While the life sciences industry has traditionally been shaped by large pharmaceutical companies, there are several transformational forces that are shaping the metapharmaera—the next stage of life science market innovation for large and mid-size pharmaceutical and emerging biopharma (EBP) organizations. This is due to the growing segment of EBP companies, a rising innovation start-up ecosystem, big tech’s investments in digital health, and the convergence of life sciences with the healthcare industry for offering holistic personalized care. Each is a transformational force impacting the changing face of the market. At the same time, global pharmaceutical growth is projected to slow down in the next five years. Thus, the question becomes: how do pharma organizations stay ahead of the curve in this ever-changing environment?


In 2022, global pharmaceutical sales were $1.482 billion (vs. $1.450 billion in 2021), with 63% attributed to larger companies,30% to mid-small-size firms, and 14% to EBP companies.

The top 15 large pharma companies grew by 9% overall; and when counting the impact of the COVID-19 vaccines, the figures more than double.1Drivers behind this growth are mature brands. In fact, 40% of total pharmaceutical growth is driven by just 25 brands, all of which belong to the top 15 companies.

Looking at the pipeline, EBP organizations are responsible for approximately 65% of the molecules in the global R&D pipeline, and they are holding onto launching their assets, putting pressure on large pharma companies’ need for innovation, and current dependency onmature brands.

Pharmaceutical growth has been healthy to date (a 7.3% five-year compound annual growth rate from 2016-2021),

but it’s expected to slow down to 3% to 6% CAGR through 2027 in almost all major markets—with the US market decreasing from 4% to 2% CAGR, while Latin America, Asia-Pacific, Africa, and the Middle East are expected to grow by more than 10%.

COVID-19 vaccines and therapeutics will add close to $250 billion globally by 2026.

The evidence clearly suggests that the pandemic years were challenging to launch new medicines and devices. Apart from a few exceptions, most new drug launches underperformed when compared to other historic launches. This underperformance has been driven by a combination of three environmental factors: 1) the reduction in available patients as journeys to diagnosis and treatment slowed and became more complex, 2) budgetary challenges on healthcare systems, and 3) the long-term changes to the healthcare professional (HCP) engagement model—which has become more virtual but also with reduced interactive engagement in many countries.

Healthcare practitioners are spending more time online, thus, pharma companies must embrace a hybrid model for engagement. For instance, in a February 2022 webinar, a poll of participants found that 66% of these firms were already embracing the hybrid interaction model and another 22% were piloting it.

Implementing a flexible, omnichannel model is what will lead to success.


To add to the challenges the pharma industry faces, governments are slowly shifting the focus from disease treatment to prevention as better health is inherently less expensive than poor health. In the context of rising costs of healthcare infrastructure, payers will prioritize healthcare delivery efficiencies and rationalize pharmaceutical spending, requesting additional evidence to support claims. In the EU, for example, €210 billion is being spent on the total cost of care with the major drivers of cost consisting of healthcare (excluding medication) at €95 billion, productivity losses at €54 billion, and informal care at €45 billion.

Preventative care, earlier diagnostics, and patient empowerment are major drivers to bring these costs down, which also becomes a goal of governments and pharma companies in the metapharma era.


How can pharma organizations stay ahead of the curve in such disrupted times?The answer is taking advantage of three key areas of innovative investment:1)doubling down on digital transformation, 2) adopting artificial intelligence (AI) at a scale, and 3) embracing innovation at the core and not atthe periphery. Doubling down on digital transformation. Adopting digital at scale and predominantly across the patient care pathway is a market mandate, effectively catalyzed by the pandemic. It assisted in minimizing the disruption felt by patients during the pandemic with the offering of new solutions and engagement models.

Digital solutions have become essential for driving innovation in the healthcare sector. Digital therapeutics (DTx) and digital care products that incorporate software to treat, prevent, or manage specific diseases or conditions have been proliferating. There are more than 250 such products, such as DTx, digital diagnostics, and more now identified, including approximately 150 products that are commercially available and the rest are in development. Apps are increasingly focused on health condition management rather than wellness management, with the former now accounting for 47% of all apps in 2020 (up from 28% in 2015) and with mental health, diabetes, and cardiovascular disease-related apps accounting for almost half of disease-specific apps.

Enabled by digital technologies, such as medical devices for passive data collection, provider-patient platforms, and selfhelp disease management mobile apps, patient experience becomes key to expanding the value constructs; thereby, moving slowly away from basic drug treatment to holistic patient care.

Digital biomarkers to remotely monitor patient health are being validated by feasibility studies with the intent to incorporate them into clinical trials and patient care. In total, 438 studies have examined 933 distinct biomarkers, with more than half of the trials in neurology, musculoskeletal disorders, and sleep.8Among these are digital biomarkers for neuromuscular disease to track muscular dystrophies and motor neuron diseases. Additionally, sensors and digital biomarkers are being incorporated into the design of clinical trials, enabling decentralized and hybrid trials with home visits, reducing patient and investigator burdens, and accelerating study timelines. Since 2016, the percentage of trials using connected medical device technologies doubled and is now 8%, with 10% of Phase II and III trials now including connected devices.

 Hybrid decentralized trials are expected to reduce the number of on-site visits required of patients in Phase II and III trials by 44% to 61%, depending on the therapy area, as visitsshift offsite.

There is also the rise of companion digital biomarkers and/or patient engagement apps for holistic treatment delivery. Clinical research organizations and an increasing number of startups are rolling out solutions to match patients directly to clinical trials, offering trials as a care option and, again, revolutionizing the patient experience of matching.

Digital engagement, as this relates to promotional activity, is also impacting patients and healthcare practitioners, although in different manners. Direct-to-consumer (DTC) advertising varies across countries due to regulatory guidance. However, AI embedded in sales and marketing strategies is effective to understand profiles and archetypes of patients and enhance pharmaceutical promotional activity for a patient-centric approach. For healthcare practitioners, the life sciences digital transformation is mostly focused on targeting the right practitioner through the right channel with the right content. Several offerings from small to large agencies are forever changing marketing to hyper-targeted approaches, embedding AI with behavior-changing intelligence for decision-making.

