Oligonucleotide therapeutics have developed into a viable drug platform capable of delivering first-in-class therapeutics to patients. A virtual panel of experts from across the oligonucleotide industry answer questions about the state of the industry and what the future holds for the field of oligonucleotide drug development.
DEFINITIONS Extractables are chemical substances that can be extracted from the product using aggressive
Following the idea to discuss the synthesis of recently approved APIs, in this issue
INTRODUCTION In the first article of this column, privacy compliance has been thoroughly examined
This note (parts 1 and 2) suggests learning from real world examples of value pricing for products and services. It is important to realize that they are the outcome of many years of trying and failing and trying again. An approach in 4 major steps is recommended:
Understanding customer needs
Comparing your own offering versus competitors
Embedding value pricing in a value selling journey
How to create fair sharing as a foundation for long term equitable economic benefits for all parties
The process starts with your belief that you (can) create real value for your customers. The challenge is that what you think the value is may not be (fully) correct. So, you need to be a little schizophrenic about this. On the one hand fully convinced and driven that you can bring superior value, but at the same time open and self-critical to want to learn what your customer really needs.
Mr. Gilles de Preux, CEO of SSE Holding, has more than 13 years
A particular challenge associated with commercializing a cell and gene therapy (CGT) product is defining and performing a successful process and product validation campaign. This is particularly challenging due to limited experience, data and guidance currently available for CGT products. BioPhorum’s CGT validation workstream have published an article highlighting these issues, showcasing a number of unique validation challenges, and potential solutions, associated with CGT validation. Here we speak with one of the lead authors, Sharif Ahmed of Bayer, who kindly highlights some of these challenges, key takeaways/recommendations from the team, and the benefits of working as a cross-industry collaboration to discuss and identify potential solutions to common challenges.
INTRODUCTION Today CDMOs face excellent growth opportunities in a pharmaceutical market environment where
From the most ancient to the most developed societies, health has been perceived to
In May 2018 in Boston world renowned Professor Fernando Albericio and our colleague
