A conference for those looking to engage in paradigm-shifting dialogue that leads to solutions for staying ahead.

PharmaLink Conference Agenda


Tuesday, November 15, 2022

09:30 A.M. – 10:00 a.M.

Connect

10:00 A.M. – 10:10 A.M.

Welcome and Conference Kickoff

Moderator
  • Lindsey Fleischman, Consumer Safety Officer, FDA
  • Cynthia Culmo, Principal Consultant, Culmo Compliance Consulting dba CC Consulting
10:10 A.M. – 11:00 a.M.

Novel Digital Technology in the Product Life cycle

The pandemic impacted non-COVID related products in a way that has been detrimental to patient health around the world. Join this session to learn about the unexpected impact, what actions were needed to address the supply shortages, and what actions are needed to prevent similar impact in the future.

Moderator
  • Chris Markus, Partner and Deputy Chair for FDA & Life Sciences, King & Spalding
Speakers
  • TBA – to be announced
11:00 A.M. – 11:45 a.M.

Novel Manufacturing Technology in the Product Life cycle

Are you curious about new manufacturing technologies, especially drug product continuous manufacturing? What about the modeling used to support continuous manufacturing? This session will provide an overview of both the theoretical and practical sides of continuous manufacturing, as well as some challenges associated with registering these technologies for commercial use.

Two Sides of the story: Theoretical vs Successful Implementation

Content to Cover:

• The theoretical side of continuous manufacturing – where are we going/what is the ideal future state? How do we use modeling and predictive technology to get us there? (This might be a nice session to follow from the “Novel Digital Technology” session, which will focus on digital tools for training; this session will focus on the use of digital tools for manufacturing.)
• The ‘actual’ side – a current case study of Pfizer’s updated continuous manufacturing process, based on a product still in development (that Pfizer would like to get in front of the FDA ETT who will be presenting at the next session in the conference).
• Either/both speaker may try to sneak in a bit of content about any global regulatory hurdles that are anticipated regarding this new technology (the FDA might be getting more comfortable with these new technologies, but what about the rest of the global regulators?).

Moderator
  • Jen Brown, Senior Director and Team Leader, Global Regulatory Chemistry, Manufacturing & Controls, Pfizer
Speakers
  • To be announced
11:45 A.M. – 12:00 P.M.

Break

12:00 p.M. – 1:25 P.M.

FDA’s Emerging Technology Program:  Modernizing the World of Pharma

Are you considering a novel approach to your manufacturing process? Are you wondering about the regulatory acceptability of your new technology? The FDA Emerging Technology Program encourages and supports the adoption of innovative technology to modernize pharmaceutical development and manufacturing through close collaboration with industry and other relevant stakeholders.

Two Sides of the Story: Commercialization Readiness versus Approval Readiness

Content to Cover:

Basics of how and when to approach the ETT, what types of innovative technologies and strategies they have advised. An industry case study on a portfolio level change to a container closure. Member of the FDA ETT to speak about the ins and outs of the program. Industry speakers that have direct experience with the ETT.

In this session you will learn about when and how to engage with FDA Emerging Technology Team from experts at the FDA. You will also hear about the advantages of this program through a real industry case study.

Moderator
  • Connie Langer, Regulatory Strategist, Pfizer
Speakers
  • Sau “Larry” Lee, Deputy Director of Science, Office of Pharmaceutical Quality, FDA-CDER (Invited)
  • Joel Welch, Associate Director for Science and Biosimilar Strategy, FDA
  • Timothy Watson, Executive Director/Leader of the Global CMC Advisory Office, Pfizer
1:25 p.M. – 2:10 P.M.

U.S. Government Covid Task Force – Moving to Action

Join Rob Handfield, Joint Acquisition Task Force for the National Stockpile member, to learn incredible insights on the current supply chain situation and future actions for global preparedness. Handfield will share the state of the United States at the start of the pandemic, possible changes on the horizon for our industry (such as clinical trials, data governance, and analytics), and moving toward a state of control.

Two Sides of the Story: Working through today’s supply chain limitations versus establishing tomorrow’s reliant supply chain

Content Covered:

Overview of COVID and its impact to suppy chains

Working through today’s supply chain limitations versus establishing tomorrow’s reliant supply chain

Moderator
  • David Lowndes, Member of the Board of Directors, SK Pharmteco; Member of the Board of Directors; Yposkesi; President, DL Advisors LLC; former SVP, Shire
Speakers
  • Rob Handfield, Bank of America University Distinguished Professor of Supply Chain Management, North Carolina State University Poole College of Management, and Executive Director and founder of the Supply Chain Resource Cooperative based in Poole College
2:10 p.M. – 2:55 P.M.

Attempting Global Vaccination with Cold Chain Challenge

Lessons learned from the rapid rollout of a global, temperature-sensitive vaccine while navigating unique circumstances, including disposing forces and urgency throughout the supply chain without a sufficient workforce to maintain product integrity.

