PharmaLink 2015 Program & Agenda
Key Outcomes for the Conference
Making a Difference…
March 24, 2015[Print]
|5:00 PM - 7:00 PM||
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 refreshments and beverages will be served.
March 25, 2015[Print]
|8:30 AM - 9:00 AM||
PharmaLink Conference Welcome
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.
|9:00 AM - 10:00 AM||
MHRA Perspective on Global Supply Chain Challenges
Hear directly from MHRA on the challenges that are most prominently facing global ministries of health. Where are they focusing efforts to confront the challenges of globalization and import safety? How are they collaborating with other agencies? And how does this affect you?
Moderated by: Headley Rees, PharmaFlow
|10:00 AM - 10:20 AM||
|10:20 AM - 11:10 AM||
How to Leverage New Standards for Excipient Manufacturers
FDA is working closely with industry to develop a standard for excipient manufacturing GMPs. Understand what is being developed, how FDA views such standards, where it is being adopted, and how you can leverage these standards in your supplier relationships.
Moderated by: Gabey Cosel, Pew Charitable Trust
|11:10 AM - 12:10 PM||
Increasing Supply Chain Reliability – Shifting paradigms
As an industry, we are not focusing on areas that are proving to increase the reliability of our supply chain. Understand paradigm shifts uncovered by manufacturers and suppliers working together through the Xavier University Integrity of Supply Initiative that hold the key to the answers we are all looking for. It is through this renewed focus that our efforts can turn toward meaningful and impactful solutions.
|12:10 PM - 1:20 PM||
|1:20 PM - 2:10 PM||
Barriers to Quality and Supply Chain Excellence
Quality and Supply issues continue to plague our industry. In an attempt to understand what we need to do differently we have asked FDA and MHRA to identify the Top 3 flags that tell them there is a higher risk to quality and supply. We have also asked CMOs and suppliers to share feedback on barriers that contribute to quality and supply issues and what works well from their more global perspective.
Moderated by: David Lowndes, Shire
|2:10 PM - 3:10 PM||
Nobel Prize-based Alignment Optimization
Understanding the degree of alignment is essential for groups collaborating on a shared topic. However, alignment has been a soft concept, something vague and sensed. Through the use of algorithms derived from the work of Nobel-prize recipient, Prof. Thomas Schelling, Alignment Optimization (AO) is now a management science enabling groups to understand their alignment with hard data and visualizations, with proven, practical methods to maximize alignment around valuable, viable, and endorsed outcomes. In this presentation, SchellingPoint will explain some of the concepts of AO, and present three case studies of AO’s use in supply chain and customer/supplier relationships.
Moderated by: Bill Mullin, Keystone Compliance Partners
|3:10 PM - 3:30 PM||
|3:30 PM - 5:00 PM||
Quality Metrics beyond compliance to drive strategic value
Using a case study workshop approach, this session will challenge you to apply Quality Metrics to your decision-making and management responsibilities in real life scenarios such as mergers and acquisitions, distribution, licensing, CMO’s and Regulatory authorities.
Moderated by: Jim Wulfeck, CompleteMastery
|5:00 PM - 7:00 PM||
Benefit from the open dialog while enjoying drinks and hors d’oeuvres. You and your colleagues can continue to share ideas and explore issues with Strategic Committee Members and Speakers in a pleasant, informal setting.
March 26, 2015[Print]
|8:30 AM - 9:30 AM||
Living Life at Performance Level
Speaker and best-selling author Curtis Zimmerman will highlight the benefits of trust and collaboration. His patient-centric, leadership focused session will inspire MedCon participants to live their life at a higer level of performance.
Moderated by: Marla Phillips, Xavier Health
|9:30 AM - 10:20 AM||
Are you ready for a paradigm shift in FDA inspection approach?
FDA has indicated that there is a paradigm shift for how they approach inspections at CMOs and pharma facilities. Explore how ready, willing and able you are to demonstrate your product knowledge and the controls you have established for continuous product quality. Contract manufacturers have to be able to respond for their client’s product, and pharma has to be able to answer for work done by their CMO.
