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A look at how to develop a generic drug and the resources FDA supplies to Abbreviated New Drug Application applications.

FDA’s Generic Drug Program Offers Assistance, Resources For ANDA Applicants

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

Ivonescimab plus chemotherapy demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) compared to tislelizumab plus chemotherapy in the first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC), according to interim results from the Phase III HARMONi-6 trial. Full results from the trial evaluating Akeso’s first-in-class PD-1/VEGF bispecific antibody are expected to be presented later this year at a medical conference.

"The interim analysis results from the HARMONi-6 study show that ivonescimab in combination with chemotherapy significantly prolonged PFS compared to tislelizumab with chemotherapy,” principal trial investigator Lu Shun, director, Shanghai lung cancer, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, said in a press release.

The HARMONi-6 trial was conducted across 66 centers in China and included 532 patients with sq-NSCLC, 63% of whom had centrally located squamous cell carcinoma. The study’s primary endpoint was PFS at the first pre-specified interim analysis.

Ivonescimab showed meaningful PFS benefits in both PD-L1-positive and PD-L1-negative patient populations. Additionally, the combination of ivonescimab and chemotherapy significantly outperformed tislelizumab plus chemotherapy in the intent-to-treat population. Ivonescimab was found to have a favorable safety profile, with no new safety signals identified. The occurrence of treatment-emergent adverse effects and grade 3 or higher bleeding events was similar between the ivonescimab group and the control group.

“In patients with up to 63% central squamous carcinoma, ivonescimab demonstrated a safety profile comparable to the control group,” added Shun, in the press release. “This highlights its potential to overcome the limitations of bevacizumab in treating squamous non-small cell lung cancer, ultimately enhancing the clinical benefits of immunotherapy for NSCLC. With its combined immune and antiangiogenic mechanisms, ivonescimab offers a promising new treatment option for patients with advanced squamous carcinoma."

According to Akeso, the HARMONi-6 trial marks ivonescimab’s third Phase III success in lung cancer and its second head-to-head win over a PD-1 inhibitor.1 Currently, the treatment is approved in China for epidermal growth factor receptor tyrosine kinase inhibitor-resistant, non-squamous (nsq) NSCLC, with a supplemental New Drug Application as a monotherapy for the first-line treatment of PD-L1-positive NSCLC currently under review.

"Ivonescimab has gained widespread recognition for treating EGFR-TKI-resistant, advanced nsq-NSCLC since its approval in China nearly a year ago,” added Lu, in the press release. “The HARMONi-2 study showed strong positive results for PD-L1-positive squamous and non-squamous NSCLC in first-line treatment. Additionally, the recent HARMONi-6 study demonstrated significant positive outcomes in first-line squamous NSCLC, further confirming ivonescimab's exceptional efficacy in both squamous and non-squamous cancers.”

, lung cancer is the most common form of cancer globally. It is the most common form of cancer in men and the second most common in women. In 2022, China had the highest number of people with lung cancer, at just over 1 million. In a distant second, the United States had approximately 226,000.

"Today, we are incredibly excited to announce the third significant positive result for ivonescimab in a Phase III study,” said Xia Yu, founder, chairwoman, president, CEO, Akeso, in the press release. “PD-1 combined with chemotherapy remains the global standard of care for first-line treatment of NSCLC. Ivonescimab has once again demonstrated its breakthrough clinical value and market competitiveness as a next-generation cancer therapy through compelling clinical data. We sincerely thank all the investigators, participants, and patients who have contributed to this clinical study."

1. Ivonescimab in Combination with Chemotherapy Demonstrates Statistically Significant and Strongly Positive Results in First-Line Treatment of Squamous Non-Small Cell Lung Cancer (sq-NSCLC) vs. Tislelizumab in Combination with Chemotherapy. 

