PharmaLink Conference Sessions Agenda: Day 1

WEDNESDAY, MARCH 13, 2019

 

7:45 AM - 8:30 AM

Breakfast

Join your colleagues from around the country as we kick off PharmaLink 2019 with a complimentary warm breakfast.


8:30 AM - 9:00 AM

Let’s Make a Difference!

Welcome to the conference, welcome to Xavier University, welcome to FDA Pharma Division III, and welcome to the FDA Cincinnati District. This purpose-driven conference will lead you to actionable learning and implementation plans.

Moderator: 

  • Marla Phillips (Co-Chair), Director, Xavier Health, Xavier University

Speakers:

  • Steve Barber, Cincinnati District Director, FDA (invited)

  • Art Czabaniuk, Program Division Director, Division of Pharmaceutical Quality Operations III, FDA-ORA (invited)

  • Marla Phillips (Co-Chair), Director, Xavier Health, Xavier University


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.  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.

Facilitators:

  • Jennifer Brown, Director, Global Chemistry, Manufacturing & Controls, Pfizer

  • Cathleen Carson, Associate Director, Treyburn & Supplier Quality Assurance, Purdue Pharma

  • Tami Frederick, Global Director, Corporate Quality Systems and Programs, Perrigo


9:45 AM - 10:05 AM

Break


10:05 AM - 11:20 AM

Be in the Know: Chief Quality Officers Redesigning Quality for the 21st Century to Protect and Promote Patient Health

Quality Leaders across the pharmaceutical, medical device and consumer goods industries are collaborating on leading-edge solutions that drive the future of the industry with and for all stakeholders. As these leaders work to Create the Quality Organization of the 21st Century, engage on how Quality can be viewed as a valued business partner that maximizes patient success by achieving true cross-functional quality ownership and optimizing organizational agility. Importantly, the panel will explore the skillsets you will need to lead through modern complexities. Walk away inspired to become part of the path forward!

Moderator: 

  • Marla Phillips, Director, Xavier Health, Xavier University

Speakers:

  • Industry TBA


11:20 AM - 12:40 PM

Applying Emerging Technology to Advance Your Operations

Learn from FDA and industry experts about the possibilities of emerging technology – where are we, where are we going, and how do we get there? Early adopters of technology will discuss hurdles and their key experiences. Learn how this technology is currently being used to significantly reduce the time and cost of drug development and commercial manufacturing.

Moderator:

  • Brent Conatser, Senior Consultant, Elanco Animal Health

  • Bill Webb, Pharmaceutical and Compliance Consultant

Speakers:

  • FDA and Industry TBA


12:40 PM - 1:40 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.


1:40 PM - 3:10 PM

TRACK 1 (QUALITY/REGULATORY)

FDA Mock Inspection: Knock Knock! Guess Who’s at Your Door?  

Participate in a rare opportunity to engage in an interactive FDA mock inspection with FDA investigators! By exploring challenging scenarios, you will understand how to prepare your organization for success. Participants will be exposed to 21st Century Inspectional Techniques and how to manage them during the stress of an ongoing FDA inspection. FDA investigators focus on different areas based upon their individual expertise. Learn how to navigate and respond to questions that may seem daunting, while demonstrating a culture of quality at your firm—and avoid FDA leaving with the wrong impression.  

Moderator: 

  • Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding

Speakers:

  • FDA TBA

TRACK 2 (SUPPLY CHAIN)

How Qualified Are You to be Part of Your Own Supply Chain?

FDA and industry professionals have developed Good Supply Practices (GSPs) through the identification of a key paradigm shift—we either cause or could have prevented all supply chain failures we experience. Hard to believe? Become empowered through this session to end the cycle of surprise failures that put your patients at risk. This practical session is filled with tools you will test and explore, and will leave you armed with successful practices you can implement today.

Moderator: 

  • Marla Phillips, Director, Xavier Health, Xavier University

Speakers:

  • David P. Geoghegan, Senior Vice President, Technical Operations, Trevena

  • Adam Hostetler, Director of Operations, Cook MyoSite

  • Hal Hunt, Director of Technical Operations and CMC Supply Chain, Trevana


3:10 PM - 3:30 PM

Break


3:30 PM - 5:00 PM

TRACK 1 (QUALITY/REGULATORY)

You Don’t Get a Second Chance to Make a First Impression with FDA! 

Learn constructive ways to interact with FDA that will save your reputation, your product and stock value. The importance of effectively responding to FDA-483s is critical to FDA’s assessment of your recent inspection and firm. Learn key aspects needed to build successful responses that demonstrate the data, studies, and systems you have in place to ensure product quality, efficacy and safety. Current FDA officials and industry experts will share their experiences and discuss successful methods for preparing effective FDA-483 responses that demonstrate a strong commitment to a culture of quality.

Moderator: 

  • John Taylor, President and Principal, Compliance and Regulatory Affairs, Greenleaf Health

Speakers:

  • Art Czabaniuk, Program Division Director, Division of Pharmaceutical Quality Operations III, FDA-ORA (invited)

  • Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding

  • Nicholas L. Paulin, Drug Specialist and Pre-Approval Manager, FDA, Cincinnati District Office (invited)

  • Jim O'Reilly, Professor, University of Cincinnati, College of Law

  • John Taylor, President and Principal, Compliance and Regulatory Affairs, Greenleaf Health

TRACK 2 (SUPPLY CHAIN)

Getting Your Product into China, Now through 2050

As China becomes the number 1 economy in the world, is your company’s supply chain strategy set to secure the most critical market access for long-term viability?Industry experts who have regional accountability for China will share an inside view of the challenges and opportunities involved in building vital in-country presence.

Moderator: 

  • Ashley Goldberg, Sr. Director, Quality Operations, Merz North America, Inc.

Speakers:

  • Industry TBA


Cincinnati Art Museum

5:45 PM - 8:30 PM

Annual PharmaLink Dinner – Cincinnati Art Museum

Network with FDA, speakers, committee members and peers, while touring one of the oldest museums in the United States. Its collection of over 67,000 works spanning 6,000 years of human history make it one of the most comprehensive collections in the Midwest and is sure to spark interesting conversation. The evening will be capped with a dinner.