Allucent

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 advance products further is increasingly difficult. 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 the appropriate trial and ensuring its smooth and efficient execution.

" 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 "

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 ongoing difficulties. Historically, most sites have failed to meet their recruitment targets, and numerous trials struggle to retain a sufficient number of patients until completion, hindering the achievement of analytical goals.

To address this issue, efforts should be made to attract patients to trials, provide them 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?

An essential aspect we strive to emphasize is the voice of the patient, ensuring that their perspectives are fully considered as we optimize protocols and design clinical strategies. Patient-centric approach is particularly critical for our small and mid-size biopharma clients, who may not have extensive internal expertise and resources. By bringing together our regulatory, scientific, clinical pharmacology, and operational experts, we can leverage the patient’s voice and medical insights to design trials that are more likely to succeed.

Protocol optimization is crucial in clinical trials to address challenges arising from burdensome or complex protocols for patients. Reducing patient burden while leveraging technology, such as imputation or other analytical methods, is essential for generating necessary insights without compromising data quality. Optimization should focus on minimizing the frequency and quantity of required samples, streamlining visit schedules, and minimizing on-site time.

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.