Many of the change agents I have seen in 2019 are derived from changes in regulatory law, commercial downscaling, and impact from patent expiry strategies. The largest external regulatory change came from the issuance of the long-awaited EMEA Annex I, clarifying which technologies are required and acceptable, when and why.
Thom O’Sullivan
Director of Aseptic Process Technology, Process GS&T, IPS-Integrated ProjectServices, LLC
The challenges involved in biologic drug development differ greatly to those of small molecule drugs, and today’s innovators are more often focused on discovery, so they need to outsource other activities to progress programs.
Stacey Treichler, Ph.D
Group Product Manager, Catalent Biologics
The most exciting technological or scientific advancement that has influenced our business strategy in 2019 is our novel epigenetic regulator program. Unlike gene therapies, which target and modify DNA directly by inserting specific genes into patient’s cells, epigenetic regulators control or modify gene expression through processes that do not alter the sequence of DNA directly.
James E. Brown, D.V.M.
President and Chief Executive Officer, DURECT Corporation
One breakthrough technology that has had a transformative effect on our research and development efforts this past year has been advances in next-generation sequencing(NGS) technologies, including single-cell RNA sequencing (scRNA-seq).
Alexis Peyroles
Chief Executive Officer, OSE Immunotherapeutics
Although continuous flow has been utilized in a variety of industries for over a century, the pharmaceutical industry has been slow to adopt this technology for historical and regulatory reasons. The advantages that continuous flow has for chemical synthesis include both safety andefficiency, and there are a number of examples of pharmaceutical companies looking to leverage the technology for process improvements in clinical phase development.
Shawn Conway
Director of Engineering Research & Development, Cambrex
