PharmaLink 2015 Program & Agenda


Key Outcomes for the Conference

Inspiring Collaboration…
•Feel the Purpose-Driven nature of this conference as soon as you enter the room.
•Expect orchestrated engagement with your peers across the industry on topics you are passionate about.
•Find attendees openly sharing their expertise to help advance the industry in collaboration with global regulators.
•Work side-by-side with regulators to deepen the understanding on both sides of challenges and opportunities.

Leading Innovation…
•Identify solutions that will protect your patients around the world, your company brand, and your business.
•Talk about the “elephant in the room” to get to the real pain that plagues our industry.
•Learn what you didn’t know you didn’t know! Other industries successfully demonstrate what the pharmaceutical industry lacks. Walk away with real solutions.
•Hear directly from speakers who passionately challenge the status quo.

Making a Difference…
•Work through real working models that can improve the reliability of your product…today.
•Learn how you can be part of the solution.
•Understand who your stakeholders are so you can implement meaningful and sustainable change.
•Leave the conference armed with action plans that are orchestrated throughout the conference and solidified before you leave.

March 24, 2015

Time Description
5:00 PM - 7:00 PM

Welcome Reception

Please join the PharmaLink Strategic Committee at the Hilton Netherlands hotel for an evening Welcome Reception, to reconnect with colleagues and make new connections. Light hors d’oeuvres and beverages will be served.

March 25, 2015

Time Description
8:30 AM - 9:00 AM

PharmaLink Conference Welcome

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.

9:00 AM - 9:45 AM

Update from ORA

Assistant Commissioner Ellen Morrison will share insights on key strategies and initiatives from the Office of Regulatory Affairs, which houses all investigators in the 19 FDA districts across the country.  ORA is working to implement changes to inspection practices domestically and abroad to address the most pressing challenges facing patient safety.  These initiatives include the formation of a Foreign Inspectorate of specially trained investigators, work towards global regulator mutual reliance through FDA participation in PIC/s, the development of a new inspection protocol with CDER, and Program Alignment impacting the organization of all 19 districts.

Moderated by: Steve Niedelman, King & Spalding

9:45 AM - 10:05 AM


10:05 AM - 11:05 AM

FDA-Driven Initiatives through FDASIA Implementation

Understand the strategy behind the Office of Pharmaceutical Quality realignment and how that impacts operations within FDA.  Key FDA initiatives related to FDASIA will be shared, and expected impact to both FDA and industry.

Moderated by: Gabey Cosel, Pew Charitable Trust

11:05 AM - 12:05 PM

Establishing Good Supply Practices (GSPs)

As an industry, we are not focusing on areas that are proving to increase the reliability of our supply chain.  Understand paradigm shifts uncovered by manufacturers and suppliers working together through the Xavier University Integrity of Supply Initiative that hold the key to the answers we are all looking for.  It is through this renewed focus that our efforts can turn toward meaningful and impactful solutions.

Moderated by: Gwyn Murdoch, Eli Lilly

12:05 PM - 1:15 PM

Lunch Networking by Topic

1:15 PM - 2:05 PM

Barriers to Quality and Supply Chain Excellence

Quality and Supply risks continue to plague our industry, but what can be done to overcome these challenges?  We have asked CMO and supplier representatives to share the Top 3 Flags that create barriers to quality and supply excellence.  As suppliers, they have an opportunity to experience a variety of relationships and support a vast array of products.  Through this session, understand existing risk trends from a more global and diverse perspective, as well as potential mitigation strategies.

Moderated by: Jonathan Patroni, Shire

2:05 PM - 2:55 PM

Toyota Production System – Cultural Requirements

Break the paradigms by learning how firms in other industries embrace a culture focused on quality.  This session will focus on how the Toyota Production System thinking creates a business organization that is continually solving problems to improve safety, quality, cost, lead time and human engagement.  Direct examples will be given on gaps that exist in how the pharmaceutical industry has attempted to implement TPS.

Moderated by: Bill Mullin, Keystone Compliance Partners

2:55 PM - 3:15 PM


3:15 PM - 5:00 PM

Nobel Prize-based Alignment Optimization

Understanding the degree of alignment is essential for groups collaborating on a shared topic. However, alignment has been a soft concept, something vague and sensed. Through the use of algorithms derived from the work of Nobel-prize recipient, Prof. Thomas Schelling, Alignment Optimization (AO) is now a management science enabling groups to understand their alignment with hard data and visualizations, with proven, practical methods to maximize alignment around valuable, viable, and endorsed outcomes. In this presentation, SchellingPoint will explain some of the concepts of AO, and present three case studies of AO’s use in supply chain and customer/supplier relationships.

Moderated by: Bill Mullin, Keystone Compliance Partners

5:00 PM - 7:00 PM

Networking Reception

Benefit from the open dialog while enjoying drinks and hors d’oeuvres.  You and your colleagues can continue to share ideas and explore issues with Strategic Committee Members and Speakers in a pleasant, informal setting.

March 26, 2015

Time Description
8:30 AM - 9:45 AM

Living Life at Performance Level

This patient-centric, leadership focused session will inspire participants to live their lives at a higher level of performance.  This nationally-recognized keynote transforms organizations by inspiring individuals to live their lives at a higher level of performance. Inspired by Curtis’ 25 years in the entertainment industry, Living Life at Performance Level is a dynamic, experiential program that hands participants the tools to ignite their ultimate potential. Curtis guides participants to lead with transparency and authenticity, to fail successfully, to take risks, to make character-driven decisions, and to create a life of accountability.

Moderated by: Marla Phillips, Xavier Health

9:45 AM - 10:05 AM


10:05 AM - 11:05 AM

MHRA Perspective on Global Supply Chain Challenges

Hear directly from MHRA on the challenges that are most prominently facing global ministries of health.  Where are they focusing efforts to confront the challenges of globalization and import safety? How are they collaborating with other agencies?  And how does this affect you?

