Mind the Gap: The Importance of Gap Analysis in Securing Regulatory Approval

Significant pressure to achieve regulatory approval to start generating return on investment can affect any sponsor, but it is of the greatest importance to small biopharma companies without existing marketed products. Biopharma companies may have conducted successful research and put in the work to warrant approval and market access, but to an uninitiated sponsor bridging […]

Advancing Cancer Vaccines to the Forefront of Immunotherapy

Immunotherapy has revolutionized cancer treatment by using a patient’s own immune system to target and eradicate tumor cells. Therapeutic tumor vaccines, as one avenue in this emerging area, are designed to elicit antigen-specific antitumor immune responses. In this paper we provide a comprehensive summary on how our expanding knowledge of immune-oncology, genomics, and bioinformatics has […]

Journal for Clinical Studies: Combination Approaches in Immuno-Oncology Trials: New Horizons for Multiple Tumor Indications

Cancer immunotherapy has steadily been gaining momentum over the last decade, due to its proven efficacy as monotherapy in patients with various tumors, including tumors resistant to chemo- or radiotherapy. With an ever-increasing amount of clinical trials reporting significant benefits in long-term overall survival of patients with specific cancers following mono-immunotherapy, the goal has shifted […]

Put to the Test

Typical Phase 1 oncology studies have changed and evolved as new techniques have developed, and target therapies have begun to reach the market. By looking at the types of drugs used, the dose levels tested and the patient populations focused on, it is possible to see where the current emphasis lies, and where unmet needs […]