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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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Strategic Advisor, Rocket Pharmaceuticals

Outlining the key touchpoints for embracing change and opportunity in the “messy, tough—and fun” R&D-to-commercial transition journey. 

From Lab to Market: Tracking Today’s Shifting Pathways for Biotech

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

As pricing pressures, health technology assessments (HTAs), and payer gatekeeping continue to reshape the global pharmaceutical landscape, securing regulatory approval is no longer sufficient. Success now requires companies to embed market access considerations at the core of drug development, starting early and planning strategically.

Two tools stand out in this effort: the Target Product Profile (TPP) and Value Evidence Archetypes. When effectively aligned, these frameworks significantly improve the odds of securing favorable reimbursement, competitive pricing, and timely patient access.

This article explores how these tools complement each other and provides actionable insights for pharmaceutical executives aiming to build value-based success from Phase I through launch and beyond.

The Evolving Role of the Target Product Profile

The TPP is a foundational strategic document that articulates the ideal characteristics of a drug candidate. Developed early—often in the preclinical or early clinical stages—the TPP guides development toward both regulatory approval and commercial success.

It serves as a “north star” for cross-functional teams, aligning stakeholders across clinical, regulatory, commercial, and Health Economics and Outcomes Research (HEOR) functions. A robust TPP typically includes:

Intended indication(s) and target patient population

Route of administration and dosing regimen

Efficacy goals (e.g., symptom reduction, survival benefit)

Acceptable safety and tolerability thresholds

Desired labeling outcomes, aligned with regulatory strategy

Crucially, the TPP is not static. It evolves in response to emerging clinical data, regulatory feedback, competitive dynamics, and payer expectations. Internally, it ensures alignment among functional teams; externally, it provides a cohesive narrative for engagement with regulators, HTA bodies, and payers.

In today’s market environment, the TPP must extend beyond clinical ambition. It must anticipate the types of evidence that payers and HTA agencies will require to justify broad access and premium pricing. That’s where Value Evidence Archetypes come into play.

Value Evidence Archetypes are strategic frameworks that define the kinds of evidence required to support access and reimbursement decisions. They help teams prioritize and tailor evidence generation to the perspectives of key stakeholders, especially payers and HTA bodies.

While specific archetypes vary across indications and markets, most fall into the following categories:

: Demonstrates superior efficacy or safety over standard of care.

: Shows cost-effectiveness, budget impact, or health system savings.

Patient-Reported Outcomes (PRO) Archetype

: Captures improvements in patient quality of life.

: Validates effectiveness in clinical practice using registries, claims data, or observational studies.

: Makes the case for access based on breakthrough innovation or lack of alternatives.

Selecting the right archetype or combination is not a check-the-box exercise. It should be informed by the product’s clinical profile, competitive landscape, regulatory pathway, and ultimately, the strategic intent embedded in the TPP.

When done well, this alignment ensures that evidence generation plans yield data that resonate with HTA reviewers and payers, not just regulators.

Aligning TPP and Value Evidence: A Strategic Imperative

The relationship between the TPP and the selected value evidence archetype is both dynamic and reciprocal. The TPP defines the product’s intended value; the archetype clarifies how that value must be demonstrated in the eyes of decision-makers.

Aligning these tools early enables coordinated planning across clinical trials, HEOR studies, and access strategies. Consider a hypothetical company developing a novel inhaled therapy for chronic obstructive pulmonary disease.

If the TPP prioritizes symptom relief and reduced exacerbations, the team may initially lean toward a Clinical Benefit Archetype. But if payers are more focused on reducing hospitalizations and emergency care costs, the company may need to pivot toward an Economic Value Archetype, integrating health system utilization data into Phase III and developing robust budget impact models.

Alternatively, a biotech developing a therapy for a rare neuromuscular disease with no approved treatments may focus on an Unmet Need/Innovation Archetype. In this case, the TPP might emphasize orphan drug designation, surrogate endpoints, and accelerated pathways that are all aligned with access strategies that highlight societal impact and urgency.

Evidence strategy should flow directly from the TPP and the TPP must be crafted with an eye toward the archetypes most persuasive to payers.

Strategic Use Across the Drug Development Lifecycle

A coordinated, lifecycle-based approach ensures alignment between TPP development and evidence strategy. The table below outlines how the two should evolve in tandem:

This integrated approach ensures that internal teams and external stakeholders encounter a consistent and compelling value narrative from early development to market adoption.

Novartis’ Entresto (sacubitril/valsartan), a therapy for heart failure, exemplifies successful alignment. Early clinical data supported a Clinical Benefit Archetype, with reductions in mortality and hospitalization.

Novartis also developed compelling economic evidence, including real-world cost-offset data and budget impact models. This dual archetype strategy helped secure formulary placement despite the drug’s premium price.

