Newsletter | August 14, 2019

08.14.19 -- GenSight Uses Gene Therapies To Target Neurodegenerative Diseases

 
Featured Editorial
GenSight Uses Gene Therapies To Target Neurodegenerative Diseases
 
By Ed Miseta, chief editor, Clinical Leader

GenSight Biologics believes it is on the cutting edge of ophthalmology, gene therapy, and drug development. The company is focused on finding treatments for patients with neurodegenerative diseases and is developing products that are a combination of gene therapy, its mitochondrial targeting sequence technology, and optogenetics.

3 Critical Areas To Review In Strategic Site Selection
By Débora S. Araujo

Have you ever put off doing something you knew needed to be done, even though you had the ability and money for it? Think exercising, getting a will, or going to the dentist (hopefully you have dealt with at least the latter). In the same way, many study sponsors put off aggregating and utilizing key intelligence on their previously used investigator sites for use in future strategic site selections. At times, there will be unique reasons for engaging with a certain investigator site or the need to use research-naive sites. However, if previously used sites will be considered for a new study, it is vital to review some key information for a truly strategic site selection process. Let's take a look at some of these key, yet often forgotten, areas.

Industry Insights
5 Questions To Ask About Your Clinical Trial Packaging
Article | By Greg Keizer, Bellwyck Pharma Services

By driving your packaging strategies at the onset of a project you can be sure that your packaging aligns with how your trial is planned to be run. While every study is unique, following are questions that should be asked at the beginning of every relationship.

The Digital Pill
Article | By Sofija Jovic, Ph.D., MBA, WCG

Although there are clear benefits with the first pill to include a digital sensor that tracks if and when it has been ingested, there are also questions regarding  patient privacy and choice.

Using Precision Medicine In Cancer Trials
Article | By Jennifer Dennis-Wall, Ph.D., Biorasi

Precision medicine, while seemingly just a buzzword to most people, is a revolutionary strategy to deal with variation. This newer approach to medical research is quickly advancing the field of cancer therapeutics. Naturally, these advances introduce new challenges for researchers, such as evolving regulations and experimental design.

Nobody Wants CRA Turnover: But Some Are Using eSource To Address It
Article | By Nick O’Brien, Medrio

Every day, the eSource revolution is reducing organizations’ reliance on monitoring visits and source data verification — and thus serving as a crucial safety net in the event of unforeseen changes to monitoring staff, particularly the ability to minimize the disruption caused when a CRA leaves an organization mid-study.

Simplifying CRA Reconciliation: 5 Ways To Improve Site Visits
Article | TransPerfect

CRAs are tasked with making sure all documentation and data is as it should be: current, compliant, and following the study protocol(s). Read how, with cloud-based web and mobile eTMF solutions, CRAs can throw away their spreadsheets and experience the following process improvements.

Behind The Scenes: In-House vs. Outsourced Clinical Trial Websites
Article | TrialScope

A sponsor’s clinical trial website should be about more than just recruitment. It should educate patients. It should help them throughout the clinical trial journey — before, during, and after. But creating a website from scratch is easier said than done. Learn the pros and cons of DIY vs. outsourcing the project.

Overcoming The Challenge Of Enrolling Sickle Cell Patients In Clinical Trials
Case Study | Premier Research

Premier Research was given a tight timeline of less than four months from delivery of the final protocol to first patient in. With proper site selection to accommodate the needs of a fast start-up along with open and frequent communication with the principle investigator and the project team, they were able to meet this timeline.

Has Joining ICH Accelerated Innovation In China?
Podcast | DIA

“China joining ICH is a magnificent milestone for the pharmaceutical industry in China,” explains Dr. Jingsong Wang, chairman and chief executive officer of Harbour Biomed. “We can see clearly more and more local pharmaceutical companies adopting the international standards to have a more innovative portfolio to face the competition from their global partners or counterparts.” Dr. Wang serves on the steering committee for our DIA China 2019 Annual Meeting in Beijing.

How Artificial Intelligence Will Revolutionize Safety
Webinar | Oracle Health Sciences

Watch this webcast to learn how artificial intelligence, natural language processing, and machine learning are poised to change the way we do pharmacovigilance.

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