April 22, 2025. Accessed April 23, 2025. https://prnmedia.prnewswire.com/news-releases/ivonescimab-in-combination-with-chemotherapy-demonstrates-statistically-significant-and-strongly-positive-results-in-first-line-treatment-of-squamous-non-small-cell-lung-cancer-sq-nsclc-vs-tislelizumab-in-combination-with-chemo-302435143.html

2. Akeso Announces the Completion of Patient Enrollment in the Phase III Clinical Trial (HARMONi-6) Comparing Ivonescimab and Tislelizumab for First-Line Treatment of Sq-NSCLC. 

February 5, 2025. Accessed April 23, 2025. https://www.prnewswire.com/news-releases/akeso-announces-the-completion-of-patient-enrollment-in-the-phase-iii-clinical-trial-harmoni-6-comparing-ivonescimab-and-tislelizumab-for-first-line-treatment-of-sq-nsclc-302369543.html

Accessed April 23, 2025. https://www.wcrf.org/preventing-cancer/cancer-statistics/lung-cancer-statistics/

In the Phase III HARMONi-6 trial, ivonescimab plus chemotherapy significantly outperformed tislelizumab plus chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer.

Akeso’s PD-1/VEGF Bispecific Antibody Demonstrates Meaningful Progression-Free Survival Benefits in Advanced Squamous NSCLC

In the rapidly evolving landscape of healthcare, Pharma Patient Assistance Programs (PAP) have been a lifeline for many patients seeking access to essential medications. These programs aim to help those who may not be able to afford their prescriptions, ensuring that financial constraints do not become barriers to necessary treatment. However, traditional PAPs have faced numerous challenges, from administrative inefficiencies to delays in service delivery, often resulting in patient dissatisfaction and suboptimal care outcomes.

KnippeRx, an innovator dedicated to transforming Pharma PAPs with cutting-edge solutions tackles these enduring problems. By utilizing advanced technology and a patient-focused strategy, KnippeRx has reimagined the operation of these assistance programs, providing a smooth, efficient, and effective experience for healthcare providers and patients alike. This article will delve into the solutions that are reshaping the industry, highlighting their key features, practical applications, and the future of PAPs.

KnippeRx leads the way in innovation within Pharma PAPs, approaching industry challenges with a fresh outlook. Traditional programs often grapple with cumbersome manual tasks, resulting in backlogs and delays that can impede patient care. KnippeRx’s strategy emphasizes streamlining these processes through state-of-the-art technology aimed at optimizing operations while upholding a strong commitment to patient-centered service.

One major challenge addressed is the inefficiency in enrollment and dispensing processes. By implementing the "KnippeRx Cares Technology Ecosystem," KnippeRx has developed a comprehensive end-to-end solution that simplifies patient experiences. This ecosystem utilizes automation, AI, and data analytics to ensure timely and precise service delivery, significantly decreasing turnaround times and operational costs while enhancing patient satisfaction.

These solutions also aim to improve data transparency, a vital aspect of maintaining trust and reliability in patient assistance programs. By employing KADABRA

, KnippeRx's proprietary real-time data and analytics platform, healthcare providers can access accurate, up-to-date information, enhancing decision-making and optimizing patient care strategies.



Key Features and Benefits of Knipper's Solutions

KnippeRx’s innovative approach is characterized by several essential features that distinguish it from traditional Pharma PAPs. These elements are designed to provide direct benefits to both patients and healthcare providers, ensuring a smooth and efficient experience for all parties involved.




At it’s core is a sophisticated technology infrastructure that streamlines every facet of the patient assistance process. Features such as automated online patient enrollment, electronic benefits and income verification, and AI integration exemplify how KnippeRx utilizes technology to improve service delivery. These advancements reduce manual intervention and errors while empowering patients to take greater control over their healthcare journeys.




Dedication to a patient-centered approach is reflected in the efforts to enhance the overall patient experience. By minimizing enrollment processing times and focusing on the patient journey, KnippeRx ensures that patients receive timely care. The use of comprehensive eligibility tools and advanced communication technologies further boosts accessibility, simplifying the process for patients to access needed services.




