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News & Views
Biopharma launches science huddle
Biopharma Excellence (www.biopharma-excellence.com), a fusion of three scientific powerhouses, PharmaLex, ERA Consulting and Biopharma Excellence, under the PharmaLex brand is launching a ground-breaking Science Huddle with a series of quarterly thought leadership panel discussions, featuring key stakeholders from across the life sciences ecosystem, focusing on the complex challenges in the race to bring critical, cutting-edge treatments to patients.
The powerful forum will bring together senior representatives such as regulators, investors, product developers, scientists and patient advocacy groups, for frank exchanges that give rise to actionable ideas.
Participants at the first panel discussion on 2 November 2022 will include Daniel O’Connor, Deputy Director, Innovation Accelerator and Regulatory Science, MHRA, Nick Sireau, CEO and Chair of Trustees for the AKU Society, and Rachelle Jacques, President and CEO, Akari Therapeutics. They will discuss the scope of Bayesian statistics, predictive approaches, and pre-hoc analyses to overcome population challenges as biopharma becomes more narrowly targeted. Dr. Christian K. Schneider, Head of Biopharma Excellence at PharmaLex, and a world expert in adapting existing regulatory frameworks for biopharmaceuticals, will moderate the event.
“Advanced/Cell and Gene Therapies are a huge and growing focus for life science product developers, investors, regulators, patients with rare conditions and the clinicians treating them. Yet, despite huge efforts to expedite new innovation, some significant and complex challenges remain,” says the Head of Biopharma Excellence, Dr. Christian K. Schneider.
“It has never been more important for stakeholders from across the life sciences ecosystem to join forces and find answers to the issues threatening to delay market access to these critical treatments. From achieving statistical significance with small clinical trial populations, to the criticality of an integrated product development strategy, to tackling the risks of empty capsids in trials of gene therapies, each Science Huddle will bring together some of the sharpest minds in their field to air the emerging issues and identify practical ways forward.”
From medical science to data science, product commercialisation and reimbursement, the Science Huddle panel series will examine challenges and devise viable and sustainable solutions across the full lifecycle of Advanced/Cell and Gene Therapy development and delivery.
Future Science Huddles, due to take place quarterly, will address issues such as proposed approaches to the practical problem and associated risks of empty capsids in gene therapy trials; the fallout of poor global product development planning, and the advantages of starting a dialogue with regulators much earlier in the cycle; and the difference a more aggressive strategy can make in biosimilar delivery and market success.
More information about the Science Huddle can be found at www.biopharma-excellence.com/the-science-huddle
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