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With the world of gene therapy still rapidly evolving, an Interactive Response Technology system might help a sponsor navigate new and complex steps throughout the supply chain.






The unforeseen challenges with clinical trial execution in gene therapy and regenerative medicine studies, such as unchanging FDA regulations, discussed.




Dominique Demolle, CEO of Tools4Patient, discusses the effect artificial intelligence is having on the statistical impact of clinical trial placebo response.







Linda Reuter, CIP, Director of BRANY IRB, discusses the Revised Common Rule that now requires informed consent to begin with a concise and focused presentation of key information that will help the patient better understand the reasons why they might or might not want to participate in the research.

Irina Petrova, Director of Clinical Operations for OCT Clinical Trials, explores why U.S. companies are turning to Russa after having secured approval for 108 trials there in 2018.

Yaky Yanay, CEO of Pluristem, talks with Moe Alsumidaie about his experience and the strategies Pluristem implemented in regenerative medicine clinical trials.






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