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Press Release
October 10, 2017
2 minute read

Accelerated Path to FDA Approval Subject of Upcoming Panel at CCIT


Life Sciences Experts to Discuss 505(b)(2) Pathway

TRENTON (October 10, 2017) –  An alternate path to Food and Drug Administration (FDA) approval that is gaining popularity will be the focus of a panel discussion on Wednesday, October 18 at the New Jersey Economic Development Authority’s (EDA) Commercialization Center for Innovative Technologies (CCIT) in North Brunswick. 

Known as the 505(b)(2) new drug application (NDA), this approach to pursuing FDA approval represents an appealing regulatory option for many companies launching new drugs, as it helps them to avoid unnecessary expense, reduce risk, and potentially gain market exclusivity. Aside from being a regulatory pathway, this competitive strategy affords companies a faster speed-to-market than generics and allows them to avoid duplication of studies already performed on previously approved active ingredients. 

This panel discussion, entitled Biotech Growth in New Jersey’s 505(b)(2) Sector, will feature three leading New Jersey biotechnology executives who have successfully navigated the 505(b)(2) process, for a discussion of this route to FDA approval.  The panel will be moderated by Paul Woitach, Managing Partner of Pharmaceutical Advisors LLC.  Panelists will include:
 

  • Navneet Puri, PhD, CEO, Nevakar (former CEO of InnoPharma)
  • S. George Kottayil, PhD, CEO, Grace Therapeutics  
  • John W. Maki, President and CEO, Vicus Therapeutics

Notably, both Puri and Kottayil are associated with companies that have benefited from EDA resources for technology and life sciences companies.

Biotech Growth in New Jersey’s 505(b)(2) Sector will take place on Wednesday, October 18, 2017 from 5:00 p.m. to 7:00 p.m. at CCIT, 675 US Highway One, North Brunswick, New Jersey 08902. To register, visit www.njeda.com/505b2panel.

This event also presents an opportunity for companies to visit CCIT, one of the more significant incubation facilities in the nation dedicated to life sciences and biotechnology companies. CCIT is a 46,000-square-foot life sciences incubator that is home to nearly two dozen businesses. With 27 wet labs and access to offices, conference rooms, a supportive staff, and a variety of additional resources, CCIT is ideal for emerging companies looking to grow in the Garden State. CCIT is located within the Technology Centre of New Jersey, a 50-acre research park that houses such companies as Chromocell and Orthobond, both of which are CCIT graduates, and Merial. Companies interested in touring CCIT should visit www.njeda.com/CCIT or contact Harcum at lharcum@njeda.com.
 

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