In contrast, Biogen’s Aduhelm (aducanumab), a discontinued Alzheimer disease treatment, illustrates the risks of misalignment. While the TPP emphasized disease modification based on amyloid plaque reduction, the supporting evidence failed to convince payers.

The lack of clear clinical outcomes and cost-effectiveness led to limited coverage, even after FDA approval. Here, a disconnect between the TPP and the value evidence archetype resulted in access failure.

Implementation: Building the Bridge from Vision to Value

How can pharma leaders ensure TPPs and archetypes remain aligned?


Engage commercial, HEOR, and market access leaders early. This ensures the TPP incorporates real-world payer expectations, not just regulatory goals.


Commit to one or more value archetypes before Phase III design is finalized. This guides endpoint selection, comparator choice, and data strategy.


Align clinical trials, RWE, PROs, and health economic modeling into a single narrative that supports the selected archetype(s).


Tailor submissions to local HTA requirements, using archetypes as an organizing framework to prioritize relevant data.


Stay agile. As clinical or real-world data emerge, reassess whether the original archetype(s) remain optimal, and adjust the evidence plan as needed.

Conclusion: Access is Not an Afterthought

In today’s environment, regulatory approval is necessary but not sufficient. Aligning the Target Product Profile with the appropriate Value Evidence Archetype is not just good practice, it is a strategic imperative.

Pharmaceutical leaders who adopt this approach from early development through launch are better equipped to deliver therapies that reach patients, gain payer support, and generate long-term value.

The winners in tomorrow’s pharma market will be those who understand that value is not discovered at the finish line—it’s built into the blueprint.

Dr. Thani Jambulingam, Professor of Food, Pharma and Healthcare, Erivan K. Haub School of Business, Saint Joseph’s University, Philadelphia.

In today’s environment, aligning the Target Product Profile with the appropriate Value Evidence Archetype is not just good practice, it is a strategic imperative.

Bridging Vision and Value: How Target Product Profiles and Value Evidence Archetypes Must Align for Market Access Success

The FDA’s recent decision to undertake the next iteration of the Quality Management Maturity (QMM) Protocol Evaluation Program (2025) by building upon insights gained from past pilots indicates that the QMM initiative is steadily evolving toward formalization. Pharmaceutical manufacturers who undertake preparatory steps now will be best poised to reap competitive advantages after they enroll in the FDA QMM Program when it becomes fully operational. This article continues a series of publications relating to the FDA’s QMM initiative

 and shares practical insights for C-suite decision-makers from a recent QMM readiness review at a global pharma manufacturer.

Enrolling in FDA’s QMM Program is a strategic decision to demonstrate commitment to continuous product quality and process improvement, but readiness and continued vigilance are essential.

The concept to develop an FDA program to rate quality management maturity at drug manufacturing establishments, first proposed by the Interagency Drug Shortage Task Force in 2019, was aimed at incentivizing pharma organizations to adopt more mature quality practices that go beyond compliance. The FDA began building a program that has evolved over the past five years through multiple pilots. The agency’s QMM program is currently under development.

The 2024 voluntary QMM Prototype Assessment Protocol Evaluation Program assessed and scored a drug manufacturing establishment’s level of maturity using a protocol that evaluated five key practice areas:

A QMM assessment does not evaluate a drug manufacturing establishment’s compliance with current good manufacturing practice (GMP) regulations or statutory requirements. The voluntary QMM Prototype Assessment Protocol Evaluation Program considers establishments with an inspection classification of ‘No Action Indicated’ or ‘Voluntary Action Indicated’ to participate in an assessment. QMM scores are site-specific and cannot be extrapolated to other sites within a company or group. QMM scores may eventually be considered in commercial procurement decisions by wholesalers, global purchasing organizations, and hospitals and may even be used by product license holders to select their contract development manufacturing organizations (CDMOs). Further, the FDA may incentivize the industry by providing potential regulatory flexibility to a site with a high QMM score, such as reduced inspection frequency or expedited reviews of product submissions.

Once the QMM Program is launched, higher QMM scores may play a role in attracting and retaining customers, especially in highly competitive markets. Early adoption of FDA’s QMM Program could, therefore, provide an advantage over competitors in both regulatory and commercial spheres. However, to become an establishment that successfully achieves higher QMM scores (i.e., demonstrates higher levels of maturity) at the initial assessment will require companies to prioritize which site(s) to get assessed first, and to review the readiness of site personnel and processes to be scrutinized by the FDA QMM team. In addition, sustaining higher QMM scores in the future or aspiring to be rated as such would also require a comprehensive corporate strategy to exercise continued vigilance by way of commitment to undertake continuous improvement in people, processes, and technology.

