Replies to post #192246 on Avid Bioservices Inc (CDMO)

[biopharm]

Development of Surrogate Endpoints for Cancer Immunotherapy Trials

Oct 5, 2014
7 A.M.

This year, in conjunction with the CRI Symposium, we will be hosting a special Cancer Immunotherapy Consortium (CIC) satellite meeting on Sunday, October 5, 2014 entitled Development of Surrogate Endpoints for Cancer Immunotherapy Trials. The meeting will consist of a full day of presentations and panel discussions addressing the key rationale, challenges, and solutions surrounding the development of surrogate endpoints for cancer immunotherapy. This meeting will represent the culmination of a CIC-led community-wide effort that brings together the major stakeholders in the field, including experts from industry, academia, and regulatory bodies as well as patients. The output of the meeting will be a consensus-driven roadmap for the efficient regulatory approval of future immunotherapies.

http://www.cancerresearch.org/grants-programs/cancer-immunotherapy-consortium/annual-scientific-colloquium/2014-satellite-meeting

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Hot off the press... Sept 30, 2014.... and again, surrogate endpoints all the talk ...

The Use of Surrogate Endpoints in Regulating Medicines for Cardio-Renal Disease: Opinions of Stakeholders


Bauke Schievink,

Hiddo Lambers Heerspink mail,

Hubert Leufkens,

Dick De Zeeuw,

Jarno Hoekman

Published: September 30, 2014
DOI: 10.1371/journal.pone.0108722

Received: February 26, 2014; Accepted: September 3, 2014; Published: September 30, 2014

Abstract
Aim

There is discussion whether medicines can be authorized on the market based on evidence from surrogate endpoints. We assessed opinions of different stakeholders on this topic.

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Thirdly, alternative ways of using biomarkers in the regulatory assessment of medicines are currently considered. The FDA and EMA recently introduced a procedural framework for the qualification of novel biomarkers

http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0108722

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