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Partner with IP law firm MBHB and the co-chair of its biotechnology and pharmaceuticals practice group

Issue represents a potential threat in fighting future pandemics.

The True Nature of Danger Behind IP Waiver Proposal

Kevin E. Noonan asks, what do the biosimilars provisions of the Trans-Pacific Partnership portend for global biologic drug development?

Global Biologic Drug Development and the TTP

AbbVie Pedro Valencia ADCs

PE: How is AbbVie using novel cancer biomarkers to develop potential first-in-class ADCs for the treatment of advanced solid tumors?

We're constantly looking for biomarkers that can help us to do two key things. The first is to tackle cancer cells. and spare normal cells. We’re looking for specific antigens that are over-expressing tumor cells, and you see limited expression in normal cells. We want to make sure that target that’s over-expressed is critical for the survival of the cancer cell. Once you block it, you can actually drive a cancer cell death. That’s what we're looking for. In that perspective, c-Met is one of those biomarkers that is over expressing multiple tumor types such as lung, colorectal, gastric, and other GA tumors. We as an industry have tried to tackle c-Met in the past but have been unsuccessful. It would actually be successful to tackle what we call met, which is a gene inside the cell.

There’s this thing called met amplification, where the cancer cell produces multiple copies of the gene, and around 30% of patients have it. We can actually tackle that with small molecules. But once the gene becomes a protein and gets over-expressed in the cell, that over-expression is something we haven’t been able to target. For example, we know that on lung cancer, c-Met over-expression is about 25% to 50% in colorectal cancer, and it could be anywhere from 30% to 70% depending how you measure it, so it’s quite prevalent.

With ADCs, we’re trying to tackle c-Met over-expression on the surface of cancer cells. That was novel, and we can do it through ADCs. 706 has a target called SEZ6, and it’s a target that is over expressed in neuroendocrine cells or neuroendocrine neoplasms. When you think about it, multiple tumor types kind of have a subset of cells that are neuroendocrine driven. Small cell lung cancer is one of the few that has everything driven by neuroendocrine cells. The beauty of SEZ6 is over-expressing those cells and limited expression in normal cells. So, we can tackle it with an ADC and drive the results that we're seeing today.

PE: ADCs have redefined the treatment of cancer in recent years. Can you please discuss the promise of this emerging class and what the future may hold?

At the end of the day, ADCs work like a trojan horse. You have a good antibody that cancer cells are happy to receive, but once you hook into the cancer cell receptor, you deliver the payload, which is pretty much chemotherapy. It’s actually a highly potent version of the regular chemotherapy cancer patients are given on a regular basis. So, from that perspective, our goal is to replace chemotherapy. Our grand goal with ADCs is to replace good old, decades old chemotherapy that is really toxic for some patients. That’s how we see the redefinition of cancer treatment in the future with ADCs. So, what do we see in the future? Well, if you think about it, chemotherapy is being given in combination with other agents. In the future, we see ADCs being given in combination with chemotherapy. There will be one with other agents such as immuno-oncology agents. So, if you combine the ADC and the PD1s, you can start seeing that synergy come together and kind of start really dreaming about cures for the patients. All in all, we're super excited about ADCs replacing chemotherapy. 

In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses using novel cancer biomarkers to develop potential first-in-class antibody drug conjugates (ADCs) and the promise that they offer. 

Utilizing Biomarkers to Develop First-in-Class Antibody Drug Conjugates to Treat Advanced Solid Tumors

Health Economics and Outcomes Research (HEOR) in the biopharmaceutical industry has been established for over 50 years, but rising drug prices, tightening payer budgets, and increasing competition have recently put the spotlight on the discipline. Healthcare ecosystem stakeholders (payers, patients, providers, policymakers, etc.) are demanding more robust evidence of value to support healthcare decision making as evidenced by major policy developments like the Inflation Reduction Act (IRA) and European Union Regulation on Health Technology Assessment (EUHTAR).

