Articles By Gail Dutton

31. Compassionate Use Trials Complex, But Improving 11/1/2015

    Expanded access (compassionate use) clinical trials aren’t as straightforward as they seem, and applications to expand access for cannabinoid drug trials are even more complicated.

32. How Geographic Expansion Increases Risks In Biopharma 10/1/2015

    Risk. In the age of social media, biopharma companies have to be more careful than ever about approving or denying compassionate use of investigational drugs. There is no safe “in or out” option.

33. Building A Narrative: Develop Emotional Connections To Raise Capital 8/1/2015

    For 55 years, comedian Jerry Lewis hosted Labor Day Muscular Dystrophy Telethons featuring “Jerry’s Kids,” the poster children who made muscular dystrophy real for millions of Americans. By creating an emotional connection with the audience, those telethons raised more than $2 billion.

34. Japan's Take On Regenerative Medicine: Early Commercialization, Early Reimbursement 5/4/2015

    New regulations accelerating the approval of regenerative therapeutics in Japan took effect Nov. 25, 2014, propelling that nation onto the radar screens of life sciences companies around the world. The chief benefit of these new rules is that they enable companies to receive conditional marketing approval and generate revenue from regenerative products while trials are being conducted.

35. Why Eastern Europe May Be The Best Location For Your Next Clinical Trial 1/31/2015

    Eastern Europe is becoming the new bright spot for clinical trials by offering significant opportunities and the fewest challenges of any of the emerging regions, according to a recent IQPC survey of pharmaceutical executives.

36. Aging Facilities: Retrofit Or Build New? 10/2/2014

    When BD Rx introduced prefilled syringes to flush IV lines in 2005, it converted an existing facility to produce these integrated devices. Later, when the prefilled format was extended to four generic injectable drugs, BD designed a new manufacturing facility to meet the more stringent manufacturing and regulatory concerns.

37. Reengineering The Pharma Supply Chain 9/2/2014

    The life science supply chain shouldn’t be the same as it was 10 years ago. Reengineering is imperative to deal with pressures that include transforming the industry from a volume-based to value-based model; ensuring profits despite reduced margins and the patent cliff; and addressing the complexities triggered by increased regulations, new product types, and globalization of both R&D and markets.

38. Merck's Continuous Process Improvement 7/1/2014

    Continuous improvement doesn’t just depend upon Lean principles and/or zero-based budgeting. It depends upon people inspired by a culture that values learning, promotes problem-solving skills, and strives toward big goals by making small improvements every day.

39. cGMP Issues Are Increasing In Pharma 1/7/2014

    Big Pharma and small companies alike are failing when it comes to cGMP violations. The increasing number and complexity of global regulations, outsourcing, price pressures, and compressed time to market all contribute to these failures. Consequently, the number of compliance issues is expected to rise.

40. Israel Drives Middle East Biotech Start-ups 7/31/2013

    Israel has been called, accurately, a nation of start-ups. With its scientifically oriented population and entrepreneurial drive, the nation is driving Middle East biotech. Approximately 60 percent of Israel’s life sciences companies focus on medical devices, while about 35 percent focus on biopharmaceuticals. Typically, 40 to 60 biotech companies are founded each year.