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CAPT Brenda Stodart, PharmD, FDA Small Business and Industry Assistance Program Director

FDA's Brenda Stodart outlines the services of the Agency's Small Business and Industry Assistance (SBIA) Program.

FDA's Helping Hand to Small Pharma

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

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

Phreesia and Kick Health recently released a study detailing the diversity of experiences that patients struggling with obesity have when interacting with the healthcare system.

 According to the study, the ways that these patients feel they are perceived by the industry and the ways that treatment options are presented to them can have a significant impact on how they develop their healthcare journey in relation to obesity.

The study surveyed a variety of patients with body mass indexes (BMI) from 27-29.9%, 30-30.9%, and BMIs of over 40%. The participants also included a variety of races, ethnicities, and socio-economic conditions in order to account for the full spectrum of patient experiences. The survey showed that as BMI increased, patients were more likely to show concern for their BMI in regard to how it impacted their health.

However, when it comes to interacting with the healthcare industry, the results showed that many of these patients aren’t necessarily looking for medications to decrease their BMI.

“Obesity medications like Novo Nordisk’s Wegovy™ and Eli Lilly’s Zepbound™ have gained popularity, but lifestyle changes remain the dominant choice for many patients,” the study says. “More than 80% of patients who expressed concern about their weight as it relates to their health had made lifestyle changes in the past. Of these patients, three-quarters (75%) of those with a BMI from 27 to 29.9, and about 65% of those with a BMI of 30 or greater, still relied on this method to manage their weight.”

Most importantly, the results suggest that when it comes to interacting with the healthcare industry, a significant number of respondents across the board said they had not discussed weight with their doctors. A variety of reasons were listed, such as patients feeling that they’d rather make lifestyles changes on their own or feeling uncomfortable discussing their weight with their doctors.

However, a significant number of respondents said that while they had had conversations with their doctors about their weight, they were the ones to initiate the conversations. However, these conversations were only likely to continue if the doctor brought up the topic first.

According to the study, “Only a minority of concerned patients reported that their doctors collaborated with them to develop a comprehensive weight-management plan, indicating room for improvement when it comes to tailoring personalized weight-management strategies. This opportunity is just one of many for healthcare providers to engage more effectively with their patients by customizing support for overweight and obese patients who view and relate to their weight in a variety of different ways.”

Patients with higher BMIs said they were more likely to seek out information about weight management. These sources, however, did not necessarily include their doctors. Patients discussed getting information from a variety of sources, such as advertisements, commercial weight-loss programs, and even social media platforms. The accuracy of these sources can vary significantly.

According to the study, “Trust in pharmaceutical ads ticked up significantly among people with a BMI of 40 or greater who were concerned about their weight. About half or more concerned patients reported seeing advertisements related to weight-management products or medications ‘all the time’ or ‘most of the time’ compared to about one in three of patients who were not concerned about their weight. Of the concerned patients, nearly six in 10 felt that these sources broadly represent the experiences of people who are overweight or obese.”

Closing the Gap: Tailoring Support for Patients with Obesity. 

. https://lifesciences.phreesia.com/reports/closing-the-gap-tailoring-support-for-patients-with-obesity/

A study detailing how patients struggling with obesity interact with the life sciences industry suggests that they don’t get weight loss information from their doctors.

Patients Getting Weight Loss Information from Advertising as Opposed to Doctors: New Study Suggests

Picture this: You're a marketing executive for a pharmaceutical company, and you've just been handed a challenging assignment. Your task? To breathe new life into a mature product that's facing increasing competition. It's a scenario many of us in the pharma industry have encountered.

In this article, we'll dive into strategies that can help you not just maintain, but grow your market share. We'll explore how to adapt to new competitive pressures and evolving customer needs, turning potential threats into opportunities for innovation and growth.

Prioritizing patients for sustainable success

With an established product, your existing customer base is your greatest asset. We can achieve continued success by prioritizing patients and addressing their entire healthcare journey. Take inspiration from Pfizer's "This is living with cancer" program.

 The program offered coordinated services with human care champions and an integrated digital tool to organize information, build communities, and track symptoms.

 Create partnerships with stakeholders to offer coordinated services that go beyond medication, fostering patient loyalty and improving overall health outcomes.

Evolving brand campaigns to inspire hope and action

Refreshing your brand's creative campaign can change the dialogue around the disease state and reignite interest in your product. Entresto's "Heart Failure meet Heart Success" campaign exemplifies this approach, empowering patients and HCPs to view heart failure not as a death sentence, but as a manageable condition with treatment options.

 Develop campaigns that focus on patient empowerment and reframe disease narratives, moving beyond product features to inspire hope and action.

Exploring new formulations to address patient needs

Improving the customer experience through new formulations can breathe new life into mature products. For example, a citrate-free version of ixekizumab was developed to reduce injection site pain, directly addressing a key patient concern.

