| |
Pub Talk
"Revolutionizing Late Stage Clinical
Trials:
The 1747, Inc. Direct-To-Participant Method"
THURSDAY, MAY 23, 2002
By Dr. Naomi Fried
General Manager and Vice President of Business Development
1747, Inc.
Open to the Public. No fee. 5:00 - 7:00 p.m.
The Pub Talk begins at 6:00 p.m.
At this Pub, come hear how
1747 has developed an online system that dramatically reduces recruitment
time, clinical trial duration, and direct trial costs, which means
getting drugs to market faster.
The U.S. Food and Drug Administration (FDA) requires that the safety
and efficacy of new drugs be demonstrated in randomized clinical
trials before they can be marketed. Traditionally, a pharmaceutical
company contracts with a contract research organization (CRO) to
coordinate the complex process of conducting a clinical trial. The
CRO recruits, identifies, and enrolls principal investigators (PIs)
and clinical trial sites which, distribute the drugs, monitor their
effects, and collect data from the participants. This conventional
method of setting up and conducting clinical trials at physical
trial centers can take years and cost millions of dollars per year.
For a typical drug, every additional day it stays under patent
protection can result in an additional $1-2 million of lost revenue.
ABOUT NAOMI FRIED
Naomi Fried is General Manager and Vice President
for Business Development at 1747, Inc. Dr. Fried has over
12 years of experience in engineering and healthcare. During
the past four years, she has assisted eHealth start-ups in fundraising,
developing business strategies and strategic partnerships, and creating
Web-based revenue models. Former clients have included medical
content Web sites, vertical health portals, alternative health networks,
and risk and disease management providers. Dr. Fried advised
Stanford’s School of Medicine in the creation and spin-out
of its medical informatics Internet start-up e-SKOLAR (formerly
SHINE), as well as served as Interim President during its first
year. Dr. Fried earned a B.S. in Chemistry from the University
of California at Berkeley (summa cum laude) and a Ph.D. in Materials
Science Engineering from MIT.
ABOUT 1747, INC.
1747, Inc. (http://www.1747.net)
was founded by a team of healthcare and research professionals with
many years of expertise in conducting clinical trials. e.Lilly
has invested in 1747, Inc. and Eli Lilly is 1747's first customer.
1747 has developed a proprietary, patent-pending online system
that will eliminate the need for intermediaries such as CROs, clinical
sites, and numerous PIs to conduct Phase III and Phase IV clinical
trials. 1747's Direct-to-Participant (D2P) system verifies
participants' eligibility, collects their informed consent, and
then enrolls them using the Internet. Participants are randomized
online and study treatments are delivered directly to their homes.
Data is collected directly from the participant without the
need for them to physically go to a trial center. Using a
virtual trial center rather than a "brick and mortar"
one allows 1747, Inc. to conduct clinical trials more quickly and
at significantly reduced cost. Using the 1747 method, clinical
trials that would take 3 years and cost $5mm using conventional
trial centers can be completed in less than a year and at a fraction
of the cost. For example, a clinical trial (KALM trial) conducted
using Version 1.0 of the 1747 system resulted in savings of approximately
85% in recruitment time, 65-75% in total trial duration, and nearly
80% in direct trial costs.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Dr. Naomi Fried
General Manager & Vice President of Business Development
1747, Inc.
T: 510.530.0796
mailto:naomi_fried@1747.net
|
