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Pharmaceutical Executive - Leadership, Strategy & Market Access

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Latest Executive Roundtables

Asembia 2025 

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Sales and Marketing

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DSCSA Is Not the Finish Line, It’s the Starting Gate

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

Pharmaceutical Executive: What cost management initiatives have you undertaken to enhance efficiency?


As CFO, my commitment to financial discipline and strategic decision making is rooted in driving sustainable growth and delivering long-term VALUE, both to the people we serve and Astellas as a whole. With accountability and efficiency at the core of my approach, we’ve strengthened the balance sheet.

Our cost management initiatives are focused on improving our organizational effectiveness, costs and ways of working across the company, setting Astellas up for future growth and transformation. For example, we’ve optimized resource allocation throughout our global network to ensure we’re directing resources to areas of the company with the highest potential for growth. We do this by incorporating innovative analytics tools to help us manage our resource use in real-time.

We’re also investing in the growth of our employees by building critical in-house capabilities, especially related to clinical trials and research and development (R&D), to reduce outsourcing. This strategy has had a direct impact on our core operating profit growth.

Improving Astellas’ cost optimization is one of the accomplishments I’m most proud of since joining the company in 2023. In our last fiscal year (April 1, 2024-March 31, 2025), we achieved cost optimization of 40 billion yen, and we continue to make steady progress in FY25.

PE: How are you positioning Astellas to weather near-term challenges while pursuing future opportunities?


Before joining Astellas, I had the opportunity to work in diverse sectors, including electronics, food service, logistics and consumer goods. This experience provided valuable insights as I’ve stepped into the pharmaceutical industry, which has its own unique challenges, including a higher risk profile, higher revenue to R&D expense ratio, and longer pathway to product launches and commercialization – factors that impact cash flow. The cyclical nature of the pharmaceutical industry requires constant transformation to address challenges.

I’m focused on maintaining and improving profitability while investing in innovation. To be successful, close alignment with our R&D group has been critical because sustained investment in the pipeline is essential for driving long-term growth. My team works to ensure they understand the science behind our on-market and investigational therapies and can clearly articulate how our products differentiate in the market, especially when speaking with the investment community or informing business decisions.

In collaboration with our Business Development and R&D teams, we prioritize financial flexibility to pursue bold, forward-looking collaborations that will create and deliver VALUE. From a finance perspective, I’m focused on reducing interest-bearing debt so we can improve our financial leverage. We also strive to take a creative, solutions-oriented approach to structuring agreements, taking into consideration the needs of all stakeholders involved. This strengthens our ability to ensure we’re forging strategic partnerships and acquisitions that will drive future growth. Through successful partnerships, in-house innovation and acquisitions, Astellas has built a portfolio that delivers life-saving treatments with future potential to address wider unmet patient needs through new modalities.

PE: How do you plan to sustain growth despite market volatility?


 To sustain growth in a volatile market, we must prioritize pragmatism and strategic long-term planning in tandem. From exchange rate fluctuations to policy shifts and evolving business laws, the pharmaceutical industry is facing unique challenges that can hinder both patient care and business growth. To overcome these, I’ve implemented strategies that address immediate operational needs while building long-term resilience.

For example, I’m focused on reducing interest-bearing debt and prioritizing high-growth markets or aligning operations with emerging trends to enable the company to remain agile and sustain momentum, even during uncertain times. We continually review changing global regulations and business laws, assessing their impact and ensuring our own priorities are aligned with local and global requirements so we can quickly adapt to industry changes.

In addition, we’re tapping into the latest technology to implement new integrated cash flow management systems and robust financial planning frameworks, including in-depth scenario analyses, to anticipate and adapt to fluctuations in the market. My team has also incorporated robust financial forecasting and situational planning systems to help anticipate shifts in the market and potential risks to our business goals. This approach has been integral to our ability to quickly respond to challenges while ensuring we have smooth financial operations and strong budget control.

As the pharmaceutical landscape evolves, we’re making deliberate decisions to focus our resources where they can deliver the greatest impact. This helps us reduce the impact of market volatility on our operations, allowing us to stay focused on delivering innovative solutions for patients.

PE: In what ways are you securing capital for strategic partnerships?


 Strategic partnerships have played an important role in establishing Astellas’ proven track record of successful innovation, our broad pipeline, and our expertise in novel modalities. More than 50% of our pipeline and products originate from external partnerships. These include academic alliances, emerging and established company collaborations, licensing arrangements, global pharma partnerships, and acquisitions.

From an M&A perspective, we’re focused on late-stage assets where risks have been reduced. We know this will require larger investment compared to early-stage assets. To withstand this, I am working to strengthen our balance sheet as well as our core operating profit – which is the source of free cash flow generation – while also reducing the balance of interest-bearing debt. We have made steady progress across these efforts, which helps us have the financial flexibility to pursue bold and forward-looking collaborations with organizations who share our dedication to transforming patient outcomes.