 Invest in R&D to develop extended-release versions, combination therapies, or more convenient delivery methods that address unmet patient needs. These strategies may help extend market exclusivity.

Leveraging real-world data to demonstrate long-term value

In mature markets, extensive real-world data can be a powerful differentiator. Johnson & Johnson's use of real-world evidence for Invokana in diabetes management helped maintain its competitive edge against competitors and new entrants, while demonstrating better patient outcomes such as adherence and cost.

 Conduct post-market studies to gather economic and clinical data. Use this information to demonstrate long-term value to payers, providers, and patients.

Embracing digital ecosystem to streamline patient access

In today's digital age, innovative marketing approaches can set your product apart. Biohaven's launch of Nurtec showcases this strategy in action.5 They partnered with Cove telemedicine network, enabling website visitors to schedule evaluations and, if appropriate, receive prescriptions delivered to their homes or local pharmacies. This seamless digital experience, coupled with $0 copay cards, improved access to their solution - a tactic mature products can employ for renewed market relevance.

 Create integrated digital ecosystems that streamline patient access, enhance treatment journeys, and provide value-added services, setting your mature product apart in a crowded market.

By implementing these strategies, pharmaceutical companies can evolve their marketing approaches to protect and grow market share in competitive mature markets. The key lies in balancing the established reputation of the product with continuous innovation in both the product itself and the marketing strategies employed.

https://www.pfizer.com/news/press-release/press-release-detail/pfizer_launches_novel_programs_to_put_important_support_services_at_the_fingertips_of_cancer_patients

https://investor.lilly.com/news-releases/news-release-details/lillys-taltzr-ixekizumab-now-available-new-citrate-free#:~:text=Lilly%27s%20Taltz%C2%AE%20(ixekizumab)%20Now,Experience%20%7C%20Eli%20Lilly%20and%20Company

https://www.jnj.com/media-center/press-releases/real-world-evidence-shows-oral-invokana-canagliflozin-results-in-greater-weight-loss-and-treatment-adherence-than-injectable-glp-1-receptor-agonists-in-type-2-diabetes-patients

https://www.fiercepharma.com/marketing/biohaven-accelerates-dtc-campaign-timing-for-migraine-med-nurtec-odt-launches-tv-digital

Strategies that can help  maintain and grow your market share. Plus how to adapt to new competitive pressures and evolving customer needs.

Revitalizing Mature Pharma Brands: 5 Winning Strategies

It’s 11 AM and a large insurer is threatening to walk away early from a three-year contract for your most profitable drug unless you agree to significant new concessions. Meanwhile, the next round of negotiations with the largest US Medicare plan for your newly launched drug awaits you after lunch. But at this moment, you’re on a call with your CEO’s chief of staff who is asking you to investigate ways to bypass pharmacy benefit managers and go straight to employers—or even patients—potentially risking key relationships for uncertain gain. Meanwhile, without serious intervention, your colleagues are planning a new formulation that will surely antagonize payers more than appeal to them. And don't forget, you still have to interview three candidates for your vacant VP of Trade position before the end of the week. All that, and the new administration has thrown the future of federal drug policies into all-out upheaval, making it even more challenging to predict and plan. And did we mention it’s only Tuesday?

Welcome to the tumultuous life of the vice president of market access––undoubtedly the hardest job in biopharma.

Market access is a unique balancing act. It’s not just about ensuring product access is optimized for profitability, it’s about navigating a web of complex decisions by PBMs, health plans, health systems, wholesalers, policymakers, and internal stakeholders. In short, it’s about aligning internal strategies with external realities—external realities that often change without warning and at a frequency likely not experienced by other biopharma executive roles.

“Next to delivering a medicine of true value, market access is the most critical function in ensuring a biopharma company’s commercial success and long-term viability,” says Dave Moules, a seasoned leader whose career includes pivotal roles at both GSK and Pfizer. Over the years, Moules earned respect across the payer and manufacturer landscape for his strategic insights and integrity. “Given what’s at stake, market access leaders operate under immense pressure to secure quality access for their products,” he continued. “Leading this function in today’s environment is not for the faint of heart.”

Every day brings competing pressures. On one hand are the internal demands from multiple brand marketing teams, finance, legal, various sales leaders, and other departments, all of whom expect—and need—your team to make their priorities your own. And, let's be honest, many of these internal folks are naively confident they could do the job better than those with decades of relevant experience. On the other hand, there are external pressures from payers, policymakers, and the public that complicate decision-making. One wrong move can collapse a partnership, put your product out of reach for patients, or, in some cases, even sink your stock price. Few jobs across the entire economy, never mind biopharma, require so many touchpoints with so many stakeholders across more domains of knowledge and expertise, all while carrying such a high risk of consequence.

