Helen (Johansen) Blanco: A Devotion to Science in the Service of Saving Lives 

Medical innovation begins long before a new treatment reaches patients—it starts with a fundamental question: how do we alter the course of disease? The human body, with its intricate networks and unseen battles, presents both mystery and possibility. Scientists decode the language of cells, engineers craft new delivery mechanisms, and visionaries push the boundaries of what is possible. But discovery alone is not enough. The path from an idea to a life-saving treatment is filled with obstacles—scientific, financial, and logistical. Progress demands more than just breakthroughs; it requires the right minds to turn potential into reality. 

Bringing a new therapy to life is no simple feat. The traditional approach to evaluating medicines has been both a safeguard and a bottleneck—ensuring safety but often at the cost of time, resources, and accessibility. The demand for smarter, faster, and more cost-effective methods has reshaped the way new treatments are assessed. Master protocols allow for collaboration, adaptive trial designs speed up decision-making, and patient advocacy groups have become key players in shaping research. Yet, for all these advancements, some of the most promising fields—such as radiopharmaceuticals—remain complex puzzles, requiring expertise across science, regulation, and business to unlock their full potential. 

Helen (Johansen) Blanco, Chief Operating Officer of Node Pharma AS, stands at this intersection of science and strategy. With a background spanning biophysics, medical technology, and business leadership, she is driving a new era of radiopharmaceutical development.  

The Architect of Innovation in Patient-Centered Science 

At Node Pharma, she has had the opportunity to reconnect with her engineering roots, as the company has developed a nanoparticle labelled with a radioisotope. Under her leadership, tThe team has successfully labelled the nanoparticle with several alpha-emitting radioisotopes, demonstrating the broad potential of this innovative technology platform. Her deep understanding of the drug has been instrumental in selecting the appropriate Contract Development and Manufacturing Organization (CDMO) and identifying a preferred Contract Research Organization (CRO) partner with the necessary expertise. 

Her MBA further enhances her ability to navigate the financial complexities of clinical development, enabling her to structure funding strategies effectively. Additionally, it equips her with a long-term strategic vision—guiding indication selection, gathering competitive intelligence, and positioning Node Pharma’s investigational product within the broader market landscape. 

Smarter Trials for Faster Breakthrough 

Helen has observed significant shifts in clinical trial methodologies over her 25-year career in the pharmaceutical and contract research industries. She notes that the approach to selecting study types has evolved considerably, with an increasing emphasis on historical data comparisons. This shift has been largely driven by the need for more cost-effective clinical research strategies. 

She highlights the growing adoption of Master protocols, which enable biotech and pharmaceutical companies to collaborate—often in partnership with Patient Advocacy Organizations—to identify the most effective treatments for patients. By establishing standardized comparisons to the current Standard of Care, these protocols set high expectations for treatment success and improve efficiency in clinical development. Helen also emphasizes the value of adaptive trial designs, which allow for seamless transitions between clinical phases, accelerating time-to-market and ultimately benefiting patients. 

Regulatory authorities have placed greater focus on risk management in clinical trials, enhancing patient safety and overall trial integrity. To ensure Node Pharma remains at the forefront of these evolving methodologies, Helen prioritizes partnerships with experienced CDMOs and CROs. Additionally, the company actively engages with patient organizations in its priority indications, reinforcing its commitment to patient-centric research and innovation. 

Mastering the Art of Clinical Trials 

Helen emphasizes the importance of quality and proactive risk management in clinical trials. She highlights the necessity of conducting a thorough risk assessment at the start of a trial, identifying high-risk areas early, implementing mitigation strategies, and preparing predefined actions to address potential issues swiftly. This proactive approach ensures rapid resolution of challenges, ultimately enhancing trial efficiency and integrity. 

Maintaining quality and efficiency, she explains, requires clear oversight of performance, both internally and externally. Open discussions about Key Performance Indicators (KPIs) with teams and external partners help establish clear expectations from the outset, setting the study up for success. 

Helen also advocates for integrating innovation into every aspect of clinical trial operations. As a contributor to the development of the ISO 56000 standards series for Innovation Management, she believes innovation should extend beyond research and development to every function and process. Encouraging team-wide participation in idea generation fosters continuous improvement in trial methodologies. Additionally, she highlights the role of Standard Operating Procedures (SOPs) in ensuring consistency and alignment across all aspects of clinical trial execution, further optimizing efficiency and quality. 

