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Iilun Murphy, MD, serves as the director of the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER).

The Generic Drug User Fee Amendments, designed to facilitate the delivery of safe and effective generic drugs to the public and improve the predictability of the ANDA assessment process, has undergone changes that will impact the pre-ANDA and ANDA approval process—and ultimately the path for generic drugs to approval. 

FDA Offers GDUFA III Insight 

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

While the pharma industry has openly embraced AI, there are still serious concerns related to the use of the technology with health data. Primarily, AI relies on collecting massive amounts of data in order to feed its algorithms. When it comes to patient-data, however, there are privacy concerns. When it comes to using AI in pharma, the main question is: can it be trusted with patient-data and will it respect privacy?

DeepL, an AI-focused tech company, announced that it has an AI platform that is HIPAA compliant. This federal law requires organizations to keep sensitive medical information private and to store any related data in a secure location. If DeepL’s technology can maintain HIPAA compliance, this would be a big step forward in AI-adoption in healthcare.

In a press release, DeepL founder and CEO Jarek Kutylowski said, “We built DeepL's Language AI platform to be the most reliable and trusted translation solution for global businesses, delivering both exceptional quality and the security they need to operate with confidence. HIPAA compliance is an important milestone that reflects our commitment to helping our healthcare customers overcome language barriers while meeting the highest standards of privacy and compliance."

DeepL is becoming a leading name in the AI space. In April of this year, the company announced that it had been named to Forbes’ 2025 AI 50 List for the second year in a row. This list recognizes companies that Forbes believes are using the technology to solve real-world problems.

AI-Driven Analytics: From Competitive Advantage to Essential Business Tool

In a press release issued at the time, Kutylowski said, “Being named to the Forbes AI 50 list for the second year running is a huge honor. This recognition reflects the very real impact that DeepL's language AI platform is driving for businesses and professionals around the world - helping them scale and collaborate more effectively across languages and markets. It also underscores our commitment to staying ahead of the curve through constant innovation. We're proud to be a leader in Language AI and look forward to continuing to drive the category forward."

DeepL’s technology focuses on solving language-related problems. In May, the company released the results of a survey that suggested that the majority of US enterprises face daily challenges related to language barriers.

In a press release issued at the time, Kutylowski said, “Many US companies assume that English is enough for business communication, but that's a risky mindset – the reality is that only 18% of the world speaks English, and even within the US, over 60 million people speak a language other than English at home. Our latest research underscores the huge impact that underestimating language barriers can have on US enterprises: 69% of executives report that these barriers lead to unforeseen difficulties in daily operations, with a tangible negative impact on their expansion goals and bottom line. As the world becomes more connected, the scope and impact of these issues will only intensify."

The CEO continued, “With more than half (59%) of enterprises already using Language AI tools to address these barriers, and 96% planning to adopt them in the next few years, failing to embrace these technologies now means risking falling behind. Seamless multilingual communication is now a business imperative for any enterprise operating internationally or aiming to expand its global footprint.”

DeepL achieves HIPAA compliance, setting new standard for secure, enterprise-ready AI solutions in healthcare. 

. May 14, 2025. https://www.prnewswire.com/news-releases/deepl-achieves-hipaa-compliance-setting-new-standard-for-secure-enterprise-ready-ai-solutions-in-healthcare-302454899.html

DeepL Named to Forbes's AI 50 List for Second Consecutive Year. 

. April 11, 2025. Accessed May 14, 2025. https://www.prnewswire.com/news-releases/deepl-named-to-forbess-ai-50-list-for-second-consecutive-year-302426438.html

New DeepL research finds that nearly 70% of US enterprises face daily unexpected operational challenges due to language barriers. 

. May 8, 2025. Accessed May 14, 2025. https://www.prnewswire.com/news-releases/new-deepl-research-finds-that-nearly-70-of-us-enterprises-face-daily-unexpected-operational-challenges-due-to-language-barriers-302449137.html

The protection and privacy of healthcare data is a massive hurdle for the new technology to overcome.

