This two-part article explores the use of various tools and the emergence of intelligent solutions in the industry.The first part provides an overview of how technological advancements and data analytics are critical in enabling regulators and the life sciences industry.

There is a trend within the pharmaceutical, biopharmaceutical, medical device, and vaccine industries to hire more consultants, leading to a staffing ratio that can be up to 50 percent consultants to staff for small to large capital projects.

There have been considerable updates in the Brexit situation since April 2017, including, the surprising result of the U.K. general election. If anything, news regarding Brexit and the biopharma industry has started to heat up in recent months, and there have been a number of relevant developments that manufacturers must keep their eye on.

IPR provides an adversarial process for challenging patents at the U.S. Patent Office. As of earlier this year, there were over 50 IPR petitions reportedly on file challenging patents relating to the large molecule biopharma space.

India and China represent nearly 40 percent of the world’s population, so their domestic markets for biologics alone represent a remarkable opportunity. However, currently, the opportunities for sales of biological therapeutics remain in more developed countries.

In the ongoing battle to cut costs while delivering quality and technically sound product, the biotech industry has spent the past two decades gradually moving toward single-use pre-sterilized plastic equipment for both clinical batch and, where applicable, production scale manufacturing. Single-use process equipment can be used and then disposed of, eliminating the development time to validate the sterilization and in-facility sterilization downtime, as well as development time to qualify and verify the cleaning and commensurate cleaning downtime.

Cell therapies have the potential to revolutionize the biopharmaceutical world, but today’s processes, logistics, and delivery make for a challenging entry into the sector’s growth curve.

Inadequate communication between the consultant and the client, especially at the initial engagement phase, is often not taken seriously enough or addressed sufficiently on both sides.

We need to teach people how to think again. Then, we need to encourage them to think on a day-to-day basis so that they’re comfortable with it when a problem arises that requires out-of-the-box, beyond-the-SOP thinking.