Leadership Rooted in Global Expertise 

Helen’s experience working across Switzerland, Australia, Iceland, Sweden, and Norway has deeply influenced her leadership style and decision-making in a preclinical radiopharmaceutical company. Having been involved in clinical trials across multiple global regions, she recognizes that it is impossible to be an expert in every country's regulatory framework. Instead, she emphasizes the importance of building a team with specialized knowledge in each applicable country, particularly in areas such as regulatory affairs and contractual processes during trial start-up. 

This approach has shaped her leadership by reinforcing the value of collaboration and informed decision-making. Helen prioritizes seeking input from those with the necessary expertise before making critical decisions. However, she also highlights the importance of being able to assess the depth of knowledge within the team. To ensure she stays informed, she actively engages with regulatory updates, attends conferences, and follows discussions on the latest priorities and focus areas of regulatory authorities. This continuous learning enables her to navigate complex regulatory environments effectively while fostering a culture of expertise and adaptability. 

Overcoming the 'Valley of Death' in Drug Development 

Helen identifies securing financing as the biggest hurdle in bringing radiopharmaceutical treatments from preclinical stages to human trials, though she notes that this challenge is not unique to radioligands. The transition between nonclinical evaluations and First-In-Human clinical trials—often referred to as the "valley of death"—presents additional risks. These include ensuring proper scale-up for human trials, completing the necessary nonclinical testing, and compiling sufficient documentation for manufacturing and preclinical studies. 

According to Helen, the key to overcoming these challenges lies in assembling a team with experience in navigating these critical stages. Identifying talent and expertise becomes one of the most crucial aspects of the process, as having professionals who have successfully addressed these hurdles before can make a significant difference. She also emphasizes the importance of Quality Assurance from an early stage, ensuring that all necessary documentation is in place to meet regulatory requirements. In a biotech startup, understanding the need for expertise in not just Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP), but also Good Clinical Practice (GCP), is essential to successfully advancing therapies to human trials. 

Building Bridges in Biotech 

Helen acknowledges that the cost of developing an investigational medicinal drug has risen significantly over the years, posing a major challenge for small biotech companies aiming to follow the optimal strategy for progression. Balancing R&D investments, clinical trial costs, and long-term sustainability in the radiopharmaceutical industry requires innovative approaches to clinical trial design. 

She advocates for new methodologies that ensure the industry's long-term viability, such as Master protocol trials led by patient advocacy organizations like PanCAN (Pancreatic Cancer Action Network in the USA). These initiatives allow multiple biotech and pharmaceutical companies to collaborate, optimizing clinical trial design and maximizing benefits for patients. Helen also highlights the role of patient advocacy organizations that conduct their own clinical trials at a lower cost than traditional setups, making clinical development more accessible for emerging companies. Additionally, she emphasizes the importance of strategic partnerships and negotiations with CROs, CDMOs, and other vendors to optimize financial resources while maintaining high-quality research and development. 

Helen emphasizes the crucial role of collaboration in driving success at Node Pharma. Over the years, the company has engaged in discussions with numerous pharmaceutical firms, reflecting the growing interest in radioligand therapies. However, she acknowledges that Node Pharma's progress would not have been possible without strong partnerships, particularly with Oslo University Hospital. 

To optimize clinical trial execution, Helen and her team have strategically identified clinical institutions with high recruitment potential for the rare diseases they are targeting. Given the short half-life of their alpha-particle emitter, proximity is a key factor, ensuring that the product can reach trial sites within 24 hours. Additionally, Node Pharma prioritizes collaboration with institutions renowned for their high-quality standards, reinforcing the company's commitment to excellence in clinical research. 

Pioneering Safer and More Effective Radiopharmaceutical Therapies 

Helen sees great promise in the use of radioisotopes that emit alpha particles for the selective destruction of cancer cells. Alpha particles possess high energy, ranging from 5-9 MeV, while maintaining an extremely short path length in human tissue—less than 0.1 mm, equivalent to fewer than ten cell diameters. This unique property allows for precise targeting of cancer cells while minimizing damage to surrounding healthy tissue. 

Node Pharma is strategically positioning itself in this space by leveraging alpha-emitters such as Ra-223 and Ac-225. By utilizing targeted delivery mechanisms, such as antibodies or nanoparticles designed to reach specific organs, the company aims to maximize treatment efficacy. Compared to beta emitters, alpha-emitters produce lower total radiation exposure, and when combined with a targeted approach, they significantly reduce systemic side effects. This results in a highly favourable safety profile, reinforcing Node Pharma’s commitment to pioneering safer and more effective radiopharmaceutical therapies.