What were BioNJ’s main achievements in 2023?

In 2023, BioNJ rose to the many challenges and opportunities facing the industry. We increased our public policy activities in response to policy challenges at the federal level, including the Inflation Reduction Act, March-In Rights, and the potential for policy changes regarding Pharmacy Benefit Managers (PBMs) being entertained by policymakers. At the same time, we used our voice to educate on the value of medical innovation to the patients who are served by the innovations of our industry and boasted the strength of New Jersey’s vibrant ecosystem, which was responsible for more than 50% of all novel FDA approvals in 2023. Can you speak to the current regulatory environment in the US, and the impact the IRA will have?

The Inflation Reduction Act raises significant concerns due to its potential adverse effects on innovation and patient access — seemingly contrary to its intended purpose. One troubling aspect is the reduction from 13 to 9 years, discouraging investment in small molecule therapeutic development and leading to delays or outright failure in bringing vital therapies to patients. Estimates from Vital Transformation suggest that numerous drugs currently available would not have reached the market under IRA policies, and as many as 139 therapies may not be developed over the next decade due to these regulations. Already, companies are scaling back programs due to IRA concerns.

We are hopeful that policymakers will consider supporting a new piece of legislation, the “EPIC Act” (Ensuring Pathways to Innovative Cures Act), which would set both categories of medications at 13 years. What makes New Jersey special for life science investment?

Leveraging its rich pharmaceutical heritage and bolstered by ongoing investments from both industry and government, New Jersey stands poised to expand and deliver crucial innovations for patients. With a unique and diverse workforce, encompassing talent across the spectrum from early-stage discovery to commercialization, the state boasts a comprehensive talent pool. Its ecosystem spans the entire drug development value chain. Moreover, New Jersey hosts more FDA-registered manufacturing facilities than any other state. Notably, over 50% of all novel FDA drug approvals in 2023 originated from companies with a strong presence in New Jersey.

Statistics highlighting the vitality of New Jersey's ecosystem reveal significant growth in bioscience-related venture capital investments, which surged by US$2.3 million in 2021 compared to 2020, reaching US$706.4 million and marking an increase of over US$100 million since 2018. NIH funding has experienced consistent growth since 2018, with the majority directed toward biological, biomedical, and health sciences. Additionally, establishments in the medical devices and equipment sector have grown by 21.4% since 2018. What are the catalysts ahead for 2024 to ensure New Jersey remains a leading life sciences hub?

The growth of New Jersey's ecosystem continues, marked by global companies expanding in the Garden State and concerted efforts to bolster the very earliest-stage companies. Notably, the New Jersey Commission on Science, Innovation and Technology's US$16 million investment in 274 startups over four years and the Innovation Evergreen Fund attracting fresh venture capital signal ample growth prospects.

Moving ahead, we will see more partnerships between academia, industry and the public sector to ensure New Jersey remains a leader in life sciences and ultimately bring more drugs to market. Key innovation hubs like the HELIX in New Brunswick, NEST Center in Kenilworth, and SciTech Scity in Jersey City underscore the state's commitment to advancement.

Moreover, Governor Phil Murphy's array of economic innovations and initiatives, including the AI Moonshot and collaboration with Princeton University to establish an AI institute, reaffirm New Jersey's dedication to maintaining a leading position in innovation, cementing its reputation as a premier hub for groundbreaking advancements. What are the key priorities for BioNJ in 2024?

In 2024, BioNJ will maintain its steadfast commitment to policy advocacy, ensuring future innovation and that patients have access to the medicines they need when they need them. Committed to leaving “no patient behind,” we will continue to build upon our Health Equity in Clinical Trials Initiative, while telling the value of medical innovation story, including developing and placing educational information on Pharmacy Benefits Managers right at the pharmacy counter for consumers and patients.