For your convenience, the FDA/Xavier PharmaLink presentations are loaded onto this page as they are received from the presenters, unless a presenter has requested that their presentation not be posted. In keeping with Xavier’s conservation commitment, printed versions of presentations will not be available at the conference. If you have any questions, please contact Heather Harwood, Director, Art & Communications, at harwoodh@xavier.edu.


PharmaLink 2018 Presentations

APEC Supply Chain Security Toolkit

Presenters:

  • Katie Neckers, Regulatory Counsel, Office of Compliance, FDA
  • Phillip P. Nguyen M.D., DABFM, Director, International Regulatory Affairs and Programs, United States Pharmacopeia (USP)

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

Presenters:

  • Xavier AI Initiative - CPQA Team: Charlene Banard, Senior Vice President, Global Quality, Technical Operations, Shire Pharmaceuticals
  • Xavier AI Initiative - CLS Team: Berkman Sahiner, Electrical Engineer, FDA-CDRH; Kumar Madurai, Principal Consultant, CTG

Big Data Analytics:  Right-Sizing Operational Excellence

Presenters:

  • Michael Shepherd, AI Research Technologist, Dell EMC
  • Ryan Smith, VP of Product & Engineering, Sight Machine

Day 2 Opening

Presenter:

  • Cathleen Carson, Associate Director, Treyburn & Supplier Quality Assurance, Purdue Pharma

FDA Investigator Case Study Insights

Presenters:

  • Brent Conatser, Senior Consultant, Elanco Animal Health
  • Art O. Czabaniuk, Program Division Director, Division of Pharmaceutical Quality Operations III, ORA, FDA
  • Dell Moller, Supervisory Investigator, FDA
  • Nicholas L. Paulin, Drug Specialist and Pre-Approval Manager, FDA, Cincinnati District Office

FDA Office of Regulatory Affairs Update and Strategic Priorities  

Presenter:

  • Ellen Morrison, Assistant Commissioner for for Medical Products and Tobacco Operations, FDA-ORA

Global Trade Compliance and Successful Practices

Presenters:

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

How Do Global Regulators Decide Who to Inspect?

Presenters: 

  • Elizabeth Philpy, Senior Advisor, Office of Surveillance, Office of Pharmaceutical Quality, CDER
  • Tracy Moore, Senior GMDP Inspector and GMDP Operations Manager, MHRA

The ICH Q12 Solution

Presenter:

  • Ajay Pazhayattil, Industrial Pharmacist

New Legislation and the Impact to Your Product Approvals

Presenter: 

  • Christina Markus, Partner, King & Spalding

Regulatory Strategy for Supply Chain Success

Presenters:

  • 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

Strategic Supply Chain Development through the Last Mile

Presenters:  

  • 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

Supply by Design – Meaningful Supplier Engagement

Presenters:  

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

Supply by Design: New! “Relationship Risk”

Presenters:

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

Total Quality Ownership Enterprise-wide: The Missing Piece of the Puzzle

Presenter:

  • Patrick Hughes, Quality Engineering Manager, Energy Products, Ethicon

TPLC Playbook: Putting the Lifecycle Matrix in Action

Presenters: 

  • 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

Unlocking End-to-End Supply Chain Success

Presenters:

  • Mandy Bosse, Site Head, Patheon
  • Julie Brautigam, Head of Procurement Risk, Sustainability, Performance & Innovation, Takeda Pharmaceuticals
  • Elaine Shannon, Senior Director - Global Quality Compliance and Systems Knowledge Management, Takeda Pharmaceuticals

You Have No Leverage? Now What?

Presenters:

  • Dale Carter, Head of Quality, Business Line Silica, Region North America, Evonik
  • Christina Markus, Partner, King & Spalding
  • David Nowak, Quality Assurance Supplier Manager, AstraZeneca