Newsletter | November 13, 2019

11.13.19 -- Rafael Pharmaceuticals Is Starving Cancer Cells

Featured Editorial
Rafael Pharmaceuticals Is Starving Cancer Cells
By Ed Miseta, chief editor, Clinical Leader

While many other oncology companies are focused on the development of targeted immuno-oncology therapies, Rafael Pharmaceuticals is working on a cancer metabolism drug that has the potential to revolutionize cancer treatment. Its primary objective is to produce anticancer agents that have minimal toxic effects on normal cells and tissues.

Driving Innovation: Blockchain Adoption For Clinical Trials Optimization
By Maria Palombini, IEEE Standards Association

Pharmaceutical companies and research institutions are feeling the pressure to reduce the time, financial, and other resource costs associated with conducting clinical trials. With the influx of emerging applications for technologies such as machine learning, robotics, and automation, and blockchain and other distributed ledger technologies (DLTs), many see a new path to more efficient and effective processes that can address the challenges faced today.

Industry Insights
Patient Reported Outcomes And The Common Terminology Criteria For Adverse Events (CTCAE)
Article | By Kristen Mason, MS, Rho

The Common Terminology Criteria for Adverse Events (CTCAE) was developed to standardize reporting of adverse events (AEs). Originally developed for oncology trials by the National Cancer Institute (NCI), the CTCAE is now used widely across all types of clinical trials, and as a result it has become an essential tool for evaluating trial safety.

How To Reduce Clinical Supply Expense Using An IRT System
Article | By Korinne D’Orsi, YPrime

Mismanaging clinical supplies can threaten study outcomes, bring studies to a halt, and even jeopardize a clinical research program. This article outlines a solid clinical supply management program, defines interactive response technology (IRT) and its role in clinical supply management, and explains how implementing it can reduce risks and costs.

Bringing Quality, Innovation, And Experience To Rescue Studies
Article | By Dan Pavitt, Cenduit LLC
Can you really improve the economics and safety of clinical studies by choosing expedience over expertise? The answer is a decisive “no.” Read insights from Cenduit on their experiences with sponsors that needed them to rescue a study due to problems with their original IRT selection.
Making Clinical Trials More Effective By Keeping Focus On The Patient
Q&A | A Q&A with Justin Schroeder, PCI Clinical Services

The need for clinical trials to meet the requirements of regulators, deliver high-quality data, and come in on budget has led to study designs that focus on timeliness and convenience but may unduly burden and inconvenience patients. Today, priorities are changing as sponsors realize studies designed around the needs of patients also result in benefits to other stakeholders. This has led to the rise of patient-centric clinical trials.

Planning A Gene Therapy Trial? Ask An Expert — And Pay Attention
Article | Premier Research

Whether the experts come from a CRO or a regulatory consultancy, their help will be critical in helping develop the trial, meet with the Institutional Biosafety Committee, establish a timeline, and manage expectations. Here’s why.

Advancing Oncology Development With A Synthetic Control Arm Trial
Case Study | Cytel

A specialized biopharmaceutical company had a breakthrough therapy that had the potential to be first-in-class for a rare and aggressive hematological cancer and had shown great potential in an earlier clinical trial. Read how synthetic control offers a practical, effective way to leverage real-world evidence and how it has been applied in regulatory approvals.

Questions You Need To Ask About Clinical Supply
Infographic | Catalent

Planning on using a CRO to support your next clinical study? Here are the top nine questions you should always ask to help your CRO or partner of choice better understand your clinical supply needs.

  ClinBiz Summit 2020

A place where clinical research professionals can connect on the latest topics, trends, and technologies for streamlining the business aspects of clinical trials, exploring topics such as:

  • Clinical Trial Outsourcing and Vendor Management
  • Clinical Trial Contracting and Budgeting
  • Clinical Trial Financial Management
  • Clinical Trial Business Operations
  • Accelerating Clinical Trial Star-Up Timelines
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