Outsourcing Pharma

51. The Global Regulatory And Quality Environment For Biopharma Outsourcing 4/1/2020

    It is critical that organizations looking to engage an external contract service provider be aware of new regulations to align their programs with the latest expectations for each relevant market.

52. Strategic Outsourcing For Virtual Companies — Lessons Learned In The Trenches 4/1/2020

    A virtual company advancing a drug candidate into product development faces a deluge of challenges. The reality is you do need the assistance of pharmaceutical scientists and advice from industry professionals to help you navigate the twists and turns in the road.

53. Why You Need People Like Jana Spes At Your Company 4/1/2020

    Industry veteran Jana Spes provides some uniquely qualified analysis and guidance on the outsourcing industry and working with CDMOs. Don’t be surprised if you come away thinking for your next outsourcing operations hire, specialization is out, and the Spes model is in.

54. How To Avoid Data-Integrity Woes In Pharma 11/1/2019

    This article discusses what should be addressed to mitigate enterprise risks as they pertain to data integrity. It also lists what data-integrity compliance issues you should assess when choosing a CDMO.

55. Why Aren’t More CDMOs Using Continuous Manufacturing For API Production? 10/8/2019

    This is the first of a two-part article exploring the factors creating a demand from innovator biopharmaceutical companies for continuous manufacturing facilities in the U.S. and EU. It also covers the economic and technical challenges facing CDMOs considering building API CM facilities.

56. Ending Generic Drug Shortages At Hospitals: A Capitalist Goes Nonprofit 7/1/2019

    The nonprofit CivicaRX continues to gain momentum, and the company’s president and CEO, Martin Van Trieste, believes it’s a business model that is “pro-competition,” and one that others throughout the biopharma industry can adapt as well.

57. How To Ace Your Next CDMO Capabilities Audit 6/18/2019

    Site visits require a significant investment of resources on the part of both a sponsor and its prospective CDMO, so swapping out the time required to prep, travel, meet, and follow up in favor of a two-hour teleconference is understandable … to a limited extent.

58. Influence Of Size In CRO Selection 5/1/2019

    ISR surveyed hundreds of clinical development outsourcers about what they consider important when selecting providers. To capture the increasing role that preferred provider agreements are playing in the selection process, respondents were asked about attribute importance in several scenarios.

59. Regeneron Manages Clinical Costs In A Fast-Growing Organization 5/1/2019

    Bari Kowal, VP and head of global clinical operations at Regeneron, says sponsors and CROs must partner to make clinical trial execution more efficient and cost-effective.

60. The Honest Truth About Enrollment, And What You Can Do About It 5/1/2019

    Insights for the simple things you can do to mitigate the most common patient enrollment problems that every study (with very few exceptions) will inevitably face.