Ethnic and racial minorities are commonly underrepresented in clinical trials. This problem is so severe that in April, the U.S. Food and Drug Administration (FDA) expanded upon existing guidance to further emphasize recommendations to sponsors developing treatments to increase enrollment from underrepresented populations in the U.S., including African-American, Hispanic, Asian and other persons of color, in clinical trials. In the updated guidance, the FDA provided details on what sponsors
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Pharma
Protecting AI’s Boundless Potential in Healthcare
Artificial intelligence can do amazing things for patients, providers and the healthcare business — but only if the right cyber safeguards are in place.
For more than a decade, a cybercrime syndicate known as Evil Corp has tormented organizations around the world with malware and ransomware attacks. And now, it seems, the group has designs on healthcare companies.
“Evil Corp should be considered a significant threat to the U.S. health sector,” the Health Sector Cybersecurity
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Specialty Pharma’s Next Big Opportunity: It’s Time for Patient Access to Adopt an Open Protocol
In January 2020, the financial conglomerate Visa announced it was acquiring a relatively unknown startup, Plaid, for $5.3 billion. Corporate acquisitions like these are not uncommon, but someone at the United States Department of Justice took notice of this announcement. Visa had established a stranglehold on financial transactions. The Justice Department moved to stop the acquisition on grounds that Plaid posed “a threat to this monopoly: it has been developing an innovative
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Site Enablement Platforms Can Accelerate Clinical Trials by 6 Weeks and Reduce Costs by Over $1M
What You Should Know:
- Florence HealthcareTM, a clinical research technology company headquartered in Atlanta, Georgia, recently announced the completion of a year-long third-party study on the impact of Site Enablement PlatformsTM on clinical research timelines and costs.
- The study by Marketcap Consulting is the first to compare how traditional site management approaches differ from site-first Site Enablement Platforms. The study looked at the impact of traditional sponsor
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The $2.8M Medicine: How Data Can Help Insurers Pay for Life-Changing Therapies Without Breaking The Bank
Advanced medical research has brought us to the point where many serious conditions can potentially be treated and even cured - with people who have essentially faced a lifetime of being incapacitated finally able to conduct normal lives. Many of these treatments are drug-based gene therapies–- but they come with an extremely high price tag. The latest example–and most expensive medication to date– is bluebird bio’s recently-approved $2.8 million gene therapy to treat a rare blood
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ConcertAI CEO Talks COVID-19 & The De-Risking of Technology to Keep Trials Moving
Nothing like it had ever happened before – a global slowdown in new study starts and a massive decrease in trial accruals for open studies. The turn of events was a shock for sponsors and providers. Sudden disruptions on that scale rarely hit multiple players in an ecosystem at the same time. But that’s exactly what happened at the intersection of clinical care and clinical development during the pandemic. Researchers and clinicians were forced to change how they operated trials, and
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Drug Price Transparency: Planning for Change
Currently, some 22 states have enacted prescription drug transparency laws that require entities across the drug supply chain to report pricing information to state officials. Designed to shed light on the true cost of drugs and to ensure that consumers and insurers aren’t being gouged, drug pricing transparency laws seek to level the playing field by delivering greater visibility into drug costs. And given the fact that prescription drug prices continue to increase, the topic of drug price
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Apple Adds Medication Tracking to iPhone. How Will It Impact The Specialty Patient Journey?
Imagine visiting your doctor’s office. Instead of swiping a copay card and filling out a paper form by hand, the receptionist says, “We take Apple Health.” You wave your iPhone over a digital kiosk, instantly uploading your current medical record and insurance information. Your copay is then deducted from a health savings account. Voila! The doctor will see you now.
This scenario is no longer relegated to the distant future.
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3 Reasons to Implement an IDMP Solution Early
The European Union (EU) has announced guidance on the Identification of Medicinal Product (IDMP) — and pharmaceutical companies around the world should take notice. While the EU will be the first to design and implement IDMP, other countries, including the United States, will need to begin following suit. It’s imperative that companies begin evaluating what changes need to be implemented, and the sooner pharmaceutical companies act, the better.
Designed to connect data elements and
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The Gains and Pains of Using AI in the Pharmaceutical Industry
The costs for drug discovery and development are skyrocketing, but AI (artificial intelligence) is introducing new efficiencies to help find effective treatments faster.
A study in 2020 concluded that the estimated median capitalized research and development cost per product was $985 million. Contributing factors to this included larger trial sizes, the need to assess health technology, the requirement to provide data on comparative drugs’ effectiveness, and most
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