Each year, we designate the last day in February as Rare Disease Day to raise awareness about the potential impact we can make for this important segment of the world’s population. From policy makers to researchers to health authorities, we all play a part in making a difference for more than an estimated 300 million people in the world suffering from a rare disease.
To mark the event, I would like to reflect on my role to move the needle and make a difference to patients that are awaiting life-changing treatment. My journey started as a clinician where I had the privilege in caring for patients with a variety of rare diseases. At a personal level, I am also the aunt of a very special boy who suffered for 8 years with a rare cardiopulmonary disease. To me, rare diseases are not so rare. Continue reading
Facing ever-increasing costs of running a clinical trial, sponsors must ensure they are properly directing their budget and resolving the areas of highest risk while maintaining patient safety and data integrity.
How can sponsors implement a robust process to allow earlier identification of emerging risks during the course of a trial? This article covers five tips for defining risk levels, categorizing risk and maintaining oversight to ensure that risks and responses are appropriately identified, documented, tracked and managed throughout the life cycle of a study. Continue reading
The Chinese pharmaceutical market continues to grow steadily, but drug developers in China face similar challenges as their global counterparts: Development times are increasing and success rates are declining. Xiaoning Guo, PhD, PMP, clinical development program director of Covance Asia Pacific, recently discussed potential strategies to improve investment returns and accelerate global development.
An evolving landscape
“Regulations in China have changed a lot with new policies and guidelines as the China Food and Drug Administration (CFDA) is strongly promoting innovation,” said Guo. “Domestic pharma companies in China can benefit from revised IND review timelines and approval processes to get their clinical trials in Phases I through III approved simultaneously.”
Each year, new medicines are launched globally but few are available to Chinese patients, in comparison to those in the US or EU. Drug developers are working to reduce this gap and expand the reach of new molecular entities (NMEs) so that they can improve healthcare to patients in need. Confronting this issue requires navigating the evolving regulatory environment in China and capitalizing on parallel development opportunities in the global market.
Bill Hanlon, PhD, vice president, head of Global Regulatory Affairs, shares some of the latest thoughts and strategies from his recent presentation at the Covance Clinical Seminar in China.