Industry Insights

81. The Brexit Deal And Its Impact On The Pharmaceutical Industry 11/30/2018

    According to trade groups, approximately 45 million packs of medicines leave the U.K. for Europe every month, and 37 million go in the opposite direction. In a year, that’s almost 1 billion packs of medicines. What those borders would look like after a Brexit deal would significantly impact major industries in the U.K. and EU economies.

82. What Risks Do Annuity Pricing Models Present To Cell & Gene Therapy Developers? 5/9/2019

    Over the past four decades, and especially in recent years, progress in the development of cell and gene therapies has reached unprecedented levels. In gene therapy alone, between 1989 and 2015 there were more than 2,330 clinical research programs targeting almost 50 different indications.^1,2 As more cell and gene therapies reach commercial stage, industry insiders expect research in the sector to continue to expand in the coming years. For patients, clinicians, and health systems, new cell and gene therapies bring the promise of historic and transformative advances in the treatment of many serious diseases. 

83. Incorporating Natural Hazards & Distributed Infrastructure Into Risk Management For Biopharma Operations 4/25/2019

    Natural hazard events may seem like distant topics to some in the biopharmaceutical industry, but they hold relevance for all companies. Opportunities exist for risk management, including an important lesson in avoiding the gradual acceptance of such events as normal, until an even greater catastrophic event occurs.

84. A Mouse (Trap) For Disease 2/4/2014

    About a quarter century ago, a trio of scientists developed a game-changing technology that enabled researchers to genetically engineer mouse strains with a particular gene missing. Finally, researchers had a tool to observe—in a backhanded way—how mice behaved when a critical piece of their DNA was missing. By Rosalba Sacca, Ph.D. and Regina McEnery

85. Commissioner Gottlieb, CAR T-Cells, & The Future Of Rare Disease Therapies 9/27/2017

    This article explores some of the policy changes happening now in the regulatory rare disease space as the FDA’s leadership team implements these changes at the agency.

86. Storing Biologics At Non-Traditional Temperatures 6/21/2019

    Maintaining the appropriate storage temperature of biological material is critical for downstream use. However, due to the complexity of this material and its sensitivity to temperature we are seeing an increase in non-traditional storage temperature requests. In this article, we’ll explore some of the reasons why this is occurring and the associated challenges.

87. The First FDA-Approved Digital Pill — What It Means For Pharma 1/2/2018

    The FDA’s approval of Otsuka Pharmaceutical’s Abilify MyCite for certain psychiatric conditions — a first for digital medicine —willl be seen as a landmark in patient-centered care. Over time, it can help solve three core problems bedeviling the development and the delivery of healthcare around the world.

88. Anticipating Manufacturing Costs — And Improving Process Development 8/1/2017

    No matter the type of organization you are in — from big pharma to virtual, small molecule to biologics, active ingredient to drug product — it is important to understand the cost structure of your program.

89. The Gene Therapy Pipeline — And The Biggest Challenges Facing Developers 3/26/2018

    With several first-in-class gene therapies now approved, distinct new challenges are now coming into focus. This article provides a high-level overview of the gene therapy pipeline for non-oncology rare diseases and discuss key issues impacting clinical development.

90. FDA’s Drug Shortages Root Cause Report: Does It Miss The Mark? 2/7/2020

    At the behest of Congress, an inter-agency Drug Shortage Task Force, led by the FDA, published the "Drug Shortages: Root Causes and Potential Solutions" report. The very first root causes listed in the report are “economic forces,” but there's a lot more to the story.