Developing Cancer Therapies and Diagnostics: 4 Pieces of Advice

Insights in to the molecular and genetic basis of disease are driving new product and therapeutic opportunities while changing the treatment paradigm for many cancers. The use of companion diagnostics in oncology may play a role in optimizing and expediting the development of targeted therapies for many cancers and other conditions.

Focusing on these new markets, a panel of industry executives and investors at the 2011 BIO Investor Forum discussed some of the most compelling new technologies and applications for companion diagnostics in oncology.

Scott Allocco, president and co-founder of Biomarker Strategies, moderated the discussion and asked the panelists to provide advice to companies that using their limited resources to develop a drug when, in fact, they might also need to dedicate resources to the development of diagnostics. Here are the panelists’ responses:

1. “Our advice is certainly to engage early, even with a small number of patients, in developing a package for a phase one. By that time, the FDA is required to at least have an understanding that there are biomarkers involved and that is part of a solution for the drug company.” Rollie Carlson, PhD, president, Asuragen

2. “It’s important to partner with organizations that understand diagnostics; that understand the value of different platforms; and then can help a pharmaceutical company or biotech company translate that potential biomarker in to a test that can be very robust.” Steven Anderson, PhD, chief scientific officer of oncology and genetics, Labcorp and Monogram Biosciences

3. “When you start early, it doesn’t mean that you qualify for your biomarker at day one. It’s simply recognizing the fact that there could be a marker, or a set of markers, you want to track – one of which may be validated and part of the package that goes to the FDA.” Vivek Mittal, PhD, manager, Health Advances, LLC

4. “[My company needs] some indication if the antibody reaches a target that it does something to that tumor. By that, I don’t mean a reduction in tumor size, I mean molecular signature, so signal that you’re directly detecting anti-tumor activity.” Alan Wahl, senior developer oncology, global pharmaceutical research and development, Abbott

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One Response to Developing Cancer Therapies and Diagnostics: 4 Pieces of Advice

  1. Raghu Pandurangi says:

    Dear all;

    Yes, although tumor regression is the clinical end point, we can not afford to wait to understand the efficacy of therapy. Development of blood-borne markers based on the mechanism of action of drug or target can ease our ways to estimate the efficacy quickly. One may also want to consider the estimate of cell death above the base level using ELISA assays (to be validated) in patient blood.

    We have shown CR-18 or HGM protein as a good common biomarker of induction of cell death irrespective of mechanism of drug and/or target.

    Also, during early design, one needs to consider several dysregulated paths in cancer and try to activate those signal pathways using targeted approach and such revamping is found to help induce a better response from existing therapies. We have developed “A priori activation of Tumor Technology” AATT with 7-10 biomarker platforms as pretreatment strategies to evoke a better response from therapy. In every case, we have used CR-18 biomarker for assessing therapy cost effectively in days Vs weeks taken by conventional approach.

    Thanks for sharing;

    Raghu Pandurangi, Ph.D.

    President: Sci-Engi-Medco Solutions Inc.
    St Louis MO, USA

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