Susan Haigney

Marcio Temtem, vice president, Strategic Business Management, Hovione, addresses molecule complexity, speed, and regionalization via integrated manufacturing.

Hovione’s Strategy for Complexity, Speed, and Regional Supply Chains

The landscape of small molecule manufacturing is rapidly evolving, according to Marcio Temtem, vice president, Strategic Business Development, Hovione, who provides an expert look into how his firm is evolving their approach as the industry changes. With 17 years of experience at Hovione, a family-owned CDMO with a 66-year legacy, Temtem identifies three pivotal trends currently shaping the industry: increased complexity, accelerated development speed, and the regionalization of supply chains.

Temtem observes that small molecules have grown significantly in size and complexity, often requiring multiple chemical steps and high-potency handling. This shift necessitates a specialized "toolbox" to overcome modern bioavailability challenges. Highlighting Hovione's technical approach to these hurdles, Temtem states, "We use a platform called amorphous solid dispersions, produced by spray drying to address this challenge of bioavailability.” This platform represents a core area in which Hovione maintains global leadership, utilizing innovative tools to scale processes efficiently while minimizing the use of APIs.

Temtem also mentions the increased influence of AI in drug discovery and deployment, which requires CDMOs to bridge the gap from grams to tons at a much faster pace than in previous years. He further addresses the trend of regionalization, noting the rise of countries such as the US and China prioritizing regional supply chain strategies. He explains that Hovione is uniquely positioned to navigate these new challenges with supply chains through its FDA-inspected sites across three continents.

Central to Hovione’s competitive advantage is their integrated manufacturing offer, which combines drug substance and drug product expertise at a single location. Temtem emphasizes the value of this model, stating, “The company… has been investing in an integrated offer, bridging the problems of chemists and formulators all at the same shop.” To support this integration, the company continues to pioneer advanced manufacturing avenues, including continuous flow for drug substances and continuous tableting for drug products.

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

I’m Marcio Temtem. I'm currently vice president for strategic business management at Hovione. I've been in the company for 17 years. Hovione is a CDMO for pharmathat has been in the business for 66 years. Still a family-owned business that supports small molecule synthesis, production of drug product intermediates, and drug product, for pharma clients. First, and my answer will focus on the small molecule side, and I will try to cover three big trends. One of the trends that we see today is the increased complexity. Small molecules, they are not so small anymore. These days, they have come to a size and to a complexity, that require multiple chemical steps and that very often require high potency. They also require, on the formulation side of things, not just on the chemistry, but on the formulation side of things they also require a new toolbox. A new toolbox to address some of the challenges related with bioavailability. In our case at Hovione, we use a platform called amorphous solid dispersions, produced by spray drying to address this challenge of bioavailability. One other trend that we see happening as we speak relates with acceleration speed. I think it reach a different definition in 2025. There's a need to develop new molecules, new candidates at a faster pace. AI, it's booming all over the place, in the deployment of new molecules. And with this, new way of synthesizing molecules also comes complexity, bridging to what I said before. But it also requires companies like Hovione to develop the CMC section, to develop the process that will take the program from grams to tons at a much faster pace. So that's the second trend. The third trend is that there is an increased concern with the regionalization of the supply chains. You see a big trend in US for US, China for China. In our case, we look at this as an opportunity. Hovione has sites in three continents. In Asia, China, Macau, in Europe, Portugal, and Ireland, and the US. And we believe that, all these sites, they are FDA-inspected, I could say. And we believe that this is also an opportunity for Hovione to continue serving as it has been doing so far, all these markets. I would like to highlight two of our platforms. One of the platforms, I already touched before, that relates with the addressing solubility, bioavailability challenges through the making of amorphous solid dispersions. This is an area where Hovione has, today, the global leadership. And not just over 2025, but over the last years, we have been developing a number of tools, that allow to scale up the process, to develop the formulation with minimum use of API, and with a high probability of success. This is one element where innovation has played an important role to us in 2025. One other aspect to it is that the company, Hovione, has been investing in an integrated offer, bridging the problems of chemists and formulators all at the same shop. And when I say at the same shop, at the same site, which is something very, very unique in the CDMO environment. And in order to do so, we have also been developing new ways of manufacturing. I can tell you that, for instance, in the drug substance space, we have been exploring new avenues, such as, continuous flow, or on the drug product manufacturing, we have been exploring new ways of manufacturing, such as continuous targeting, in order to accelerate, in order to address some of these needs that clients today, bring to our shop.

