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Asembia 2025 

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While COVID-19 has shifted some of the rules, research reveals that practice changes were already afoot for market newcomers.

New Standards for First-to-Launch Players

While COVID-19 has shifted the rules of the healthcare industry, research shows there was already progress on changes being made for how pharma companies are launching products.

Research Reveals New Launch Standards for First-to-Launch Pharma and Biotech Companies in the U.S.

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

Market access is one of the key issues for the pharmaceutical industry. It’s important to innovate, but it’s significantly more important to make sure that those innovations make it to patients. Putnam’s CEO Matt Riordan spoke with 

 about how this is playing out in the oncology space.

Pharmaceutical Executive: How can the industry bridge the gap between innovation and access in community oncology?


 Innovation is moving at an incredible pace in oncology. There are several new technology platforms that are emerging in clinical practice, including CAR-Ts, antibody-drug conjugates, bispecifics, and radioligand therapies. And the list keeps growing, including dual PDL1/VEGF inhibitors, trispecific antibodies, and targeted protein degraders. Making sure those advances reach the full spectrum of practicing oncologists, not just those at major academic centers, can be challenging.

Community oncology is where the majority of patients are treated in the United States, and the community setting faces unique barriers when it comes to adopting new modalities. This includes:

Investing in community-level medical affairs engagement so physicians in non-academic settings are equipped to use cutting-edge therapies with confidence

Thoughtful design of product ordering, administration, and monitoring that is easily onboarded into the community care environment

Simplifying diagnostics and embedding biomarker testing into standard workflows to ensure appropriate patients are identified without delay

Developing tailored hub services that support insurance approvals, accelerated product delivery, and patient access

Educating patient and their families about the available options in the critical “micro-moments” where there is an opportunity to influence treatment direction

Overall, the way we will be successful in bridging this gap starts with decentralized clinical trials and community research networks that ensure that the latest science reaches beyond major cancer centers, creating equity in access to innovation and providing key insights to pharmaceutical developers on what it takes to make these innovations work in the community setting. Bringing together development, marketing, medical, market access, and regulatory functions to all have a shared vision of success in the community makes an enormous difference. If we can shorten that lag between breakthrough and standard of care, even by a few years, we can change outcomes for thousands of patients.

PE: What are some ways the industry can improve access to complex therapies?

 Access to complex therapies is never just one problem to solve; it’s a chain of challenges that all have to be addressed in parallel. This includes considerations of proper and prompt insurance access, placement of medical innovations on appropriate protocols and pathways within clinics and physical access to products in a convenient and timely manner. At ASCO this year, you could see how rapidly these new technologies are advancing through clinical trials, but also how operational realities such as manufacturing timelines, site capabilities and reimbursement models can slow that progress.

Improving access starts with forward planning. As an industry, we need to be thinking about infrastructure and education well before launch. That means developing rapidly scalable solutions that ensure that treatment sites, especially in the community, having the right training and protocols in place to handle the therapy safely and effectively. It also means aligning payer engagement and evidence generation early, so the reimbursement conversation is ready at the point of FDA approval.

One of the key learnings from launches we’ve supported is that you need to remove as much friction as possible from referral pathways. That might mean creating digital platforms that guide clinicians and patients through eligibility, scheduling and follow-up, or equipping community providers with clear, accessible decision tools.

Finally, the message has to be consistent across the organization. Commercial teams, medical affairs, market access, and regulatory all have to be working from the same blueprint, so that what’s promised in the clinic is supported by what’s delivered in the field. When that alignment is there, you can take what might otherwise be a slow, selective rollout and turn it into something that scales quickly and equitably.

PE: What challenges are emerging in the CAR-T in solid tumors space?

 CAR-T therapy has reshaped the treatment paradigm for several hematologic malignancies, offering long-term remission for patients with otherwise limited options. However, translating this success into solid tumors has proven far more complex. The scientific, clinical, operational, and economic challenges form a multi-layered barrier that the industry must confront with urgency and creativity.