Transparency and accuracy in data are crucial for effective patient assistance programs. KnippeRx’s KADABRATM platform offers PAP Sponsors real-time insights into program data, facilitating informed decision-making and improved care outcomes. This extensive analytics capability also fosters better communication among all stakeholders, encouraging a collaborative approach to healthcare delivery.




KnippeRx’s innovative solutions are not just transforming current PAPs, but also paving the way for the future of patient assistance programs. As the healthcare landscape continues to evolve, integrating advanced technologies and patient-centric strategies will be essential in meeting the increasing demands of both patients and providers.

Looking ahead, additional advancements will further redefine the future of Pharma PAPs. Ongoing development in AI and machine learning technologies will facilitate even more personalized and proactive patient care, allowing providers to anticipate needs and tailor services accordingly. Moreover, the growing adoption of online platforms for both patients and healthcare providers will enhance accessibility, granting patients greater flexibility and convenience in managing their healthcare.

KnippeRx's commitment to innovation positions it as a leader in this evolving landscape, prepared to address tomorrow's challenges with cutting-edge solutions that prioritize patient needs and optimize healthcare delivery.

To learn more about KnippeRx’s Patient Assistant Programs, please visit 

 or contact KnippeRx at 848-373-7052 / access@knipper.com.


Revolutionizing Pharma Patient Assistance Programs, KnippeRx Leads the Future of Patient Care

The pharmaceutical industry is watching the new US administration closely, as some of its proposed plans and policies are likely to have a significant impact on the sector. While much of the conversation has been focused on President Trump’s tariffs, new Health and Human Services Secretary Robert F. Kennedy Jr. has also suggested certain policies that could produce considerable reverberations as well. One of those proposals is a ban on direct-to-consumer (DTC) advertising for pharma companies.

 spoke with Sonam Dubey, a partner at Beghou Consulting, about how these potential regulatory issues could impact pharma marketing strategies, and various ways manufacturers are preparing to address them.

PE: How can companies strategize given the uncertain regulatory landscape?

From a strategy perspective, there is a lot of speculation, more than anything else. These are areas that pharma companies are always planning for. However, there are so many avenues to go down in these discussions based on recent events. One of the main focuses that pharma companies are considering is how do they engage with customers if there are certain restrictions in place. Since everything is more speculation than anything else at this point, the best approach is still just a broad-based strategy on how to approach whatever may come.

PE: How is pharma reacting to the potential DTC ban that’s been discussed? Are organizations looking into alternatives?

Starting off, DTC ads are a big part of the mix for patient marketing, especially for any pharma company. And it is one of those situations where you see a tangible return on investment. It is a front-end [priority] for any kind of media mix. There are other kinds of media, like digital channels, social media, and more, where pharma companies can utilize above-brand marketing strategies. This includes talking about disease education and experience, management, support programs, and stuff like that. That already prevails, for sure. But, today, obviously, the mix is a little more skewed to direct-to-consumer ads in any form. It could be TV ads, banner ads, or digital ads. To answer your question, there are those alternative avenues there today, but pharma companies aren’t as focused or spending on those kinds of activities yet.

PE: What role would influencer marketing play in this potential scenario?

 First, it may not be a ban. It could be just some restrictions that could happen. Regardless, influencer marketing could become very powerful, because at the end of the day for patients, they need someone to connect and engage with them in the right way and share the right kind of information. This isn’t just about the drug, it’s also about sharing information about managing the disease. I think there are things already happening that pharma should focus on, such as the rise of well-knit communities of patients with rare diseases. This is happening in other areas as well and it’s creating a lot of awareness.

There’s also the rise of patient ambassadors who have lived through the whole journey and fought or battled cancer or some kind of a rare disease. They become ambassadors, not for the brand, per se, but for the disease itself. And pharma companies do collaborate with them to provide patients support with their journeys. They can talk about the stories of disease management.

