CRC/EORTC/NCI Joint Formulation Working Party: experiences in the formulation of investigational cytotoxic drugs.

The pharmaceutical formulation of a new anti-tumour agent has often been perceived as the bottleneck in anti-cancer drug development. In order to increase the speed of this essential development step, the Cancer Research Campaign (CRC), the European Organization for Research and Treatment of Cancer (EORTC) and the National Cancer Institute (NCI) agreed in 1987 to form the Joint Formulation Working Party (JFWP). The main goal of the JFWP is to facilitate the rapid progress of a new drug through pharmaceutical developmental to preclinical toxicology and subsequently to phase I clinical trial. Under the auspices of the JFWP around 50 new agents have been developed or are currently in development. In this report we present our formulation experiences since the establishment of the JFWP with a selected number of agents: aphidicolin glycinate, bryostatin 1, carmethizole, carzelesin, combretastatin A4, dabis maleate, disulphonated aluminium phthalocyanine, E.O.9, 4-hydroxyanisole, pancratistatin, rhizoxin, Springer pro-drug, SRI 62-834, temozolomide, trimelamol and V489. The approaches used and problems presented may be of general interest to scientists in related fields and those considering submitting agents for development.     

NCI Image-Guided Drug Delivery Summit

On April 17, 2010, scientists from academia, the National Cancer Institute (NCI), and the Food and Drug Administration (FDA) assembled at "The NCI Image Guided Drug Delivery Summit," in Washington D.C., to discuss recent advances, barriers, opportunities, and regulatory issues related to the field. The meeting included a scientific session and an NCI/FDA session, followed by a panel discussion of speakers from both sessions. Image-guided drug delivery (IGDD) in cancer is a form of individualized therapy where imaging methods are used in guidance and monitoring of localized and targeted delivery of therapeutics to the tumor. So, a systematic approach to IGDD requires mechanisms for targeting, delivery, activation, and monitoring of the process. Although the goal in IGDD is to optimize the therapeutic ratio through personalized image-guided treatments, a major challenge is in overcoming the biological barriers to the delivery of therapeutics into tumors and cells. Speakers discussed potential challenges to clinical translation of nano-based drug delivery systems including in vivo characterization of nanocarriers, preclinical validation of targeting and delivery, studies of biodistribution, pharmacokinetics, pharmacodynamics, and toxicity as well as scale-up manufacturing of delivery systems. Physiologic and quantitative imaging techniques may serve as enabling tools that could potentially transform many existing challenges into opportunities for advancement of the field.     

Thirteenth AACR Special Conference on Cancer Epigenetics

The 13th American Association of Cancer Research (AACR) Special Conference on Cancer Epigenetics was held in San Juan, Puerto Rico, on January 20-23, 2010. This event heralded insights arising from the large sequencing efforts within the NIH Epigenetics Roadmap Project and the Cancer Genome Atlas Project, as well as important new discoveries in the basic biology of epigenetics and results of epigenetic drug clinical trials. A summary of the recent findings is presented here, with particular emphasis on the major themes of the conference.     

EORTC Imaging Group

Imaging data have the potential to provide information on disease profiling pertaining to diagnosis, prognosis, selection of therapy, monitoring of response to therapy and pharmacokinetic information of drugs. Selection of the most appropriate imaging modality for a specific task will be vital for diagnosis, stratification, treatment response or treatment efficacy, toxicity assessment, and treatment outcome measures (progression-free survival). The EORTC Imaging Group was formed to establish and maintain the scientific and clinical value of advanced imaging in EORTC clinical trials. The group focuses on the development of specific analytical and review procedures as well as quality control procedures, in the context of clinical trials conducted by the EORTC groups.