Synteract Offers Consulting Expertise to Venture Capitalists Funding Biopharmaceutical Start-ups

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Wed Jun 10, 2009 11:28am EDT

Clinical Contract Research Organization Provides Incubator Expertise to Mitigate
Risk Factors


SAN DIEGO--(Business Wire)--
Synteract, Inc., a full-service contract research organization (CRO) dedicated
to meeting the clinical research, technology, and safety needs of biotechnology,
medical device, and pharmaceutical companies, has expanded its consulting
offerings to include expert advice to venture capital organizations (VCs) that
fund biotech, medical device, and pharmaceutical start-ups. 

Many biopharmaceutical companies approach VCs when they are at the stage of
conducting phased trials to get their products to the next level of development
and eventual marketing approval. Venture capitalists, even those who specialize
in pharma and biotech, often do not have in-house clinical expertise to assess
product development programs for integration of sound science with the realities
of the regulatory and marketing environment, despite their business expertise.
Clinical study protocols must be developed that reflect clinical potential of
the product, anticipate its marketability and maximize successful outcomes. It
is advantageous for the VC to gain clinical assistance from a consulting
organization that has expertise in clinical, safety, regulatory, data management
and post-marketing knowledge. 

Synteract`s offering provides support for the due diligence process by
contributing:

* Comprehensive evaluation of current clinical study program(s) planned or in
progress, with a review from clinical, regulatory, statistical, pro forma
budgeting, timeline/milestone and marketing perspectives 
* Assessment of the prospective portfolio company`s plans for successfully
executing the clinical development programs to achieve marketing approvals,
based on thoroughness, sufficiency of resources and timing.

In addition, Synteract can provide an assessment that will help the start-up
company understand what aspects of its studies may need assistance. Synteract
often designs and supports comprehensive product development programs for its
VC-funded clients, integrating key clinical, market and regulatory
considerations. 

"With Synteract's strong background and experience in early clinical development
for biotech, pharma and medical device firms, the company is uniquely positioned
in the CRO space to provide these much needed services to early or mid-stage
portfolio companies of life science VC firms. In addition, the utilization of
Synteract`s expertise during the diligence process in evaluating potential
investment opportunities would be an asset for life science VC firms," said
Michael J. Magliochetti, Ph.D., CEO of Claros Diagnostics and past
Entrepreneur-in-Residence at Oxford Bioscience Partners LP. 

About Synteract

Established in 1995 by two veterans of the pharmaceutical industry, Synteract is
a privately held, full-service contract research organization, dedicated to
meeting the clinical needs of biotechnology, medical device, and pharmaceutical
companies. The company`s mission is to provide high quality yet personal
service, working closely with drug and device sponsors as though a department
within their company. Headquartered in Carlsbad, California, with a second
office in Research Triangle Park, North Carolina, Synteract has clinical trial
expertise in a wide range of therapeutic areas, including a strong emphasis in
oncology, central nervous system (CNS), cardiovascular disease, and
ophthalmology. Information, http://www.synteract.com or (760) 268.8200. 



For Synteract
Beth Walsh
beth@clearpointagency.com
858-724-2500 



Copyright Business Wire 2009

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