Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success

Antibody drug conjugates (ADC) are a unique way to obliterate tumor cells and represent an underutilized immunotherapeutics option in oncology, whether as monotherapy or in combinations. The first FDA approval of an ADC was in 2011, with the introduction of brentuximab vedotin (trademarked Adcetris) by Seattle Genetics (1). ADC development is inherently challenging because it … Continued

Development considerations for pioneering a NASH clinical program

The National Institute of Diabetes and Digestive and Kidney Diseases considers nonalcoholic fatty liver disease (NAFLD) as a condition wherein the liver stores excess fat and nonalcoholic steatohepatitis (NASH) as one type of NAFLD. Individuals with obesity and type 2 diabetes appear to be at greater risk of developing NAFLD. Many innovative and scientifically intriguing … Continued

5 Points to Consider When Designing an Immuno-oncology Clinical Pharmacology Program

Immunotherapy presents interesting and proximally viable therapeutic options in the growing armamentarium of treatment modalities to combat complex, multifactorial diseases. Indeed, its revolution within oncology is astounding. The field has witnessed rampant and clinically significant advances, with the approval of several checkpoint inhibitors. Clinical trials with these inhibitors suggest that there are more robust and … Continued

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