Guest Columns

41. Stand By To Stand By: Organizational Contingency Planning 4/6/2020

    The coronavirus (COVID-19) pandemic has been a wakeup call, exposing the vulnerability of the global supply chain and the lack of emphasis placed on contingency planning.

     

42. COVID-19, Medical Drones, & The Last Mile Of The Pharma Supply Chain 4/6/2020

    During crises like this pandemic, bottlenecks in drug distribution and sample testing can be improved through automation, artificial intelligence, and robotics. This article provides an overview of the medical drone industry, with a particular emphasis on its adoption by the pharmaceutical sector to solve logistical problems in healthcare during times of heightened need. 

43. EMA Publishes 3 Noteworthy Updates Amidst Avalanche Of COVID-19 Communications 4/3/2020

    While communications from health authorities continue to pour in regarding actions they are taking to mitigate the impact of the COVID-19 pandemic, the EMA published three new items that merit attention from the life sciences industry. Two of them result from the pandemic; the third has been under development.

44. What Pharma Can Learn From A Parent Turned Patient Advocate 4/2/2020

    I am humbled and honored to introduce you to Andrew McFadyen — founder of the Isaac Foundation. Andrew is a husband, a father, and an advocate who tirelessly works to advance actionable dialogue around access, care, and policy for patients with rare diseases. Recently, I had the opportunity to chat with Andrew about the unique challenges that patients and their families face when dealing with serious illness and how we may better serve their needs.

45. Implementing Data Quality By Design For Improved Data Integrity 4/1/2020

    We must adopt more planning in our data quality activities. This is data QbD in its simplest explanation, and we must include data integrity planning in those activities (e.g., considering how to meet ALCOA requirements).

46. Why Controlling CQAs Isn’t Good Enough For Gene & Cell Therapies 3/31/2020

    It's frequently stated in the biopharma industry that to control a product’s critical quality attributes (CQAs) one must control the process’ critical process parameters (CPPs). While the statement is accurate literally, it does not convey the true technical requirements for controlling product quality.

47. Which Biosimilar Companies Will Thrive In 2025? 3/31/2020

    Five years after the first biosimilar was made available for prescription in the U.S., the American biosimilar market may be turning a corner on the road to sustainability.

48. The Little-Known Coalition Tasked With Saving The World From COVID-19 3/27/2020

    Vaccine manufacturing veteran James Robinson details a little-known organization (i.e., the Coalition for Epidemic Preparedness Innovation [CEPI]) and their task of saving the world from COVID-19.

49. Biosimilar Pipeline Experiencing 12% Annual Growth: A Progress Update 3/26/2020

    This article compares aspects of the biosimilar development pipeline and related market evolution since 2013, including what has and hasn’t changed.

50. COVID-19: 5 Steps To Achieve Situational Awareness In The Pharma Supply Chain 3/26/2020

    To address the current worldwide COVID-19 pandemic, more controls are being imposed by cities, states, and countries. Trucks are being delayed at borders. Flights are being canceled. It is important to be capable of adapting work practices around this ever-changing situation.