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Content director at The Vanguard Network, an advisory organization that connects industry leaders through in-person forums and virtual exchanges. His work has appeared in publications such as 

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

Mike Ryan, general manager of Europe and Asia Pacific at EVERSANA, spoke with 

 about the unique challenges market access challenges pharma companies face in Europe.

Pharmaceutical Executive: How complex is it to bring a new therapy to multiple countries in Europe?


 Bringing a new therapy to multiple countries in Europe is hard for a variety of reasons. From a highly fragmented reimbursement landscape to diverse regulatory requirements across the 27 European Union member states, not to mention additional markets like the United Kingdom and Switzerland, it’s no small task.

In Europe, each country conducts its own Health Technology Assessments or HTAs, which are systematic evaluations, on a country-by-country basis. These look at the cost and health benefits of a drug or medical device. These detailed analyses are then used by each country to determine if a therapy should be considered for usage and paid for by the national health service in each country. Each is unique, and if a company is working to enter three or four different markets, the timelines for each assessment can vary, as can the ultimate price each governing body will pay.

In the United States, by contrast, once approved by the FDA, the process can go much faster. Because of this complexity in Europe, launch times can take some time.

PE: What are some of the common challenges you hear from clients who want to come to Europe that prevent them from doing so?


 By far, the biggest challenge brands face when considering a European launch is navigating the diverse and complex reimbursement systems, dealing with longer approval timelines, and managing the high costs associated with bringing new therapies to market. But that’s not all.

Europe is such a blend of countries with unique cultures and languages, and these all must be considered when determining what a market access approach may look like. For example, how a certain therapy might be perceived in Spain may be very different from how it is perceived in Finland. Additionally, the economic challenges of prioritizing cost-effectiveness and the need for better access to rare and orphan disease products are significant hurdles. In addition, U.S. companies may also have concerns about the costs of opening and maintaining subsidiaries in various countries. These can be expensive and complex, time-intensive efforts to stand up.

It’s not easy, but what we’ve seen is where brands can see strong value is in a partner that know the market and has relationships with governing bodies, clinical experts, and patient advocacy groups.

PE: What should companies consider in a partner to help them come to Europe?


 Companies should look for partners with a deep understanding of the European reimbursement landscape, experience in navigating HTAs, and the ability to manage price negotiations effectively.

Additionally, it is beneficial to identify partners who can offer solutions like outsourced sales representative teams, local legal infrastructures that may help minimize the need to open multiple subsidiaries, and partners with local marketing expertise.

Finally, as companies consider European launches, data insights into local markets should be built across all strategies. This will help to ensure that appropriate commercial resources are assigned to each market only when it’s necessary to do so. In doing so, partners must understand the intricacies of European data privacy laws and have a proven track record in this area. An effective outsourced partner must take every precaution to manage budgets as appropriately as possible.

PE: Are any countries “easier” from a market access standpoint than others?


 Yes, some countries are easier from a market access standpoint. For example, Germany typically has the fastest HTA pathways, where approvals can take anywhere from one to three months. In contrast, in Italy and Spain, our experiences show that it may take between 20 to 26 months for the same process. Wealthier nations like Switzerland and France often expedite the reimbursement process for innovative treatments, while countries in Eastern and Southern Europe face significant delays due to budget constraints and less robust healthcare infrastructures.

PE: Any additional final thoughts you hear from customers looking to launch a product in Europe?


 Based on feedback we have received from our existing clients, we see that companies value a partner that not only understands the nuances of the European markets but also brings integrated commercialization capabilities, allowing them to remain agile while ensuring compliance, market access, and commercial success.

Customers continuously emphasize the need for seamless execution - from launch strategy to field deployment teams and ongoing engagement with stakeholders. Clients believe a strong partner can help bridge the gaps between strategy and execution, ensuring that every decision is informed by both data-driven insights and deep local expertise.When done right, the European market can be a valuable market prospect for companies looking to introduce new therapies. It’s not easy, but in the end, the value to the companies and, most importantly, to patients across the region is worth the effort.

