Defining the Critical Hurdles in Cancer Immunotherapy

ABSTRACT: Scientific discoveries that provide strong evidence of antitumor effects in preclinical models often encounter significant delays before being tested in patients with cancer. While some of these delays have a scientific basis, others do not. We need to do better. Innovative strategies need to move into early stage clinical trials as quickly as it is safe, and if successful, these therapies should efficiently obtain regulatory approval and widespread clinical application. In late 2009 and 2010 the Society for Immunotherapy of Cancer (SITC), convened an "Immunotherapy Summit" with representatives from immunotherapy organizations representing Europe, Japan, China and North America to discuss collaborations to improve development and delivery of cancer immunotherapy. One of the concepts raised by SITC and defined as critical by all parties was the need to identify hurdles that impede effective translation of cancer immunotherapy. With consensus on these hurdles, international working groups could be developed to make recommendations vetted by the participating organizations. These recommendations could then be considered by regulatory bodies, governmental and private funding agencies, pharmaceutical companies and academic institutions to facilitate changes necessary to accelerate clinical translation of novel immune-based cancer therapies. The critical hurdles identified by representatives of the collaborating organizations, now organized as the World Immunotherapy Council, are presented and discussed in this report. Some of the identified hurdles impede all investigators, others hinder investigators only in certain regions or institutions or are more relevant to specific types of immunotherapy or first-in-humans studies. Each of these hurdles can significantly delay clinical translation of promising advances in immunotherapy yet be overcome to improve outcomes of patients with cancer

The James Webb Space Telescope mission

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Evaluation of a biological risk management tool on large western United States dairies

Critical to changing biosecurity practices on the farm is an individual assessment of those practices contributing to disease transmission. The purpose of this project was to assess, implement, and refine a biological risk management survey for use on large western United States dairy farms. Assessment tools developed by Iowa State University Center for Food Security and Public Health (Ames, IA) were refined using a focus group process and by testing them on 40 dairy herds in California. Each question was evaluated using standard criteria and producer responses. Some survey questions required refinement for clarity and others were considered unnecessary. New questions were added based on a biosecurity literature review, resulting in a new set of questions that can be used by extension educators and food animal veterinarians to help identify disease risk areas and educate dairy producers