PharmaLink 2017 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 14, 2017

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 15, 2017

Time Description
7:45 AM - 8:30 AM

Join us for Breakfast

Join your colleagues from around the country as we kick-off PharmaLink 2017 with a nice complimentary warm breakfast.

8:30 AM - 9:00 AM

Let's Make a Difference!

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.

Moderator: Marla Phillips (Co-Chair)

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 to 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.

9:45 AM - 10:05 AM


10:05 AM - 10:35 AM

FDA Metrics Program - Path Forward to Reduce Risks within FDA and across Industry.

FDA is innovatively working to address resource constraints and patient risks through a collaborative effort with industry to measure product risk.  FDA will address the status and plans for their draft guidances on Metrics and Technical Conformance.  Understand what FDA is doing and why, how you can prepare, and what you can do today.

Moderator: Grace Breen

10:35 AM - 11:50 AM

Predictive Capabilities through a Living Metrics Model.

The key to the FDA metrics program is for industry to own its own metrics and own its own product risk.  This session will take you through case study exploration with successful practices on how to inform decisions and trigger action through Enterprise-wide management of risk.

Moderator: Grace Breen

11:50 AM - 12:20 PM

How Big Data and Artificial Intelligence can Enhance your Proactive Risk Monitoring Programs.

Through this session you will be exposed to truly innovative ways to gather and assess textual (non-structured) data throughout your internal systems and across the global internet.  Learn how to proactively identify signals that would otherwise have been missed – putting your patients at risk.

Moderator: Marla Phillips

12:20 PM - 1:30 PM Track 1

Lunch Option 1: 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, on the following topics:

  • How to Measure Culture
  • Due Diligence Auditing
  • Data Integrity
12:20 PM - 1:30 PM Track 2

Lunch Option 2: Beyond Metrics - Networking with FDA and IBM Watson

Join Xavier, FDA’s Tara Bizjack, IBM Watson’s John Daley, and your colleagues in an informal lunch setting to discuss where our industry can go beyond metrics and the next steps for metrics in our industry by exploring predictive capabilities through artificial intelligence.

Moderator: Marla Phillips (Co-Chair)

1:30 PM - 1:35 PM

Conference Day 1 Milestone: Your Learning put into Action


1:35 PM - 2:35 PM

Connecting Culture to Performance

A good culture can foster outstanding performance.  A bad culture can force outstanding performance – but is it sustainable?  This session will increase your ability to assess cultural alignment with internal and external stakeholders using real data and successful practices.  Set yourself up for success from Day 1.

Moderator: Steve Niedelman

2:35 PM - 2:55 PM


2:55 PM - 4:10 PM

Data Integrity - Detection and Successful Practices.

Learn insight directly from FDA on data integrity breach case studies observed on inspection.  Successful practices on how to address cultural and systemic failures will be shared so you can implement solutions in your organization, and reduce risk to your company and your patients.

Moderator: Nicholas L. Paulin (Co-Chair)

4:10 PM - 5:00 PM

Building a Bridge Across Generations

You won’t want to miss this fishbowl session as members from all 5 generations that are present in today’s workplace are interviewed to explore:  who they are,  what motivates them, misconceptions about them, what concerns they have about each other.  The similarities will be sure to amaze you.

Moderator: Rebecca Bishop

5:45 PM - 8:30 PM

Keynote Dinner

Bei Ma, Vice President at the British Standards Institute (BSI), will share broad insight across continents and across industries as to the driving forces behind key strategies that impact you and your organization.
The evening event will be held at the Anderson Pavilion in Smale Park overlooking the Ohio River.  Join your colleagues for a relaxing evening of refreshments, dinner, and thought-provoking conversation.


March 16, 2017

Time Description
7:45 AM - 8:25 AM

Join us for Breakfast

Join your colleagues from around the country as we kick-off PharmaLink Day 2 with a nice complimentary warm breakfast.

8:25 AM - 8:30 AM

Conference Day 2 Milestone: Your Learning Put into Action


8:30 AM - 9:15 AM

Supply by Design - Good Supply Practices for the 21st Century

Industry manufacturers, suppliers and FDA officials have been working together since 2012 with Xavier University to uncover true root causes to supply chain challenges experienced throughout the pharmaceutical and medical device industries.  This team is solidifying practical, business-smart solutions that are commensurate with the needs of your supply chain.  Leave this session with tools you can implement immediately for measurable differences in your supply chain effectiveness.

Moderator: Rebecca Bishop

9:15 AM - 10:30 AM

How to Develop and Execute a Robust Risk-Based Due Diligence Plan.

Set yourself up for a successful merger and acquisition lifecycle process.  Panel members will share direct experiences on how a robust risk-based due diligence plan can be developed, despite the limited information known and available during the diligence stage of mergers and acquisitions.  You will walk away with a deep understanding of key challenges to consider, what is often missed, and successful practices to implement that will become the foundation for true integration.

