Articles By Ed Miseta

  1. Navigating The Turbulent Waters From Discovery To Clinical 1/17/2019

    “A partnering deal with a bigger pharma company would certainly help us through [the Phase 3] process,” explains Jeff Davidson, CEO of Keystone Nano, a company that develops nanoparticles that target solid tumors by going after cancer cells and leaving the normal cells intact.

  2. Oncology Studies Show Pharma The Future Of Clinical Trials 12/3/2018

    What does the future hold for oncology trials, which now comprise around 80 percent of all clinical research? We spoke to three experts who shared their insights into where the industry is headed in 2019 and beyond.

  3. A Patient's Journey To Join A CAR-T Cell Therapy Trial 11/8/2018

    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.

  4. A Small Biotech Takes On Some Big Clinical Trial Challenges 11/7/2018

    Evofem Biosciences is on the cusp of releasing a revolutionary birth control product. But before the FDA gives its approval, this small biopharma has to navigate two very different clinical trials.

  5. Cannabis Trials Move Forward…But Lag In The U.S. 11/5/2018

    For researchers hoping to conduct clinical trials on cannabis-based products, the U.S. is not the most hospitable place. While other countries are legalizing the drug and conducting research on its possible medicinal uses, state and federal regulations on marijuana in the U.S. continue to stymie its use.

  6. Science Driving Gene Therapy Development At bluebird bio 10/3/2018

    For patients with sickle cell anemia, just getting through the day can be a struggle. Symptoms of the disease include vision problems, swelling of the hands and feet, and periodic episodes of pain that can last from a few hours to a few weeks. In this article Nick Leschly, CEO at bluebird bio, discusses the progress being made with its investigational gene therapy for sickle cell disease.

  7. Should You Look At China For Your Next Clinical Trial? 9/18/2018

    At the 2018 DIA Annual Meeting in Boston, one of the topics I heard a lot of discussion around was China. Once known as a low-cost producer of generic drugs and pharmaceutical APIs and excipients, the country is now stepping up the quality and timeliness of its manufacturing to attract the attention of pharmaceutical companies.

  8. Novartis Turns To Digital Technologies For Clinical Trials 9/3/2018

    Jake LaPorte, head of digital development for Novartis, talks about how AI, IoT, and machine learning are all being leveraged for better clinical trials.

  9. FDA's Gottlieb Addresses Effort to Advance New Innovations 8/30/2018

    In a nearly 3,700 word missive by Scott Gottlieb, posted on August 29, 2018, the FDA commissioner attempts to bring some clarity to efforts by the agency to bring more innovation into the drug development process. Gottlieb notes innovative new technology platforms, such as digital health, targeted medicines, and regenerative medicine, including cell and gene therapies products, are helping the industry advance drug development.

  10. Lessons Learned From 7 Years Of Pharma Partnering 5/16/2018

    Ron Squarer believes for a company to be successful, especially in a capital-intensive area such as biotechnology, it has to know what it is good at and target those skills. Squarer is the CEO of Array BioPharma, a company focused on the discovery, development, and commercialization of targeted, small-molecule drugs to treat patients with cancer.