Newsletter | January 6, 2020

01.06.20 -- Study Reveals Nearly $215 Billion Economic Burden Of Nocturia

Featured Editorial
Study Reveals Nearly $215 Billion Economic Burden Of Nocturia
By Ed Miseta, chief editor, Clinical Leader

Dr. Jay Jhaveri, lead investigator for Ferring Pharmaceuticals, knew that nocturia was a burden to many patients and to the U.S. economy. Unfortunately, no HEOR existed for nocturia. For that reason, Ferring decided to produce its own. To get the real-world information it needed on the prevalence of the condition, the company turned to the National Health and Nutrition Examination Survey (NHANES).

Analyzing The Top Clinical Trial Technology Trends
By Mathini Ilancheran, principal analyst, R&D, Beroe Inc.

Technology plays a critical role in drug development and the R&D value chain by revolutionizing clinical trials and decreasing the failure rate. Though the supply of technology has been increasing and regulation of innovative methods is easing, pharmaceutical companies have been slow to use the emerging technologies due to the ambiguity prevailing around this space and a highly fragmented supply market. This article outlines the key technologies that have a high impact across trial phases.

Industry Insights
Building Faster, Patient-Centric Studies In A Changing Regulatory Environment
Article | By Cindie Kazmer, Cenduit LLC

IRT USA 2018 resonating themes: the need for better project management and never losing sight that the patient is at the center of everything we do.

Successfully Managing The Unique Demands Of Cell Therapy Supply Chains
Article | By Rachel Griffiths, PCI Clinical Services, and Dr. Matthew Lakelin, TrakCel

While cell therapy is playing an increasingly important role in the treatment of a variety of conditions, the real challenge in delivering it successfully is not necessarily in the manufacturing protocol alone, but in the administration and coordination of the complex supply chain as a whole. Therefore, supply chain risk management (SCRM) becomes an essential part of the process. Risks associated with production and transportation need to be assessed in advance and formulated into a robust risk assessment strategy.

Commonalities Of Rare Diseases
Article | By Jennifer Dennis-Wall, Ph.D., Biorasi

Along with a fear of a low ROI, pharmaceutical companies have been hesitant to take on rare disease drug development because the indications can be challenging to study. Although each rare disease is unique, some elements of the clinical operations of rare disease trials are consistent across indications. Here are some common challenges experienced during the course of researching rare diseases.

5 Must-Haves In A Contract Packaging Partner
Article | By Yves Massicotte, Ropack Pharma Solutions

A contract packaging partner should function as an extension of the pharma’s organization, so careful consideration should be devoted to initiating this relationship. 

Maximizing Success In Early-Stage Oncology Trials: Considerations And Strategies In The Era Of Molecularly Targeted Agents
White Paper | By Luke Gill, MSc, MBA, Premier Research

Making a meaningful impact on the survival and quality of life of patients with cancer remains a significant challenge. This white paper discusses considerations and strategies for maximizing the likelihood of success in early-phase oncology trials and developing significantly improved therapeutics for patients.

Clinical Supply Optimization: Enhanced Service Model Saves Client Time On Supplies
Case Study | Thermo Fisher Scientific

The vice president of manufacturing for a clinical-stage biopharmaceutical company faced an avalanche of work when a reorganization left him without a clinical supply manager. Planning to start five new clinical trials in six months while managing quality assurance, manufacturing, and supplies for new and ongoing studies, he turned to his Fisher Clinical Services account executive with a simple question: “How am I going to do all that?”

Managing eCOA Data: Principles And Best Practices For Data Managers
E-Book | Signant Health

With the quality of data captured throughout a trial playing a crucial role for the success or failure of a study, clinical data management (CDM) is a key element of any research program. During a study life cycle data managers will deal with data from many sources, such as MRI scans, ECGs, and lab data, as well as eCOA, all of which are equally important.


SCOPE Summit 2020 takes place February 18 to 21 in Orlando, FL. Over the course of four stimulating days of in-depth discussions in 20 different conferences, with three plenary keynote sessions, the annual Participant Engagement Awards, and the ever-popular interactive breakout discussions, the programming focuses on advances and innovative solutions in all aspects of clinical trial planning, management, and operations.

Cytel Services
Risk Management And REMS
United BioSource LLC (UBC)
Pharmacovigilance And Risk Management Strategies Conference

January 27 to 29, 2020 | Washington, D.C.

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