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As the market for specialty and generic products continues to become more competitive and pricing pressures increase, the 505(b)(2) pathway may allow companies more options to diversify their portfolios.

505(b)(2): A Pathway to Competitiveness Through Innovation for Specialty and Generic Companies

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

Amgen Aims to Cut US Cardiovascular Events by 50% by 2030

, 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: Are there specific programs, collaborations, or policy initiatives Amgen is advancing to improve LDL-C awareness and testing in high-risk populations?

Amgen is deeply committed to improving cardiovascular care, and we’ve set an ambitious goal: to cut the number of heart attacks and strokes in the US in half by 2030. It's a bold objective—a moonshot—but we believe it’s achievable through strong partnerships and a multi-faceted approach.

As I’ve mentioned before, there are several interconnected reasons why certain populations remain at high risk for myocardial infarction. These range from policy challenges to clinical practice gaps, lack of patient-provider communication, and insufficient guideline clarity. Because of this, there’s no single intervention that will solve the issue. We need a collective effort across the ecosystem.

One major focus is raising awareness that elevated LDL-C is one of the most modifiable risk factors for cardiovascular disease. It accounts for roughly 49% of the population-attributable risk. To that end, we’re collaborating with several organizations to expand access to LDL-C testing and education. These partners include the Family Heart Foundation, the Association of Black Cardiologists (ABC), and the Black Heart Association. Additionally, we’re working with CVS MinuteClinics to offer free LDL-C testing—either in person or through at-home test kits—so patients can know their numbers and take action.

We’re also focusing on lipoprotein(a), or Lp(a), an important and underrecognized biomarker of CV risk. While research is still underway—some of it involving Amgen—we’re committed to understanding its implications and potential as a therapeutic target.

Beyond testing, we’re driving system-wide change through initiatives like the LDL-C Action Summit, where we bring together key stakeholders—medical societies like the American College of Cardiology, the Association of Black Cardiologists, and others—to develop aligned, sustainable solutions.

Finally, Amgen is part of the LATTICE Consortium, which focuses on implementation science. Currently, it can take up to 17 years for clinical evidence to be fully integrated into practice. Our goal is to dramatically shorten that timeline by working with partners across the country to identify where we can deploy proven strategies more quickly and effectively.

These are just a few of the ways we're working to reach our 2030 goal—and we know we can't do it alone.

: 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 the company's nationwide push to reduce cardiovascular risk through free LDL-C testing, public-private partnerships, and implementation science initiatives—all aimed at cutting CV events in half by 2030.

Video Series

As a child, Reshema Kemps-Polanco was taught by her family to work hard to understand the world around her and to figure out not just how things worked, but why they worked. While her mother initially tried to steer her toward a career in finance, Kemps-Polanco found herself drawn to work that focused on fixing people problems. While she was aware this path might involve taking more risks (something her parents were very willing to remind her of), she says she felt like this was always the right path for her. Now, 25 years later, she’s one of the leading voices in the healthcare industry.

In early 2025, the Healthcare Businesswomen’s Association (HBA) named Kemps-Polanco as its Woman of the Year. The prestigious title is awarded to a woman in the healthcare industry who has made a significant, positive impact on the industry. In her role as executive vice president and chief commercial officer at Novartis US, Kemps-Polanco is responsible for driving the growth of new medicines, ensuring patient access, and shaping future leaders in the industry.

According to Kemps-Polanco, her skill as a leader has less to do with what she brings to the table and more to do with what she’s able to bring out of the people that work for her. She says she aims to help people to understand their own passion and work in ways that aren’t just profitable for the company, but also improve the world around them in some way.

One of the driving goals of Kemps-Polanco’s career has been to actually help people who need it the most. As a leader in the pharmaceutical industry, this means that she has pushed the people around her to understand the need to improve access to medicine for all people.

“Novartis, being a global organization, is active in over 100 countries. It’s very important for us as we think about end-to-end clinical development and commercialization, to think about the non-clinical barriers patients will face,” she says. “Many times, those are dependent on things like geography, where they live in the world, and where they may live in the US. My team, from a commercial standpoint, comes in at the early stages of clinical trial design to give those inputs and insights around what will it take for the patient to access this medicine.”

Kemps-Polanco explains that the largest indicator of health disparity in the US is what zip code somebody lives in. For her, this means that she has learned to think about the specific patient communities that Novartis intends to serve with the medicines it is developing. Her team also considers what barriers might exist that prevent those patients from having timely access to those medicines.

“I’ll give you a couple of examples,” she says. “One of them is radioligand therapy (RLT), which is a technology where Novartis is leading in the industry. We are the only approved RLT in the prostate cancer space, and with a medicine that is truly personalized, you have five days from the time it is manufactured to get it to the patient. This started off in the academic medical centers, where patients are in very late stages of prostate cancer. Being able to get this from manufacturing to the patient within those five days, and making sure that all of the prerequisites that need to take place in terms of having the patient prepared are done, takes a very strong operational capacity.”

She continues, “Now, we are dedicated to researching and developing this technology in earlier stages of the disease. We believe the earlier you can treat the cancer and the medication is active, the better. But these patients are not just in Boston or New York; they are in all types of communities around the United States. One of our huge missions is to scale this technology in the community setting so that any patient who needs it does not have to travel hours, where they may not even have the transportation infrastructure to do that, to have an opportunity for innovative medicine.”

