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 The
examples below illustrate how WinPharm assisted client companies
with promising early stage products.
WinPharm played the key role in the design and implementation
of the plans that led to the rapid acquisition of proof-of-concept
clinical data. |
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| Cardiac surgery combination drug-device
product |
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| A novel approach to stopping and starting
the heart during surgery to facilitate bypass surgical procedure
without using cardioplegia and aortic cross-clamping. |
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| In porcine models, the product stopped
the heart safely and allowed surgery. The traditional Phase
I normal volunteer first-in-human study was inappropriate
for this product. The company needed proof-of-concept human
data as soon as possible. |
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| WinPharm helped conceive and design
a single cardiac surgery study that allowed first-in-human
safety data to be collected from a cohort of patients followed
by sequential cohorts of patients that provided proof-of-concept
data. |
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| WinPharm worked with the sponsor to
secure Pre-IND approval of the study design, file the IND
and then complete the study as planned. The data from the
study enabled an End-of-Phase 2 meeting with FDA to define
the requirements for approval. The timespan from Pre-IND meeting
to End-of-Phase 2 FDA meeting was 18 months. |
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| Locally-acting drug delivery therapy |
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| Anti-thrombotic agent |
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| The anti-thrombotic molecule bound
to vessel walls near the site of injection. The choice of
initial therapeutic target as well as the clinical studies
to be conducted would provide validation of the sponsor's
technology platform. |
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| WinPharm identified occluded hemodialysis
shunts as an attractive clinical setting for a combined first-in-human
and proof-of-concept study. WinPharm aided in the Pre-IND
meeting with the US FDA and then designed and conducted the
study on Sponsor's behalf. |
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| The study provided both initial safety
data and proof-of-concept data and will enable progression
directly to Phase 2-3 studies. |
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| Immunologic therapy for prostate
cancer |
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| A vaccine that produces antibodies
to gonadotrophins |
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| The Sponsor had secured several plans
from larger consulting firms outlining a multiple study sequence
to proceed from first-in-human through proof-of-concept studies.
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| WinPharm was able to design and conduct
a single study to collect first-in-human safety data as well
as proof-of-concept data. |
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| The on-time, on-budget delivery of
proof-of-concept clinical data enabled the Sponsor to reach
an informed decision about the viability of the product. |
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