ISPE Pharmaceutical Engineering® Article “ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma” Honored with 2024 APEX Award

25 September, 2024

Apex 2024ISPE has been honored with a 2024 APEX Award of Excellence in Writing for “ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma” by Frederick Blumenthal, Martin Heitmann, Stefan Münch, and Brandi Stockton published in the July/August 2023 issue of Pharmaceutical Engineering®. This marks the fifth consecutive year that Pharmaceutical Engineering® has received an APEX Award.

The APEX Awards commend excellence in writing, editing, and graphics across a wide range of communications in nonprofit and for-profit publishing and communications organizations. Awards of Excellence recognize exceptional entries in 100 subcategories. ISPE’s article was recognized in the Writing/Topics – Artificial Intelligence (AI)/Robotics subcategory.

“ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma” explores the possibility of applying artificial intelligence large language model tools in a safety-critical, product-related environment and whether the technology could be helpful in regulated areas of the pharmaceutical industry. The authors examine the issue from quality, risk, and efficiency perspectives and present ways these tools can shift thinking around validation and quality assurance.

The authors note in the introduction: “ChatGPT and other large language models are positioned to change the world. They can also shift acceptance and prevalence of machine learning solutions in regulated industries in general. However, their arrival requires reconsiderations on risks, quality assurance, and validation from a GxP perspective.”

This award recognition comes on the heels of ISPE’s announcement of ISPE AI®, ISPE’s new artificial intelligence initiative. The initiative includes the launch of a new Artificial Intelligence Community of Practice (CoP). ISPE will also develop new ISPE Guidance Documents, conference sessions, training courses, and more to help the pharmaceutical industry prepare for AI-related planning and implementation.

Brandi Stockton, co-author of the award-winning article, an active member of the new ISPE AI CoP, co-lead for the GAMP® Software Automation and Artificial Intelligence Special Interest Group, and Founder as well as Managing Partner for The Triality Group LLC, said: “ISPE’s AI CoP and initiatives are expanding on the foundations created by the GAMP® Software Automation and Artificial Intelligence Special Interest Group by connecting pharmaceutical knowledge to enable the industry to realize the full potential of artificial intelligence. To me this award highlights the significance of connection and collaboration and serves as a reminder that our greatest achievements are not the result of individual efforts but are born from our collective wisdom. I envision the AI CoP as the place where its members can learn, share, grow and evolve together.”

Review the award-winning article, “ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma.”

Learn more about ISPE AI. Existing ISPE members are invited to join the ISPE Artificial Intelligence CoP by selecting “Artificial Intelligence” in the Communities tab in their ISPE profiles. 

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About the APEX Awards

The APEX Awards is an annual competition for publishers, editors, writers, and designers who create print, web, electronic, and social media. Managed by Communications Concepts, Inc., the awards recognize excellence in publishing by professional communicators. The APEX Awards are based on excellence in graphic design, editorial content, and the ability to achieve overall communications excellence. Learn more at apexawards.com.