Pharma companies face unique challenges with market access in this region.

The Challenges of Market Access in Europe that Pharma Companies Face: Q&A with Mike Ryan

When it comes to emerging biotechnology or biopharmaceutical organizations, the typical product launch strategies for novel and promising medicines won’t necessarily work. New technologies come with new challenges, and companies working in this space need to be aware of these challenges ahead of time. This is especially true for those smaller entities hoping to expand to a global launch for their product.

John Arena is president of global pharma services at Cencora, managing a team that offers a broad range of solutions to biopharma companies of all sizes—from startups to large pharma—to support market-entry success and patient access worldwide.

Historically, emerging biopharma companies would be looking to get acquired by a larger company, who would then handle the commercialization of their product. In fact, back in 2001, emerging biopharma companies were responsible for only 34% of the molecules in the R&D pipeline

 without a larger firm involved. However, recent trends show that more emerging biopharma companies are bringing their products to market directly.

“We track the trends in the market, one of which is biopharma funding,” Arena tells 

. “Post-COVID, there was a decline in biopharma funding, but that has not only stabilized, we’re also seeing funding in this area pick up and definitely return to growth.”

Emerging biopharma companies appear to be responsible for driving the growth, as they account for 70% of the clinical-stage industry pipeline,

 while 60% of their assets are unpartnered, according to recent research. But these organizations also face unique challenges in moving their products from drug discovery and development through to commercialization.

“Oftentimes, these companies have more limited resources and less organizational experience managing the commercialization of a product, but we’ve seen that, when flanked by the right partner, they can go to market on their own,” says Arena. “They’ve got to be very intentional in how they manage their resourcing to do that.”

Arena pointed to the cell and gene therapy (CGT) space as an example of the growing biopharma market, citing the record-breaking nine CGTs approved by the FDA in 2024, including Mesoblast’s Ryoncil. Cencora, a partner, is providing integrated support

–including cryogenic storage and transportation and patient services–to aid in the commercial launch of Ryoncil in the US.

“It’s such an exciting area of science, and it really speaks to true innovation, which is just great for patients worldwide,” says Arena. “We believe that the next five years has significant promise for growth in that overall market—as evidenced by the nearly 2,000 CGT trials underway globally and the increasing number of regulatory approvals. We continue to invest in solutions that enable us to deliver enhanced support across the product lifecycle to help developers navigate the unique challenges, including those related to patient access, logistics, and market access.”

One of the biggest issues that emerging companies are facing when it comes to strategizing is the ever-evolving regulatory landscape globally, including policy and legislative uncertainty in the US. Meanwhile, in Europe, life sciences organizations are adapting to the EU’s new Health Technology Assessment regulation, including the Joint Clinical Assessment process.

“This question comes up all the time,” says Arena when asked about the regulatory landscape, “and the complexities of bringing these drugs to market continue to mount. Early-stage planning and cross-functional collaboration is paramount to effectively navigate and stay ahead of the constantly changing regulatory requirements.”

Of course, the regulatory climate in the US isn’t the only thing companies need to consider. For emerging biotechs preparing to launch their first or second product, developing a global launch sequencing strategy early in the process is essential—as is understanding the varying regulatory processes and requirements across global markets.

“One common misperception is that you can leverage the same go-to-market strategy used for the US to support your European launches,” notes Arena. “That’s just not the case. The regulatory standards are different, down even to the country level. You really need a go-to-market strategy that’s tailored to each country’s requirements. Companies need to understand compliance, supply chain, and regulatory and quality standards, as well as the factors that influence pricing, market access, and reimbursement in each market. You must deploy a level of local market expertise to tailor your strategy and investment to make sure you’re set up for commercial success.”

