Agenda: Day 2
Thursday, March 15, 2018

 

7:45 AM - 8:30 AM

Breakfast

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


8:30 AM - 8:45 AM

Day 2 Opening

IMG_2802_rev.jpg

Participants will feel the Xavier Difference at PharmaLink, a purpose driven, action-oriented conference. We will start the day recapping the take away points from Day 1 through the Act-Change-Transfer process that will lead to the development of action plans for your key learnings. We insist that our content is meaningful and impactful, so you can’t help but walk away with practical applications to implement when you return to work!

Speaker:

  • Cathleen Carson, Purdue Pharmaceuticals

8:45 AM - 9:45 AM

New! APEC Supply Chain Security Toolkit

FDA is teaming with regulators from the 21-nation Asia-Pacific Economic Cooperation (APEC), non-APEC countries, industry stakeholders, representatives from non-governmental organizations, international organizations, and academia to develop strategies to better secure the medical product supply chain across APEC economies and around the world. The Toolkit is a comprehensive resource that covers the entire supply chain and lifecycle of medical products – from raw materials to patient use. Learn firsthand what FDA is recognizing as important supply chain practices for your organization.

Moderator:

  • Marla Phillips, Xavier University

Speakers:

  • Ilisa Bernstein, FDA (invited)
  • Phillip Nguyen, USP and Director of USP Center of Excellence for APEC

9:45 AM - 10:00 AM

Break


10:00 AM - 11:00 AM

Lifecycle Matrix:  Development Phase

1.  Supply by Design Track

Supply by Design – Meaningful Supplier Engagement: “Supply by Design,” as its name implies, is an intentional development of a product’s supply chain that will perform as intended, and as needed. Participants will be given a practical and intricate map of supplier engagement to ensure material requirements are fit-for-use, the suppliers are engaged at the right time and with purpose, and internal alignment is achieved before engaging suppliers too soon. Learn how to establish your supply chain Right First Time, and hear prevalent examples of how companies fail so you can avoid these missteps.

Moderator:

  • Jim Wulfeck

Speakers:  

  • Troy Fugate, Compliance Insight
  • Dave Rothenberger, Eli Lilly
  • Jack Solomon, Core Risks

 

2.  Global Product Stewardship Track

Strategic Supply Chain Development through the Last Mile: Distributors will provide invaluable insights into the world of how your product is distributed. How can your company strategically identify the right pathway for your products through the Last Mile? Learn who actually governs distributors, what rights you have to your product, and how to partner with distributors to ensure end-to-end product quality assurance.

Moderator:  

  • Ashley Goldberg, Merz

Speakers:  

  • Matt Sample, AmerisourceBergen
  • Michelle Rich, Xavier University
  • Industry Representative (TBA)
  • Specialty Distributor (TBA)

 

3.  Regulatory Strategy Track

Regulatory Strategy for Supply Chain Success: Successful companies have recognized the significant role of the Regulatory Affairs function in setting the strategy to achieve global product approval. Participants will gain practical advice on how to establish an approval pathway within their organizations that will encompass the complexities of the global market–for supplies coming into your products, and for products being released to the market. Enjoy a right-first-time approval pathway in your organization!

Moderator:

  • Jen Brown, Pfizer

Speakers:

  • Industry Representative (TBA)

11:00 AM - 11:15 AM

Break


11:15 AM - 12:15 PM

Lifecycle Matrix:  Launch Optimization and Commercialization Phase

1. Supply by Design Track

Supply by Design: New! Relationship Risk”: You are most likely familiar with “Supplier Qualification,” but how qualified are you to engage in any relationships with your suppliers? We have a self-qualification tool for industry use, since supply chain failures start with the manufacturers, not the suppliers. Then, importantly, participants will learn how to overlay supplier-risk and self-risk in order to establish the most important aspect – the never-before-considered, relationship risk. These paradigm-shifting applications will truly result in step-jump improvements in supply chain performance for your organization.

Moderator:

  • Bob Zinser, Patheon

Speakers:

  • Elaine Shannon, Takeda
  • Patrick Henry, avantor Puritan Products

 

2. Global Product Stewardship Track

Establishing Launch Playbook Success: So you have everything in place and are anxiously awaiting product approval…but then, everything that could go wrong, does. What happened? Learn the keys to success by understanding the significance of alignment on your organization’s Launch Playbook. And importantly, understand the lack of alignment you did not realize you had with your Contractor’s launch playbook. Panel members will share the trends of failures/breakdowns for you to avoid, as well as provide practical advice on how to be successful.

