What has BioNJ achieved in the past 12 months?  

BioNJ has stayed laser-focused on our core mission, to help our members help patients and make sure that New Jersey is a robust life sciences ecosystem where innovation is supported, and patients can access that innovation. New Jersey remains a life sciences powerhouse, leading the way in medical innovation. The State stands out in its breadth of industry with employment concentration in three key industry subsectors – pharmaceuticals; research, testing and medical labs; and bioscience-related distribution – as well as a high concentration in a fourth subsector: medical devices and equipment. BioNJ continues to work diligently with our State partners to attract new companies, such as BeiGene, Gilead and Eisai. Over the last 12 months, we witnessed the groundbreaking of The Hub in New Brunswick and SciTech Scity at the Liberty Science Center. We ensure that entrepreneurs have the tools they need to flourish through our support of the activities of the New Jersey Commission on Science, Innovation, and Technology which has provided over 200 companies with more than $9M in grant funding in the past two years. 

Can you expand on the Health Equity in Trials Initiative and the MBA Business plan competition?

In 2022 we launched our Health Equity in Clinical Trials Strategic Initiative to help deepen the understanding of the safety and efficacy of medicines in under-represented populations. BioNJ’s Health Equity in Clinical Trials MBA Business Plan Competition was designed to promote the next generation of diverse clinical trial innovators and to identify innovative approaches and successful models that can be used nationally to strengthen diversity in clinical trials and expand health equity. During the Competition, business schools from across the country, competing for more than US$20,000 in prize money, were tasked with developing a business plan defining a new solution, application or technology that can be used nationally to strengthen diversity in clinical trials and expand health equity.

What will BioNJ’s main public policy priorities be in 2023?

At the federal level, we believe that the recently passed Inflation Reduction Act (IRA) fell short in its attempt to solve the underlying issues driving higher patient out-of-pocket costs and that it threatens future medical innovation. Its price-setting provisions are projected to result in 135 fewer new cancer drug approvals by 2039, and 551 fewer HIV/AIDS clinical trials over a similar time.

We also have serious concerns about the role of pharmacy benefits managers (PBMs) on the cost of drugs and access to them. PBMs negotiate rebates and fees with drug manufacturers, create drug formularies, and reimburse pharmacies for patients’ prescriptions. However, far too often, PBMs fail to pass along these manufacturer rebates and discounts to patients at the pharmacy counter. Just three PBMs, all owned by giant for-profit insurance companies, control approximately 80% of the entire PBM middleman industry in the US. State legislation requiring insurers and PBMs to share negotiated discounts and rebates at the pharmacy counter could save some New Jersey patients nearly US$1,000 each year. 

How does the current regulatory environment impact investment in the industry?

The US is responsible for most new biopharmaceutical innovations. And while there are a variety of regulatory components in the US that have contributed to this massive wave of innovation, a recent pursuit of policies that will inevitably inhibit this innovation is worrying. A central pillar of the nation’s hospitable environment for the life sciences ecosystem has been its strong, predictable, and reliable intellectual property framework. Discussions among international entities focused on weakening or outright sacrificing these IP protections, such as potentially expanding the TRIPS waivers, are concerning, as this would directly jeopardize the historically reliable IP protection framework. Finally, enabling the government to arbitrarily set the prices of medications will inevitably inhibit investment. The price-setting provisions of the IRA will result in fewer new drugs and disincentivize the industry from investing in diseases with large unmet burdens. Further, the discrepancy in how small molecule and biologic therapeutics will be targeted for price setting has already been seen to put a thumb on the scales of future investments between these two classes of medicines.

What must New Jersey do to remain a life sciences leader?

With nearly 4,500 biopharma establishments, including eight out of the top 10 global pharma companies, New Jersey is the “Medicine Chest of the World” leading the tri-state region with an annual economic impact of US$108.3 billion. In 2022 alone, companies with a footprint in New Jersey were responsible for nearly 50% of all new FDA approvals. To ensure that New Jersey maintains this leadership position, BioNJ will continue to work with State government to support industry and stave off onerous proposals.