Current FDA efforts build upon insight gained from past QMM pilots, industry comments, and stakeholder feedback.

 (2020-2022) to gain insight from third-party assessments of a facility's quality management maturity to inform the FDA for future development of a QMM rating system. Since the original pilot programs, the agency has continued to explore QMM, evaluating nine additional drug manufacturing establishments through their QMM Prototype Assessment Protocol Evaluation Program in 2024. The FDA announced the continuation of that program earlier this year.

We supported the Foreign Active Pharmaceutical Ingredient (API) Manufacturers Pilot (2020-2022),

 in which we developed a QMM Assessment Protocol (see Figure 1 below) and a standardized scoring system. The rubric consisted of a set of evaluation queries, covering topics that go beyond the scope of traditional compliance-based audits, such as operational excellence, supply chain resilience, manufacturing contingency planning, employee recruitment, and quality culture.

Although the pharma industry has not yet achieved consensus on the value of QMM assessments as observed per the 2023 FDA Public Docket Request for Comments, those who participated in the 2020-2022 FDA pilot noted that QMM assessments provided a comprehensive understanding of site operations and identified opportunities for improvement not previously considered by site management.

FDA continues to solicit industry comments on the QMM program through Federal Register announcements and discussions with a range of trade associations, academic, and other private/public sector stakeholders to inform development of FDA’s QMM program. These outreach efforts will assist the agency in efforts to fine-tune the QMM protocols, identify incentives for the industry to participate, and develop scalable program implementation processes.

Proactive planning is key to improving readiness for initial and sustained participation in the program: Selected practical lessons for pharma executives to consider

Leveraging experience gained from the FDA QMM Foreign API Manufacturer Pilot, we recently independently performed a multi-site QMM Readiness Assessment for a multi-billion-dollar global pharma manufacturer and top-ranked prescription provider to the US market. We provided detailed recommendations for each participating site, including cross-site benchmarking and highlighted key factors for the global corporate team to consider in their QMM journey. This experience generated valuable lessons for API and drug manufacturers planning to participate in future FDA QMM assessments.

As a first step, drug manufacturers should prioritize and shortlist those site(s) that qualify for the FDA QMM program, undertake QMM readiness assessments, conduct cross-site benchmarking, and decide which site(s) may be best poised to participate in the QMM program when FDA starts accepting applicants. By doing so, firms can address potential adverse ratings in advance and avoid negative impacts prior to enrolling in the FDA QMM program, such as diminished reputation and weakened financial prospects.

Prior to participating in the FDA QMM program, firms should also strategize how to implement and monitor continuous improvement activities to become ready for potential QMM re-evaluation by the FDA following initial assessment at a site. Additionally, if resources permit, developing an in-house QMM center of excellence would be a strategic investment by corporate to sustain QMM-related activities that may involve both remediation and continuous improvement.

Achieving FDA QMM assessment readiness may require a combination of short, medium-term, and multi-year efforts with corporate executive leadership support to assure success.

Our experience conducting the FDA QMM pilot and subsequent QMM assessments revealed that most organizations were not prepared for a QMM assessment to the same extent they were ready for regulatory compliance audits and inspections. This is unsurprising as many of the covered topics are outside the scope of traditional compliance audits, which industry is accustomed to. To aid pharma manufacturers in understanding the scope of QMM, the FDA has published a white paper

 describing their QMM approach and the five practice areas at a high level. Further details may be forthcoming once the QMM assessment protocol is finalized.

QMM assessment for a site goes beyond minimum compliance (i.e., the quality system) and covers the gamut of site business processes (both GMP and non-GMP), many of which may be centralized at the corporate level across all sites. A site readiness review would, therefore, reveal the extent of effort necessary to transform the site into a more mature quality organization, which could involve updating both site-level and corporate processes and procedures. Remediation could involve updating processes and procedures, many of which could be completed relatively rapidly in the matter of months or up to a year, whereas long term, multi-year efforts may be necessary to implement more robust changes such as new technology for achieving digital maturity or manufacturing process improvements.

Corporate executives would have to pay attention to a slew of other interconnected considerations such as, but not limited to:

Is our level of corporate centralization optimized to allow sites to focus on their core activities and still foster a proactive culture?

Is there sufficient resiliency in our supplier ecosystem, corporate/site IT systems, and production equipment?

Will our digital maturity strategy achieve the requisite level of cross-functional integration and maximize the use of relevant data and sources of knowledge?

Are our site quality objectives well aligned with business objectives, and are we monitoring to ensure their realization as a measure of quality system effectiveness?

Do our employees sufficiently understand the importance of their role in the organization and appreciate the responsibility they bear toward patients?

Are our sites ready to promptly embrace organizational changes resulting from remediation or continuous improvement initiatives?

