PharmaLink 2016 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 15, 2016

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 16, 2016

Time Description
8:30 AM - 9:00 AM

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

Office of Compliance Key Initiatives

The top strategic priorities of the CDER Office of Compliance will be shared so attendees can understand how these key initiatives involve and impact industry.  This session will address topics, such as domestic and foreign enforcement trends, surveillance activities and drug shortages.

Moderated by: John Taylor, Greenleaf Health

9:45 AM - 10:05 AM


10:05 AM - 11:35 AM

Protecting and Promoting Data Integrity

Understand why there is a resurgence of data integrity concerns across our global industry, and the devastating impact it can have to your business.  Learn how to detect and trace data integrity issues, and importantly, what you need to know to achieve and sustain data integrity.

Moderated by: Gretel Benavides, Lachman Consultant Services

11:35 AM - 12:20 PM

MHRA Update - Strategic Priorities and Initiatives

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: Kelly Taylor, Eli Lilly

12:20 PM - 1:40 PM

Lunch Networking by Topic

1:40 PM - 2:25 PM

Operating in India and Southeast Asia

Many organizations across our industry either have operations in India and Southeast Asia themselves, or rely on contract operations and sourcing from that region.  Understand from first-hand experience how to navigate quality, technical and business factors that are unique to this culture such that your organization can minimize patient and business risk.

Moderated by: Michael Kaminski, Procter & Gamble

2:25 PM - 3:10 PM

Serialization - Are you ready?

We are 1/3 of the way into the 10 year implementation.  Where are you and what’s next?  Understand the timeline and impact to manufacturers, repackagers, wholesalers, and dispensers.

Moderated by: Ashley Goldberg, Merz North America

3:10 PM - 3:30 PM


3:30 PM - 5:00 PM

Paradigm Shift - Meaningful Solutions for your Supply Chain

Through the work of FDA, pharmaceutical and medical device manufacturers and suppliers, this Xavier initiative has uncovered major paradigm shifts that are enabling the industry to approach risk to supply and product through a dramatically different approach that has immediate impact.  Join us for this interactive session to start implementing changes in your operations today.

Moderated by: Marla Phillips, Xavier University

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 17, 2016

Time Description
8:30 AM - 9:15 AM

The Strategic Direction and 2016 Goals of the Office of Pharmaceutical Quality

CDER is developing a New Inspection Protocol to guide FDA investigators on a refreshed approach to inspections.  Be part of the discussion, and understand the impact to your organization, as insight on the protocol development is shared.

Moderated by: Agnes Ortega, Abbott

9:15 AM - 10:05 AM

Office of Regulatory Affairs Update and New Strategic District Operations

In 2017, ORA will fully implement its alignment of all investigators, compliance officers, supervisors, and managers by program area.  Learn how this will impact your company during future inspections.  in addition, we will share information about “eNspect” – ORA’s new electronic inspection tool.

Moderated by: Steve Niedelman, King & Spalding

10:05 AM - 10:25 AM


10:25 AM - 11:25 AM

How to Measure Quality Culture and Why

Michael Taylor from Schellingpoint will provide insight on the development of a cultural assessment methodology and cloud-based alignment tool that can be implemented across the pharmaceutical industry.  Understand the practical application possibilities for your organization and FDA.

Moderated by: Bill Webb, US World Meds

11:25 AM - 1:15 PM

Lunch: World Café Discussions (highly interactive and fast paced)

  • Pharmaceutical Metrics
  • Integrity of Supply
  • Measuring Culture
  • Data Integrity
1:15 PM - 2:30 PM

Pharmaceutical Metrics. Value Proposition?

Learn from the Xavier/PwC Metrics Initiative, how metrics can be used from a systematic approach to drive improved quality and compliance and add value for FDA, Industry and Patients. This session provides an approach that is ready-for-implementation in your organization today.

Moderated by: Grace Breen, Impax

2:30 PM - 3:00 PM

The 21st Century Cures Act - Goals and Impact

This Congressional Act aims to tackle major barriers to product development ranging from modernization of clinical trials, to removing regulatory uncertainty for medical app development, to keeping jobs here in America.  Understand the goals of this Act and how it impacts your organization and your family.

Moderated by: Jim O’Reilly, University of Cincinnati

3:00 PM - 3:20 PM


3:20 PM - 4:05 PM

ICH Q12 - Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

Develop a harmonized pharmaceutical quality system applicable across the life cycle of the product emphasizing an integrated approach to quality risk management and science.

Moderated by: Bob Zinser, Patheon

4:05 PM - 5:00 PM

Quality and Supply Chain Excellence: Overcoming Complex Barriers

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: David Lowndes, Shire

5:00 PM - 5:45 PM

Travel to Paul Brown Stadium

  • For those signed up for the Shuttle, the driver will take you directly from the Cintas Center to the Stadium.
  • For those driving, directions to a reserved parking lot will be available at the Cintas Center.

1 Paul Brown Stadium, Cincinnati, OH 45202

(513) 455-4800

PharmaLink 2016 Reception, Dinner, & Keynote Address

***Seating is limited for this exclusive event.***

The evening event will be held at Paul Brown Stadium, Home of the Cincinnati Bengals.

Our keynote speaker is Vincent C. Caponi, FACHE, who serves as an Executive Vice President of Ascension Health, the nation’s largest Catholic and not-for-profit health system.  Caponi is a 40 year veteran of healthcare and has been a CEO since 1979. He has led multiple joint ventures, program developments, hospital expansions and affiliations with health providers and community partners.  In May of 2015 Mr. Caponi received the “Distinguished Alumni Award” from Xavier University. He brings us the Provider’s perspective on the importance of assured, consistent quality in the drug and device products which serve patients.

March 18, 2016

Time Description
8:30 AM - 10:00 AM

Proactive and Systematic Quality Implementation - Case Studies across functional areas

Participate in a working session addressing case studies that take a cross-functional approach to supplier quality, complaints, and potential recall scenarios.  Learn best practices from industry experts and understand common 483 findings from FDA.

Moderated by: Michael Davidson, Pfizer

10:00 AM - 10:20 AM


10:20 AM - 11:50 AM

FDA and MHRA Investigator Insights

Hear what FDA and MHRA are 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: Agnes Ortega, Abbott

11:50 AM - 12:20 PM

Conference Closeout/Action Plan

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

12:20 PM

Pick-up Pre-ordered Boxed 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.

12:35 PM

Shuttle Departs

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