SCOPE 2024
From Prinicpal to Univo IRB, Julie Blasingim on a mission to revolutionize research ethics
It is a next-generation institutional review board (IRB) recently acquired by QHP Capital, an investment manager exclusively focused on building and supporting tech-enabled life sciences and pharma services companies. The company is focused on full-scale IRB services, bringing decades of IRB and clinical operations experience to support today’s clinical trials.
At last week’s SCOPE Summit in Orlando, Florida, Univo IRB shared its plans to bring the voice of patients closer to research by creating an agile and efficient IRB review experience.
OSP was delighted its president, Julie Blasingim had some time to sit down and discuss her work and her hopes for the future.
She says that in clinical research, where science, ethics, and patient welfare converge, there exists a profound need for innovation and empathy.
She believes that for too long, the voices of patients have been muted in the cacophony of regulatory compliance and corporate interests. However, she insists that amidst this landscape, there is a beacon of change in her company that is dedicated to reshaping the narrative of research ethics.
This journey is not just a tale of corporate growth, but a testament to the unwavering commitment of its founder, whose passion for patient advocacy has been the guiding force behind every milestone achieved. Reflecting on that journey, Julie says, "I started with a simple desire to help people. Little did I know that this path would lead me to the heart of clinical research."
Her foray into the research world began humbly, as a young college student juggling multiple jobs. It was in a phase one research unit that her fascination with clinical trials was ignited. "I fell in love with the fast-paced environment and the opportunity to contribute to scientific advancement," she says. This initial spark led her to delve deeper into the intricacies of research ethics, eventually landing her a pivotal role in an Institutional Review Board (IRB).
Placing patients at the forefront
“At the IRB, I found my calling – ensuring that research participants were not just subjects, but partners in the pursuit of knowledge,” she says. Her tenure at various IRBs honed her expertise in regulatory compliance and operational management, paving the way for groundbreaking initiatives in the field.
As Principal IRB embarked on its seventh year, it sought to redefine its identity beyond accreditation and regulatory adherence. "We realized the need to place patients at the forefront of our mission," she explains.
Thus, began a transformative journey towards patient-centricity – a philosophy ingrained in every facet of the company's operations.
The announcement of the company’s renewed focus was combined with a speech and toast at the company’s booth and detailed its mission towards inclusive and compassionate research practices. "We wanted to make it clear – we are not just another IRB. We are a partner in progress, committed to amplifying the voices of patients," Julie said.
Central to Univo’s ethos is the recognition of patients as active participants, not passive subjects, in the research process. "Our goal is to empower patients with knowledge and agency," she emphasizes. Through innovative approaches such as decentralized trials and patient-centric technology platforms, Univo seeks to revolutionize the research landscape.
"We envision a future where research is not just about data collection but a collaborative endeavor between scientists, clinicians, and patients," she adds.
With the imminent launch of its cutting-edge platform in April, the company is poised to usher in a new era of research ethics – one where compassion and innovation intersect seamlessly.
Empowering patients in research
As they continue their journey towards redefining research ethics, one thing remains clear – at Univo, the patient will always come first.
During our conversation, Julie reflected on the company's evolution: “We aim to push information to patients, empowering them to be informed partners in research. We provide tips, definitions, and resources to help them navigate their role as research participants.
“The emphasis on patient-centricity has gained momentum. The popularity of patient-centric approaches has exceeded our expectations. It signifies a collective shift towards prioritizing patient welfare in research.”
Univo IRB remains committed to innovation, with plans to launch a state-of-the-art technology platform in April. This platform, purpose-built for modern research needs, promises enhanced functionality and user experience. Additionally, the company is expanding its services to include Canadian research and institutional biosafety committee oversight, further solidifying its position as a global leader in research ethics.
Navigating the intricacies of sales has been a learning curve, particularly for Julie, who says: “As a compliance-focused individual, adapting to the sales aspect has been challenging. However, our commitment to ethical conduct remains unwavering."
The founder's journey has not been without obstacles, with gender bias presenting a significant challenge. "As a woman in a male-dominated industry, I've faced adversity, but I've also been fortunate to have supportive mentors and allies," she reflects.
In an industry often overshadowed by corporate interests, Univo says it wants to shine as a beacon of compassion and innovation. As they forge ahead on their mission to revolutionize research ethics, they do so with a steadfast belief in the transformative power of patient-centricity.
Patients - more than just data points
Julie says the role of patients cannot be overstated: “We aim to push information to patients, empowering them to be informed partners in research. We provide tips, definitions, and resources to help them navigate their role as research participants.
“The popularity of patient-centric approaches has exceeded our expectations. It signifies a collective shift towards prioritizing patient welfare in research.”
Reflecting on her experiences managing diverse trials, Julie shared a poignant observation: “Patient retention has been on my mind lately. I'm involved in two trials, each vastly different in approach. One lacks human interaction entirely, while the other offers unparalleled support, with the principal investigator providing direct access for questions and concerns."
This dichotomy, she says, underscores the importance of human connection in research. The notion that patients are more than just data points resonates deeply, prompting a fundamental shift in language and perception within the industry. “We no longer refer to participants as 'subjects'. They are patients, they are research participants – individuals with their own stories, not merely statistics.”
She says gone are the days of sterile, impersonal clinical environments. Instead, there is a growing recognition of the importance of creating supportive, inclusive spaces for research participants. “Treating patients like humans, not lab rats, is essential.
“Innovative approaches to patient care within clinical settings are also gaining traction. The mention of a phase 1 clinic that prioritizes patient comfort and wellness is met with enthusiasm.
“Providing a positive experience for patients can significantly impact retention rates. Patients deserve to feel valued and respected throughout their participation in research.”
Yet, challenges persist, particularly concerning the integration of telehealth and remote research methods. Julie is adamant about addressing these hurdles, advocating for a more flexible and patient-centered approach to IRB reviews. “We must adapt to meet the needs of patients, whether they are visiting a clinic or participating remotely,” she says.
As the conversation draws to a close, it becomes evident that the future of clinical research lies in embracing patient-centric principles wholeheartedly.
“Patients are the cornerstone of research," she says. “Their voices, their experiences – they are invaluable. It's time we truly listen and prioritize their well-being above all else.”
In an era defined by scientific progress and ethical considerations, the call to humanize clinical research reverberates loudly at Univo. As stakeholders across the industry unite in this endeavor, Julie says she hopes a new chapter in research ethics will unfold – one guided by compassion, empathy, and a steadfast commitment to patient welfare.