Focus on Oncology: July 2012

BIO would like to invite you to participate in our upcoming educational webinar series in September and October on key provisions contained in the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Jumpstart Our Business Startups (JOBS) Act.

The FDASIA webinars, scheduled for September 13 and September 26, will provide information on the intent and goals of the provisions in FDASIA, including Enhanced Communications, NME Reviews, Expanded Accelerated Approval, and Breakthrough Therapies.  Industry experts will also discuss implementation issues and timelines.

The JOBS Act webinars, scheduled for September 18 and October 3, will offer companies information on the key facets of the law and offer expert analysis on how to navigate the new rules.  The JOBS Act contains exciting new fundraising methods for biotech companies, including the IPO On-Ramp, Crowdfunding, and changes to SEC Regulations A and D.

The webinars are free for all BIO R&D members and BIO state affiliates.  Non-member R&D companies are invited to join for $100.  For more information or to register for the webinars, please email Charles Crain at ccrain@bio.org. 

NCATS Announces Institutional CTSA Program

The NCATS CTSA program supports disease- and condition-specific networks funded by other NIH Institutes and Centers.  NCATS has announced that its CTSA program will include Institutional CTSA Awards.  Institutional CTSAs are made to degree granting institutions or groups of institutions that receive significant funding from the NIH.  CTSAs require institutional commitment, the status of a major scientific and administrative entity within and across an applicant and partner institution(s), and a CTSA PD(s)/PI(s) with the authority and influence necessary to successfully create an institutional home for clinical and translational research.

To learn more about the NCATS Institutional CTSA Program (RFA-TR-12-006), please click here.  The letter of intent is due December 10, 2012 and the application is due January 8, 2013.