In order to effectively extend the capacity of its organization using external partners, Merck & Co., Inc. decided to shift from limited, tactical, piecemeal outsourcing to a strategic outsourcing model. This article summarizes the first five of 10 key elements — or best practices — that were critical for the successful implementation of its strategic partnerships.
The first two articles in this series discussed the physical elements of facility design that sponsors look for in their contract development and manufacturing organizations (CDMOs) and sponsor requirements for dedicating equipment to GMP operations, equipment redundancy, and immediate disclosure of equipment and facility issues. This article presents solutions to improve transparency during sponsor audits of CDMOs.
The FDA recently issued a draft guidance entitled “Quality Considerations for Continuous Manufacturing” in an effort to advance greater predictability for companies adopting CM technology. Specifically, the FDA hopes this draft guidance will support the development and adoption of CM for brand, generic, and over-the-counter drugs.
The FDA issued the first warning letter citing failure to comply with requirements of the DSCSA amendments to the FD&C Act. This article takes a close look at this warning letter, but first it examines why McKesson may have received the first warning letter in this category, and explains why pharmaceutical manufacturers should care and what precautions they should take.
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.
When SMEs, management, and others gather to perform a risk assessment or a root cause analysis on a failure, they’re sure to achieve the desired outcome, right? Perhaps for a simple risk assessment or investigation, but success is not very likely for one that is even moderately complicated. That’s where a skilled facilitator is needed.
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.
Equipment qualification seems like a straightforward process. However, things usually go awry when gathering a validation team and defining and documenting the intended use and system requirements.
Although we expect the FDA approval of therapies for non-radiographic axial spondyloarthritis (nr-AxSpA) to be an important event in the coming year, questions remain about the U.S. market potential. Because three therapies are expected to be approved within a similar timeframe, any first-to-market advantage may be limited.
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.
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