Doubling down on AI across the supply and value chain. AI is driving greater efficiency and providing an edge within the pharmaceutical market. This technology is finding application in a plethora of use cases, such as in drug development, clinical trials, during the drug approval and launch processes, as well as in real-world evidence. While use cases, such as AI in drug discovery and development, are now on the rise to be proven and mature, others are already delivering tangible proof points when employing AI compared to traditional approaches. Nearly eight out of 10 (78%) Phase II protocols and 69% of Phase III protocols have at least one substantial protocol amendment, and they average 2.7 and 3.3 per protocol, respectively.

It’s estimated that pharma and biotech companies spend $7 billion to $8 billion (USD) annually to implement protocol amendments. Previous research showed that 23% of these amendments were considered “completely avoidable” because they were due to protocol design flaws, inconsistencies, and/or errors.

We can also predict Phase III trial success with more than 80% accuracy. Using AI has demonstrated that 90% of protocols can be revised to mitigate risks before study start-up. It also helps to speed site identification and results in faster patient recruitment vs. historical benchmarks.

Another case in point is right patient identification with digital diagnostics and supporting HCP productivity. As an example, type 1 diabetes is often misdiagnosed as type 2 diabetes in adulthood, leading to treatment paradigms most characteristic of type 2 diabetes. Approximately, 40% of cases fall into this category.

Up to 10 million people with type 2 diabetes in the US are likely to be receiving treatment for a disease they don’t have. As an example, IQVIA, in collaboration with JDRF, developed an AI solution to identify type 1 diabetes patients most likely to be misdiagnosed and generate the “true type 1 diabetes” population.

JDRF is currently planning deployment as a decision support tool for clinicians to aid in greater diagnostic evaluations.

Embracing and accelerating innovation.For large- and mid-sized pharma companies to stay ahead of the curve in the metapharma era, innovation should be embraced more broadly and reflected across applications on innovative mechanisms of action, new trial design, advanced drug delivery, novel reimbursements, and business models. The goal is to cater to patient affordability and health equity, offering the latest innovative solutions to century-old problems.

When it comes to launches, it’s not enough for the product to be innovative. The way it’s launched must be unique, too. In fact, embracing innovation is the only strategy that proved effective for drug launches during the COVID pandemic. Examples of successful launches in the last two years have brought forward some real innovation and disruption. Biohaven, with the migraine treatment Nurtec, addressed the unmet patient need by approaching the patient experience more holistically.

For instance, Nurtec combines prophylaxis and acute treatment with a dual action; while at the same time, Biohaven was unusually fast in rolling out its digital-first strategy in the US and had a highly impactful DTC campaign. At the height of the pandemic, the company used novel channels—such as TikTok, social media celebrity ambassadors, and a race car sponsorship—to elevate the solution, which was combined with a strong virtual infrastructure for diagnosis and prescription and an effective affordability campaign.

Novo Nordisk treatment Wegovy focuses on obesity. Innovation is not about breakthrough change with reference to the mechanism of action but also about the simplicity of dosing or patient convenience. Kesimpta, by Novartis, and Phesgo, by Roche, are good examples of improved patient experience and simpler formulations that take the burden off healthcare systems, while Kesimpta also stands out for a strong patient support program.

AI and digital transformation are driving forces behind innovation and successful cases in the metapharma era. This innovation also comes from healthcare startups that challenge the art of possible breakthrough solutions and partner with established pharma organizations to co-create disruptive solutions. With more than $100 billion invested in healthcare startups alone in 2021 and 1,300 global incubators in corporations,14there is no end in sight for how AI, digital reformation, and innovations will continue to push the industry forward.

The life sciences sector is growing, but the increase is projected to slow down while launch challenges, customer engagement, and broad disruption trials continue to persist. Digital transformation and AI technologies deliver tangible proof points on how to rise to these challenges. Embracing innovation is the key ingredient for success in the metapharma era.

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Articles

Feature

As the life sciences industry enters this next stage of growth, capitalizing on AI and digital transformation will be key to propelling innovation and ensuring that companies are prepared to tackle the challenges ahead.

Navigating Disruption in the Metapharma Era

Pharmaceutical and biotechology merger and acquisitions in 2022 were heavily driven by strategic priorities, business trends, and the stock market performances of the two sectors. These factors are also driving the outlook for 2023.

Although the pace of innovation was strong for both pharma and biotech companies, their financing and stock market situations could not have been more divergent in 2022. Although there was a slight improvement in the early part of 2023, there was a huge decline in the biotech stock market prices, the number of initial public offerings (IPOs), the number of secondary offerings, and the market values of biotech companies in 2022. For example, according to Young & Partners data analyses, the number of IPOs dropped from 126 in 2021 to 17 in 2022. This made it much harder to raise money for public and private biotech companies.

Many biotechs that had plans to go public have been experiencing serious funding problems since the IPO market has been an important source of attractive equity funds to extend their research and regulatory runways and to provide a way for the private owners to achieve liquidity. The suppressed market values and the plunge in public offerings have driven many to sell themselves earlier and to pursue strategic partnerships with other companies.

The huge drop in biotech stock market valuations and IPOs has also pushed down the private equity funding valuations and availability. Venture capital firms took big paper losses on the existing ownership positions in private and public biotech/biopharma companies and are cautious about making new investments in private companies if there is an uncertain route to an IPO.

With many of the private biotechs running out of money, downsizing announcements will continue to be seen on a regular basis. Some of the biotech companies will not survive and will have to shut down. This down cycle has happened to biotech many times historically; so, this is not a new development in the history of the industry. Unfortunately, downturns generally last a number of years before there is a recovery.

