Articles By Ed Miseta

71. Tackling The Challenges Of A Rare-Disease Clinical Trial 4/7/2017

    Regulatory agencies today are looking for Phase 3 trials to demonstrate a reduction in mortality as well as greater patient mobility. Unfortunately, Phase 3 trials also cost a lot of money to run, making them a challenge for small biotech firms.

72. Janssen Turns Clinical Data Over To Patients 4/7/2017

    Andreas Koester, MD, Ph.D., global head, R&D operations innovation at Janssen, discusses how the company is attempting to make patient data available to participants while a clinical trial is underway.

73. New ADC Technologies: Deadlier For Tumors, Safer For Patients 3/8/2017

    According to Anna Protopapas, president and CEO of Mersana Therapeutics, the “circuitry” around cancer cells goes haywire, causing the antigens to appear. ADCs attempt to use those antigens to attack the tumor cells.

74. FDA Reports On 2016 Diversity Results 2/28/2017

    In a recent blog post, John Whyte, director of professional affairs and stakeholder engagement at CDER, notes until the late 1980s, clinical trials were conducted primarily on men. But a lot has changed over the last 30 years. We now know that some drugs affect men and women differently. This is why it is important for sponsors to test drugs on the appropriate patient populations, especially when developing “novel drugs.”

75. Finding The Right CRO For Rare Disease Trials 2/27/2017

    CRO selection is a challenge for every company outsourcing clinical trials. When the trial you are about to launch is for a rare genetic disease and has 30 patients spread across multiple countries and continents, the challenges are multiplied. This was the situation for Cerenis Therapeutics, which recently launched a Phase 3 trial for patients having very low levels of high-density lipoprotein.

76. Janssen Uses Trial Simulations To Capture Patient Concerns 1/1/2017

    Bert Hartog, Ph.D., innovation leader, in R&D Operations Innovation at Janssen Research & Development, has a plan in place to make trials more patient-friendly. Janssen’s goal is to incorporate the patient voice into clinical research, make patients a partner in the research process, and ensure all future collaborations are a two-way street.

77. Improving Clinical Trials Via Patient Insights 12/1/2016

    In preparing for this trends issue of Life Science Leader, there were numerous clinical topics I could have discussed. Many new technologies are emerging that will change how trials are conducted and impact everyone involved in the process. All of them are deserving of attention.

78. Clinical Trials In China: A Model For Advancing Cancer Therapies 11/1/2016

    Increasingly, pharmaceutical and biotechnology companies are enrolling patients in countries outside the U.S. Richard Brand, CFO for BeyondSpring Pharmaceuticals, believes this trend will continue going forward, especially for larger Phase 3 clinical trials.

79. What GSK Learned From Using Mobile And Wearable Technologies 10/1/2016

    As a company that is moving forward with mobile technology adoption, I can tell you that regulators are probably the least of our concerns,” says Rob DiCicco, VP, clinical innovation and digital platforms at GSK.

80. How BMS Is Leveraging The Patient Voice To Improve Clinical Trials 8/1/2016

    “We knew to compete in immuno-oncology — and to be successful — we had to fundamentally change our model.”