Catalyst Pharmaceutical Partners, Inc. Names Director - Corporate Clinical Compliance
Catalyst Pharmaceutical Partners, Inc. today announced the appointment of Patrick Kenny as Director - Corporate Clinical Compliance. In this capacity, Mr. Kenny will be responsible for ensuring the effectiveness and GCP compliance of the CROs, clinical contractors and clinical trial sites involved in the clinical trials conducted under Catalyst's sponsorship.
Commenting on today's announcement, Douglas Winship, Catalyst's Vice President of Regulatory Operations, noted, "Mr. Kenney joins Catalyst at a key point of our corporate development, the initiation of our first series of U.S. clinical trials. He will play a critical role in auditing the performances of our contractors involved in our sponsored clinical trials to assure overall compliance with current Good Clinical Practices guidelines. Pat will also identify opportunities for implementation of improvement programs and training needs, as well as help determine additional resource needs required by the clinical trial sites to facilitate expeditious trial completion. I am confident that his strength in the areas of clinical development planning and coordination, FDA regulations and project leadership will allow him to play an important role at Catalyst as we push forward with the clinical development and ultimate commercialization of CPP-109 for the treatment of both cocaine addiction and methamphetamine addiction."
Mr. Kenny brings to Catalyst 18 years of experience in conducting clinical research programs leading to product approvals in the pharmaceutical industry. Prior to joining the Company, Mr. Kenny was employed by Kendle International, Inc., a leading contract research organization, as a Senior Clinical Research Associate. Prior to joining Kendle, Mr. Kenny served as a Clinical Research Associate for several pharmaceutical companies including Acorda Therapeutics, Elan Pharmaceutical Research Corporation and Sandoz Pharmaceutical.
"We are pleased to welcome Mr. Kenny to Catalyst at such an important juncture for the Company," said Patrick McEnany, Catalyst's Chief Executive Officer. "Our clinical programs are generating solid momentum, including the continued enrollment of subjects for our U.S. Phase II cocaine trial and the expected initiation in the second quarter of our U.S. Phase II methamphetamine trial. The cutting-edge research we are undertaking to stem the cycle of drug addiction through treatment with vigabatrin is continuing to garner interest in the market. We were especially pleased that the positive results obtained under the Catalyst-funded, investigator-sponsored, Phase II, double-blind, placebo-controlled clinical trial in Mexico, treating patients addicted to cocaine with vigabatrin, was included in Newsweek Magazine's cover article on addiction in the March 3, 2008 issue. In the article, one of the foremost experts in the field of addiction noted that the results of this trial provide the best efficacy signal of any trial conducted so far for cocaine treatment and that treatment with vigabatrin seems especially promising, even for patients that are hardest to treat -- long-term cocaine addicts. We believe strongly in the viability of our technology and the promise that treatment with CPP-109, our version of vigabatrin, may bring to patients, the healthcare system and society at large. We have many goals to achieve and look forward to the innumerable contributions that Mr. Kenny will bring to the Company as we pursue this important work."
Source : money.cnn.com
Commenting on today's announcement, Douglas Winship, Catalyst's Vice President of Regulatory Operations, noted, "Mr. Kenney joins Catalyst at a key point of our corporate development, the initiation of our first series of U.S. clinical trials. He will play a critical role in auditing the performances of our contractors involved in our sponsored clinical trials to assure overall compliance with current Good Clinical Practices guidelines. Pat will also identify opportunities for implementation of improvement programs and training needs, as well as help determine additional resource needs required by the clinical trial sites to facilitate expeditious trial completion. I am confident that his strength in the areas of clinical development planning and coordination, FDA regulations and project leadership will allow him to play an important role at Catalyst as we push forward with the clinical development and ultimate commercialization of CPP-109 for the treatment of both cocaine addiction and methamphetamine addiction."
Mr. Kenny brings to Catalyst 18 years of experience in conducting clinical research programs leading to product approvals in the pharmaceutical industry. Prior to joining the Company, Mr. Kenny was employed by Kendle International, Inc., a leading contract research organization, as a Senior Clinical Research Associate. Prior to joining Kendle, Mr. Kenny served as a Clinical Research Associate for several pharmaceutical companies including Acorda Therapeutics, Elan Pharmaceutical Research Corporation and Sandoz Pharmaceutical.
"We are pleased to welcome Mr. Kenny to Catalyst at such an important juncture for the Company," said Patrick McEnany, Catalyst's Chief Executive Officer. "Our clinical programs are generating solid momentum, including the continued enrollment of subjects for our U.S. Phase II cocaine trial and the expected initiation in the second quarter of our U.S. Phase II methamphetamine trial. The cutting-edge research we are undertaking to stem the cycle of drug addiction through treatment with vigabatrin is continuing to garner interest in the market. We were especially pleased that the positive results obtained under the Catalyst-funded, investigator-sponsored, Phase II, double-blind, placebo-controlled clinical trial in Mexico, treating patients addicted to cocaine with vigabatrin, was included in Newsweek Magazine's cover article on addiction in the March 3, 2008 issue. In the article, one of the foremost experts in the field of addiction noted that the results of this trial provide the best efficacy signal of any trial conducted so far for cocaine treatment and that treatment with vigabatrin seems especially promising, even for patients that are hardest to treat -- long-term cocaine addicts. We believe strongly in the viability of our technology and the promise that treatment with CPP-109, our version of vigabatrin, may bring to patients, the healthcare system and society at large. We have many goals to achieve and look forward to the innumerable contributions that Mr. Kenny will bring to the Company as we pursue this important work."
Source : money.cnn.com
Posts
Post a Comment