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

Business Wire, June 10, 2009

Clinical Contract Research Organization Provides Incubator Expertise to Mitigate Risk Factors

SAN DIEGO -- 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.