Collectively, business uncertainties and the difficult public and private equity markets have had an impact on the biotech M&A market with regard to the value expectations of sellers and buyers. On the other hand, pharma company shares did quite well in the stock market on both an absolute and general relative basis. Pharma M&A has been a more normal function of pharma company business strategies. Although the big pharma organizztions have revived their ability to invent new drugs, they still need to supplement their own efforts with acquisitions of and collaborations with mid-sized pharma and biotech companies. This is particularly true for manufacturers facing patent cliffs for their major drugs.

The rest of this article focuses on pharma and biotech M&A activity. All the numbers cited are Young & Partners proprietary data.

Pharma M&A market: 2022 recap, 2023 outlook

In 2022, the dollar volume of pharma deals was about the same as the year before—$59.9 billion vs. $61.2 billion in 2021. However, there was a remarkable increase in the number of deals, from only 14 in 2021 to 42 in 2022. The average deal size dropped from $4.4 billion to $1.4 billion. Biotech deals are not included in these numbers. This shift to a large number of medium-sized deals is a reflection of a number of driving factors.

Big pharma’s balance sheets and cash flows are strong in general. As such, they have a great deal of dry powder. However, their more selective, cautious acquisition of medium- to small-size pharma companies reflects 1) concerns about the overall business environment; 2) a move away from mega deals; and 3) access to a wide variety of other strategic asset avenues, such as biotech acquisitions, partnering, and in-licensing.

Big pharma companies have rightly come to realize that mega mergers/acquisitions are less effective compared to targeted acquisitions of pharma companies for a specific strategic purpose. The mega deals in the past did have significant cost synergies. But for the most part, it did not drive an increase in innovation and research results.

The M&A market outlook for pharma deals this year will likely be very strong in terms of the number of deals and flat to slightly up in terms of dollar volume. The only possible exception will be if one of the regional global players does a large deal in order to change its geographic profile. The driver of activity will remain the same as in 2022.

Biotech M&A market: 2022 recap, 2023 outlook

In 2022, 45 biotech deals worth $24 billion were completed, as compared to 48 deals worth $27 billion finalized in 2021—representing modestly lower numbers in terms of the amount and dollar volume of deals. There were no large transactions, except for Pfizer’s $6.2 billion acquisition of Arena Pharmaceuticals.

Although the industry is well off the record dollar volume of $53 billion that was set in 2020, the last two years have been the highest in years in terms of the number of deals completed. The next highest year over the last 30 was 2016, when 35 deals closed.

What is driving this trend? First of all, most of the acquisitions are being executed by pharma companies who are looking to build their pipelines and revenues. Second, with the collapse of the IPO market, a severe reduction in equity funding, and a dramatic drop in the share prices of biotech companies, the latter are more willing to consider a sale of the company at an earlier stage than they were just a year and a half ago. Third, pharma organizations are using strategic partnerships and licensing to access biotech company technologies and drug candidates. Thus, M&A is not the sole method available to achieve pharma company goals.

What is the outlook for biotech M&A in 2023 and beyond? Expect more of the same in the future, driven by the same factors, with a relatively robust number of biotech deals being completed for the next couple of years, along with strategic partnerships and licensing.

How will senior management approach M&A in this environment?

Big Pharma management will be heavily focused on acquisitions for which there are compelling strategic reasons and where the same results cannot be obtained internally or through licensing and strategic partnerships. There will be a particular focus on targeting companies with synergistic technologies and drug candidates and new technologies deemed to be strategically critical to add.

However, it will be challenging to determine what the right valuations are for each deal. With the collapse of the public market values for biotechs and the downward repricing of private biotech companies in down rounds, matching buyer and seller expectations will be a challenge. The use of earn-outs has ballooned in the last couple of years as a way to bridge the gap between buyer and seller value expectations.

Separately, there are pharma companies facing major revenue shortfalls due to patent expirations and geographic pressures faced by non-Western players who are too dependent on their home countries, such as organizations in Japan and South Korea.

Regulatory restrictions, such as the expanded CFIUS rules that impose serious review requirements for Chinese companies and investors seeking ownership of US pharma and biotech companies, will continue and inhibit those deals. Similarly, movements by foreign organizations and investors in China are being constrained by the uncertainties related to Chinese government regulation and controls around a variety of industries, such as healthcare.

Geographic considerations for the M&A market

The largest volume of M&A deals in biotech was in the US, accounting for 31 of the 45 deals in 2022. As we know, the biotech industry started in the US, and the US has had the best overall ecosystem to support biotechnology drug innovation for many decades. For that reason, the US is home to the largest number of biotechs by far; therefore, one would expect greater M&A activity in North America The rest of the deals have been primarily in Europe. Very few biotech and pharma deals are being executed in Asia and the rest of the world, but this will change over time as biotech activity in Asia continues to expand.

The picture, surprisingly, has been different in pharma, with Europe equaling the US as the location where deals were completed. In 2022, 15 deals were completed in Europe, compared to 18 in the US. Traditionally, Big Pharma has been far more diverse geographically compared to biotech.

The potential impact of economic and geopolitical trends

Although we may be facing recessions in many global regions (particularly in the EU and emerging markets), no one expects the downturn to last for a long time. As we all know, pharmaceuticals are much less cyclical than most industries. Although the war in Ukraine and the geopolitical tensions between the West and China have become severe, these factors will not have a dramatic effect on pharmaceutical demand or strategies.

Although the biopharma industry is facing a few challenges that are global in nature, such as the ongoing challenges related to supply chain problems and the disruption that zero COVID-19 policies in China and the war in Ukraine have had on clinical trials, most of the challenges are industry specific. Examples include the sector’s dependence on China and India for many active pharmaceutical ingredients and drug production of certain products, the ongoing efforts globally to constrain drug pricing, and the rapidly changing technologies related to drug discovery innovation. These industry-specific challenges will have a major effect over time on pharma and biotech companies and the role that M&A will play in their strategic plans.

, CEO and president of Young & Partners, and a member of Pharm Exec’s Editorial Advisory Board. He can be reached at 

Features

While industry financial markets continued to experience subdued dollar volumes in 2022, dealmaking held steady—with factors such as pharma pursuing strategic priorities and biotech funding woes playing major roles.