To meet these growing demands for evidence, HEOR functions within pharma need to optimize their organizational architecture and ways of working to deliver marketplace impact efficiently. Benchmarking empowers HEOR leaders with industry best practice to continuously grow and optimize their teams sustainably.

Previous benchmarking exercises have included aspects of HEOR as a component within Market Access or Medical Affairs functions.

 This timely HEOR benchmarking exercise fills an unmet need for a more comprehensive review of the HEOR function and comes at a critical point of inflection for the discipline where many HEOR groups are experiencing organizational shifts and focused on effectively demonstrating their impact and value.

We conducted a 2024 benchmark of HEOR organizations based on qualitative and quantitative data from seven biopharmaceutical companies: one small (zero-10 billion USD annual revenue), three medium (>10-30 billion USD annual revenue), and three large (>30 billion USD annual revenue). Over 60 interviews were conducted with HEOR leaders and team members including representation from Global, Canada, EU, Japan, UK, and the US. The benchmark focused on collecting data and insights on the HEOR function’s operating model including organizational structure and positioning, team characteristics and capabilities, and ways of working.

Pharmaceutical companies are generally organized into two major divisions – Commercial (customer-facing) and Research and Development (research, medical focused), to ensure the scientific integrity of research activities. HEOR holds a dual mandate—

 to support healthcare decision-making (aligned with Commercial functions). Over the years, HEOR’s position has swung between these divisions, but within our sample of companies more HEOR functions have been integrated into the 

 teams, to better align value evidence generation with market access strategies. The HEOR functions in our sample companies are also mostly centralized, providing dedicated product and geographic level support with dedicated local HEOR support for major markets, including the US, as countries develop their own value assessment methods. There were no regional models in our sample of companies.

HEOR is an umbrella for multiple disciplines of evidence generation; platform (or centers of excellence) teams enable HEOR functions to scale and standardize these disciplines and efficiently support multiple products and geographies (see Figure 1).

RWE has a broad range of applications and as a result, RWE is being produced by HEOR and other functions without clear roles and responsibilities, ultimately causing tension and inefficiencies such as duplication of efforts. Only some companies exclusively held RWE responsibilities within HEOR, while the remainder shared this capability with other functions.

HEOR functions require a diverse team due to HEOR’s broad scope of disciplines and applications. All HEOR functions in our sample of companies had highly credentialed teams with a mix of discipline specialists and product strategy experts. Given this diversity, career development pathways need to be tailored to support the unique roles within HEOR, rather than a one-size fits all approach. Most HEOR functions in our sample had career development pathways documented, however these were mostly for team members working in a product centered role; pathways for specialist roles were identified as a key gap.

Recruiting for HEOR talent is highly competitive. HEOR leaders are retaining top talent through competitive salaries, allowing for remote/hybrid work policies, and increasing development opportunities. They are also looking at formalizing career pathways for individual contributor roles or propelling HEOR team members into different technical areas and geographic areas.

. HEOR Teams are embracing digital technology and are investing in areas like AI, digital health, and real-time data analytics to provide insights for payer engagements. For example, some teams are using AI to conduct literature reviews, reducing the time to complete these routine HEOR activities from weeks to days. In another example, teams are utilizing digital health technologies to build registries for more robust data collection to better understand disease burden.

“I feel like population health organizations are starting to realize the power of the data they have and AI can now help them leverage that data to support decision-making. They are actively trying to build up their capabilities to effectively leverage that data in ways I haven't seen before and we have to keep up." - US Head of Field HEOR

In our sample of companies, HEOR groups were often labeled as being “too academic” or “too publication focused” and were not fully effective at disseminating key evidence to their audiences. To combat this label, some companies are developing communication workshops to upskill storytelling capabilities and dissemination of HEOR evidence.

HEOR generates evidence that is applicable for a diverse group of stakeholders (Figure 2). To ensure that evidence generated is relevant and effectively reaches these groups, HEOR functions must collaborate closely with cross-functional internal stakeholders. While the established trifecta of HEOR, Medical Affairs and Market Access was well recognized as an effective commercialization model, interviewees identified the relationship between HEOR and clinical/regulatory teams as a key area for improvement; this was even when HEOR was positioned under the Medical organization.  

