Articles By Ed Miseta
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How To Improve CRO Oversight With Data & Analytics
9/19/2017
Karen Brooks holds the title of senior director of clinical operations at Adare Pharmaceuticals, but the title may be misleading. With Adare being a growing specialty pharmaceutical company, Brooks is currently the entire clinical operations department. That means she wears many different hats, including operations, monitoring, management, recruitment, and retention. At the inaugural Clinical Leader Forum in Philadelphia, Brooks discussed her role in overseeing CROs.
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Lessons In Collaborating With Big Pharma
9/8/2017
Any small biopharma knows the importance of collaborating or partnering with larger companies and academic institutions. But where do you start, and who should be involved? And what kind of risk should you take on?
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Pharma “Not Prepared” For New EU Data Protection Regulation
8/23/2017
Pharmaceutical companies, CROs, and software/application vendors with operations in the European Union (EU) may be at serious risk from the new EU General Data Protection Regulation (GDPR). Violations of the regulation, which is set to go into effect in 2018, can result in penalties of €20 million or 4 percent of worldwide revenue.
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Government Funding And Technology: The Right Ticket For Small Pharma
8/9/2017
Soligenix is a late-stage biopharmaceutical company focused on rare diseases. The company’s president and CEO discusses how government grants and contracts can be one way to help fund research.
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Genentech Masters Breakthrough Therapy Designation
6/7/2017
Genentech has garnered 15 Breakthrough Therapy Designations for its medicines since 2013, which is more than any other company. Jeffrey Siegel, senior group medical director for Genentech, believes this success reflects the company’s focus on developing new approaches to address unmet medical needs.
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CRO Partnering: The Only Constant Is Change
5/9/2017
"Change is the only constant in life.” That quote is attributed to Greek philosopher Heraclitus, but its theme still resonates today in many areas, including pharma. When it comes to clinical outsourcing, it certainly seems like the only thing that doesn’t change is change.
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The Risk & Rewards Of A Fully Outsourced Clinical Model
5/9/2017
For years, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany used a mixed clinical outsourcing model. The company conducted some trials in-house but outsourced others to external service providers. For trials in development around the world, the company had four global CRO providers. For regional Phase 4 and label expansion studies there were as many as 100 different providers, which included niche CROs from around the world.
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Takeda Outsourcing Model Seeks The Best Of Both Worlds
5/9/2017
Dr. Azmi Nabulsi will tell you that one of Takeda’s principal beliefs is that it cannot do everything on its own. Therefore, the company strives to achieve excellence in R&D by working with trusted partners. As the deputy CMSO (chief medical and scientific officer) and head of strategic and professional affairs for Takeda, Nabulsi understands that the benefits of those partnerships can manifest themselves in everything the company does, from bringing new compounds into the pipeline to increasing operational efficiencies. The strategic partnership Takeda formed with PRA Health Sciences last year was a major part of that philosophy and the company’s drive toward excellence in clinical trials.
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Finding The Right CRO For Rare Disease Trials
5/9/2017
CRO selection is a challenge for every company outsourcing clinical trials. When the trial you are about to launch is for a rare genetic disease and has 30 patients spread across several countries and continents, the challenges are multiplied.
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Lessons Learned From The Rise And Fall Of Scios
4/7/2017
When Roger Mills began his career in the medical profession, he never imagined he would one day end up working for a Big Pharma company or find himself in the middle of a controversy over attempts to bring a new cardiology drug to market. That journey would see a small company teeter on the brink of bankruptcy, experience the highs of a new drug approval and acquisition by a large company, and finally, the downfall and collapse of the approved medicine.