Significant scientific and biological challenges exist. This starts with the tumor micro-environment, which is not just a hurdle – it’s an active defense system that neutralizes CAR-T activity. Cracking that code is the key to success in solid tumors. The next challenge is antigen heterogeneity in solid tumors; without a universal target like CD19, we must innovate around multi-antigen and personalized approaches. A final biological challenge is cell trafficking and tumor penetration, as CAR-T cells often struggle to traffic efficiently to solid tumors and penetrate dense stromal barriers.

Manufacturing also remains a challenge; autologous CAR-T therapies are costly, time-intensive, and logistically complex, which is particularly problematic when treating patients with rapidly progressing solid tumors. Moreover, safety concerns, including cytokine release syndrome and off-tumor, on-target toxicity, are magnified in solid tumors.

While the path forward is fraught with complexity, the stakes are too high to retreat. Solid tumors represent the vast majority of cancer cases worldwide, and if CAR-T therapies can be successfully translated, they could redefine the standard of care for millions of patients.

PE: How will precision medicine play a role in this area?

 Precision medicine has been a pillar of oncology treatment for more than two decades. As precision medicine advances in new and exciting ways, it will help us overcome the barriers of both access and efficacy in oncology. By integrating comprehensive genomic profiling into routine care, clinicians can identify patients most likely to benefit from advanced therapies, ensuring resources are deployed where they will have the greatest impact. In CAR-T and other cell therapies, precision medicine enables the development of tailored constructs targeting specific tumor antigens, while predictive biomarkers can help stratify patients for whom risks outweigh benefits. Beyond biology, precision medicine also opens doors to adaptive trial designs, reducing time-to-market for innovative therapies. Importantly, embedding precision approaches in community oncology settings ensures equitable access, allowing patients outside major centers to benefit from cutting-edge science.

For the industry, this has two major implications. First, it improves the clinical value proposition by increasing the likelihood of durable benefit, critical for payer confidence and adoption. Second, it makes the delivery model more sustainable, because resources can be concentrated on the patients who stand to gain the most, easing some of the capacity constraints that come with complex therapies

An exciting frontier in oncology today is how precision diagnostics may change who we treat and who we do not. Biomarker-driven selection and tools like circulating tumor DNA (ctDNA) can refine patient cohorts, improving both efficacy and quality of life. For example, peri-operative durvalumab in muscle-invasive bladder cancer showed benefit across all patients, but the strongest results were in those who were ctDNA-positive, suggesting it’s possible to focus high-intensity treatments where they’re most likely to have an impact. Monitoring the emergence of ESR1 mutational clones in the ctDNA of advanced breast cancer patients has now shown us who can benefit from treatment interventions before disease progression occurs. The holy grail of precision diagnostics remains routine panel-based monitoring of large populations of healthy individuals to identify the first signs of cancer when it is early enough to intervene with curative intent – we’re getting closer and closer to accessing that grail.

The end goal is clear: every patient should have access to a therapy that’s designed for the specifics of their disease biology, delivered at the right time and supported by a system ready to manage it.

Innovation in oncology is advancing rapidly, with new therapies like CAR-Ts and bispecifics emerging. However, ensuring these innovations reach community oncologists is crucial, as most patients are treated outside major centers. Addressing barriers in community settings, such as insurance approvals and diagnostics, is essential. Precision medicine plays a pivotal role by integrating genomic profiling and adaptive trial designs, enhancing access and efficacy. Overcoming challenges in CAR-T for solid tumors requires addressing scientific, operational, and economic barriers. Aligning industry functions and forward planning are vital for improving access to complex therapies.

Putnam’s CEO discusses advancements in oncology and how companies are working to ensure patients have access to these new treatments.

Bridging the Gap Between Innovation and Access: Q&A with Matt Riordan

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?

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.

Justin Zamirowski

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