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SUMMARY:OPT Congress: Oligonucleotides & mRNA Therapeutics
DESCRIPTION:OPT Congress is the premier event for scientists and executive directors involved in discovering and developing oligonucleotide and mRNA therapeutics. For 2025 we are delighted to expand our content and offer a conference program dedicated to emerging oligo modalities\, sharing cutting-edge research and technologies used in designing new targeted therapies. \nNow in its 10th year\, this unique event brings together leading chemists\, biologists\, toxicologists\, CMC experts\, regulatory specialists and technology providers to discuss advances in next-generation therapeutics. In addition to 2 days of inspiring keynotes\, breakout discussions and 95+ scientific presentations\, we deliver two in-depth short courses to further add to the learning opportunities. We look forward to welcoming you to our community focused event\, offering robust and customizable programming tailored to your specific needs.
URL:https://scienceinboston.com/event/opt-congress-oligonucleotides-mrna-therapeutics/
LOCATION:Seaport Hotel Boston\, 1 Seaport Lane\, Boston\, MA\, 02110\, United States
ATTACH;FMTTYPE=image/png:https://scienceinboston.com/wp-content/uploads/sites/6/2025/01/OPS25-Header-Rotation-1-e1737567094343.png
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SUMMARY:MassBio Expert Panel: Advancing Development with Innovative Trial Design and Regulatory Strategies
DESCRIPTION:Join us at the MassBioHub in Cambridge\, Massachusetts on March 12\, 2025 for this exclusive complimentary event and expert panel discussion showcasing the impact of unified trial design and regulatory strategies on derisking and accelerating clinical development. \nRegistration: From 11:30 am \nPanel discussion:12:00 \nPost discussion lunch: 12:45-13:30 \nSecure faster development and regulatory pathways\nBiotech organizations face a series of high-stakes decisions as they design their clinical development programs. These decisions include trade-offs between factors such as speed and cost\, as well as delivery and regulatory risk. In this balancing act\, too often\, companies default to traditional study designs and endpoints\, often missing opportunities for innovative approaches that could reduce patient numbers or secure a faster regulatory pathway. \nLearn from our regulatory and statistical experts\nThis panel-led session\, brought to you by MMS and featuring Aiden Flynn\, SVP Statistical Consulting\, Amanda Beaster\, Director Regulatory Strategy\, and Ben Dudley\, Chief Commercial Officer\, will examine real-life design optimization case studies\, including using powerful statistical simulation software like KerusCloud. The presenters will explore innovative strategies including Real-world-data (RWD) augmentation\, innovative trial designs\, model-informed drug development\, the role of statistical simulation in optimizing the probability of success\, and best-practices for Regulatory risk management when pursuing non-standard designs. At the conclusion of the panel discussion\, there will be the opportunity for the audience to ask the experts their most pressing questions in an interactive Q&A.
URL:https://scienceinboston.com/event/massbio-expert-panel-advancing-development-with-innovative-trial-design-and-regulatory-strategies/
LOCATION:MassBioHub\, 700 Technology Square\, Cambridge\, MA\, 02139\, United States
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