How One Woman’s Personal Struggle Fueled Her Pursuit of Life-saving Innovations!
“When life hands you lemons, make lemonade,” as the saying goes. Life has a way of throwing unexpected curveballs our way, be they setbacks, failures, or unforeseen circumstances. In those moments, it’s easy to feel defeated, to dwell on the sourness of the lemons life has handed us. However, it’s how we choose to respond to these challenges that truly defines our journey.”
For Dr. Mary Tagliaferri, those words have taken on a profound, personal meaning. It was her own diagnosis of breast cancer that propelled her into the realm of clinical research, where she now stands as a leader, driven to discover novel therapies capable of combating the very diseases that have touched her life.
As the Senior Vice President and Chief Medical Officer at Nektar Therapeutics, her scientific acumen is matched only by her diligence to improve the lives of patients. “My personal experience has given me a deep understanding of the challenges patients face,” she reflects. “It’s that understanding that fuels my work every single day.”
Indeed, Mary’s journey has been one of turning adversity into triumph. Fueled by her own battle with breast cancer, she has channelled her experiences into a relentless pursuit of inventive treatments—therapies that not only exhibit efficacy but are also well-tolerated and surpass the standards set by existing options.
“It’s not enough to simply develop a new drug,” she explains. “We have to ensure that it truly makes a difference in the lives of those who need it most. That’s what drives me, and that’s what I strive for in every project I undertake.”
With a thoughtful understanding of the complexities of medical research, Mary directs the complex industry of drug development, always with an eye towards improving the lives of those affected by autoimmune diseases and cancer. Her vision is one where patients find solace in advancements that promise not just survival but a life enriched with health and vitality.
“Every day, I’m inspired by the endurance and courage of the patients we serve. Their stories fuel my determination to create solutions that not only extend life but also enhance its quality,” Mary says with conviction.
As she continues to explore the horizons of medical research, Mary remains grounded in the belief that her personal experience has imbued her with a unique perspective that drives her work. “Cancer taught me the true value of time and the urgency with which we must act to improve the lives of those in need. That’s the guiding principle behind everything I do.”
Below are the interview highlights:
Please brief us about yourself and what inspired you to embark on this sector.
Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments that address the underlying immunological dysfunction in autoimmune and chronic inflammatory diseases. Nektar’s lead product candidate, rezpegaldesleukin (REZPEG, or NKTR-358), is a novel, first-in-class regulatory T cell stimulator being evaluated in two Phase 2b clinical trials, one in atopic dermatitis and one in alopecia areata.
Last year, we launched a global Phase 2 clinical trial in patients who have moderate to severe atopic dermatitis (AtD) and whose disease is not adequately managed with topical anti-inflammatory agents. As a chronic skin disorder, AtD can significantly impact the quality of life of patients and their families. Patients can suffer from social stigmas due to the visible eczematous patchy areas on the skin, and the intense itching can dramatically interrupt sleep. With relentless itching and multiple sleepless nights, AtD can untowardly impact emotional well-being and lead to depression.
Nektar’s lead immunology therapy in clinical development, Rezpegaldesleukin, is a unique molecule that aims to address the underlying immune dysregulation by restoring the T regulatory cells in both number and function to dampen the overactive effector T cell response. Our therapy provides a completely different mechanism of action compared to the currently approved drugs for atopic dermatitis, and we believe it has the potential to make a difference in the lives of patients.
Nektar previously announced preliminary efficacy data for Rezpeg in AtD that showed the agent had superior efficacy to the currently approved biological agents and provided a durable, lasting effect without treatment for up to 9 months. Because of these promising new data, we are excited to advance the clinical development of Rezpeg in biologic-naïve patients with moderate to severe atopic dermatitis who are seeking a safe and efficacious drug with a remittive or long-lasting effect.
Our pipeline also includes a preclinical candidate, NKTR-0165, which is a bivalent tumor necrosis factor receptor type II agonist antibody. Nektar, together with various partners, is also evaluating NKTR-255, an investigational IL-15 receptor agonist designed to boost the immune system’s natural ability to fight cancer, in several ongoing clinical trials.
Could you give our readers an insight into Nektar Therapeutics and its inception story?
Nektar Therapeutics has emerged as a pioneering force in the realm of biomedical innovation, with a rich history rooted in the pursuit of transformative therapies for autoimmune disorders, chronic inflammatory conditions, and cancer.
Established in 1990 by Dr. Ajit Gill, Dr. John Nicholson, and Dr. Harris S. “Handy” Gelbard, Nektar Therapeutics initially set out to explore novel drug delivery systems. Over the years, the company’s focus evolved towards harnessing the power of the immune system to combat a diverse array of diseases.
With a steadfast commitment to scientific excellence, Nektar Therapeutics has propelled numerous breakthroughs in the field of immunotherapy, pioneering the development of innovative drugs designed to selectively modulate immune responses. Through strategic collaborations and internal research initiatives, Nektar Therapeutics has cultivated a robust pipeline of promising candidates, each aimed at addressing unmet medical needs and revolutionizing the landscape of healthcare.
