Newsletter | August 12, 2019

08.12.19 -- Developing Triple-Combination Immunotherapies: Lessons Learned From HIV

Featured Editorial
Lupus Community Tackles Treatment And Clinical Trial Barriers
By Ed Miseta, chief editor, Clinical Leader

Few treatments have been approved for lupus, and the industry has seen many failed clinical trials. Variations in care worldwide, as well as poor overall access to care, has also hampered efforts to bring relief to patients. For those reasons, the international lupus community has come together to conduct a study aimed at identifying clinical and treatment barriers that must be overcome.

Developing Triple-Combination Immunotherapies: Lessons Learned From HIV
By Ramon Mohanlal, M.D., Ph.D., chief medical officer, BeyondSpring
Our body’s immune system appears to be the most effective therapy to fight cancer —more so than chemotherapy, radiotherapy, or any other anticancer therapy currently available. However, the immune system is only effective if it can detect cancer cells.
Industry Insights
Building In Quality To Design Trials For Change
Article | By Mark Gasdaska, Cenduit LLC

Sponsors want to achieve increasingly ambitious research goals in a growing number of indications, across geographies and global patient populations, faster than ever before, driving the need for increasing flexibility to adapt and change studies. Read how an experienced IRT provider can keep the day-to-day operations running smoothly as unanticipated protocol amendments arise.

Age Diversity In Clinical Trials: Addressing The Unmet Need
Article | By Ryan Bailey, Rho

In a recent New York Times article, Paula Span raises the concern that elderly subjects are frequently omitted from clinical trials. Consequently, physicians know very little about how a given treatment may affect their older patients. Is a medication effective for the elderly? Is it safe? Without data, how is a physician to know?  

Speed Clinical Trials With A Modern CTMS
Article | By Henry Galio, Veeva Systems, Inc.

To speed trial execution, improve decision making, and streamline clinical operations, many life sciences companies are moving toward modern, cloud-based CTMS applications.

Understanding The Continuum Of Clinical Collaboration
White Paper | By Mark Scullion, Syneos Health

Vendor-selection processes are tilting toward finding as broad and deep a fit as possible, the better to capture the efficiencies from scale and repeatability that those moves are intended to deliver.

Patient-Focused Clinical Trial Design For Rare Diseases Such As Duchenne Muscular Dystrophy
Article | Medpace

For clinical rials of rare diseases, challenges such as recruiting patients, staying within timelines, and handling the inevitable trial amendments can be amplified since the eligible patient population is so limited. This article highlights recent changes that are benefitting rare disease trials including multicenter trials, regulatory bodies establishing programs aimed at incentivizing rare disease drug development, and smaller requirements for the number of patients in which a therapy must be tested before it can be considered for approval.

The Role Of Pharmaceutical Packaging Partners In Times Of Growth
White Paper | Ropack Pharma Solutions

The expanding global pharmaceutical industry projects a 4 percent to 6 percent annual growth and forecasts that it will reach a value of $1T by 2014.

A Sleeping Giant No More: Opportunities And Challenges For Clinical Research In China
White Paper | Thermo Fisher Scientific

This paper examines the opportunities and challenges of conducting clinical trials in China, and offers proven strategies for overcoming hurdles.

  Festival Of Biologics 2019

October 15 to 17, 2019 | Basel, Switzerland

The Festival of Biologics 2019 will address the strategic and commercial aspects of discovering, developing, and bringing new biologics to patients with high-level, global speakers from Big Pharma, biotech, academia, and industry. We will bring you three days packed full of top-level science, data and case studies, workshops, roundtables, and networking opportunities. With 350 speakers and 1,500 attendees, this is an event not to be missed.

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