Market access is a balance of strategic planning and immediate crisis management. Negotiations with payers over drug coverage take months and are built on a holistic understanding of the marketplace, company needs, product demand, the regulatory environment, and more. So when a large payer suddenly threatens to walk away from an existing contract unless a company significantly hikes its rebate rates, the risk of a major financial blow could have far-reaching consequences. These moments are inevitable and demand that the VP of market access shift to an entirely different skill set in order to lead his company through such a high-pressure challenge.

Biopharma CEOs don’t think like payers, and understandably, they are often frustrated when a critical revenue stream is put at risk by them. The VP of market access must serve as a go-between, fluent in the language of both, but they can easily get caught in the crossfire. This can be a thankless job: no company wants to cough up more than originally expected, and to the CEO and the rest of the C-suite, the idea that some revenue is better than none at all is often cold comfort. The market access team is at high risk of being scapegoated for not anticipating the challenge, even though external market forces are the true cause. In these stressful circumstances, even positive outcomes are often met with minimal acknowledgment and maximum scrutiny.

The market access VP is both the chief diplomat and chief negotiator, constantly juggling the interests of payers, patients, and the company. Succeeding in this role requires an ability to think like a payer, and that mindset can’t be conjured out of thin air. It takes cultivating and maintaining personal connections with people at dozens of different payer organizations. What’s more, each payer has its own rules, strategy, and idiosyncrasies at the organizational level.

The payoff of building and managing these relationships is immense. Rather than being the last to hear about a potential change from payers, market access VPs can be the first if they’ve built trusting relationships. These are some of the most important and valuable external relationships a biopharma company can have, but they take immense patience and years of work. The payoff comes in the form of a competitive advantage in time and space that permits frank, internal discussions about what is required in the moment.

While market access is about mastering the external world, the VP also needs to be a versatile leader internally. This role demands fluency across a wide range of departments including marketing, legal, R&D, sales, finance, and government affairs. Each department has its own language and priorities, and the VP must be adept at translating across them. For example, research is rightfully focused on scientific innovation, but the market access VP must ensure that clinical evidence is positioned in a way that makes sense to both payers and regulators, balancing scientific potential with practical business concerns.

In addition to technical knowledge, the VP must also be a skilled communicator, able to collaborate with legal and finance on compliance and pricing matters, as well as with government affairs to navigate shifting policy landscapes and synthesize all of this into one coherent strategy. That’s to say nothing of management responsibilities over a team that often includes hundreds of individuals.

Additional challenges come not only from outside the walls of the company but from beyond the industry itself. In such a highly regulated industry, the market access VP must be astute in both public policy and politics––and especially so at this particularly volatile political moment. In just 2022, the Inflation Reduction Act reshaped drug pricing negotiations, altering the calculus for market access teams. And with a new administration in office that ran on repealing the law, the game could be upended all over again. Meanwhile, leadership changes at HHS bring even more uncertainty for pharmaceuticals. That’s to say nothing of state-level policies. These days, market access leaders aren’t just monitoring policy changes or speculating with government affairs colleagues. They’re in war rooms, mapping out every potential scenario, anticipating ripple effects, and preparing contingency plans before new rules can even take shape.

Policy is yet another layer of uncertainty for market access leaders to grapple with. VPs need to synthesize regulatory updates in real time, translate legal jargon into actionable strategy, and ensure their company isn’t caught flat-footed when policies change. And the work doesn’t stop when the policies take hold. The VP must shape internal pricing strategies to stay compliant, adjust negotiating stances to reflect the new realities, and help the C-suite understand the potential implications of new regulations––all while staying vigilant for the next round of regulatory upheaval.

What every market access VP needs: alignment on expectations

For all this complexity and all the high stakes, market access teams and leaders too often go overlooked as expectations are imposed on these teams rather than built with them. But success isn’t about pushing for a preferred outcome—it’s about aligning expectations with the realities of the healthcare landscape and optimizing the results. Leaders across an organization––from the C-suite to brand marketing teams, sales, and government affairs––must collaborate early with the market access VP to ensure their strategies account for payer needs and other potential challenges.

Market access will always be a complicated mix of strategy, diplomacy, and crisis management. Even with the right alignment, companies still won’t be able to perfectly forecast every market shift. But they will be better prepared for how quickly the forecast can change, how to pivot when it does, and how central the VP of market access is in making those adjustments. And if the entire team shares that outlook, they might even give the VP a rare and precious gift: a moment here and there to breathe.

Pete Vaccaro and Amy Heath, managing partners at Petauri Advisors, bring decades of experience leading and supporting market access functions.

Market access is about aligning internal strategies with external realities that often change without warning and at a frequency likely not experienced by other biopharma executive roles.

CAPT Brenda Stodart

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