PharmaLink 2014 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 18, 2014

Time Description
5:00 PM - 7:00 PM

Welcome Reception

Please join the PharmaLink Strategic Committee at the Hilton Cincinnati Netherland Plaza for a Welcome Reception in the 2nd floor mezzanine of this historic hotel.   Reconnect with colleagues and make new connections.  Light hors d’oeuvres and refreshments will be served.

March 19, 2014

Time Description
8:30 AM - 9:00 AM

Conference Welcoming

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

Next Steps for the CDER Challenge

As an industry we work to achieve quality products that are effective and safe for the patients we serve while meeting their intended use.  Learn what is at the heart of CDER’s challenge to industry to measure the level of quality achieved, and how that information could be used.  CDER will share their vision, goals, status and next steps.

Moderated by:  Kathleen Culver, FDA

9:45 AM - 10:00 AM


10:00 AM - 11:15 AM

Comparing Metrics with Other Companies – Is There a Way? Why is it Vital?

Everyone is measuring something, but are you measuring anything that matters?  Join this session to expand your thoughts on what can be measured and why it might be important.  Then explore ideas and concerns about how your company could be compared to other companies by your stakeholders.

Moderated by Nikki Willett, Accenture

11:15 AM - 12:00 PM

Business Drivers and Incentivizing Quality

As CDER wants to challenge industry to achieve high quality performance, explore what will or will not change behavior. As manufacturers are working to drive internal change, and FDA is looking for ways to recognize better performance, learn what drives the financial change that would catch the attention of your CEO.

Moderated by:  Jim O’Reilly, University of Cincinnati

12:00 PM - 1:00 PM


1:00 PM - 2:30 PM

FDA and Industry – Making a Difference.

A working session with the audience and panel members that is designed to explore how FDA and Industry can move forward in a way that will make a difference. Deeper concepts will be explored from the morning, and all input from the day will be vetted against the FDA goals of this initiative. The target is to capture input that will actually change behavior.

Moderated by: Marla Phillips, Xavier Health

2:30 PM - 2:45 PM


2:45 PM - 4:00 PM

FDASIA: The New Frontier

Understand how FDA is implementing the largest sweeping legislation for our industry in decades.  How will the actions of your company, your contract partners and your suppliers impact you today?

Moderated by:  Jim O’Reilly, University of Cincinnati

4:00 PM - 5:00 PM

Innovation Versus Safety – CDER’s Restructure

CDER is restructuring its organization to be expertise-based in a way that matches review functions and inspections with supporting science.  Hear directly from Contract Manufacturing Organizations on how knowledge transfer paves the way for successful innovation.

Moderated by:  Gabey Cosel, Pew Charitable Trusts

5:00 PM - 6:45 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 20, 2014

Time Description
8:30 AM - 8:45 AM

Opening and Act/Change/Tranfer Planning

Moderated by: Marla Phillips, Xavier Health

8:45 AM - 9:45 AM

Complex Supply Chain Development

Increasing complexity within the supply chain is compounded by continuous changes in business strategy – Mergers, Acquisitions, and outsourcing vs. in-sourcing.  This session will focus on key learnings needed to develop best practices for your own Supply Chain development and management.  Participants will be able to develop action plans on designing a system that is proactive and not reactive.

Moderated by:  Bill Mullin, Merck

9:45 AM - 10:00 AM


10:00 AM - 10:45 AM

MHRA Perspective on Global Supply Chain Challenges

What challenges 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:  Kathleen Culver, FDA

10:45 AM - 11:45 AM

Increasing Supply Chain Reliability – Shifting Paradigms

Lack of supply chain reliability has come to the attention of Congress and media as concerns rise for patient safety globally.  Industry efforts are focused on areas that are not proving to be the true cause of this lack of reliability.  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 need.  It is through this renewed focus that our efforts can turn toward meaningful and impactful solutions.

Moderated by:  Hedley Rees, Biotech PharmaFlow

11:45 AM - 1:00 PM


1:00 PM - 2:00 PM

How Did They Do That? Learn from Other Industries!

How are other industries managing globalization, regulatory requirements, and supply strategy – all while maintaining high quality, speed and agility?  See how their solutions can be applied to our industry – today.

Moderated by:  Jack Solomon, Core Risks

2:00 PM - 2:15 PM


2:15 PM - 3:45 PM

Operationalizing Effective Integrated Supply Chains

In an ever-changing, complex, environment where flexibility and versatility in product offerings and delivery are expected, how do we establish and effective low risk supply chain delivering high quality products?  Learn how to implement a paradigm shifting model that works.

3:45 PM - 5:00 PM

How to Influence Meaningful Change

Understand how to have your voice heard – communicate effectively when you have an idea or need support.  What type of communication does your management need and when, and how does your management make decisions.  Understand your role and responsibility in your company as you will be involved in situational analysis, and will walk-away with tools that will help you communicate business needs and ideas effectively.

Moderated by:  Grace Breen, CorePharma

5:00 PM - 5:45 PM

Travel to Great American Ballpark • 100 Joe Nuxhall Way, Cincinnati, OH 45202

  • For those signed up for the Shuttle, the driver will take you directly from the Cintas Center to the event.
  • For those driving, directions to a reserved parking lot will be posted in the near future.

** Dinner seating is limited.  Sign up today for this exclusive event **

5:45 PM - 8:15 PM

Reception, Dinner & Keynote Address

Leadership in a Complex Global Supply Chain  -  Join us as James Mullen, CEO of Patheon, shares his thoughts on how all players in the complex global supply chain have a vital and interdependent leadership role in ensuring our medicines are safe and effective for patients around the world. The evening event will be held at Great American Ball Park which serves as the home of the Cincinnati Reds, baseball’s first professional franchise. The reception will be held in the Riverfront Club, which offers spectacular views of the Ohio River. If you want to explore the stadium we will be offering a walking tour so you can get a behind-the-scenes look at the ballpark and visit areas such as the dugout and press box.

March 21, 2014

Time Description
8:30 AM - 10:00 AM

Supplier Partnership Systems that Work

The state of the industry – manufacturers do not trust suppliers, clients do not trust contract manufacturers, and the agency wants industry to take responsibility and be accountable.  FDA will share insight on the draft Quality Agreement guidance and expectations of supplier relationships.  Hear from experts on how to build supply chain partnerships that work – operationalize best practices and agency expectations.

Moderated by:  Michael Kaminski, Procter & Gamble

10:00 AM - 10:15 AM


10:15 AM - 11:45 AM

FDA and MHRA Investigator Insights

Hear what the 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:  Bill Mullin, Merck

11:45 AM - 12:15 PM

Action Plan Writing

Participants will be guided through a process to take their top learning priorities from the conference and turn them into actionable plans.  Return to work and make a difference!

Moderated by: Marla Phillips, Xavier Health

12:15 PM - 12:30 PM

Conference Close-out

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 Departure

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