Moderated by: Michael Davidson, Pfizer

11:05 AM - 12:05 AM

Global Supply Chain Risk Management Case Studies

Through case study examination and small group discussions, participants will dissect ways to secure the supply chain in the Asia/Pacific region, as well as, how to recognize external material signals that impact the integrity of their supply chains.  Industry representatives will provide their expertise by discussing practical approaches to each of these scenarios.

Moderated by: Ashley Goldberg, Merz

12:05 PM - 1:55 PM Track 1

Deep Dive Lunch Session--Clinically Relevant Metrics

Join this interactive “World Cafe” style session as participants learn how to assess metrics for clinical relevance and gain a greater understanding of how to measure the strength of the culture of quality.

Moderated by: Grace Breen, CorePharma

12:05 PM - 1:55 PM Track 2

Deep Dive Lunch Session--Data Integrity: How to Verify You are Okay

Explore successful methods industry and regulators have used to navigate the data pathway to verify authenticity.  Use these methods for your internal audit techniques and to audit your suppliers.

Moderated by: Gretel Benavides, Perrigo

12:05 PM - 1:55 PM Track 3

Deep Dive Lunch Session--Integrity of Supply Workshop

Provide your input and ideas as the Integrity of Supply initiative has launched into the development phase of drafting GSPs (Good Supply Practices).  Join industry and FDA members of the initiative to assess the solutions being proposed. Help shape the outcome!

Moderated by: Marla Phillips, Xavier Health

1:55 PM - 2:55 PM

Systematic Approach to Managing Your Global Supply Chain

The FDA Safety and Innovation Act (FDASIA) includes a requirement for Unique Facility Identifiers (UFI).  This session will provide a practical approach to utilizing the Data Universal Numbering System (DUNS number), and how this approach can be utilized to manage your material supply chain beyond drug establishments and excipient manufacturers.  The time to start is now…this is not a simple exercise, and those who have been through it are ready to share what they’ve learned.

Moderated by: Steve Niedelman, King & Spalding

2:55 PM - 3:15 PM


3:15 PM - 5:00 PM

How to Measure Quality Performance

Whether you want to know the Cost of Quality or the Cost of Poor Quality, find out what is meaningful to measure. A readout from the Xavier/PwC USA Metrics Initiative will explore Product, Process, and cultural measures that can help guide areas of opportunity for your organization. An update from the ISPE Initiative will be shared. Come prepared to discuss how industry and FDA can benefit from these initiatives.

Moderated by: Marla Phillips, Xavier Health

5:00 PM - 5:45 PM

Travel to Newport Aquarium

1 Aquarium Way, Newport, KY 41071; (859) 261-7444

  • For those signed up for the Shuttle, the driver will take you directly from the Cintas Center to the Aquarium.
  • For those driving, directions to a reserved parking lot will be available at the Cintas Center.
5:45 PM - 8:15 PM

PharmaLink 2015 Reception, Dinner, & Keynote Address

The evening event will be held at the state-of-the-art Newport Aquarium. The Newport Aquarium was named the No. 1 aquarium in the 2012 Readers’ Choice Travel Awards from

Dr. Kristi Henderson will paint the picture of the future of healthcare in the United States.  In her current role as Chief Telehealth & Innovation Officer at the University of Mississippi Medical Center, Dr. Henderson has been asked to testify to the White House Domestic Policy Council as well as the House Energy & Commerce Committee on health system innovation due to her successful models which have advanced the access of health care for patients across the United States.   She has been consulted by multiple health systems, technology vendors, policy makers and regulators on her model of care and was a featured TEDx speaker in 2014.  Find out what your own healthcare will look like tomorrow.

March 27, 2015

Time Description
8:30 AM - 9:20 AM

FDA Forensic Chemistry Center

The FDA Forensic Chemistry Center (FCC) is the only FDA forensic laboratory in the country, and is located just 2 miles from the campus of Xavier University.  The FCC is responsible for providing rapid response and specialized analytical services for activities related to product tampering, chemical terrorism, and counterfeit products. Understand the sophistication involved with the criminal attacks on your products, what products are typically targeted, and how the evidence is developed to help catch the criminals.

Moderated by: Kathleen Culver, FDA

9:20 AM - 10:50 AM

Held at the Border? Understand Why.

Global supply chains cross borders every day; some drug shipments are held up for reasons you don’t understand. Hear from the FDA and a major broker about common mistakes discovered during import screening, best practices for a smooth importation process, and the new trusted importer program.

Moderated by: Kathleen Culver, FDA

10:50 AM - 11:10 AM


11:10 AM - 12:20 PM

FDA Investigator Insights

Hear what the FDA is finding on inspection and what they are looking for directly from Field Investigators. Regulators will share examples with participants, as well as trend data on inspections across the industry.  Understand what is new and how that impacts you and your company…and your contract partners and suppliers.  Prepare today for tomorrow.

Moderated by: Steve Niedelman, King & Spalding

12:20 PM - 12:45 PM

Action Plan Writing and Conference Close-out

Participants will turn the top priorities they have captured on their “Act – Change – Transfer” forms into Action Plans.

12:45 PM

Pick-up Pre-Ordered Box Lunch

Pick-up your pre-ordered boxed lunch and take the opportunity stay in the conference center and continue networking with your colleagues.

For those of you who have to catch a flight or drive home, this is a great way to make sure you get a good meal to start your journey.

1:00 PM

Shuttle Departs

Shuttle departs Xavier for Cincinnati Airport (CVG) and Hilton Cincinnati Netherland Plaza Hotel.