COVID-19

41. COVID-19 & The Virtual Trial Rush: Front-Line Insights 5/19/2020

    The COVID-19 pandemic caught many sponsor companies and sites unprepared. Clinical trial participants were told to stay home for their own safety and to relieve the burden on site personnel. For companies that had millions invested in trials that required data from those patients, panic set in and the rush was on for new technology solutions.

42. View From Tokyo: Rise Of The “Values” Chain 5/15/2020

    The Wuhan coronavirus outbreak has brokered a virulent "value" chain debate around the world, including a global CDMO's CEO situated in Tokyo. 

43. Pfizer Shifts Outsourcing And Communication To Fight COVID-19 5/14/2020

    Pfizer’s speaking in real-time – actually forward-looking pronouncements of manufacturing intentions and locations – is refreshing, and should be applauded. Does this represent an industry "shift"?

44. Navigating The FDA's Emergency Use Authorization Process 5/14/2020

    The FDA has been authorized to grant Emergency Use Authorizations for SARS-CoV-2. This will impact both internal manufacturing and the CDMOs that drug sponsors employ. 

45. How Military Thinking Can Improve Pharma Decision Making Under Stressful Conditions 5/8/2020

    As a result of the COVID-19 pandemic, many companies are struggling to make both the decisions they would on any other day as well as those that are required in the current environment. This article explores what military decision-making practices can teach us about how to reach appropriate conclusions during the pandemic or other stressful conditions.

46. Developing A Clinical Trials Strategy For A Post-COVID World 5/4/2020

    It’s becoming clear that we need proactive, collaborative planning and execution to mitigate the impact we’ll absorb when the pandemic loosens its grip on our industry, along with a significant effort to advance our virtual capabilities forward.

47. Question Your Buyer Motivation And Supply-Chain Origins 5/1/2020

    Don Buckner left a comment to my recent '50 By 25" editorial: “Will have success if the buyers demand it.” I liked the idea of buyer-driven demand as a path to explore your supply-chain decisions. It also led to some fundamental questions of your motivations.

48. High Absenteeism & The Production Of Medically Necessary Drugs During COVID-19 4/29/2020

    A structured approach to problem solving using quality risk management (QRM) techniques can aid in the development and implementation of action plans and knowledge transfer programs to ensure the production of safe and effective drug products in times of staff shortages related to the COVID-19 pandemic.

49. A COVID-19 Vaccine, Outsourcing, And Made In The USA 4/27/2020

    That’s an unwieldy title for an editorial. But we’ll bundle those three components quickly, thanks to U.S.-based GeoVax Labs CEO David Dodd. He's the quintessential professional to assist readers in assessing and contemplating current and future realities.

50. Ensuring Quality In Ventilator Production Scale-Up For COVID-19 4/24/2020

    Chief Editor Louis Garguilo asked Outsourced Pharma Advisory Board member and COO/CSO of Pharmatech Associates, Inc., Bikash Chatterjee, to update our readers periodically on what he is seeing and experiencing during this coronavirus pandemic. This is his first update.