Articles By Ed Miseta

  1. Should Drug Repurposing Be A Part Of Your Strategic Plan? 1/1/2016

    Cures Within Reach has been around since 1998, but the nonprofit, which started as a family foundation, did not become a public charity until 2005. The organization has primarily been funding medical research to accelerate the search for cures, but by 2010 its 190 de novo (new drug) projects had not touched the life of a single patient.

  2. J&J Hopes To Change The Paradigm On Compassionate Use Review 1/1/2016

    “It was clear we needed to have a better [compassionate use] process in place.” Dr. Amrit Ray, CMO, Janssen

  3. Technology Will Continue To Drive Efficiencies In Clinical Trials 12/1/2015

    Our expert panel predicts mobile technologies are poised to gain traction in clinical trials next year. Other hot trends in the clinical space include more focus on patient-centricity and greater adoption of risk-based monitoring and EHRs.   

  4. How One Biopharma Improved Patient & Clinical Site Relationships 11/1/2015

    Eileen Daniel, executive director of clinical operations at Nektar Therapeutics, always felt there were ways the clinical trial planning process could be improved. 

  5. Genentech Pushes The Clinical Trial Envelope 10/1/2015

    Having spent more than 11 years at Genentech, Joling Mew has heard a lot of industry discussion about patient-centric trials. Mew is development excellence leader in product development and also works closely with the Strategic Innovation Group.

  6. The Challenge Of Moving From Transactional To Strategic Partnerships 10/1/2015

    Suzanne Besaw’s job as strategic alliance manager in Strategic R&D Services Outsourcing for Bayer HealthCare has undergone a huge transition. Eight years ago, she had Bayer’s U.S. clinical outsourcing department reporting to her, and there were numerous service providers she needed to manage.

  7. How Social Media Might Be Sabotaging Your Clinical Trial 9/1/2015

    In many ways, social media has been good for the advancement of clinical trials. It is an effective way for pharma to find and recruit patients, make patients aware of trials, and even educate the public on the benefits of trials. It has also become an efficient way for pharma to interact with patient advocacy groups.

  8. Why Is Takeda Focusing On Vaccines? 8/1/2015

    Succeeding in the vaccines business is not easy. Low margins and manufacturing challenges make it a difficult business for any pharma company. In fact, two large manufacturers, Baxter and Novartis, recently pulled the plug on their vaccine efforts. Four of the remaining sponsor companies, GSK, Merck, Pfizer, and Sanofi Pasteur, are formidable competitors. Despite the challenges that exist, Takeda decided in 2012 to enter this global market, building upon its 70-year history of Japanese vaccine business, with plans to be the world leader by the year 2020.

  9. Lilly's Approach To Discovery Via Collaboration 5/27/2015

    Being a large pharmaceutical company located in the Midwest has some advantages, but the location is still evolving as a recognized pharma or bio hub. Today’s drug development challenges are also more complex, and some cannot be solved by one company alone. That means pharma firms such as Eli Lilly and Company have to perform research without boundaries, so as to access the best innovators and thought leaders wherever they exist.

  10. Measuring Quality In Clinical Trials: Why You're Probably Doing It Wrong 5/4/2015

    Quality is undoubtedly one of the top concerns you will hear cited by pharma executives when it comes to clinical trials. When you talk to sponsors about what they look for in a service provider, quality is always at or near the top of the list.