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AI in Operations Team

Artificial Intelligence – Advancing the Pharmaceutical and Medical Device Industries

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AI Working Teams > AIO

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.

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.

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.

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 Timothy Hsu, Director of Health Technology Initiatives, at thsu@healthcareproducts.org.

AI in Manufacturing Process Improvement white paper

2019

2018

Team Leaders

Lacey Harbour

Sr. Regulatory and Quality Manager, Lima Corporate

Harbour is a classically trained Molecular Biologist turned Regulatory, Quality, and Clinical Strategist with experience in the Clinical Laboratory, R&D, Pharmaceutical, and Medical Devices industries.  Leveraging a diverse background, Harbour has led and 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 regards joining think tanks like AFDO/RAPS an honor. The ultimate goal? Ensure that the future of medical care is state of the art while maintaining safety and effectiveness and, hopefully, will encouraging global accessibility of good health care products. 

Cynthia A. Ipach

President and CEO, Compliance Insight

Cynthia Ipach, President and CEO of Compliance Insight, Inc., founded the company in 2000. With over 30 years of experience in the pharmaceutical, medical device, dietary supplement, and biologic industries, Ipach has supported hundreds of companies in their pursuit of FDA compliance.

She began her career in Analytical Research and Development and later moved to Regulatory Affairs and Quality Assurance positions within the Pharmaceutical Industry. In 2000, Ipach left the corporate environment and her position as Director of Scientific Affairs for Pharmacia to start the Quality Assurance and Regulatory Affairs consulting firm known as Compliance Insight, Inc.; its mission is to align with client initiatives to move beyond the regulations to compliance that makes sense.

Toni Manzano

Co-founder and CSO, Aizon

Toni Manzano is co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry. Since 1996 he has led software projects for international pharmaceutical companies covering the entire production process and supply chain (R&D, clinical trials, production, laboratory, quality assurance, warehousing, and logistics). In pharma manufacturing he was specifically dedicated to biotech processes, always improving critical operations. He has also led projects implementing solutions based on the 3 ICH (Q8, Q9, and Q10) and executing audit, qualification, and validation tasks. Today Manzano is on the scientific committee of the PDA Europe supporting annual events for the innovation and technology in pharma.

Manzano also worked as a researcher at the University of Barcelona as physicist, and he teaches Big Data and Artificial Intelligence subjects related to the Pharma Industry in specific postgraduate courses at the University (UAB). 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 post graduate in quality systems for manufacturing and research pharmaceutical processes.

Sundar Selvatharasu

Chief Compliance Officer – GxP Operations, Sierra Labs

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

Head of Technical Operations and Portfolio Management, X-Vax Technology, Inc.

Kip Wolf is Head of Technical Operations and Portfolio Management at X-Vax Technology. Wolf has more than 25 years of experience as a management consultant, during which he has also temporarily held various highly visible leadership positions at some of the world’s top life sciences companies. Wolf has temporarily worked inside the life sciences industry on two occasions, both during periods of significant transformational change: first inside Wyeth, pre-Pfizer merger; and, again inside Merck, post-Schering merger. In both cases he led business process management (BPM) groups: at Wyeth, in the manufacturing division; and, at Merck, in the research and development division. Wolf consults, teaches, speaks, and publishes regularly on topics of data integrity and quality systems.