May 2020

When to sprint and when to breathe in the race from lab to clinic – 5 critical steps to success

As an early-stage or small-sized biotech company, you need to move fast and be nimble.  Success is measured in sustained progress towards milestones.  Time is not on your side and you need to get it right the first time. The key to success is understanding that while the fastest path is often tempting, the right …

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Hiring Challenges in Bioprocessing for Start-ups

Creating Bottlenecks in Europe; Opportunities for Production Staff BioPlan Associates, Inc. Hiring of bioprocessing professionals has remained a stubborn problem over the past 11 years, and will only get worse, according to BioPlan’s 17th Annual Report and Survey of Biopharmaceutical Manufacturing[1].  This is bad news for bioprocessing, but potentially good news for experienced staff seeking …

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Investigator’s Brochure (IB)

FDA Rules for the Content, Tone and Format of an Investigator’s Brochure

Investigator’s Brochure template is provided to attendees. An Investigator’s Brochure (IB) is perhaps one of the most important documents used in clinical trials after the clinical protocol. The IB provides the detailed background of the investigational product to the doctors participating in the trial and gives talking points to discuss with the subjects and IRBs. …

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