Many internal partners struggle to grasp the full scope of HEOR's role and its relevance to their work or its impact on their external stakeholders. This lack of understanding is compounded by the absence of robust metrics that could effectively demonstrate HEOR's value to all stakeholders. Despite the critical role of HEOR, only a limited number of companies include HEOR experts on global product teams, and even fewer incorporate them into brand teams. This underrepresentation limits HEOR's ability to shape strategic decisions and leverage its unique methodologies and expertise to address business challenges.

"We need to dispel the misconception that HEOR only generates evidence for payers" - Health Economist 

: HEOR insights ensure trial designs address key evidence needs for payers and policy markets and align clinical outcomes with real-world applications.

: Increasingly regulators themselves are also interested in HEOR disciplines such as RWE and PED to bolster the real-world relevance of trial data.

: HEOR inputs are directly relevant to key policy developments worldwide (eg, HTA, EU HTAR, IRA and PDAB requirements). HEOR evidence can also support the prioritization of unmet needs in certain disease areas by policy-makers.

:As patients increasingly are taking ownership for their healthcare, HEOR evidence empowers them to actively participate in shared decision-making with their physicians.

HEOR functions in our sample are largely focused on productivity or project management metrics (see Figure 3). Impact metrics are desired, however, HEOR functions havedifficulty attributing broader access and commercial impact to HEOR. In some companies, even though linking HEOR metrics to access/commercial metrics would resonate best with internal partners there exists a compliance challenge to directly connect research activities with sales number, prescribing impact, etc.

 Some companies have delineated RWE responsibilities by external audience or research type with limited success. Given HEOR’s broad scope and capabilities, senior leaders believe that HEOR is uniquely positioned to play a role in RWE governance across the company to ensure that RWE execution is streamlined, and that generated research is widely communicated.

“RWE experts are going to exist in various other functions because various external stakeholders are asking for RWE. It's going to be counter-productive to try to centralize execution of RWE...the strategic aspects should be centralized with HEOR." - Global/ US Head of HEOR

Recent shifts in HEOR functions across major pharmaceutical companies confirm a lack of internal understanding of the value of HEOR despite the robust external demand for evidence of value. HEOR is often perceived as too academic, with a disconnect in the translation of evidence to impact for external stakeholders. Many teams face challenges in effective dissemination of HEOR deliverables, citing issues such as the lack of storytelling capabilities, longer study timelines not meeting end-user or launch needs, and the lack of measurable metrics to demonstrate the impact of their work. We identified some companies that were proactively addressing these issues, investing FTE to specifically package and translate HEOR evidence for stakeholders and identifying communication channels for evidence dissemination.

The shift of HEOR organizations to Value/Market Access aligns HEOR closer to business and payer needs, potentially streamlining HEOR’s path for evidence to impact access. However, this shift could potentially limit career paths, investments in methodology, and evidence for healthcare providers and patients.

It is therefore essential that in this next iteration of the HEOR function, senior leaders prioritize the development of HEOR translation capabilities, coupling evidence communication planning with best-in-class evidence synthesis and HEOR/value storytelling. To demonstrate value internally, leaders should invest in impact metrics in collaboration with internal functions including compliance and harness technology for the required data collection. Finally, tailoring the HEOR value proposition to individual internal partner functions will also be important to demonstrate HEOR’s grasp of their stakeholder’s evidence needs. By addressing these areas, HEOR can better align itself with biopharmaceutical organizational goals and solidify its indispensable role in responding to the ever increasing access landscape challenges.

Vice President, Management Consulting Practice; 

 We would like to thank Patricia Deverka, Amy Wu, and Kenneth Wu for their support and collaboration throughout this project. Their commitment and expertise were instrumental in bringing this project to fruition. We would also like to thank Kate Burslem, Elizabeth Brooks, John Byrd, Ruslan Horblyuk, Ruchik Patel, and Victoria Schliep who have helped support the benchmarking effort.

