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INDUSTRY RESOURCES

16
Oct
Collaborating With Patients: 3 Key Considerations For Drug Sponsors

Historically, patient involvement has been vital in the design and execution of clinical trials, but in recent years there has been an increased desire to engage patients from start to finish during the drug development process. Today, patients are empowered by technological advances that have given them access to more information than ever before, especially regarding diseases and drug development.

Posted in: Clinical,
07
Oct
FDA FY2018 Drug Inspection Observations And Trends

The FDA recently published GMP drug inspection data from CDER that addresses drug inspections conducted during the agency’s 2018 fiscal year. This article examines the FY2018 data and evaluate six years’ worth of trends in FDA GMP inspection enforcement.

Posted in: FDA, Manufacturing,
01
Oct
Pharma 4.0: Building Quality Into Pharma Manufacturing, From Molecule To Medicine

One of pharma’s greatest foibles as an industry has been the penchant to focus on the wrong things. We saw this with process analytical technology (PAT), where we focused on the design and implementation of the technology and ignored the impact of foundational material characterization and supplier control. Pharma 4.0 has the potential to fall into the same trap.

Posted in: Manufacturing,
30
Sep
An Introduction To Prefilled Syringe Selection — Needle-Free And Dual-Chamber Devices

This two-part article will provide an introduction to the three general prefilled syringe (PFS) types and will share important factors to take into consideration for your drug product. In this first part, we will discuss the needle-free PFS and the dual-chamber system.

Posted in: Manufacturing,
25
Sep
Danger Ahead: What Biotech Companies Need To Know About Leasing Space

One of the most significant moves for a growing biotech or pharmaceutical company — sometimes considered as a graduation step — is the acquisition of property to conduct clinical trials and manufacture commercial products. In the first installment of this two-part series, we will explore what considerations companies need to make before they decide what type of property to pursue.

Posted in: Manufacturing,
24
Sep
Do The Arguments For Pharmaceutical Price Increases Make Sense?

This article will share recent analysis of price increases within the healthcare sector in an effort to understand the growth of healthcare expenditures and pharmaceutical prices over time.

Posted in: Manufacturing,

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