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Steve Smith

President, Patient Advocacy


Steve Smith is a seasoned patient advocate with an extensive career in software, consulting, process transformation, health care systems and patient-focused drug development. He joined WCG as President Patient Advocacy in 2019 inspired by the incredible value to patients embedded in the wide range of WCG solutions that reduce the time and cost of clinical trials.

Steve’s strong sense of mission to increase the rate at which new treatments for disease can be developed to address unmet medical need, is complemented by his conviction that we can develop drugs faster, while remaining safe. Paramount is the interests of patients whose needs include not only new medicines, but also quality of life. Modern science, modernizing regulatory processes, and modern computing technology, when combined with best practices in collaboration and process improvement, can give us new drugs developed faster, safely, and at a lower cost.

Steve started his career working for several leading, global software technology vendors in a wide variety of roles including product management, operations planning, partnerships, sales, marketing, international operations, and process transformation across industries. Steve has worked for Pansophic, JD Edwards, SAP, IBM, and Medidata, and in his 14 years as an independent consultant has provided planning and management services to senior leadership of numerous software technology vendors, and biotech-pharmaceutical companies.

When his three-year old was diagnosed with a rare, progressive disorder for which there was no treatment, he naturally viewed the ways we conduct and regulate clinical trials as processes in need of transformation. Lacking FDA-approved treatments, and with no clinical trials in sight, he attended his first patient advocacy meeting in 1990 and met other families, the researchers, and specialty physicians focused on such diseases. He saw the need for investment, research, clinical trials, and reform of regulatory processes. He has been active with patient communities since then.

He first called on the FDA and members of Congress in the year 2000 and outlined what needs to change in clinical trials regulatory policy. Since then he has been involved in the growing, and more sophisticated, collaboration across all stakeholders. He helped start the EveryLife Foundation for Rare Diseases, and worked on legislative efforts including PDUFA V, 21st Century Cures, and has gone to “the Hill” many times to speak to members of Congress about clinical research and patient needs. He is an Abbie Award nominee for giving patients a voice on Capitol Hill and was recognized as a member of the PharmaVoice 100 for his advocacy work.

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