Overcoming regulatory challenges to licensing new biotherapeutics

Mayo Clinic’s Symposium on Regenerative Medicine and Surgery will explore the challenges and opportunities of bringing next-generation biotherapeutics to patients. Julie Allickson, Ph.D., the Michael S. and Mary Sue Shannon Director of Mayo Clinic’s Center for Regenerative Medicine, will deliver a keynote presentation addressing regulatory hurdles standing between the billions of dollars invested in regenerative therapies and the people who desperately need new options for healing.

“Last year, there was an almost a $20 billion investment in regenerative biotherapeutics. There’s a significant investment, but not many products being licensed and generating commercialized solutions for patients. What are the challenges, and what are the obstacles,” asks Dr. Allickson. “It requires a partnership to move new discoveries to licensure, engaging industry and working with government agencies to facilitate production of biotherapuetics.” Dr. Allickson is also the Otto Bremer Trust Director, Biomanufacturing and Product Development, Center for Regenerative Medicine.Continue reading

Roche announces PathAI collaboration for artificial intelligence-based digital pathology applications for improved patient care

  • Artificial Intelligence technology shows promise in advancing pathology imaging, which can benefit cancer patients through more precise diagnosis leading to targeted treatment.
  • Collaboration with PathAI expands pathologist access to innovative AI-powered technology to support companion diagnostic and drug development programs.
  • Builds on Roche’s Digital Pathology Open Environment, expanding the company’s commitment to improving patient outcomes and advancing personalised healthcare through innovation

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SynCardia Systems LLC acquired by Picard Medical, Inc

Tucson, AZ – based SynCardia is the only company in the world with a US FDA-approved temporary Total Artificial Heart (TAH). It is also CE marked in Europe and approved for use in over 30 countries around the world. The SynCardia TAH has been saving and extending lives in Europe and North America, having been implanted over 2,000 times to-date and it has accumulated hundreds of years of proven patient use and safety data.Continue reading