Shepherding Therapeutic Cancer Vaccines through Clinical Development | Page 9

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current and previous medications. When tissue staging is critical to the study
design, it’s important for the eligibility criteria to specify that patients must
either have previous tissue samples or be willing to undergo a biopsy prior to
enrollment.

Partnering with
regulatory
consultants can
also be helpful in
navigating the
complexities of
the regulatory
environment.

Important regulatory relationships. Knowing how to navigate

adaptive trial design or understanding what the FDA may be looking for in a
study submission can save valuable time and resources. The FDA’s Office of
Oncology Drug Products takes a collaborative approach to working with
sponsors and will often provide input on a study design. In his experience, Rooth
of Quantum Immunologics has found, “By presenting a reasonable and cogent
plan to the agency, we received very thoughtful consultation and advice specific
to our development program.” Partnering with regulatory consultants can also
be helpful in navigating the complexities of the regulatory environment. Quality
assurance organizations can conduct audits to ensure GCP is maintained
throughout a study.

Conclusions
Despite setbacks, the strategy of using immunotherapy to target tumor cells
remains popular. The vaccine Provenge, for prostate cancer, is in the
marketplace, and approximately 10 other therapeutic cancer vaccines are in
phase 3 clinical development. As genomic technology continues to provide
insights into tumor cell identification, the field of therapeutic cancer vaccines is
poised to make great strides in improving clinical benefit to patients.

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