Should the final goal of drug development also be the first goal?

Please join us for the second INVOForward seminar during which Mitchell Glass (CEO & Chairman, Accolade Pharma; Principal, Broom Street Associates) will discuss clinical significance as a primary endpoint in the development of a therapeutic. His talk will focus on the impact of clinical significance on sample size, biostatistics, and financing. Dr. Glass will discuss the relevance of biomarkers and how much one can rely on them. He will explore clinical significance in lieu of statistical significance and address scenarios where clinical significance may raise the bar too high. He will also discuss clinical significance in context of “failing fast” and licensing.

This seminar is part of the INVOForward Therapeutics lecture series focused on helping Northwestern researchers gain insight into how to build a compelling therapeutic data package. While the INVOForward mentorship program has four select faculty-led teams participating, the lectures are open to Northwestern Faculty, Post-docs and Students.

Other INVOForward Therapeutics lectures may be found here.

OUR SPEAKER

Mitchell Glass, M.D.

Dr. Glass was Chief Scientific Officer at the University City Science Center (Philadelphia, PA) where he advised 54 client companies on strategy for developing and commercializing devices, diagnostics, and therapeutics. Dr. Glass was the principal liaison to academic stakeholders of the Science Center, and a member of the Keystone Innovation Zone Executive Committee.

Since 1999, Dr. Glass has been a principal of Broom Street Associates, which offers a full range of regulatory services to pharma, specialty pharma, biotechnology and device companies. Areas of focus have included narrative and document writing, medical product risk assessment and reduction, IND and End of Phase 2 presentations.

From 2012 to 2019, Dr. Glass has been Executive Vice President, Chief Medical Officer and Executive Director of Invion Limited (ASX:IVX), with offices in Australia, and Delaware. In February, Dr. Glass spun out the respiratory assets of Invion into Chronic Airway Therapeutics. For the past year, Dr. Glass has been the Chief Medical officer of Tikkun Olam Pharmaceuticals, targeting FDA-regulated development and approval of marijuana strains under strict FDA regulations. In 2014, Dr. Glass and colleagues formed Accolade LLC to exploit non-oral formulations of Zafirlukast.

Positioning and Establishing Your Clinical Significance