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Biotech Growth in New Jersey’s 505b2 Sector

Location: 675 US Highway One, North Brunswick, New Jersey 08902

Date:  Thursday, October 19, 2017
Time: 5:00 pm - 7:00 pm

This event hosted in partnership with:

 

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Biotech Growth in New Jersey’s 505b2 Sector -   

What Are They?

Who Are They?

Who Is Funding Them?  


An Increasing Number of Companies Are Using a Once-Obscure FDA Drug Approval Pathway.  The FDA’s 505(b)(2) approval pathway can offer faster approval, reduced development costs, lower risk and, in certain cases, market exclusivity.  505(b)(2) development is more than just a regulatory pathway - it is a competitive strategy that can lead to product approval with lower risk, reduced development costs and faster speed to market than generics.  From 2014, 50% of all NDAs approved were 505b2 drugs.  This percentage is expected to rise to more than 80% over the next few years.

Learn more about the recent trends in New Jersey’s 505b2 community from this panel of experts:

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Navneet Puri, PhD​, CEO, Nevakar (former CEO of InnoPharma)


Dr. Puri is a pharmacist by education, and a pharmaceutical business executive by training and experience. After earning his MS and PhD in Pharmaceutics, Dr. Puri worked for several years at Baxter Healthcare Corp and Amgen Inc., in the areas of parenteral drug development and drug delivery.

Dr. Puri founded InnoPharma, Inc. in 2005 with a focus on developing complex generic pharmaceuticals of sterile injectable dosage forms. This business model was targeted to provide options to health care providers and patients for some of the products where no generic option was available, primarily attributed to complexity of developing and manufacturing the drug products.

Between 2005 and 2014, InnoPharma, Inc. grew as a major player in generic injectable space, with numerous approved and filed generic products that had very limited competition in the marketplace. InnoPharma, Inc. was acquired by Pfizer in Sept 2014 and became an integral part of Pfizer’s Global Establish Pharma business thereafter. Dr. Puri stayed with Pfizer, following acquisition, as President InnoPharma, Inc. – a Pfizer Company and VP of Pfizer’s Worldwide R&D, and left Pfizer in July 2015.

Dr. Puri received Smart CEO award by Future 50 magazine in Jan 2015. He was also awarded E&Y Entrepreneur of the year award from the state of NJ, in June 2015. 


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S George Kottayil,
PhD, CEO, Grace Therapeutics  

Dr. Kottayil is the Founder and CEO of Grace Therapeutics LLC. He has spent over 20 years working in senior positions at small and medium life science companies. During that time he has held positions of increasing responsibility in product development, business operations and general management. Dr Kottayil co-founded Insys Therapeutics Inc., a NASDAQ listed company. He is the principal inventor of the company’s lead product SUBSYS® – sublingual fentanyl spray that was approved by the FDA in 2012 for the treatment of breakthrough cancer pain. SUBSYS has current annual sales of about $200M and is the only product in its space that has shown statistically significant pain relief at 5 minutes (SPID 5). He served as Insys’ President and a member of its board of directors. Prior to Insys, he directed business operations at Unimed Pharmaceuticals Inc., a division of Solvay Pharmaceuticals now Abbvie.  He played a key role in product development and obtaining FDA approval for the company’s NDA products most notably ANDROGEL®. ANDROGEL has been the market leader in male hormone replacement therapy for well over a decade with peak annual revenues that exceeded $1 billion. ANDROGEL when launched in 2000 redefined the male hormone replacement therapy market which until then was well below $50 million and was primarily served by ANDRODERM® patch and deep intra-muscular injections. He was instrumental in formulating and executing the strategy that resulted in the down-scheduling (CII to CIII – a first in the prescription drug industry) of the controlled prescription drug MARINOL® by the US DEA.  


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Moderator - John Pennett, EisnerAmpner  


John Pennett is the Partner-in-Charge of the Life Sciences Group and Technology Group. He has 30 years of public accounting experience, with a strong emphasis on public and private life science and technology companies. John is a frequent writer and speaker on topics related to issues impacting businesses in the life sciences and technology space. He is the publisher of Catalyst, a magazine focused solely on issues related to life sciences and pharmaceutical companies. John supports entrepreneurial organizations around the country with content and program development, and serves as a mentor to several early-stage companies.

John has led the accounting, auditing and strategic advisory work for more than a hundred IPOs, private financing and mergers and acquisitions with an aggregate valuation in excess of $1 billion. In addition, he has served as the interim lead of the firm’s Risk Advisory Practice, leading internal audit, contract compliance and Sarbanes-Oxley implementation and testing. John previously worked as an Audit Partner for an international accounting and consulting firm.