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INDUSTRY RESOURCES

07
Mar
Raising The Bar: The Silver Lining Of FDA Commissioner Gottlieb’s Exit

It was the announcement many have been dreading — but expecting — for several months now. Dr. Scott Gottlieb, 23rd Commissioner of the FDA, announced his decision to step down after 663 days (22 months) on the job. The news is sure to raise concerns for many. But I think the biggest surprise is how equally sad thought-leaders within the agency will be to say goodbye.

Posted in:FDA,
27
Feb
Big Data And AI In Pharmaceutical Development & Manufacturing — An Inside Look

Artificial intelligence and Big Data have the potential to lower the cost and time of drug trials, to better determine patient outcomes with established drugs, and to better design new drugs.

Posted in:Manufacturing,
26
Feb
Implementing Risk-Based Monitoring: 6 Lessons From The Trenches

While risk management as a concept has always played a role in the clinical trial space, there is increased pressure to identify and manage trial-related risks more systematically. This article discusses six important considerations when making the decision to utilize RBM as part of your operational growth strategies.

Posted in:Clinical,
25
Feb
Recalibrating The Supply Chain For Allogeneic Cell Therapies

In November 2018, I wrote an article about establishing a supply chain for autologous cell therapies — those formulated using a patient’s own cells. This partner piece highlights considerations that need to be taken into account when developing a commercialization and supply chain strategy for allogeneic cell therapies, in which cells from a single donor are expanded and used to treat multiple patients.

Posted in:Manufacturing,
14
Feb
Digital Platforms For Patient Engagement In Clinical Trials — Trends & Outlook

Pharmaceutical companies have three targeted users: physicians, pharmacists, and patients. Various digital platforms are used to create a good customer experience for educating these end users. The core focus is on patients driving patient care, education, and adherence.

Posted in:Clinical,
11
Feb
How Technology (And The People Who Use It) Will Reshape The Future Of Aseptic Processing

Using new and existing technologies to improve aseptic processing manufacturing may provide the need and opportunity for new approaches to process control and monitoring.

Posted in:Manufacturing,

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