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5 things to know in life sciences: Week of Sept. 12

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life sciences five things to know This week, we look at a new executive order encouraging biomanufacturing, a rare company going public through a special purpose acquisition company and what an executive can do when a trial is placed on a clinical hold. We also look at how progress in curing hepatitis C remains slow despite revolutionary drugs that are available. Finally, Sony gets in the over-the-counter hearing aid business. Each week we highlight five things affecting the life sciences industry. Here’s the latest.

President Biden issues executive order promoting biomanufacturing and biotech

Looking back on disruptions to medical supply chains during the pandemic, alongside the growing amount of medical supplies coming from China, President Biden issues an executive order to increase investment in on-shore manufacturing and to promote the development of new drugs. The executive branch hopes to cement the role of the U.S. as a leading innovator even in the face of reduced private investment in the sector.

SPACs may not be making headlines now, but many still have capital and are looking for deals

It has been a rollercoaster ride for SPACs in the past two years. Although the mechanics of SPACs have been around for years, they had quite a resurgence as numerous SPACs were formed and went public in the past two years. After additional scrutiny from regulators, the volume of new SPACs forming and deals taking companies public through a de-SPAC are both down substantially. However, when SPACs are formed they have a short timeline (generally two years) to merge with a private company. So, as Apollomics shows in this article, SPAC deals will likely continue to avoid having to return capital to investors.

Leading through a clinical hold

No CEO wants to see headlines saying a drug candidate has been placed on a clinical hold. It can mean significant delays, increased costs and a risk that the candidate won’t come off hold to resume the trial. The president and CEO of Immunome shares the story of why the drug candidate was put on hold, what the company did in response and how other biotech leaders should respond in a similar situation.

Sometimes developing a miraculous drug is the easy part

Developing a cure for hepatitis C was, rightfully, seen as a breakthrough. However, years after the drug’s approval, and despite significant investment by state governments and deals to reduce the high costs of the drugs, progress in helping patient populations with hepatitis C remains elusive. Even after solving for the costs and access to the drugs in Washington and Louisiana, patient advocates and health care providers struggle to get the treatment into the hands of high-risk patient populations that don’t have reliable access to doctors, or a stable environment for treatment.

Consumer electronics giant Sony targets over-the-counter hearing aids

In August of this year, the Food and Drug Administration issued a new rule allowing over-the-counter sales of hearing aids. Now, Sony has announced a partnership with WS Audiology Denmark to bring self-fitting hearing aids to a store near you. The White House estimates that the new rule allowing over-the-counter sales will save consumers as much as $2,800 per pair and improve access to these devices.

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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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