 All facts, insights and opinions were generated through the research conducted in full by AESARA. Artificial Intelligence (AI) was used to assist with language edits and to enhance clarity.

Hochstrasser M, Grueger J, de Gorgolas M, Vaidyanathan S, BCG Members, BCG Market Access Roundtable. A New Era for Market Access: Organizing the Function’s Broader Strategic Role. 

. 2023;43(5). Accessed September 19, 2024. https://www.pharmexec.com/view/new-era-market-access-organizing-function-broader-strategic-role

Algazy J, Garcia A, Ryan S, Westra A, Zemp A. 

A Vision for Medical Affairs 2030: Five Priorities for Patient Impact

.; 2023. Accessed September 19, 2024. https://www.mckinsey.com/industries/life-sciences/our-insights/a-vision-for-medical-affairs-2030-five-priorities-for-patient-impact#/

The recent shift in Health Economics and Outcomes Research functions across major pharmaceutical companies highlights a lack of understanding of its value. 

HEOR: From Proving Product Value to Proving Its Own Worth

"You’re building the airplane while you’re flying it, but are you repairing it en route?”

This was just one of the ways in which Noël Auguston, managing director at Russell Reynolds Associates, framed the issue of talent management at a Vanguard Network Life Sciences CEO Forum late last year in Boston.

Auguston kicked off an animated session titled “The People Factor” by outlining all the ways in which the CEO role in biopharma has become increasingly complex—from a fractured economic environment through geopolitical challenges, hybrid workforces, and technological advances such as artificial intelligence (AI).

Talent, Auguston stressed, is the main engine driving organizational success, and the industry’s explosive growth during the COVID-19 pandemic “from 400 public biotechs to 800,” she reported, has only placed more pressure on CEOs striving to build out their companies.

Given such a volatile landscape, it is critical that leaders monitor and assess their organizations continually to ensure alignment with evolving priorities. And while “some folks are naturally hard-wired to think very opportunistically about talent, to constantly reevaluate their teams,” noted Auguston, such a mindset does not come easily to everyone, she added.

Nevertheless, those C-suite leaders in biopharma who avoid proactive talent management are setting themselves up for serious problems down the road.

“The biggest pitfall we see is waiting too long and just hoping that something you know is festering will get better,” said Auguston. “I’ve never had a client say, ‘Oh my gosh, the CFO turned around—it wasn’t going well, and all of a sudden, it’s great.’”

Given the general shortage of seasoned talent, ”finding the “been there, done that” CEO is the exception rather than the rule,” Auguston asserted. Hence, the role of an organization’s board of directors becomes even more crucial. As board members, these often experienced professionals who have witnessed the ups and downs of the industry can offset skill gaps in leadership teams.

As critical as leadership development is for the long-term success of a biopharma company, it often gets deprioritized due to short-term pressures, Augustin concluded.

“How do you convince someone to spend more time figuring out a successor when their pants are on fire?” she posed.

Following the engaging back-and-forth, Auguston reiterated the key points of her address, which included:

 She emphasized the importance of creating time within organizations to strategically evaluate and plan for talent needs. Leaders should seek out great people who can enhance their teams—even if the need isn’t immediate.

Successful companies, Auguston noted, are proactive about assessing and reassessing their teams. They act decisively instead of waiting for issues to worsen. When working with firms such as hers, Auguston stressed the importance of alignment and clarity around role definitions and success metrics.

 Auguston encouraged leaders to critically evaluate what’s working and identify specific gaps. Over-hiring too early can strain resources—she often advises Series A companies to consider roles such as vice president of finance or a strong controller rather than hiring an expensive CFO, for example, prematurely.

 Auguston highlighted the risks of searching for a single hire to solve multiple organizational challenges. No one person can fix every issue, and trying to find such a “unicorn” potentially sets the hire up for failure. Instead, leaders should focus on targeted solutions to specific problems.