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Women in STEM: Early Phase Drug Development

Dr. Maria de Miguel, MD, PhD, MBA, an oncologist and Director, Clinical Research for 

, offers her perspective on the evolving landscape of early phase oncology drug development. With a decade of experience spanning phase 1 clinical trials, her expertise covers a broad spectrum of novel therapies, including immunotherapies, antibody drug conjugates (ADCs), and targeted therapies.

Regarding the industry's talent pipeline, Dr. de Miguel highlights the importance of education programs in the fields of science, technology, engineering, and mathematics (STEM) in building the confidence and critical thinking skills necessary to manage the uncertainties of scientific research.

According to Dr. de Miguel, although women constitute nearly half of the biomedical workforce, they occupy only 20–30% of leadership roles. She attributes part of this gap to a “natural pipeline effect” as more women have entered these fields relatively recently, but she stresses that STEM initiatives are vital for ensuring women progress into positions where their expertise and judgment can shape high-impact decisions.

In the specialized sectors of rare disease treatment and early drug development, Dr. de Miguel stresses that the contributions of women are essential. Because these areas often involve limited data and high ethical stakes, they require a blend of scientific rigor and clinical reality. Women in the field frequently bring a collaborative, patient-centered perspective that is indispensable when evidence is scarce and every decision is important.

Technological “revolutions” are impacting the pharmaceutical sector. Dr. de Miguel expresses significant enthusiasm for precision medicine and advanced biologics, specifically bispecific antibodies and ADCs. These clinical advancements are being matched by the implementation of more adaptive and clever trial designs that allow for better-informed decisions earlier in the development cycle, improving efficiency and reducing uncertainty to ensure meaningful therapies reach the market more rapidly.

Dr. Maria de Miguel is an oncologist and Director, Clinical Research at 

. Dr. de Miguel is focused on establishing START Rioja as a regional hub for oncology research in northern Spain and expanding patient access to innovative treatments. Inspired by the collaborative efforts between specialized pharma teams, CROs, and clinical investigators, she emphasizes that thoughtful clinical decision-making remains the most powerful tool for impacting the trajectory of new treatment development.

Hello, I'm Dr. Maria de Miguel. Thank you very much for having me today.

I am a medical oncologist specialized in early phase oncology drug development. Over the last decade, I have worked in phase one, first in human clinical trials, covering all novel cancer therapies, including immunotherapies, antibody drug conjugates, and targeted therapies.

I currently direct START Rioja, an early phase clinical trial unit within the public healthcare system in northern Spain. I'm very passionate of my work, which is beautiful at the intersection of clinical care, translational science, and execution of complex trials.

What are some of the benefits of STEM programs for girls in school? How do these programs translate to women building careers in the pharmaceutical industry?

STEM programs are about building skills and confidence. They help all the students to learn how to think critically, solve problems, and work with uncertainty, which are abilities that are essential in science.

In biomedical and health science, women represent close to half of the workforce. However, we only account for 20–30% of leadership roles, and these rates drop significantly when we talk about other STEM fields.

Part of this reflects, in my opinion, a natural pipeline effect, as large numbers of women have entered these fields relatively recently, thanks to these kind of programs, among other factors, and some might relate also to differences in career interests.

So, to me, what really matters is that STEM programs give girls the tools and confidence not only to enter scientific careers, but also to progress into positions where their expertise and judgment shape high-impact decisions, including my field, early phase, drug development.

How do women working in STEM fields uniquely contribute to areas such as rare disease treatment development?

So, in rare diseases and early drug development, decisions are often made by limited data and a high responsibility toward patients. What matters most in this context is careful judgment, collaboration, and a strong patient-centred perspective.

So many women bring a way of working that integrates scientific rigor with clinical reality, which is particularly valuable when evidence is scarce and every decision carries an ethical weight. In this setting, the role of women is essential.

What exciting innovations do you see on the horizon for the pharmaceutical industry?

Nowadays, we are very excited to see many different revolutions in cancer therapy, from precision medicine to advanced biologics, such as bispecific antibodies and antibody drug conjugates, and this is coming all along to more adaptive and clever trial designs.

These advances allow us to make better-informed decisions earlier in development, improving efficiency while deepening biological understanding. The goal is not only to move faster, but to develop smarter by reducing uncertainty and increasing the likelihood that meaningful therapies reach patients.

All of these have translated into significant achievements in cancer treatment during the last years and many, many drug approvals throughout my career.

Who are you inspired by in the pharmaceutical industry?

