Webinar: Advancing Cell & Gene Therapies from Bench to Scale by New Jersey Innovation Institute

About This Webinar

Please join Joseph Tarnowski, SVP, Cell & Gene Therapy, R&D Medicinal Science and Technology at GSK, Hari Pujar, Ph.D., Operating Partner at Flagship Pioneering, Haro Hartounian, Ph.D., SVP & General Manager, BioCentriq and Michael Lehmicke, Director of Science and Industry Affairs, Alliance for Regenerative Medicine, for a discussion on how to scale your cell and gene therapy and prepare for clinical trial.

This event will be moderated by Michael Lehmicke, Director, Science and Industry Affairs for the Alliance of Regenerative Medicine (ARM) and he will interview Joe Tarnowski, Hari Pujar and Haro Hartounian about their respective experiences.

The group will discuss unique challenges biotech teams face as they move their therapies from bench to scale and prepare for clinical trials and ultimately, commercialization.

Discussion will focus on the following topics:

- Investments firms must make in manufacturing
- Manufacturing as a competitive differentiator
- The importance of technology development
- Capacity issues as a result of the global pandemic
- The role of workforce development and training

There will be live Q&A.

Michael Lehmicke

Director of Science and Industry Affairs, Alliance for Regeneratve Medicine (ARM)

Michael joined ARM in 2018 as its first Director of Science and Industry Affairs. Michael has over 20 years of R&D experience in biomaterials, medical devices and regenerative medicine. He has led product development teams for class II devices, human cell and tissue-based products, and drug/device combination products. He is a creator and an inventor with multiple U.S. patents to his name.

Michael has a MSc in /Biomedical Engineering, with a focus on tissue engineering, from Drexel University. Michaels areas of expertise include cell-based tissue engineering, bioceramics, biodegradable polymers, project management, strategic pipeline development, and business development.

He is passionate about regenerative medicine and believes that it represents our best hope for meeting many unmet clinical needs, thereby changing patient’s lives for the better.

Haro Hartounian

Dr. Hartounian earned his Ph.D. in Chemical Engineering from the University of Delaware. He leads the Biopharma Division at NJII, working with colleagues in industry and academia to help biopharmaceutical companies transform discovery into commercial production. He has 30 years of experience in the biotechnology industry working for companies such as DuPont, Monsanto, SkyePharma and Vyteris. He also founded the companies MicroIslet, Protagenic Therapeutics, and DiaVacs and has worked in a variety of product lines — including cell therapy, oncology, women’s health, pain management and drug delivery. In addition, Dr. Hartounian is an adjunct associate professor of Chemical Engineering at Columbia University, and is on the Affiliated Faculty in NJIT’s Department of Chemistry and Environmental Science.

Hari Pujar

Operating Partner at Flagship Pioneering

Hari Pujar, Ph.D., serves as Operating Partner, at Flagship Pioneering, helping create breakthroughs in human health and build life science companies. Previously he was Chief Technology Officer of Spark Therapeutics, a pioneer and leader in AAV gene therapy. He led technical operations, process and technology development and quality assurance organizations. He was responsible for growing and scaling the company’s cutting-edge technology capabilities for an expanding development pipeline.

Prior to Spark, Hari was Head, Technical Development & Manufacturing, at Moderna, where he built and led the technology and early manufacturing organizations that delivered on supply for more than a dozen clinical programs in a brand-new technology area of mRNA.

Before Moderna, he spent 18 years at Merck & Co in the company’s R&D, manufacturing, and commercial divisions focused on vaccines and biologics, culminating in the E2E leadership of a third of the vaccine portfolio, comprising of pediatric and adult vaccines, representing nearly $2b in annual revenue.

Hari has a Ph.D. in Chemical Engineering from the University of Delaware and an MBA from the Wharton School at the University of Pennsylvania.

Joseph Tarnowski

SVP, Cell & Gene Therapy, R&D Medicinal Science and Technology at GSK

Prior to his current role in CGT, Joe was the Senior Vice President of Biopharm CMC R&D. Before joining GSK in June, 2010, Joe was the Senior Vice President, Biologics Manufacturing and Process Development in the Technical Operations division of Bristol-Myers Squibb Co. in New Brunswick, NJ. Joe was responsible for building the manufacturing capabilities needed to supply the company’s biologic medicines to worldwide markets, including the construction of the company’s new $750 million large-scale multi-product bulk biologics manufacturing facility in Devens, Massachusetts, and the integration of Medarex, Inc. He has spent over 35 years in the pharmaceutical industry focused primarily on the research, development, registration and commercialization of biopharmaceutical products made using recombinant DNA technology. He holds 13 patents and has several patent applications pending for biologic products.