Advances in pharmaceutical medicine over the last 100 years have largely been accredited to the pioneering research of scientists and technological breakthroughs developed by engineers, who discovered, commercialized, and produced new medicines at scale.

As technology took on a more significant role in pharma, it was mainly thought of only as operations support, providing computer services (such as hardware and software assets), manufacturing, security and data processing, and management.

Today, technology is an engine of innovation, integrated throughout the enterprise to accelerate advances in discovery and innovation. Nowhere has this been more evident—and vital—than in the pharma industry’s response to the COVID-19 pandemic, as researchers, data scientists, digital technology professionals, engineers, and others worked hand-in-glove to fast-track the development of COVID vaccines and antibody treatments that saved millions of lives.

As the events of the last two years have made abundantly clear, the goal of discovery and innovation within pharma is to bring new medicines to patients with speed and purpose and to make life better for people around the world. But what is the “secret sauce” to achieving those goals? Among the most crucial ingredients is how we leverage digital tools, like machine learning (ML), across the enterprise.

The potential of ML in drug discovery is no more evident than in its power to develop and discover models of new and existing molecules that warrant further research as potential new medicines. For generations, the process of drug discovery has been a time-consuming and tedious process, dependent on the exceptional skills and intuition of scientists and researchers to painstakingly identify, through trial-and-error, potential new drug targets.

Today, we must use our expertise to employ ML to distill billions of data points that can develop 3D modeling of the most promising molecules and targets for those molecules. This model-driven drug discovery gives scientists a better, more accurate starting point for their research and offers the potential to shorten the time it takes to bring new medicines to patients by several years. Additionally, digital tools need to continue transforming clinical trials, especially if we are to reach diverse and underserved patient populations.

Digital tools and connectivity give us the power to gather large amounts of real-time data in new, more efficient ways, bringing entirely new ways to track patient symptoms. Whether it is a wearable heart rate or sleep monitor, or even the new digital watch, these devices can remotely monitor health status in real time and produce digital biomarkers that can completely transform how we conduct clinical trials. In the past, physicians and researchers would have relied on subjective reports from patients.

This remote monitoring capability is making clinical trials more accessible to people who would otherwise be unable to participate by reducing or in some cases eliminating the burden of the time and travel necessary for the multiple clinic visits that have been the hallmark of most clinical trials. This also helps improve diversity in clinical trials, a topic of importance in the industry today. Just as important, these devices provide more accurate real-time and objective information that can significantly reduce the time it takes to conduct a trial. Once a new medicine has been approved, the connectivity of these monitoring devices, integrated with the therapeutic itself, can help a patient work with their physicians to maximize the health benefits of their medicines.

Finally, pharma will need to develop data platforms, often referred to as “sensor clouds,” that enable data and analytics experts to access the most appropriate information more efficiently, leverage ML, and create algorithms that better reflect a patient’s disease journey. The industry can then translate that data into information patients can use immediately—empowering them with connected apps and delivering a patient-first approach to their care.

The integration of technology is having a profound and powerful impact on pharma. While the industry continues to test the mettle of these digital tools, we are again experiencing ways to continue to revolutionize pharma via faster, more efficient clinical trials, empowering patients, and discovering critical new medicines.

, executive vice president and chief information and digital officer, Eli Lilly and Company

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Their integration across enterprise remains pivotal driver for success.

Digital Tools are Key to Advancing the Tech Revolution in Pharma

 skit a few years back in which a woman named “Lyrica” Williams was suing Merck for intellectual property theft, not only because of her own first name but also for her daughter “Seasonique Boniva’s” first and middle names. It’s not uncommon for the average person, or the gifted comedy writer, to wonder why on earth a drug is called what it’s called.

When prompted, people can usually come up with a few drug brand names that stand out in the realm of public consciousness for one reason or another. One of the first names that leaps to mind is Viagra. It’s all a bit subjective because different words, syllables, letter strings, and phonetic properties can elicit different reactions from different people, but the names that make an impact on the most people both through appearance and perceived meaning are the most impressive. The ability to conjure a range of emotion as well as a meaningful association is what advertising and branding are all about. With Viagra, there’s a theory the name comes from the Sanskrit word vyaghra, which means tiger

—a pretty good theory and certainly apropos. However, the word itself, stripped of its not-so-familiar Sanskrit meaning, evokes attributes like vitality, power, and hints of surging energy (perhaps because Viagra rhymes with the falls of Niagara).

It all starts with a chemical compound—one that shows promise as a treatment for a disease and may lead to the development of a new drug. Finding a lead compound is the first step in making a new drug to treat a disease safely and effectively. Every new drug intended to reach the market requires a pair of names: its non-proprietary/generic name (e.g., ibruprofen), and its brand name (e.g., Advil).

Whether designing a brand name or a generic name, the drug naming process is a long journey, often spanning years and multiple clinical trial phases—one that undergoes many formal reviews that extend beyond the walls of client and agency boardrooms and Zoom calls. There are legal, regulatory, and often linguistic review processes as most clients are looking for a globally-viable name. It requires a great deal of symbiosis between the drugmaker and its naming agency, while also considering patients, pharmacists, physicians, and other healthcare professionals (HCPs). The organizations holding the keys to approval are international regulatory bodies like FDA, European Medicines Agency (EMA), Health Canada, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), among others. The original aim of the regulatory bodies’ reviews, which is still of great importance, was safety. Not far behind safety were branding and marketing.

With the continued explosion of emerging biopharma companies (EBPs), there are many companies taking their first shot at drug development, the naming process, and subsequent marketing strategy. According to the IQVIA Institute for Human Data Science, the research and analysis arm of IQVIA, EBPs represent 65% of the total drug development pipeline, which is currently nearly 4,000 drugs (more than double the number in 2016).

 Additionally, 7% of the pipeline is being developed by EBPs in partnership with larger firms; meaning 72% of all drugs in the development pipeline have an EBP’s stamp on it.

 The road to launch is extremely complicated, and naming is just one hurdle along the way—albeit an exciting one. EBPs and large pharma companies should be prepared to engage with a good naming agency. 

enlisted the expertise of three agencies to navigate the process: Leaderboard Branding, Eversana Intouch, and Brand Institute.

What separates pharma brand naming from other industries are the safety bumpers that restrict what a drug can be called. There are really no restrictions when it comes to naming outside of the pharmaceutical industry other than trademark considerations, which, according to World Intellectual Property Organization (WIPO), stood at 18.1 million new registrations in 2021,

 With drug naming, the review process is significantly more extensive.

 spoke with Maximilian Straka, director of drug safety at Leaderboard Branding, and former FDA Division of Medication Error Prevention and Analysis safety evaluator, and registered pharmacist, about the topic.

