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LIFESCIENCELEADER.COM NOVEMBER 2014
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C o m b o c r i t e r i a ?
Biologic rationale based on the mecha-
nisms of action will be used to prioritize
testing of combinations. Preclinical mod-
els may provide additional insights, but
ultimately, combinations will need to be
tested empirically in the clinic.
N a r r o w o r w i d e a p p l i c a t i o n s ?
Initial approvals will be in advanced
patients with relatively narrow indica-
tions based on single arm trials in some
cases. Subsequent confirmatory tri-
als earlier in the treatment paradigm
will be randomized and address larger
patient populations. If dramatic anti-
tumor effects with clear clinical bene-
fit are observed in individual patients,
then we can anticipate that cohorts of
patients in smaller indications could be
sufficient for label expansion or at least
reimbursement.
P e r s o n a l o r b r o a d ?
Initially, combinations will be tested on
groups of patients rather than on indi-
viduals. By appropriately investing in
biomarkers that can help predict which
patients are benefiting, we will have the
opportunity to tailor the agent or com-
bination to a particular patient. Some of
the pathways or immune mechanisms are
common across various disease types, and
it is possible to imagine moving towards
a paradigm where we screen patients for
a biomarker and treat them based on the
biomarker, as opposed to whether they
have a particular cancer type.
C o m m e r c i a l i z a t i o n c h a l l e n g e s ?
Historically, companies have been hesi-
tant to let their drugs be tested in com-
binations prior to obtaining regulatory
approval. That appears to be changing,
and we are seeing several companies part-
ner on combination studies early in the
drug development process. Regulators
also are more receptive to new approach-
es to bringing combinations to market.
Cost of goods will need to be controlled
with novel biologic therapies, but the
increased clinical benefit that can poten-
tially be provided by these approaches
should still translate to value for patients
and payers.
We have run as many company responses as
space allows this month and will follow with the
remainder next month and beyond if needed to
follow this rich vein of lessons in translational
R&D;, business development, scale-up, and
commercialization of breakthrough medicines.
We are still open to hearing from other
companies that either missed our first invitation
or believe they belong in the conversation.
Meanwhile, please join the discussion on Twitter
at #CCIRLSL.
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