Biopharma M&A: Year in Review, Ripples Ahead

When the economy is good, companies expand their workforce. This is true across a lot of industries, especially the pharmaceutical sector. Over the past
few years, some companies initially found themselves flush with cash as the pandemic put a spotlight on the industry for investors. Over the past several months, however, the overall economy has started to slow down—fearing of a looming recession—and there’s less funding available for biopharma companies.

Over-expanding during a boom can lead to a variety of problems. The biggest issue is that when the economy tightens, organizations may find themselves in a position where they have to downsize and lay workers off.

recently spoke with Greg Skalicky, president and chief revenue officer of Eversana. While the conversation was mainly focused on how pharma companies can utilize outsourcing, he also shares some issues specifically impacting smaller, or emerging, life sciences firms that are focused on developing new drugs. Many of these issues are related to employee costs. Recognizing and understanding them may help leadership teams at these companies avoid having to reduce staff when the overall economy is hurting.

“We met with one pharma company, and they did a deep dive across the entire business as it pertains to commercial,” says Skalicky. “They said that if they were to whiteboard it today, the model they put in place is an exact example of what to not do. We determined that on a healthcare provider basis, they have 15 touchpoints within the organization if they have a question.”

He explains that there are often too many different teams working on an individual product. At another company Skalicky met with, it was discovered that half of the employees working on the same product had never even met each other. This can overcomplicate the process and make solving problems take longer, as it may not always be clear who needs to be contacted. More importantly, high employee costs can put stress on the company’s resources and force them to make cuts if, or more likely when, a launch is delayed. Leadership needs to take these issues into consideration, especially when looking to expand the company or develop and launch a new product. They must consider the financial risks and benefits of hiring people prior to launch to ensure that they can then retain those employees post-launch. Under normal circumstances, this is especially important with new products since market entry can be risky.

“About 70% of product launches fail to meet expectations,” explains Skalicky. “It’s a very low success rate. [There] are about 40–45 FDA approvals each year, with a similar number of clinical response letters [CRLs] administered. If a company receives a CRL, that means they are delayed about 12-18 months from their original launch window. If they have hired staff, they will have to terminate 90% of their employee base the next day.”

As the economy becomes more unsteady, the situation becomes even riskier. Many smaller companies’ revenue streams rely on developing new products to either launch commercially or license out to larger organizations. Investors may be harder to find, and funds will likely be tighter. Unfortunately, there aren’t many ways to speed up the development process; meaning, companies can’t reduce the amount of time they have to cover employee costs prior to launch.

Smaller companies are often focused on developing just one drug or treatment. Having to reduce the workforce at a critical moment can cause serious problems and further delays, which could trigger more financial stress. The current economic climate is a good reminder that it’s important for a company’s leadership arm to avoid constructing overly complex teams with too many moving parts.

“Pharma is one of the most highly regulated industries in the world, and there are no shortcuts that life sciences companies can take in drug development,” notes Skalicky. “You may see digital transformation helping companies be faster at moving products through the process; but at the end of the day, they need to enroll patients in clinical programs to prove that the product is safe and effective. There are things that will speed it up a bit, but there won’t be dramatic cuts to timelines.”

As Skalicky points out, there are no shortcuts to drug development, and companies need a solid workforce to get the job done. Having the discipline to avoid over-expanding during good times will provide life sciences organizations a greater chance to hold onto valuable team members when things slow down.

Leadership

The importance of not over-expanding during development, launch.

Balancing Pharma Hiring Practices in Good Times and Bad

The healthcare industry has made an emphatic and admirable shift toward putting the patient first in recent decades. While it might be relatively straightforward for healthcare providers (HCPs) to be patient-centric, it is not always so clear for life sciences companies.

What can the industry do to ensure that our customer engagement, our clinical focus, and our product education is focused where it needs to be?

Pharmaceutical companies can be more patient-focused by effectively engaging with HCPs and physician leaders on the frontline of medical care. Tapping into physicians’ knowledge and experience throughout product development—from R&D to commercialization—can help to focus the industry’s efforts on producing the best results for patients. Working closely and compliantly with a range of key opinion leaders (KOLs) has often made the difference when it comes to ensuring that a new product most effective and able to efficiently reach those who will benefit from it once it comes to market.

Most KOLs are being slammed on all sides and channels by information and engagement from the pharmaceutical industry. They are drowning under the deluge yet need it to stay on top of the latest medical science innovation. For instance, there has been a steady increase in the publication of scientific information as the number of scientific papers has grown by 9% each year for the past several decades.

 Meanwhile, there are fewer physicians to consume such mountains of new information. The Association of American Medical Colleges projects a shortage of as many as 124,000 physicians by 2034.

 Companies need to work harder than ever to break through the increasing level of noise and work effectively with KOLs.

On the other hand, pharmaceutical companies’ medical affairs teams are also slammed. Medical science liaisons (MSLs) have an increasingly broader set of responsibilities to capture more information and disseminate it to the right experts, which now include digital opinion leaders (DOLs).

While commercial sales and marketing teams have the advantage of relevant technology, MSLs are frequently left without the right type of tech support. To compensate, medical affairs teams often purchase physician-centered data from various third-party vendors, such as Definitive Healthcare or Veeva Link. This data may be records of physician attendance at conferences or published research and more. While this data has value, it is not easily actionable. MSLs must sift through each data point and synthesize it all to draw conclusions before taking action, and this takes time. With artificial intelligence (AI) technology, however, all these data sources are analyzed in an instant and run through advanced machine learning models to provide MSLs with reliable insights and suggestions on the next best action to take with KOLs—such as the next best message, the next best time to engage, and through the next best channel.

Scientifically engaging with KOLs while remaining aligned with the rest of the organization’s outreach to the same physician requires more sophisticated tools and technology. It’s time to be as KOL-centric as we are patient-centric.

The starting point is to understand the needs and interests of KOLs. Look at the opportunities, initiatives, and programs in a pharma company’s R&D pipeline and clinical development programs and start to bring their needs and interests together. It’s about finding that sweet spot between unmet patient needs, corporate scientific objectives, and the interest area of the KOL.