Kemps-Polanco cites Novartis’ 2025 Super Bowl ad as the second example. The commercial, she notes, wasn’t pushing a product. Instead, it promoted the importance for women to get screened for breast cancer. The ad was a launchpad for a larger Novartis campaign to educate people on the risks of cancer, the importance of screenings, and the risk of recurrence for certain types of breast cancers.

“We know only one-in-two eligible women are getting their mammograms,” she says. “That’s another example of how you can democratize outcomes. Ultimately, we can talk about access to medicine, but what we really want to do in this industry is democratize outcomes, meaning that wherever you find yourself, you have the same chance at a good and positive outcome. It shouldn’t matter whether it’s cancer or cardiovascular disease. You should have the same opportunities as someone who is at a higher socio-economic bracket, or who maybe find themselves closer to an academic medical center. It is my personal mission as a leader in this industry to do my part to help to democratize those outcomes and create access to better health outcomes for patients.”

“A few years ago, we announced that we were going through a major transformation,” Kemps-Polanco tells 

 “Prior to this change, we were a conglomerate. Since then, we changed our operating model and, more importantly, became a focused medicines company. We decided to focus on four core therapeutic areas: immunology; oncology; neuroscience; and cardio, renal, and metabolic. We want to build on our deep expertise in certain diseases in these core therapeutic areas, where we believe there is a right to win on behalf of patients.”

The change was centered on making sure that the company could really focus on specific treatments and finding ways to positively impact patients. By focusing on these four core areas, the company is able to develop a deep understanding of where it has good science and then determine ways to use that information to overcome non-clinical barriers.

This enables treatment pursuits on not just extending patients’ lives, but also finding ways to improve quality of life. According to Kemps-Polanco, this is the area where Novartis truly wants to be.

When asked what inspired her to get into healthcare, Kemps-Polanco explains that she initially majored in finance in college before switching to social work. Many of her family members work in that area, including her mother and sister. She says that growing up, she was always told that if she truly wanted to understand how the world works, she needed to understand how money works.

While Kemps-Polanco is not working in finance, she finds that this advice still applies.

“I was much more interested in solving people problems, because if you think about how money flows, it’s still solving some type of people problem,” she says. “I come from a military family. My dad was a Marine, I had uncles that served in Vietnam. That was a great experience, having these educators in my family. When I think about healthcare, hindsight is 20/20. I look back on it, I always had this idea of servant-leadership, that your life is not just for yourself but is for others.”

She continues, “When I was first starting out, I did not categorize it this way. It was an unconscious confidence and I fell into it. When I look back on it, it’s so clear to me that I was destined for it. It was just my upbringing around the concept that my life should be a light to others, and it should be to impact others. To do that, you need whatever platform that you have. I didn’t always have this large platform, but I always was told that I had influence and power; that I might feel out of control, but I was never without my own power.”

That’s a lesson Kemps-Polanco carries with her to this day. She says that she tells her teams to work in the way they would if they were in the room with the patient. This keeps them focused on what the work is really about. Naturally, her teams must also meet the expectations of the shareholders and meet certain financial goals. This doesn’t mean, however, that they can’t also keep focused on the higher good that they are working toward: solving problems, extending lives, and ensuring treatment access to all those eligible.

When asked about her leadership style, Kemps-Polanco reveals that she did something fun in preparation for the question. Prior to our discussion, she spoke with her team and asked them what they thought her style was. She says she wanted to see if there was any kind of misalignment in this area.

“I would say, in a nutshell, my superpower when it comes to leadership is helping others discover their own power,” she tells 

. “Whether it’s with patients, my teams, leaders, my peers, there is nothing that gives me more gratification than watching that light go off. When that happens, a person or a team can accomplish more than they thought that they could. Their confidence builds and they are unstoppable. I always hold up my breast cancer team as an example, along with our spinal muscular atrophy (SMA) product team.”

SMA is the No. 1 genetic cause of infant mortality. “I’m really thankful that in the United States, we’ve got 99% newborn screening,” Kemps-Polanco adds. “It is imperative that we get to those babies ASAP.”

When collaborating with her teams, she says the desire to work toward the higher good is palpable. This focus allows them to stay centered on their mission, but also ensures that they understand the importance of maintaining a successful business. If they’re not able to hit their numbers, then they won’t be able to continue to work toward the broader, purpose-driven goals.

“The members of this team, they weren’t always like this,” she says. “They used to get nervous, and they would ask about expectations and things like that. But they broke past that. Now, they work to do something more than they thought they could and have higher ambitions on behalf of the patients. For me, I look at those teams and I say that they have discovered their own power. I give them what they need and then get out of their way. You do that one person, one leader, one team at a time, and then it multiplies its impact into the industry and patients.”

Reshema Kemps-Polanco, executive VP and chief commercial officer, Novartis US, and the 2025  Healthcare Businesswomen’s Association Woman of the Year, uses the lessons she learned from her family to bring out the best in her teams.

Reshema Kemps-Polanco: Taking Risks for Greater Reward

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.

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.

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.

Doug Balogh

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