Ed Miseta

Ed Miseta



Ed Miseta is the editor of ClinicalLeader.com. In this capacity he educates readers by providing the latest news and trends in the clinical research industry.

ARTICLES BY ED MISETA

  • For CRAs, There’s Less Turnover Than You Might Think

    ISR recently decided to look at the current market for CRAs by focusing on salaries, signing bonuses, retention bonuses, raises, and turnover. The research group collected data from 227 CRAs from around the world with the goal of benchmarking industry trends.

  • PreClinical Video Aims To Attract Patients

    Every company moving into clinical trials on humans will face the challenge of attracting both investors and patients to their study. These challenges can be difficult, but Anthony Hayes, president, CEO, and director of Spherix, believes a 90-second video the company has in its possession will help them overcome both.  

  • FDA Hopes To Advance Clinical Testing To Deliver New Cures

    The FDA notes new diagnostic tests that undergo rigorous FDA review must demonstrate they are analytically and clinically valid. Unfortunately, the majority of laboratory developed tests (LDTs) currently do not demonstrate to FDA that they meet those standards. A new approach may simplify this process.

  • How Can Government Promote Orphan Disease Research?

    Mallory Factor, chairman of IntraBio, has worked with regulatory agencies in both the U.S. and Europe on matters relating to clinical development programs. In doing so he had the opportunity to observe the obstacles that serve to delay and even restrict novel orphan therapies from getting to patients. He believes orphan drug developers and the FDA must collaborate more closely to bring more treatments to approval.

  • Now That Right To Try Is Law, What Does It Mean To You?

    On May 30, 2018 President Trump signed Senate Bill 204 into law. The law, more commonly known as Right To Try (RTT), allows certain patients access to investigational drugs outside of clinical trials. Now that it is law, what will RTT mean to you?

  • Study Startup Technology Investment Pays Off

    For companies conducting clinical trials, study startup remains a major hurdle. A new report from Industry Standard Research (ISR) titled, eClinical Technology Adoption and Challenges in Study Startup, shines a light on the issues surrounding startup and how eClinical technologies are helping companies overcome these challenges.

  • Overcome The Challenges Of An Ultra-Rare Disease Trial

    ArQule is a personalized medicine company working in the oncology space to develop treatments that target specific mutations. While attempting to overcome a challenge with its product, ArQule was approached by a group at the NIH which wanted to partner to help patients with an ultra-rare disease known as Proteus syndrome.

  • Want To Partner With Big Pharma? Take This Expert Advice

    When preparing for a large Phase 3 trial, many small companies may need a Big Pharma partner to help them through the process. But how do you connect with large companies? And what are the best practices for working with them? A panel at the 2018 Clinical Leader Forum in Philadelphia attempted to bring some clarity to those questions.

  • Clinical Trial Consortium Aims To Eliminate Inefficiency

    On March 1, 2018, the Partners in Innovation, Education, and Research Consortium™ (PIER) became an LLC in the State of Delaware. The six founding members of PIER (Jefferson Health, Atlantic Health System, Drexel University, Einstein Healthcare Network, Geisinger Health System, and Main Line Health) hope to bring efficiencies and cost reductions to clinical research.

  • A Patient’s Journey To Join A CAR-T Cell Therapy Trial

    Nicole Gularte is currently battling cancer for the 8th time. The last time she had to do so, it seemed a CAR-T cell therapy trial might be the solution. This article is about her long battle with cancer, the struggle to get into a CAR-T cell trial, and the ups and downs she has faced along the way. Her story is an inspiration to others.

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