Chemoprevention Strategic Initiative

The C-Change Cancer Chemoprevention Research Initiative aims to resolve major barriers – limitations in patent and intellectual property law; uncertainty of reimbursement; lengthy clinical trial processes involving the emerging science of biomarkers; and the uncharted regulatory approval process – to stimulate an increased intellectual and financial investment in chemoprevention and cancer research.

By accelerating the development of promising chemoprevention agents, cancer can be prevented.

ISSUES SUMMARY 

Opportunities
Supporting the development of cancer-preventing drugs offers three important opportunities:

  1. To reduce the burden of cancer. We have discovered ways to prevent cancer with drugs that we are not able to pursue due to barriers that do not support science
    or stimulate the business model.
  2. To further accelerate the emerging national priority of health prevention. Recognizing and embracing the importance of healthy living and early detection to reduce the risk of cancer, the value of research and drug intervention are often overlooked in the context of prevention.
  3. To maintain and advance our position as a global leader in science and in this emerging field. The environment in other nations is simply more supportive of these advances. 

Barriers
Several major barriers deter the research community from investing time, attention, and funding in this field:

  1. The process for conducting clinical trials and seeking drug approval using new scientific techniques - namely biomarkers - is uncharted.
  2. Patent and intellectual property law for preventive drugs and vaccines that require longer clinical trials are too limited.
  3. Reimbursement for preventive agents is highly uncertain.

Solutions

  1. Cancer-preventing drug and vaccine research should be prioritized and well funded and the drug approval process should be updated to support the science and accelerate discovery.
  2. Patent and intellectual property protection as well as tax incentives should be implemented for preventive drugs and vaccines to stimulate investment and make the business model feasible.
  3. Reimbursement for cancer-preventing agents should be provided to ensure patient access to treatment.

HILL BRIEFING

On July 20, 2009, C-Change and Friends of Cancer Research hosted a Hill Briefing. Please click on the link below to view the program from the event.

PDF of Hill Briefing Program

     
Left photo: Senator Dianne Feinstein, Vice Chair, C-Change. Right photo: Ron Herberman, Intrexon; Frank Meyskens, Chao Family Comprehensive Cancer Center, University of California, Irvine; Marty Smith, patient advocate; Catherine P. Bennett, Prevent Cancer Foundation Board; Bruce Pyenson, Milliman, Inc., Victor G. Vogel, American Cancer Society; Samir N. Khleif, National Cancer Institute

     
Left photo: Victor G. Vogel, American Cancer Society; Ron Herberman, Intrexon. Right photo: Bruce Pyenson, Milliman, Inc.; Catherine P. Bennett, Prevent Cancer Foundation Board; Frank Meyskens, Chao Family Comprehensive Cancer Center, University of California, Irvine; Samir N. Khleif, National Cancer Institute; Ron Herberman, Intrexon; Marty Smith, patient advocate; Victor G. Vogel, American Cancer Society.


PUBLICATIONS

Executive Summary & Recommendations

Background

Patent Law

Reimbursement

Clinical Trials and Regulatory Approval

  • White paper working title: "Therapeutic Prevention for Cancer Risk Reduction: Proposed Pathway to Regulatory Approval for Chemoprevention," C-Change / Meyskens, Curt, et al. (Completion pending - Winter 2010).

Full Compendium - contains all of the above publications:

Removing Barriers to a Larger National Investment in Chemoprevention Drug Development 2008


Factsheets
The C-Change Cancer Chemoprevention Factsheets were developed by participants in the 2007 C-Change Summer Internship Program. These emerging leaders made a unique contribution to the C-Change Chemoprevention Initiative by developing a set of resources for the public. With input from the National Cancer Institute, interns developed patient-focused factsheets that provide easy to understand information regarding cancer, chemoprevention, cancer vaccines, and clinical trials. The fact sheets were presented at the American Association for Cancer Research, Frontiers in Cancer Prevention Research Public Forum on December 7, 2007 in Philadelphia, PA, and can be readily accessed below:

C-Change recognizes the contributions made to the research and development of the C-Change Chemoprevention Series Fact Sheets:
 

 Summer Intern Internship Host 
Jennifer Sponsler, Project Leader      
Leigh Joan Boghossian
Jennifer C. Evans
Margaret Iverson
Candace Marshall
Gabriela Pena
Veronica Wright
National Cancer Institute
American Cancer Society
American Association for Cancer Research
Friends of Cancer Research
National Cancer Institute
Baylor College of Medicine Intercultural Council
National Cancer Institute