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 - 10:00 AM

Most Pressing Initiatives for the Office of Global Regulatory Operations and Policy

During this session, participants will understand the strategy employed by the Office of Global Regulatory Operations and Policy as it works to address the landscape challenges facing FDA, including domestic and international product quality and safety efforts, global data-sharing, development and harmonization of standards, field operations, compliance, and enforcement activities.

10:00 AM - 10:20 AM


10:20 AM - 11:10 AM

How to Leverage New Standards for Excipient Manufacturers

FDA is working closely with industry to develop a standard for excipient manufacturing GMPs.  Understand what is being developed, how FDA views such standards, where it is being adopted, and how you can leverage these standards in your supplier relationships.

Moderated by: Gabey Cosel, Pew Charitable Trust

11:10 AM - 12:10 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: David Lowndes, Shire

12:10 PM - 1:20 PM


1:20 PM - 2:10 PM

Barriers to Quality and Supply Chain Excellence

Quality and Supply issues continue to plague our industry. In an attempt to understand what we need to do differently we have asked FDA and MHRA to identify the Top 3 flags that tell them there is a higher risk to quality and supply. We have also asked CMOs and suppliers to share feedback on barriers that contribute to quality and supply issues and what works well from their more global perspective.

Moderated by: David Lowndes, Shire

2:10 PM - 3:10 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

3:10 PM - 3:30 PM


3:30 PM - 5:00 PM

Quality Metrics Beyond Compliance to Drive Strategic Value

Using a case study workshop approach, this session will challenge you to apply Quality Metrics to your decision-making and management responsibilities in real life scenarios such as mergers and acquisitions, distribution, licensing, CMO’s and Regulatory authorities.

Moderated by: Jim Wulfeck, CompleteMastery

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 - 9:30 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

9:30 AM - 10:20 AM

Setting the Foundation for Inspection Readiness

FDA officials want to be sure you are able to demonstrate continuous product quality, even across contract relationships.  In a world of complex supply chains, proprietary information and disjointed transparency, has your company determined how to establish and maintain product knowledge across your contract relationships – whether you are the contract giver or the contract receiver?  Explore how ready, willing and able your company is to effectively demonstrate continuous product quality.

Moderated by: Bill Webb, Aptalis

10:20 AM - 10:40 AM


10:40 AM - 11:50 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: Paul Weninger, Perrigo

11:50 AM - 1:20 PM Track 1

Deep Dive Lunch Session--Clinically Relevant Metrics

Join this lively 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

11:50 AM - 1:20 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

11:50 AM - 1:20 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

1:20 PM - 2:20 PM

Systematic Approach to Managing Your Global Supply Chain

Industry has not fully recognized the challenges that lie ahead in implementing the Unique Facility Identifier (UFI) requirements of the FDA Safety and Innovation Act (FDASIA).  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: Industry Leader, TBD

2:20 PM - 3:20 PM

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

3:20 PM - 3:40 PM


3:40 PM - 5:00 PM

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 (Invited), FDA

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

***More details to follow on speaker and logistics.***

March 27, 2015

Time Description
8:30 AM - 10:00 AM

Major Changes at FDA Affecting You

Major changes are happening at the FDA, and these changes will affect how FDA oversees your operations. Hear from a distinguished FDA panel about the GDUFA inspection program, significant realignment of FDA offices, and the new Office of Pharmaceutical Quality.

Moderated by: Steve Niedelman, King & Spalding

10:00 AM - 10:20 AM


10:20 AM - 11:50 AM

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

11:50 AM - 12:30 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.

12:30 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.

12:45 PM

Shuttle Departs

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