“The first thing to do is make sure that names do not have look-alike or sound-alike similarity to other marketed drugs using the FDA’s POCA (Phonetic and Orthographic Computer Analysis) tool,” says Straka. “POCA scores are part of the puzzle, but when evaluating them, you have to consider product characteristics like the dosage form, the dose, the strength, the indication, and dosing intervals—all of those product characteristics are the other half of a picture to a drug. It has its name, and then it has its product characteristics.”

In addition, prescription studies are conducted where names are handwritten in cursive along with the instructions. Agencies will send the samples out for interpretation by a number of practitioners. Sound-alikes are also covered by reading the drug names aloud to practitioners. It’s an exhaustive process, and for good reason. Every year, in the US alone, 7,000 to 9,000 people die as a result of a medication error.

 And hundreds of thousands of other patients experience but often do not report an adverse reaction or other medication complications.

Take Velban (vinblastine) and Oncovin (vincristine) as an example. These are look-alike and sound-alike drugs listed by the Institute for Safe Medication Practices (ISMP). While the brand names are unique, the generic names can also cause issues. Fatal errors can occur when patients are given vincristine at a vinblastine dose.

In 2016, an issue arose when Takeda and Lundbeck’s Brintellix, a prescription medicine approved to treat major depressive disorder (MDD) in adults was deemed to cause confusion in the marketplace between Brintellix and the anti-blood clotting therapy Brilinta.

 Takeda and Lundbeck, in coordination with FDA, changed the name to market the drug as Trintellix in the US.

Internationally, each governing body has a process in place for naming drugs. The most active regulatory agencies—EMA, Health Canada, and MHRA—all have different processes for evaluating names. Naming teams at agencies like Leaderboard, Eversana Intouch, and Brand Institute consider existing POCA scores for European evaluation, and then incorporate linguists to research sections of the name to see if there are suggestive words (e.g., slang, and even names in history) or sounds that might have negative connotations across the different languages and cultures. Perhaps the most legendary example in the consumer world is the Chevy Nova. It’s a car that sounds new and shiny in the US, but if you’re expanding to Spanish-speaking markets, it translates to “won’t go.” The story, whether true or not, elucidates the point.

Rules around non-proprietary/generics have their roots in the late 1950s when Tennessee Senator Estes Kefauver discovered consumers—and many physicians for that matter—didn’t have any idea that two brand name drugs contained the same ingredient simply because there wasn’t a single generic name. He held very public, televised Senate hearings in 1959 resulting in a mandate requiring all pharmaceutical products to have one standard and universally agreed upon generic name that could capture a sense of the structure of the drug without being overtly long and unpronounceable.

 It marked a significant update to the United States Pharmacopeia, or USP, the dictionary that contains the list of generic drug names used by the United States Adopted Names (USAN) Council, which is the body that assigns these names.

 spoke with Suzanne Martinez, Eversana Intouch’s group director of strategic planning and resident naming expert, to learn more about the process. “In the generic name, the long and often more cumbersome names that sit below the brand name in a logo, the suffix is known as a stem, which defines the class of medication the drug is in,” says Martinez. “That stem cannot be embedded in your brand name because of potential confusion. I love generic naming because it’s a scientific formula for a doctor or prescriber, and you can get a little creative with the prefix.”

She believes that the pharma name is "a perfect example of where art meets science.” “Not only do you want to often communicate the science in the name, but it’s also the science of navigating all the regulatory challenges combined with the art of telling a story in the smallest, most succinct, most beautiful way possible,” adds Martinez. “It’s mission-critical to have that brand name serve as the first chapter of the story that you want to tell from a marketing perspective. But from my experience, it’s important that the brand name, as much as possible, sets you up for success in telling a strategic story, and a marketing story that is compelling for your different audiences.”

The long process of brand naming usually starts in Phase II or III clinical trials and begins with a kickoff meeting between the client’s project team and the agency’s team to discuss their asset and to scope out strategies and opportunities for the name—a completely original word in most cases. All agencies agree that it’s of the utmost importance to have the client with them on the entire journey. That way they understand how name creation aligns with their preferences based on the information of the asset they provided; what’s important to target audiences both on the HCP and patient/caregiver side; the background provided on the competitive landscape; and how their asset will fit into that landscape. The client is looking to discover that unique selling proposition and find where an opportunity lies in the market.

According to Scott Piergrossi, president, creative of Brand Institute, it’s a fact-finding mission with a lot of questions. “We usually prioritize our naming strategies: Is it a mechanism of action-associated name? Is it a specific attribute or benefit we want to suggest like improved tolerability or speed of onset? Do we want an association with the company name? Or do we want to paint an image or an aspirational association, maybe a name like Lunesta with its lunar imagery?” he tells 

. “Who are we speaking to? If it’s an oncology drug, usually we’re speaking to the oncologists who are making prescribing decisions and recommendations. That is one reason why cancer drug brand names often highlight the product’s mechanism of action, because it’s a message that resonates with prescribing oncologists. If it’s more of a consumer-facing drug, sometimes it’s a benefit-driven name. If the nonproprietary name has been in the public for some time, perhaps we leverage elements of that nonproprietary name.”

Naming options can start at as many as 2,000 names and can be whittled down very quickly when running it through software, whether that’s FDA’s regulatory POCA database or proprietary software such as what Brand Institute uses that covers all obstacles, both domestically and abroad. Brand Institute sees its proprietary software as a necessity, viewing itself more as a tech company operating in the name game. And Piergrossi believes that the greatest value it can provide for its clients is clarity and certainty regarding whether or not an agency will approve or reject a name. More and more names are taken off the board and trademarked every year, so it gets more challenging with each passing year.

The second big meeting is a workshop where about 75 to 100 names are presented, and cross-functional participation is encouraged: creative, regulatory, legal, marketing, commercial, etc. It’s not about narrowing down to a couple of favorites, because there are bound to be disappointments once names have gone through trademark and regulatory review.

“It’s very much a subjective process so clients can’t help identifying some favorites, but we really encourage client teams to be more inclusive than exclusive, to only remove names the team just can’t live with during the early stages of the process,” shares Amy Baynard, creative director at Leaderboard Branding. “Later on, there are steps where we evaluate the benefits of a name and what it can bring to the table. In those steps, names can move up or down in the list of the team’s preferences—perhaps starting as a neutral in early reviews and then gaining momentum and rising to the top in further discussions and evaluations.

