Agenda: Day 1
Wednesday, March 14, 2018
7:45 AM - 8:30 AM
Join your colleagues from around the country as we kick off PharmaLink 2018 with a complimentary warm breakfast.
8:30 AM - 9:00 AM
Let's Make a Difference!
Welcome to the conference, welcome to Xavier University, and welcome to the Cincinnati District of the FDA. This purpose-driven conference will lead you to actionable learning and implementation plans.
- Marla Phillips (Co-Chair), Director, Xavier Health, Xavier University
- Art Czabaniuk, Program Division Director, Division of Pharmaceutical Quality Operations III, ORA, FDA
- Steve Barber, Cincinnati District Director, FDA
- Marla Phillips
9:00 AM - 9:45 AM
The Solution Xchange
Start your day with solutions! This fast paced, engaging session draws out your experience and ideas by having you work collaboratively with your colleagues to address the challenges that will be discussed throughout the conference, while tying your ideas to the hopes of a patient whose life is depending on you.
- Jennifer Brown, Director, Global Chemistry, Manufacturing & Controls, Pfizer
- Cathleen Carson, Associate Director, Treyburn & Supplier Quality Assurance
- Tami Frederick, Global Director, Corporate Quality Systems and Programs,
9:45 AM - 10:05 AM
10:05 AM - 10:45 AM
Message from the Office of the Commissioner
FDA Commissioner Scott Gottlieb, MD, was sworn into office in May 2017, and has an aggressive vision to shape the future of public health policy. Understand how Gottlieb’s vision and actions impact our industry, your organization, and all of us as patients. On the top of Gottlieb’s list are:
- Addressing opioid drug use
- Bringing high quality prescription drugs to market faster
- Reducing the cost of prescription drugs
- John Taylor, President and Principal, Compliance and Regulatory Affairs, Greenleaf Health
- Anna Abram, Deputy Commissioner for Policy, Planning and Legislation, FDA
10:45 AM - 11:45 AM
New! APEC Supply Chain Security Toolkit
FDA is teaming with regulators from the 21-nation Asia-Pacific Economic Cooperation (APEC), non-APEC countries, industry stakeholders, representatives from non-governmental organizations, international organizations, and academia to develop strategies to better secure the medical product supply chain across APEC economies and around the world. The Toolkit is a comprehensive resource that covers the entire supply chain and lifecycle of medical products – from raw materials to patient use. Learn firsthand what FDA is recognizing as important supply chain practices for your organization.
- Marla Phillips, Director, Xavier Health, Xavier University
- Katie Neckers, Regulatory Counsel, Office of Compliance, FDA
- Phillip P. Nguyen M.D., DABFM, Director, International Regulatory Affairs and Programs, United States Pharmacopeia (USP)
11:45 AM - 12:30 PM
FDA Office of Regulatory Affairs Update and Strategic Priorities
The Office of Regulatory Affairs (ORA) houses all the investigators across the country, and has launched an extensive realignment of its operations in response to the growing sophistication and complexity of industry technological advances and globalization. ORA partners with CDER on inspection and harmonization initiatives, and works with industry to ensure safe and effective drugs are available and accessible for the patients you serve. Understand the key ORA initiatives that are on the horizon, and the expectations FDA has of your organization to reduce the risk of your product quality.
- Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding
- Ellen Morrison, Assistant Commissioner for Operations, Office of Regulatory Affairs, FDA
12:30 PM - 1:30 PM
Lunch Networking by Topic
Sit with FDA officials, speakers, industry experts and your colleagues at tables dedicated to topics that are important to you. Enjoy the discussion with others who share your passion. Participants can choose from the following topics:
- Regulatory Strategy for Supply Chain Operations
- Supplier Relationship Challenges and Successful Practices
- Big Data Analytics and Operational Excellence
1:30 PM - 2:45 PM
Unlocking End-to-End Supply Chain Success
During the initial phase of the Good Supply Practices (GSP) work conducted by the FDA, the pharmaceutical industry and the medical device industry through Xavier University, the “secret” of supply chain success was identified, which has created a solid foundation for supply chain development and management. Learn how cross-functional alignment is more than just a cliché. The GSP Team delineated this alignment into meaningful steps that are commensurate with your organization’s operations. Understand how this alignment impacts internal and external operations, and how timing is critical – too soon does not decrease your risk. In this “how to” session, also learn how to ensure alignment on risk factors beyond quality that are critical to your Brand protection and business continuity.
- David Lowndes, Head of Small Molecule Operations, Shire Pharmaceuticals
- Mandy Bosse, Site Head, Patheon
- Julie Brautigam, Head of Procurement Risk, Sustainability, Performance & Innovation, Takeda Pharmaceuticals
- Al Kentrup, VP Global Quality Compliance and Systems, Takeda Pharmaceuticals
2:45 PM - 3:05 PM
3:05 PM - 3:50 PM
Big Data Analytics: Right-Sizing Operational Excellence
Right-sizing Risk Management is a sophisticated skill that not many organizations have mastered, and therefore struggle to achieve Operational Excellence. Through the power of Big Data analytics, the interconnectivity of meaningful trends increases the effectiveness of senior leaders in a way that triggers action. Walk away with practical understanding of how to effectively harness the power of Big Data analytics as your product travels throughout your global supply chain.
- Agnes Ortega, Divisional Vice President Compliance and Operations Services, Abbott
- Michael Shepherd, Technical Staff Technologist, Support & Deployment Services, Dell EMC
- Ryan Smith, VP of Product & Engineering, Sight Machine
3:50 PM - 5:00 PM
Beyond Metrics Through the Power of Artificial Intelligence: Applications You Can Use in Quality Today
The future is here. It is time for our industry to move from reactive to predictive! AI enables our industry to go beyond metrics, and to identify signals that predict the conditions that will lead to product failure. FDA and industry work teams from the Xavier AI Summit 2017 will present real pathways to the power of AI for your operations. Work teams have been established to address:
- Evaluation of Continuously Learning Systems - CLS
(Team Leaders: FDA’s Berkman Sahiner and Abbott’s Mohammed Wahab),
- Continuous Product Quality Assurance - CPQA
(Team Leaders: Shire’s Charlene Banard, and Lachman’s David Lonza).
Participants will be engaged in table discussions for input on application development and progress, and will walk away with practical strategies to implement in their organization today…with or without AI!
- Marla Phillips, Director, Xavier Health, Xavier University
- Xavier AI Initiative - CPQA Team: Charlene Banard, Senior Vice President, Global Quality, Technical Operations, Shire Pharmaceuticals
- Xavier AI Initiative - CLS Team: Berkman Sahiner, Electrical Engineer, CDRH, FDA; Kumar Madurai, Principal Consultant, CTG
5:45 PM - 8:30 PM
Annual PharmaLink Dinner – The American Sign Museum
Network with FDA, speakers, committee members and peers, while touring America’s largest public sign museum. The museum’s collection is sure to spark thoughts of art, history, and fond memories. The informal atmosphere is the perfect place to continue conversation from the day’s sessions or start new ones. The evening will be capped with a dinner in the museum’s community room.