Mike Novotny, founder and CEO of Medrio, shares an experience from early in his career of building databases that showed him by having the right data at the right time, doctors can make decisions allowing patients to live their best lives possible.
Conducting the advanced therapy supply chain orchestra is more than waving a stick at people – it is an “end to end”, complicated, inter-related system that requires controlled, consistent management. Following are some things you need to think about to develop the capability to provide a harmonious supply chain management system.
What it is, why it is important, and what sponsors need to think about as it gets closer.
Preventing patients from receiving “counterfeit, diverted, sub-potent, substandard, adulterated, misbranded, or expired drugs” is a critical element of the mission of the US Food and Drug Administration (FDA). Chain of custody for genetic and cell therapies differs and is more complex than for traditional pharmaceuticals, and the requirements for documentation vary as well.
Read how new initiatives reinforce the importance of the patient’s voice, acknowledge the limitations of traditional approaches and build on the lessons that emerge from each new study.
Clinical research is complicated. At WCG, we frequently get questions about the ethical conduct of research from clinical team members at biopharma companies and study sites. We know that for many of the questions we get, the person asking is not the only one struggling with that issue. Read the questions your peers are asking – and if you don’t see yours, submit one of your own.
A common issue regarding “faltering” studies – studies that are not satisfying their time, cost, and quality parameters – is poor recruitment. Recruitment issues can delay deadlines and jeopardize the drug’s ultimate approval, if left unresolved. If your study is struggling because of recruitment issues, here are some considerations that can be used to rescue your clinical trial.
Don’t assume your clinical trial will survive endless change orders, extended deadlines, cost overruns, and missed objectives. Recognizing early warning signs that your trial is in trouble, and taking quick decisive action, can often get studies back on track. Improving operations can solve most failure risk factors, thus increasing the odds of success.
The longer you addressing a faltering clinical trial, the greater the risk your trial progresses from faltering to failure. And the deeper a trial's problems, the more likely you'll have to ask for a substantial budget increase—another difficult conversation. Here are some tips to act quickly for the best ROI.
For all its demographic promise, the Asia-Pacific (APAC) region has been slow to emerge as a center for US and EU biotech clinical drug research. Patient access in this region is now a strong motivator. Read further observations about the future of the APAC region in biotech drug research.
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