conferences.

Pharmaceutical Executive-11-01-2022