Agenda: Day 1
Wednesday, March 14, 2018

 

7:45 AM - 8:30 AM

Breakfast

Join your colleagues from around the country as we kick off PharmaLink 2018 with a 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), Xavier University

Speakers:

  • Art Czabaniuk, FDA
  • Steve Barber, FDA
  • Marla Phillips, Xavier University

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.

Facilitators:

  • Jennifer Brown, Pfizer
  • Cathleen Carson, Purdue Pharmaceuticals
  • Tami Frederick, Perrigo

9:45 AM - 10:05 AM

Break


10:05 AM - 10:45 AM

Message from the Commissioner, Scott Gottlieb

FDA Commissioner Scott Gottlieb, MD, was sworn into office in May 2017, and has an aggressive vision to shape the future of public health policy. Understand how Gottlieb’s vision and actions impact our industry, your organization, and all of us as patients. On the top of Gottlieb’s list are:

  1. Addressing opioid drug use
  2. Bringing high quality prescription drugs to market faster
  3. Reducing the cost of prescription drugs

Moderator: 

  • John Taylor, Greenleaf Health

Speaker:

  • Scott Gottlieb, FDA (invited)

10:45 AM - 11:45 AM

Global Regulator Priorities: Where are they Focusing?

As the “global” world becomes even closer and more interconnected, it is imperative that we work together with global agencies to understand emerging complexities of risk to our global supply chains. Global regulators are able to share the trends and rising threats they are seeing across the industry – a perspective that is challenging to observe for any single company on its own. Walk away with a clearer understanding of the strategic and tactical actions regulators are taking, and actions your company can take today to ensure your product success globally. 

Moderator:

  • John Taylor, Greenleaf Health

Speakers:

  • Ilisa Bernstein, FDA (invited)
  • MHRA (TBA)
  • TGA (TBA)

11:45 AM - 12:30 PM

FDA Office of Regulatory Affairs Update and Strategic Priorities  

The Office of Regulatory Affairs (ORA) houses all the investigators across the country, and has launched an extensive realignment of its operations in response to the growing sophistication and complexity of industry technological advances and globalization. ORA partners with CDER on inspection and harmonization initiatives, and works with industry to ensure safe and effective drugs are available and accessible for the patients you serve. Understand the key ORA initiatives that are on the horizon, and the expectations FDA has of your organization to reduce the risk of your product quality.

Moderator: 

  • Steve Niedelman, King & Spalding

Speakers:

  • Ellen Morrison, FDA

12:30 PM - 1:30 PM

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. Participants can choose from the following topics:

  • Regulatory Strategy for Supply Chain Operations
  • Supplier Relationship Challenges and Successful Practices
  • Big Data Analytics and Operational Excellence

1:30 PM - 2:45 PM

Unlocking End-to-End Supply Chain Success

During the initial phase of the Good Supply Practices (GSP) work conducted by the FDA, the pharmaceutical industry and the medical device industry through Xavier University, the “secret” of supply chain success was identified, which has created a solid foundation for supply chain development and management. Learn how cross-functional alignment is more than just a cliché. The GSP Team delineated this alignment into meaningful steps that are commensurate with your organization’s operations. Understand how this alignment impacts internal and external operations, and how timing is critical – too soon does not decrease your risk. In this “how to” session, also learn how to ensure alignment on risk factors beyond quality that are critical to your Brand protection and business continuity.

Moderator: 

  • David Lowndes, Shire

Speakers:

  • Al Kentrup, Takeda
  • Industry representative (TBA)

2:45 PM - 3:05 PM

Break


3:05 PM - 3:50 PM

Big Data Analytics:  Right-Sizing Operational Excellence

Right-sizing Risk Management is a sophisticated skill that not many organizations have mastered, and therefore struggle to achieve Operational Excellence. Through the power of Big Data analytics, the interconnectivity of meaningful trends increases the effectiveness of senior leaders in a way that triggers action. Walk away with practical understanding of how to effectively harness the power of Big Data analytics as your product travels throughout your global supply chain.

Moderator: 

  • Agnes Ortega, Abbott

Speaker:

  • Michael Shepherd, Dell
  • Ryan Smith, Sight Machine

3:50 PM - 5:00 PM

Beyond Metrics Through the Power of Artificial Intelligence: Applications You Can Use in Quality Today

The future is here. It is time for our industry to move from reactive to predictive! AI enables our industry to go beyond metrics, and to identify signals that predict the conditions that will lead to product failure. FDA and industry work teams from the Xavier AI Summit 2017 will present real pathways to the power of AI for your operations. Work teams have been established to address:

  1. Evaluation of Continuously Learning Systems - CLS
    (Team Leaders: FDA’s Berkman Sahiner and Abbott’s Mohammed Wahab),
  2. Continuous Product Quality Assurance - CPQA
    (Team Leaders: Shire’s Charlene Banard, and Lachman’s David Lonza).

Participants will be engaged in table discussions for input on application development and progress, and will walk away with practical strategies to implement in their organization today…with or without AI!

Moderator: 

  • Marla Phillips, Xavier University

Speakers:

  • CPQA Team: Charlene Banard, Shire
  • CLS Team: Berkman Sahiner, FDA; Kumar Madurai, CTG

American Sign Museum_Joseph Fuqua II_Enquirer Media.jpg

5:45 PM - 8:30 PM

Annual PharmaLink Dinner – The American Sign Museum

Network with FDA, speakers, committee members and peers, while touring America’s largest public sign museum. The museum’s collection is sure to spark thoughts of art, history, and fond memories. The informal atmosphere is the perfect place to continue conversation from the day’s sessions or start new ones. The evening will be capped with a dinner in the museum’s community room.