NJII Hosts FDA Director for Biologics Evaluation and Research at Industry Roundtable

The New Jersey Innovation Institute (NJII), an NJIT Corporation, hosted Food and Drug Administration (FDA), Director Center for Biologics Evaluation and Research (CEBR), Peter Marks M.D., Ph.D., at a roundtable with biopharma industry leaders in early December. Dr. Marks is responsible for assuring the safety and effectiveness of biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue and gene therapies. FDA colleagues joining Dr. Marks included Senior Advisor for Counterterrorism and Medical Countermeasures, Dr. David Cho and the Head of the Advanced Manufacturing Portfolio, Dr. Manuel Osorio.

In his opening remarks, Dr. Marks highlighted the dramatic increase in new cell and gene therapy and viral vector product submissions received by the FDA and ways in which the agency was working with industry to improve procedures for applying for product approval. New cell, gene and viral vector therapies are highly complex with an abundance of moving parts that include innovative manufacturing procedures. In response, the FDA has staffed the CEBR with scientists from multiple disciplines working collaboratively to fully understand the complete therapeutic process. Dr. Marks added that the FDA is fully aware of the manufacturing challenges these new therapies demand in terms of process automation and cost reduction.

NJII Senior Executive Director, Biotechnology & Pharmaceutical Innovation, Dr. Haro Hartounian, pointed to NJII’s development of the Cell and Gene Therapy Manufacturing Center as a resource and solution to the manufacturing challenges facing the biotechnology industry, particularly in the area of CAR-T manufacturing and viral vector scale-up.

Dr. Marks and the CEBR center staff are committed to facilitating the development of biological products and providing oversight throughout the product life cycle.  Examples of their activities include:

• reviewing and providing advice during product development;
• evaluating applications and making approval decisions based on safety and effectiveness data;
• monitoring the safety of biological products; and
• conducting research that supports product development and characterization.

Leading biopharmaceutical companies and technology developers who participated included; Novartis, Celgene, J&J, Pall Life Sciences, Legend Biotech, GE Healthcare, Thermo Fisher Scientific, Parthenon EY, Celularity and Rutgers University. During the roundtable discussions, Drs. Marks, Cho and Osorio responded to questions from industry representatives and emphasized the willingness of the FDA to work collaboratively to streamline the regulatory process.

The New Jersey Innovation Institute (NJII) is an NJIT corporation that applies the intellectual and technological resources of the state’s science and technology university to challenges identified by industry partners. Through its Innovation Labs (iLabs), NJII brings NJIT expertise to key economic sectors, including healthcare delivery systems, bio-pharmaceutical production, civil infrastructure, defense and homeland security, and financial services.