Sponsored Podcasts

Allucent’s Katy Moore, Pharm. D., R.Ph. President, Clinical Pharmacology Modeling and Simulation, offers insightful commentary for small and mid-sized biotechs developing scientific breakthroughs. Learn from Katy’s expertise how applying modeling and simulation can improve drug development and help bring new therapies to light.

If the last few years have taught us anything, it’s that so much more can be achieved when all players in the life sciences and pharmaceutical industries work together in a truly collaborative way. The opportunity for the clinical development industry is to take what we have learned about how we can work together and use this to continue to drive progress. To strategically support clients, at ICON, this means partnering with sponsors in a way that goes beyond a traditional CRO. It means being a trusted partner.

Europe’s new Medical Devices Regulation (MDR) is four times longer than the previous Medical Device Directive, and it has raised the bar for clinical evaluations. It’s imperative that manufacturers proactively identify the gaps in their data and take the necessary steps to fill them — from pre-clinical through post-market. Many companies are unprepared for this task. Our guest, Dr. Kim van Noort, will walk us through some of the biggest challenges that MDR poses, and tell us how to overcome them.

Sponsors and CROs have historically been responsible for ensuring full chain of custody for their own clinical supply even though the clinical supply is typically outside of their control. It is the burden of the Sponsors and CROs to determine the most efficient way to do that. An eClinical Supply Chain Management platform provides Sponsors and CROs with the assurance that they are meeting their regulatory requirement of full chain of custody and more importantly ensures that all needed clinical supplies are available and all samples get where and when they are needed.

First-in-human (FIH) is a critical milestone for companies pursuing medical device development. Medical device developers often experience great pressure to shorten timelines and get to the clinic. However, it is important to keep certain aspects top of mind to have a successful FIH clinical experience.

R&D growth from biotech and emerging biopharma companies is strong. With that comes a transformation of the end-to-end services needed to meet the strategic, clinical, and operational needs of these smaller companies. Join this podcast to learn about clinical development and outsourcing trends that emerged in 2021 and a discussion of what to expect in 2022.

Kurt Mussina, MBA, president of Frenova Renal Research, explains how the site landscape is changing for clinical research. He has years of experience leading a global network of investigators, patients and data scientists involved in clinical studies. He brings a unique perspective to what the major problems in clinical research sites are, including private equity and industry consolidation. Refreshingly, he provides solutions Frenova is implementing that will promote better clinical research sites.

A direct-to-patient (DtP) clinical trial design, where investigational medicinal products (IMP) and clinical supplies are shipped or delivered directly to patients, fits within a decentralized clinical trial (DCT) model. Although patients, sites, and sponsors can all benefit from this trial design, there are unique complexities to DtP trials, that can be managed with advanced technology. Learn about this trial strategy, the unique challenges, what the industry is doing to address these challenges and how technology can help facilitate adoption of this trial design.

On a global scale, Frontage Central Lab Business is assisting clients with their drug development needs across all clinical phases. In this podcast, the Frontage Central lab team will discuss some of the best practices to keep in mind when choosing a lab partner for PK/PD and routine/specialty central lab support.

This podcast will discuss: • How partnering with specialized research organizations can help identify large, diverse patient populations to facilitate clinical studies designed around the patient • How advanced study planning and communication with regulators can ensure more successful execution of decentralized and hybrid clinical trials • The importance of the patient-physician dyad in implementing successful research studies

Lori Convy, Assistant Director, Clinical Research Monitoring, Sanofi discusses what risk-based monitoring mean to Sanofi's CRAs and site monitors?

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