Obviously, it can never be—and it shouldn’t be—direct influencer marketing that you would see in normal social media. But some of these ambassadors could become even more important, and you would see more and more of them and other influencers coming in and providing support for the disease. And, of course, that treatment element comes in in the middle of it. So, absolutely, there’ll be a doubling down on that.

PE: This would likely put more importance on the way that marketing teams engage with healthcare providers (HCPs), correct?

Absolutely, but first I want to take a step back. Post-pandemic, there was a slight weakening in the way HCP engagement was being viewed, because HCPs also were not engaging with sales reps directly at that point of time. They realized that they could go through remote and other digital channels and get the information they needed. We have seen that trend reversing again. There is a lot of doubling down on traditional sales reps coming in and engaging with HCPs. And, of course, remote reps are coming up as well, along with the use of AI chatbots or other kinds of remote channels where the sales rep can still talk to the HCP when it’s convenient for the HCP, rather than a direct call.

If there is any kind of restriction on DTC ads, there will definitely be a doubling down of effort on the HCP engagement, because that really continues to be a channel to raise awareness about the drug directly. In fact, we would see a lot more emphasis on the field force, not only going to physicians, but expanding to other primary care physicians. It fills that gap of awareness that patients may have for that disease or for that drug.

 I would just say that while there’s a lot of speculation about how things might change, I think it’s important to step back for a moment. For pharma, change could be a catalyst for improvement.

We hear from our clients in pharma and they wonder what they really know about a patient’s disease journey. Do they really know what patients are going through? How can they support the whole quality of life for those patients?

This could be a good opportunity, in a way, to really go deep into new ways HCPs can understand those journeys. New intervention points can be created or discussed.

Sonam Dubey, a partner at Beghou Consulting, discusses the potential impact of a possible ban on direct-to-consumer advertising amid policy and government agency overhauls in the US.


The Future of DTC in Pharma

Health Economics and Outcomes Research (HEOR) in the biopharmaceutical industry has been established for over 50 years, but rising drug prices, tightening payer budgets, and increasing competition have recently put the spotlight on the discipline. Healthcare ecosystem stakeholders (payers, patients, providers, policymakers, etc.) are demanding more robust evidence of value to support healthcare decision making as evidenced by major policy developments like the Inflation Reduction Act (IRA) and European Union Regulation on Health Technology Assessment (EUHTAR).

To meet these growing demands for evidence, HEOR functions within pharma need to optimize their organizational architecture and ways of working to deliver marketplace impact efficiently. Benchmarking empowers HEOR leaders with industry best practice to continuously grow and optimize their teams sustainably.

Previous benchmarking exercises have included aspects of HEOR as a component within Market Access or Medical Affairs functions.

 This timely HEOR benchmarking exercise fills an unmet need for a more comprehensive review of the HEOR function and comes at a critical point of inflection for the discipline where many HEOR groups are experiencing organizational shifts and focused on effectively demonstrating their impact and value.

We conducted a 2024 benchmark of HEOR organizations based on qualitative and quantitative data from seven biopharmaceutical companies: one small (zero-10 billion USD annual revenue), three medium (>10-30 billion USD annual revenue), and three large (>30 billion USD annual revenue). Over 60 interviews were conducted with HEOR leaders and team members including representation from Global, Canada, EU, Japan, UK, and the US. The benchmark focused on collecting data and insights on the HEOR function’s operating model including organizational structure and positioning, team characteristics and capabilities, and ways of working.

Pharmaceutical companies are generally organized into two major divisions – Commercial (customer-facing) and Research and Development (research, medical focused), to ensure the scientific integrity of research activities. HEOR holds a dual mandate—

 to support healthcare decision-making (aligned with Commercial functions). Over the years, HEOR’s position has swung between these divisions, but within our sample of companies more HEOR functions have been integrated into the 

 teams, to better align value evidence generation with market access strategies. The HEOR functions in our sample companies are also mostly centralized, providing dedicated product and geographic level support with dedicated local HEOR support for major markets, including the US, as countries develop their own value assessment methods. There were no regional models in our sample of companies.