Moderated by: Bill Webb, Aptalis
|10:20 AM - 10:40 AM||
|10:40 AM - 11:50 AM||
Global Supply Chain Risk Management Case Studies
Through case study examination and small group discussions, participants will dissect ways to secure the supply chain in the Asia/Pacific region, as well as, how to recognize external material signals that impact the integrity of their supply chains. Industry representatives will provide their expertise by discussing practical approaches to each of these scenarios.
Moderated by: Paul Weninger, Perrigo
|11:50 AM - 1:20 PM Track 1||
Deep Dive Lunch Session--Metrics
|11:50 AM - 1:20 PM Track 2||
Deep Dive Lunch Session--FDA Q&A
|11:50 AM - 1:20 PM Track 3||
Deep Dive Lunch Session--Data Integrity
|11:50 AM - 1:20 PM Track 4||
Deep Dive Lunch Session--Integrity of Supply
|1:20 PM - 2:20 PM||
Systemic Approach to Managing Your Global Supply Chain
Industry has not fully recognized the challenges that lie ahead in implementing the Unique Facility Identifier (UFI) requirements of the FDA Safety and Innovation Act (FDASIA). This session will provide a practical approach to utilizing the Data Universal Numbering System (DUNS number), and how this approach can be utilized to manage your material supply chain beyond drug establishments and excipient manufacturers. The time to start is now….this is not a simple exercise, and those who have been through it are ready to share what they’ve learned.
Moderated by: Gwyn Murdoch, Eli Lilly
|2:20 PM - 3:20 PM||
Top acquisition challenges – how to make it through
Acquisitions are heavily based on financial decisions, but beware of the quality and regulatory hurdles that lie ahead during the complex integration process. This session will explore the top challenges that arise during acquisitions, how to react and recover, and how to remain relevant.
Moderated by: Michael Kaminski, P&G
|3:20 PM - 3:40 PM||
|3:40 PM - 5:00 PM||
Held at the Border? Understand why
Global supply chains cross borders every day; some drug shipments are held up for reasons you don’t understand. Hear from the FDA and a major broker about common mistakes discovered during import screening, best practices for a smooth importation process, and the new trusted importer program.
Moderated by: Kathleen Culver (Invited), FDA
|5:00 PM - 5:45 PM||
Travel to Newport Aquarium
1 Aquarium Way, Newport, KY 41071
|5:45 PM - 8:15 PM||
PharmaLink 2015 Reception, Dinner, & Keynote Address
The evening event will be held at the state-of-the-art Newport Aquarium. The Newport Aquarium was named the No. 1 aquarium in the 2012 Readers’ Choice Travel Awards from 10Best.com.
***More details to follow on speaker and logistics.***
March 27, 2015[Print]
|8:30 AM - 10:00 AM||
Major Changes at FDA Affecting You
Major changes are happening at the FDA, and these changes will affect how FDA oversees your operations. Hear from a distinguished FDA panel about the GDUFA inspection program, significant realignment of FDA offices, and the new Office of Pharmaceutical Quality.
Moderated by: Steve Niedelman, King & Spalding
|10:00 AM - 10:20 AM||
|10:20 AM - 11:50 AM||
FDA Investigator Insights
Hear what the FDA is finding on inspection and what they are looking for directly from Field Investigators. Regulators will share examples with participants, as well as trend data on inspections across the industry. Understand what is new and how that impacts you and your company…and your contract partners and suppliers. Prepare today for tomorrow.
Moderated by: Kathleen Culver (Invited), FDA
|11:50 AM - 12:20 PM||
Action Plan Writing and Conference Close-out
Participants will turn the top priorities they have captured on their “Act – Change – Transfer” forms into Action Plans.
Pick-up Pre-Ordered Box Lunch
Pick-up your pre-ordered boxed lunch and take the opportunity stay in the conference center and continue networking with your colleagues.
For those of you who have to catch a flight or drive home, this is a great way to make sure you get a good meal to start your journey.
Shuttle departs Xavier for Cincinnati Airport (CVG) and Hilton Cincinnati Netherland Plaza Hotel.