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Mark E. Kolb is CEO of Taratec Development, a consulting firm that provides e-technology and regulatory solutions for the life sciences industry.

Companies Face Costly System Overhauls With New FDA Regulations

The Next Y2K

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

2025 State of the Industry Survey

recently conducted an in-depth survey on the current landscape and potential outlook for the life sciences industry, drawing valuable feedback from top decision-makers in biopharma.

In this special slideshow presentation, we highlight those findings, capturing expert input on evolving industry trends—from business and innovation strategies, to policy and pricing shifts, to workforce challenges.

Data was collected during the period of Jan. 1 through March 16, 2025, and reflects responses from more than 90 participants. Marketing leaders and business unit/brand directors comprised the largest responder segment, at 21%. They were followed by those in R&D and clinical trials; consultants/vendors/investors; the pharma C-suite; the biotech C-suite; market access/patient support; regulatory and global affairs; and IT and data analytics.

Please note that the survey was conducted before the US-driven trade war materialized, including the very real threat of pharmaceutical tariffs, as well as any impacts borne out of recent US executive orders.


Our exclusive poll captures today's top trends and perspectives—shaped by those pharma decision-makers impacted the most. 

Pharm Exec's 2025 State of the Industry Survey

The Greek philosopher Epictetus said, “We have two ears and one mouth so that we can listen twice as much as we speak.” In the business world, however, the balance between listening and speaking is sometimes off-kilter. For instance, a Doximity report found that nearly seven out of 10 (68 percent) of physicians feel overwhelmed by the amount of new research, clinical trials, products, treatments and procedures. Data suggests many pharma companies are doing too much speaking, leading to noise for healthcare providers (HCPs).

In marketing terms, a more effective strategy would be to optimize listening to inform a more targeted, omnichannel approach. Prioritizing deeper customer insights, specifically the voice of HCPs, helps life sciences marketers understand how to engage their HCP audiences effectively with the right message, through their preferred channels, from their preferred source.

The voice of the customer (VOC) isn’t a new concept. Leaders, pharma sales reps, product managers and marketers, who all benefit from understanding their customers, know that the VOC can reveal a customer's needs and preferences. But is the voice of HCPs consistently at the center of pharma engagement strategies? And is collecting the voice of HCPs achievable by all pharma marketers? Let’s dive in to answer these questions.

Current dynamics in omnichannel marketing and HCP preferences

For many years, pharma organizations have faced hurdles when it comes to collecting the voice ofHCPs and integrating it into omnichannel marketing strategies to execute effective, precision marketing. These include:

Analyzing large amounts of complex data quickly: 

Pharma companies have often been challenged to draw insights from data. For example, organizations might have received valuable verbatim comments from hundreds of doctors about their exposure to and retention of marketing content—and how that experience changed from channel to channel. Maybe the same message delivered by a key opinion leader (KOL) at a conference sticks with doctors more than seeing it in a newsletter. Or perhaps doctors trust a drug that promises “superior efficacy” over “efficacy.” But the unstructured nature of this data means it needs cleaning, quality control and could also need translation. This previously rendered unstructured data may be too resource-intensive and impractical to use for timely insights that could inform the decision to adapt messaging and channel deployment.

Keeping pace with the latest technology advances: 

The pace of technology – particularly AI – innovation can be daunting for organizations to keep up with. But being a late adopter leaves commercial pharma teams at risk of losing competitive advantage and HCP loyalty because other companies will use advanced AI to accelerate and scale how they capture the voice ofHCPs.

 Beyond knowing a doctor’s preferred channels of engagement, there’s also a question of their preferred source. Overall, doctors are less likely to open and engage with a mail shot from a pharma company than a thoughtful email from their trusted sales rep. There is a valuable opportunity for marketers and sales reps to collaborate more closely on engagement strategies. By working together, these teams can leverage their unique strengths and relationships to create a more coordinated and effective approach. This collaboration can lead to clearer and more impactful communication with HCPs, enhancing the overall experience and reducing unnecessary noise.

Finding the right partner who understands the complexity and volume of life sciences data has held some companies back from advancing marketing with precision. Collaborating with the right external partner who deeply understands the industry and can keep pharma organizations up to date on best practices. Technological innovations ensure commercial pharma teams continuously advance HCP marketing with the most modern precision techniques, not adding to HCP marketing noise.

The Opportunity for Digital to Advance Women’s Health: Q&A with Nicola Partridge

Ideally, omnichannel engagement requires not only multi-channel orchestration, but also orchestration that transcends department lines. This remains a challenge, yet recent advancements in AI are paving the way for life sciences marketers to prioritize the voice of HCPs and reach them with an orchestrated, tailored omnichannel approach.