DeepL Announces HIPAA-Compliant AI

Real-World Data Shows Poor LDL Control Despite Available Treatment

Leandro Boer, MD, PhD, VP, US general medicines, Amgen, discussed the striking findings of the US arm of the VESALIUS-REAL study, presented at the recent American College of Cardiology (ACC) meeting. The observational study, which analyzed data from over 278,000 high-risk patients between 2016 and 2022, uncovered major deficiencies in lipid management following cardiovascular events such as heart attacks and strokes. The conversation shed light on why these care gaps persist, particularly among patients over 50, and highlighted the urgent need to rethink prevention strategies, streamline treatment guidelines, and increase accountability across care transitions.

Pharmaceutical Executive: What were the most surprising or concerning findings from the VESALIUS-REAL study regarding gaps in LDL-C testing and treatment in high-risk patients?

I think the most surprising finding is that this is happening in the US. VESALIUS-REAL is a large observational study across 11 countries, and the specific data we presented at ACC last week focused on the US population. What we’re seeing is really remarkable.

Seventy percent of patients who had a myocardial infarction (MI) or stroke did not initiate any lipid-lowering therapy after the event. Eighty-eight percent of those patients did not intensify their treatment over the following year. That, in itself, is quite significant.

Another very concerning aspect is that, over a one-year follow-up after the event, 50% of patients never had an LDL test performed or ordered. Among those who did get tested, 82% didn’t reach the guideline-recommended LDL goals.

This is particularly alarming because we have so many available treatments to address this—statins, ezetimibe, PCSK9 inhibitors. We've had statins since the 1990s, yet it feels like we’re frozen in time. The number of patients on high-intensity statins is only 9.8%, which is extremely low, especially considering that statins are now generic.

We’re not seeing forward progress. Despite having the tools to help patients meet their targets, real-world data from 2016 to 2022—including more than 278,000 patients in a US database—shows that these patients are simply not moving in the right direction.

The VESALIUS-REAL study revealed alarming gaps in LDL-C testing and treatment among high-risk U.S. patients. Notably, 70% of patients who experienced a myocardial infarction (MI) or stroke did not begin lipid-lowering therapy afterward, and 88% failed to intensify treatment within a year. Even more concerning, 50% of these patients never had a follow-up LDL-C test, and of those tested, 82% did not achieve guideline-recommended goals. Despite the availability of proven therapies like statins, ezetimibe, and PCSK9 inhibitors, usage remains low—with only 9.8% of patients on high-intensity statins—suggesting the United States remains stuck in outdated treatment patterns.

For patients over 50 without a prior cardiovascular event, several factors contribute to under-treatment. These include being in the "pre-Medicare gap" with limited insurance, poor risk perception of cardiovascular disease compared to cancer, over-reliance on lifestyle interventions, limited time with primary care providers (PCPs), and overly complex treatment guidelines. Together, these barriers prevent effective prevention and intervention.

Findings from VESALIUS-REAL may shape future guidelines by emphasizing treatment urgency, simplifying decision-making, and streamlining guidelines—particularly for primary care. Collaborative efforts, such as Amgen’s LDL-C Action Summit and partnerships with the National Lipid Association, aim to raise awareness, improve communication, and promote treatment adherence.

Amgen is pursuing a bold ambition to cut the number of heart attacks and strokes in the US in half by 2030. The company is advancing this goal through initiatives such as free LDL-C testing in collaboration with CVS MinuteClinics, community partnerships with organizations like the Association of Black Cardiologists and the Family Heart Foundation, and the LATTICE Consortium—focused on implementation science to reduce the time from discovery to practice. These collective efforts aim to close existing care gaps and ensure more patients achieve life-saving LDL-C targets.

Leandro Boer, MD, PhD, VP, US general medicines, Amgen, discusses new real-world data showing that most high-risk cardiovascular patients in the US are not starting or intensifying lipid-lowering therapy—and few are achieving guideline-recommended LDL-C targets.

Video Series

Growth and innovation require confident decision-making. While large corporations inherently recognize risks, strategic progress hinges on making deliberate choices and embracing necessary trade-offs.

For more than a century, Novo Nordisk has been driving change to improve the lives and health of people living with serious, chronic diseases. Our evolution from a diabetes-focused company to one encompassing multiple therapy areas has enabled us to provide vital treatments to millions of patients and significantly expand our business.

