Allucent

Anita Nelsen

In an interview with Life Sciences Review, Anita Nelsen, senior vice president, clinical trial operations, Allucent, provides a general outlook on the current clinical trial landscape and highlights the value of a patient-centric approach.

How has your journey been in the life sciences industry?

I am the Head of Clinical Trial Operations at Allucent, overseeing project management, patient engagement, study startup, site engagement, monitoring, centralized monitoring, and documentation management for clinical trials.

Prior to joining Allucent in January, I held a leadership role in translational medicine at Parexel International for almost nine years, focusing on early-phase clinical units, clinical pharmacology, modeling and simulation, and biomarker and genomic medicine services. Having a background in genetics and genomics, I spent 20 years at GlaxoSmithKline supporting drug discovery and development, establishing a human sample biorepository to facilitate biomarker and genomics research in clinical trials.

What are the trends and challenges you see impacting the industry today?

Across the biosciences industry, particularly among small and mid-size companies, securing financing has become a significant challenge. Obtaining funding to progress compound development and maintaining sufficiency to further advance production is a cumbersome task. Companies now face a higher bar when presenting evidence to demonstrate the value of their product and attract investment.

To overcome these funding hurdles, companies require a strategic partner capable of conducting trials in a cost-sensitive manner while adhering to timelines and commitments. This partner should also contribute value by assisting in trial design and executing operations efficiently. By focusing on operational efficiency throughout the trial process, companies can expedite data generation and analysis, leading to faster availability of results.

Many companies also find themselves in a dilemma when choosing between advancing different assets within their pipeline due to limited resources. It is crucial that these decisions are supported by guidance and assistance in designing a robust clinical trial workflow and ensuring its smooth and efficient execution.

Apart from financing, another significant challenge, regardless of the organization's size, is patient access. Engaging patients effectively during clinical development and retaining them throughout the trial pose some serious difficulties. Historically, most sites have failed to meet their recruitment targets, and numerous trials struggle to retain a sufficient number of patients until completion, posing as a hurdle in achieving analytical goals.

To address this issue, efforts should be made to provide patients with a clear understanding of the trial's impact on their lives and lifestyles, and simplify their engagement throughout the trial. 

What are some of the technological trends that excite you when it comes to the life science space today?

I have maintained a keen interest in the development and implementation of e-consent technology which is still an emerging and evolving field.

I have personally been involved in projects and while it is not yet widely adopted in clinical development, the pandemic has heightened its integration.

Another area that is gaining importance in clinical development is the use of everyday technologies. Mobile applications on smartphones for study data collection and wearable devices have become increasingly significant. Even simple tools like text message reminders for study visits or medication adherence are making the lives of patients easier and facilitating their participation.

Is there any latest project that you have been working on and what are the tools and process elements that you have leveraged to make this project successful?

Allucent has recently introduced a Patient Direct Trial Solution in collaboration with Thread. This solution is specifically designed for small and mid-size biotech companies, providing them with access to advanced technologies, operational experience, and regulatory expertise that larger companies often possess internally. By leveraging these resources, our solution empowers these companies to conduct patient-focused trials more effectively, benefiting from improved patient engagement and patient-centric solutions. Ultimately, this approach enhances clinical operations and outcomes while enabling greater efficiency.

We are striving to leverage the voice of the patient, ensuring that their preferences are fully considered as we optimize protocols and design clinical strategies. Through our Patient Direct Trial Solution we are bringing together our regulatory, scientific, clinical pharmacology, and operational experts to design trials that are more likely to succeed.

Protocol optimization plays a crucial role in clinical trials to address challenges arising from burdensome or complex protocols for patients. Our goal is to minimize sample requirements and utilize technologies like imputation and other analytical methods to generate the necessary insights for advancing clinical development and making informed clinical decisions, all while ensuring minimal patient burden.

What is your advice for your peers in the industry?

Choose a career aligned with your passion. In my case, I've always been drawn to drug development, particularly precision medicines. The recent advancements in personalized treatments excite me, as they optimize patient outcomes while minimizing side effects. Secondly, learn from experienced professionals who have overcome the challenges of clinical design and development. Their expertise can help you avoid pitfalls and tap into a supportive community that fosters growth in the field.