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This two-part article on biocontainment is a companion to our discussion of potent compounds, which focused primarily on chemically derived drug substances and drug components. While analogous to chemical potent compounds, biologically derived ingredients, intermediates, and products are produced by human manipulation of naturally occurring lifeforms and their byproducts.
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.
Training provides an opportunity to lay the groundwork for a Voluntary Quality Assurance (VQA) culture, which is a culture that involves trust, collaboration, and ownership among many people and departments.
We recently reached out to biosimilar experts from several prominent management consulting firms to ask for their perspectives on biosimilar company archetypes, emerging biosimilar development and business strategies (as well as mistakes to avoid), and the market’s future. First up is Mark W. Ginestro, principal in KPMG’s Healthcare and Life Sciences strategy team.
Regulators in China have long been concerned that this multitiered network inflates drug prices. A 2017 pilot program, known as the “two-invoices” system, aims to address this issue by changing the way manufacturers, distributors, and healthcare facilities operate in the procurement process.
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.
Thanks to our relationship with LSTI and an outstanding team here at Accelovance, we have built a training program that is able to be leveraged moving forward to address an industry need.
My main reason for taking the course was to re-evaluate quality agreements and how to improve our current template. Coming out of this, I would like to compare a few of our supplier quality agreements against the structure and checklist given in the course to see how they align.
Cook Pharmica LLC
All parts of the training were useful, including the topics of Documentation, Change Control and Revisions. I will now review our current Quality Agreement to make sure the requirements are included, and if not, add them.
I took the course to get a better understanding of FDA requirements. As an ISO 9001 registered organization, we need to control and cooperate with suppliers and this gave me some ideas on more formal ways to do that. The webinar was easy to attend with clear audio.