The Potential of Biosimilars – for Drug Makers and Patients

The production of biosimilar drugs remains at a rapid pace and represents not only an advantage for patients but also a remarkable profit opportunity for drug makers. And for patients, the approval of biosimilars may represent the only alternative of treatment due to the extremely high cost of many original biologic drugs. That said, in […]

The Case for Early Regulatory Consideration for Clinical Development of Chimeric Antigen Receptor T cell (CART)

By Jessica Lee, VP, Regulatory Strategy, Head, Cell/Gene Therapy Chimeric Antigen Receptor T cell (CART) has revolutionized the treatment of hematological malignancies, including B-cell acute lymphoblastic leukemia, B-cell lymphomas, and multiple myeloma. Currently, there are five autologous CART therapies approved for various hematologic malignancies. However, there are limitations in producing autologous CART products, including manufacturing […]

Long-Standing Partnerships: Immutep’s CEO, Marc Voigt in an interview for CEO Magazine

In an interview with CEO Magazine, Marc Voigt, CEO of Immutep, discusses the company’s partnership with CATO SMS and the importance of choosing the right partner to support drug development programs. Immutep is a biotechnology company working primarily in the field of cancer. The two companies are collaborating on two clinical trials for treatments of […]

Adaptive Design Considerations for Early Phase Oncology Trials

“Adaptive designs” in clinical research refer to study designs where certain features are left flexible on purpose, so they can be modified within pre-defined limits during the conduct of the trial. The decision on which modifications are selected is taken on the basis that data only becomes available during the study conduct. A most basic […]

Indolent NHL Immuno-Oncology Rescue Study

Background Non-Hodgkin’s Lymphoma (Indolent NHL, PI3K inhibitor) Allucent was contracted to provide rescue study services by a small-emerging biotech company after the originally contracted CRO had difficultly enrolling patients in the challenging indication of refractory, indolent NHL (Follicular Lymphoma, Marginal Zone Lymphoma, or Small Lymphocytic Lymphoma), as well as other quality issues. Allucent set up […]

The Role of Liquid Biopsies in the Clinical Trial Setting

A liquid biopsy is a testing technique where a sample of blood is analysed for cancer cells from a tumour that is circulating in the blood, or for pieces of DNA from tumour cells that are in the blood.i Types of liquid biopsy methods include cell-free DNA (cfDNA), circulating tumour DNA (ctDNA), and circulating endothelial […]

Cancer Clinical Trials: Recent Oncology Research Studies in Review

Oncology is a multi-faceted field of study and a popular one. Cancer clinical trials account for more than 19% of the research studies in progress – but popularity is not a sure predictor of success. Oncology as a therapeutic area has experienced some ups and downs over the past year. In this article, we will summarize some […]

How to Choose Sites for Cancer Trials: Central and Eastern Europe

Site location can have a significant impact on clinical trial success. Study protocols often have established timelines and budget restrictions that offer little room for flexibility. There are also different regulations and regulatory timelines that have to be considered and managed – and that’s when there isn’t a pandemic. The COVID-19 Crisis has forced many researchers to […]

CAR T-Cell Therapy Challenges to Development & Approval

Chimeric antigen receptor T-cell (CAR T) therapy is a revolutionary immunotherapy that uses cells from the patient’s immune system to fight certain kinds of cancer. The first two FDA approved CAR T therapies, Yescarta™ and Kymriah™, were both approved in 2017. Former FDA Commissioner, Scott Gottlieb, noted the significance of these approvals in his October […]