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


  • TBD

9:05 AM - 9:50 AM

CDER’s Approach to Innovation, Internally and Externally

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. What have they seen and how is this process working? Also, FDA will share how they are using predictive analytics on your post-market data, and what they are doing with that information.


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


  • Christina Capacci-Daniel, (Acting) Quality Assessment Lead, FDA (invited)

  • Alex Viehmann, Operations Research Analyst, FDA (invited)

9:50 AM - 10:20 AM

Staying Ahead of the Global Curve in an Increasingly Innovative, Complex, Regulated World

Learn how your organization can grasp the speed of evolving expectations and proactively prepare your organization while addressing the area of complexity along the way.

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


  • Connie Langer, Global CMC, Environmental Sciences, and Pharmacokinetics, Dynamics, and Metabolism, Pfizer


  • Søren Thuesen Pedersen, Senior Director, External Affairs, Quality Intelligence and Inspection, Novo Nordisk A/S

10:20 AM - 10:40 AM


10:40 AM - 11:50 AM — TRACKS

Track A

Track A:
Factory of the Future

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

TRACK A1, Part 1
10:40 am - 11:05 am

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

Speakers: TBD


TRACK A1, Part 2
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

Track B

Track B:

Global Regulatory Strategy

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

Moderator: 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; Sandra Suarez, Master Biopharaceutics Reviewer/Biopharmaceutics Lead, FDA-CDER

11:50 AM - 1:05 PM


1:05 pM - 2:15 pM — TRACKS (cont’d)

Track A

TRACK A2, Part 1
1:05 Pm - 1:35 Pm

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

Speaker: Sarah Nielsen, Principal Scientist, Janssen


TRACK A2, Part 2
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: HPRA and ANVISA TBD

TRACK B2, Part 1
1:05 Pm - 1:40 Pm

The Next Frontier: Regulatory Filing Challenges with Innovative Technologies

Speakers: Melissa Calmann, Director, CMC Regulatory Affairs, Janssen; Joann Parker Sr. Director Regulatory CMC Team Leader Pfizer


TRACK B2, Part 2
1:40 Pm - 2:15 Pm

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

Speakers: Christina Capacci-Daniel, (Acting) Quality Assessment Lead, FDA (invited)

2:15 PM - 2:35 PM


2:35 pM - 3:35 pM — TRACKS

Track A

Track A:
Advancing Supplier Partnerships

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

TRACK A3, Part 1
2:35 Pm - 3:05 Pm

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

Speakers: TBD


TRACK A3, Part 2
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)

Track B

Track B: Global Regulatory Strategies

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

TRACK B3, Part 1
2:35 Pm - 2:55 Pm

Key Learnings from a Drug Substance Continuous Manufacturing Case Study

Speakers: TBD


TRACK B3, Part 2
2:55 Pm - 3:15 Pm

Clinical Trial Authorization Experience from an Industry Perspective

Speakers: TBD


TRACK B3, Part 3
3:15 Pm - 3:35 Pm

Regulatory Perspective on Filing Expectations

Speakers: TBD

3:35 PM - 3:45 PM


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.