Why You Should Participate in the Voluntary FDA Oncology Center of Excellence Assessment Aid Program

In 2018, the FDA’s Oncology Center of Excellence developed an Assessment Aid document to help facilitate review of New Drug Applications (NDAs)/Biologics License Applications (BLAs) (including supplements) submitted to the Center for Drug Evaluation and Research’s (CDER’s) Office of Oncology Diseases (OOD). Providing the Assessment Aid with your NDA/BLA is voluntary. As noted by the … Continued

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

Maximizing Oligonucleotide Therapeutic Development: Pre-clinical and Translational Considerations

This is the second of three blog posts discussing best practices for developing oligonucleotide therapeutics. The first blog in the series explained how these therapies work. Characterizing the pharmacokinetics (PK) of an investigational oligonucleotide drug is an important part of its pre-clinical development program as well as informing its later clinical development. In this blog, … Continued

Watershed Moment for the Future of Cell Therapy Development – FDA Advisory Committee Meeting

Every FDA Advisory Committee meeting is unique, and the Cellular, Tissue, and Gene Therapies Advisory Committee meeting that took place on April 15, 2021 was not any different. The agenda included discussion of a biologics license application (BLA) for donislecel (purified allogeneic deceased donor pancreas derived Islets of Langerhans) for the treatment of brittle Type … Continued

SNDS: A Goldmine for Effective Decision Making?

Real-World Data (RWD) have been increasingly used to further understand the natural history of a disease or condition, treatment patterns in RW practice, as well as the effectiveness, safety and costs associated with treatment options. They help exploring research questions, potentially complement clinical trial findings, and fill knowledge gaps. Different existing data sources can be … 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

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