Baynard confides that a naming decision carries a lot of weight—the name isn’t meant to be around for a year or two, it’s intended to exist for a very long time.

Sometimes companies do all that work discovering everything they can about the client, the drug candidate, its mechanism of action, and the competitiveness of the market, and perhaps they decide to move forward with a “blank canvas” name.

For example, Prozac—which was introduced in 1987—is an extremely well-known brand. It had huge success as an antidepressant, was widely discussed in popular culture domestically, and was used by tens of millions of people worldwide. This period marked a time in naming history when pharma companies really started considering the branding advantages and nuances associated with drug naming. Although Prozac can be described as a blank canvas name, or one that doesn’t really hold any discernible meaning, it rolled off the tongue easily and was short and sweet at two syllables. One can see a potential positive association with the “Pro” prefix in Prozac, but when competitor names like Zoloft (1991) and Paxil (1992) enter the naming conversation, it’s clear they offer a bit more in terms of positive meaning and invoking emotion. The “loft” in Zoloft has a very positive association with shedding a weight one might be carrying, and the “pax” in Paxil conveys a sense of peace.

That said, there are a great deal of names already taken; therefore, using a blank canvas name is a strategy employed by naming teams today to limit the number of syllables and make it easily pronounced and memorable. Blank canvas names can also convey a certain tone without implied meaning and can cleverly differentiate themselves from other drugs in the same therapeutic space—drugs that all might have similarly tried to convey the scientific or other descriptive attributes of a name.

The drug brand naming process is a long one, so the earlier the manufacturer starts, the better. “We like to say, the earlier you start, in theory, the more shots you have on goal,” says Piergrossi. “If you have a name that you like commercially, but there are concerns from a regulatory standpoint, such as potential similarity with another drug name, you can submit that name and get feedback. Sometimes the name will get approved, sometimes it won’t, so we’re always well prepared with backups.”

The pharmaceutical name is just the beginning, it’s the springboard for the next creative team or agency to build strategy around the product and come up with compelling marketing campaigns to bring that brand to life in a very competitive market.

is Pharm Exec's senior editor and can be reached at

Clarke, G. The Origins of 5 Well Known Drug Names. Pharma IQ, July 17, 2013. 

https://www.pharma-iq.com/pre-clinical-discovery-and-development/articles/the-origins-of-5-well-known-drug-names

Pollaro, F. Biopharma’s Untapped Value: The Quest to Reverse First-Launch Failure Trends. 

https://www.pharmexec.com/view/biopharma-s-untapped-value-the-quest-to-reverse-first-launch-failure-trends

https://www.wipo.int/en/ipfactsandfigures/trademarks

Number of Trademark Applications Worldwide from 1990 to 2021. Statista, 

https://www.statista.com/statistics/257628/number-of-trademark-applica tions-worldwide/

Tariq, R.A.; Vashish, R.; Sinha, A.; et al. Medication Dispensing Errors And Prevention

https://www.ncbi.nlm.nih.gov/books/NBK519065/

Brintellix (vortioxetine) Renamed Trintellix (vortioxetine) in US to Avoid Name Confusion. Takeda press release, May 1, 2016. 

https://www.takeda.com/en-us/ newsroom/news-releases/2016/brintellix-vortioxetine-renamed-trintellix-vor tioxetine-in-u.s2.-to-avoid-name-confusion

Similarity and Difference in the World of Drugs. USP. 

https://www.usp.org/our-impact/generics/similarity-difference-world-of-drugs

Features

Branding agency experts share what to know when it comes to legal, regulatory, and creative approaches in the complex drug-naming process, with its potential to shape a campaign’s success.

Inside the Pharma Name Game: Drug Word Choice Key to Building a Lasting Identity

Health equity has become top-of-mind both for the general public and biopharmaceutical organizations in recent years, not least due to COVID-19, racial and gender equity movements, and the resulting need to refine environmental, social, and governance (ESG) strategies. With this in mind, Boston Consulting Group (BCG) set out to better understand the current landscape of how health equity is addressed in biopharma by conducting a study with 18 global drug manufacturers across five dimensions:

 Have biopharma companies articulated health equity strategies, and what is their scope?

How and at what stages of the product life cycle are health equity considerations integrated?

 How do companies engage with the ecosystem and think about partnering?

What types of metrics are tracked systematically, and how are they reported?

How are health equity roles and responsibilities anchored, and how do teams collaborate?

Insights on these topics were gathered via a survey filled out by key health equity representatives within the company and structured 1-on-1 interviews with more than 40 participants across the 18 companies. The survey was conducted from May to October 2022.

Health equity in biopharma is nascent, with significant efforts to ramp up strategy

Out of the 18 companies surveyed, 15 had a global policy position on health equity in place; two companies, instead, had set up regional and functional health equity mandates; and only one organization had no formal position but planned to complete one within the next six months. The majority (15 out of 17) of these policy positions had been set up in the past five years, and all had been recently updated. Health equity mandates were typically integrated within both ESG and corporate social responsibility (CSR) mandates (11 of 17) or in ESG alone (3 of 17), while three companies did not connect health equity with either ESG or CSR. Additionally, more than half of the companies included in the study have formal plans to include health equity goals in their strategy (11 of 18).

Overall, there has been a rapid increase in general awareness and willingness to create structured programs. Biopharma companies have not yet agreed on a unified formal understanding of the scope of health equity for industry, but when surveyed on health equity policies and programs they systematically engage in, there was a high degree of overlap.

In addition to corporate-level policy positions, companies report an increasing need to articulate specific geographic, functional, disease area, or product-related health equity positions. Geographic mandates are deployed to detail approaches for regional contexts with differentiated needs, such as specific population segments within higher-income countries (e.g., Black populations in the US) or to expand access and uptake to lower income countries (9 of 17).

Some companies also established functional positions to clarify responsibilities between the diverse teams required to operationalize health equity (10 of 17). Disease area or product mandates address disease-related equity challenges, such as vaccine rollout in lower- and middle-income countries or rural care infrastructure requirements for oncology (10 of 17). Companies with portfolios requiring a more cognizant approach to equitable access and uptake, such as those with women’s health or infectious disease products, tend to be early movers in formalizing specialized mandates, while no company has set up specialized positions for the full portfolio to date.

