Topic

SVP, Clinical Pharmacology & Translational Medicine

Articles

Oncology drug developers must start asking questions in preparation of FDA’s dose optimization initiative.

With Project Optimus, Success Favors the Prepared

Rik de Greef, senior vice president of global quantitative science services at Certara discusses the organization's training initiatives in Africa. 

Program Aims to Tap Africa's Potential in Pharmacometrics

CEO, Createrna Science and Technology, former Director of FDA’s Division of Pharmacometrics

Sirj Goswami, PhD, CEO, co-founder of InsightRX

Continued embrace of precision dosing will reduce costs and optimize clinical outcomes.

Understanding FDA’s Perspective on Precision Dosing

Gabi Hanna, MD highlights the need for an effective therapy for acute pancreatitis.

Moving Toward the Pharmaceutical Industry of the Future with Translational Medicine

Radiomics can help life sciences companies realize the full value of their imaging pipelines. 

Radiomics: What It is and What It Can Do for Clinical Trials

Pharmaceutical industry trends will directly impact the clinical diagnostic world, resulting in a more integrated therapeutic strategy.

The Future of Clinical Diagnostics

The rapid emergence and global acceptance of new regulatory guidance has thrust cardiac safety to the forefront of new drug development during recent years. This is because the cardiac safety effects of new drugs is the most common cause of drug withdrawal from the market, or delays and a lack of regulatory approval for marketing. The resulting ECG Global Regulatory Imperative creates issues and offers opportunities for new drug developers striving for Best Practices in this important area.

Early Phase Development