Industry Insights
-
What's All The Hype About mRNA Vaccinology?
3/7/2022
The COVID-19 mRNA-based vaccine success is spurring a further stream of medicines to come. This article provides an overview of mRNA for those who aren't already working in the field, how mRNA is being used in vaccines, and how mRNA can be used for future developments.
-
Data Integrity In A Cloud-Based World: Regulations & Best Practices
5/11/2020
There was a time when cloud computing was thought of skeptically by the life sciences community, through both the critical observations that are typical of science-based industry and the ingrained cultural resistance to change that comes along with a heavily regulated environment. But today, cloud solutions are ubiquitous in the industry.
-
Bioanalytical Services To Accelerate Drug Development
3/3/2022
Through the use of robust bioanalytical techniques, biological samples can be processed and analyzed to identify and quantify compounds of interest.
-
340B: A Game Plan For Success
11/20/2013
By Nate Taninecz, Model N
I recently had the pleasure to participate in a panel discussion at the 2013 HDMA Contracts and Chargeback conference held at the historic Hotel Du Pont in Delaware. For two days, industry thought leaders educated the attendees on the challenges of the day. There was one particular theme that was a conference highlight and at the forefront of most attendees’ minds: 340B.
-
Meet Barbara Holland, Business Development Director
5/12/2022
Barbara Holland, Business Development Director at Pii, is a bit of a renaissance woman. Learn about her personal interests and why she came out of retirement to work with customers.
-
Stability Chambers: Testing, Equipment, And Uses
3/7/2023
Performing stability studies is a critical step in the drug development process. Discover the ways to ensure that your drug is safe and effective as it goes to market.
-
Five Questions To Ask When Sourcing An R&D Freeze Dryer
5/21/2015
Freeze dryers can be complicated pieces of specialized equipment, with controlled heating, cooling and vacuum interacting with each other to provide the best drying conditions. They are used for many different types of product and there are therefore a variety of different types of system with hundreds of options to enable them to suit the requirements of different industries and applications.
-
What You Need to Know About Phase-Appropriate Quality Requirements
12/9/2021
A discussion on implementation of a phase-appropriate QMS, the importance of starting early in the product development life cycle, and the advantages of digital QMS over a manual approach.
-
Classification And FDA Regulations: Medical Device, Pharma, Combo Products
4/12/2016
How the FDA regulates various product classes and the guidance documents driving regulatory enforcement varies from product to product.
-
5 Steps To Avoid Mismanaging Biopharma Grant Funds
9/7/2022
You've finally received the grant you need to make your biopharma business a reality. The tough part is over, right? Not exactly. If you mismanage your funds, you could end up on the government’s naughty list.