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Regulatory Insights from 2022 ISPE Annual Meeting

Regulatory Insights from 2022 ISPE Annual Meeting

By the ISPE Regulatory Team

ISPE’s regulatory volunteer groups are charged with bringing visibility and solutions to major challenges faced by the industry with regard to regulatory/quality matters, and facilitating the flow of information between ISPE members and global Health Authorities. Support for that mission was on display at the 2022 ISPE Annual Meeting and Expo with the Regulatory/Quality track and several technical sessions having been developed and led by members of ISPE’s Regulatory and Quality Harmonization Committee (RQHC), ISPE’s Product Quality Lifecycle Implementation (PQLI)® Committee, and ISPE’s Drug Shortages and Advancing Pharmaceutical Quality (APQ) initiative teams.

Development of the Regulatory and Quality track was led by Ciby Abraham, Senior Director and Group Manager, Project and Product Leadership, AstraZeneca who is a member of the RQHC North America Regional Group; and Connie Langer, CMC-Global Regulatory, Pfizer, who is a member of the PQLI Committee’s Q12 Implementation team.

The technical sessions kicked off with the session Building a Quality Organization which was led by Christine Moore, Executive Director, External Advocacy & Policy, Organon and 2022 PQLI chair. Presentations included Right Sizing and Simplifying Quality Compliance to Enable Company Success; Building Quality and Managing Risk in Unprecedented Times: A Story About Quality Culture from the Front Line; and Building-in Quality and Compliance from the Beginning.

The Regulatory Challenges in ATMPs session provided a diverse set of perspectives on regulatory/quality topics as it pertains to late stage/commercial ATMPs, primarily autologous cell therapy. The session was led by Peter Millili, Senior Director, Manufacturing Science and Technology, BMS and a co-chair of the RQHC North America Regional Group. Presentations included How to Use EMA Q&A and PIC/S Annex 2 to Identify and Defend a Strategy for Starting Materials: Perspectives from the ex-Chairperson of PIC/S Annex 2 WG; the Industry Perspective on Development of Autologous Cell Therapy Aseptic Process Simulations for CAR-T Cell Therapy Products; Inspections for Global Regulators for CAR-T Products; and a Regulatory Update on Cell and Gene Therapy. The final presentation was Regulatory Considerations and Challenges in Development of Cell Therapy Products – CMC Perspective delivered by Dr. Melanie Eacho, Cell Therapies Branch Chief within the Office of Tissues and Advanced Therapies (OTAT) , US FDA/CBER.

ISPE’s Advancing Pharmaceutical Quality (APQ) Program and Quality Management Maturity (QMM) were the topic of a session led by Tami Frederick, Senior Director, Corporate Quality Systems & Cultural Excellence, Perrigo, and chair of the ISPE APQ Team whose presentation focused on the fifth and most recent APQ Guide, Cultural Excellence. A presentation on ISPE’s Pharma 4.0® program was delivered by the chair of that program, Christian Wölbeling, Executive Industry Advisor, Körber. Djamila Harouaka, an advisor in the Office of Pharmaceutical Quality, USFDA/CDER, presented FDA’s Quality Management Maturity Program.

The session on a New Analytical Paradigm was led by the chair of the Analytical Methods ICH Q2(R2) and Q14 team - a working group under the PQLI Committee - Bryan Castle, Executive Director Synthetic Molecule Design & Development, Eli Lilly & Company, who spoke on How the Concepts of ICH Q14 Might Enable Rapid Drug Supply Continuity through Lifecycle Changes. His presentation was followed by the Industry Perspective on Considerations for Analytical Procedure Development, Validation, and Lifecycle Management in ICH Q2(R2) and Q14 presented by Nina Cauchon, Director Regulatory Affairs-CMC, Amgen and 2023 PQLI Committee chair. The session concluded with a joint industry and regulatory panel with Dr. Raphael Sanches Pereira, Health Regulation and Surveillance Specialist, ANVISA; and Jayda Siggers, Senior Biologist/Evaluator, Health Canada.

