Eric S. Langer
The biomanufacturing industry continues to have problems with downstream operations, as evidenced by the 7 in 10 (71.9%) respondents to our 9th Annual Report and Survey of Biopharmaceutical Manufacturing who report this year that they are seeing at least minor capacity issues due to their downstream processing.
Greg Christoph, Ph.D., JoAnne Saye, Ph.D., Lewis B. Kinter, Ph.D.
In-licensing is perhaps the fastest growing component for augmentation of R&D pipelines in the pharmaceutical industry today. In-licensing opportunities can span the entire range of drug discovery, development, and commercialization and include proprietary research technologies designed to explore novel biological targets, promising but untested new chemical platforms, new compound entities (NCEs) at various stages of preclinical or clinical development, and marketed products.
Andrea Gruber
The global economy relies upon air transport to deliver high quality products at competitive prices to consumers worldwide. International trade is now estimated at over USD 15 trillion and about 35% of that value is transported by air.
From my perspective, High Potency APIs have been exhibiting a continued growth in its market. My professional experience and focus has long been on Active Pharmaceutical Ingredients and the need for their Production, Distribution, and Quality to meet the intention of the internationally accepted API GMP.
Matilde Damian
R&D organizations are facing big challenges of which the most critical are the reduction of timelines to conduct a clinical trial and associated expenses. This means getting results from clinical trials faster while using fewer resources. In response to these challenges, the structure and functionality of Clinical Operations is changing. Horizontal organizations are replacing long vertical structures but also new areas of specialization are emerging.
In February 2011, ResearchDx, based in Irvine, CA, launched the first-ever Contract Diagnostics Organization (CDO). The CDO facilitates simple, straightforward options to initiate the development of companion diagnostics in synergy with drug development. The use of companion diagnostics in conjunction with custom pharmaceuticals is expected to continue to expand as personalized medicine continues to evolve. In this context, the CDO fills a need in the co-development of diagnostic tests and drug therapies – a need significantly different than the current pharmaceutical development model meets.