DPharm 2024 Recap: Key Topics, Challenges, and Solutions

The DPharm 2024 conference was a melting pot of ideas, innovation, and collaboration, offering a platform for industry leaders to discuss emerging trends, challenges, and solutions in clinical trials. For those who couldn’t attend, here’s a recap of the key presentations, their insights, and the future they painted for clinical development.

Driving Innovation and Operational Efficiency

Several presentations emphasized the importance of balancing innovation with operational efficiency, particularly as the clinical trial landscape becomes increasingly complex.

Nareen Katta, Head of Data Science & Analytics at AbbVie, discussed organizational ambidexterity, highlighting how companies must simultaneously explore new opportunities while optimizing existing operations. AbbVie leverages AI and machine learning to scale safety surveillance and site engagement, using tools like the PASSPORT platform to enable clinicians to make data-driven decisions swiftly. Katta warned against pitfalls like inertia and "shiny-object syndrome," which can derail even the best strategies.

Similarly, Candice Fitzgerald, Head of Clinical Development & Operations Regions at Boehringer Ingelheim, introduced a strategy for collaborative partnerships in end-to-end clinical development. Emphasizing early engagement and cross-functional collaboration, she outlined how strategic vendor partnerships and customer-centric approaches can ensure launch readiness and successful trial execution.

Aakarsh Shard, Senior Director at Novo Nordisk, also addressed innovation in his presentation on change management. Shard shared lessons learned from Novo’s transformation journey, underscoring the importance of giving employees control over change and addressing both the emotional and technical aspects of transformation.

Accelerating Trial Startups and Reducing Burden

Several presentations focused on the complexities of trial startups and the need for more efficient vendor management processes.

Kenneth G. Olovich, Executive Director of Sourcing at Eli Lilly, and Patty Leuchten, Founder and CEO of Diligent Pharma, presented a solution for centralizing vendor qualification. Their model streamlines the traditionally chaotic process of vendor onboarding, reducing inefficiencies, and accelerating trial startup times. By adopting a centralized platform, sponsors can onboard vendors faster while maintaining high-quality standards.

Amy Spaziani, Director of Clinical Feasibility at Parexel, focused on data-driven site selection. She emphasized how better patient outcomes can be achieved by aligning site capabilities with diversity goals. By asking the right questions during the site selection process, Parexel ensures that trials are set up for success, with a focus on patient diversity and site engagement.

Leveraging Digital Technologies for Patient-Centric Trials

A prominent theme throughout the conference was the integration of digital technologies in clinical trials to enhance patient-centricity.

Charmaine Demanuele, Executive Director of AI/ML Quantitative & Digital Sciences at Pfizer, alongside Carrie Northcott, Head of Digital Sciences at Pfizer, presented on the integration of digital health technologies (DHTs) and novel digital endpoints (NDEs). These technologies enable continuous and passive monitoring of patients’ health, improving both trial efficiency and patient engagement. The duo highlighted key challenges in scaling DHTs, such as regulatory alignment, data monitoring, and site burden. Despite these challenges, they emphasized that DHTs can significantly reduce geographical barriers and enhance data quality.

Continuing the focus on digital innovation, Biogen introduced Novoic Storyteller™, an AI-powered digital biomarker platform for Alzheimer’s disease. Senior Clinical Country & Site Lead, and Associate Director of Patient Centricity at Biogen presented how the tool enhances patient pre-screening by analyzing vocal data, reducing screen failures and accelerating trial enrollment.

Ken Getz, Executive Director at Tufts CSDD, discussed the short and long-term ROI of decentralized clinical trials (DCTs). He highlighted the potential for faster cycle times and reduced trial costs through remote monitoring technologies, wearable devices, and telehealth.

Automation and AI in Clinical Trials

Several companies showcased the potential of automation and AI to revolutionize various aspects of clinical development.

AlphaLife Sciences Group highlighted its GenAI-powered CSR writing automation platform, which streamlines the clinical study report (CSR) creation process. With built-in quality control and automation, the platform promises to reduce submission times by 40% while cutting costs by 50%. Sharon Chen, CEO, and Gavin Zhang, CBO, emphasized the system’s flexibility, allowing templates to be customized for various trial phases without any coding.

In another session, Bayer shared reflections on remote decentralized clinical trials (DCTs), outlining lessons learned during the pandemic and how to optimize these methods for future trials. Similarly, Pfizer presented their use of GPT-4 for document creation in clinical trials, improving speed and operational efficiency.

Johnson & Johnson highlighted their Team of Teams Automation and Integrated Workflows, which leverages Slack and other collaboration tools to improve trial coordination. By adopting a "hub" model for trial execution, J&J has seen reduced silos between internal teams and external partners, speeding up decision-making and ensuring smoother trial execution.

Addressing Patient Burden and Engagement

Patient burden and engagement were also key topics of discussion, as more trials strive to improve the patient experience.

Ken Getz, in a separate presentation with Ben Geelan, Director of Strategic Operational Intelligence at Roche, focused on incorporating the patient voice in protocol design. They presented data showing how overly complex trial designs can increase patient dropout rates and slow down trials. They advocated for simplifying protocols and better aligning them with patient needs and expectations.

Sanofi introduced a data-driven feasibility platform, which has led to better patient recruitment and more accurate enrollment predictions in clinical trials. The platform leverages AI-driven insights to optimize site selection and patient engagement, enhancing overall trial performance.

Conclusion: A Future of Innovation and Collaboration

DPharm 2024 made it clear that the future of clinical trials lies in the seamless integration of digital technologies, automation, and patient-centric approaches. As companies like Pfizer, Novo Nordisk, and Biogen push the boundaries of innovation, the focus remains on reducing patient burden, increasing trial efficiency, and ultimately bringing new treatments to market faster. From the adoption of AI in medical writing to the integration of novel digital endpoints, the path forward requires collaboration, innovation, and a commitment to transforming the clinical trial ecosystem.

If you missed the conference, these presentations serve as a valuable resource for understanding the latest trends and challenges in clinical development. Stay tuned for more innovations as the industry continues to evolve.