Articles By Ed Miseta
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Are Absolute Cell Counts Essential In Drug Discovery?
5/11/2015
While absolute cell counts have been a part of diagnosis for a long time, what is new are absolute count relevance to drug discovery and development.
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TransCelerate Moves Forward With Electronic Label Initiative
5/5/2015
TransCelerate BioPharma has announced an innovative electronic labels (e-labels) information channel to support its member companies. The initiative will work to enhance label usefulness for patients, while providing more consistent labeling approaches for sites. The initiative offers the potential to reduce clinical labeling timelines in the investigational supply chain and create cost efficiencies for pharma companies.
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Will 21st Century Cures Modernize Drug Discovery? Part 2 – Issues & Solutions
5/4/2015
I recently had the opportunity to attend a dinner discussion in Washington DC, attended by many industry executives and dignitaries, to discuss 21st Century Cures. In this article, the focus is on issues with physician and patient involvement in trials, possible remedies, and hopes/concerns regarding the legislation.
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Will 21st Century Cures Modernize Drug Discovery And Development?
5/1/2015
After a year of discussions, white papers, roundtables, and the vetting of issues by stakeholders across the industry, both democrats and republicans are ready to move forward with legislation that would attempt to bring the drug discovery and approval process into the 21st century.
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To Hear The Voice of the Patient, Create An Advocacy Department
3/31/2015
Lori Abrams, head of advocacy, diversity and patient engagement for Global Development Operations at BMS, had to build a department and recruit personnel to form a group that would ensure the voice of the patient is included in the design and execution of trials.
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Opdivo And Praluent Expected To Lead The Class Of 2015
3/25/2015
Which pharma offerings should you keep an eye on in 2015? Thomson Reuters has released its 2015 Drugs To Watch report, with insights into those medications expected to enter the market this year and make a big splash for their developers.
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When Measuring Clinical Quality, Beware Of The Metrics Trap
3/18/2015
When discussing the topic of measuring quality in clinical trials, Mike Howley advises sponsors and CROs not to place too much focus on metrics.
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Pharma Outsourcing Trends: Industry Leaders, Equity Financing, And Vendor Consolidation
2/26/2015
The outsourcing industry continues to gain a bigger share of the dollars spent on preclinical, clinical, and post approval functions. To accurately quantify the size of various segments of the outsourcing market, this report acknowledges that task is next to impossible.
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Hiring A Chief Medical Officer May Sound Good, But…
2/18/2015
Laurie Halloran has seen many firms succeed where others have failed. She will tell you she started her company after speaking to many executives about how to grow their companies, get funding, make it through clinical testing, and finally going commercial.
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WIB Profile: Emerging Markets Drive Growth In Biologics
2/12/2015
I was able to catch up with Daniella Kranjac, integration leader and head of commercial operations, to discuss her position with GE Healthcare and the trends she sees occurring in the biologics market.