Auguston underscored the importance of moving quickly when the right person comes along. While perfection is rare, acting decisively to secure aligned talent ensures the company keeps progressing. This intentional, forward-looking approach is essential for navigating today’s dynamic life sciences market, she added.

The Vanguard Network forum continued with an informative session led by Viq Pervaaz, senior vice president at the New York City Economic Development Corporation. Pervaaz reflected on the challenges and opportunities of integrating AI into life sciences, emphasizing the importance of clarity in conversations about AI. He found it frustrating when terms such as AI, machine learning (ML), and deep learning were used interchangeably or without specificity, often causing confusion instead of driving meaningful outcomes.

Two of the first priorities Pervaaz identified in his current role were to define these terms for his organization, and to explore how AI can intersect with practical processes to deliver tangible benefits. As an example, AI could speed up drug discovery for startups, or enhance patient retention for more mature companies in the clinical development stage.

Pervaaz noted that while healthcare and life sciences have been relatively slow to adopt AI in comparison to other industries, some major players are making progress. He cited Johnson & Johnson, Bristol Myers Squibb, and Sanofi as having “already created partnerships with AI or ML organizations,” and using those partnerships to “accelerate either drug discovery or the clinical development process.”

Pervaaz dismissed the notion that AI and traditional life sciences operate in separate worlds, likening them instead to complementary components, “like chocolate and peanut butter in a Reese’s Cup.”

This amounts to a fundamental shift in mindset regarding the role of AI in biopharma. Rather than viewing AI as an auxiliary tool, Pervaaz proposed that it should be treated as part of the workforce—essentially akin to “considering a robot as part of your talent pool.” This requires investing in the development of AI; evaluating its performance; and ensuring it functions effectively within its intended role. By incorporating AI into their organizational structure, and maintaining it as one would an employee, companies will be better able to leverage its potential, Pervaaz believes.

He qualified his position by highlighting the importance of using AI to complement human talent rather than replacing it altogether. Pervaaz argued that AI should augment capabilities—such as helping medicinal chemists analyze data or refine experimental directions—and that its performance needs to be actively managed and improved. Central to this perspectiveis the understanding of AI as a dynamic, evolving phenomenon needing support and nourishment to achieve its full potential.

In closing, Pervaaz emphasized that AI is only one piece of what he deemed a “broader convergence of technology and healthcare.” Innovations from Silicon Valley and other centers of innovation, Pervaaz maintained, are enabling a range of groundbreaking tools that extend far beyond AI, offering a multitude of new ways to enhance healthcare delivery and patient outcomes. The key to success for biopharma companies, Pervaaz concluded, lies in fostering collaboration between technology and life sciences to improve products and processes across the board.

Following the animated exchange, Pervaaz reinforced his key themes and made some additional points relating to life sciences personnel and hiring practices. These included:

 Pervaaz discussed the challenges of bringing in outside talent, particularly at senior levels. He highlighted the risk of “organ rejection,” where even highly experienced individuals fail to integrate due to assumptions about their ability to adapt. He stressed the importance of being disciplined and purposeful in ensuring a strong cultural fit for new hires.

Pervaaz emphasized the need for leaders to have the courage to make difficult decisions, even if they disrupt traditional expectations. This could involve convincing the board to integrate technologies such as ML into drug discovery, or bringing tech talent into executive teams and boards to meet evolving challenges.

Pervaaz acknowledged the difficulty of bypassing long-groomed internal candidates for leadership roles when they may not align with the organization’s immediate needs. He encouraged life sciences leaders to have the courage to prioritize what’s right for the company’s current situation over what feels expected.

The skill of seeing clearly in interviews.

 Pervaaz highlighted the critical skill of assessing talent effectively during interviews. Drawing a parallel to acting, he described the importance of not just observing what candidates say or reading their CVs, but noting their behavior from “moment to moment.” This nuanced awareness, he argued, helps leaders discern candidates who might thrive versus those who could be rejected by the organization in six months.