A key concern echoed by many respondents is the need to raise organizational awareness and better understand the required capabilities needed to drive health equity initiatives. Half of the companies have developed health equity-related trainings, and many others plan to roll out training programs soon. Among those who offer training, there is a diversity of approaches, with the majority integrating health equity into diversity, equity, and inclusion (DE&I) trainings, ESG modules, or access and pricing modules. Only two companies reported dedicated, function-specific health equity trainings, while many others plan to do so in the future.

Corporate-level statements can be operationalized at the product level across the full life cycle through diverse policies and programs. During portfolio prioritization, budget commitments, and R&D, targets for novel products addressing the unmet needs of underserved populations can be set up alongside equity-related prioritization criteria. Ensuring that products are designed with the specific needs of underserved populations in mind, such as appropriate formulations (e.g., shelf-stability without cold storage in case cooling infrastructure is not available) and dosage (e.g., longer dosage cycles to account for more difficult access to treatment) can further help bridge the gap. During development, ensuring inclusive clinical trial populations that represent the target population is a key concern.

To support patient availability and uptake, supply chain stability, and distribution infrastructure, broad filing and licensing commitments based on unmet medical need and commitments to achieve affordable access in underserved markets can be tackled. Finally, dedicated outreach and awareness efforts, healthcare provider (HCP) education, and general health system-strengthening activities tailored to underserved population segments can aid demand creation.

All 18 companies report initial efforts to integrate health equity considerations at a product level; however, this integration remains fragmented. There is a growing drive to become more systematic, particularly within clinical trial operations and market access. But no company has yet achieved a systematic integration of health equity considerations across the life cycle for a single product or systematically within a segment (e.g., access) for all products. Commitments and related guidance to reach these goals tend to be at a high level and would benefit from a more systematic and cross-functional approach.

The complexity of addressing underlying health equity drivers has prompted industry to increasingly look toward effective partnering strategies, with all 18 companies actively engaged in broad partnerships within and beyond healthcare. Frequently-voiced objectives include the need to access local expertise for rollout, share relevant capabilities, and address social drivers of health equity beyond the scope of biopharma, such as through educational outreach, community programs, and supply chain infrastructure in lower income countries.

High interest to do more collaborative work within the biopharma industry was recorded, as companies tend to invest resources on common causes of health disparities but lack the overarching coordination to optimize results, lack a common language and narrative, and have no established sharing platforms to exchange best practices. The majority (13 of 18) companies survey present at external conferences, but concerns were raised regarding the ability of biopharma to clearly voice its role and contributions within the health equity space. Nevertheless, contributors recognize biopharma’s unique potential role as an orchestrator of health equity conversations across a broad range of stakeholders (e.g., governments, patient advocacy groups, payers, providers, global organizations) if the industry were to approach the topic more systematically.

Health equity measurements are at an early stage within industry. In our survey, most companies (16 of 18) indicated they track some related metrics, such as the number of patients benefitting from patient support programs, donations, and philanthropic programs as well as the total number of patients treated. However, all companies voiced methodology and data privacy challenges in assessing this across equity dimensions such as income, race, or gender. Thirteen companies additionally track efforts around health system strengthening—but often with vastly different metrics behind them. Biopharma lacks a commonly agreed-upon measurement framework and approach for health equity, and grapples with navigating increasingly restrictive data protection regulations, which, so far, have prevented the reporting of metrics across equity dimensions.

Dedicated efforts to better tailor health equity measurements are well underway through various academic partnerships, and it can be expected that first movers will launch attempts at segmenting patient groups based on unmet needs and equity considerations soon.

In line with the absence of a rigorous methodology, most organizations do not have dedicated, regular reports on health equity. Eight companies have released external health equity communications, but the scope and data-driven nature of these reports is highly variable. Currently, formal health equity reporting is embedded within ESG reporting, with all surveyed companies reporting health equity-related key performance indicators in their 2021 ESG reports. However, of the 20-plus metrics listed in these reports, most organizations only report four to five, and the underlying measurement and reporting approaches vary significantly.

All companies reported recent internal efforts to systematically organize health equity roles and responsibilities in line with corporate health equity targets and strategies in a wide range of potential operating models. Despite many ongoing initiatives, coordination across functions remains the key issue to solve for.

Two companies have not yet formalized responsibilities for health equity roles. Of those with formalized roles, eight share responsibilities across existing groups and are currently investigating how to integrate cross-functional perspectives optimally. Six have mandated one of the existing involved teams with a major role in driving health equity initiatives, and two have recently set up dedicated health equity units.

Teams involved, much like the operating models chosen, vary widely dependent on geographic reach, portfolio needs, and product-level integration of health equity considerations. Beyond the two companies reporting new health equity teams, major mandates were frequently allocated to global health units, advocacy, ESG/CSR/sustainability offices, market access and pricing, or regions (for local implementation). Contributing teams include the above mentioned as well as corporate functions
(e.g., communications, marketing, HR, and DE&I), public and governmental affairs, medical, R&D, and product teams.

No single company reported the same health equity setup, and many voiced interests in jointly examining suitable organizational models. The complex nature of the topic is also reflected in how it is handled within biopharma and the complexity that is inherent in coordinating the efforts. This is also reflected in the number of employees engaged within health equity across the different companies. It varies broadly across our survey, with the majority (12 of 18) reporting less than five employees and three early movers reporting team sizes above 20 full-time employees.

Industry representatives responding to our survey expressed five key areas of focus going forward. These are areas where they are deploying significant, systematic efforts to formalize and map out their health equity roles and contributions:

Effectively balancing health equity goals with overarching strategy, set suitable health equity goals tailored to the portfolio, and anchor these considerations within ESG and CSR agendas.

Defining which metrics are suited to measure and track health equity across geographies and portfolio, and developing datasets and sensible targets.

Understanding disease populations across health equity dimensions, and ensuring representative diversity within clinical trials.

Developing access to medicine programs and differential pricing, and launching region-specific programs to remove barriers to access, such as lack of healthcare infrastructure.

Understanding the role of biopharma in advancing health equity, and partnering with the right stakeholders to coordinate effective initiatives.

What’s next: High interest in cross-industry collaboration

Across the board, biopharma industry representatives voiced a huge need to establish an exchange forum on health equity to share experiences and jointly develop ideas. There is an understanding that a coalition addressing common topics of concern (e.g., rare diseases, infrastructure in low- and middle-income countries) would enable more impactful solution design and deployment by sharing relevant know-how, best-practices, and capabilities.

The forum could be leveraged to identify meaningful health equity metrics; monitor progress toward health equity; illustrate what industry is doing today; and assist with identifying suitable partners within and beyond healthcare.

