Developing products in the life sciences industries is complex. Basic quality tools can be used to bring the complexity into focus and help streamline the development strategy. These tools can help identify your primary goals and assess potential risks and failure modes to enable agile thinking early in development, where experimental outcomes often indicate the need to alter your development strategy.

The genome editing market is estimated to reach $3.5 billion in 2019 — an increase from $2 billion in 2014 — with a CAGR of 13 to 14 percent. The factors driving this market include increased R&D funding for genomic research, a growing demand for synthetic genes, new technologies in genome editing, and high utilization in plant breeding. However, high regulatory stringencies, lengthy approval processes, and ethical issues associated with the fear of genetic research hamper market growth. This article examines the utilization of genome editing tools and technology and their impact across the drug discovery industry.

The evolution and complexities of drug development have prompted biopharmaceutical organizations to seek collaboration much earlier in their research and development (R&D) programs and better appreciate the value of collaboration in areas such as study planning and start-up. These arrangements are becoming critical to business strategies for many in the industry hoping to create greater efficiencies and advance the R&D of innovative medicines. One key factor that is driving the success of these collaborations is the willingness and commitment to share information such as study materials and training documentation.

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.