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Nanobio Delivery in AAPS Workshop on Development of Control Strategies for Oligonucleotides and Peptide: Regulatory and Industry Perspectives

  Synthetic oligonucleotide and peptide-based therapeutics is developing fast as a new generation treatment for various disease. They are unique in the complexity of molecular structures but smaller size comparing to biological product. Specific regulatory guidance in the design of control strategies is not currently available. This workshop cosponsored by AAPS and USP gathered experts from industrial companies, regulatory agencies from FDA, EMA (European Medicine Agencies) and USP, discussed in depth on the challenges faced by companies and regulatory agencies, and explored the gaps in the guidance and technology during the panels and break-out sessions.

  The workshop started with an overview about current guidance from regulatory perspectives by Kavita Vyas Ph.D. and Mohan Sapru Ph.D. from U.S. Food and Drug Administration (CDER) and Brian Dooley, B.Sc., European Medicine Agency. Key scientific and technical considerations in the following aspects are discussed among the attendees:
      - Approaches to developing appropriate specification
      - Impurity thresholds
      - Degradation and stability issues
      - Analytical tools for characterization

  Nanobio Delivery CEO Haibo Hu, and Project Manager Fengmei Pi joined this two-day workshop in Silver Spring, Maryland USA during Apr 11-12, 2018. They did deep discussions with company peers and FDA oligonucleotide experts in the perspective of quality control for key oligonucleotide synthesis starting materials, in-process control for oligonucleotide quality assurance, and impurity analysis and requirements, etc. RNA therapeutics have rapidly advanced over the past few years and is now considered to be the future of medicine. Today, there are a fair number of RNA related drugs in late-stage development and increasing companies working in the field. Overall, more than 150 ongoing clinical trials are using RNA to treat cancer, infection, and some other diseases. The discussion in AAPS provides guidance in accelerating RNA nanotechnology based anti-cancer drug development in Nanobio Delivery.

  Website for the event:
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