PharmaLink 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

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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, Associate Director, Treyburn & Supplier Quality Assurance, Purdue Pharma

8:45 AM - 9:45 AM

MHRA Update: Strategic Priorities

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 MHRA is taking, and actions your company can take today to ensure your product success globally. 

Moderator:

  • Tami Frederick, Global Director, Corporate Quality Systems and Programs, Perrigo

Speaker:

  • Tracy Moore, Senior GMDP Inspector and GMDP Operations Manager, MHRA


    9:45 AM - 10:05 AM

    Break


    10:05 AM - 11:05 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, CEO and President, Complete Mastery

    Speakers:  

    • Troy Fugate (GSP Initiative Co-Leader), Compliance Insight
    • Dale Carter, Head of Quality, Business Line Silica, Region North America, Evonik

     

    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, Sr. Director, Quality Operations, Merz North America, Inc.

    Speakers:  

    • Terrence Jones, Director-IT Relationship Management, AmerisourceBergen Specialty Group
    • Michelle Rich, Associate Director of Program Development, Xavier Health, Xavier University
    • Matt Sample, Senior Director, Secure Supply Chain, AmerisourceBergen
    • David Ulrich, QA Director - Supply Chain, Abbvie

     

    3. Regulatory Strategy Track

    Regulatory Strategy for Supply Chain Success: Suggestions are offered for interacting with drug product vendors during clinical development, with a focus on regulatory compliance and interactions.  This session will include a discussion of vendor-related regulatory/CTA queries, global acceptance of clinical supplies and a case study of using commercial vendors (i.e. vendors being used for commercial products) for clinical supplies.  The discussion will also challenge where change management typically starts in the development lifecycle, how changes at external vendors can be managed during clinical development and how internal change control systems can be used to ensure compliance.  Participants will hear about the practicalities of dealing with regulatory complexities when using vendors during product development.

    Moderator:

    • Jennifer L. Brown, Director, Global Chemistry, Manufacturing & Controls, Pfizer

    Speakers:

    • Diana L. Grohs, Senior Manager, External Party Quality Operations, Pharmaceutical Sciences Small Molecules, Pfizer
    • Scott R. Mackin, Senior Manager, Clinical Drug Product Supply and Sourcing, Pfizer 

    11:05 AM - 11:25 AM

    Break


    11:25 AM - 12:25 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, Vice President for Commercial Technology North America, Patheon

    Speakers:

    • Elaine Shannon, Senior Director - Global Quality Compliance and Systems Knowledge Management, Takeda
    • Patrick Henry, Strategic Account Manager, Avantor Puritan Products

     

    2. Global Product Stewardship Track

    Tech Transfer, Launch, and Your CDMOHow you and your CDMO work together can mean success or failure of your product and the patients who are depending on you. It is important to understand, upfront, your CDMO’s defined approach to tech transfer and launch: What is their process? How are decisions made? And perhaps most importantly, how do they make sure you are both aligned to prevent misunderstandings and mishaps? During this panel presentation, learn how two CDMOs have structured their tech transfer and launch programs and why, and discuss takeaways from the trenches that you can implement in your company today.

    Moderator:

    • James O’Reilly, Professor, University of Cincinnati, College of Law

    Speakers:

    • Andrea Franks, Senior Manager, Development Services, Pfizer CentreOne Contract Manufacturing
    • Isabelle Lafosse, Global Technology Transfer Director, Thermo Fisher Scientific

     

    3. Regulatory Strategy Track

    New Legislation and the Impact to Your Product Approvals: As regulation and legislation evolve at lightning pace, it is critical for companies to understand how best to navigate the expectations and requirements for successful product approval. Additionally, regulatory affairs professionals will value the insight provided during this session on how new laws are applying pressure in the competitive landscape of our industry. Don’t miss this opportunity to understand how the influence of Safe Harbor, FDARA, and the 21st Century Cures Act can affect your filing success.

    Moderator:

    • Grace Breen, Senior Vice President, SCA Pharmaceuticals

    Speaker: 

    • Christina Markus, Partner, King & Spalding

    12:25 PM - 1:40 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

    1:40 PM - 2:40 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, Associate Director, Treyburn & Supplier Quality Assurance, Purdue Pharma

    Speakers:

    • Neil Lewis (GSP Initiative Member), Global Technical Leader Microbiology Delivery, P&G
    • Marla Phillips (GSP Initiative Co-Leader), Director, Xavier Health, 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:

    • Andrea Jeglum, Director, Global Trade and Controlled Substance Compliance, Brand Protection, Shire

    Speakers:

    • Andrea Jeglum
    • John Morelli, Associate Director of Transportation, Shire
    • Sean Murray, Partner, Miller & Company (Trade Compliance Counsel)
    • Karen Stone, License Broker, Anchor Customs Brokerage

     

    3. Regulatory Strategy Track

    The ICH Q12 Solution: As development of the ICH Q12 guidance is underway, take this opportunity to understand how a key component of that document can improve your organization's ability to manage change. Change management is one of the most highly cited challenges by your peers across the global pharmaceutical industry, and it is often said that “change is the only constant.”  Change within your organization, as well as with contract and supplier operations, is critical to control and manage in order to keep unwanted variability out of your product and processes. Through the development of a Post-Approval Change Management Protocol, ensure you are set to implement the critical aspects of Q12 into your internal and external approval processes to protect the quality of your product, the continuity of your business, and the safety of your patients. (Click here to access current ICH Q12.)

    Moderator:

    • Michael Kaminski, Principal Scientist, Oral Care Regulatory Affairs, Procter & Gamble

    Speaker:

    • Ajay Pazhayattil, Industrial Pharmacist

    2:40 PM - 3:00 PM

    Break


    3:00 PM - 4:00 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, Senior Vice President, SCA Pharmaceuticals
    • James O’Reilly, Professor, University of Cincinnati, College of Law

    Speakers: 

    • Jennifer L. Brown, Director, Global Chemistry, Manufacturing & Controls, Pfizer
    • David Lowndes, Head of Small Molecule Operations, Shire Pharmaceuticals
    • Marla Phillips, Director, Xavier Health, Xavier University

    4:00 PM - 5:00 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.

    Moderators: 

    • Grace Breen, Senior Vice President, SCA Pharmaceuticals
    • Jim Wulfeck, CEO and President, Complete Mastery

    Speakers:

    • Dale Carter, Head of Quality, Business Line Silica, Region North America, Evonik
    • Christina Markus, Partner, King & Spalding
    • Ashley Goldberg, Senior Director, Quality Operations, Merz North America, Inc

    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.