 |
Press Releases and Publications |
|
|
Norwich Clinical Research Associates to join at the Evolution Summit 2011, hosted by marcus evans March 28, 2011
Norwich Clinical Research Associates (NCRA) is a moderately sized, flexible and competitively priced contract research organization (CRO) headquartered in central New York State, USA. Privately held, NCRA is an independent CRO committed to providing quality work cost effectively. NCRA has been trusted since 1994 by a pharmaceutical, medical device, biotech and nutraceutical clientele for expert product development consulting and regulatory guidance and for quality clinical research services. The Evolution Summit (www.evolutionsummit.com) has been designed to provide a unique interactive forum for Chief Medical Officers and Chief Scientific Officers working in a cross-section of industries. Over the course of three days, a carefully scheduled series of presentations, case studies and one-to-one business meetings will provide NCRA with strategic advice as well as networking opportunities with leading industry experts. NCRA representatives will have a number of pre-scheduled meetings with senior executives from reputable Fortune 1000 companies. The Evolution Summit attendees will follow a personalized agenda designed to maximize their limited time and to effectively meet their business needs and interests. A sampling of keynote speakers include: Rebecca Kush, President & CEO, Clinical Data Interchange Standards Consortium; Dr. Douglas J. Manion, Vice President, Development, Neuroscience and Virology, Bristol-Myers Squibb Company; and Paul Beninger, MD, FACP, Vice President, Global Patient Safety, Genzyme Corporation. marcus evans Summits (www.marcusevans.com), produces high-level business platforms for the world’s leading decision-makers. These dynamic and innovative forums initiate and develop business relationships one-on-one between director and C-level practitioners from the world’s most influential organizations and with leading product and service suppliers. marcus evans Summits guarantees an exclusive format which enables participants to achieve the maximum amount of business and knowledge interaction over a three day event in a stimulating environment. Please note that the Evolution Summit is a closed business event.
NCRA collaborating as BTLs preferred CRO on Regulatory Submissions and Upcoming Trials:Beech Tree Labs' Urinary Incontinence Trial Begins: Release Date: April 13, 2011 Providence, RI--(BUSINESS WIRE)--Beech Tree Labs, Inc. announced today that it has initiated a Phase 1/2a clinical evaluation of its novel therapeutic agent, UISH001, for treating urinary incontinence (UI). This FDA-approved study is a 60 patient, placebo-controlled trial. As referenced by the National Association for Continence, UI affects 200 million people worldwide. Twenty five million adult Americans experience transient or chronic UI with 75 to 80 percent of those sufferers women, 9 to 13 million of whom have bothersome, severe, symptoms. In addition, one-third of men and women ages 30 to 70 have experienced loss of bladder control at some point in their adult lives and may be still living with the symptoms. The cost of managing UI in the U.S. alone exceeds $20 billion. Treatment approaches have ranged from drugs to plugs to hypnosis. In one small IRB-approved blinded study, the Company's product candidate for the treatment of UI has demonstrated efficacy in treating urge, stress, and mixed incontinence. Beech Tree's founder and CEO, Dr. John McMichael said, "The incidence of urinary incontinence is increasing as a consequence, in part, of our aging society. It represents an unmet medical need since most of the products now available are accompanied by adverse effects for a significant number of patients. This phase 2a trial is being conducted to determine if UISH001 can meet that need." Beech Tree Labs is a privately held biopharmaceutical company, a leader in novel molecular signaling technology with an extensive patent portfolio that includes other potential therapeutics targeting a broad spectrum of chronic disorders. The Company specializes in discovery and early-stage development through Phase 2 clinical trials and out-licenses to larger pharmaceutical and biotech firms for continued evaluation and marketing. In addition to this trial, Beech Tree is currently conducting a FDA Phase 1/2 clinical trial for recurrent oral herpes. Beech Tree Labs' Oral Herpes Trial Begins: Release Date: September 14, 2010 Providence, RI--(BUSINESS WIRE)--Beech Tree Labs, Inc. announced today that it has initiated a Phase 1/2a clinical evaluation of its novel therapeutic agent for treating recurrent oral herpes infections. This FDA-approved study is a 210 patient, multi-site, placebo-controlled trial of its agent BTL-TML-HSV. According to WHO and CDC statistics, over 80 percent of the population have oral herpes with about 20 percent of these expressing symptoms. In addition, one of four adults has genital herpes, with the incidence steadily increasing. Treatment options for herpes are limited. Beech Tree's founder and CEO, Dr. John McMichael said, "While our initial clinical focus in on oral herpes, we have evidence that suggests our patented agent may address a broad range of herpes virus indications." He went on to say, "The active agent is also embodied in a product candidate that recently received FDA approval of an IND targeting influenza, reflecting a growing anti-viral platform." Patient enrollment for the influenza trial will begin at the onset of the upcoming flu season. Beech Tree Labs is a privately held biopharmaceutical company, a leader in molecular signaling technology with an extensive patent portfolio that includes other potential therapeutics targeting a broad spectrum of chronic disorders. The Company specializes in discovery and early-stage development through Phase 2 clinical trials and out-licenses to larger pharmaceutical and biotech firms for continued evaluation and marketing. In furthering its partnership outreach, Beech Tree is attending BioPharm America 2010 being held this week in Boston. FDA Approves Beech Tree Labs' Recurrent Oral Herpes Infections IND Application Another successful collaboration milestone for NCRA and BTL! News source: Business Wire. July 7, 2010 Providence, RI--(BUSINESS WIRE)--Beech Tree Labs, Inc., announced today that the FDA has approved its IND for a Phase 1/2a clinical evaluation of BTL-TML-HSV, a novel therapeutic agent for treating recurrent oral herpes infections. The study will be a 210 patient, multi-site, placebo-controlled trial and is anticipated to begin later this summer. According to WHO and CDC statistics, over 80 percent of the population have oral herpes with about 20 percent of these expressing symptoms. One of four adults has genital herpes, with the incidence steadily increasing. Herpes simplex, the virus causing oral herpes, serves as the prototype of a Beech Tree Labs' approach that potentially addresses a broad spectrum of herpes virus indications. The active agent is also embodied in a product candidate that recently received FDA approval of an IND targeting influenza, presenting evidence of a growing Beech Tree anti-viral platform. FDA Approves Beech Tree Labs' Influenza IND Application
|