Now more than ever, to be successful and ensure that their products best serve patients in need, companies must design their entire operation to facilitate easy and effective collaboration with KOLs.

KOL-centricity must be fundamentally rooted in empathy. According to psychologist and author, Daniel Goleman, there are three types of empathy, each of which is crucial to establishing a long-lasting partnership with another. Those three types include:

 The ability to understand another’s perspective.

The ability to physically feel what another person feels.

The ability to sense what another person needs.

Combined, it comes down to considering the relationship from the other person’s point of view—which, in this case, is the KOL’s. MSLs should put themselves in the KOL’s shoes and think carefully about why they would be interested in working with them. What’s in it for the KOL? What specifically do they need from the relationship?

“First and foremost, MSLs should work to understand what we are looking for specifically, what is important to me in caring for my patients with a specific disease or complication,” says Vidit Bhargava, MD, a pediatric critical care specialist at the Children’s Hospital of Alabama and an assistant professor in the department of pediatric critical care at the University of Alabama at Birmingham, in an interview. “Learn more about the medical problems that I am trying to solve in my practice. Start there, and I will listen.”

Life sciences companies should also design the full scope of their medical affairs operations, including new clinical evidence dissemination, publications, conference presentations, advice-seeking plans, and one-on-one engagements to make it easy and fruitful for KOLs to engage with them. It should always be a seamless experience. Having the same conversation with multiple representatives of the same company, for example, is frustrating. Streamlining engagement will help KOLs feel like their time is respected and valued—and that sentiment goes a long way to cementing a relationship.

KOLs must also gain value from their interactions with the company. It cannot be a one-sided relationship. As influential and seasoned professionals, these healthcare leaders have worked hard to get to the pinnacle of their field and are eager to use their hard-earned knowledge and experience to drive progress and improve patient lives. Organizations that engage with KOLs most successfully employ high levels of emotional intelligence, constantly thinking about how their own goals and objectives align closely with the goals and objectives of KOLs. Considering why a KOL might need a company as much as the company needs the KOL is key to ensuring an ongoing and mutually beneficial relationship.

One way to facilitate meaningful relationships is to create opportunities for KOLs to proactively engage with a company and ask about new products that might be useful for their patients. Creating this environment will set the stage for a productive relationship.

“I meet with companies to find out what the new developments are and to learn how I can do things better,” says Bhargava. “For example, when I attend annual scientific meetings—most recently, at the Society of Critical Care Medicine Annual Meeting—I am often able to meet with a range of industry professionals. I like this because then I can reach out to many of them at the same time.”

Through such interactions, Bhargava often has his interest piqued, enabling him to follow up with those whom he would like to engage with further. As he explains, his interest is driven by his academic and research interests as well as professional goals.

“We are looking for new innovations that will enable us to measure the function of the heart in real-time, second by second,” says Bhargava. “This is critical for being able to catch an aberration in the heart early and prevent larger issues for the patient. I’ve spoken to MSLs to understand this technology better and how it has been validated specifically for use with children.”

For Bhargava, engaging in conversations with MSLs can be helpful because they are often at the forefront of knowledge about new products. Scientifically-valuable engagement can often be the starting point for understanding how KOLs might deploy new technology or prescribe new drugs to benefit patients.

“Not every conversation with pharmaceutical or medical device companies must be about a sale. Provide information and demonstrate how a new technology or medicine can improve a patient’s life,” says Bhargava. “Don’t sell me. It’s too impersonal and deters me from learning.”

Clearly, having informed and targeted engagements with KOLs is more impactful than taking a one-size-fits-all approach. The impact of this kind of engagement can extend well beyond discussions that KOLs have with MSLs or sales reps. Useful engagement with KOLs can extend across an entire organization, even helping to inform and serve the research and development process as well as the commercialization of new products. The more company representatives can speak directly to the interests and needs of a KOL, the more likely their product truly serves patients.

Companies can most effectively optimize all interactions with KOLs by sharing information across teams.

All too often, sales teams’ interactions with KOLs will go unnoticed by medical affairs and vice versa due to strong compliance firewalls build between both teams. This can lead to awkward and often inefficient exchanges that waste the KOL’s time and sour the relationship. Everyone needs a complete picture of who is interacting with a KOL and have compliant visibility into relevant pieces of the information exchanged. Integrated customer relationship management (CRM) systems specifically designed for the unique needs of both commercial and medical teams open windows of visibility. When those systems are boosted by AI technology, it enables collaboration between sales reps, brand teams, and MSLs for personalized, orchestrated engagement with KOLs.

As an example, in preparation for a new product launch, MSLs could capture and share valuable insights from KOLs about potential headwinds the product might face in a certain subgroup of hospitals—such as the ease of conducting any required companion diagnostic tests for patients. Armed with such nuanced product information ahead of launch empowers brand managers to develop collateral that educates patients about how and where to get the diagnostic tests. Similarly, this insight helps inform the sales process. AI technology can ingest this information, analyze it against all of the target physician personas, and automatically present commercial teams with the right content to present to each physician across an omnichannel launch campaign to strike the right chord.

The same benefit happens in reverse. As sales reps introduce the new product to physicians, they can capture physicians’ technical questions and route these to MSLs. This information, filtered through AI analytics models, automatically informs MSLs what information should be proactively explained or emphasized with each KOL they engage with in their next conversation, or it can alert the MSL to reach out to a KOL immediately if there is an urgent need to solve a patient problem.

Most organizations have CRM systems and subscribe to multiple data sources. What they lack is the intelligence technology to make the information meaningful and actionable for MSLs.

Life sciences companies often don’t share such potentially valuable information, in part, because the industry discourages information-sharing out of fear of compliance-related issues. Yet, valuable data that could easily (and compliantly) be collected from all the various interactions a company has with KOLs fall by the wayside out of an abundance of caution. Instead, leverage technology to employ compliant solutions that will create “interest maps,” or profiles that can help inform representatives from across a company about what patients a KOL sees, what conferences they attend, what research they publish, and more. It helps MSLs understand a KOL’s engagement preferences, such as timing, channel, content, and format.

