Feasibility Studies Featured Articles
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How One Bio Company Tackled Its Data Visualization Challenge
7/16/2015
Data visualization is a problem for many life science companies. Being able to visualize reliable data in real-time, and make smarter decisions faster, is vital to delivering speed and quality across clinical trials.
While many companies struggle with quality uncertainty and surfacing relevant data trends, those that specialize in rare diseases have a more unique challenge. With rare diseases, trials are open label (patients and researchers both know which drug is being administered) and non-comparative. By design, personnel have access to data in an unblended way. That provides the opportunity to see actual data as it emerges, enabling personnel to understand the data in a way that would not be possible in a blended trial.
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Quality Of Outsourced Trials: Why Do Disconnects Still Exist Between Sponsors And CROs
7/14/2015
The requirement for quality during the conduct of clinical trials is an absolute; a given that few in the pharmaceutical, biotech, and CRO industries would debate. Yet longitudinal survey data collected by The Avoca Group highlight that disconnects - the definitions of what constitutes quality, alignment on required levels of quality, and success at delivering to these expectations - continue to exist. Business models for designing and implementing clinical trials require that multiple stakeholder organizations (e.g. pharma/biotech, CROs, co-development partners, and regulators) align on and successfully implement to mutually agreed quality expectations.
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Lilly's Approach To The Clinical Trial Paradox
2/2/2014
When I sat down with Eli Lilly (NYSE: LLY) and Company’s chief medical officer and coleader of the company’s Development Center of Excellence, Timothy Garnett, it was shortly after the drugmaker’s annual investment community meeting where bankers grilled the leadership team with questions.
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Companies To Watch: Cempra
6/3/2013
Cempra is one of a rare but expanding breed of companies answering the call for new antibiotics.
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Repurposing And Rescuing Pharmaceutical Drugs
4/26/2013
Repurposing marketed drugs or rescuing compounds that failed in clinical trials offers entrepreneurs the potential to replenish pipelines with reduced risk and time.
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Outsourcing Insights From The President Of A Virtual Drug Discovery Company
4/16/2013
Carolyn Green, is the President and Director for Atreaon, Inc., a privately held biopharmaceutical company developing a novel engineered protein called Atsttrin, for the treatment of inflammatory diseases such as rheumatoid arthritis. Having recently completed a $20 million Series A financing to support the pre-clinical development of Atsttrin, Green took time out from her busy schedule to share some of her thoughts and insights regarding the outsourcing of clinical research.
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Toxicometabolomics For Compound Attrition To Reduce Late Stage Failures Due To Safety
4/10/2013
Many ’omics’ technologies have now become the primary way of discovering new biomarkers, and validation of these biomarkers is a relatively new and evolving concept. By Michael V. Milburn, John A. Ryals, and Lining Guo
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How Pfizer Navigates Changing Biosimilar Regulations
4/1/2013
The imminent loss of patent protection on blockbuster biologics is creating an interesting and highly lucrative market opportunity in biosimilars.
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Don't Take It For Granted
3/20/2013
Investigator grant payments are typically the single greatest expense in a clinical trial budget, often accounting for 40 to 60 per cent of the total budget. By Kevin Williams, CFS Clinical
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Online Patient Communities: Accelerating Clinical Trials And Improving Patient Outcomes
3/1/2013
As patients take an increasingly active role in managing their own healthcare, online communities increase the possibility of physician-less clinical trials.