Avid Bioservices Inc (CDMO)

[biopharm]

FDA Review Article Provides New Insights into Cancer Immunotherapy Product Development; Beneficial to all Involved in Cancer Treatment

June 14, 2013

A picture of what the FDA is looking for in cancer immunotherapy product development appears in an extensive review article published in the inaugural issue of the Journal for ImmunoTherapy of Cancer. This review outlines a series of recommendations from the FDA, including cited FDA guidances, which should streamline the development of cancer immunotherapy products today and potentially allow for better treatment options for patients with cancer.

A plan for combination treatment is also part of the FDA review, and recommends that researchers characterize each product individually and provide a strong scientific rationale for the combination. Further, even if the combination regimen uses a standard cytoreductive agent with immunologic effects, dose and timing of administration need to be presented.

“Importantly, the flexible parameters for development and evaluation presented in the document reflect the broader experience now in place and deeper understanding of how immune therapies might be applied in the new generation of trials in development,” said Lisa Butterfield, Associate Professor of Medicine, Surgery and Immunology at the University of Pittsburgh Cancer Institute.

Prior to this review, the definition of product potency, purity, and toxicology evaluation were difficult to define, due to the complexity of cancer immunotherapy products. However, from the series of recommendations made by the FDA in this review, along with the cited FDA guidances, including the state of the art data needed for manufacturing, pre-clinical studies, and clinical trial designs of cancer immunotherapies, the complex landscape of cancer immunotherapy can now be better understood.

The document also addresses the issues of previously only using immunotherapy treatment in advanced and metastatic disease patients. It is now understood that both early and late stage patients can be included in immunotherapy trials, and considerations for both settings are addressed. The potential importance of keeping patients who show signs of early tumor progression on a study from which they may subsequently benefit later is also discussed.

Based on the early new data in the field of cancer immunotherapy, it is a very crucial time for all those involved in the treatment of cancer. This FDA review provides clarity in the development of cancer immunotherapies, which will advance the field forward, and help to make the word “cure,” a reality for patients with cancer.

http://www.news9.com/story/22596283/fda-review-article-provides-new-insights-into-cancer-immunotherapy-product-development-beneficial-to-all-involved-in-cancer-treatment

----------------------------------------------------------------

Can anyone hear "Bavituximab" when reading: "It is now understood that both early and late stage patients can be included in immunotherapy trials.." and I conclude that means early stage patients to be included in Breast, Lung and more importantly, in Pancreatic Trials all to come......

------------------------------------------------------------------

Also, I suspect the latest job posting for a Sr. Scientist, protein characterization is for assistance possibly.... due to the paragraph that states:

researchers characterize each product individually and provide a strong scientific rationale for the combination. Further, even if the combination regimen uses a standard cytoreductive agent with immunologic effects, dose and timing of administration need to be presented.

------------------------------------------------------------------

GLTA!