Moderator:

  • Jim O'Reilly, University of Cincinnati

Speakers:

  • Andrea Franks, Pfizer CentreOne
  • Isabelle Lafosse, Patheon
  • Kieran McKillop, AstraZeneca

 

3. Regulatory Strategy Track

Launch Readiness – Pitfalls and Success: In this session, participants will learn from FDA and former FDA what pitfalls they see from across the industry related to the regulatory application review and approval process, especially related to applications involving complex global supply chains. Importantly, FDA will share advice on how to navigate the approval pathway by setting up your application right-first-time, understanding when and why to proactively meet with the FDA, and when to submit information throughout the approval process. Additionally, the ORA Ombudsperson will share examples of inspection issues that impact approval, how ORA and CDER collaborate, and how the Ombudsperson has become involved in the significance of inspection findings. Don’t miss this session to set your organization up for success!

Moderator:

  • Grace Breen

Speakers: 

  • Theresa Mullin, FDA (invited)
  • Jessica Zeller, FDA (invited)
  • Industry Representative (TBA)

12:15 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:

  • Mitigating “Lack of Leverage”
  • Supplier Qualification Successful Practices
  • Leading a Meaningful Quality Management Review Process

1:30 PM - 2:30 PM

Lifecycle Matrix:  Lifecycle Management Phase

1. Supply by Design Track

Supply by Design – the Lifecycle Pathway: Through the Good Supply Practices developed by FDA, pharmaceutical representatives, medical device representatives, and Xavier University, a lifecycle management process was established that is commensurate with the need and grounded in the Supply by Design methodology.

Moderator:

  • Cathleen Carson, Purdue Pharma

Speakers:

  • Neil Lewis, P&G
  • Marla Phillips, Xavier University

 

2. Global Product Stewardship Track

Global Trade Compliance and Successful Practices: Participants will have an experience that they won’t soon forget as representatives across the global trade ecosystem share practical examples of how to effectively navigate global trade compliance – beyond quality. Hear directly from a customs broker for pharmaceutical companies, company representative from a global trade compliance function, a trade attorney, a freight forwarder/transportation manager and a regulatory professional. Walk away with practical actions you can implement today!

Moderator:

  • David Lowndes, Shire

Speakers:

  • Andrea Jeglum, Shire
  • Industry Representatives (TBA)

 

3. Regulatory Strategy Track

The ICH Q12 Solution: Learn how the ICH Q12 guideline will provide a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. It is often said that “change is the only constant.” With this in mind, ensure you are set to implement the critical aspects of Q12 into your internal and external approval processes to ensure the quality of your product, the continuity of your business, and the safety of your patients.

Moderator:

  • Michael Kaminski, P&G

Speakers:

  • Industry Representative (TBA)

2:30 PM - 2:50 PM

Break


2:50 PM - 3:50 PM

TPLC Playbook: Putting the Lifecycle Matrix in Action

Position your organization for Total Product Lifecycle success, and walk away from the Lifecycle Matrix sessions with big picture actionable and practical learning. Putting your work into a larger context across operations and across the phases of the product lifecycle will enable you to strategically increase the interconnectivity of product and supply chain development, launch and sustainability. Prevent missteps as you achieve a Right First Time supply chain!

Moderators:

  • Grace Breen
  • Jim O'Reilly, University of Cincinnati

Speakers: 

  • Jen Brown, Pfizer
  • David Lowndes, Shire
  • Marla Phillips, Xavier University

3:50 PM - 4:50 PM

You Have No Leverage? Now What?

The challenge of “Lack of Leverage” with some suppliers is very real in our industry, and very challenging, especially when critical materials are sole sourced. Participants will gain practical and “real” advice on how to navigate these challenging situations, but yet, situations that are prevalent across the industry.

Moderator: 

  • Grace Breen
  • Jim Wulfeck

Speaker:

  • Dale Carter, Evonik
  • Christina Markus, King & Spalding
  • Dale Nowak, AstraZeneca

4:50 PM - 5:00 PM

Day 2 Closeout


5:00PM - 7:00PM

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.