BioMAN Activities – Research Area 5

Regulatory Science

Regulatory science is an applied science focused on developing new tools, standards and approaches to assess safety, efficacy and quality. There has been an increased focus on regulatory science across government (NIH, FDA), academia and industry in recent years. Through workshops, conferences and collaborations BioMAN is contributing to the enhancement of regulatory science. Specific topics in Theme 5 have focused on:
 

Biotechnology & Standards: 2013 BioMAN Summit

Standards are used in all areas of life science research and are critical to assure the quality and safety of biomanufactured research tools, diagnostics, and therapeutics. Standards also have the potential to enhance research productivity, limit duplication and facilitate future biomedical innovation. The purpose of this groundbreaking conference was to identify key opportunities for standards in life sciences research, encourage more systematic evaluation of the role that standards might play, and initiate the formation of a community committed to the development of robust and meaningful standard-setting in the life sciences going forward. For more information see the Conference Agenda

 

The Impact of Biosimilars and Biobetters on Biopharmaceutical Manufacturing: 2012 BioMAN Summit

On November 15th, 2012 BioMAN held its 5th Annual Biomanufacturing Summit bringing together thought leaders from industry, government and academia in the MIT Faculty Club to discuss the impact of biosimilars and biobetters on biopharmaceutical manufacturing. The topics discussed ranged from managing risks associated with biosimilars and biobetters to new technologies and analytics that will be needed for biosimilar development. There was a special keynote presentation by Steve Kozlowski, the Director of the Office of Biotechnology Products at the FDA, on the Regulatory Approach to Biosimilars. Over 100 participants attended the all day conference full of invited talks and panel discussions. For more information see the 2012 Summit Agenda

 

Implementing Innovation in Biomanufacturing – The Hurdles and Opportunities: 2011 BioMAN Summit

On November 18th, 2011 BioMAN held its 4th Annual Biomanufacturing Summit bringing together thought leaders from industry, government and academia in MIT’s Bartos Theater to discuss the hurdles to and opportunities for implementing innovation in biomanufacturing. The topics discussed ranged from the effect of regulatory science on the biopharmaceutical manufacturing industry to what can be done to innovate in downstream processing. Over 100 participants attended the conference which included a poster session that showcased new technologies developed in MIT labs, as well as others, with the potential to impact biomanufacturing. For more information see the 2011 Summit Agenda and Summary.