Additionally, organizational topics and themes such as health equity operating models and defining a common scope and view on health equity domains would better align language and boost effectivity.

, director for market access and pricing in healthcare and BCG Henderson Institute fellow, 

, BCG Henderson Institute ambassador, and 

, managing director, senior partner, and BCG Henderson Institute fellow; all with Boston Consulting Group

A survey of 18 biopharmas, measuring their scope and implementation across key health equity dimensions and activities, uncovers useful context as companies seek better alignment of these goals with overall strategy.

Clues on Equity Engagement Levels

It is no secret that there are racial—and gender—biases within the pharmaceutical and healthcare industries. This is apparent through the types of treatments that are researched and developed as well as through the people and communities who have historically had access to and been included in clinical trials. There is, of course, other evidence of these biases in present times, such as diagnostic tools created for white individuals and patients with lighter skin (i.e., pulse oximeters). But in recent years, there has been a renewed push for diversity, equity, and inclusion (DE&I) and to better address racial inequity specifically.

“The pharmaceutical/biotechnology/life sciences industry is very focused on racial bias as a driver of health inequity, including how it can undermine the inclusion of underrepresented populations in clinical trials as a function of improved health outcomes,” says Rose Blackburne, MD, vice president, global head, general medicine, PPD Clinical Research, part of Thermo Fisher Scientific. “While addressing racial bias is not a new interest for the industry, there has been [a] much renewed focus on this issue as a result of recent societal events, like the severe racial and ethnic disparities in COVID-19 outcomes seen early in the pandemic and the racial unrest stemming from the murder of George Floyd in 2020, as well as similar racially motivated violence prior to the pandemic that brought a wider recognition that racism has a structural basis and is embedded in long-standing social policy.”

Patrice Matchaba, MD, head of US corporate responsibility at Novartis and president of the Novartis US Foundation, also emphasizes changes that have transpired due to the pandemic.

“COVID tells us everything. COVID tells us that we should and can be doing much more,” says Matchaba. “[W]hen COVID struck, people saw two things: the lack of participation of communities of color in the clinical trials initially, and then the impact of COVID on the Black and Brown communities in terms of hospitalization and deaths. Then the whole discussion was—is this a genetic thing, or is it a social deterrent? And the basic answer is this: there has been no inclusion of Black and Brown communities and women in the R&D ecosystem.”

When it comes to R&D, Matchaba describes how there are countless therapeutic areas that heavily impact—or specifically impact—Black and Brown individuals as well as therapeutic areas specific to people assigned female at birth, and there are currently no or few treatments. Those therapeutic areas include:

Pregnancy-related diseases and conditions

Historically researched and developed treatments target therapeutic areas that typically impact white individuals, specifically white people assigned male at birth. Other diseases, such as leprosy, heavily impact Black and Brown communities in some countries due to a lack of access to diagnostics as well as proper treatments.

Another example of racial disparity was hospitalizations and mortality rates during the COVID-19 pandemic, which showed that Black and Hispanic/Latinx patients were disproportionately impacted, Jamie Freedman, PhD, MD, senior vice president, head of US medical affairs, Genentech, explains. But beyond the pandemic, Freedman also points to how patients living in rural areas are often excluded from clinical trials (usually at large academic medical centers) due to travel limitations.

Unfortunately, there are more underserved communities in medicine, which include Native Americans, Alaska Natives, and the First Nation.

“American Indian and Alaska Native (AI/AN) make up approximately 3% of the US population and face significant disease burden across disease areas and specifically higher cancer mortality rates compared to the general population,” says Freedman. “Health disparities and inequities in this population are attributed to poverty, lack of access to preventive and screening services through Indian Health Services, [and] distance to health facilities as many live in remote tribal and rural areas (54%).”

Nan Gu, associate principal of patient health and equity, ZS, a management consulting and technology firm, describes additional racial bias in medicine, specifically how Native Americans and Alaska Natives have the lowest rate of private insurance coverage of anyone.

One glaring example of racial bias is pulse oximeters. It has been discovered that, during COVID-19, pulse oximeters measured the oxygen levels of Black and Brown patients incorrectly, saying the patients were fine when they were not.

 As a direct result of this, Black and Brown patients were refused hospital admission and not given an ICU bed or access to ventilators—leading to increased levels of mortality rates. FDA met in 2022 to discuss pulse oximeters and this very issue.

While this example is geared toward diagnostics and devices, it is a glaring example of health inequities that are being brought to the surface, and Matchaba believes this is only the beginning.

“Look at the discussion from the FDA on the pulse oximeters. It is going to create an avalanche because it’s not just the pulse oximeters,” says Matchaba. “What about every other diagnostic that has come before us that has not included women or people of color? And I bet you, it’s all of it.”

Fundamentally, many things need to be changed to truly address racial bias in medicine, and it’s a long road ahead. But what can the industry do to combat bias and inequities today? Some of the first things to address in Black and Brown communities, according to Matchaba, are to:

Regain trust in medicine (which is poor due to incidents such as Tuskegee).

Provide access to further education/educational resources.

Give historically Black medical schools access to clinical trial centers of excellence

Efforts are currently underway. According to Judith Kulich, principal, patient health and equity lead, ZS, the industry is targeting health inequities in the following ways:

 This includes increased representation among clinical trial investigators and participants “through enhanced outreach and trial site selection, designing protocols that ensure trials reflect real-world demographics and comorbidities, and investing in drug candidates that reflect medical need across diseases and populations,” says Kulich. The most progress has been made on patient outreach and trial recruitment. An example of this is the Beacon of Hope initiative.

 This includes building partnerships with other healthcare stakeholders to expand disease awareness, screening, testing, and diagnosis. One example of this is Gilead’s COMPASS initiative.

 Manufacturers can, in some instances, provide patients with support through logistical assistance (e.g., transportation, language, education, and nutrition) and financial assistance, which impacts patient adherence—though there is much to be done in this area.

Both Kulich and Matchaba talk of the Beacon of Hope as an example of what is being done in the clinical development space. It’s an initiative between Novartis, Merck, and Sanofi to address systemic health disparities through working with historically Black medical schools to enable the next generations of leaders, increase clinical trial diversity, and support research to reduce racial health disparities. Those schools include Morehouse School of Medicine, Howard University College of Medicine, Charles Drew University College of Medicine, and Meharry Medical College.

