PharmaLink 2017 Program & Agenda

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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

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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

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Time Description
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

Break

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: Agnes Ortega

12:20 PM - 1:35 PM

Lunch Networking by Topic

Attendees select topical discussions to join as they enjoy dialog and lunch with their industry and FDA colleagues.  Strong networks that last a career are formed as ideas and successful practices are shared.

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

Break

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

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 a thought-provoking presentation.

March 16, 2017

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Time Description
8:30 AM - 9:15 AM

Good Supply Practices (GSPs) - Paradigm Shifting Solutions

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: Michael Kaminski

9:15 AM - 10:30 AM

Your Company Bought a new Business - Now What?

Product and Company acquisitions are increasingly more common in our business today.  We will explore the impact of ineffective Due Diligence to your:  company finances, supply chain, patients, and company reputation.  So – how can we execute due diligence well?  Join us and find out.

Moderator: Ashley Goldberg

10:30 AM - 10:50 AM

Break

10:50 AM - 11:20 AM

Maximizing Post-Merger Success.

Through the SchellingPoint Alignment Optimization process, learn successful practices 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 next time.

Moderator: Agnes Ortega

Speakers:

11:20 AM - 12:35 PM

How to Develop a Risk-Based Diligence Plan that Translates into a Robust Integration Plan.

Understand how to translate the results of the diligence exercise into an Integration Plan that is financially viable, in line with compliance requirements, and aligns the cultures of the integrating organizations.

Moderator: Agnes Ortega

12:35 PM - 1:40 PM

Lunch Networking by Topic

Attendees select topical discussions to join as they enjoy dialog and lunch with their industry and FDA colleagues.  Strong networks that last a career are formed as ideas and successful practices are shared.

1:40 PM - 2:55 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

2:55 PM - 3:15 PM

Break

3:15 PM - 4:15 PM

Regulatory Strategy for products in China.

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: Marla Phillips (Co-Chair)

Speakers:

4:15 PM - 5:00 PM

Strategic Direction of the FDA Office of Pharmaceutical Quality.

As the FDA works to implement new product approval strategies that approach risk in a different way, understand how your organization can align with and support the agency’s vision.

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

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Time Description
8:30 AM - 9:30 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

9:30 AM - 9:50 AM

Break

9:50 AM - 11:50 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 your colleagues to explore what could have been done differently that will allow you to walk away with actionable solutions.

Moderator: Steve Niedelman

11:50 AM - 12:20 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)

Speakers: