Patient and site relationships are a primary concern to pharma and bio companies. The desire to be a sponsor of choice to both groups, as well as CRO partners, is suddenly a hot trend in the industry. Bristol-Myers Squibb saw both of these trends coming years ago, and has been taking steps to improve those relationships.
In part one of this series, we examined the history of companion diagnostic approvals by FDA and identified trends to suggest better approaches to optimize the review process. Here, we will analyze new avenues sponsors may consider to further streamline the review of these important products through the assessment of various regulatory submission types and FDA guidance.
In this article — part one of a two-part series — we will examine the history of companion diagnostic approvals by FDA. Through this process, trends can be identified to suggest better approaches to optimize review times.
Though the announcement may seem recent, it was actually in October of last year when Vice President Biden boldly announced the “moonshot to cure cancer,” a personal passion fueled by his son’s death from the disease. Half a year later, this tall-order still has the industry – and world’s – attention, remaining the cause of consistent speculation and debate.
Your clinical trial is finally underway, and most of the sites you engaged are ready to start enrolling patients. Yet for some reason, your study is already behind schedule. What went wrong? What can you do to get it back on track? Is a protocol amendment required?
While the annual meetings of the American Society of Clinical Oncology (ASCO) can almost always be counted on to generate news about scientific breakthroughs in understanding and treating cancer, the theme for this year’s conference goes beyond that conventional approach. ASCO 2016 Annual Meeting will prominently feature discussions about how clinicians can best integrate recent advances, and particularly how to best assess the impact on real-world patients.
Over the years, an entire system called ‘cold chain supply (or cold chain transport)’ has developed in the food industry to ensure that foods that need to be kept cold are stored and transported in appropriate conditions and are monitored so consumers and regulators can be assured of their safety.
Vaccines, one of the most useful and cost-effective means of reducing illness and death from infectious diseases, are enjoying a resurgence of interest that some have pronounced a renaissance. With hundreds of vaccines in research and development worldwide, vaccines are among the fastest growing segments of the biopharmaceutical market today.
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Electronic Data Capture (EDC), which collects clinical trial data electronically rather than on paper, is becoming an increasingly popular solution for streamlining data processing.
It’s important to take advantage of a slow-down in activities to plan for the future. Use any downtime during summer to plan ahead for your patient enrollment push in September and into the following year.
Clinical supply teams have been managing a surge in packaging, labeling, and distribution projects due to a rapidly increasing number of investigator initiated clinical trials. Theses are studies in which the primary investigator also serves as the study sponsor with investigational drugs or devices typically donated by a manufacturer.
Mortalities are rare during a clinical trial, especially during the initial stages. But in January 2016, six men in France who had enrolled in a phase I trial of a pain relief drug suffered brain damage. One man died. FDA regulators began working with their French counterparts to understand what happened to the six men who signed up to test the drug, which goes by the name BIA 10-2474.
The broad appeal of emerging markets for comparator sourcing is offset by the innumerable challenges that can arise in such regions. By addressing concerns prior to the jump into uncharted territory, risks can be minimised and common pitfalls avoided.