Based on the capital allocation guidelines, we have the opportunity to think about how to make effective decisions and optimize within that framework. I organize and provide information in a way that makes it easier for decision makers to make choices while posing questions from a neutral standpoint. Ultimately, my job is to ensure we’re managing our resources and risks carefully to help create open discussions with potential partners to find the best opportunities for future, sustainable growth.

Astellas is enhancing efficiency through strategic cost management, focusing on resource allocation and in-house capability development, particularly in R&D. The company achieved significant cost optimization in the last fiscal year and continues to progress. To navigate industry challenges, Astellas emphasizes financial flexibility, reducing debt, and strategic partnerships. The company is also implementing advanced financial planning systems to manage market volatility. Strategic partnerships, especially in late-stage assets, are crucial for innovation and growth, with a focus on maintaining a strong balance sheet and core operating profit.

Kitamura discusses implementing cost management initiatives and positioning the company to weather near-term challenges.

A Commitment to Financial Discipline: Q&A with Astellas’ CFO Atsushi Kitamura

In today’s rapidly evolving life sciences market, small biotechnology companies and startups face complex challenges and decisions, particularly when it comes to the capital-intensive world of process development and manufacturing. These challenges can include a lack of specialized in-house expertise, the high cost of development and equipment, and the complexities of navigating the ever-evolving regulatory environment (or landscape), all of which must be balanced against the expectations of shareholders.

With ever-increasing costs to put a single molecule on the market estimated between $300 million and over $2 billion, the pressure to reach clinical milestones quickly and efficiently often drives a focus on short-term gains that can create significant long-term liabilities, jeopardizing the path to commercial viability.

Consider for example a biotech company developing antibody-drug conjugates (ADCs), an innovative therapy for cancers. Developers might prioritize a liquid formulation to accelerate Phase 1 clinical trials, as it’s often faster to develop than a lyophilized (freeze-dried) formulation. However, this decision can be a strategic misstep. Most commercially successful ADCs are lyophilized due to their inherent instability in liquid form. As such, a developer may have to redo earlier chemistry, manufacturing, and controls (CMC) studies to switch to a lyophilized formulation enabling enhanced stability and extended shelf-life for ADCs. What seems to save time at the outset can necessitate a complete process re-engineering later—a costly and time-consuming undertaking that may compromise a commercial launch.

Similarly, a company might try to preserve cash flow by onboarding a less expensive contact materials product supplier. One underestimated yet crucial factor may be the quality of materials used throughout manufacturing, storage, and transportation, for example vial type for a lyophilized product. As such, thorough studies designed to well define quality target product profile (QTPP) complying with global regulatory requirements is essential for product optimization. While it may appear to be a favorable financial decision, the risk may be to impact the stability of the product or fail a regulatory submission and restart some product development work. The consequence is a costly and time-consuming revalidation of the manufacturing process, which ultimately will delay getting medicines to patients who need them.

To avoid these pitfalls, emerging biotechs must adopt a "think big, start smart" mindset. A successful path to commercialization is not just about advancing to the next milestone; it’s about strategically building a foundation for a successful, long-term commercial product. Let’s consider how contract development and manufacturing organizations (CDMOs) can help reduce risk and accelerate time-to-market in a competitive global environment in the following keyways:

Success begins with a clear vision of the final product. This requires a deep understanding of the regulatory landscape to ensure successful market entry and adoption.

: The regulatory landscape is often a minefield full of complexities requiring knowledge of the specific requirements for the molecule, especially with new drug modalities, as regulatory requirements for submissions are still being updated. Failure to comply can result in clinical holds, rejection of filings, and significant delays for approval.

CDMOs either employ or partner with dedicated regulatory affairs teams who are skilled in preparing documentation, assisting with submissions, and guiding clients through the complex regulatory process efficiently. Their experience with an extensive number of modalities and regulatory agencies can help streamline the process and reduce the risk of regulatory hurdles, helping to manage timelines and costs.

2. Define a quality target product profile

A company should define the critical quality attributes (CQAs) for a new drug using a systematic, risk-based approachknown as quality by design (QbD). While this method may involve additional investment upfront, it mitigates the risk of a complete overhaul later.

Define the Quality Target Product Profile (QTPP)

: A key component of a QbD approach is defining the QTPP and process stabilizing the active molecule. The QTPP is a summary of the desired quality characteristics, considering its safety, efficacy, and clinical use and is comprised of multiple CQAs and critical process parameters (CPPs), which can be influenced by the environmental factors described above. For example, typical CQAs for ADC products include the drug-to-antibody ratio (DAR), ADC potency, aggregation level, and stability during storage and transportation as these directly impact the drug's safety and efficacy. This profile is the foundation for all subsequent development.

