PharmaLink Conference Sessions Agenda: Day 2

THURSDAY, MARCH 14, 2019

 

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:

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


8:45 AM - 9:30 AM

FDA Provides Insight on the World of FDA Investigators!

The Office of Regulatory Affairs (ORA) manages all the investigators across the country, and is responsible for effectively implementing the inspectional programs at your sites. ORA partners with CDER on inspection and harmonization initiatives, and works with industry and international regulatory partners to ensure safe and effective drugs are available and accessible for the patients you serve. Understand how key ORA initiatives on the horizon, and implementation of Concept of Operations (ConOps), may affect you.

Moderator:

  • Art Czabaniuk, Program Division Director, Division of Pharmaceutical Quality Operations III, ORA, FDA (invited)

Speaker:

  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs, FDA (invited)


9:30 AM - 10:15 AM

Industry 4.0 and the Total Cost of Quality:  The Bi-Modal Challenge Facing our Industry Today

As the fourth industrial revolution and disruptive product innovations are reshaping healthcare, the patient moves ever closer to the center of the supply chain and the pharmaceutical industry faces increasing tensions across a bi-modal challenge.  We have an exciting opportunity to advance our tools and techniques to support the sophistication of today’s pharma industry and its rapidly approaching future.  With the rise of continuous manufacturing, cloud computing, gene therapy and personalized medicine, we can no longer sustain our business and uphold patient safety with immature systems.  During this session, you will learn how digital transformation is lowering cost while ensuring product quality, safety, efficacy, and supply chain continuity.  Don’t miss this opportunity to hear thought-provoking ideas for your organization that will result in the superior performance your patients are relying on.

Moderator:

  • Lauryn Congedo, Associate Director, PDQA, Allergan

Speakers:

  • Steve McCarthy, Vice President of Digital Innovation, Sparta Systems (former Vice President, J&J)


10:15 AM - 10:35 AM

Break


10:35 AM - 11:50 AM

TRACK 1 (QUALITY)

Situational Analysis for You to “Navigate the Gray” with Practical Solutions for Real-World Quality Challenges

The complexities of today can be vague and gray, and cannot be solved with yesterday’s solutions. The pharmaceutical professional is often faced with scenarios that have no clear path forward, and must create tomorrow’s solutions with new technology, collaboration and total enterprise perspectives. Participants will gain “real” advice on how to navigate these challenging and prevalent situations with practical solutions that will assure product quality and enable business continuity.

Moderator:

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

  • Grace Breen, Senior Vice President, SCA Pharmaceuticals

Speakers:  

  • Industry TBA

TRACK 2 (SUPPLY CHAIN)

Add Value Through Advanced Supply Chain Strategies You Can Implement Today!

Your complex global supply chains are ready for sophisticated proven strategies that will enable you to identify and optimize value for your organization.  Learn best practices on how to pull together a toolbox of six sigma techniques such that you can find areas of opportunity that are hiding in your supply chains.  Explore how to use value stream mapping, risk management triage, performance metrics, and common/special cause variation in a way you have never used them before.  Move from fearing blind spots to seizing opportunities that will lead to patient and business success.

Moderator:

  • David Lowndes, Senior Vice President, Head of Small Molecule Operating Unit, Technical Operations, Shire

Speakers:  

  • David Lowndes, Senior Vice President, Head of Small Molecule Operating Unit, Technical Operations, Shire

  • Eda Ross Montgomery, Senior Director, Technical Steward, Shire

TRACK 3 (REGULATORY)

Surprising Reasons for Clinical Holds and Successful Practices to Avoid Them!

According to the Pink Sheet, IND clinical holds by the US FDA have risen 36% since 2014. These holds cause huge concerns for patients for whom an IND offers a glimmer of hope. Companies hoping to speed their drug candidate to market fear the impact that a clinical hold might have on their bottom line. During this interactive session, regulatory experts will discuss common reasons for clinical holds and how to avoid them. Walk away prepared to set your organization up for successful product and approval and launch!

Moderator:

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

Speakers:

  • Daniela Drago, Associate Professor and Director, Regulatory Affairs, George Washington University

  • Fred Senatore, M.D., Medical Officer, CDER/OND/DCRP, FDA


11:50 AM - 1:05 PM

Lunch: Drug Reimbursement: Did You Know?

How do insurance companies determine which drugs to reimburse, and how does the FDA risk ranking outcome influence those decisions? The insight gained through this session will empower you to understand how you can affect the outcome for your company and patient success.

Moderator:

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

Speakers:

  • Mike Margevicius, R.Ph., Director of Pharmacy, Anthem BC/BS


1:05 PM - 2:15 PM

TRACK 1 (QUALITY)

Quality Risk Management Across the Product Lifecycle: An Enterprise-Wide Approach                                             

Effective use of Quality Risk Management, as part of the Pharmaceutical Quality Management System enhances the quality and safety of medicines, enables a state of control, and drives continual improvement by incorporating science- and risk-based decisions related to product quality. Industry Experts will engage participants in proven case studies of Quality Risk Management within Supply Chain/Manufacturing, Internal Audit, Post Marketing Surveillance and Supplier Quality Management programs. These successful practices and strategies will enable you to handle risk management across the full product lifecycle in your company.