Despite the changing political landscape, the US still has many advantages for emerging biotech. It remains many companies’ top choice for their initial launches, and their launch strategies are generally still tailored for a US entrance. In fact, 34 of the 50 novel drugs approved by the FDA in 2024 were cleared in the US before any other country.

“Bringing a product from clinical through commercialization stages while considering global market expansion is an inherently complex process. The earlier a company can start planning–with an eye toward future markets–the greater likelihood of market expansion success,” Arena tells 

. “Companies need to understand the interdependencies throughout the planning process–including coordination-related commercialization planning, regulatory filing, and market access—as any missteps along the way can delay product launch and impact success. Our goal is to simplify the process and provide our partners with the support they need to accelerate speed-to-market.”

1. Emerging Biopharma’s Contribution to Innovation. IQVIA. June 13, 2022. 

https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/emerging-biopharma-contribution-to-innovation

2. Biopharma M&A: Outlook for 2025. IQVIA blog. January 27, 2025. 

https://www.iqvia.com/locations/emea/blogs/2025/01/biopharma-m-and-a-outlook-for-2025

3. Ryoncil Commercial Launch Update and Product Pipeline. Mesoblast press release. January 30, 2025. 

https://investorsmedia.mesoblast.com/static-files/f5e08d4a-20c0-4b7b-a71f-20822e1903cc

4. New Drug Therapy Approvals 2024. FDA. 

https://www.fda.gov/media/184967/download?attachmen4t4

A look at the current landscape and how young companies can set the stage for product launch.

Emerging Biopharma Launches: Strategizing in Today’s Global Market

Between 1989 and 2006, the most widely held monograph in the US was a business book called 

. Written by then–McKinsey consultants Thomas J. Peters and Robert H. Waterman, the book ushered in a radically new approach to organizational effectiveness. Prior to Peters and Waterman’s publication, an organization’s structure—its roles and reporting arrangement—was seen as the core drivers of success. 

, featuring insights from more than 40 companies, instead posited that 7 interconnected factors determined organizational effectiveness: structure, strategy, systems, shared values, skills, style, and staff.

This framework grouped the aforementioned factors into hard elements determined by companies—structure, strategy, and systems—and soft elements driven by culture—shared values, skills, style, and staff. The model is based on the theory that, for an organization to operate at peak performance, these seven elements need to be aligned and mutually reinforced.

For traditional business strategists in the 1970s and 1980s, the idea of interconnection and equal importance being placed on hard and soft factors was revolutionary, even more so for having shared values sit at the center.

, Tom Peters and Robert H. Waterman Jr, were driven to write the book by a desire to understand what made certain companies highly successful compared with others. As biopharma companies stand up and/or significantly expand thought leader liaison (TLL) with varying degrees of effectiveness, an opportunity exists to leverage a similar approach to enable success.

TLL teams sit at the intersection of multiple functions—marketing, sales, key account management, market access, and corporate relations—creating a need for an integrated approach to team strategy and execution. However, the approach for assessing and design of TLL has been very similar to a 1970s or 1980s business ethos with a focus on the hard elements of structure, strategy, and systems.

When we apply the 7S framework to TLL teams, we can uncover insights that are vital to optimizing how these teams engage with healthcare professionals, key opinion leaders (KOLs), and internal stakeholders.

Applying the 7S Framework to Review Your TLL Team:

How many TLLs are required to ensure appropriate engagement with national, regional, and local leaders?

Have we leveraged local and regional data insights to define how territories or regions should be aligned? Medical or field sales regions, or by location and density of thought leaders?

Do TLL or regional marketing team reporting structures reinforce strategic goals?

Strategy: Overarching Goals and Plan for the Team

What are the current strategic imperatives for TLL teams? How do these align with the brand’s strategic imperatives?

Which metrics and KPIs will define the strategy and success of engagement activities?

Which metrics will define when teams need to expand or pivot?

What is the vision for where the TLL or regional marketing team will be in a year?

