Newsletter | October 7, 2019

10.07.19 -- Idera Pharmaceuticals: A Patient Recruitment Success Story

Featured Editorial
Idera Pharmaceuticals: A Patient Recruitment Success Story
By Ed Miseta, chief editor, Clinical Leader

Every company conducting clinical trials knows recruitment is a challenge. Slow recruitment can delay the start of a trial and, in some cases, cause them to be cancelled altogether. This is one factor that makes Idera Pharmaceuticals different. The company is months ahead on its patient recruitment goals.

RWE In Clinical Research: Challenges, Opportunities, And Two Case Studies
By Alethea Wieland, founder and president, Clinical Research Strategies, LLC

This is the second article in a two-part series addressing real-world evidence (RWE) for life sciences leaders who may be struggling to make sense of the rules. In this part, we will explore the challenges and opportunities RWE presents for life sciences companies, review two recent examples, and discuss how this newer way of thinking will transform the way we design and conduct clinical research or evaluate value-based decisions for the better.

Industry Insights
Understanding Right-To-Try And FDA’s Expanded Access Programs
White Paper | By Dr. David Shoemaker, Ph.D., Dr. Kevin Barber, Ph.D., and Dr. Karl Whitney, Ph.D., Rho

Programs providing seriously ill patients with early access to investigational products are of great interest to the public, but what are the implications to pharmaceutical and biotechnology product companies? This article examines Right-to-Try legislation as well as the FDA’s existing expanded access programs from the perspective of companies who are considering providing investigational products to patients with serious or life-threatening diseases who have exhausted all other treatment options.

The Current Biomarker Landscape In Immuno-Oncology
White Paper | By Dr. El Mustapha Bahassi, Medpace

Dr. El Mustapha Bahassi, associate director of clinical laboratories at Medpace, gives an overview of central laboratories and the evolving world of immuno-oncology as well as current immuno-oncology biomarkers and detection methods.

University Of Louisville Improves Regulatory Efficiency With Veeva SiteVault
Article | By Anna Argyris , Veeva Systems, Inc.

Discover how the University of Louisville set out to transform their regulatory operations to promote efficiency and collaboration across their teams and study partners.

What Clinical Teams Should Know About The Benefits Of Auto-Injectors
White Paper | Thermo Fisher Scientific

For a host of reasons, auto-injectors are becoming biopharma companies’ delivery method of choice for commercial use and late-stage clinical trials. Auto-injectors ensure that the prescribed dose of medication is delivered fully and completely, making it easier to track compliance in clinical trials.

Key Operational And Design Considerations In Contraceptive Development
Article | Health Decisions Inc.

Early contraceptive development often progresses through testing of multiple prototypes for devices or doses and formulations for hormonal contraceptives. After selection of the best candidate for Phase 3 studies to support marketing submissions, contraceptive developers need to be aware of several design and operational considerations.

Empowering Today’s Patients To Help Tomorrow’s
Podcast | DIA

As Johnson & Johnson chief medical officer, DIA 2019 co-chair Dr. Joanne Waldstreicher is responsible for the company’s collaborations in ethical science, technology, and R&D policies, including those related to clinical trial transparency and compassionate access. “When you ask people why they’re participating in a clinical trial, a big part of it is to benefit themselves; they might have a condition or a disease where they’re looking for a new treatment option,” she explains. “But a very large part of their motivation is to contribute to medical knowledge that will advance or help care for a future patient.”

2019 Health Trend Ten E-Book
E-Book | Syneos Health

Life sciences leaders need ideas and insights to help them invest and act with confidence. Discover 10 macro trends shaping the healthcare industry in the year ahead. Download the 2019 Health Trend Ten e-book.


The 9th CROWN Congress is the leading industry event to discuss clinical operations challenges, trends, and best practices. By diving deep into the role of the clinical professional, we will touch on relevant topics such as disruptive technology, data management, regulation overview, and the effects that the operations role has on clinical trials. Register here! Use Discount Code “LSCVIP” for 15% off.

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