The promise of agentic AI to better understand the voice of HCPs

The latest AI advancements can empower life sciences companies to better understand the voice of HCPs when making channel investment decisions and adapting their marketing strategies. Life sciences commercial teams face the challenge of determining when to engage HCPs on digital channels versus in-person channels to maximize impact. Agentic AI can analyze vast amounts of data, including unstructured forms, from disparate or previously siloed sources—across CRM systems to market research. The technology can identify the channel preferences and behaviors of HCPs, quickly, and at an unprecedented scale. This allows organizations to make informed decisions on channel choice and deployment.

AI-powered insights could show that a certain group of HCPs is doing their own research online. Investing in digital ads linking to an interactive, self-guided presentation on a new drug in these HCPs’ areas of research, is therefore an opportunity for pharma marketers. To achieve the right channel mix and optimal sequencing at scale, pharma companies must look to AI.

With access to the right data, today's advanced AI technology, and internal alignment, organizations can enhance their HCP-centric omnichannel marketing strategies. Regardless of their progress in integrating AI into HCP engagement, it is imperative that all pharma organizations listen to the voice of HCPs. With the understanding gained, executing a precision marketing approach will not only enhance the relevance and impact of marketers’ engagement strategies, but also help build stronger relationships with HCPs, ultimately leading to better outcomes for both.

Prioritizing deeper customer insights helps life sciences marketers understand how to engage their HCP audiences effectively with the right message.

The Promise of Agentic AI to Cut Through HCP Marketing Overwhelm

The modern media landscape is incredibly fragmented. Traditional advertising methods are struggling to capture the attention of audiences that more media options than ever before. The days of airing commercials in between segments of movies and TV shows seem to be long gone.

How can pharma companies use currently popular forms of media to reach their intended audiences?

GSK announced a partnership with Lifetime, a TV network that features content targeted towards women. Lifetime is popular for its original movies, which typically feature stories that resonate with female audiences. Through this partnership, GSK and Lifetime have developed an original movie that tells the story of a family hit by meningitis.

 stars Haylie Duff as the mother of a teenage girl who is competing in a beauty pageant when the family is impacted by meningitis. According to a press release from GSK, the film is designed to educate parents about how their children may not have the meningitis B vaccine.

The film is associated with GSK’s Ask2BSure campaign, which also focuses on the vaccination issue. Actress Alyson Hannigan is a celebrity spokesperson for the campaign.

In a press release, Hannigan said, “As a mom, I know how hard it can be to stay on top of everything, especially when it comes to my teen’s health, and it is so important to ask the right questions about meningitis risk and vaccination. I’m proud to have joined the Ask2BSure campaign so that I can empower other parents to speak up and ask their teen’s doctor for more information.”

In the same press release, GSK’s US medical affairs lead for Neisseria vaccines Cynthia Burman said, “Working with Lifetime on this longer-form creative and educational film allows us to deliver impactful content to help empower parents in the US to start the conversation with their teen’s doctor to find out if their teen is missing any meningococcal vaccinations.”

 debuts on Lifetime on June 28, 2025 and will be available on Lifetime’s streaming platform the following day.

In April of this year, GSK announced that its 5-1 meningococcal vaccine Penmeny received a positive recommendation from the US Advisory Committee on Immunization Practices.

In a press release issued at the time, GSK’s chief scientific officer Tony Wood said, “We welcome this positive recommendation that can help strengthen disease prevention efforts in the US. Pentavalent vaccines can reduce the number of injections required to help protect against invasive meningococcal disease – especially disease caused by serogroup B. Their use could improve immunization rates among adolescents and young adults in the US, who are at an age with increased risk.”

In February of this year, GSK announced that the same vaccine was approved by FDA to be used as protection for the A, B, C, W, Y and strains of meningitis.

In a press release issued at the time, Wood said, “We are excited about the opportunities ahead to help improve meningococcal vaccination coverage in the United States, especially for IMD caused by serogroup B. Building on our global leadership in meningococcal vaccination and our longstanding commitment to address unmet need in disease prevention, we aim to help protect more teens and young adults at a life stage when they are at an increased risk.”

GSK and Lifetime® launch original movie to raise awareness about the impact of meningitis. 

GSK’s 5-in-1 meningococcal vaccine PENMENVY receives positive recommendation from US Advisory Committee on Immunization Practices. 

. April 16, 2025. Accessed May 20, 2025. https://us.gsk.com/en-us/media/press-releases/gsk-s-5-in-1-meningococcal-vaccine-penmenvy-receives-positive-recommendation-from-us-advisory-committee-on-immunization-practices/

PENMENVY, GSK’s 5-in-1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY. 

. February 14, 2025. Accessed May 20, 2025. https://us.gsk.com/en-us/media/press-releases/penmenvy-gsk-s-5-in-1-meningococcal-vaccine-approved-by-us-fda-to-help-protect-against-menabcwy/

The film tells the story of a family impacted by the disease and shares the importance of checking to make sure that children are vaccinated against all strains.

GSK and Lifetime Produce Meningitis-Themed Film

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.

Mark E. Kolb

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