Breast cancer is the most common malignancy in women and the second most common cancer worldwide.1 Rates of breast cancer are increasing in many parts of the world, reflecting its association with social and lifestyle factors related to economic development, as well as increases in life expectancy.2 Although the disease …
Cell and Gene Therapy Answers: Bioanalytical support for cell and gene therapy
Your source for answers to the complex challenges of cell and gene therapy development. We recently spoke with Daniel Sikkema, executive director of global immunochemistry at Labcorp drug development, regarding bioanalytical support for cell and gene therapy modalities. He shared some of the current challenges in cell and gene therapy, …
Rare Disease Day 2022: Supporting patients, celebrating advancements
February 28 is Rare Disease Day, a day dear to the hearts of many at Labcorp. The day is observed to raise awareness and give support to the more than 300 million people worldwide living with rare diseases, as well as their family members and caretakers. At the heart of …
Cell & Gene Therapy Answers: Addressing Complex Analytical Needs with ddPCR/qPCR
Your source for answers to the complex challenges of cell and gene therapy development. Watch the Video As the rate of cell and gene therapy development increases, Labcorp Drug Development has continued to invest in the technology, capacity and expertise globally to support the evolving and complex analytical needs of …
Cell & Gene Therapy Answers: The Evolving Cell & Gene Therapy Landscape
Your source for answers to the complex challenges of cell and gene therapy development. We recently sat down with Maryland Franklin, Vice President and Enterprise Head of Cell & Gene Therapy at Labcorp Drug Development, to discuss key considerations for developing cell or gene therapies in today’s quickly expanding pipeline.
IND-Enabling programs for gene therapies
Gene therapies continue to hold promise as treatments for many diseases but there are numerous and unique challenges to developing them for submission as an Investigational New Drug (IND)/ Investigational Medicinal Product Dossier (IMPD) application for use in clinical trials. These applications require an optimized scientific program designed to address …
IND-Enabling programs for adoptive cell therapies
Chimeric Antigen Receptor T Cells, In Vitro and In Vivo Preclinical Models, plus regulatory and safety considerations We presented on and discussed in a webinar the adoptive cell therapy preclinical program central to an IND/IMPD submission. The following is a brief summary, plus insightful Q&As from that event.
Emerging immuno-oncology therapies: life after checkpoint inhibitors
The clinical approval of biological therapeutics inhibiting CTLA-4 (ipilimumab), PD-1 (nivolumab, pembrolizumab) and PD-L1 (atezolizumab, avelumab, durvalumab) has ushered in a revolution in the field of cancer immunotherapy. Thus far, the approvals have occurred in a small number of cancer histotypes including melanoma, non-small cell lung cancer and urothelial cancers, …