In addition to being the Co-Chair for the ISPE Advanced Therapy Medicinal Products Community of Practice, she is the Co-Chair for the ISPE Carolina-South Atlantic (CASA) Chapter’s education committee and helped plan the educational tracks for this year’s CASA Annual Tech Show. A member of ISPE since 2019, Patel is also a member of ISPE’s Women in Pharma®.
Can you describe a memorable project?
One project I’m especially excited about is Assurea’s expansion into emerging tech. This year, we launched AI-powered solutions to help clients automate processes like annual product reviews, documentation review and analysis, inventory management, and shipping lane validation. It’s exciting to see how our custom AI solutions will help our clients streamline operations and drive efficiency in life sciences.
As Assurea grows, we are committed to expanding our global impact in STEM (science, technology, engineering, and mathematics)—solving problems and creating waves for positive change. Our #RootingForYou campaign was created to help women and underrepresented groups get recognized for their ideas in STEM. We promote this mission through our goal-setting programs, including STEM KITS for Students, highlighting inspiring leaders, and hosting workshops with our journal prompts.
We’re especially excited about the STEM KITS for Students initiative, which is designed to spark curiosity in the next generation by showing how STEM experiments connect to everyday life. It’s been incredible to see this initiative grow, and we’re excited to keep building on it.
What’s next for your area in the industry?
I see the pharmaceutical and biotechnology industries evolving faster than ever, especially with the increased adoption of emerging technologies such as AI and blockchain. More companies are turning to AI to streamline everything from quality processes to regulatory compliance, making data analysis and decision-making more efficient and insightful. It’s exciting to see how technology is no longer just a tool but a driving force in shaping the future of biotech.
The industry is recognizing the need for purpose-built process automation and advanced analytical tools to enhance the efficiency and scalability of cell and gene therapy manufacturing where this shift is especially important because scaling up manufacturing has been a challenge. The industry is realizing that off-the-shelf solutions aren’t enough: we need automation and advanced analytics designed specifically for C>. As AI and automation become more embedded in the process, they’ll help streamline development and improve efficiency, ultimately making these therapies more accessible to patients who need them.
What projects is your group working on?
We have a lot of exciting initiatives coming up in the ATMP CoP. I’m especially excited about our latest initiative—a united Asia-Pacific (APAC) region ATMPs CoP collaboration which kick off at the 2025 ISPE Japan Affiliate Annual Meeting in Tokyo, Japan. Until now, ISPE affiliates in APAC regions like Singapore, Malaysia, India, Japan, South Korea, Australia, and others have had their own individual CoPs, each hosting local initiatives. For the first time, we’re bringing these groups together to foster cross-collaboration across the region. Representatives from the ATMP CoPs from each APAC affiliate will now meet monthly to combine efforts and enhance engagement in the C> community through webinars, technical articles, and regional events. Additionally, we’re in early discussions to establish an ISPE ATMP CoP for the Middle East and North Africa (MENA) region, recognizing the rapid growth of C> in that area of the world. Countries like Saudi Arabia and the United Arab Emirates are making major investments to position themselves as biotech hubs. For example, Saudi Arabia has established a national biotech strategy in an effort to become an international biotech hub by 2040. By engaging with these emerging markets, we hope to foster collaboration and knowledge exchange, supporting the region’s expanding C> ecosystem.
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Are you an ISPE Member looking for a better way to connect with your colleagues from around the globe? Or are you a Member seeking information on new trends, issues or concerns affecting your profession and your day-to-day work life? Join an ISPE Community of Practice (CoP). CoPs are groups of ISPE Members with a common interest and similar job functions who collaborate on topic-specific discussions using the ISPE networking forum, ISPE Engage.