How does the team’s strategy and approach compare with other TLL teams within the same company, as appropriate, and with the competitor’s TLL teams?

How will the TLL team use stakeholder profiling and management systems?

Does the team need a bespoke TLL CRM tool to capture and track engagements and insights, or can current systems be used?

What processes and templates are in place for gathering insights, integrating them into the broader business strategy, and tracking the application of these insights in marketing campaigns?

How can systems and tools support decision-making and not just track activity?

Do systems and tools enable compliant communication between TLL team and other functions?

Shared Values: Core Values, Mission, and Culture to Guide Behavior and Decision-Making

What do we want our TLLs to be known for?

How do we want TLLs to engage with cross-functional stakeholders?

Does the team’s name and reporting structure support the shared values?

What systems and tools are needed to enable alignment with “shared values”?

Example: If being data-driven is a core value, are we providing TLLs with relevant and updated data sets? If collaboration is a core value, have we created cross-functional forums that enable discussion?

Skills: Distinctive Competencies and Capabilities

What skills are critical for the team, given the product or portfolio needs, as well as the metrics they are measured on?

Examples: Do TLLs require negotiation skills to discuss benefits relative to entrenched competitors, clinical knowledge to explain the nuances of a new mechanism of action (MOA), or business acumen to engage in discussions about practice economics?

What training does the team need to effectively display these skills?

How can our hiring process focus on the skills required?

Style: Leadership Approach and Management Style

What is the leadership style of the TLL leader and the TLL team?

How is TLL team morale and how can we boost it?

Does the TLL team have support from the very highest levels of the organization?

Staff: People, Their Skills, Capabilities, and How They Are Managed and Developed

How are the teams managed and developed over time to address the evolving needs of the business?

What types of previous experience make some team members most successful and how can we incorporate this into the hiring process?

How does the naming of the team-eg, TLL, regional marketer, customer engagement, regional insights-pact the team approach?

What incentives or rewards can we put in place to drive teams?

In a 1980 article, McKinsey consultants Thomas J. Peters and Robert H. Waterman emphasized that “structure is not organization.” The same concept applies to TLL teams. The sheer number of individuals doesn’t determine the success of your team—it’s how those elements work together to form a cohesive, high-performing organization that matters.

The first step in applying the 7S Framework is conducting a thorough analysis of the current state of your team across these 7 dimensions. Use the framework and key questions to:

Spur discussion among leadership and team members about what is working and what needs improvement

Identify misalignments between elements, such as strategy and structure or leadership style and skills

Map out gaps and uncover opportunities for alignment

With increasing limitations on HCP access and growing competition for KOL engagement, TLL teams play a crucial role in ensuring brand success.

As Thomas J. Peters and Robert H. Waterman observed: 

"We found that the excellent companies tend to have tight interrelationships among the seven S’s—structure, strategy, systems, style, skills, staff, and shared values. The interplay of these elements is what truly defines an organization’s success.”

Start today—leverage the McKinsey 7S Framework to refine your team’s strategy, strengthen stakeholder relationships, and drive lasting success.

Evaluate existing tools and systems that support TLL engagement

Proactively define TLL strategy to align with business objectives

Incorporate style and skills into training and professional development

By regularly assessing these key elements, TLLs teams can position themselves and their companies optimally in support of their search for excellence.

Applying the McKinsey 7S Framework to TLL and regional marketing teams.

From 1990s Business Wisdom to Today’s BioPharma Success

 podcast, Jennifer Butler, chief commercial officer of Pleio, discusses:

The threat of misinformation to public health and how emotional appeal plays a part.

Where patients are turning for trustworthy health information.

Strategies that can be used to verify information.

Jennifer Butler, chief commercial officer of Pleio, discusses misinformation's threat to public health, where patients are turning for trustworthy health information, the industry's pivot to peer-to-patient strategies to educate patients, and more.

Jamie Pallot

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