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#411: Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts
Monday June 15, 2026 11:00am - 12:15pm EDT
118C
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-519-L04-P; CME 1.25; RN 1.25

The recent focus by the US government to increase US-based pharmaceutical manufacturing has created opportunities to revisit the regulations and guidelines that lead to the lengthy time that it takes to construct or expand a manufacturing facility.

Learning Objectives

Discuss critical path items that lead to extended construction and regulatory approval timelines; Describe how FDA's innovative regulatory concepts address these challenges; Identify the similarities and differences between bolstering domestic manufacturing by onshoring manufacturing to established facilities versus new or expanded US based facilities.

Chair

Joseph Kutza, PHD

Speaker

Modernizing Oversight: Enabling the Future of U.S.-Based Pharmaceutical Manufacturing
Lisa Wright, MS

Innovative Regulatory Approaches to Increasing US-based Pharmaceutical Manufacturing
Cecilia Tami, PHD

Building U.S. Biopharmaceutical Manufacturing Workforce Capacity: Challenges, Opportunities, and Innovations
John Balchunas, MSC


Speakers
avatar for John Balchunas

John Balchunas

Workforce Director, National Institute for Innovation in Manufacturing Biopharma, United States
John Balchunas is the Workforce Director for the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) where he is responsible for guiding strategy around workforce and talent development for a federally-funded public private partnership focused on transforming... Read More →
JK

Joseph Kutza

Senior Director Regulatory Policy - CMC, Eli Lilly and Company, United States
Currently Senior Director Global Regulatory Policy and Strategy - CMC at Lilly. Focus on global regulatory policy and external engagement for all product types. Formerly in Regulatory Affairs CMC at AstraZeneca and a reviewer of monoclonal antibodies at the FDA. Ph.D. in Immunology... Read More →
avatar for Cecilia Tami

Cecilia Tami

Head US CMC Regulatory Policy, Genentech, A Member of the Roche Group, United States
Cecilia Tami is currently the Head of US Technical Regulatory Policy at Genentech-Roche. In her role, she leads and executes US CMC regulatory policy strategies and advocacy plans and external outreach in technical, regulatory and legislative CMC related topics. Before joining Genentech-Roche... Read More →
avatar for Lisa Wright

Lisa Wright

Director Regulatory Policy, Novo Nordisk A/S, United States
Lisa Wright brings over a decade of experience in the pharmaceutical and biopharmaceutical industry. She has held multiple positions with a primary focus on regulatory affairs and policy. In her current role at Novo Nordisk, Lisa engages with the FDA on regulatory CMC and device issues... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC
  • Tags Session

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