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5 things to know in life sciences: Week of March 14, 2022

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life sciences five things to know This week we highlight patent infringement claims, ongoing manufacturing expansion, underrepresentation of pregnant women in clinical data, and the National Institutes of Health’s All of Us genomic study. Each week we highlight five things you need to know about in the life sciences industry. Here’s the latest.

Companies sue Pfizer and Moderna for patent infringement

A few companies have sued Pfizer and Moderna claiming patent infringement in development of their COVID-19 vaccines. In this case, Alnylam says its original patent covers “a breakthrough class of cationic biodegradable lipids used to form lipid nanoparticles that carry and safely deliver.” The companies are not seeking to halt vaccine production but are seeking damages.

Indian pharma and U.S. philanthropist expand into Africa

An Indian drug maker has partnered with a U.S. physician and philanthropist to build a $50 million drug manufacturing facility in Akwamu, Ghana. The facility will manufacture medicines to treat high blood pressure, diabetes, malaria and pain. This is one of several manufacturing expansions we’ve seen in Africa over the past year.

The challenge of pregnancy underrepresentation in clinical trials

Pregnant women are significantly underrepresented in clinical trials. As a result, approximately 90% of prescription medications have little to no information on fetal safety. This article explores this challenge and possible paths forward.

NIH’s All of Us study releases first 100,000 genomes

The NIH’s All of Us study is a diversity-focused health and genetics study aiming to enroll 1 million volunteers in the United States to collect and share their genomic data. The study recently released the whole genomes of approximately 100,000 participants. The data will be shared with approved researchers and institutions via a cloud-based platform.

Thermo Fisher’s $97 million expansion near Richmond, Virginia

Thermo Fisher is set to expand its bioanalytical labs in the greater Richmond, Virginia area. The expansion will cost an estimated $97 million. Thermo Fisher’s president of analytical services stated that “this expansion will provide additional capacity for existing analytical capabilities in the immunochemistry and chromatography space, in addition to supporting our continued growth in vaccines and cell and gene therapy work.”

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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 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.

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