With a legacy defined by innovation, Nektar Therapeutics continues to push the boundaries of scientific possibility, offering hope to millions of patients worldwide grappling with autoimmune disorders, chronic inflammatory conditions, and cancer.
Can you share a pivotal moment in your career that significantly influenced your approach to oncology and immunology drug development?
My journey with cancer has been a profound catalyst for my unwavering commitment to advancing therapies for patients. Diagnosed with early-stage breast cancer at the age of 30, followed by a recurrence of pre-cancerous breast disease in my 40s leading to a bilateral mastectomy, and then facing a new form of cancer in my 50s, I’ve navigated through extensive treatments amidst the challenges of the COVID pandemic, which reshaped clinical practices and made the treatment journey more arduous and impersonal.
Enduring the rigors of treatment, its side effects and the journey of recovery emphasized the critical need for new cancer treatments that prioritize patient well-being with minimal toxicities and life-disrupting side effects. My own experiences serve as a driving force behind my passion for biopharmaceuticals.
With nearly three decades of expertise in drug development across various fields, including oncology, immunology, and women’s health, I’ve held leadership roles as the Chief Medical Officer in three biotech companies, including Nektar. At Nektar, I provide strategic and operational guidance across clinical development, clinical operations, biostatistics, drug safety, and regulatory affairs. Before my tenure at Nektar, I co-founded Bionovo, focusing on women’s health and cancer treatments.
My contributions have been recognized through awards such as The Most Influential Women in Business and Woman of the Year from the State of California, reflecting my dedication to women’s health and mentorship in biotech. One of my most cherished accomplishments is the impact I’ve had on young female researchers, like a former employee who rediscovered her purpose in biotech after our conversation, leading her to pursue the development of innovative medicines for patients. This profound influence on others underscores the fulfilment and significance I find in my work.
How do you navigate the complexities of clinical trials and regulatory affairs to ensure successful outcomes for Nektar Therapeutics’ portfolio?
Navigating the intricacies of clinical trials and regulatory interactions with agencies like the FDA and EMA requires a multifaceted approach that balances logical rigor, patient-centricity, regulatory compliance, and a drive for accelerated development. It’s essential to adhere meticulously to regulations while keeping the patient’s perspective at the forefront of decision-making processes.
Collaborating with experienced regulatory consultants, particularly those who have spent decades at the FDA or EMA, provides invaluable insights into the agencies’ perspectives and expectations, helping to streamline interactions and ensure alignment with regulatory standards.
In addition to regulatory expertise, taking a hands-on approach to clinical trials is crucial. Engaging directly with principal investigators, investigators, and study staff allows for clear communication of the potential benefits of the new therapy and fosters a deeper understanding of the patient’s journey throughout the treatment process. By actively involving ourselves in these conversations, we can address any concerns or questions promptly while also gaining valuable feedback that informs the development process.
Moreover, finding ways to accelerate development without compromising patient safety or regulatory compliance is paramount. This involves leveraging innovative trial designs, such as adaptive, and exploring expedited pathways offered by regulatory agencies for promising therapies.
Ultimately, successful navigation of clinical trials and regulatory interactions requires a balanced approach that prioritizes patient well-being, adherence to regulations, and collaboration with regulatory experts and clinical stakeholders. By combining logical reasoning, patient-centricity, regulatory compliance, and a commitment to accelerated development, we can navigate the complexities of drug development effectively and bring much-needed therapies to patients promptly.
Can you share a memorable recognition or award you received for your contributions and achievements in the field, and how it has motivated you in your career journey?
Receiving multiple awards recognizing women leaders in life sciences has profoundly motivated me in my career journey, serving as both a source of validation and inspiration. These accolades not only acknowledge my achievements but also highlight the collective impact of women in driving innovation and shaping the future of the industry.
Each award serves as a reminder of the progress we’ve made in advancing gender diversity and inclusion within the life sciences sector. As a woman leader, I recognize the importance of representation and the power of role models in inspiring the next generation of female leaders. These awards share our experiences and advocate for greater opportunities for women in leadership roles.
Moreover, receiving recognition for my contributions to the field reaffirms my sense of purpose and commitment to making a meaningful difference. It validates the long hours, hard work, and sacrifices invested in advancing scientific research, improving patient care, and driving business success. It serves as a reminder that my efforts are valued and appreciated, fueling my determination to continue pushing boundaries and achieving even greater impact.
Additionally, these awards catalyze personal and professional growth, providing opportunities for networking, mentorship, and collaboration. They open doors to new connections, partnerships, and opportunities for career advancement, enabling me to expand my influence and make a broader impact within the industry.
Furthermore, these accolades inspire me to pay it forward by mentoring and supporting other women in their career journeys. By sharing my experiences, insights, and lessons learned, I hope to empower the next generation of female leaders and create a more inclusive and equitable workplace for all.
In essence, receiving multiple awards recognizing women leaders in life sciences has been a transformative experience, igniting a renewed sense of purpose, empowerment, and determination in my career journey. It reminds me of the progress we’ve made, the challenges we’ve overcome, and the limitless potential of women in shaping the future of the industry.
