Oncology & Hematology
Adaptive Trial Designs in Early Oncology: Minimizing Risk & Accelerating Timelines
Over the past decade, significant advances have improved our understanding of the genetic and molecular mechanisms that lead to cancer.
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Oncology & Hematology
Med Ad News – Optimizing Early Oncology Studies Through Adaptive Trial Designs
Despite advances in technology and our understanding of the genetic and molecular underpinnings of cancer, making a meaningful impact on the survival and quality of life of patients with cancer remains a significant challenge. In fact, a recent review revealed...
Oncology & Hematology
iPSP Considerations for Molecularly Targeted Cancer Drugs
With the passage of the Pediatric Research Equity Act (PREA) of 2003, drug manufacturers were required to submit an initial pediatric study plan (iPSP) prior to commencement of Phase 3 studies (or new drug application [NDA]/biologics license application [BLA] submission...
Oncology & Hematology
5 Things to Know About the FDA RACE for Children Act
The Research to Accelerate Cures and Equity (RACE) for Children Act aims to improve and expand treatment options for pediatric cancer patients by mandating that all new adult oncology drugs also be tested in children when the molecular targets are...
The Research to Accelerate Cures and Equity (RACE) for Children Act The Research to Accelerate Cures and Equity (RACE) for Children Act aims to improve and expand treatment options for pediatric cancer patients by mandating that all new adult oncology...
Oncology & Hematology
Contract Pharma – Realizing the Full Potential of Precision Medicine in Oncology
Innovation in oncology drug development is being driven by “precision medicine." Precision medicine promises a new paradigm in oncology where every patient receives truly personalized treatment. This approach to disease diagnosis, treatment and prevention utilizes a holistic view of the...
If you are planning to submit a New Drug Application (NDA) for an oncology drug product in 2020, revised pediatric study plan requirements could have an impact on the submission. FDA recently released draft guidance on changes to pediatric study...
Oncology & Hematology
Unlocking the Full Potential of Precision Medicine in Oncology
Precision oncology promises a new standard of care where therapies are tailored to the molecular profile of a specific tumor. For the full potential of precision medicine to be realized, regulatory, technical, clinical, and economic frameworks will need to evolve to the nuances of these novel treatments.
Oncology & Hematology
Considerations for Operationalizing Pediatric Oncology Studies
Remarkable progress has been made in our understanding of the genomics of pediatric cancers, and these advancements have led to the recognition that products being studied for use in adult cancer indications may have health benefits for pediatric patients. By...
Oncology & Hematology
The Challenges in Fulfilling the Promise of Personalized Oncology
Personalized oncology promises a new model of cancer care where medical decisions are based on a holistic view of the patient, including their genes, environment, and lifestyle, and tailored to the molecular profile of their tumor. To date, great strides...