I have been very lucky to work alongside a wide range of professionals who are deeply committed to advancing oncology research. This includes very early career oncologists asking sharp, relevant scientific questions, as well as internationally recognized leaders, men and women, in the field whose experience has really shaped the way we think about cancer today.

But I'm also inspired by progress driven by the pharmaceutical industry and CROs, where highly specialized teams can translate very complex science into viable clinical development programs. And I think that we all have in common the love for science and belief in having fruitful discussions to push the field forward for our patients.

What are you currently working on that you are passionate about?

I'm currently focused on consolidating START Rioja as a regional hub for oncology research, expanding access to innovative therapies for patients across all the north part of Spain.

Of course, I remain deeply involved in early drug development as a principal investigator because I really think that thoughtful clinical decision-making can have a real impact on how new treatments are developed.

Oncologist Dr. Maria de Miguel, MD, PhD, MBA, Director, Clinical Research for START Rioja, spoke with PharmTech about the importance of STEM education in early phase drug development.

Women in STEM: Cultivating Scientific Confidence

For pharmaceutical manufacturing and biotech leaders, maintaining a robust pipeline of technical talent is essential for innovation. Elisabeth Gardiner, chief scientific officer at Tevard Biosciences, highlights that while the pharmaceutical industry relies on multidisciplinary talent—including experts in chemical engineering, data science, and regulatory science—there remains a significant gender gap in these critical roles.

“From an economic perspective, having talented, engaged people in STEM is a win for the United States and, obviously, for the world,” Gardiner says. “New technology and new medicines come from bright minds.”

What is the state of women in the pharmaceutical workforce

Despite the industry's growth, representation for women in the fields of science, technology, engineering, and mathematics (STEM) has stagnated. Gardiner points to several concerning statistics regarding the current workforce:

• Gender imbalance. In the US, women comprise nearly half of the general workforce but occupy only 35% of STEM jobs .

• Pharma representation: Within the pharmaceutical industry specifically, women hold only 20–30% of STEM roles, meaning the sector remains approximately 70% male-dominated.

• Global stagnation. Globally, women make up 35% of STEM graduates, a figure that has remained unchanged for over a decade.

According to Gardiner, a critical takeaway for industry stakeholders is the “confidence paradox.” While interest in STEM has increased over the past decade, the self-reported confidence of girls and women in their scientific and mathematical abilities has dropped from 70% to 60%. Current investments in the space may not be providing the specific confidence-building training or mentorship required to sustain a long-term career in pharmaceutical manufacturing.

How can companies build a future talent pipeline?

Gardiner argues that the pharmaceutical and biotech industries must support early, hands-on exposure to demystify complex concepts. Because STEM requires physical execution and repetition, early engagement helps students—particularly girls—see themselves as competent STEM learners.

For the manufacturing sector, this foundation is vital for several reasons. Early exposure builds the groundwork for essential skills like coding, automation, and experimental design.

Early interest guides students toward college majors in biochemistry, molecular biology, and bioinformatics, which are the primary feeders for pharmaceutical careers.

New medicines and global technologies depend on a talented, engaged workforce; therefore, engaging diverse “bright minds” is a strategic move. Going beyond general investment toward structured mentorship and training fosters scientific confidence from an early age.

Elisabeth Gardiner, PhD, CSO, Tevard Biosciences

Dr. Elisabeth Gardiner is chief scientific officer at Tevard Biosciences, joining the leadership team in 2025 to spearhead the company’s pioneering tRNA-based gene therapies for rare diseases with high unmet need. With more than 25 years in the biopharmaceutical industry, she has directed and managed drug discovery and development efforts yielding 11 investigational new drug filings, four Phase I/II trial candidates, and one Phase III candidate. Prior to Tevard, Dr. Gardiner held senior R&D leadership roles at Tactile Therapeutics, Alterome Therapeutics, Aravive, and Kinnate Biopharma, where she directed multidisciplinary teams and advanced programs from discovery to clinical-stage development across neurology, oncology, and rare disease. Dr. Gardiner gained experience in tRNA biology while working at aTyr Pharma and at Scripps Research Institute in the lab of Paul Schimmel. Dr. Gardiner’s commitment to the ethical development of effective and accessible medicines is her key focus in life. In addition to her professional work, Dr. Gardiner acts as a patient advocate in the rare disease and oncology space. She earned her PhD from the University of Wisconsin-Madison and holds a B.S. and an M.S. from Texas A&M University.