While internal discussions around risk management are important, an overly cautious approach can lead to stagnation. A strategy without clear direction and conviction lacks the power to drive meaningful change.

Here are five essential steps to create, implement, and animate a robust and enduring strategy throughout an organization.

While expressing a desire for revenue growth is common, understanding the “why” behind that intention is crucial. Delving deeper to uncover underlying reasons (asking “why” multiple times) allows an organization to define specific objectives—whether related to a patient ambition, defined patient outcomes, or entering new therapy areas.

Start with a candid assessment of your company’s current standing. This unbiased diagnostic helps ensure you find the right balance between maintaining what is working well and what needs to be changed, while being clear about what you still do not know. Clarity around the current and projected future health of your organization informs your strategic intent and highlights necessary trade-offs.

For example, if embracing data and digitalization is deemed essential to success moving forward, you could decide it is not a core strength and partner externally to maximize your balance between effort and value. Or you could prioritize being experts in your data and invest in the people and technology you need to drive the change in-house. Either choice could be correct, but clarity in intent ensures focused, coherent efforts across the value chain.

A successful strategy begins with a well-defined foundation that articulates your strategic intent. This foundation then guides decision-making, defines priorities, and aligns leadership, creating a disciplined and actionable path forward. Establishing a clear decision-making hierarchy and roadmap for strategy management will create the momentum needed for success. A compelling strategy, supported by a detailed implementation plan, transforms ideas into impactful results that drive sustainable growth.

Prepare your workforce at every level to carry the strategy forward. Success depends on engaging teams, equipping them with the necessary skills, and fostering a culture of adaptability and commitment.

Organizations must ensure that employees have the skills and resources needed to bring the strategy to life. Investing in training, mentorships, and cross-functional collaboration will help teams embrace new initiatives and execute with confidence. Appointing strategy “champions,” those who provided input along the way, throughout the organization can be a powerful tool to mitigate perceptions of an overly top-down approach, facilitating effective execution.

And as each strategic initiative presents unique challenges, providing targeted support ensures that teams can execute effectively in new and evolving environments.

A well-structured execution plan, aligned to clear ambitions, is key to making sure your strategic roadmap is implemented as intended.

4. Communicate your strategy holistically

A successful strategy must engage and align the entire organization with a broader vision. Notably, that does not necessarily mean every employee will directly relate to every aspect. There are parts of the business that are critical for subsets of customers or patients but are capable of running themselves and do not require an enterprise-wide effort to achieve success or simply do not meet the criteria of being an enterprise-wide strategic priority. There may be other parts of the business that have a strong legacy but are simply not value drivers moving forward. Either way, the strategy needs to be just that—one that clarifies the priorities and trade-offs required for success moving forward. A strategy that neatly illustrates where every part of your current and future business fits is typically not really a strategy, but a mere description of your business.

For example, when Novo Nordisk pivoted commercial focus toward emerging GLP-1RA therapies, we visualized this to the broader organization in a way that made it crystal clear the potential these therapies held, while also redefining the roles of certain other therapy areas to refocus effort in these areas appropriately. This approach resulted in a clear plan of action with sharpened therapy area plans and aligned execution. Creating these defined “swim lanes” at the highest level was one of our keys to success.

A successful strategy thrives on unwavering commitment from leaders, fostering trust and alignment throughout the organization.

Frequent changes in strategy should serve as a warning sign; a strong strategy should be durable yet adaptable to evolving dynamics, triggers and milestones, and the outcome of pre-defined scenarios. Life is unpredictable, though, and therefore, an organization should regularly pressure test its strategy to evaluate necessary strategic, operational, or execution-related adjustments.

Effective strategy development and implementation requires both conviction and adaptability. By clarifying strategic intent, equipping teams for execution, communicating effectively, and remaining flexible, organizations can bring enterprise-level strategies to life and achieve lasting impact.

David Kamenir is Vice President, US Enterprise Strategy and Business Development, at Novo Nordisk

Five steps for organizations in bringing enterprise-level strategies to life.

Bridging the Gap:  A Large Pharma Blueprint

Tardive dyskinesia (TD) is an involuntary movement disorder that is associated with the use of antipsychotic medications. Due to the social stigma surrounding mental health issues, people suffering from the condition often struggle with acknowledging the symptoms and getting properly diagnosed.