Pharma executives in the US and abroad should consider aligning now with the FDA QMM as part of their strategic growth plans.

The QMM initiative is directly aimed at operationalizing the vision laid out in the FDA’s report on Pharmaceutical Quality for the 21st Century: “a maximally efficient, agile, flexible manufacturing sector that reliably produced high-quality drug products without extensive regulatory oversight”

Ongoing QMM efforts by FDA from 2019 to 2025 indicate that their QMM program for drug manufacturers is actively working toward full operationalization. Once finalized, the FDA QMM program is anticipated to bring wide-ranging changes in the pharma industry that could substantially disadvantage consistently low QMM-scoring pharma companies and those that don’t participate in the program. Therefore, it is imperative that manufacturers consider incorporating QMM principles into their site operations now and initiate development of an internal QMM Center of Excellence.

By proactively preparing for QMM and performing a readiness review prior to enrolling in the FDA QMM program, an organization can succeed in its efforts to achieve a more mature state of quality culture, which will make a drug manufacturer, API supplier, and CMO/CDMO attractive to both regulatory authorities and the public.

Somnath Mishra is President; William Hauck is Senior Associate; and Sarah Akers is a Consultant; all with Shabas Solutions LLC. The trio participated in a recent multi-site QMM Readiness Assessment at a global prescription drug manufacturer in Asia.

Shabas Solutions LLC sincerely acknowledges Clyde Schultz, PhD, and Zachary Royal, both members of the Shabas QMM team, which also contributed to the review of the article.

Shabas Solutions LLC was contracted by the FDA to plan and conduct a QMM pilot study for the foreign API manufacturers between 2020 - 2022.

This article was not written by any employees of the FDA and does not reflect the views or policies of the Agency.

1. Mishra, S.; Hauck, W.; Royal, Z.; Michalik, R. Introduction to Pharmaceutical QMM Model: QMM Assessment to Promote Pharmaceutical Operational Excellence. 

https://www.pharmtech.com/view/introduction-to-pharmaceutical-qmm-model-qmm-assessment-to-promote-pharmaceutical-operational-excellence

2. Mishra, S.; Hauck, W.; Schultz, C.; Royal, Z.; Michalik, R. QMM for Pharmaceutical Manufacturers–Implications for Drug Manufacturers, API Suppliers and Contract Manufacturers. 

https://www.pharmtech.com/view/qmm-for-pharmaceutical-manufacturers-implications-for-drug-manufacturers-api-suppliers-and-contract-manufacturers

3. Michalik, R., Hauck, W. The FDA’s Quality Management Maturity Program. Regulatory Focus. Published online July 25, 2024. 

https://www.raps.org/News-and-Articles/NewsArticles/2024/7/The-FDA-s-Quality-Management-Maturity-Program

4. Office of Pharmaceutical Quality (OPQ), CDER, FDA. White Paper: Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals. 2022. 

https://www.fda.gov/media/157432/download

5. Maguire, J.; et al. Lessons from CDER's Quality Management Maturity Pilot Programs. 

https://link.springer.com/article/10.1208/s12248-022-00777-z

6. FDA. Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program for Foreign Facilities; Program Announcement. Last updated October 16, 2020. 

https://www.federalregister.gov/documents/2020/10/16/2020-22977/quality-management-maturity-for-active-pharmaceutical-ingredients-pilot-program-for-foreign

7. Quality Management Maturity Pilots: CDER’s Lessons Learned. May 24, 2022. 

https://www.fda.gov/media/166247/download?attachment

8. Maguire, J. CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development. 2023. 

https://www.fda.gov/media/171705/download?attachment

9. Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach Final Report. Department of Health and Human Services U.S Food and Drug Administration. FDA. 2004. 

The FDA's Quality Management Maturity (QMM) Protocol Evaluation Program is evolving towards formalization, aiming to enhance pharmaceutical quality practices beyond compliance. The program, developed from insights gained through past pilots, evaluates drug manufacturing establishments on five key practice areas, including management commitment and technical excellence. High QMM scores could influence procurement decisions and offer regulatory flexibility. Early adoption of the QMM Program may provide competitive advantages. Proactive planning and readiness assessments are crucial for pharmaceutical manufacturers to align with the FDA's QMM initiative and achieve a mature quality culture.

An examination of proactive preparedness and readiness review for future enrollment in the agency’s QMM program—now in the pilot stage as an effort to incentivize pharma manufacturers to achieve a more mature state of quality culture.

Going Beyond Compliance: Early Adoption of FDA’s Quality Management Maturity Program—and the Practical Considerations for Executives

What Are the Core Tenets of Diagnostics 2.0?

Marc Stapley, CEO of Veracyte, discusses the importance of ongoing evidence collection.

Carlos Martin

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