Articles by Anna Rose Welch

71. Patient Centricity: Where Can Pharma Go From Here? 12/10/2014

    The pharma industry is no stranger to the terms “patient-centric” and “patient centricity,” however there is still a lot of work ahead before pharma can begin turning these buzzwords into a reality. As enrollment and retention become more arduous tasks than ever before, pharma has its work cut out for it to ensure that patients remain the heart of the industry.

72. FDA News Roundup: MedImmune, Celgene, Lundbeck, And More 9/29/2014

    AstraZeneca’s R&D arm, MedImmune, received fast track designation from the FDA for its investigational monoclonal antibody (mAb) MEDI3902 indicated to prevent Pseudomonas aeruginosa (P. aeruginosa)-caused pneumonia.

73. Clinical Research News Roundup — September 26, 2014 9/26/2014

    The European Medicines Agency has proposed a single development plan for vaccines that fight against diphtheria, tetanus, and whooping cough in an effort to cut down on children’s exposure to clinical testing.

74. FDA News Roundup: Eli Lilly, Tekmira, Regeneron, AstraZeneca, And More 9/25/2014

    In the face of the Ebola threat, the FDA has granted Tekmira Pharmaceuticals permission via an “Expanded Access” or a “Compassionate Use” program to distribute its investigational Ebola treatment, TKM-Ebola, to people with confirmed or suspected infection.

75. FDA News Roundup: Baxter, Mylan, Shire, And More 9/22/2014

    NPS Pharmaceuticals received a nod of approval from an FDA Advisory Committee for its Hypoparathyroidism disorder drug, Natpara.

76. EMA, EC, NICE Weekly News Roundup: Roche, GSK, Janssen, And More 9/19/2014

    Roche’s and Chugai Pharma’s RoACTEMRA was approved in the EU for those with severe rheumatoid arthritis (RA) that were not previously treated with methotrexate (MTX).

77. Clinical Research News Roundup — September 18, 2014 9/18/2014

    Citeline released a report last week that suggests clinical data transparency (aka responsible data sharing) is “in a much healthier state” than in the past. In previous studies, 23 to 57 percent of completed clinical trials did not reveal results of the study. However, in its recent analysis of 7,500 phase 2 and 3 industry sponsored trials that occurred between 2008 and 2012, Citeline found 78 percent of these trials had distributed interim or final results. This percentage increased to 81 percent when only looking at the more costly, high-profile phase 3 trials.

78. How To Avoid A Checklist-Based Approach To Risk Assessment 9/18/2014

    As Risk-Based Monitoring takes hold in the clinical space, it is becoming more important to ensure you are monitoring the proper data, processes, and indicators. The clinical space is growing at a rapid pace, and with the introduction of more trials and complex protocols regulating those trials, relying on a standard, cookie-cutter approach to risk assessment will only lead to trouble down the road.

    Clinical Leader turned to inVentiv Health Clinical’s Sherry Merrifield, Sr. Director, Clinical Monitoring, and Michael Macri, Director, Strategic Services, as well as Jeff Fetterman, President of inVentiv Health’s ParagonRx, to better understand some of the strategies that can ensure a thorough, defensible risk-based monitoring approach.

79. “Everyone's Risk, Everyone's Benefit”: The Keys To Effective Strategic Partnerships 9/16/2014

    Whether it be a collaboration between Big Pharma companies, a sponsor and CRO, or a pharma company and a research foundation, partnerships are dependent on the proper alignment of goals, trust, and risk management. As the industry is faced with increasing demand for timely drug research and development, partnerships need to be a balance of equals, and both parties need to be ready to tackle whatever challenges might arise.

    Clinical Leader spoke with Mark Scullion, Senior VP, Strategic Resources, from inVentiv Health Clinical to learn more about the changes in the industry that are influencing partnership strategies, collaborative drug development, and innovation. 

80. EMA, NICE, EC News Roundup: Allergan, Alexion, Innate Pharma, And More 9/10/2014

    Vifor Pharma was granted marketing authorization in Europe for Velphoro (sucroferric oxyhydroxide), which is intended for the treatment of Chronic Kidney Disease (CKD) patients that are on hemodialysis or peritoneal dialysis. The drug is a non-calcium, iron-based chewable phosphate binder that demonstrated in a phase 3 trial it could sufficiently control hyperphosphatemia in fewer pills than the current standard of care, sevelamer carbonate. The FDA approved Velphoro for the treatment of patients with CKD that are undergoing dialysis in November 2013, and the drug entered the market in March.