Moderator:

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

Speakers:

  • Stephanie Gaulding, Principal Consultant, DPS Group

  • Michael Reske, Quality Engineering Manager, Perrigo

TRACK 2 (SUPPLY CHAIN)

Is There Power and Potential for Blockchain in the Pharmaceutical Industry?

Could Blockchain and Bitcoin provide the return-on-investment your company is looking for from all the effort and that has been poured into compliance with the Drug Supply Chain Security Act? Having chain of custody established from end-to-end can unlock possibilities for gaining efficiencies, trust, and security while opening new avenues for transactional operations. Learn how to take advantage of the DSCSA groundwork for your company today!

Moderator:

  • Ashley Goldberg, Sr. Director, Quality Operations, Merz North America, Inc.

Speaker:

  • Eric Garvin (Co-Lead of the MediLedger Project), Pharma Solutions Executive, Chronicled

  • Matt Sample, Senior Director, Secure Supply Chain, AmerisourceBergen

  • Susanne Somerville (Co-Lead of the MediLedger Project), Pharma Solutions, Chronicled

TRACK 3 (REGULATORY)

Fact or Fiction? Filing Challenges for Emerging Technology

As a Regulatory Affairs professional, you have the ability to pave the way for successful product approval, but can feel thwarted while navigating hurdles related to regulator reviews of new and perhaps unfamiliar technology. Do you try, or do you avoid innovation? As the pace of innovation is only increasing, now is the time to decipher what is fact and what is fiction for true regulatory filing challenges. Learn successful practices you can implement to best support your product filing for the patients you serve.

Moderator:

  • Michael Kaminski, Principal Scientist, Oral Care Regulatory Affairs, P&G

Speakers:

  • CDR Tara Gooen Bizjak, Senior Science Policy Advisor, Office of Policy for Pharmaceutical Quality, FDA (invited)

  • Leslie Weiss, Director, Global CMC Regulatory Affairs at Janssen Research & Development, LLC; a division of Johnson and Johnson


2:15 PM - 2:30 PM

Break

Participants are provided a short break for anyone wishing to attend a different track.


2:30 PM - 3:30 PM

TRACK 1 (QUALITY)

External Surveillance Programs to Protect and Promote Patient Health

In today’s reality, we are inundated with a continual stream of information from a myriad of sources that span the globe—varying languages, cultures, credibility, and criticality. The viability of your company’s business is dependent upon your ability to protect and promote patient health. Learn successful practices on how you can bolster your surveillance program to process all available information and remain at-the-ready to take action based on signals you have never had at your fingertips before.

Moderator:

  • Bill Webb, Pharmaceutical and Compliance Consultant

Speakers:

  • Brian McCormick, Associate Director, Global Patient Safety, Perrigo

  • Robert Tollefsen, National Expert Investigator, FDA (invited)


TRACK 2 (SUPPLY CHAIN)

I look forward to sharing our work with industry members so together we can prevent fraudulent and adulterated products from entering the supply chain
— Cheryl Flurer, Supervisory Chemist, FDA

Are Your Drugs Counterfeit? How FDA Can Help You!    

As the complexity of the global pharmaceutical supply chain increases, the threat of criminal tampering and counterfeiting puts your patients and business at risk. The FDA Forensic Chemistry Center will share the latest trends in criminal activity, and the technological advances it is developing to protect patient safety. Learn how industry and FDA can collaborate to combat criminal activity.

Moderator:

  • Steve Eastham, Supervisor, Consumer Safety Officer, FDA (invited)

Speaker:

  • Cheryl Flurer, Supervisory Chemist, FDA (invited)


TRACK 3 (REGULATORY)

Navigating Product Registration in China

China is a key global market for the pharmaceutical industry, but it can be difficult to navigate the review and approval process for a new product registration.  In this session, you will be provided with an overview of the review process, including recent changes, and will have your questions addressed. Walk away with vital information on how to successfully gain approval for your new product in China.

Moderator:

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

Speaker:

  • China National Medical Products Administration (NMPA, formerly CFDA) (invited)


3:30 PM - 3:45 PM

Break


3:45 PM - 5:00 PM

The Secrets of Successful Meetings with Health Authorities—What You Don’t Know May Hurt You

Imagine if you had a reputation for preparing meetings with health authorities that led to great outcomes. Well-run meetings are effective ways to make decisions, solve problems and build long-term positive relationships with regulators. Mastering the art and science of effective regulatory interactions can make a difference in your job. During this facilitated interactive session, a panel of thought leaders will offer hands-on advice for challenging scenarios requiring meetings with regulators. You will be fully engaged and will walk away with best practices on how to prepare and run successful regulatory meetings.

Moderators:

  • Daniela Drago, Associate Professor and Director, Regulatory Affairs, George Washington University

Speakers: 

  • Davy Chiodin, Vice President Regulatory Science, Quality Assurance, and Compliance at Acerta Pharma (AstraZeneca group)

  • Fred Senatore, M.D., Medical Officer, CDER/OND/DCRP, FDA


5:00 PM - 7:00 PM

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.