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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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Primrose Bio Announces New mRNA Polymerase

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

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

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

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

The Unique Complexity of Oncology Market Access

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

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

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

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

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

Three Pillars of Product Market Access for Oncology

1. Clinical Evidence and Optimizing Outcomes: Beyond Payer Barriers

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

The Impact of Oncology Pathways on Product Access


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

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

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

2. Building Trust with Healthcare Ecosystem Stakeholders

Establishing trust with HCPs is paramount. In oncology, engagement is particularly challenging due to the complexity of treatment decisions, rapid innovation, and personalized regimens. Unlike other therapeutic areas where treatment decisions may involve single agents spanning one benefit design, oncology treatments may include both medical and pharmacy benefits, span multi-specialty treatment modalities, and extend throughout the patient journey from diagnosis to survivorship.

To build trust, biopharma companies must demonstrate a deep understanding of the clinical, operational, and financial complexities that oncologists face. This includes education using an omnichannel approach, articulating value across different treatment settings, and supporting outcomes from biomarker testing through therapy integration and post-prescribing considerations such as adherence and toxicity management. Studies show oncologists manage over 200 cancer conditions with limited field engagement, emphasizing the need for efficient, meaningful messaging.

A lack of effective field tactical approaches designed to reduce educational and operational product implementation may limit prescribing for oncologists that do not have resources with staffing shortages. Effective engagement should include compliant tactical solutions such as order sets, biomarker testing resources, and seamless collaboration between commercial and medical teams to support scientific exchange on toxicity management and adherence.

This robust approach builds trust and strengthens biopharma relationships beyond the individual product while reflecting positively on the overall biopharma company that may be planning for future line extensions or new product launches in the oncology space.

3. Financial Value Proposition and Payment Model Considerations

A well-defined financial value proposition is critical given oncology’s diverse payment models and practice economics. Unlike other therapeutic areas, oncology practices derive over 50% of their revenue from buy-and-bill drug reimbursement.8 In contrast, areas like primary care rely more on evaluation and management services rather than pharmaceuticals.

Misunderstandings of the non-clinical factors that drive prescribing repeatedly misinform strategy, a negative consequence that can be avoided with targeted market research. Below are some financial levers that should be considered when designing contracting strategies and other financial models. Not getting this piece effectively designed can strangle market access.

 Contracting strategies must address both fee-for-service (FFS) models—where drug margins and rebates drive value—and value-based care (VBC) models, where success depends on total cost of care or outcomes. Biopharma companies must also navigate evolving drug pricing regulations, such as the Inflation Reduction Act (IRA) and the impact of regulatory change on reimbursement.

 Some therapies, such as bispecific antibodies, require inpatient initiation but outpatient maintenance administration, introducing multi-stakeholder financial considerations. Additionally, drug costs can vary significantly based on the site of care, with hospital outpatient settings often being more expensive than private practices.

 Emerging trends, including infusion suites, home administration, and physician-owned SPs, may further influence product adoption and financial viability.

 For oral therapies covered under the pharmacy benefit, the network dispensing strategy is a critical consideration, particularly for limited distribution products. Including a stakeholder in the dispensing network has significant financial and relationship implications, making it essential to align market access strategies with network design. For example, incorporating integrated medical dispensing within the network can strengthen engagement with community oncology practices, enhance care coordination, and improve medication adherence.

 Conversely, a network centered on traditional SPs may offer greater scalability and deeper PBM integration and experience. Beyond dispensing strategies, practice alignment can be further enhanced through medical affairs collaborations, such as real-world evidence generation—an asset in the context of VBC contracts.

Biopharma companies should implement flexible financial value proposition strategies that deliver value across diverse customer segments and payment models. Traditional rebate-focused contracting at the PBM or payer level may not provide sufficient value at the practice or IDN level, where additional barriers such as pathways exist. VBC or other flexible or combination financial pricing considerations can offer a more adaptable solution, particularly if improving outcomes across the patient journey, capturing real-world patient experience, or balancing financial drivers beyond drug margin is important.

The Path Forward: Deep Oncology Expertise as a Necessity

Oncology market access requires a tailored approach that extends beyond traditional commercial frameworks. With rising drug costs and increasing payer controls, the future will demand bespoke managed market strategies to balance product access with affordability and outcomes. Future oncology market access strategies should incorporate:

Integrated insights and omnichannel engagement. Example solutions include tools to support multi-disciplinary education across different learning platforms, operational tactics such as order sets to streamline adoption and key support programs like patient assistance initiatives. Ultimately, biopharma cross-functional collaboration remains key for execution. This includes aligning market access, patient services, and medical affairs, when possible, to develop customized solutions that address access barriers and improve patient outcomes.

Deep clinical expertise spanning the patient journey from the key areas such as diagnosis, treatment selection, and beyond into survivorship and end-of-life care. It also includes incorporating different stakeholder experiences beyond payers and PBMs, and considers others such as IDNs, GPOs, and community oncology.

Forward-looking clinical and economic value aligned with diverse payment models across both FFS and VBC arrangements not just for the healthcare environment today. Strategies need forward-looking positioning for the evolving healthcare, regulatory, and treatment landscape.

In an era of rapid innovation and shifting payment landscapes, oncology-focused market access expertise is no longer a competitive advantage—it is a necessity. Biopharma companies that embrace this specialized approach will optimize product launches and ensure transformative therapies reach the patients who need them most.

1. www.drugdiscoverytrends.com/top-50-pharma-companies-by-drug-discovery-patents-and-other-insights/.

2. www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/global-oncology-trends-2024.

3. www.nccn.org/professionals/physician_gls/pdf/bladder.pdf.

4. www.mmitnetwork.com/thought-leadership/pathway-or-perish-the-two-pronged-hurdle-to-ensuring-access-in-oncology/.

5. www.zs.com/insights/restricted-access-pharma-reps-rethinking-sales-planning-oncology.

6. www.cancerresearchuk.org/about-cancer/what-is-cancer/how-cancer-starts/types-of-cancer.

7. www.pharmexec.com/view/driving-innovation-how-collaboration-between-medical-affairs-and-commercial-teams-is-transforming-the-industry#.

8. www.appliedpolicy.com/the-impact-of-the-inflation-reduction-act-on-physicians/?utm_source=chatgpt.com.

9. www.valuebasedcancer.com/issues/2021/december-2021-vol-12-no-6/3001-avbcc-panel-explores-value-based-contracting-in-oncology-care?utm_source=chatgpt.com.

10. https://www.cardinalhealth.com/en/services/specialty-physician-practice/resources/healthcare-policy/inflation-reduction-act.html.

11. www.ebri.org/health/publications/issue-briefs/content/cost-differences-for-oncology-medicines-based-on-site-of-treatment.

12. www.prnewswire.com/news-releases/prime-therapeutics-finds-1-1-million-waste-reduction-opportunity-with-medically-integrated-dispensing-compared-to-central-specialty-pharmacy-301559458.html.

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

Oncology Brands Face Uniquely Complex Market Access Challenges: A Specialized Approach for Commercial Success

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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.”

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

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