Check out our Application Note, which discusses a recent report published by the Economist Intelligence Unit, The Changing Biopharma Risk Equation, which revealed that biopharma executives were eager to explore new possibilities ­ from developing novel therapies to expanding in emerging markets. However, they were also concerned about risks, especially regulatory uncertainty. In this Q&A, Heike Michaelis shares her thoughts on the evolving regulatory landscape and what this means for the future of biopharma.

We also invite you to check out our Podcast. This Q&A is designed to help guide small- and mid-size pharma companies through the steps required to prepare the chemistry and manufacturing process information expected by FDA in an IND application. While the focus is on novel small-molecule therapeutics, the elements discussed will be useful background for large-molecule programs as well.

Experts will discuss the application process and communications with FDA; identify required information about the quality, purity, strength, preparation, and stability of the drug substance and drug product; and explain the crucial analytical methods and validation processes needed for a successful filing.