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5 things to know in life sciences: Week of Feb. 13, 2023

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5 things to know in life sciences This week we look at the Food and Drug Administration’s approval of an over-the-counter naloxone nasal spray, promising vaccines nearing approval to treat respiratory syncytial virus, and the FDA’s new guidance on diversity considerations for later-stage clinical trials. We also look at a new founder-focused biotech fund that will help entrepreneurs navigate the difficult early stages of a company’s formation. Finally, we review plans for a next-generation biologics plant based in Southern California. Each week we highlight five things affecting the life sciences industry. Here’s the latest.

FDA panel supports over-the-counter sales of naloxone

A panel of FDA experts voted unanimously this week to recommend over-the-counter sales of naloxone, an overdose-reversing drug. The recommendation is non-binding and came despite concerns about confusing packaging and instructions. While there are ongoing studies evaluating the safety of the drug, the panel recommended that the FDA act swiftly to approve over-the-counter sales.

RSV vaccines progressing through trials and may be nearing approval

Respiratory syncytial virus (RSV) is fatal for over 10,000 people per year in the United States. Pharmaceutical companies have researched the virus for years and have been unable to produce a vaccine. However, currently there are 11 RSV vaccines in various stages of clinical trials. Two of these have been submitted to the FDA for approval and it is possible that a decision will be made in the next year.

FDA to require diversity among clinical trial participants

Companies conducting late-stage clinical trials will soon be required to submit a plan detailing diversity considerations for trial participants before receiving FDA approval. Before the requirement taking effect, the FDA will publish draft guidance and allow for a comment period, which could take several years. Diversity in clinical trials has been a topic of discussion in the life sciences industry and the media, of late, as there are concerns that trial populations are not adequately representative of the entire population of potential patients.

New founder-focused biotech fund raises over $500 million

Curie.bio has launched its first fund focused on helping founders launch new therapeutic companies. The fund will provide both seed capital and act as a copilot through the drug discovery process. The team will leverage its experience bringing over 60 drugs into the clinic with 12 approvals to help founders navigate the difficult early stages of a biotech’s formation.

Next-generation biologics plant breaks ground in Southern California

Genentech has unveiled plans for its first facility designed specifically for fast, efficient and sustainable commercial production of biologics for smaller patient populations including rare disease and personalized medicines. Scheduled to be operational by early 2025, the facility will reduce the time needed to transfer production from the clinical to commercial site to days compared to the six to 18 months it currently requires.

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About Justin Culbertson

Justin has more than 10 years of experience serving publicly traded and privately held companies through technical accounting and financial reporting services. He focuses on clinical research organizations and similar service organizations in the constantly evolving life sciences industry. He has previously advised clients in the areas of new standard implementation, external audit, internal audit, risk management, mergers and acquisitions, process design and improvement, and internal and external financial reporting. He is also a member of RSM’s life sciences national industry leadership team.

In May 2021, Justin was selected as a senior analyst in RSM’s cutting edge industry eminence program, which positions its senior analysts to understand, forecast and communicate economic, business and technology trends shaping the industries RSM serves.

About Steve Kemler

Steve manages the Philadelphia market NetSuite team and provides NetSuite consulting services to a variety of clients in industries including life sciences, technology and wholesale distribution. Steve leads projects that require complex integrations, customizations and complex finance requirements.

As a member of RSM’s life sciences team, Steve consistently supports clients in the industry across the country. He also participates in the PACT MedTech series and is involved in multiple regional life sciences initiatives.

In May 2020, Steve was selected as a senior analyst in RSM’s cutting edge Industry Eminence Program, which positions its senior analysts to understand, forecast and communicate economic, business and technology trends shaping the industries RSM serves.

About David Stuart

David has more than eight years of corporate finance and capital markets experience supporting debt and equity transactions for various industries including technology, telecommunications, life sciences, renewable energy and consumer products. His experience includes negotiating and facilitating transaction closings for private equity, venture capital and financial institutions across North America.

In May 2020, David was selected as a senior analyst in RSM’s cutting edge Industry Eminence Program, which positions its senior analysts to understand, forecast and communicate economic, business and technology trends shaping the industries RSM serves.

About Brian Winne

Brian Winne is a senior manager in RSM’s audit services focused on the life sciences industry. He was selected for the firm’s Industry Eminence Program in 2022 as a senior analyst covering the life sciences industry, working alongside the firm’s chief economist and other program participants to analyze trends and themes affecting life sciences companies in the middle market.

Brian has experience providing audit and business advisory services to his clients. He provides diverse accounting and compliance services to public and private clients in a variety of industries with a focus on biotech, life sciences and technology companies.

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