In this ISSUE

Scientific Advances Require Innovative Clinical Research Models

Can Sponsors Answer 6 Questions Regulators Ask During Audits?

A Glimmer Is All That's Needed for Alzheimer's

Investigative Sites

The Importance of Age Diversity in Clinical Trials

Age diversity in clinical trials benefits both the patient experience and the success of the trial.
... /Read more/

A Pan-cancer View of Immune Cell Activity, Immune Checkpoints, and Tumor Mutational Burden
Thursday, October 11, 2018 at 11am EDT

FDA Policy

FDA Promotes Surrogate Endpoints, "Seamless" Clinical Trials

As part of efforts to speed patient access to effective new therapies, FDA is rolling out policies designed to streamline drug development, particularly for new cancer therapies to treat life-threatening conditions.
... /Read more/

On the brink of change: How academic data and machine learning can revolutionize Alzheimer's drug development
Thursday, October 4, 2018 at 11am EDT

eClinical Software

How to Manage Machine Learning Algorithms in Clinical Trials

Machine learning algorithms can be used to both manage the complex outputs in clinical trials and make those trials move faster with less risk, reducing timelines and minimizing expenses.
... /Read more/

Artificial Intelligence: A Transformative Journey for Pharmacovigilance
Thursday, September 27, 2018 at 11am EDT

Certification

Mandatory Certification—It's Time

It is time for mandatory certification to be required for everyone involved in a clinical study.
... /Read more/

Challenging the Status Quo: The Diffusion of Technology in Study Startup
Tuesday, September 25, 2018 at 1pm EDT | 12pm CDT | 10am PDT

Pain Therapies

FDA Supports More Focused Development of Targeted Pain Therapies

To help combat the nation's opioid epidemic, FDA is promoting a more tailored approach to developing and testing effective analgesics, with the aim of bringing less addictive pain treatments to market more quickly.
... /Read more/

A Next Generation Sequencing Approach to Influenza Vaccine Development
Thursday, September 20, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

Calendar

/ American Pharma Outsourcing Summit 10/2-10/3 /

/ Rare Diseases & Orphan Products Breakthrough Summit 10/15-10/16 /

/ Basket and Umbrella Trials for Oncology 10/17-10/18 /

/ eCOA / ePRO 2018 10/23 /

/ Crossroads: An Artia Solutions Conference 11/7-11/9 /

Decoding the Distinction: DMCs, CECs, and Their Role in Medical Device Research
Wednesday, September 12, 2018 at 11am EDT | 10am CDT | 4pm BST | 5pm CEST

Ask the editor

Lisa Henderson
Editor in Chief
Lisa.Henderson@ubm.com

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Todd Baker
Group Publisher
todd.baker@ubm.com

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