My name is Elisabeth Gardiner. I'm the Chief Scientific Officer of Tevard Biosciences. We're based in Boston, Massachusetts. Tevard Biosciences is a drug development company focused on rare disease.

We're specifically focused on genetic diseases caused by nonsense mutations that result in premature stop codons, which is a type of mutation that's actually responsible for 10–40% of all genetic disease.

We are hard at work trying to bring therapeutics to the clinic for genetically defined dilated cardiomyopathies and muscular dystrophies caused by nonsense mutations.

I think that encouraging people from all walks of life to enter STEM fields is really important.

Engaging with students when they're young and showing them that science is interesting, and then providing them with ideas and examples of the jobs that they can do in the STEM field is crucial to having a thriving scientific community in general, and incredibly important to human health and, and global technology.

From an economic perspective, having talented, engaged people in STEM is a win for the United States and, obviously, for the world. New technology and new medicines come from bright minds.

In particular, with women, studies have shown that girls report increased confidence if they're exposed to STEM early, and this allows them to have more scientific and technical confidence in their own abilities after being exposed to STEM in school. They start to see themselves as competent STEM learners, and I think that that's critical in whether or not they're going to pursue either advanced coursework, advanced education, or a STEM career.

STEM's something you really have to be able to physically execute, and it doesn't really matter whether you're doing math or you're doing computer programming or you're a doctor or a nurse or someone working in a lab, it requires [that] you understand the concept, but then it requires hands-on exposure and repetition. So doing that early is much better. You know, the earlier it can happen, the more your brain learns to think that way.

I think that it's something that some people's brains really like and are excited by. If you're never exposed to STEM, you don't know whether or not your brain is going to like it or not.

Pharmaceutical and biotech industries really rely heavy on deep scientific training, so biology, chemistry, engineering, data science, regulatory science.

Every STEM exposure has long-term effects on the workplace representation, and so you get exposed in elementary school or middle school or high school, then it may guide your choice of a college major. So, if your college major is biochemistry, molecular biology, chem—you know, some other type of chemistry, bioinformatics, computer science, chemical engineering, you're going to actually, after spending that time in college, probably go into a career that represents that learning. So that's exciting.

And from alignment for the pharmaceutical industry, pharmaceutical work actually relies on multidisciplinary technical talent, and STEM exposure early really builds a foundation.

So, whether you're working in a lab, whether you're just learning how to think and design experiments, from the perspective, of coding and automation, I mean, again, that requires exposure, it requires training, requires some sort of mentorship.

And then I think a lot of people are scared of, learning math and thinking about data, and so early exposure helps demystify it and make it a more straightforward concept for people.

Evidence shows that investment exists, but it's probably not sufficient to close the gender gap that exists currently, and that probably more needs to be done.

So globally, women make up about 35% of STEM graduates, and that's really across the board. And unfortunately, this 35% has not changed in over a decade. So, this is global monitoring, US monitoring. And in the US, actually, women comprise 48–49% of the workforce, but they occupy only 35% of STEM jobs, and in fact, only 20–30% of STEM roles in the pharmaceutical industry are actually held by women. And so that means that almost 70% of the STEM workforce in the pharmaceutical industry is still male dominated.

It's not a bad thing, but it just means that there is a definite difference in representation. One of the reasons why this may be occurring is that over the past 8–10years, although girls' and women's interests in STEM have actually increased, you actually see the global confidence that girls and women have in themselves in STEM fields has actually dropped.

And so, 10 years ago, if you asked young women how they felt, you know, "Do you feel like you're good at math and science?" You know, 70% percent of them said, "Yes, I feel like I'm good at math and science." But now it's only 60%, and that number appears to be dropping, and it's unclear why that is. Is there not the mentorship? Are they being discouraged? It's unclear.

So, what that suggests is that while interest is rising and there's clearly investment in this space, the investment is likely not matching the need, and it's not really providing the kind of confidence-building training that is going to be leading to a long-term career in the Pharmaceutical industry.

PharmTech spoke with Elisabeth Gardiner, chief scientific officer at Tevard Biosciences, about how hands-on, early exposure to STEM fields can demystify complex concepts.

IMUNON, a clinical-stage company, currently has a DNA-mediated immunotherapy for advanced ovarian cancer in phase 3 development. The company’s TheraPlas platform utilizes a an IL-12 DNA plasmid vector encased in a synthetic nanoparticle delivery system that enables cell transfection to produce and secrete the IL-12 protein directly into the tumormicroenvironment.

 spoke with Dr. Stacy Lindborg, president and CEO of IMUNON, about the company’s immunotherapy, her background in biotech, and her philosophy on leadership.