HEOR is an umbrella for multiple disciplines of evidence generation; platform (or centers of excellence) teams enable HEOR functions to scale and standardize these disciplines and efficiently support multiple products and geographies (see Figure 1).

RWE has a broad range of applications and as a result, RWE is being produced by HEOR and other functions without clear roles and responsibilities, ultimately causing tension and inefficiencies such as duplication of efforts. Only some companies exclusively held RWE responsibilities within HEOR, while the remainder shared this capability with other functions.

HEOR functions require a diverse team due to HEOR’s broad scope of disciplines and applications. All HEOR functions in our sample of companies had highly credentialed teams with a mix of discipline specialists and product strategy experts. Given this diversity, career development pathways need to be tailored to support the unique roles within HEOR, rather than a one-size fits all approach. Most HEOR functions in our sample had career development pathways documented, however these were mostly for team members working in a product centered role; pathways for specialist roles were identified as a key gap.

Recruiting for HEOR talent is highly competitive. HEOR leaders are retaining top talent through competitive salaries, allowing for remote/hybrid work policies, and increasing development opportunities. They are also looking at formalizing career pathways for individual contributor roles or propelling HEOR team members into different technical areas and geographic areas.

. HEOR Teams are embracing digital technology and are investing in areas like AI, digital health, and real-time data analytics to provide insights for payer engagements. For example, some teams are using AI to conduct literature reviews, reducing the time to complete these routine HEOR activities from weeks to days. In another example, teams are utilizing digital health technologies to build registries for more robust data collection to better understand disease burden.

“I feel like population health organizations are starting to realize the power of the data they have and AI can now help them leverage that data to support decision-making. They are actively trying to build up their capabilities to effectively leverage that data in ways I haven't seen before and we have to keep up." - US Head of Field HEOR

In our sample of companies, HEOR groups were often labeled as being “too academic” or “too publication focused” and were not fully effective at disseminating key evidence to their audiences. To combat this label, some companies are developing communication workshops to upskill storytelling capabilities and dissemination of HEOR evidence.

HEOR generates evidence that is applicable for a diverse group of stakeholders (Figure 2). To ensure that evidence generated is relevant and effectively reaches these groups, HEOR functions must collaborate closely with cross-functional internal stakeholders. While the established trifecta of HEOR, Medical Affairs and Market Access was well recognized as an effective commercialization model, interviewees identified the relationship between HEOR and clinical/regulatory teams as a key area for improvement; this was even when HEOR was positioned under the Medical organization.  

Many internal partners struggle to grasp the full scope of HEOR's role and its relevance to their work or its impact on their external stakeholders. This lack of understanding is compounded by the absence of robust metrics that could effectively demonstrate HEOR's value to all stakeholders. Despite the critical role of HEOR, only a limited number of companies include HEOR experts on global product teams, and even fewer incorporate them into brand teams. This underrepresentation limits HEOR's ability to shape strategic decisions and leverage its unique methodologies and expertise to address business challenges.

"We need to dispel the misconception that HEOR only generates evidence for payers" - Health Economist 

: HEOR insights ensure trial designs address key evidence needs for payers and policy markets and align clinical outcomes with real-world applications.

: Increasingly regulators themselves are also interested in HEOR disciplines such as RWE and PED to bolster the real-world relevance of trial data.

: HEOR inputs are directly relevant to key policy developments worldwide (eg, HTA, EU HTAR, IRA and PDAB requirements). HEOR evidence can also support the prioritization of unmet needs in certain disease areas by policy-makers.

:As patients increasingly are taking ownership for their healthcare, HEOR evidence empowers them to actively participate in shared decision-making with their physicians.

