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

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Tuesday, November 15, 2022

10:00 A.M. – 10:10 A.M.

Welcome and Conference Kickoff

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Moderator
  • Lindsey Fleischman, Consumer Safety Officer, FDA
  • Cynthia Culmo, Program Lead, Combination Products and PharmaLink, AFDO/RAPS Healthcare Products Collaborative
10:10 A.M. – 11:00 a.M.

Tackle the complexity of biopharmaceutical processes through AI

Biopharmaceutical processes are combining the complexity provided by manufacturing operations and biological systems. A classic way of managing the complex reality of biomanufacturing is by simplifying reality through approximations and explaining operations based on a few variables. AI is the perfect tool to deal with complexity as it is, complex, multivariate, and continuously varying.

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Moderator
  • Chris Markus, Partner and Deputy Chair for FDA & Life Sciences, King & Spalding
Speakers
  • Toni Manzano, Co-Founder & CSO, Aizon
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.

Moderator
  • Jen Brown, Senior Director, Global Regulatory Affairs Chemistry, Manufacturing and Controls, Pfizer Inc
Speakers
  • Dan Blackwood, Research Fellow, Pfizer
  • Pankaj Doshi, Pfizer
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

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

Moderator
  • Connie Langer, Regulatory Strategist, Pfizer
Speakers
  • Lisa Skeens, VP Global Regulatory Affairs CMC, PfizerView Presentation
  • Joel Welch, Associate Director for Science and Biosimilar Strategy, FDA
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

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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. – 2:15 P.M.

End of Day Close-out

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Speaker
  • Cynthia Culmo, Program Lead, Combination Products and PharmaLink, AFDO/RAPS Healthcare Products Collaborative

Wednesday, November 16, 2022

10:00 A.M. – 10:10 a.M.

Welcome Back!

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Moderators
  • Lindsey Fleischman, Consumer Safety Officer, FDA
  • Cynthia Culmo, Program Lead, Combination Products and PharmaLink, AFDO/RAPS Healthcare Products Collaborative
10:10 A.M. – 10:40 a.M.

Overcoming Industry Challenges in Bringing  Cell and Gene Therapies to Market

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
  • Mike McCormick, SVP Quality and Regulatory, Centers for Breakthrough Medicines
10:40 A.M. – 11:40 a.M.

FDA overview of current agency status/perspective

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Moderator
  • Estela Barnes, External Supply, Quality Head (US), Takeda
Speakers
  • Jeffrey Meng, Program Division Director, Office of Pharmaceutical Quality Operations, ORA , FDA-ORA
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!

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Moderator
  • Grace Breen, Consultant, MGB Solutions 
Speakers
  • Marla Phillips, CEO and President, Pathway for Patient Health
  • Alan Johnson, AstraZeneca
  • Shirley Murphy, Takeda
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

Explore 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.

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Moderator
  • Lindsey Fleischman, Consumer Safety Officer, FDA
Speakers
  • Rebecca Dowd, Supervisor Consumer Safety Officer, FDA
  • Jeffrey Meng, Director of Investigations Branch, Division of Pharmaceutical Quality Operations III, FDA-ORA
  • Ashar Parikh, Foreign Pre-Approval Manager, FDA
2:55 p.M. – 3:00 p.M.

End of Day Close-out

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Speaker
  • Cynthia Culmo, Program Lead, Combination Products and PharmaLink, AFDO/RAPS Healthcare Products Collaborative