Main Conference Sessions Agenda: Day 2



7:45 AM - 8:30 AM


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

8:30 AM - 8:40 AM


Day 2 Opening

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! 


  • Grace Breen, Senior Vice President, SCA Pharmaceuticals

8:40 AM - 9:05 AM

Virtual Reality: It’s Time for a Change

We need to move beyond “more training” as the CAPA identified for so many human error failures. Your employees are bright scientists who are capable of very complex operations. So why do they fail? Experience an on-stage demo of how Virtual Reality is actively being used to increase employee readiness and effectiveness so they can give you their best.


  • Amanda Bosse, Vice President and General Manager, Thermo Fisher Scientific


  • ThermoFisher Scientific Virtual Reality Team

9:05 AM - 9:50 AM

CDER’s Approach to Innovation

Learn what the CDER Emerging Technology Team is doing to proactively engage you and your company in discussions about your innovation before you submit an application. FDA is working to encourage and support the adoption of innovative technology to modernize pharmaceutical development and manufacturing through close collaboration with industry and other relevant stakeholders. Learn how you can engage with FDA to advance your innovation related to Pharmaceutical Novelty and Product Quality Advancement.


  • John Taylor, President and Principal, Compliance and Regulatory Affairs, Greenleaf Health


  • CDER invited

9:50 AM - 10:20 AM

CDER’s Approach to Predictive Analytics

CDER will share how they are using predictive analytics on data from your product submissions, inspectional history, post-market data and social media to predict the likelihood of failure. Understand how FDA is evaluating information related to your company so you too can predict even more fully how likely your products will fail. Protect the patients who are counting on you!

Great experience. Very valuable use of my time.
— PharmaLink 2019 Attendee


  • John Taylor, President and Principal, Compliance and Regulatory Affairs, Greenleaf Health


  • CDER Confirmed, Speaker TBA

10:20 AM - 10:40 AM


10:40 AM - 11:50 AM — TRACKS

Factory of the Future Track

Factory of the Future Track

Pushing the boundaries of today’s Quality Management System. Learnings for all.

Moderators: Grace Breen, Senior Vice President, SCA Pharmaceuticals; Elaine Shannon, Senior Director Global Quality Compliance and Systems – Knowledge Management, Takeda Pharmaceutical Company

10:40 am - 11:05 am

Exploring How Gene Therapy Pushes the Boundaries of Today’s Quality Management System

Speakers: Cameron Jones, Head of VVS Quality Compliance & Regulatory , Pharma Services, Viral Vector Services, Thermo Fisher Scientific


11:05 am - 11:50 am

How the AGILE Methodology Can Be Used to Implement a Quality Management System that Embraces Change

Speaker: Kent Joshi, Associate Director, Takeda

Global Regulatory Strategy Track

Global Regulatory Strategy Track

Advancing Regulatory Strategies to support the speed of innovation and the needs of your global patients

Moderators: Michael Kaminski, Principal Scientist, Oral Care Regulatory Affairs, Procter & Gamble; Connie Langer, Global CMC, Environmental Sciences, and Pharmacokinetics, Dynamics, and Metabolism, Pfizer

10:40 am - 11:50 am

Navigating the Complex Global Regulatory Domain while Managing Divergent Dissolution Requirements: Perspectives from Agency and Industry

Speakers: Dorys Diaz, Director of Regulatory Affairs, Pfizer

11:50 AM - 1:05 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 on these topics:

  • Journey to Realtime Release

  • Digital Innovation - Process and Systems

  • Global Regulatory Strategy Development

1:05 pM - 2:15 pM — TRACKS (cont’d)

Track A

Factory of the Future Tracks

1:05 Pm - 1:35 Pm

The Journey to Real-Time Release: Current and Future State

Speaker: Sarah Nielsen, Principal Scientist, Janssen; BioPhorum Industry member TBA


1:35 Pm - 2:15 Pm

Regulator Reactions to the Ability of Today’s Quality Management System to Support the Speed and Creativity of Innovation

Speakers: FDA invited

Global Regulatory Strategy Tracks

1:05 Pm - 1:40 Pm

The Next Frontier – Regulatory Filing Challenges for Innovative Technology

Speakers: Melissa Calmann, Director, CMC Regulatory Affairs, Janssen


1:40 Pm - 2:15 Pm

Innovative Product Filing Application Case Study from the CDER Emerging Technology Team: A Proactive Approach with Industry

Speakers: FDA invited; ANVISA confirmed, Speaker TBA

2:15 PM - 2:35 PM

Relocation Break

2:35 pM - 3:35 pM — TRACKS

Advancing Supplier Partnerships Track

Advancing Supplier Partnerships Tracks

Transcending organizational boundaries through digitalization and true partnership. Building a supply chain as an extension of your own company.

Moderator: Lauryn Congedo, Associate Director, R&D Quality, Allergan; Elaine Shannon, Senior Director Global Quality Compliance and Systems, Takeda

2:35 Pm - 3:05 Pm

Digitalization for Real-time Data Sharing and Visibility that Transcends Your Partnership

Speaker: TBD


3:05 Pm - 3:35 Pm

An FDA Perspective:  Evaluation of Supplier Qualification Inspection Findings and Responses

Speakers: Lauren Howard, Investigator, FDA (invited); Jeff Meng, Director of Investigations Branch, Division of Pharmaceutical Quality Operations III, ORA, FDA (invited)

Global Regulatory Strategies Track

Global Regulatory Strategies Track

Advancing Regulatory Strategies to support the speed of innovation and the needs of your global patients

Moderator: Jen Brown, Director, Global Chemistry, Manufacturing & Controls, Pfizer

2:35 Pm - 3:35 Pm

Key Learnings from a Drug Substance Continuous Manufacturing Case Study

Speaker: Alex O'Brien, Process Chemist, GSK


3:35 PM - 3:45 PM

Relocation Break

3:45 PM - 5:00 PM

The Lost Art of Cultivating Human Capital in a World of Rapid Innovation

During this high-energy, interactive session, discover how to make an emotional connection even with dry content. Learn innovative ways to communicate insights that will foster change and increase operational effectiveness.


  • Nancy Singer, Founder, Compliance-Alliance

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.