“Figure out the right time to provide me information so I can fully take it in without taking time away from patients,” says Bhargava. “This allows me to focus and better absorb information.”

A KOL’s professional journey—what patients they see, what drugs or products they are interested in, and what research they engage in—should be fully understood and shared across the entire company, even outside the commercial and medical affairs groups. Yet, this information is locked in silos. One typical example of this kind of blind spot pertains to clinical trial investigators who are often identified using a centralized database. Many times, information that is available about emerging investigators is not shared widely across a company. That means that all company representatives who might interact with prospective KOLs are doing so without a complete picture of their knowledge and experience.

It also helps the organization in far-reaching ways. For example, an MSL who uncovers a KOL’s research interests can bring that information back to R&D as a potential candidate for a clinical trial investigator role, or an MSL gains important insight into an unmet need through a discussion with a KOL. When channeled compliantly along to commercial and R&D colleagues, these insights can be used to appropriately position a product, educate patients, as well as inform the company’s R&D pipeline.

According to a survey conducted by the Society for Participatory Medicine in 2017, more than 80% of surveyed physicians reported that they believe personalized interactions with pharma companies can be beneficial for patient care.

 Life sciences organizations must take this data to heart and do their best to value these critical relationships and what they can do to serve patients’ needs. The role that KOLs play in helping to ensure that the work that pharma companies do focuses on improving lives is undeniable. That is why, now more than ever, the pharma industry must ensure these important relationships are given the respect they deserve. KOLs should be provided with what they need when they need it. To do this properly, the industry must shift away from the one-size-fits-all approach to more personalized engagement—to become as KOL-centric as patient-centric.

, senior director of medical strategy, Aktana

Landhuis, E. Scientific Literature, Information Overload,” 

https://www.nature.com/articles/nj7612-457a#citeas

Renfrow, R. AAMC Estimates 124k More Physicians Will Be Needed by 2034, with the Largest Gap Among Specialists. 

https://www.fiercehealthcare.com/practices/physician-shortage-continues-to-widen-now-estimated-at-124-000-by-2034

Sands, D. Evidence! New S4PM Survey Shows People Want to Collaborate with Their Doctors and Co-Produce Their Clinical Data. Society for Participatory Medicine, February 2, 2016, 

https://participatorymedicine.org/epatients/2016/02/s4pm-survey-shows-people-want-to-collaborate-w-docs-and-co-produce-clinical-data.html

Global medical affairs teams seek better support to manage relationships with key opinion leaders—and find that balance between patient needs, scientific objectives, and the interest areas of KOLs.

Being KOL-Centric: More Meaningful Expert Engagement

The life sciences industry has always partnered with key opinion leaders (KOLs) for their expertise to raise awareness of new products, treatments, and/or other key issues. Over the past few years, however, the industry has had to adapt how it interacts with KOLs. The COVID-19 pandemic caused many key conferences to either cancel major events or switch to online platforms. When live conferences were still held, event planners often had to implement safety measures that included social distancing policies.

The result was that KOLs—who were very active at these events—were not able to interact with other doctors, researchers, and key figures in the industry as they normally would have. This led to a rise in a different type of opinion leader: the digital opinion leader (DOL). These influencers use digital platforms, such as social media networks, to connect with audiences, other doctors, and key patient groups and suddenly found themselves in a much more important position within the industry.

spoke with Donna Short, executive vice president, global ambassador strategies, MJH Life Sciences, about the differences between KOLs and DOLs and how each were uniquely impacted
by the pandemic.

“KOLs lead in thought, perspective, and vision for the future,” says Short. “Part of what they missed during the pandemic was the ability to have spontaneous conversations with industry leaders at conferences and events about data to discuss how they might be able to optimize trials in a better fashion, unless the meeting was set up for that specifically. Digital KOLs (DOLs), meanwhile, are willing to share thoughts and take a stand, but they may not be the ones leading the research or applying for grants. Sometimes, an opinion leader can be an influencer as well. They also usually have a lot of emotional intelligence around what they share and how they share it. They have many patients [who] follow them as well.”

As the world begins to move past the pandemic, many of the restrictions are being lifted. Live, in-person events are returning, and attendees are facing fewer and fewer limitations. KOLs and DOLs both adapted to the changes brought about by the pandemic, but they are now facing a new question: how do they adapt to a world that’s returning to normal?

On one hand, things could go back to how they were prior to COVID’s onset. But the pharmaceutical industry started to notice certain benefits to how DOLs operate. In addition, while KOLs and DOLs are two separate groups, there is a lot of overlap. Experts who previously worked as KOLs discovered new digital platforms to spread their expertise. Other KOLs teamed up with DOLs for various strategies to create unique ways of interacting with their intended audiences.

Moving things backward may not be the right answer.

Christian Rodgers, senior vice president of social media at branding and advertising firm Precision Effect, spoke with Pharm Exec about his work with both KOLs and DOLs, specifically how each adapted to recent times. According to Rodgers, both groups complement each other, and one doesn’t have to replace the other.

“I do see KOLs and DOLs coexisting,” says Rodgers. “Social media usage by doctors varies, with some easily adapting to platforms like TikTok or Instagram Reels, influencing their audiences with authority. While some may possess varying degrees of polish, others just have an unwavering passion for the conditions they treat and their scientific intricacies. For example, as an agency that’s worked extensively with eye care companies, we have gotten to know numerous DOLs who produce captivating content showcasing their fervor for corneas and the more visual aspects of eye science.”

 also talked with Veeva Systems’ Kilian Weiss, general manager ofVeeva Link, a platform for medical, commercial, and clinical teams to gain real-time intelligence on KOLs, conferences, health systems, scientific awareness and sentiment, and medical insights. He’s noticed a long-term trend of fragmentation of experts. Opinion leaders are becoming more and more focused on specific disease areas, treatments, or technologies. This is partially a result of the rise of precision medicine, which has resulted in more segmented patient and disease groups and, thus, many more channels ofcommunication.