Can you please introduce yourself and give our audience a bit of background on your role and expertise?

 My name is Dr. Stacy Lindborg, and I am the president and CEO of IMUNON, a clinical-stage company in phase 3 development with our lead DNA-mediated immunotherapy for advanced ovarian cancer. I have worked in the pharmaceutical and biotechnology industries for about 30 years. After graduating from Baylor University with a PhD in statistics, I wanted to use my STEM training to help tackle real-world problems affecting family members, friends, and the broader community, and turned to the world of biotechnology and biopharmaceuticals, where I could help create a meaningful impact in areas of significant unmet medical need such as ovarian cancer.

Over the past 30 years, I have provided strategic counsel and leadership across R&D, regulatory affairs, analytics and clinical data, executive management and strategy development in both US and international markets. My expertise lies in empowering my team, fostering a culture of collaboration and innovation and guiding long-term visions for growth. Early on in my career, one of my biggest takeaways was that leadership is not primarily about your talent and having all the answers—it is about learning what you can do with a supportive team behind you.

At IMUNON, I am fortunate to work with such a talented and dedicated team and together we have made great strides in the last year alone, reporting unprecedented clinical data of our novel IL-12 immunotherapy and advancing into phase 3 in our journey to transform the ovarian cancer treatment landscape for women who desperately need new treatment options.

How can women help improve innovation within the pharma industry?

There have been prior studies showing that women consistently underestimate their abilities to lead in any industry. But interestingly, this can be leveraged as a strength. Even as experts in the biopharmaceutical industry, many women leaders are dedicated to learning, humility, and growth, which can help foster healthy debates, remove barriers to allow teams to move forward quickly, and create a more collaborative and inclusive environment where many different perspectives are valued, which is essential to advance innovative science.

Through our work at IMUNON to drive progress in frontline treatment for advanced ovarian cancer, it is very important to seek insights from as many people as possible, not only at the company but also from outside experts and the families who are impacted daily by this disease to better inform our research efforts. For example, I have spoken to women and cancer survivors at events, such as a recent National Ovarian Cancer Coalition (NOCC) walk, who encouraged their daughters to get tested for genetic mutations associated with ovarian cancer so they could better understand their personal risk of developing the disease. In these conversations, I imagine what it might be like if my own daughter were diagnosed, which carries a much heavier image than imagining myself in the same place. I connect with these women who only want more time to see who their children will grow up to be. Their stories are incredibly humbling, revealing, and reinforce my passion for our research and commitment to the goal of extending overall survival for women living with advanced ovarian cancer. Leading with empathy, as a woman and as a mother, is a real strength in the pharmaceutical industry.

Is there a specific lesson you have learned from being the CEO of a life-sciences company?

I did not initially aspire to be a CEO. Occasionally, some people have said that my statistics background makes me a bit of a non-typical CEO in the life sciences and biotechnology fields. I remember early in my career listening to an all-employee meeting being led by Eli Lilly’s prior CEO John Lechleiter, who has a PhD in organic chemistry, and wondering if any statistician had risen to these ranks. Many years later, when considering taking on the CEO role at IMUNON, initially joining the team as a Board member, one valuable conversation with a well-known scientist instilled a crucial lesson for me about leading in this industry—no one is uniquely positioned for the CEO role. We all come to the table with specialized knowledge in hand that is important to the core of life sciences, and with areas in which we are not experts. No matter your background, being dedicated to learning, understanding how to face uncertainty, and empowering your team makes you fit to lead.

In the past 30 years, I have also come to understand the value of a servant leadership style grounded in humility and learning, which can be a catalyst for growth. The most critical factor that I must think about as the leader of my organization is my team and how my team will accomplish the very difficult task of delivering a novel therapeutic to extend the life of people with ovarian cancer. By surrounding yourself with brilliant people, relying on them, empowering them, seeking their input, and letting their insights factor into your decision-making, you help create a culture of collaboration, productivity, and nimbleness that is essential for propelling innovative research forward.

Our mission at IMUNON is to advance novel immunotherapies that harness the body’s natural immune system to fight serious diseases. Currently, we are focused on our ovarian cancer program. We are advancing a DNA-based immunotherapy that harnesses the well-known cancer-fighting molecule interleukin-12 (IL-12), designed using our proprietary TheraPlas platform technology. Our therapy is an IL-12 DNA plasmid vector encased in a synthetic nanoparticle delivery system that enables cell transfection followed by durable, local production and secretion of the IL-12 protein directly into the tumor microenvironment of women with advanced ovarian cancer. Essentially, we give the body a recipe for seeing the tumors—ovarian cancers are immunologically ‘cold,’ meaning the body cannot see them—and for allowing our therapeutic to change the intraperitoneal cavity where the cancer resides to a ‘hot’ tumor microenvironment. It is an amazing process.

