Debbie Hart, President & CEO,


"With nearly 40% of all new FDA approvals over the last two years coming from companies with a footprint in NJ, our state continues to lead the way in bringing new therapies and cures to patients."

Can you give an overview of BioNJ’s activities and performance over the past year?

The theme has been flexibility. BioNJ spent significant time collaborating with government making sure that our members had what they needed in terms of Covid-19 education. In terms of public policy, we worked to ensure that government is supporting industry and that innovation and access are protected. With regards to education and networking, we had to adapt and we adopted a completely virtual way of interacting. We have also continued to ensure that our members attain cost savings on a wide variety of essential services and have access to talent. We have also been laser focused on health equity, making sure that everyone has equal access to healthcare and medicines.

Have you felt a palpable change following the administration change?

New Jersey’s (NJ) governor was re-elected for a second term in November 2021. He is incredibly dedicated and inspired towards making a difference in terms of innovation. We are seeing more companies moving their operations to NJ, more companies being created in NJ, and increased funding due to the state government’s commitment to innovation. However, we are concerned with a number of proposals at the state level and what they may mean for innovation and access for patients and will be reviewing and monitoring them as we move forward. In addition, we are anticipating challenges on the policy front at the federal level as well. Changes proposed by the President and the new congress have the potential to harm innovation and patient access.

What key policies and regulations are under review?

It will be interesting to see in which direction the new FDA commissioner, Robert M. Califf, will move as he has previous experience and will be able to hit the ground running. It will also be interesting to see whether or not impactful things that came out of Covid-19, such as emergency use authorization (EUA), streamlined clinical trials and remote clinical trials, will be able to continue and improve the affordability of healthcare. There are proposals in different states across the country, including NJ, for a prescription drug affordability board (PDAB), and we are very concerned about the impact a PDAB could have on the number of companies being created, the funding making its way to companies, and ultimately the number of drugs making it to market and patients’ ability to access that innovation.

NJ still stands out in terms of investment and the impact and nature of the various programs in the state. The NJ Innovation Evergreen Fund (NJIEF), being launched by the NJ Economics Development Authority later in 2022, has the intention to bring additional venture capital to the state through a public-private partnership where capital investment by the state is intended to be matched by private companies.

How will the biopharma sector navigate skilled labor shortages?

The talent shortage is a critical challenge that was exacerbated, but in some ways also addressed, by the pandemic. Companies can now recruit from around the world as people can be located anywhere and work remotely. We are, however, in a situation where many companies were formed during the pandemic and the talent pool just cannot keep up with the requirement. NJ has initiated the Pathways to Careers program, a collaboration between the NJ Department of Labor and Workforce Development and the NJ Community College Consortium, where academic partners, industry, and government are coming together to understand industry skill and talent requirements and work together to develop the required skills and talent for the future.

Do you have a final message for our readership about BioNJ and NJ as a biopharma hub?

In 2021, we were thrilled to see Governor Phil Murphy break ground on “The Hub” in New Brunswick, which will bring together industry, academia, government and investors in a physical space. Equally exciting is "The Cove," which is an even larger physical space with everything from housing, grocery shopping, industry, academia, government and investors – all in a walkable and waterfront complex.

With nearly 40% of all new FDA approvals over the last two years coming from companies with a footprint in NJ, our state continues to lead the way in bringing new therapies and cures to patients.