“DOLs have a very important role as an intermediary to bring this information into a very wide audience that is consuming digitally,” Weiss tells 

. “That can be physicians, who we’ve seen consuming information increasingly via these digital channels. There are new audiences, which include both patients and disease experts. The macro view is that the world is more complex; so, we have more experts in more specialized areas and many more groups that are bridging that information to everyone.”

Another factor that is changing the way that opinion leaders interact with the modern life sciences industry is new, high-tech therapies. As Weiss explains, KOLs and/or DOLs who are focused on a disease may have to team up with an opinion leader who is focused on the technology being used. As an example, Weiss points out that experts at MIT are working on algorithms to detect biomarkers in a patient’s voice that have been discovered by doctors that can indicate a COVID infection. These algorithms could be used with phones to detect the virus through the sound of someone’s voice.

To properly discuss this research, a COVID opinion leader would have to team up with an opinion leader in the tech field who has expert knowledge in how algorithmslike this work.

“These types of experts don’t meet at any conference, or really anywhere,” notes Weiss. “It’s a totally different world. Traditionally, you’d have an expert who knew the science, and they knew the patient. It was one community, and they were figuring it out. Now, however, there’s incredible potential for life sciences companies with these specialized problems to bring these various experts together. There’s no organic process to do that, and it could transform how patients arebeing treated.”

According to Short, KOLs are already used to working with teams, so reaching out to new types of experts shouldn’t be an issue. She notes how, in oncology, there is a KOL for radiation, medical oncology, and surgery. The key, she says, is allowing each opinion leader to focus on their area of expertise, and then allow the other experts to lead the conversations or education when it’s appropriate.

One issue consistently comes up during conversations about opinion leaders using digital platforms such as social media, and it’s completely unrelated to the pandemic or the easing of restrictions. Unlike medical conferences and industry events, social media platforms can be very unpredictable. For example, multiple experts point out that Twitter has recently gained a reputation for becoming more caustic and experiencing more troll behavior. While it’s impossible to confirm whether the tone of a social media network has changed, the perception that it’s become less friendly due to outside changes can be enough to drive people away.

This can force DOLs to have to change their platform, as it’s important for them to be active on the same platforms as their intended user base. Short mentioned that she’s seen a lot of the experts she works with switch from Twitter to LinkedIn, where they feel the general atmosphere is less caustic. Rodgers, however, points out that many of the topics discussed by medical DOLs don’t attract too much bad behavior on social media.

“Trolls don’t typically show much interest in disrupting medical or surgical conversations ,” he says. “Sometimes a DOL will post on Instagram a video answering a few questions about a procedure or therapy, and a related healthcare company wants to post the video on its own channel. If it does, agencies like ours will monitor all the online activity associated with that piece of content on their platforms. Wherever it goes on that company’s social media channels, and if a comment comes up that is troll-ish, it can be
deleted or hidden.”

It’s also important for DOLs to focus on the social media platforms that work best for the type of content they are producing. Someone that’s proficient at producing short form written content and static images will probably do best on Twitter. Meanwhile, a DOL that’s talented at creating conversational videos may prefer TikTok, Instagram Reels, or YouTube, all of which also have
strong platforms for people looking to engage with other doctors
or patients.

Rodgers also notes that he’s seen doctors shifting away from Twitter. He describes it as a place where doctors used to be able to openly chat with each other, but the network doesn’t seem to work for that kind of discussion anymore. He says that LinkedIn is the first place people are going to look for DOLs; therefore, every opinion leader should have a fully built-out profile on that network.

A significant benefit of using digital channels is the scope of data that they provide. Traditional KOLs would appear at conferences and speak with trade publications, which have proven to be effective ways to get a message out. The benefit of using digital platforms, however, is that they can provide a much more exact measurement of the reach.

“When you have a product, you can measure digital channel use by KOLs,” says Weiss. “You can look at more than a million people and see how they consume and/or publish on these channels. There’s some fluctuation, especially around the smaller, closed social networks. There is also some consistency, however. Twitter is still an important channel. It differs by community and country.

The US and Germany are different. Japan is different, and China is obviously very different. Long story short, there’s some fluctuation on the smaller closed networks. There’s stability on the larger channels.”

For pharma companies, the biggest question is whether to focus on KOLs and traditional methods of communication or DOLs and the new digital channels that are available. According to the experts, the answer is: they should do a mix of both.

However, there was some disagreement about how balanced this mix should be.

“There will always be the need for a small circle of KOLs forpharma companies, about eight to 12 of them, who are their go-to doctors who are under contract,” says Rodgers. “With DOLs, we’re looking at circles of 100 doctors, or even more, who may or may not be under contract. We have the technology, however, to be able to track them, map them, see when they get published, quoted somewhere, and when they tweet.”

Weiss has a differing view on the subject. He sees the fragmentation among experts as the main driving force behind opinion leader strategies. Pharma companies should be looking to bring the proper experts together, which may mean introducing lung cancer experts to artificial intelligence opinion leaders.

“We have to be realistic,” says Weiss. “Digital community leaders are valuable, but not everything is moving into the digital space. If I was a pharma company, I’d consider it one area to focus on, and it’s just an additional channel with better real-time signals. The classic models will return after the COVID hiatus, but they won’t replace digital. Digital used to be about 10%, then ramped up to 40% to 50%, and now is at 30%. It’s not going to be 80% since people are going to major conferences again.”

Another reason why KOLs are unlikely to be fully replaced by DOLs is because, for many experts, maintaining a strong online presence is something they’re either uninterested in or not capable of. Everyone’s interests, abilities, and accomplishments will determine what their relationship with the digital landscape is.

“I think it is important for doctors to get social media training, but it’s not mission-critical,” says Rodgers. “Someone in the office could do it. It’s an easy channel to manage if you’ve got the right person to manage it. If you’ve got a doctor who is a digital caveman, there’s no point in trying to get that person to create Facebook ads. It’s better to just find someone who can do it for them. It’s going to be expected that you have a presence. You don’t have to be making TikTok videos every day, but at the minimum, you should have a fully built-out LinkedIn profile with publications and some pieces you’ve written yourself.”