HEOR functions in our sample are largely focused on productivity or project management metrics (see Figure 3). Impact metrics are desired, however, HEOR functions havedifficulty attributing broader access and commercial impact to HEOR. In some companies, even though linking HEOR metrics to access/commercial metrics would resonate best with internal partners there exists a compliance challenge to directly connect research activities with sales number, prescribing impact, etc.

 Some companies have delineated RWE responsibilities by external audience or research type with limited success. Given HEOR’s broad scope and capabilities, senior leaders believe that HEOR is uniquely positioned to play a role in RWE governance across the company to ensure that RWE execution is streamlined, and that generated research is widely communicated.

“RWE experts are going to exist in various other functions because various external stakeholders are asking for RWE. It's going to be counter-productive to try to centralize execution of RWE...the strategic aspects should be centralized with HEOR." - Global/ US Head of HEOR

Recent shifts in HEOR functions across major pharmaceutical companies confirm a lack of internal understanding of the value of HEOR despite the robust external demand for evidence of value. HEOR is often perceived as too academic, with a disconnect in the translation of evidence to impact for external stakeholders. Many teams face challenges in effective dissemination of HEOR deliverables, citing issues such as the lack of storytelling capabilities, longer study timelines not meeting end-user or launch needs, and the lack of measurable metrics to demonstrate the impact of their work. We identified some companies that were proactively addressing these issues, investing FTE to specifically package and translate HEOR evidence for stakeholders and identifying communication channels for evidence dissemination.

The shift of HEOR organizations to Value/Market Access aligns HEOR closer to business and payer needs, potentially streamlining HEOR’s path for evidence to impact access. However, this shift could potentially limit career paths, investments in methodology, and evidence for healthcare providers and patients.

It is therefore essential that in this next iteration of the HEOR function, senior leaders prioritize the development of HEOR translation capabilities, coupling evidence communication planning with best-in-class evidence synthesis and HEOR/value storytelling. To demonstrate value internally, leaders should invest in impact metrics in collaboration with internal functions including compliance and harness technology for the required data collection. Finally, tailoring the HEOR value proposition to individual internal partner functions will also be important to demonstrate HEOR’s grasp of their stakeholder’s evidence needs. By addressing these areas, HEOR can better align itself with biopharmaceutical organizational goals and solidify its indispensable role in responding to the ever increasing access landscape challenges.

Vice President, Management Consulting Practice; 

 We would like to thank Patricia Deverka, Amy Wu, and Kenneth Wu for their support and collaboration throughout this project. Their commitment and expertise were instrumental in bringing this project to fruition. We would also like to thank Kate Burslem, Elizabeth Brooks, John Byrd, Ruslan Horblyuk, Ruchik Patel, and Victoria Schliep who have helped support the benchmarking effort.

 All facts, insights and opinions were generated through the research conducted in full by AESARA. Artificial Intelligence (AI) was used to assist with language edits and to enhance clarity.

Hochstrasser M, Grueger J, de Gorgolas M, Vaidyanathan S, BCG Members, BCG Market Access Roundtable. A New Era for Market Access: Organizing the Function’s Broader Strategic Role. 

. 2023;43(5). Accessed September 19, 2024. https://www.pharmexec.com/view/new-era-market-access-organizing-function-broader-strategic-role

Algazy J, Garcia A, Ryan S, Westra A, Zemp A. 

A Vision for Medical Affairs 2030: Five Priorities for Patient Impact

.; 2023. Accessed September 19, 2024. https://www.mckinsey.com/industries/life-sciences/our-insights/a-vision-for-medical-affairs-2030-five-priorities-for-patient-impact#/

The recent shift in Health Economics and Outcomes Research functions across major pharmaceutical companies highlights a lack of understanding of its value. 

HEOR: From Proving Product Value to Proving Its Own Worth

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.

Edward Sherwood

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