While there are many areas and sectors that require improvement in addressing health inequity, clinical trials are a current focus of the industry. Blackburne discusses the need to offer decentralized clinical trials (DCTs) and take advantage of digital and decentralized tools, which could increase patient access in Black and Brown communities.

“There is a huge opportunity for continued innovations that bring research closer to patients, leveraging real-world data and bringing the voice of the patient more fully into the drug development process,” Blackburne tells 

Freedman also adds: “[DCTs] are an important approach, creating greater access for patients from remote or underserved communities. Patients are provided wearable devices that are used to interact with study investigators and have their labs and vitals monitored remotely.”

However, it is important to note that some marginalized communities have socioeconomic limits and may not have access to the internet or WiFi. Sometimes, even great technology can prevent people from having access to care.

Another way to support underserved communities in accessing clinical trials, according to Freedman, includes offering transportation vouchers or free rideshare options. Freedman also emphasizes the importance of having staff members at clinical trials who speak the language of the patient population, which is important for discussing consent forms as well as for patient advocacy.

Where to next? Matchaba stresses the importance of data as a way to address racial disparities.

“To me, [utilizing] data and race is our greatest [opportunity] to right the wrongs and improve medicine and healthcare for everybody, not just in the US,” says Matchaba.

Differentiate facts from myths in clinical trials. 

According to Freedman, it’s a myth that creating more diverse clinical trials is costly and time-consuming.

Increase diversity amongst stakeholders. 

It’s not just about bringing in diversity at the end of a program, but thinking about it at the core of a business, initiative, etc. Freedman recommends co-investing with local government and community leaders to establish a business model around equitable access to care.

To hear directly from marginalized patient populations, Freedman recommends health equity surveys, which can reveal information about conditions, treatments, and barriers to care.

While there is much work to be done that will span across decades, many in the industry are hopeful for changes in the coming years.

“This is highly speculative, but I see the possibility for numerous changes in the next five to 10 years that will greatly impact pharma’s ability to reduce health disparities,” says Kulich. “Even just focusing on the US, within five to 10 years FDA’s guidance on clinical trial representation will have been firmly established, and pharma will, I hope, have built capabilities to reach underserved populations through [DCTs and] expanded diversity among trial investigators, digital tools, and other means. The federal anti-kickback statute may have been revised, aimed at enabling pharma to more freely engage in partnerships and programs specifically targeted at improving health equity and patient outcomes. At the same time, we may have additional legislation designed to improve healthcare coverage for vulnerable Americans such that financial burden alone becomes less of a driver of inequity in care.”

is Pharm Exec’s managing editor and can be reached at

Kratzer T.B.; Jemal A.; Miller K.D.; et al. Cancer Statistics for American Indian and Alaska Native Individuals, 2022: Including Increasing Disparities in Early Onset Colorectal Cancer. 

https://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=62

FDA Executive Summary: Review of Pulse Oximeters and Factors that can Impact their Accuracy, Prepared for the Nov. 1, 2022 Meeting of the Anesthesiology Devices Advisory Committee Center for Devices and Radiological Health.

https://www.fda.gov/media/162709/download

Beacon of Hope. Novartis summary page, accessed January 20, 2023. 

https://www.novartis.com/us-en/esg/beacon-hope

Gilead COMPASS Initiative. Gilead summary page, accessed January 20, 2023. 

Health disparities brought on by racial bias remain quite prevalent in areas such as drug access, use of diagnostics, and representation in clinical trials, but society-jarring events in recent years have sparked renewed efforts by industry to tackle these issues with tangible and hopeful gains.

Taking Steps to Right the Wrongs: The Impact of Racial Bias in Healthcare and Medicine

On Dec. 1, 2022, a panel consisting of chief financial officers (CFOs) and other financial experts convened for a virtual roundtable to discuss the recent economic developments in the life sciences industry and how companies are adapting. The biopharmaceutical sector has not been immune to global economic challenges. After the COVID-19 pandemic generated a wave of new interest in the life sciences, the past year saw a retraction in the market.

The group discussed a variety of topics, including how small-to-midsize biopharma organizations are weathering the current situation and how companies can support a long-term growth trajectory. Other topics included challenges with managing budgets for clinical trials and how the market may change in the coming year.

What impact has the current macroeconomic environment had on the small-to-midsize biopharma sector?

 Obviously, we’ve had a record-breaking rise in the last seven-to-eight months in interest rates; greater than we’ve seen in four decades, and that’s the lethal enemy of long-dated assets. It has decimated valuations. That, as well as the rotation out of growth into value, has closed the doors from a capital perspective, certainly for IPOs. Follow-ons have been relegated to companies with positive data. Some of the earliest stage companies that went public in 2020 and 2021 are down 80% to 90%. And it’s estimated by the end of 2022 [that] 40% of the space will have less than 12 months of cash.

Shane Kovacs, CFO and chief operating officer (COO), Olema Oncology:

 The capital markets for this sector were always in a tough spot, I would say, prior to 2011, before and after the 2008 financial crisis. The markets started to open up with the first follow-ons and IPOs in 2011 and 2012; so, it was about a 10-year bull market for biotech of unbridled enthusiasm and an incredible amount of capital raised by companies in 2019 through 2021, which had its finale around COVID-19. Now, we’ve swung in entirely the opposite direction to what Barbara mentioned.

 Investors are much more picky now, and we see investors being highly focused and requiring a direct line—proof of concept data, the next inflection point, and the capital in the bank—to get there. Companies that don’t have these characteristics are put in a penalty box while other companies hang in. If you have the capital and the next inflection point and that’s positive, you’re well positioned to get more capital.

 I would add one additional note. As a private company, it’s getting a bit more difficult to get the attention of investors. Investors are looking at a myriad of already liquid public equity stocks that are trading at discounted valuations. You’re coming in here asking for an illiquid private investment, and they have a couple hundred public investments already with liquidity events and better valuations; and many of them, arguably, are in a more advanced R&D standpoint.

Justin Thacker, CFO, Aristea Therapeutics:

 For companies that are looking for other assets, this is a relatively good time because there are many distressed companies that are either looking to sell some of their assets or dissolve altogether. There are opportunities if you have the capital. Obviously, raising capital is very difficult now, but there are some benefits if you’re on the other side and in acquisition mode.

Back in the second quarter, we had taken the hard steps to right-size the company to make sure that our financial footprint was more heavily allocated toward the most obvious near-term milestone for us, and we had a lot of investor interest. We had significant inbound interest where they saw a great company with great fundamentals and a funding gap. The approach was generally, “Well, I firmly believe in your data; you just need the capital, and let’s do something together.”

