It can be challenging to navigate the current regulations for orphan drugs. By partnering with this industry powerhouse, clients can rest assured they have a trusted advisor at every step of the orphan drug development process.
Silver Spring, MD (PRWEB) November 10, 2014
Coté Orphan, LLC, a leader in orphan drug regulatory affairs, today announced the addition of a new line of service for its clients by providing Clinical Research Organization (CRO) services that will help organizations navigate the clinical trials process through the lens of regulatory affairs. With the addition of the CRO services, Coté Orphan provides companies a complete and robust solution to those developing or seeking to develop orphan drugs.
According to research from the Center for Information & Study on Clinical Research Participation (CISCRP), the process of creating a safe, useful medicine can take more than 20 years from start to finish. Further, CISCRP’s research finds that only 19 percent of drugs in the clinical trial process are even submitted to the FDA for approval.
Through the launch of this new CRO, Coté Orphan will provide clients with a valuable service that designs clinical trials for orphan drugs to fit the current regulatory frameworks set forth by the Food & Drug Administration (FDA) and European Medicines Agency (EMA). Dr. Timothy Coté, CEO of Coté Orphan, recently serving as the Director of the FDA’s Office of Orphan Product Development, is utilizing his vast experience and knowledge in the regulatory process while at the FDA to provide an invaluable service to organizations undertaking clinical trials.
“We are thrilled to enter this new chapter in our business,” said Dr. Coté. “We see this as a natural evolution in services that are vital for the orphan drug development process. By designing trials processes that are already in compliance with current regulations, we are helping to drastically cut the time to market for these types of drugs. This, in tandem with our other planning and execution services, puts us in a position to provide a one-stop-shop service to clients – from inception through to acceptance.”
Coté Orphan has tapped Harry Cook, possessing more than 36 years of experience in the pharmaceutical industry, as Director of the Clinical Operations. Mr. Cook’s experience includes major exposure to the NDA process and hands-on oversight of the clinical function, including clinical trial design, budgeting, investigator selection, site initiation, monitoring, data analysis, report writing and pharmacovigilance. Mr. Cook has either led or been instrumental in more than 14 major drug submissions in the United States and abroad in a variety of therapeutic areas.
“I’m honored to join the Coté Orphan team to bring this valuable service to clients seeking to develop orphan drugs to treat some of the rarest diseases afflicting individuals today,” said Mr. Cook, “It can be challenging to navigate the current regulations for orphan drugs. The necessary clinical trials are a significant endeavor to garnering regulatory approval. By partnering with this industry powerhouse, clients can rest assured they have a trusted advisor at every step of the orphan drug development process.”
You can visit Coté Orphan (Exhibit #2) at the World Orphan Drug Congress in Brussels, Belgium taking place November 12-14, 2014.
Coté Orphan, LLC, a regulatory affairs advisory firm based in Silver Spring, MD, provides valuable strategic planning and execution services to companies developing or seeking to develop orphan drugs. Under the leadership of Dr. Timothy R. Coté, an orphanology expert and former Food and Drug Administration (FDA) Director for the Office of Orphan Products Development (OOPD), Coté Orphan demystifies the FDA regulatory process. COC knows the FDA hurdles unique to orphan products and forges successful pathways to orphan product designation. To learn more about Coté Orphan’s CRO, please visit http://www.coteorphan.com or call 202-759-9599.