Shepherding Therapeutic Cancer Vaccines through Clinical Development | Page 6

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Development Strategies for Success

The challenges in
developing
cancer immunetherapeutics are
not
insurmountable,
but they require a
development
team that
understands the
space of immunetherapeutics as
well as regulatory
hurdles.

A clear understanding of where a therapeutic will fit into the marketplace is
essential to a development plan. Key considerations include the size of the
target population, potential hurdles in obtaining approval from the U.S. Food
and Drug Administration (FDA), potential for reimbursement by insurance
providers, and cost of development and manufacturing. According to Barry
Rooth, executive vice president of Quantum Immunologics, “The challenges in
developing cancer immunotherapeutics are not insurmountable, but they
require a development team t ][