ADDC Webinar Series on Bioentrepreneurship: "REGULATORY ISSUES"

Academic Drug Discovery Consortium

Join us for breakfast, lunch, or cocktails in your local time zone for our monthly webinar series on bioentrepreneurship.

ADDC 2021 Bioentrepreneurship Webinar Series

In this "Things I Wish I Knew" series, we will learn from prominent scientists, entrepreneurs, and investors about their successes, struggles, and the things they wished they knew before starting their journey. "REGULATORY ISSUES"The Regulatory GauntletNo successful bioentrepreneur ever gets new product to market without properly passing all regulatory hurdles. These protections are enacted by governments to control the safety and efficacy of all types of products including new pharmaceutical medicines, medical devices, antibodies, and cellular therapies. Without exception, local, state, federal, industrial and (where applicable) international regulations must be met. We are pleased to have Kathy Giacomini of UCSF and Michelle Rohrer of Genentech Roche on our panel to share their experiences and to provide practical guidance regarding the key issue to consider. Michelle Arkin of USCF will be our moderator.

Speakers: Kathleen M. Giacomini, PhDDr. Kathy Giacomini is a Professor of Bioengineering and Co-Director of the UCSF-Stanford Center of Excellence in Regulatory Sciences and Innovation. She is leading an effort to de-orphan transporters in the Solute Carrier 22 Family, and to determine the clinical implications of specific genetic variants in membrane transporters. Research ventures, ranging from basic discovery to clinical studies, have demonstrated that common variants of membrane transporters contribute to differences in drug response in ethnically diverse populations. Ultimately, these studies will increase our knowledge of the genetic basis underlying drug response and will contribute to advancing the era of personalized medicine. Michelle Rohrer, PhDDr. Michelle Rohrer is Global Head of Product Development Regulatory at Roche. Michelle has worked at Genentech Roche for 28 years, starting as a post-doctoral research fellow in Genentech Research. She has worked as a clinical scientist, project team leader, site head and regulatory strategist. In her current position, Michelle leads the global Development Regulatory organization. In 2013, Michelle was named by the SF Business Times as one of “The Most Influential Women in Bay Area Business.” In 2014, she was selected by PharmaVOICE as one of the 100 most inspiring leaders in healthcare. In 2015, she served as an industry representative to the FDA-industry Prescription Drug User Fee Act VI negotiation team. She currently serves as Chair of the Board for TransCelerate Biopharma Inc, is a founding member of Accumulus Synergy and is a PhRMA representative to the ICH Assembly.

This Seminar series is hosted by the Academic Drug Discovery Consortium (ADDC). The ADDC is a professional society dedicated to building the community of academic drug discovery labs and the companies, universities, and government agencies that support and partner with these centers.

Webinars in this series:<ul><li>March 4: <a href="https://webinar.addconsortium.org/March4" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">How to Get Started</a></li><li>April 1: <a href="https://webinar.addconsortium.org/April1" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">The View from Here</a></li><li>May 6: <a href="https://webinar.addconsortium.org/May6" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">Applying Your Platform</a></li><li>June 3: <a href="https://webinar.addconsortium.org/June3" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">Navigating Transitions</a></li><li>July 8: <a href="https://webinar.addconsortium.org/July8" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">Cell Therapy</a></li><li>August 5: <a href="https://www.eventbrite.com/e/addc-webinar-series-on-bioentrepreneurship-cell-based-imaging-registration-157998029359">Cell-Based Imaging</a></li><li>September 9: <a href="https://www.eventbrite.com/e/164900165835">Venture Funding</a></li><li>October 7: Tech Transfer</li><li>December 9: Regulatory Issues</li></ul>

This webinar is sponsored by

<a href="https://www.hopkinsmedicine.org/pedersen-brain-science-institute/" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">Visit the Brain Science Institute at JHMI website</a><a href="https://drugdiscovery.jhu.edu/" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">Visit the Johns Hopkins Drug Discovery website</a>

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