Through a number of those types of discussions, we were able to pull together a $205 million registered direct offering with a small handful of top tier investors. I applaud these investors who could cut through the noise of this current market and put the capital to work with high conviction.

 For the acquirers, it has been very difficult because companies could get funded in the public markets. They didn’t have to give up a piece of the action early on, and they could fund themselves through subsequent and much higher value-creating inflection points. That’s clearly changed. I am often asked, “Why haven’t we seen more?” I think that the stock market doesn’t determine whether the acquirer thinks there’s a return-on-investment there or not. Just because it’s on sale doesn’t mean the equation changes. The other piece is that the target companies, often the management teams and the boards, have a tendency to live in the rearview mirror because it was much a prettier view. I know in my board and other roles, we’re seeing that play out, and it’s starting to break. I predict we’ll have a very active M&A season.

 The macroenvironment has not only made raising money much harder and impacted valuations, but we’re also seeing inflationary pressures as well. Costs are rising, both with our external vendors and in our internal costs. So, it’s not only harder to raise money, but we’re also spending more of the money we have on the same activities.

 There is a huge issue with recruiting people. As we’re moving into clinical and late-stage trials and trying to hire people in clinical science, there is a lack of talent given the explosion that happened over the prior three or four years. We’re getting quotes from CROs (contract research organizations) for pivotal studies, and they’re billing clinical research associates at $300 per hour and medical directors at $600 per hour. And it’s the same thing at the sites. The clinical sites are reticent to take on new studies because they’re lacking internal resources.

Sharon Langan, vice president of channel and strategic partnerships, Auxilius:

 A lot of companies are seeing this materialize in timeline delays and change orders coming through. That inflationary pressure from the vendor market and from the contract research side, it’s putting an additional crunch on clinical-stage companies. We’re seeing companies dealing with an ongoing drip of change orders coming from their CRO, and that can be material on a monthly and quarterly basis.

 Contract manufacturing has also been an issue. COVID consumed a lot of the capacity out of that entire ecosystem, and companies have had to make reservations 18 months to two years in advance. That’s starting to wane a bit and the pendulum is getting more balanced there, but a year ago it was tough to get [contract manufacturing organizations’] attention.

 We’ve been coming in under budget on our clinical work partly because some timelines are getting extended, and I get billed as you enroll patients. Also, interestingly, we have studies going on in Australia where the currency has moved in their favor; so, I’ve been super pleased with how our CROs are actually performing in Australia in terms of enrollment and the overall cost coming is in pretty reasonable. That’s been a positive.

 Clinical-stage biotech companies need to have visibility across their trials and an understanding of which cost drivers have major impact. Just over the past two years, we’ve reviewed hundreds of CRO worksheets and budget grids, and I will say that north of 90% of them have some pretty significant Excel errors. I mean, seven figures in one change order level of error. That said, having oversight around what’s happening with your vendors is absolutely crucial. It’s hard because trial change orders come in constantly, often times invoices and work performed estimates are delayed. Forecasts can shift dramatically, and our take is that companies need a real-time unified view of what’s happening at the trial level.

 During the COVID years, there was a big boom, and now we’re seeing a retraction. But is sounds like from what everyone’s saying this is more than just a correction in the market, and that something else is going on. Would everyone agree with that?

 A higher interest rate environment hurts. It slows down capital and shifts it away from growth. I’m pretty optimistic, and I feel like the fundamentals of our industry are intact. Good data is getting rewarded, albeit maybe less than it had been previously, but if companies are doing good things for patients, then they are surviving and thriving. We talked about M&A, and I think there’s a lot of optimism that a couple of big M&A deals can start to recycle a lot of cash back into the system. That does attract the attention of generalists that see the potential for incredibly upsized returns, and so we could start to see a swing back into biotech because that really is a place where great returns can be had.

 I agree that the fundamentals of our industry from the top to the bottom are very strong and the biggest companies are flush with cash. There’s leading-edge technology out there that 10 years ago sounded like science fiction, and now we have actual products making it to the market. But we overshot on the upside, and now we’re living the consequences of that hangover, if you will. A lot of things were getting funded that probably don’t have a lot of value and are redundant, and so some of that will get properly cleansed out of the system. At the same time, good data is getting rewarded and will trump everything else. The market is slowly anticipating that we have a line of sight as to a plateau in inflation and interest rates, and once the market believes that’s the case, I think we will see rotation back into the sector.

 Investors have been very careful about which companies they protect. It used to be that an investor would say, “Here are my top 20 favorite companies.” In this downturn, however, it’s, “Here are my top five, and I’m going to reserve all my capital to protect those top five.” Those attributes of the strong clinical data, the strong link to the next milestone, and the cash to get there are what keeps companies in that top five list. The plan would be to exit this patch stronger than you entered it, maybe a little bit more disciplined and careful about capital allocation. The goal for us is to come out stronger than where we started.

 It seems like fund managers, too, and venture capital (VC) firms are doing exactly what you said, and they’d rather fund their portfolio companies or their core holdings through a longer period of time so that they’re not dependent on just one value inflection point and multiple rounds of dilution. That, again, drives the haves and the have nots. If you’re in that top five list, that’s great. If you were 15 and now you were in the top 20, but now you’re out of the box altogether, it’s a challenge.

 There were many companies that were very early in development, or even preclinical, which were able to raise capital through an IPO in 2020 and 2021. I think it’s going to take some time for investors to get comfortable investing in those types of early-stage companies again. It is cyclical, however, and it will likely come around eventually. I think we’re already starting to see some things open up a bit and, hopefully, over time, investors will get more comfortable and want to deploy the capital that they currently have left on the sidelines. The inflationary environment is going to impact this ramp, but things will settle down and, hopefully, [this] year activity will pick up quite a bit.

 How can companies ensure scalability and investment today to support a long-term growth trajectory?

 The name of the game for us is modesty and to do more with less. When I was originally getting situated in the company, we had a very grandiose plan looking at our development program for a number of indications with the same molecule and several different formulations. This is because we’re developing a novel non-opioid lead asset that is heavily backed by the NIH and now in Phase I trials. What we have decided to do is focus our resources on getting that first proof of concept with an indication and the most druggable, the most marketable and commercializable formulation.

So, we’re simply full steam ahead, guns blazing, with our best shot on goal rather than spreading it out. Once we establish that proof of concept, that is the time that you want to sort of branch out and go into a myriad of new directions, new formulations, and indications. But until you have that, be modest and focused and really execute on your core strategy.

