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Dr. Richard Lutes: Helping Meet Unmet Needs

Dr. Richard Lutes, MD, can trace his passion for medicine back to his childhood, when his mother, a nurse, inspired him to help others in need. This was a motivating factor in his work as a Battalion Surgeon in the … Read More

seamless trial design

Seamless Clinical Trial Designs – Risks and Rewards

After half a century of relying on the traditional three-phase clinical trial design, the US Food and Drug Administration (FDA) is providing guidelines to allow drug sponsors to change the way they test cancer therapeutics in the clinic. As we … Read More

dermatology lesions

Tools and Technologies for More Objective Dermatology Clinical Trials

From the reliance on visual assessments to the lack of a consensus on instruments for assessment and monitoring, there are many causes for this subjectivity concern. However, there are a variety of tools and technologies available that can help make this process more objective.

FDA IND Submissions, Novella Clinical

What You Need to Know About Submitting an IND to the FDA

As the nation’s principal authority overseeing the safety of food, drugs and cosmetics, the US Food and Drug Administration (FDA) requires manufacturers to provide proof of the safety and efficacy of their drugs before bringing them to market. This has … Read More

Seamless single arm clinical trials, a faster route to FDA approvals, man walking across a divide, bridged by yellow dashed line

Paving the Way for More Seamless Oncology Trials

The US Food and Drug Administration (FDA) is highlighting efforts to promote innovative trial design that will accelerate the typically time-consuming and expensive process of developing and testing drugs for cancer patients. New trial designs, often referred to as seamless … Read More

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A Silver Lining to the Immuno-Oncology “Gold Rush”

With the recent clinical success of cancer immunotherapeutics, such as checkpoint inhibitors, there has been a dramatic influx of public, academic, and industrial interest in the immuno-oncology (IO) field. Many pharmaceutical companies are looking for the next breakthrough drug and … Read More