Sigma-Aldrich offers products and services to manufacturers of diagnostics for the clinical lab

Feb. 19, 2015

Frank Wicks
President, Applied Business Unit; EVP, Sigma-Aldrich


I currently serve as Executive Vice President of Sigma-Aldrich and President of the company’s Applied Business Unit. I’ve been with Sigma-Aldrich since 1982, and have held a number of leadership positions, including President of the former Research Business Unit, Managing Director of North America and President of the former SAFC Business Unit.


BS, Microbiology; PhD, Biochemistry from Oklahoma State University Advanced Management Program, Harvard Business School


“I’ve served as an Advisory Board Member for the International School of Business at Saint Louis University and a trustee of the Covenant Theological Seminary of the Presbyterian Church of America. I’m also a member of the Board of Directors of Cass Bank in St. Louis and have served as a member of the C&E News Advisory Board (American Chemical Society). I’m married with three adult daughters and nine grandchildren. I enjoy reading, and all forms of music.”

How would you characterize Sigma-Aldrich’s primary areas of expertise? Sigma-Aldrich is a leading life science and high technology company focused on enhancing human health and safety. Our products, kits, and services are used in scientific research, biotechnology, pharmaceutical development, the diagnosis of disease, and as key components in pharmaceutical, diagnostics, and high-technology manufacturing. We provide scientific solutions to more than 1.4 million customers globally in research and applied labs, as well as in industrial and commercial markets. 

How have your company’s solutions evolved in recent years to address changing customer needs? As part of our diagnostics business, Sigma-Aldrich previously sold finished in vitro diagnostics (IVD) kits. We subsequently divested our IVD business in favor of continuing to supply our customers with raw materials for IVD kit manufacturing. Our new Applied Business Unit focuses on understanding and mapping customer workflows and building our offer to augment those workflows based on customer needs. 

Sigma-Aldrich has entered into an agreement under which Merck KGaA will acquire Sigma-Aldrich. This is exciting news, and the combined company will be positioned to deliver significant customer benefits, including a broader range of products and capabilities, greater investment in breakthrough innovations, enhanced customer service, and a leading e-commerce and distribution platform in the industry. Sigma-Aldrich has invested heavily in understanding the complex needs of our current and potential customers. Our teams in strategic marketing, executive management, supply chain, and quality control work collaboratively with customers to stay ahead of changes in the marketplace and the regulatory landscape. By providing a single, global point of contact for customer’s unique clinical diagnostic needs, we can create tailored, complete solutions that keep our customers moving forward into the future. 

How has the company’s launch of its Applied Business Unit a couple of years ago benefited customers? The Applied Business Unit was created primarily to cater to the unique needs of the diagnostics, testing, and industrial markets, where our customers’ challenges and opportunities differ significantly from those in the traditional research and commercial markets. The highly regulated nature of the Applied market creates even more demand for a dedicated business unit and sales force to serve customers with enhanced quality, tighter manufacturing controls, and supply chain that delivers consistent high-quality products on an on-time, in-full basis. 

How does Sigma-Aldrich’s Enhanced Quality Program and Change Control Notification Program help customers deal with regulations related to raw materials? The Change Control Notification Program involves a series of steps that help prevent supply disruptions during any changes in the raw material manufacturing process for IVD products. The CCNP significantly minimizes disruptions for our customers when manufacturing changes require additional verification and validation, or when critical raw material availability causes changes to the process. The Enhanced Quality Program provides customers an opportunity to select raw materials that are suitable for their manufacturing needs and also meet their requirements for Change Control Notification. We’ve launched the ELITE brand of products for the IVD industry, and beginning next year we will gain ISO13485 certification for our manufacturing site in St. Louis. All of these shifts are designed to help customers stay on top of changing regulations and manufacturing processes. 

Laboratory developed tests (LDTs) have been much in the news lately for clinical labs. How do your services address this subject? LDTs are here to stay. As bacteria continue to evolve and develop newer resistance markers and as we gain better understanding of disease states, I see a constant need for developing newer, better tests to improve diagnoses and patient management. Sigma-Aldrich’s customer base consists of diagnostics manufacturers as well as clinical and reference laboratories developing LDTs, which require the use of high-quality raw materials and documentation. Sigma-Aldrich has several teams focused on developing solutions that can be used by our testing customers for developing LDTs. Because raw materials used for making LDTs go through the highest degrees of quality control, Sigma-Aldrich’s testing customers always achieve the same level of quality and consistency in their clinical testing. We are actively participating in the continuing discussion on regulatory affairs, and with expert knowledge of our customers and the marketplace, we expect to be a leader in meeting the needs of the changing marketplace. 

How does your long tenure with the organization and your immersion in its culture impact the way you fulfill your present responsibilities? My experience over the years at Sigma-Aldrich enables me to have a clear understanding of our capabilities. This insight helps me to bring together the necessary components to create solutions to solve our customers most difficult problems.