We have had positive and unprecedented clinical data thus far, which are very encouraging. Results from our phase 2 OVATION 2 trial, which were presented at the 2025 ASCO Annual Meeting and simultaneously published in 

, demonstrated that our therapy was the first to achieve a clinically effective response in advanced (stage IIIC/IV) ovarian cancer including benefits in both progression-free survival (PFS) and overall survival (OS) in a first-line treatment setting when used with standard of care chemotherapy. Our goal is to launch a first-in-class IL-12 immunotherapy and with this to provide the first frontline immunotherapy for women with advanced ovarian cancer, a field that has not seen treatment innovation for about 30 years or longer. We are well on our way as we quickly advance this therapy in our phase 3 trial, and enrollment continues to generate strong interest.

It is time for women to have more options; they need a new treatment that is safe, durable, and affects survival outcomes, giving them more time with their loved ones. When I hear clinicians and our trial investigators speak about the conversations they have with patients, they discuss not having better options available. And unfortunately, the outcomes on the current standard of care are poor, and there is a high rate of disease recurrence. The potential to bring these women an option that may extend their lives and genuinely transform the standard of care is incredibly fulfilling. It is the reason we work so hard in this industry—to advance patient care and provide value—and it is a privilege and honor to have this opportunity.

I see significant momentum building around next‑generation immunotherapies and more precise delivery technologies. In oncology, continued progress in DNA‑based approaches and non‑viral delivery systems such as our IL-12 immunotherapy could open the door to more targeted and tolerable treatment options. These platforms are designed to direct therapeutic agents—such as cancer-fighting cytokines—into the tumor microenvironment in ways that may stimulate strong, localized immune responses while reducing broader systemic effects.

More broadly, I believe the industry will increasingly focus on technologies that improve specificity, enhance durability of response and lower toxicity across cancer types. Advances in genomic medicine, computational modeling, and biomaterial engineering are converging to help researchers understand how to modulate immune activity more precisely. As these tools mature, we may see meaningful improvements in the treatment of historically challenging cancers.

Dr. Stacy Lindborg, president and CEO of IMUNON

Dr. Stacy Lindborg is president and CEO of IMUNON, a clinical-stage company in phase 3 development with a lead DNA-mediated immunotherapy for advanced ovarian cancer. Dr. Lindborg has worked in the pharmaceutical and biotechnology industries for about 30 years. She graduated from Baylor University with a PhD in statistics.

Over the past 30 years, Dr. Lindborg has provided strategic counsel and leadership across R&D, regulatory affairs, analytics and clinical data, executive management. and strategy development in both US and international markets. Her expertise lies in empowering her team, fostering a culture of collaboration and innovation and guiding long-term visions for growth.

IMUNON has reported unprecedented clinical data of its novel IL-12 immunotherapy and advancing into phase 3 to transform the ovarian cancer treatment landscape for women who desperately need new treatment options.

Articles

IMUNON is advancing a DNA-mediated immunotherapy for advanced ovarian cancer, utilizing the TheraPlas platform with an IL-12 DNA plasmid vector. This approach aims to transform the tumor microenvironment from 'cold' to 'hot,' enhancing immune response. Dr. Stacy Lindborg, CEO of IMUNON, emphasizes the importance of collaboration, innovation, and leadership in driving progress. The company has reported promising phase 2 results, showing improved progression-free and overall survival. The focus is on providing new, effective treatment options for women with advanced ovarian cancer.

PharmTech spoke with Dr. Stacy Lindborg, president and CEO of IMUNON, about her experience at IMUNON, which is developing a novel DNA-based approach to treat ovarian cancer.

Women Leading Biotech: Advancing Treatments for Ovarian Cancer

Blood clot blocking a blood vessel | Image Source: ©peterschreiber.media -stock.adobe.com

Bristol Myers Squibb (BMS) and Johnson & Johnson (J&J) announced they have launched a new educational initiative, “Change the Target. Change What’s Possible,” aimed at redefining the approach to cardiovascular and thromboembolic care.

 This program focuses on the emerging potential of Factor XIa (FXIa) inhibition, a target to address persistent challenges in drug development, such as preventing dangerous blood clots without compromising the body’s natural ability to heal.

