AFDO/RAPS Healthcare Products Collaborative just concluded its 2022 AI Summit with the tagline –  An artificial intelligence summit where world healthcare leaders come together.

The AI Summit

This year’s AI Summit provided a real behind-the-scenes look into how Artificial Intelligence (AI) is being used in pharma, biopharma, and medical devices (ADFO/RAPS AI Summit). The in-person event was held at the Sonesta Hotel in downtown Columbus, Ohio and essentially consisted of a pre-conference workshop and two days of papers on AI/ML by top industry experts (AI Summit Speakers & Moderators). However, the organizers did spice it up with such activities as a panel discussion with AI experts on building trust in AI systems, and a concluding Fireside Chat with Jesse Ehrenfeld, AMA President-elect.

The AI Initiative Strategic Committee worked hard to produce a purpose driven, action-oriented experience with truly meaningful and impactful content. The audience at this annual event was quite broad, and participants included healthcare quality, regulatory, operations, and R&D professionals who are just beginning, or currently using, AI-based solutions. Professions represented included  clinical trial managers, business executives, consultants and service providers, data scientists and AI experts.

Since 2016, the AI Summit has strived to unite innovative and forward-thinking minds across the industry. Their goal has been to revolutionize the thinking on patient health, product quality and process improvement in the pharmaceutical and medical device industries through the power of AI. This author has been very impressed by their championing the implementation of very practical AI/ML solutions and their democratization of this by making them freely available to the global industry.

Kicking-off on October 25 the Pre-Conference Workshop was on AI/ML per se and the Predetermined Change Control Plan (PCCP). This continuous learning session began with a crash course on AI/ML terminology, data requirements, and performance metrics. There was a discussion on dealing with the ever-evolving software/device modifications. This was followed by a look at the future of the regulatory landscape and the PCCP.

Particularly well-received was a presentation by Mathew Schmucki, Data Analyst for AstraZeneca. He energetically introduced basics of data visualizations and how to efficiently show data to support your story and provided some practical steps to create or strengthen your data culture. A walk-through of a use-case demonstrating the successful utility of AI/ML tools wrapped up the day.

Daily Activities

Each day of the main session began with an interactive activity to draw out individual experiences and ideas with summit colleagues, enthusiastically moderated by Toni Manzano, Co-Founder & CSO, Aizon, and Cindy Ipach, President & CEO, Compliance Insight.  Also, the meeting organizers did a great job designing such networking as topic-designated tables for lunch.  Delegates could sit at a table with fellow colleagues interested in that particular topic.

Main Session Day 1: Wed 26 Oct

Following the warm-up session, the day continued with oral papers on such topics as an update on global regulatory releases and standards. Of particular note was the Solution Exchange exercise. The audience was invited to breakout groups, bringing value through their knowledge to address prepared real-life AI implementation problems. As this audience was so especially engaged, the output of the four groups will be collated and published for general consumption this winter.

That afternoon, two presentations demonstrated how AI is nearly an absolute requirement in SMART manufacturing and the 3D printing of devices (especially at the POC). A particularly notable paper described how such AI empowered techniques as pharmacogenomics supports remarkable outcomes in personalized, precision medicine.

The last paper of the day used actual examples to illustrate the design, development, verification, validation, and submission of AI based Software as a Medical Device (SaMD) wearable devices. The day concluded with a delightful networking reception that provided refreshments and a relaxed atmosphere to meet with accomplished AI and healthcare industry colleagues.

Main Session Day 2: Thu 27 Oct

Day 2 began with papers on such topics as deploying AI in GXP environments and a review of case studies in real-world experiences aligning AI/ML activities with a compliant QMS. Importantly, there was an activities overview and “call to participate” by leaders of the three AI initiative working teams, Good Machine Learning Practices (GMLP), AI at the Point of Care (AI@POC), and my team AI in Operations (AIO).

The AIO team was particularly proud of the recent International Society of Pharmaceutical Engineers (ISPE) winning the 2022 APEX Award for Publication Excellence in the Technical & Technology Writing category.  The award was for a paper titled AI in ATMPs that was entirely composed by AIO team members and appeared in the Nov-Dec 2021 issue of Pharmaceutical Engineering®.

The summit proper kicked off with a session moderated by Cynthia Ipach of Compliance Insight.

Conclusion

The last paper of the summit on Day 2 provided insights from Jesse Ehrenfeld, American Medical Association (AMA) President-elect, on such topics as their employment of the term Augmented Intelligence− emphasizing that AI services enhance human intelligence rather than replacing it.  The summit concluded with a “fireside chat” wrap-up from a number of AI experts.

It’s important to point out that this year’s event was produced by the AFDO/RAPS Healthcare Products Collaborative’s AI Global Initiative. Led by top FDA and industry leaders, their goal is to accelerate innovation through the use of AI and digital health advancement of healthcare. The AI Initiative Strategic Committee is supporting this by orchestrating the collaboration of targeted working groups, global regulators, AI experts, and industry leaders to identify and overcome hurdles in the design of AI-enabled products for healthcare and implement practical solutions.  All in all, this year’s AI summit was an unmitigated success− providing excellent speakers, opportunities for collaboration, and truly delicious food from the Sonesta.

Association of Food and Drug Officials (AFDO)

The Association of Food and Drug Officials (AFDO) is a well-recognized national organization that represents state, territorial, and local regulatory. The Association’s principal purpose is to act as the leader and a resource to state, territorial, and local regulatory agencies in developing strategies to resolve and promote public health and consumer protection related to the regulation of food, medical products, and cosmetics. www.afdo.org.

 Regulatory Affairs Professionals Society (RAPS)

The Regulatory Affairs Professionals Society (RAPS) is the largest organization of regulatory professionals for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. www.raps.org.

About the Author

William Whitford, Life Science Strategic Solutions Leader, DPS Group

Bill Whitford is the Life Science Strategic Solutions Leader for DPS Group Strategic Consulting Team, supporting innovative therapeutic developments and biomanufacturing processes. An invited lecturer at international conferences, Bill has published over 400 articles, book chapters and patents in the bioproduction arena and enjoys such appointments as serving on the BioProcessing International Editorial Advisory Board. He has an h-index of 16 and an i10 index of 25. An article of his recently brought the International Society of Pharmaceutical Engineers (ISPE) the 2022 APEX Award for Publication Excellence in the Technical & Technology Writing category for his article “AI’s Promise for ATMPs” published in the November-December 2021 issue of Pharmaceutical Engineering®.