The Real Economy Blog

Economic News from RSM

Home > Health care > 5 things to know in life sciences: Week of March 7, 2022 

5 things to know in life sciences: Week of March 7, 2022 

by , , and

5 things to know in life sciences This week we highlight changes in drug exclusivity, international mRNA manufacturing expansion, clinical trial challenges in Russia, and recent Food and Drug Administration activities. Each week we highlight five things you need to know about in the life sciences industry. Here’s the latest.

Top 10 drugs losing U.S. exclusivity in 2022

It’s anticipated to be a more difficult year for early-stage life sciences companies to secure capital and achieve the valuations seen in 2021. Large pharma companies are not without their challenges as there are a significant number of brands losing exclusivity this year. The top 10 drugs going generic represent more than $17 billion in annual sales. As smaller companies look for new ways to access the market or find ways to finance operations and further research, we anticipate an uptick in mergers and acquisitions and strategic partnerships across the life sciences ecosystem in 2022.

Moderna taps Kenya as a site for $500 million mRNA manufacturing facility

The need to improve global access to vaccines and therapies was made abundantly clear through the pandemic and ongoing vaccination efforts. While Moderna’s CEO, Stéphane Bancel, acknowledged that the proposed $500 million facility is unlikely to have a significant impact on the current pandemic because of the estimated build time, this is still an important move to ensure “sustainable access to transformative mRNA innovation on the African continent and positively impact public health.” The move by Moderna is only one example of the continued development of life sciences capabilities across the continent, and recently, nine development institutions have announced a partnership with South African manufacturer Biovac to expand manufacturing capabilities and create a more sustainable system.

Clinical trial recruitment on hold at top Russian medical university

Clinical trial recruitment in Russia is being put on hold by international sponsors. While trial administrators await approval from the sponsors to proceed with recruitment, approval alone will not remediate the other challenge related to supply chain disruptions. Clinical trial samples may not be transmitted timely to central laboratories in Europe or the U.S., which could lead to deteriorating sample quality. The situation has Russian trial administrators exploring domestic options.

FDA approves AI software that helps detect broken bones

The FDA recently approved Gleamer’s artificial intelligence-based software that helps physicians quickly identify and diagnose fractures and traumatic injuries by reviewing X-ray images. It’s estimated that fracture interpretation errors represent up to 24% of emergency room diagnostic errors. A recent study published by Boston University School of Medicine showed that Gleamer’s software, known as BoneView, helped improve fracture detection sensitivity while reducing the radiograph read time per patient.

FDA recommends manufacturers be “recall ready” to protect patients

The FDA published new guidance that they hope will improve public safety and limit public health risk from defective medical devices. The new guidance includes training, planning and record-keeping policies and procedures that help companies reduce the time a recalled product remains on the market. Voluntary recalls continue to be the fastest and most effective way to remove defective devices. The administration is continuing to work with manufacturers so they can be ready and limit the risk once a defect or safety concern has been identified.

Related posts

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 Adam Lohr

Adam is an audit partner and life sciences senior analyst in RSM's cutting-edge Industry Eminence Program. In addition to providing assurance services to his clients, he sits on RSM’s national life sciences team and leads the San Diego office life science practice.

His senior analyst responsibilities include advising the firm’s life sciences care clients and client servers as they work to navigate the rapidly changing industry environment. Adam regularly writes, presents and advises on capital markets, digital transformation, policy and other issues transforming life sciences. He is an instructor at the regional and national level, and is experienced in the application of ASC 606 revenue recognition for the technology and consumer products industries.

Adam has over 12 years of accounting and finance experience, serving private equity-backed and private closely held companies in the middle market. He specializes in providing financial audit services and helping clients respond to technical, regulatory and economic changes that impact their business.

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.

The Real Economy Blog