Safety/Efficacy Featured Articles

81. Opportunities And Challenges Of Cancer Immunotherapy And Other Advanced Therapies 10/14/2016

    The immunotherapy field holds great promise. Currently, as an example, these therapies represent a “breakthrough“ in cancer treatment as they have the potential to revolutionize the way we treat many forms of cancer, as well as other diseases and disorders. In this very specialized, and increasingly competitive area of drug development, biopharmaceutical companies developing these innovative therapies gain a distinct advantage.

82. TransCelerate Seeks To Improve Clinical Trial Quality 10/12/2016

    TransCelerate Biopharma is all about collaboration. The group’s goal is to identify, prioritize, design, and facilitate the implementation of solutions to help sponsors efficiently and effectively produce needed medicines for patients. In this interview Deb Driscoll, VP of quality assurance at Merck and lead of the TransCelerate QMS (quality management system), discusses how the initiative hopes to improve quality in clinical trials.

83. Clinical News Roundup: Biotrial Opens Research Facility In The U.S. 10/6/2016

    Clinical news roundup for the week of October 3, 2016 with information on Biotrial facility in the U.S., clinical trials in Australia, pancreatic cancer research, minority enrollment in trials, and cardiac gene therapy.

84. Three Questions To Ask When Evaluating a Patient Recruitment Plan 10/6/2016

    Today is a big day. Today is the day your clinical protocol is finalized. Your inclusion and exclusion criteria are polished to perfection. Your informed consent form has “IRB APPROVED” stamped on it in big, bold letters. Now is the time to deliver it into the eager hands of eligible patients.

85. Eli Lilly Steps Up Focus On Autoimmune Diseases 10/5/2016

    Managing patients having an autoimmune disease can present special challenges for researchers, from correctly diagnosing the disease to recruiting specific patients for clinical trials. I recently spoke with Chin Lee, global senior medical director in the immunology therapeutic area at Eli Lilly and Company. Lee discusses his decision to move from academia to pharma and the challenges inherent in performing clinical trials on autoimmune disease patients.

86. How Nektar Therapeutics Improves The Transactional Outsourcing Model 10/3/2016

    As pharma’s use of CROs continues to grow, so does the talk about outsourcing models. Today, one of the most popular models seems to be highly integrated strategic partnerships. Unfortunately, that model does not work for every company. Partnering agreements often seem to be built on a broad and sustainable pipeline, but for small- and mid-sized companies, that pipeline often does not exist.

87. The High Price Of Failed Clinical Trials: Time To Rethink The Model 10/3/2016

    Back in 2014, a study in Nature Biotech showed that only 32% of drugs have a probability of making it to Phase 3 trials, and only one in 10 drugs overall actually makes it to market. Things haven’t improved since then. BIO recently put out a study reporting that the average overall likelihood of approval (LOA) by FDA from Phase I was 9.6 percent – a 1 in 10 chance. The rate is even lower for major disease areas like oncology.

88. Adaptive Trials: Complex But Advantageous 9/28/2016

    When I speak with pharma executives on certain topics, it’s amazing to see the difference in where companies stand in terms of implementation. Adaptive trials is one of those topics. I will talk to one executive who will tell me it is one of the trends that will most impact the pharma industry in the coming year, and then talk to another who will tell me it’s old news and something they have been doing for years. Regardless of where you stand with adoption, one thing is clear: Adaptive trials have many advantages, but are also more complex.

89. Clinical News Roundup: HHS To Provide More Info To Patients 9/23/2016

    Clinical News Roundup for the week of September 19, 2016 with stories on HHS and ClinicalTrials.gov, FDA approval of Exondys51, DCRI coordinating National Study of Childhood Health, and the world's largest breath-based clinical trial.

90. CROs Can Be Indispensable As Pharma Companies Focus On Value 9/15/2016

    The healthcare industry’s transition to value-based care is putting a lot of pressure on pharmaceutical companies in terms of margins and the need to demonstrate improved outcomes at lower costs. In attempting to create breakthrough therapies and “beyond the pill” solutions with fewer resources, companies are demonstrating an increased appetite for outsourcing functions – and Contract Research Organizations (CROs) could be the beneficiaries.