Clinical trial optimization in CGT can help make cardiovascular therapies a reality

By Samantha Black, PhD, ScienceBoard editor in chief
October 25, 2021

A common theme throughout the 2021 Cell & Gene Meeting on the Mesa was adopting a patient-first mentality. This encompasses branching out from monogeneic diseases to more complex ones, such as cardiovascular disease. caught up with Dr. Monica Shah, who is vice president of medical strategy and head of the Cell and Gene Therapy (CGT) Center of Excellence at Iqvia. Shah moderated "Personalizing Cardiovascular Therapies to Address the Underlying Causes of Disease" on day two of the meeting.

From early clinical development to clinical trial design and execution, Iqvia's Cell and Gene Therapy Center of Excellence partners with organizations to advance their products to market. The organization is focused on helping sponsors develop a comprehensive approach to clinical development plans.

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Over 160 global clinical research sites form Iqvia's dedicated cell and gene therapy clinical trial network. Shah explained that that Iqvia expanded its network beyond North America and Western Europe to include Asia Pacific, Eastern Europe, and Latin America. The company identifies high-quality sites capable of executing trials, specifically in the cell and gene therapy space.

"We think this is really important to help expand the field of CGT and help to manage the competitive environment, but also to bring these therapies to people around the world," Shah told

The center of excellence also provides logistics management services to ensure that products are managed closely, administered carefully, and that clinical trial execution goes flawlessly. Another area of focus for the organization is follow-up studies, where Iqvia uses real-world evidence for long-term follow-up studies to make sure they are patient-centered and streamlined, Shah noted.

"We use our data and analytics in pretty much everything we do," Shah said when discussing how the company's artificial intelligence technology platform is used in clinical trials.

"Data is data," Shah continued. "But you need people to analyze it and think about it and ask the right questions -- to be able to pull it all together and come up with a unique solution."

Iqvia's Cell and Gene Therapy Center of Excellence "process maps" are essential for ensuring that the patient journey and product journey are aligned. This structure allows the company to identify potential bottlenecks and errors so it can proactively address them to speed innovation in the CGT industry.

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Last Updated 7/21/2022 8:48:07 AM