Assessing The Value Of Wearables In Interventional Clinical Trials

Posted by Fuld + Company on May 24, 2018 11:41:01 AM

By Prem Meyyan and Stephen Ames, Fuld + Company

Originally published in: Clinical Leader

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Topics: Medical Devices, wearables, technology, data, clinical trials

Wearable Devices Provide a New Look for the Modern Clinical Trial

Posted by Premdharan Meyyan on Oct 24, 2017 10:34:40 AM

Clinical development has historically been a laborious and expensive process, driven by lengthy patient recruitment timelines, increasingly complex study designs, and high procedural costs, across different therapeutic areas. Additionally, a complex and dynamic regulatory framework has made it difficult to introduce new technologies to facilitate the development process. 

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Topics: Market Analysis, Medical Devices, Life Sciences

New Video! Companion Diagnostics

Posted by Fuld + Company on Dec 11, 2015 8:00:00 AM

Companion diagnostic (CDx) devices are in vitro and imaging tools that are paired with specific drug therapies. Part of a larger trend towards personalized medicine, they are used to identify patients most likely to benefit from a specific therapeutic agent or to determine appropriate dosage. 

While questions remain about who should bear the cost for companion diagnostics, the promise of greater safety and efficacy and the potential for faster regulatory approval have made this an area of growth for both pharmaceutical and molecular diagnostics clients.

David Staknis, Principal, Practice Head Global Life Sciences, and Ken Sawka, CEO + President, discuss increased requests for monitoring development and expansion of CDx platforms, earlier coordination by pharmaceutical and diagnostics firms, and the benefits of CI for optimizing R&D spending.

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Topics: Competitive Intelligence, Early Warning Monitoring, Medical Devices, Pharma, Healthcare, Life Sciences

Companion Diagnostic Strategy: Who Bears Those Costs?

Posted by Alexis Kuchins on Sep 28, 2015 4:25:04 PM

The 2015 World CDx conference in Boston, Massachusetts brought together thought leaders from pharma, diagnostics, and companion diagnostic companies (CDx). This dynamic group of individuals engaged in a dialogue on areas such as next generation sequencing and companion diagnostics, precision medicine, and the regulatory landscape. In conversation with participants and presenters there was a consistent theme of seeking to understand companion diagnostic strategy and who will bear those costs.

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Topics: Competitive Intelligence, Brand Insights, Innovation, Manufacturing/Industrial, Market Analysis, Medical Devices, Pharma, Scenario Analysis, Healthcare, Life Sciences

Sell-Offs and Mergers and Trades, Oh My!

Posted by Bruce Chin on Aug 18, 2015 11:44:41 AM

Current Trends in Big Pharma and What It Says About the Market

After unprecedented M&A activity in the last 20 years in Big Pharma, the trend of devolution isn’t just a topic that became popularised in Scotland. The pharmaceutical industry seems to be experiencing a similar trend. From the spin-off of AbbVie from Abbott in 2012 to Baxter’s specialised medicines spin-off, Baxalta, last month, the trend seems to be continuing. It continues with the swap of Novartis’s non-influenza vaccines business for the bulk of GSK’s oncology portfolio.

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Topics: Competitive Intelligence, Market Analysis, Medical Devices, Pharma, Healthcare, Industry Convergence, Life Cycle Management, Life Sciences, Merger and Acquisition, Product Positioning, Competitive Strategy

Biosimilar Infliximab - What's All the Excitement About?

Posted by Adi Reske on Aug 11, 2015 11:05:24 AM

When in April this year the FDA accepted Celltrion’s filing for Remsima, the biosimilar Infliximab, patients and healthcare professionals in the United States were excited by the potential of a cheaper alternative to the expensive Remicade, an FDA approved tumor necrosis factor (TNF)-alpha inhibitor for the treatment of rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriasis, Crohn's disease (CD), and ulcerative colitis (UC) . However, a couple of weeks before the anticipated advisory committee, the FDA postponed discussions for an unknown date, requesting more information from Celltrion. Meanwhile, the excitement died down.

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Topics: Competitive Intelligence, Market Analysis, Medical Devices, Pharma, Healthcare, Life Cycle Management, Life Sciences, Product Positioning, Competitive Strategy

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