CDMOs are strategic partners who can guide biotech companies through the essential steps of QbD. Their extensive experience with a variety of products and regulatory landscapes allows them to proactively identify potential risks and establish a robust, scalable manufacturing process from the very beginning.From the outset, a CDMO partner can help biotech companies and startups maximize yields, minimize loss, and facilitate scalability, helping drug developers avoid costly mistakes that can cause years of delays.

3. Establish a robust manufacturing and process strategy

Once a company has defined the product’s quality attributes, the next step is to establish a manufacturing process that can consistently achieve the CQAs.

: A crucial, often-underestimated phase, this is where a company defines how a molecule will be formulated, purified, and manufactured. Every step must be meticulously documented and validated to ensure consistency and quality.

Facility and Environmental Considerations

: The manufacturing process is heavily influenced by its environment. For example, when working with cytotoxic agents like the payloads in ADCs, specialized containment and safety protocols are required. Additional considerations must also include the potential for light sensitivity that could compromise product integrity. Manufacturing viral vectors for gene therapies has its own set of unique aseptic handling requirements.

CDMOs provide access to a large, experienced team of scientists, process engineers, analytical chemists, and quality assurance professionals to help companies make the best decisions for process and manufacturing development. This is often more efficient and effective than trying to recruit and retain a comparable in-house team, which can be particularly challenging for a small company. Additionally, most small biotech companies can't afford state-of-the-art labs and equipment necessary for scale up of drug manufacturing. A CDMO can begin developing a scalable manufacturing process early on, ensuring a smooth transition to clinical supply for trials if the drug candidate proves successful.

4. Identify manufacturing resources: In-house vs. strategic partnership

Often in biotech, a major risk is the enormous capital expenditure and length of time required to build and maintain in-house development and manufacturing facilities. This can cost hundreds of millions of dollars, a burden that most companies cannot afford. As such, it’s important for startups and smaller biotechs to consider the most cost-efficient way to develop a new drug without expanding its capabilities unnecessarily.

: This approach offers full control over the manufacturing process and intellectual property and enables a company to leverage personnel and infrastructure over multiple product candidates of the same modality. However, the downsides are significant: heavy upfront capital investment, limited flexibility if a company’s pipeline pivots, and the challenge of recruiting a team with deep, cross-disciplinary expertise in a timely manner.

: Although a partner may seem like a late-stage requirement, an integrated approach to workflow can provide a strategic advantage. An emerging biotech may not have the in-house knowledge to take late-stage manufacturing needs into consideration. However,a CDMO can bring cross-functional expertise to the very beginning of the project, providing a continuity of project management to streamline the development process and accelerate readiness for commercialization. CDMOs also have a large network of vendors making the acquisition of components, equipment, and upstream or downstream services easier, faster and more affordable for small biotech companies before they might even realize they need them to further simplify the manufacturing process.

A partnership can mitigate the need for costly re-engineering and revalidation. CDMOs also prevent unnecessary capital investment in facilities and personnel if a promising drug candidate fails in early clinical development, allowing the company to pivot to other pipeline opportunities without a heavy financial burden. By outsourcing work outside of small companies’ core competencies to CDMOs, biotech companies can avoid massive upfront costs of building and maintaining their own facilities. This conserves capital and allows companies to focus on their unique strengths and competitive advantages.

The right CDMO isn't just a service provider; it's a strategic collaborator. It’s imperative to find a CDMO that will help a company determine the best, most cost-effective path for a new drug, rather than executing a development plan handed over by the company.

: Look for a CDMO that will proactively offer suggestions for process improvement and treat a smaller-scale project with the same level of attention as a much larger one. A small biotech or startup should confirm that their needs won't be deprioritized.

: In the current global economic and political landscape, a CDMO's location is a critical factor. Tariffs can impact the cost of raw materials and finished drug products, potentially creating supply chain risks and cost inflation. Partnering with a CDMO in a favorable location—one such as Simtra BioPharma Solutions that has both EU and NA facilities—can help mitigate these risks and simplify logistics and distribution.

Choosing a CDMO is a strategic business decision, not just a manufacturing one. By working with a partner who prioritizes their product and aligns with their supply chain goals, a biotech startup can hand off complex production tasks. This frees their team to focus on core activities like research, clinical strategy, business development, and commercialization (go to market strategy). This approach helps early-stage companies meet key manufacturing milestones and build a foundation for long-term profitability.

By embracing this guidance, biotech companies and startups can help transform their initial scientific breakthrough into a sustainable commercial product. A great CDMO partner doesn't just make the product—they help products get to market faster and with less risk.

