Articles By Ed Miseta

81. How Do Patients View Your Investigational Medicinal Products? 7/1/2016

    In early 2013, an initial groundbreaking survey was conducted to determine patient perspectives on investigational medicinal products (IMPs). The survey, sponsored by ISPE (International Society for Pharmaceutical Engineering), was intended to provide an international perspective on IMPs to ensure clinical supply packaging, labels, and booklet labels were patient-friendly.

82. Leveraging China Innovation For Worldwide Growth 7/1/2016

    When you talk to Dr. Mireille Gillings, the founder and executive chair of HUYA Bioscience International, her enthusiasm and passion for drug development is clearly evident.

83. How Agile Therapeutics Got Through A Critical Phase 3 Trial 6/1/2016

    The challenges of conducting a Phase 3 trial and then using that data to get an approval from the FDA are something every head of clinical research knows very well. Agile Therapeutics hired Elizabeth Garner as chief medical officer and SVP of clinical development to take control of the process.

84. Pharma Scientist Paves His Own Corporate Path 6/1/2016

    “It was a little frustrating for me, because you feel like your ideas and IP are tied up in the company.It did slow me down for a few years, and I was not able to regain control of that IP until 2006.”

85. Patient-Centricity Roundtable: Sponsors, Sites, And CROs Must Work Together To Hear The Patient 5/1/2016

    Patient-centricity continues to be the hot buzzword in clinical trials. With greater patient-to-patient interactions via the internet, social media, and advocacy groups, sponsor attention to the wants and needs of patients has never been greater. But for all of the attention being paid to it, questions still linger over what it really means and what is actually being done.

86. Roche Combines Analytics + Clinical Operations For Better Feasibility Plans 5/1/2016

    Corsee Sanders is a statistician by training, having earned both a bachelor’s degree and Ph.D. in statistics. Unlike many in similar positions, she did not grow up in a clinical trials environment, having only joined the clinical operations team at Roche four years ago, moving over from a position as the global head of biometrics. However, as the SVP and global head of clinical operations and external collaborations, her new role in overseeing trials with Roche is key to the success of her company’s studies.

87. CROs Will Play A Critical Role In The Future Of Drug Development 5/1/2016

    There are a couple of differences you will see in this 2016 installment of our annual CRO Supplement.

88. How Purdue Pharma Hopes To Use The Apple ResearchKit 5/1/2016

    Purdue Pharma is attempting to prove the viability of mHealth technologies in clinical trials by evaluating the use of the iPhone, Apple Watch, ResearchKit, and various healthcare apps for patients suffering from pain.

89. What Will The CRO Of The Future Look Like? 5/1/2016

    The world of clinical trials is changing. New technologies are changing how trials are performed. The internet and social media have enabled greater patient connections, which will continue to change how patients are recruited. And Big Data, genomics, biosimilars, and precision medicine will change the industry in still unknown ways.

90. Otsuka Alters Study Paradigms To Prepare Sites For Clinical Success 2/1/2016

    Leesa Gentry, Otsuka’s director of global clinical management, discusses the challenges of working on trials for MDR-TB, defined by its resistance to two main drugs currently used to treat TB – isoniazid (INH) and rifampicin (RMP).