 I would echo what Josh mentioned, but, obviously, having the capital is critical to ensure you’re able to scale. Even if you’re not in a position to raise money now, keeping a good open dialogue with potential investors and updating them on the status of your program will go a long way. Keep the interest alive from an investment standpoint because it’s going to take money to scale. It’s going to be significant, and probably more money than you think it’s going to take. So, you want to try and be in a good position and be ready when you need, or want, to raise money.

 Circling the wagon after you’ve achieved some milestones, even if you’re not in the market for new capital, that type of communication earns a lot of accolades from investors. Just saying, “Hey guys, we’re not in the market. We’re not raising money right now. But I do want to tell you that we’ve just generated some really interesting data on a couple of different models and wanted to keep you abreast on our development.” Doing that, I found, gets very positive responses, So, when you’re going back and actively in the market for a new round, it’s not a complete dust off of an old presentation, and they feel like they’ve been made abreast of your developments along the way.

 Investor relations really is relationship building, and I think what Justin and Josh outlined is one-on-one relationship-building. I teach my kids, “Go meet with people and talk to people when you don’t need something, so at that moment when you do need something, it isn’t transactional.”

 Be tenacious about efficiency as you scale. As companies add new indications, expand to ex-US, and advance new R&D programs, those that challenge their own status-quo process and more adeptly manage across a growing portfolio will be the most successful. A flawed or inefficient process to start is only going to be compounded at scale. So, I’d underscore that efficiency element as key to success.

 Be forward-thinking as well. Even though it might be a long way down the road, it’s never too early to start to think about what changes might be needed in the future and talk to colleagues who may have gone through the process. Engage with potential vendors who might eventually help you through the process. They might get you to think about things that you haven’t considered yet. There are many things you can do that don’t require a significant capital investment; it can be an investment of time. I would try to be forward-thinking and start those conversations early as it makes sense.

 In 2020, when money was falling out of the trees for every biotech company, the tension was relieved a little bit, so management teams were probably a little less careful and boards were probably a little less strict on the oversight. I think these tough times can make companies better.

We’re in a Phase III study and expecting topline data in 2024, and we want to be commercial ready; so, this brings a constant tension. You don’t want to be too late and mess up the launch because you only get one chance to do a launch well, but you don’t want to be too early and spend too much capital before you’re ready. Obviously, that data card when we read that Phase III data is a massive de-risking event. We’re road mapping out all the costs and spending less to get smart and get ready. Then at that one moment when we open that envelope, assuming it’s positive, we’re ready to run and raise money and get ready for commercial scale. It just puts a heavier emphasis on planning and what you can do less expensively to be ready; and then as the programs are de-risked, pull in the capital and deploy it.

 How has communicating with external markets and stakeholders changed over recent years? How has vendor accountability and oversight evolved?

 I think investors today have been pretty badly bruised, too, in their portfolios, and you don’t hear about a lot of redemptions. On the one hand, you want to keep the investor relations effort going, but you don’t want to be in their face too much. You have to be deliberate about when you’re contacting them, when you’re communicating, and make sure you have something meaningful to say with investors…when you have meaningful updates and necessarily being out there on net dollar retentions with no real update for them. There has to be a bit of a balance, given the market.

 I would agree, I think having meetings on Zoom and Teams, which is the norm these days, makes it much more convenient to schedule and time-efficient. However, that convenience can be abused, too. You don’t want to waste stakeholders’ time; so, be careful not to schedule meetings just to have meetings. Make sure that when you’re scheduling meetings that there’s a topic that you want to discuss or news that can update the stakeholders.

 One observation that I have noticed now (versus five years ago) is simply the number of companies that you’re vying for attention from the buy side and from investors has just exploded to a point where it’s hard to get a response, even from an email or a meeting request. The threshold of company formation or for an IPO has become very low. There is so much noise out there and investors are just throwing up their arms. There’s only so much time in the day, and there are 800-plus Nasdaq-traded biotech companies alone. Then when you put on top of that all the private companies, there aren’t enough hours in the day to get the attention of the investors.

 But there are something like 2,000 clinical trials going on in cell and gene therapy alone right now. I mean, how do you possibly figure out, particularly given the early nature of the field, which horse to bet on? It’s almost impossible. I think that’s why you don’t see the Big Pharma companies come in. They’d rather put a bunch of numbers on the wheel in a variety of places and see how it all plays out.

 One of my favorite areas to invest in is strategic procurement. Once you bring in a new vendor, a procurement person sticks with that vendor. I’ve seen it work well when that person reports into the CFO/COO but sits with the clinical team and/or the tech ops team and they’re planted in. They become the financial conscience at every meeting and keep the sheriff’s badge visible and funnel back to me. I think that presence is helpful.

 When it comes to planning for clinical trials, how has managing the related finances and budgets changed?

 Clinical trials have always been hard to budget for; costs constantly change and the timing is hard to predict. It seems like there’s always a change order in the works, and maybe there are more now given the rising costs. But it’s always been difficult to budget spend. Plus, when you’re trying to plan the timing of clinical start-up costs and subject spend, you’re never going to get that right. You have to be flexible. We’ve done this by trying to do a better job of ensuring we have potential rising costs built into the budget and plan for more in the future. We’ve always had some level of cost contingencies in the budget, but we’ve taken a much harder look at the budget detail and have tried to build in specific inflationary pieces into the budget rather than just layer in a general percent, or couple-percentage, increases as we had done in the past. The increases we’ve seen recently can have a material impact, and we’ve taken a more granular approach to try and stay on top of it.

Also, I think things are taking a little longer. We’ve had to plan for that as well and have contingencies in place in the budget for delays. We’ve always planned for delays to some extent, but we’re now updating the budget forecast more often because things are changing faster. In general, however, the budget management process hasn’t changed much for us.

 Ultimately, the biggest cost of a study is time. A quarter delay with a clinical trial has a huge impact on how you’re running the company. It can be costly because you’re pushing out the revenue and damaging the net present value over the long term. To offset this impact, you can synthesize the development strategy and the financing strategy by raising the right amount of capital in a tough time, which allows you to tell your investors with conviction that capital will get us to a certain inflection point. While this can be hard, ultimately it’s very important, especially these days where many investors are really underwriting a single study and a specific inflection point.

Chief financial officers and other finance experts discuss the continued market volatility impacting life sciences investment—and what biopharma companies can do to help accelerate its recovery. Quality science and “good data” still win the day.

Pharmaceutical Executive: February 2023

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