 Pervaaz concluded by emphasizing the need to be fully present and observant during the hiring processes. Leaders, he maintained, need to “step outside of themselves” to assess candidates clearly and align their decisions with the organization’s long-term success.

Jamie Pallot is content director at The Vanguard Network, a membership and advisory organization that connects industry leaders through in-person forums and virtual exchanges. His work has appeared in publications such as The Wall Street Journal and Financial Times.

Experts weigh in on today’s life sciences leadership-development priorities critical to long-term success.


The ‘People Factor’: Sourcing, Nurturing, and Retaining Talent

Primrose Bio announced a new product to improve the manufacturing on long-template mRNA vaccines.

 The Prima RNApols ExTend reportedly allows developers to produce mRNA products with improved performance at a reduced cost. It does so by producing mRNA with lower dsRNA.

In a press release, Primrose Bio CEO Helge Zieler said, “Prima ExTend is a much-needed innovation for the production of long-template mRNA therapeutics, that often struggle with integrity and quality issues that add risk to these programs. Our new enzyme is an important advancement for drug developers and researchers seeking high-integrity, high-yield mRNA. This innovation underscores our commitment to providing leading technologies that support the manufacturing of the next generation of mRNA vaccines and therapeutics."

In September of last year, Primrose Bio announced a partnership with ExPLoRNA Therapeutics to advance mRNA technologies, vaccines, and therapeutics.

 As part of the collaboration, Primrose combined its Prima RNApols (the Prima RNApols ExTend predecessor) with ExPLoRNA’s therapeutic platform that allows for increases in protein production, limits dsRNA formation, and reduces IVT cost.

In a press release issued at the time, Zieler said, “We are excited to work with ExPLoRNA to bring industry leading mRNA cap analogs to the market and pairing them with Primrose Bio's RNA polymerases. This partnership will result in broader manufacturing and design options for companies developing mRNA therapeutics and vaccines, facilitating access to the most efficient capping chemistry available."

ExPLoRNA Therapeutics CEO Jacek Jemielity added, “Through joining forces, we'll advance the mRNA as a modality from the first applications to the next generation. We aim at creating the best synergies between our cap analogs and novel polymerases to surpass current manufacturing process and what is achievable with mRNA today."

In January, Primrose Bio also announced a partnership with the Serum Institute of India to co-develop a novel multi-antigen vaccine.

 As part of the deal, Primrose will handle the manufacturing of any resulting strains.

In a press release issued at the time, the Serum Institute of India’s executive director Dr. Umesh Shaligram said, “We are eager to strengthen our long-standing relationship with Primrose to develop a new vaccine with the potential to save millions of lives globally. This ambitious program faces many technical challenges, which become more difficult when aiming for global affordability. We believe the robustness of the Pfenex Expression Technology will enable us to solve these technical challenges at a global scale."

In the same press release, Zieler added, “We are delighted to deepen our long-standing relationship with SIIPL, a global leader in vaccine innovation. This commitment demonstrates the versatility and transformative potential of the Pfenex Expression Technology to address critical vaccine antigen manufacturing and global health needs."

Primrose Bio Launches Prima RNApols™ ExTend, an RNA Polymerase for Long-Template mRNA Manufacturing. 

. March 26, 2025. https://www.prnewswire.com/news-releases/primrose-bio-launches-prima-rnapols-extend-an-rna-polymerase-for-long-template-mrna-manufacturing-302411990.html

Primrose Bio and ExPLoRNA Therapeutics Announce Strategic Partnership to Advance mRNA Medicines. 

. September 3, 2025. Accessed March 26, 2025. https://www.prnewswire.com/news-releases/primrose-bio-and-explorna-therapeutics-announce-strategic-partnership-to-advance-mrna-medicines-302236633.html

Primrose Bio to Collaborate with Serum Institute of India to Develop a Novel Multi-Antigen Vaccine. 