In the dynamic life sciences market, small biotech firms face challenges in process development and manufacturing, including high costs, regulatory complexities, and shareholder expectations. The pressure to quickly reach clinical milestones can lead to short-term decisions that jeopardize long-term viability. Strategic partnerships with contract development and manufacturing organizations (CDMOs) can mitigate these risks by providing regulatory expertise, defining quality target product profiles, and establishing robust manufacturing processes. CDMOs offer cost-effective solutions, enabling biotech companies to focus on core competencies and accelerate time-to-market while avoiding costly re-engineering and revalidation.

With ever-increasing costs to put a single molecule on the market, the pressure to reach clinical milestones quickly and efficiently often drives a focus on short-term gains that can create significant long-term liabilities, jeopardizing the path to commercial viability.

Helping Small Biotechs & Startups Navigate Complexities and Accelerate Time-to-Market

AI's Role in Commercial Pharma Strategy


Avinob Roy, Vice President & General Manager of Global Commercial Product Offerings at IQVIA, spoke with 

 about how advancements in AI, particularly agentic AI, are reshaping the future of commercial operations in life sciences. From understanding disease landscapes and identifying patient populations to optimizing brand strategy and field engagement, Avinob outlines how AI companions are augmenting decision-making across the entire commercial value chain. Drawing on real-world experience, Avinob offers an actionable perspective on what it takes to scale AI successfully and how organizations can drive meaningful value in everyday workflows.


How AI is transforming the full spectrum of commercial operations—from market assessment to field execution—by acting as a strategic companion across the value chain.

Distinguishing between hype and reality in the current AI environment, and what it takes to move from proof-of-concept to scalable, production-ready solutions.

The foundational elements required for successful AI adoption in life sciences, including the critical role of data infrastructure, domain expertise, and cross-functional alignment.

Discover how agentic AI is reshaping life sciences commercial operations.

Accelerating Pharma Commercial Strategy with Smarter, Faster, and Bolder AI

How Can the Pharma Industry Prepare for Enforcement of the MFN Order?

Peter Rubin, executive director of No Patient Left Behind, spoke with 

 about President Trump’s Most-Favored Nation (MFN) order and the widespread impact it could have on the industry. While the order seeks to reduce drug costs in the United States by enforcing a rule based on foreign prices, it’s likely that this rule could force pharma companies, large and small, to adjust the way they approach innovation. According to Rubin, the ruling is likely to impact more than just pricing. He also believes that it will be hard to even find a fair price for the drugs using the MFN order as determining a drug’s true value is more difficult that it first appears.

Pharmaceutical Executive: How can the pharma industry prepare for enforcement of the MFN order?

 When you think about the biopharma industry, it’s important to think about it as an entire ecosystem. You have the specialist investors that fund seed stage and small bio-pharmas that comprise two-thirds of the drugs before FDA. There’s the large pharmas that are very successful at bringing new drugs to market successfully.

The industry is not a monolith, it’s an ecosystem where everybody plays an important role. Specialist investors and small bio-pharmas have done a good job of raising their hands and warning of the impact of imposing foreign price controls based on ex-US health technology entities that’s going to impact US competitiveness and impact our ability to bring new drugs to market five to 10 years from now.

As we talk to people over the course of the year, I’ve told people is that this is really a 16-quarter presidency. Each quarter will have its own volatility and you should expect that. Just because deal with MFN in the first quarter doesn’t mean that it’s not going to pop up in a whole new way in the second quarter. Even if you resolve it in the third, it’s going pop up between now and the rest of the 16 quarters. It’s hard to get a sense of what’s actually going to happen.

PE: How is oncology R&D already being impacted by existing regulatory concerns?

 It’s a one-two-punch with MFN and the Inflation Reduction Act (IRA) with the small molecule penalty. That’s already caused a lot of retreat in the small molecule oncology. Prior to the IRA’s passage, half of the molecules that were approved in oncology were small molecules. As of the IRA and the pill penalty, a lot of investors, large pharmas, and everybody inbetween switching to large molecule solutions. Unfortunately, small and large molecules are just as difficult to innovate, but small molecules are easier and less expensive to manufacture. They don’t require physician administration (in most cases), they’re interchangeable at the pharmacy, and they’re easily genericized.

Many of the large molecules aren’t covered by the IRA’s $2,000 out-of-pocket cap. It’s really only Part D drugs, which are primarily small molecule drugs in most instances. From a societal and environmental perspective, oncology and small molecule drugs have been severely impacted by the IRA’s pill penalty. If you throw imposing foreign price controls (via the MFN process) on top of that, you’re going to see another negative impact on oncology R&D for both small and large molecules.

Peter Rubin discusses how the industry is an ecosystem and each of the parts will feel the impact differently.

How is Oncology R&D Already Being Impacted by Existing Regulatory Concerns?

Alongside regulations from the IRA, oncology R&D is set to face unique challenges when MFN is enforced.

Kim Fluchel

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