AIT Biosciences recently attended the Bio+Tech17 Conference in Bethesda, Maryland from April 27-28, 2017 and the AAPS NBC Conference in San Diego, California from May 1-3, 2017. Below are summaries of both conferences:
The conference is run by the MD Tech Council and seeks to bring together innovators from across the State of Maryland to bridge the conversation and collaboration between emerging technologies and scientific advances in the areas of biotechnology, and world and personal health.
The keynote speaker was Keller Rinaudo, the Founder and CEO of Zipline. His presentation was perfect for the setting as he described a life-saving venture (operating as a pilot program in Rwanda) which employs a national drone service of high speed planes that enables his group to deliver vital medical supplies and medicines across a landscape that is virtually non-traversable by standard transport means.
The conference also included interesting panels discussing women in leadership roles, innovations in personal medical care and recent advances in the areas of vaccines and oncotherapies.
If you would like to chat about the conference or learn more about AITB, please contact Dave Dehler at 540-450-6453.
AAPS NBC Regulatory Update for Biosimilars and PEG-linked Drugs
During the round table sessions at AAPS NBC, Michelle Dougherty from the FDA, made it very clear to the Biosimilar participants that the following issues are the current views of the FDA:
- That the FDA will require a full ADA, Nab analysis on biosimilars regardless of the innovators immunogenicity results. All biosimilars must have a detailed ADA analysis to file.
- All PEG-Linked, PEG associated or PEG ADC’s need full ADA analysis even though PEG drugs in the past have no immunogenicity findings.
The current guidance’s for immunogenicity should be followed and ADA assays will be looked at with more scrutiny.