This is another area where there was some disagreement among the experts. Unlike Rodgers, Short believes that KOLs can still be fully effective in today’s world with little to no online presence. It depends on the specifics of the workthey’re doing. “Doctors are choosing how much of a social media presence they need to have,” Short tellsPharm Exec. “There are some KOLs [who] don’t have a presence at all on social media, and they still function quite nicely. It’s like a group that has inside jokes and who is all-in on the joke, and there are people on the periphery who aren’t in on the joke, but others in the group may explain it to them. You’ll find a group of people who are still KOLs, but you’ll find another group of people who are KOLs [and] have a lot of people who are in their disease state [and] having lots of social media conversations. A lot of it [is] driven by thedisease state.”

Now, as the live events and conferences return, the pharma industry is figuring out the best ways to work with both KOLs and DOLs. There are benefits to both, and many experts could be described as either kind of opinion leader. Moving forward, the industry appears to be embracing both forthe time being.

“When it comes to choosing between using a KOL or a DOL, it depends on what the company is looking for,” says Rodgers. “If a company wants to do a KOL/DOL campaign, the first step is mapping out all of the doctors from that therapeutic area. Once that is done, it will depend on what work have they done, what publications have they been in, [and] what does their social graph look like? That’s the starting point, and then it’s time to figure out the different ways to utilize these doctors’ expertise to create content.”

The life sciences industry relies on the voices of experts. Whether these opinion leaders are educating doctors, shining a light on new therapies, or just bringing patient groups together, they are an essential part of the industry. Both KOLs and DOLs will likely continue to work in relationship with each other as more and more channels of communication open up.

is Pharm Exec’s editor and can be reached at 

How pharma companies can leverage the lessons learned during the pandemic around key opinion leaders and digital opinion leaders, respectively, to best use new channels of communication. Can both coexist across the healthcare engagement spectrum?

A New Era of Influence: Embracing the KOL-DOL Dynamic in Healthcare

Key opinion leaders (KOLs) are essential for communicating the benefits of a product for the right patients, but the popularity of online platforms has
brought about a new breed of “influencers”—digital opinion leaders (DOLs). These respected experts wield substantial influence in their respective fields via digital channels, including social media, industry websites, blogs, and news outlets. These platforms serve as avenues for the exchange of ideas and opinions in ways never before possible.

With the influence of DOLs on the rise, clients are asking whether their strategies should focus specifically on DOLs. Should pharma target DOLs in place of KOLs? The industry should not do an aboutface in its opinion leader outreach—both groups are important. Although differences do exist between KOLs and DOLs, they share commonalities. And reaching both may be easier than you think.

Oftentimes, DOLs are younger healthcare professionals (HCPs) who do not yet have the experience and achievements that would traditionally qualify them as a KOL. Top leadership roles in key organizations and congresses, esteemed titles at university or academic centers, and first authorship on important papers are all credentials usually required of a KOL. A DOL may not have reached these levels but, regardless, shows authority in their area of expertise.

Unlike KOLs, DOLs may also be individuals other than HCPs, such as patients, patient advocates, and organizational leaders. Regardless of their background and experience, DOLs generate a large and loyal following by sharing their uniquely informed perspectives with eager audiences.

As important as KOLs are to a pharma company’s strategy, DOLs have a leg up on disseminating scientific information. The open nature of social networks allows messaging from online experts to reach audiences far exceeding those of KOLs, whose main communication channels are conferences and published articles. Most DOLs will reach an HCP audience the size of a major medical congress daily as their posts and discussions are
spread among followers.

DOLs also engage with their audience differently. Offline communication tends to be advantageous for informing and announcing, but it lacks the ability to encourage ongoing engagement and interaction. DOLs create discussions and invite their audience to participate. They are more likely to challenge existing assumptions and present themselves as leaders in the community rather than authority figures.

Despite the differences between these two types of experts, we encourage our clients to think of KOLs and DOLs similarly when devising their strategy. For one, highly regarded KOLs who become influencers both offline and online are becoming increasingly common. In recent projects for our clients, we’ve found that more than 40% of DOLs can also be considered KOLs. In many cases, these are highly regarded experts who have been recognized
as thought leaders for years and have recently established an active online presence.

Engagement strategies for both groups should also be thought of similarly. As with KOLs, DOLs are real people who engage in the community. They, too, can be open to hearing from representatives of pharmaceutical companies to learn about the latest developments and advancements in their field—information that they then can share with their followers online.

The lines between KOLs and DOLs will likely blur nearly completely over this next decade. Although currently DOLs make up only a segment of opinion leaders, with some overlap with KOLs, the HCP landscape is evolving. We predict that younger online thought leaders will begin to be universally recognized as leaders and achieve leadership roles, qualifying them as KOLs, and maintaining some level of online presence will become expected. Over time, more DOLs will rise to prominence as KOLs, and an increasing number of KOLs will develop digital savviness.

Thought leaders and influencers are making their mark on the digital landscape. Pharma must evolve and adapt its strategies accordingly to inform the important conversations happening there.

Pharmaceutical Executive: March 2023

Navigating Disruption in the Metapharma Era

Biopharma M&A: Year in Review, Ripples Ahead

Balancing Pharma Hiring Practices in Good Times and Bad

Being KOL-Centric: More Meaningful Expert Engagement

A New Era of Influence: Embracing the KOL-DOL Dynamic in Healthcare

Food for Thought: Make Room for Multiple Opinions

The Pivot to Digital

More than Ever, Data Will Dictate Future Fortunes

Generative AI’s Breakthrough Potential in Pharma Marketing

The Challenge of Taking on Falsified Medicines in Europe

Vaccine Development Builds on COVID-19 Breakthroughs

Key Opinions Abound

Pharmaceutical Executive, March 2023 Issue (PDF)