AI in Operations Team

Artificial Intelligence – Advancing the Pharmaceutical and Medical Device Industries

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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 (i.e., 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 towards 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.

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

Lacey Harbour is the Sr. Regulatory and Quality Manager at LimaCorporate U.S.A. Inc. with a decade of exposure to machine learning algorithms within the clinical laboratory to medical device manufacturing and products, and over 20 years’ experience in highly regulated life science industries. Lacey joins the Healthcare Products Collaborative with the goals of helping to determine practical and correct ways to establish confidence and prove reliability for “AI” in operations and within Medical Devices to meet global Regulatory requirements and expectations.

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, Cynthia 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, Cynthia 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., whose 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. Nowadays Toni is in the scientific committee of the PDA Europe supporting annual events for the innovation and technology in pharma.

He worked as a researcher at the University of Barcelona as physicist and he teaches Big Data and Artificial Intelligence subjects related with 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. Toni is Physicist, Master in Information and Knowledge Society and post graduated in quality systems for manufacturing and research pharmaceutical processes.

Sundar Selvatharasu

Chief Compliance Officer – GxP Operations, Sierra Labs

Sundar is an FDA compliance expert known for his pragmatic advice to strategize and execute value-based solutions for emerging technologies in biopharma, medical devices, healthcare and cannabis industries. He constantly collaborates with current and former regulatory agency officials across different regions to train and for impacting regulations on technology adoption. Sundar has lead 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. Kip consults, teaches, speaks, and publishes regularly on topics of data integrity and quality systems.