Goal
The AI in Operations Team (AIO) is an organized, cross-industry discussion group of FDA officials and industry professionals working to increase the predictive assurance of product quality across all operations (e.g.., manufacturing, quality, supply chain, etc.) through the power of AI.
AIO Problem Statement
The medical device and pharmaceutical industries are anxious and hesitant to expand their use of artificial intelligence in operations. The saying “I want to be the first to be second” rings true in some cases, while others are forging ahead. The AI in Operations Team is collaboratively working to increase the awareness of how AI is already being used, and exploring additional applications.
AIO Work Team Deliverables
In February of 2022, the efforts of Xavier Health were assumed by the AFDO/RAPS Healthcare Products Collaborative. Because of the important work done before this transition, the Collaborative has chosen to retain documents that have Xavier branding and continue to provide them to the communities through this website. If you have questions, please contact us at info@healthcareproducts.org.
2021
- Whitepaper: Maturity Level Characterization of AI Capabilities for Self-Assessment (Link)
- Whitepaper: AI in Manufacturing Process Improvement (Link)
- AI Checklist Tool (no longer available)
2020
2019
Survey results that measure the current status of how AI is being used in manufacturing
2018
System Map demonstrating interconnectivity and potential causal relationships between GMP systems, non-GMP systems and the complaint system:
Summary of data elements that represent risks and/or potential failure modes for the events captured in the complaint system:
Definitions of AI relevant terms to harmonize understanding:
Team Leaders
George
Brunner
George Brunner is the Chief Data Scientist at Acumen Analytics. Acumen Analytics, based outside of Philadelphia and founded in 2004, is an award winning WBE technology solution provider for the pharmaceutical, biotech, manufacturing, and technology industries. Acumen is a leader in using data, technology, advanced analytics, innovation, and expertise to help drive transformation in the life sciences. Acumen helps organizations combine innovation with technology not just to improve but to accelerate outcomes and make the impossible possible. Acumen team members combine decades of Life Science experience with intelligent, resilient, future forward technology solutions, data, and a passion for possibilities.
Lacey
Harbour
Lacey Harbour is a classically trained Molecular Biologist turned Regulatory, Quality, and Clinical Strategist. Her experience includes the Clinical Laboratory, R&D, Pharmaceuticals, and Medical Devices industries. Leveraging a diverse background, she has led or supported teams that have brought orthopedic, in vitro diagnostic, SaMD, dental, physiotherapeutic, and other FDA Class I to Class III devices to the global market with high quality. Starting from the exposure of validating predictive systems in the operational and diagnostic sides of the clinical laboratory, proving safety and effectiveness of machine learning algorithms in the total product life cycle of healthcare has been a passion for many years. As an advocate of protecting patients while taking a risk-based, least burdensome approach, Harbour considers joining think tanks like AFDO/RAPS as an honor. Her goal is to ensure that the future of medical care is state of the art while maintaining safety and effectiveness and, hopefully, encouraging global accessibility of good healthcare products.
Cindy
Ipach
Cynthia Ipach, President and CEO of Compliance Insight, Inc., founded the company in 2000. With over 30 years of experience in pharmaceuticals, medical devices, dietary supplements, and biologics, she has supported hundreds of companies in FDA compliance. Ipach started in Analytical Research and Development and transitioned to Regulatory Affairs and Quality Assurance. Before starting Compliance Insight, she was Director of Scientific Affairs at Pharmacia. Recently, she has been active in AFDO/RAPS’s AI in Operations Group and co-led the development of AI maturity models and white papers on AI in healthcare.
Toni
Manzano
Manzano is the co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry. He is also co-leading CPV and Biomanufacturing groups at the PDA, and he teaches AI subjects at the University (OBS and UAB). Manzano is a member of the Science Experts in the Spanish Parliament on big data and artificial intelligence topic and an AI expert with the United Nations for biopharma. He has written numerous articles in the Pharma field and holds a dozen international patents related to the encryption, transmission, storage, and processing of large volumes of data for regulated environments in the cloud. Manzano is a Physicist, Master in Information and Knowledge Society, and postgraduate in quality systems for manufacturing and research pharmaceutical processes.
Matthew
Schmucki
Matt is the Associate Director for data automation and engineering for Vertex Pharmaceutical’s manufacturing data and analytics applications. He supports both internal manufacturing and external contract manufacturing partnerships by setting up standardized data ingestion mechanisms for data analytics. Over the past decade and a half, Matt has supported many types of products from oral solid dose to combination products, with companies ranging from startups and CMOs to top pharmaceutical and biopharmaceutical companies. Matt is a mechanical engineer from the University of Cincinnati with a Doctorate in Business Intelligence. Matt is also a Guest Lecturer for Xavier University for both the Quality Science Regulations and Industrial Product Development programs. These lectures introduce undergraduate students to concepts and practices fundamental to the pharmaceutical and medical device industries.
Sundar
Selvatharasu
Sundar Selvatharasu is an FDA compliance expert known for his pragmatic advice to strategize and execute value-based solutions for emerging technologies in the biopharma, medical devices, healthcare, and cannabis industries. He constantly collaborates with current and former regulatory agency officials across different regions to train and to impact regulations on technology adoption. Selvatharasu has led multiple audits globally for the biggest drug and device companies. He is a regular speaker at conferences and has published on topics of security, data integrity, compliance, and agile quality systems.
Kip
Wolf
My technical experience includes the fields of quality assurance and regulatory affairs, GMP and IT compliance, technical operations and product supply. My areas of leadership expertise include business transformation, new business development, organizational change leadership and program / project management. I have more than 25 years of experience as a management consultant, during which time I have also led business process management groups at Wyeth Manufacturing and at Merck Research & Development. Prior to joining X-VAX, I supported the company as a principal consultant at Tunnell Consulting, where I also led the data integrity practice. I completed graduate studies in Drug Development at Temple University, and hold an undergraduate degree in Management of Information Systems and an MBA from Eastern University.
Joining the Team
You have an opportunity to work with your industry and regulator peers to develop solutions that will advance the predictive capabilities of the industry.
The AIO Team operates virtually from September through August each year, and is led by a structured leadership team toward predefined goals and deliverables.
The team leaders present the outcome of the work during the AI Summit that occurs each August. You will be recognized for your contributions at the Summit and in team publications.
Meeting frequency and duration is based upon what is needed to support progress against the deliverables. Team members volunteer to work on specific aspects based on their expertise.
If you are interested in joining the AIO Working Team, please note:
- There is an annual participation fee of $100* per team to support Healthcare Products Collaborative’s ability to lead these initiatives.
- It is expected that you participate in the standing meetings (schedule is determined by each team).
- Plan on a time commitment of 5 hours per month, but this may vary.
THE MEMBERSHIP FEE FOR 2022 WILL BE WAIVED FOR EVERYONE AS WE TRANSITION TO MANAGEMENT OF OUR AI WORK TEAM PROGRAMS UNDER AFDO/RAPS. ANY MEMBER WHO PREVIOUSLY PAID A 2022 MEMBERSHIP FEE WILL RECEIVE A FREE MEMBERSHIP FOR 2023.