"Despite advances in cardiovascular care, some patients with thromboembolic disease remain at high risk because current therapies may require difficult trade-offs between efficacy and bleeding,” said Tania Small, MD, senior vice president and head of Medical Affairs, BMS, in the press release.

 “A better understanding of the coagulation cascade has led to the identification of new targets, such as factor XIa, informing how we approach the research of thrombosis prevention while preserving healthy clotting.”

What is the unmet need in cardiovascular treatments?

Despite a robust market of existing anticoagulants, cardiovascular and thromboembolic diseases remain a primary driver of global mortality, accounting for nearly 1 million deaths in the United States annually, according to BMS.

 The current landscape is defined by the following gaps in protection:

Approximately 40% of patients with atrial fibrillation remain untreated or undertreated.

Roughly 25% of strokes are recurrent, many of which are considered preventable.

The primary barrier to optimizing care is the risk of bleeding complications, which often leads to the under-utilization of current therapies.

“With heart disease and stroke among the leading causes of death and disability worldwide, it is imperative to continue research in preventing these events,” said Clay Johnston, MD, PhD, MPH, co-founder, chief medical officer, Harbor Health in Austin, Texas, in a BMS press release.

 “Patients at risk for stroke and other thromboembolic events really need drugs that reduce the risk of dangerous clots without increasing their bleeding risk, and targeting factor XIa may open this possibility.”

BMS and J&J have been working together to find treatments for vascular and thromboembolic diseases, with a patient-centric approach that relies on real-life experiences.

Factor XIa has a unique role in thrombin generation and clot propagation. While traditional anticoagulants often inhibit factors within the “common pathway”—which can inadvertently impair healthy clotting—targeting FXIa offers a more surgical approach.

The primary goal of this research is todecouple hemostasis (healthy clotting) from thrombosis (the formation of harmful clots), according to BMS.By inhibiting FXIa, researchers believe it may be possible to prevent the formation of dangerous clots while preserving the body’s ability to form “good clots” that reduce bleeding complications.

What is the impact of strategic collaboration?

The alliance between BMS and J&J reflects a growing trend of high-level collaboration in the pharmaceutical sector to address complex disease states. By combining their respective scientific expertise and commercial infrastructures, the two companies aim to overcome the limitations of current treatments and close the gap in thrombosis management.

The collaboration will extend to the support of broader cardiovascular and neurological communities through partnerships with patient advocacy organizations; this may signal a long-term commitment to investigating FXIa as a potential treatment for a wide range of thromboembolic diseases.

As the “Change the Target” campaign rolls out, the focus will remain on clinician education regarding the coagulation cascade and the potential of FXIa to meet currently unmet needs. The success of this initiative could redefine the standard of care for patients at high risk of stroke and other thromboembolic events, finally moving past the era of “trade-off” medicine.

BMS. Bristol Myers Squibb Introduces "Change the Target. Change What’s Possible.” to Highlight Unmet Needs in Cardiovascular and Thromboembolic Care. Press Release. Feb. 3, 2026. 

https://news.bms.com/news/corporate-financial/2026/Bristol-Myers-Squibb-Introduces-Change-the-Target--Change-Whats-Possible--to-Highlight-Unmet-Needs-in-Cardiovascular-and-Thromboembolic-Care/default.aspx

BMS. Closing the Gap: Reimagining Care for Cardiovascular Diseases. 

https://www.bms.com/life-and-science/science/reimagining-care-for-cardiovascular-patients.html

Bristol Myers Squibb and Johnson & Johnson have launched an educational initiative to redefine cardiovascular and thromboembolic care by focusing on Factor XIa (FXIa) inhibition. This approach aims to prevent dangerous blood clots while preserving healthy clotting, addressing the limitations of current therapies that often require trade-offs between efficacy and bleeding risk. The collaboration reflects a trend of strategic partnerships in the pharmaceutical industry to tackle complex diseases. The initiative emphasizes clinician education and aims to improve the standard of care for patients at high risk of thromboembolic events.

The companies’ “Change the Target. Change What’s Possible” targets the potential of Factor XIa inhibition in the development of treatments for thromboembolic disease.

Bristol Myers Squibb and Johnson & Johnson Launch Educational Program for Thromboembolic R&D

The Role of Standards in Sustainability

For pharmaceutical manufacturing professionals, sustainability is increasingly defined by the intersection of operational efficiency, digital transformation, and global regulatory alignment. Tony Lakavage, executive vice president and head of Global External Affairs at the US Pharmacopeia (USP), highlights how the drive for sustainability aims to reduce the industry's environmental footprint while simultaneously enhancing efficiency and reducing the consumption of natural resources.