Moderator
  •  To be announced
Speakers
  • To be announced
2:55 p.M. – 3:00 P.M.

End of Day Close-out

Wednesday, November 16, 2022

9:30 A.M. – 10:00 a.M.

Connect

10:00 A.M. – 10:10 a.M.

Welcome Back!

Moderators
  • Lindsey Fleischman, Consumer Safety Officer, FDA
  • Cynthia Culmo, Principal Consultant, Culmo Compliance Consulting dba CC Consulting
10:10 A.M. – 10:40 a.M.

“Non-COVID” Product Impact – the hidden story

The pandemic impacted non-Covid related products in a way that has been detrimental to patient health around the world. Join this session to learn about the unexpected impact, what actions were needed to address the supply shortages, and what actions are needed to prevent a similar impact in the future.

Focus on lessons learned and residual impacts and what we can do to mitigate the impact of Russia and Ukraine.

Moderator
  • Chris Markus, Partner and Deputy Chair for FDA & Life Sciences, King & Spalding
Speakers
  • To be announced
10:40 A.M. – 11:40 a.M.

COVID & The Global Supply Chain – Government Impact & Opportunity

Gain a better understanding of the U.S. Presidential Executive Order 13944 and the National Strategy for a Resilient Public Health Supply Chain. Join the dialog to move toward actions that can achieve a self-reliant supply chain, which would ensure all Americans have access to critical supplies and effective healthcare.

Two Sides of the Story: Executive Orders versus Industry Capabilities

Content to Cover:

How do the government and industry partner to create a more resilient and sustainable public health supply chain?

• BARDA enable/integrate – The need to reserve capacity; facilitated by government funds
• Industry response – How do we do it – concept to reality

Moderator
  • Jeffrey Meng, Director of Investigations Branch, Division of Pharmaceutical Quality Operations III, FDA-ORA
Speakers
  • To be announced
11:40 A.M. – 12:40 p.M.

QMS of Tomorrow – for Today

A good Quality Management System (QMS) drives business excellence and leads to patient success. However, QMS in our industry are developed without enough regard to the business in which they operate – creating pressure, conflicting priorities and increased risk to the patient. The Fit-for-Purpose Model (established through the Pathway Chief Quality Officer Forum) is an easy-to-use tool that incorporates quality, cost and time drivers in risk-based decisions so you can lead with agility and transparency, while meeting regulatory expectations. It is time to end the dichotomy between quality and the business, and start leading with excellence.

Two Sides of the Story: The Fit-For-Purpose QMS model vs the conventional ‘one size fits all’ QMS model.

Content to Cover:

The Pathway Chief Quality Officer Forum’s QMS initiative involves decision tools and content to inform how best to implement the QMS model for a diverse array of situations. The Fit-for-Purpose model harmonizes cross-functional expectations for the appropriate prioritization of quality, cost and time drivers – while always meeting regulatory requirements and expectations. The decision tools enable QMS agility and transparency that protects patient safety, increases consistency in decisions, uses resources responsibly, and increases trust in leadership. The presenters will share insights and tools you can use today!

Moderator
  • Grace Breen, Executive Advisor to CEO, SCA Pharmaceuticals
Speakers
  • Marla Phillips, Leader of Pharmaceutical and Medical Device Industry initiatives – Driving Collaborative Change, Pathway for Patient Health
12:40 P.M. – 12:55 P.M.

Break

12:55 p.M. – 1:55 p.M.

Putting the Science of Knowledge Management into Action – A Merck Case Study

The digital age is affording tremendous opportunities to support enterprise-wide decisions with more meaningful information than ever before. But do you feel behind? Most of the industry is. Why? Learn how to harness the power of your company’s “tribal knowledge” and external intelligence as we share key insights into the science of knowledge management.

Two Sides of the Story: “Tribal Knowledge” versus the Science of Knowledge Management

Moderator
  • Brandon Persinger, Head of Corporate Quality Compliance, Perrigo Company
Speaker
  • Marty Lipa, Executive Director, Knowledge Management, Merck
1:55 p.M. – 2:55 p.M.

FDA Alternative Inspection Approaches – The New Normal

Learn about the FDA’s alternative regulatory inspection approaches and how they are evolving to provide the Agency with a range of options to assure continued regulatory oversight when on-site inspections may not be feasible. We will discuss the FDA’s Remote Regulatory Assessment tools including the 704a4 records review process and Remote Interactive Evaluations. How often and when are these alternative methods being used?

Moderator
  • Lindsey Fleischman, Consumer Safety Officer, FDA
Speakers
  • Ashar Parikh, Foreign Pre-Approval Manager, FDA
PANEL
  • Jeffrey Meng, Director of Investigations Branch, Division of Pharmaceutical Quality Operations III, FDA-ORA
  • Rebecca Dombrowski, Supervisor Consumer Safety Officer, FDA
1:55 p.M. – 2:55 p.M.

End of Day Close-out