. January 10, 2025. Accessed March 26, 2025. https://www.prnewswire.com/news-releases/primrose-bio-to-collaborate-with-serum-institute-of-india-to-develop-a-novel-multi-antigen-vaccine-302347796.html

The new product will allow for improved mRNA production with reduced costs.

Primrose Bio Announces New mRNA Polymerase

Oncology products are a cornerstone of biopharmaceutical innovation, driving both revenue growth and scientific breakthroughs. The global oncology drug market is projected to reach $409 billion by 2028, underscoring its dominance in industry pipelines and sales.

Despite this promise, securing market access for oncology therapies is uniquely challenging. The high-stakes nature of cancer care, coupled with rapid scientific advancements and increasing payer and regulatory pressures, demands a specialized approach beyond traditional market access strategies.

Foundational market access principles such as robust clinical evidence, early engagement with healthcare ecosystem stakeholders, and compelling value propositions remain critical. However, oncology necessitates a more nuanced strategy due to its complexity, which is driven by personalized medicine, diverse treatment modalities such as immunotherapy, and evolving payment models.

Success requires deep market expertise and seamless integration of tactics spanning market access, patient services, and medical affairs to create effective, tailored strategies. Biopharma companies need a forward-looking market access strategy, or they risk being left behind and not competing to win in the growingly competitive marketplace.

The Unique Complexity of Oncology Market Access

Oncology market access is unique because it is rarely defined by payer negotiations or coverage. Rather, oncology market access requires a sophisticated, multi-dimensional strategy that integrates deep clinical expertise with a hands-on understanding of the different stakeholders in the healthcare ecosystem.

Market access leaders must navigate the interplay of clinical, operational, and financial factors across diverse customer segments, beyond the payer and pharmacy benefit manager (PBM). These include other stakeholders that influence patient access, such as integrated delivery networks (IDNs), group purchasing organizations (GPOs), oncology-oriented benefit managers, specialty pharmacies (SPs), and community oncology entities.

Multi-stakeholder perspectives are particularly critical in oncology due to the impact of medical benefit design on combined drug regimens and multi-modality treatment plans, which may include radiation and surgery. Oncology market access also involves considerations such as oncology pathways, value-based care models, site-of-care optimization, and patient support programs.

These elements facilitate access at key points in the patient journey beyond treatment selection, including patient identification, biomarker testing, adherence, and both financial and clinical toxicity management. Securing formulary placement or a positive coverage policy is just the first step in a larger picture—comprehensive market access must go further for successful adoption.

The following sections highlight how oncology complexities intersect with traditional market access principles.

Three Pillars of Product Market Access for Oncology

1. Clinical Evidence and Optimizing Outcomes: Beyond Payer Barriers

A strong clinical value story is essential in a competitive landscape. However, oncology market access requires more than payer-focused strategies. It must also consider positioning on clinical pathways, institutional protocols, and in real-world treatment settings. Without a differentiated and robust value story, a product may achieve FDA approval and NCCN guideline recommendations but fail to secure a preferred pathway position limiting access and commercial success in ways that were not anticipated.

The Impact of Oncology Pathways on Product Access


Clinical pathways, developed by payers or providers, play a pivotal role in treatment decision-making. Understanding pathway influence is as critical as securing formulary placement. For example, MMIT highlighted a case in which multiple PD-1 inhibitors were FDA-approved for late-stage urothelial cancer and covered by payer formularies.

However, an IDN’s pathway program designated only one PD-1 inhibitor option as preferred, potentially limiting the prescriber’s view and ultimately access to other appropriate PD-1 inhibitor treatments.

 This underscores the need for clinical value propositions that also support positive pathway placement with payers, IDNs, and third-party pathway companies. Ensuring positive positioning with these different stakeholders is not a one-size-fits-all solution because each stakeholder has different incentives that don’t consistently align.

The high-stakes nature of cancer care, coupled with rapid scientific advancements and increasing payer and regulatory pressures, demands a specialized approach beyond traditional market access strategies. 

Kevin E. Noonan, PhD

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