Moderator: Steve Niedelman

10:30 AM - 10:50 AM


10:50 AM - 11:20 AM

Maximizing Post-Merger Success.

Through the SchellingPoint Alignment Optimization process, learn successful practices from multiple industries on how you can prevent misalignment before any damage is done, how you can get under-performing acquisitions back on track, and what you can do differently for a Right-First-Time approach.

Moderator: Steve Niedelman


11:20 AM - 12:35 PM

Your Company Bought a new Business - Now What?


So the Honeymoon is Over!  You have completed the merger or acquisition process with another company using the robust due diligence plan you developed.  But now what?  Many companies fall short on all the hard work needed to successfully integrate two very different organizations from a lifecycle approach – different cultures, different people (but perhaps duplication of positions), different practices, different supply chains, different…..everything.  Sound familiar?  Understand how to translate the results of the diligence process into an executable and strategic Integration Plan.

Moderator: David Lowndes

12:35 PM - 1:35 PM Track 1

Lunch Option 1: 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 on the following topics:

  • Generational Differences in the workplace
  • Serialization
12:35 PM - 1:35 PM Track 2

Lunch Option 2: Update on Rx-360 Progress and Impact

Rx-360 shared audit vision for the pharmaceutical industry is coming to life through partnership with the British Standards Institute (BSI). BSI serves as an auditing and certification body for the EU on the device side of the industry, and brings that expertise and approach to the pharma industry through a robust shared audit system with Rx-360. Learn about the progress and impact in this informative session that could benefit your organization.

Moderator: Steve Niedelman


12:35 PM - 1:35 PM Track 3

Lunch Option 3: Supply By Design Breakout

Join members of the Xavier University Supply by Design initiative to provide your input on Good Supply Practices (GSP) and discuss future direction.

1:35 PM - 1:40 PM

Conference Day 2 Milestone: Your Learning put into Action


1:40 PM - 2:40 PM

Supply Chains in China – Strategies for Regulatory Success

Understanding how the regulatory landscape in China impacts your product approval will help you establish a robust supply chain and the systems needed to support its success.  Leave this session with practical solutions anchored in years of on-the-ground experience in this challenging region of the world.

Moderator: Tim Watson


2:40 PM - 3:00 PM


3:00 PM - 4:15 PM

Top 3 Challenges for Successful Serialization Implementation across your Supply Chain.

Understand the dynamics and strategies needed to enable your supply chain to work collaboratively towards successful serialization implementation for your products.  Learn the driving force behind trust, transparency and reliability.

Moderator: Ashley Goldberg

4:15 PM - 5:00 PM

Sweeping De-Regulation through the 21st Century Cures Act?

Although touted to accelerate the discovery and development of new medical products, the de-regulation of FDA approval authority through the 21st Century Cures Act is reminiscent of pre-1962 times.  Instead of accelerating innovation, the Act might just allow under-developed products to reach the market that have been prevented for decades.  The Act has been passed, the rules have been changed, and your products have already been impacted – including new competitors you might not have had before.  Learn from subject expert, Jim O’Reilly, the extent of impact we will witness for years to come.

Moderator: John Taylor

5:00 PM - 7:00 PM

Networking Reception

After the conference sessions on Thursday, benefit from open dialog while enjoying drinks and hors d’oeuvres. You and your colleagues can continue to share ideas with Strategic Committee Members and speakers in a pleasant, informal setting.

March 17, 2017

Time Description
7:45 AM - 8:30 AM

Join us for Breakfast

Join your colleagues from around the country as we kick-off PharmaLink Day 3 with a nice complimentary warm breakfast.

8:30 AM - 8:35 AM

Conference Day 3 Milestone: Your Learning Put into Action


8:35 AM - 9:35 AM

ORA Key Initiatives

As the FDA is aligning its district offices into centers of commodity based expertise, learn what you can expect to be different.  Program Alignment, Mutual Reliance, International Involvement, and the New Inspection Protocol are just examples of what ORA has on its list of priorities.  Join the discussion and understand the direction.

Moderator: John Taylor


9:35 AM - 9:55 AM


9:55 AM - 11:55 AM

FDA Investigator Case Study Insights.

FDA will share top trends in industry failures as they explore case studies on what went wrong and why.  You will engage with FDA, Industry Experts and your colleagues to explore what could have been done differently that will allow you to walk away with actionable solutions.

Moderator: Steve Niedelman

11:55 AM - 12:25 PM

To Your Success!

Thank you for joining us, but we insist that you leave with action plans that will enable you to make a difference in your organization and for the patients you serve.  Work with your colleagues on turning your learning into a full action plan.

Moderator: Marla Phillips (Co-Chair)