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FDA’s Pazdur Believes ‘Advanced Research’ Project Could Address Trial ‘Wastefulness’

 
• By Sarah Karlin-Smith

ARPA-H could be a solution to some of FDA’s long-running complaints about US clinical trial infrastructure, the agency's cancer chief says.

ARPA-H could remove waste from the clinical trial system, Pazdur suggests. • Source: Alamy

President Biden’s proposed Advanced Research Projects Agency for Health (ARPA-H) might be able to provide the leadership necessary to cut across barriers between industry and government and within the private sector to make drug development more efficient, Rick Pazdur, US Food and Drug Administration Oncology Center of Excellence Director said.

“One of the things that keeps me up at night is really the wastefulness that we see at the FDA and the clinical trial setting. For example, each company doing their own clinical trials, not working together or not working with each other. How many PD-1 drugs do we need? How many duplicate clinical trials do we need driven primarily by competitive and economic concerns for the individual drug company

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UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

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Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
• By Eliza Slawther

European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.