We’re creating a new model for virtual / site-less trials and direct-to-patient medication delivery using techniques we’ve perfected over the last 10+ years in our commercial specialty pharmacy operation. This session will review the hurdles, learnings, and success stories from our journey. Everything the FDA requires, alongside what the State Boards of Pharmacy require, delivering a better patient experience at a lower cost.

The field of digital medicine continues to experience explosive growth. DiMe's Library of Digital Endpoints observed 665% spike in the number of unique digital endpoints being used in industry-sponsored clinical trials of new medical products over the past two years. Pandemic catalyzed the use of digital clinical measures and other decentralized approaches to clinical research. But what does it mean to develop and select digital clinical measures that matter to patients? And how do we successfully deploy the digital-health technologies at scale?

As clinical trials become more complex, patient-specific, and expensive, pharmacist involvement greatly improves their efficiency and effectiveness.  For clinical drugs, federal regulations cover manufacturing while individual state pharmacy laws govern dispensing.  Reviewing state pharmacy laws and regulations reveal great state variability.  Continued individual state regulation monitoring is necessary to support successful clinical trials, especially decentralized trials.  This presentation highlights the importance of state variance awareness.

Clinical trials must be nimble and adaptive. The landscape is evolving towards fully decentralized models. We will explore how a direct to patient shipping model and process can impact and provides great benefits to study personas such as supply managers, sites, sponsors and patients.

Biospecimen derived data drives clinical trial decisions. A significant portion of biospecimens are transported via cold chain.  In this session, we will evaluate best practices for cold chain shipping. Dialog will focus on identifying historic and COVID-19-related risks and exploring solutions as they relate to biospecimen sample collection and pack out, consolidation, courier capabilities, service levels and regional strategies that can be considered for your logistics supply chain.

Join me in exploring industry trends and the evolving patient journey in decentralized clinical trials.  Together, we will examine the components of a patient-focused flexible supply chain strategy, solutions for sponsors and investigator sites as well as lessons learned.

Communication and strong partnerships are critical to ensuring a reliable supply chain. The pandemic has tested and stretched all partnerships across the supply chain and Bayer, through its External Manufacturing LatAm lead, will shed light on how teams became more agile to ensure a reliable supply. Adequate communication pacing, the sharing of the customer´s focus and the building of trust are keys to anticipate potential problems and to keep a reliable compliant cost effective and steady supply from CMOs and third-party suppliers.

The COVID-19 pandemic has created a variety of challenges across the clinical trial conduct space, and CTM supply is one of the areas impacted. To mitigate risk of infection associated with patients receiving CTM at clinical sites and hospitals, Daiichi Sankyo developed several approaches to maintain CTM supply in close collaboration with both internal and external stakeholders.