How does sustainability fit factor into operational efficiency and Pharma 5.0?

A critical component of this transition is the shift toward Pharma 5.0, which involves the integration of digital systems for real-time quality improvement. These advanced systems allow for real-time adjustments to limit the use of natural resources and automated controls to deactivate equipment when it is not in use.They also enable identification of environmentally friendly solvents and modern technologies that may replace legacy processes.Beyond facility design, efficiency in quality testing is a primary lever for sustainability, as it allows companies to save money while using fewer resources.

What is the role of harmonized standards?

Global harmonization of standards is essential for environmental progress , according to Lakavage. If different countries maintain conflicting regulatory approaches, the industry's total environmental footprint may actually increase due to redundant or inefficient requirements.

Currently, USP standards are utilized in 22,000 manufacturing facilities across 140 countries. Because of this massive scale, even small updates to these standards—such as those coordinated with the European Pharmacopeia—can have an oversized impact on global sustainability.

How is the impact of sustainability measured?

While the innovator industry is already advanced in measuring progress regarding waste reduction and fuel consumption, USP is working to further support these metrics through updated standards. According to Lakavage, USP’s key objectives for the next five years include eliminating animal testing to modernize and humanize quality benchmarks , reducing the overall use of natural resources in laboratory and production settings , and finding safer, non-toxic chemical alternatives to replace hazardous materials.

By integrating these modern technologies and sustainable practices into the core pharmacopeial standards, the industry can ensure that environmental progress is both measurable and consistent across global supply chains

Good afternoon. I'm Tony Lakavage, and I am the Executive Vice President and Head of Global External Affairs at USP.

In what ways is the drive for sustainability influencing facility design, process selection, and sourcing strategies, and how are companies measuring environmental progress?

The drive for sustainability has multiple elements to it. What we all initially think is that it's about reducing the environmental footprint of pharma manufacturing, and that's true. That's definitely true. But it's also about greater efficiency and reducing the use of natural resources, for instance, finding more, more efficient ways to, in an area that is central to our work, quality testing, is something that saves industry money using fewer natural resources and also is good for the planet.

So, what we've seen is more, we've talked about Pharma 4.0, and now we're at Pharma 5.0, which is the integration of digital systems that not only are doing real-time, quality improvement, for instance, but they're also doing real-time, adjustments to limit the use of natural resources, to limit the use of equipment when it's not necessary. So that, that's pretty essential.

And we also see within facilities that industry is doing all kinds of things to ensure that they're minimizing waste, as a matter of fact, and using, more environmentally friendly solvents is another key area. Something that we're doing at USP and working with other pharmacopeias on now is to integrate modern technologies into USP standards as a way of helping to reduce the broader, environmental footprint of the industry.

And this is one area that it's essential to harmonize, because if we have different approaches in each country, that actually may increase the environmental footprint.

So, this is one of our key objectives over the next five years, that the USP convention passed a resolution on to help reduce the environmental footprint. That also means eliminating animals in testing, for instance, reducing the use of natural resources as well, finding alternative, chemicals to toxic ones. Environmentally friendly solvents are one area, but it's not the only one.

So, how do you measure the impact? I think there are a lot of ways to measure the impact, very, obvious ones about waste and the use of fuel in facilities. The pharma industry, in particular, the innovator industry, is pretty developed in measuring and showing progress, as a matter of fact, in their environmental impact.

And, that's something that we're working to support. The impact of USP standards is something that may not be intuitive at first when we think about the impact of standards on the environment or the environmental footprint of manufacturing, or even on, on public health. How can they have such a big impact?

And the truth is that USP standards are utilized in twenty-two thousand manufacturing facilities around the world that supply medicines to the United States and to other countries. And I say that because USP standards are utilized in a hundred and forty countries around the world.

When you add that to additional facilities that may be manufacturing to European Pharmacopeia standards, for instance, and others, you have a really significant impact.

And when we can work together for the convergence or harmonization of standards, that's even better. So, this is why we take our work very seriously. And on the environment, we think that making some changes to our standards is going to have a really important, oversized impact on the planet.

Anthony Lakavage, executive vice president and head of Global External Affairs at USP, talks about how sustainability efforts are more than just protecting the environment and how pharmaceopeias are participating in the endeavor.