Podcast

Medical and Regulatory Affairs

Premier Voices #5: Operationalizing the New MDR With Janet Kube (Part 1)

If you sell medical devices in Europe and haven’t made plans to comply with the EU’s new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), it’s time to step things up. The new MDR and IVDR rules adopted a little over a year ago do have generous phase-in periods — three years for...

Clinical Research: Phase 1 - Phase 4

Premier Voices #4: The Placebo Problem Part 2 With Michael Kuss

Measuring, interpreting, and mitigating placebo response is a persistent and growing challenge in analgesia clinical trials. In the conclusion of our Premier Voices podcast series on the placebo problem, Paul Mirek, Marketing Manager, and Michael Kuss, BS, Vice President, Analgesia Product Development, examine experimental trial designs, inclusion and exclusion criteria, and other approaches to managing the...

Clinical Research: Phase 1 - Phase 4

Premier Voices #3: The Placebo Problem Part 1 With Scott Millard

 The placebo effect’s impact on drug development is widely known, but you may be surprised to learn that the word “placebo” has had multiple meanings — all of them pejorative — going back hundreds of years. Scott Millard, Premier Research’s Executive Director for Strategic Development and Analgesia, explores the role of placebos in the...

Clinical Research: Phase 1 - Phase 4

Premier Voices #2: Registry Studies & Natural Histories in Rare Disease Trials w/ Angi Robinson & Juliet Moritz

 Patient registries and natural history studies are vital tools for orphan drug researchers, who often struggle with limited understanding of diseases and sparse data due to small patient numbers. In the second installment of the Premier Voices podcast with Angi Robinson, Vice President, Clinical Development Services, Rare Disease & Pediatrics, and Juliet Moritz, we...

Study Design

Premier Voices #1: Rare Oncology w/ Colin Hayward & Peter Larson

The inaugural edition of Premier Voices focuses on rare oncology drug development and takes a looks at: Using adaptive design to limit patient exposure to ineffective treatments and increase the overall likelihood of success Making the most of small and geographically dispersed patient populations Dealing with limitations such as a lack of defined biomarkers and baseline...