What to Consider Before Conducting a First In Man Trial

Conducting a First In Man (FIM) clinical trial with a novel drug product is a complicated process that requires an abundance of caution. Also known as Phase 0 trials, FIM ...
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Do You Need an IND for Clinical Trials?

Generally speaking, if the intent of a clinical trial is to determine the safety and efficacy of a new drug, or changes to an existing drug, then IND submission is required. ...
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How Early Should Patients be Enrolled in Clinical Trials of an Investigational Substance

Traditional early clinical development programs have utilized normal healthy volunteers of both sexes in an escalating single-dose trial. These trials are often use small ...
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Should Phase II Trials Target Only One Population?

In this post, we share why it can sometimes be a good idea to expand Phase II trials. While doing so may seem counterintuitive to most medical affairs professionals, consider ...
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How and Why You Need to Build a Fully Integrated Product Development Plan

The development planning process of a biopharma candidate, balancing scientific strategy with corporate needs is imperative to success. Therefore, biopharma teams need to ...
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The Importance of Assessing ‘Value’ in Early Clinical Development

It is no longer adequate to proceed through the early clinical development phase with just an assessment of safety and tolerance. Many development programs strive to ...
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