Sunday, December 1
is World AIDS Day, an international day dedicated to raising awareness of the
AIDS pandemic caused by the spread of HIV infection, and a time to remember
those who have died of the disease. It has been observed worldwide since 1988.
Oren Cohen, MD,
Covance Chief Medical Officer, was an infectious disease physician in New York
City during the early days of the epidemic and shares this remembrance:
In 1848, the most famous Gold Rush in American history began at Sutter’s Mill near present-day Coloma, California, shaping the US economic map forever. In those days, there were no scientific tools to guide prospectors in their search. Sites of previous finds were the starting point for what became, for many, a shattered dream.
Is it possible for a global CRO to improve – and even reshape – today’s drug development industry? We think so. We work with people like you to offer unique perspectives at every stage of development – from early phase development to clinical trials and commercialization.
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Providing integrated services to the global biotech and pharma industry
Covance and Arcinova recently expanded a strategic relationship following the signing of a sales services agreement at the end of 2016. Under the terms of the agreement, Covance is offering Arcinova services alongside its own extensive range of drug development capabilities.
Arcinova is a contract research and development organization based in Alnwick, UK. The Company provides small molecule drug substance, product and analytical support from preclinical through to Phase II. Since its inception in February 2016, Arcinova has built on the legacy customer base developed when it was a Covance site, and is now serving biotechnology and pharmaceutical companies on four continents. Continue reading →
The Development Landscape for Non-Alcoholic Steatohepatitis Q&A
Q&A with Claudia Filozof, MD, PhD, Senior Medical Director in the Phase II-IV Cardiovascular/Metabolic Group and Richard Williams, PhD, JD, Executive Strategist, Global Regulatory Affairs
Is this a good time to develop a NASH drug, and if so, why?
Claudia: Yes, it’s a very good time. There are multiple companies starting NASH development, and there is a huge unmet medical need with no treatment approved so far. Health authorities also have shown a lot of interest in supporting companies to speed up development. If you have the right compound, there are multiple advantages to starting a NASH program.
Richard: The cost to society will be enormous if we can’t treat this disease. I think most pharmaceutical companies, big and small, see this as a substantial unmet medical need. With this unmet medical need, regulatory agencies can grant conditional approval (accelerated approval in the US), where the drug is approved for marketing with the condition that the company later shows it has a clinical benefit based on clinical outcomes. Continue reading →
Is it possible to get more efficiency in your conventional and specialty tests while maintaining ongoing quality? ISO 15189:2012 accreditation answers this question by delivering a comprehensive approach to quality management in medical, central and referral laboratories. Not only can these standards ensure quality, but they can reduce your risk of costly delays and ultimately save money in your trials.
“It’s no surprise that sponsors are concerned about the risk of regulatory findings and increasingly requesting ISO-accredited labs,” said Paul Kirchgraber, Vice President and Global General Manager at Covance Central Laboratory Services. “They need a demonstration of increasing quality—and savings—across their outsource vendors. Adopting ISO 15189:2012 is a powerful way to highlight our broad quality standards that meet or exceed their expectations.”