Newsletter | June 19, 2019

06.19.19 -- How Development Of A Clinical Rating Scale Provided Deeper Insights In A Rare Disease Trial

Featured Editorial
How Development Of A Clinical Rating Scale Provided Deeper Insights In A Rare Disease Trial
By Joseph P. Horrigan, M.D., chief medical officer, AMO Pharma

In research related to many rare genetic diseases, availability of long-term benchmark data to support the development of accurate assessments is limited. This can have a detrimental effect on new product development. To address this challenge and ensure that clinical development efforts render meaningful results, there is a need to develop outcome measures that assess the entire characteristic clinical phenotype of any given rare genetic condition.

Why Use RBM And How Far Have We Come With Implementation?

In March 2019 I had the opportunity to interview Jennifer Newman, global project leader, regulatory affairs/clinical operations for Celldex Therapeutics. Newman was once part of the largest implementation of RBM and was able to share insights from her experience. Specifically, she was able to discuss the benefits and challenges of RBM and what companies should be prepared for when adopting the technology. In this video, Newman discusses the history of RBM, how guidance has changed, and where the technology stands today.

Industry Insights
Minimal Residual Disease Detection: Key Considerations For Clinical Development In Oncology
White Paper | By Franklin Sedarat, M.D., MSc, Mark Edinger, and Patrick Hurban, Ph.D., Q2 Solutions

Current minimal residual disease (MRD) detection landscape, key considerations for each approach, and current advancements that will contribute to further improvements in MRD detection.

The Top 5 Questions To Ask When Developing A REMS
Article | By Natalie O’Donnell, United BioSource LLC (UBC)

Unsure if a REMS is needed during product development? This article will answer that question and give guidance as to whether implementing a REMS is necessary.

Industry-Leading Biotechnology Company Automates Clinical Payments Enterprisewide With eClinicalGPS
Case Study | Greenphire
A sponsor was facing difficulties with tracking payment details, critical for financial transparency and requirement details. Read how eClinicalGPS played an integral role in their mission to modernize clinical investigator payment processes.
CRO Helps To Identify A Highly Productive Location For Siting Future Studies
Case Study | Premier Research

Compromised data collection effectively stalled a clinical trial study of an inflammation control drug. With help from a CRO, important lessons were learned about the need for discipline and following protocol as well as the identification of Russia as a highly desirable site for clinical trials.

Regulatory Science 2019: Leading Or Holding Back Innovation?
Podcast | DIA

In 2018, the U.S. FDA approved a record high number — 59 — of new, novel drugs.

Estimands: Not Just A Statistical Issue

June 25, 2019 | 10:00 am EDT

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