A new campaign from Neurocrine Biosciences hopes to reduce the stigma attached to TD by sharing stories of people with the condition who sought treatment.

 Musician and mental health advocate Carnie Wilson is the face of the campaign, which is named ConnectING with Carnie.

In a press release, Wilson said, “Mental health is a topic close to my heart, and I'm grateful for the opportunity to partner with Neurocrine Biosciences to spread hope and positivity by sharing stories, connecting with individuals in the mental health community and encouraging those experiencing uncontrollable movements to speak with their healthcare provider about appropriate treatment. I've seen the difference that seeking support and treatment can make, and I want people who may be struggling with tardive dyskinesia to know they do not need to suffer in silence."

Neurocrine Biosciences is also using the campaign to promote is drug Ingrezza, a treatment for adults with TD.

In the same press release, Neurocrine Bioscience’s chief commercial officer Eric Benevich said, “We are moved by Carnie's passion to be a guiding voice for people impacted by TD, recognizing that even mild uncontrolled movements can significantly impact everyday activities, personal well-being, and interactions with others. Our goal for ConnectING with Carnie is to reduce stigma, increase understanding and encourage individuals with involuntary movements to consult a healthcare provider for appropriate diagnosis and treatment options, such as Ingrezza."

Neurocrine also recently released the results of a survey looking into impact of early and routine screening for TD.

 The survey, conducted by The Harris Poll, found that the majority of people living with TD said they should’ve been screened for the condition earlier and that their HCPs should’ve discussed treatment options for the condition earlier as well.

In a press release issued alongside the survey, Neurocrine Biosciences chief medical officer Eiry W. Roberts, MD, said, “These findings highlight the significant daily challenges faced by people living with tardive dyskinesia. This underscores the importance of regular screening to detect the condition early, ensuring patients can receive appropriate treatment for their involuntary movements, which often cause functional impairment, emotional distress and social difficulties."

Roberts also said, “Regular screening for tardive dyskinesia among patients on antipsychotic therapy is crucial for early detection and management, ultimately leading to better outcomes for patients, their families and care partners.”

In the same press release, Josie Cooper, executive director of the Movement Disorders Policy Coalition, added, “The involuntary movements of tardive dyskinesia can profoundly affect individuals physically, socially and emotionally. Tardive dyskinesia can often go undiagnosed, but with proactive and routine screening, we can ensure those affected receive the care and support they need to help manage the condition. That's why we are working on a national and state level to improve access to care and resources for those experiencing uncontrolled movements."

Neurocrine Biosciences and Carnie Wilson Team Up to Launch ConnectING with Carnie™ Awareness Campaign for People with Tardive Dyskinesia. 

. May 6, 2025. https://www.prnewswire.com/news-releases/neurocrine-biosciences-and-carnie-wilson-team-up-to-launch-connecting-with-carnie-awareness-campaign-for-people-with-tardive-dyskinesia-302446443.html

Neurocrine Biosciences Announces New Survey Revealing Need for Routine Screening and Earlier Diagnosis for People Living with Tardive Dyskinesia. 

. May 5, 2025. https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-new-survey-revealing-need-for-routine-screening-and-earlier-diagnosis-for-people-living-with-tardive-dyskinesia-302445385.html

ConnectING with Carnie promotes the importance of routine screening and treatment options for the involuntary movement condition.

Carnie Wilson Teams with Neurocrine Biosciences for TD Awareness Campaign

Video interview with Omar Hafez about IPAY 2028 and what it means for the industry

From Uncertainty to Opportunity: Navigating IPAY 2028

Omar Hafez, SVP of Market Access at Avalere Health, discusses the upcoming changes tied to the Initial Price Applicability Year (IPAY) 2028—the first year Medicare will include medical benefit drugs in its price negotiations. There are significant implications for therapeutic areas like oncology, immunology, and neurology, and this new pricing model could affect provider reimbursement and patient access. Hafez offers strategic insights for pharmaceutical manufacturers on how to prepare, including understanding the importance of real-world evidence and global pricing strategies.

How the 2028 Medicare drug price negotiations will reshape market access, provider reimbursement, and patient care

Iilun Murphy

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