In the session ICH Q12: Implementation Progress and Future Opportunities chaired by Eli Zavialov, Senior Director, GSK – a founding member of the PQLI Committee’s ICH Q12 Implementation Team - regulators and industry shared their aspirations and implementation challenges for this potentially transformative guidance. Regulators from Canada and Brazil discussed their pathways towards aligning and training regulators. Hugo Hamel, Senior Biologist/Evaluator, Health Canada, offered reflections on how the health authority has implemented Q12, and how changes map from Q12 to Canada’s change management system. Hamel discussed Health Canada’s Established Condition (EC) and Post-Approval Change Management Plan (PACMP) pilot programs, and commended the Q12 training that had been provided to Health Canada by ISPE. He closed with a comparison between Canada’s Certified Product Information Document (CPID) and ICH’s Product Lifecycle Management (PLCM) documents. Raphael Sanches Pereira described ANVISA’s current state of ICH Q12 implementation and progress towards internal training, adoption of PACMPs, and to looking forward with the adoption of PLCM documents and ECs. Dr. Zavialov closed the session with a presentation on industry’s aspirations for Q12 implementation, and the ways in which regulators and industry have engaged and will continue to collaborate to assist in globally harmonized implementation of this highly complex guideline.

Discussions on Addressing Divergent Global QOS Requirements were a highlight of the session Regulatory Considerations to Boost Innovation and Supply Chain Resilience which was led by track leads Ciby Abraham and Connie Langer.

The PQLI Committee’s working group on Transportable/Point of Care Manufacturing Team presented a session titled Transportable, Small Footprint Biopharmaceutical Manufacturing Facilities: A Regulatory Perspective. The speakers, Dennis Powers, Vice President of Business Development & Design Consulting, Gcon; Rick Panton, Principal Engineer, Roche; and Thomas F. O’Connor, PhD, Deputy Director, Office of Pharmaceutical Quality, USFDA/CDER, presented various aspects of Distributed Manufacturing (DM) and Point of Care (PoC) facility concepts from the perspectives the manufacturer, supplier, and regulatory agencies. The session was well attended, indicating a growing interest in the subject. During the panel discussion, interest was expressed in the Roche Genentech’s Fleet management concept where a fleet of equivalent pharmaceutical production systems are distributed across multiple sites enabling the sharing of, for example, testing, data, and quality decisions to establish a higher level of efficiencies across the production network. Rick’s presentation reinforced the position that there are companies that have implemented systems and approaches that can be leveraged to support distributed manufacturing, while highlighting that a key challenge will be to achieve agreement with assessors and inspectors on the definition of unit equivalency. There was positive feedback regarding the FDA’s engagement and commitment to work with industry to enable implementation of advanced technologies, including DM and PoC facility concepts. Dr. O’Connor highlighted CDER’s commitment through their Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) initiative that will review the current regulatory landscape to address potential hurdles to ensure their readiness to be able to accommodate new technologies over the next 5-10 years.

ISPE’s Drug Shortages team also was represented with a session titled Progress in a Challenging Year led by team member Jessica L. Hale, PharmD, Associate Director-US & Global Regulatory Affairs, Organon. Presentations included Risk Assessment for Drug Availability by Christine Moore, and a report from the ISPE Disposables Community of Practice roundtable, What to do When Urgent is Not Fast Enough. The presentations were followed by a panel discussion with Valerie Jensen, CAPT (Ret.), RPh, of the US FDA’s Drug Shortages staff and Lisa Hedman, Senior Advisor, World Health Organization.

Megan McMahon, Senior Director, Pfizer and leader of the PQLI Committee’s working group on Patient Centric Specifications, delivered a presentation titled Patient Centricity as Part of a Drug Development Program in the session titled Patient Centric Specifications.

Insights from Steven Hertz, Consumer Safety Officer, US FDA/CDER Office of Pharmaceutical Quality, were a highlight of the session titled Combination Products: Evolving State of the Art. Hertz called attention to the achievements of FDA, including the authorization of the first De Novo device-drug combination of bone graft substitute with the antibiotic gentamicin added. The De Novo request provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. De Novo classification is a risk-based classification process. Hertz also stated that FDA is proposing to amend the CGMP requirements of the Quality System Regulations for devices and combination products to align more closely with ISO 13485:2016. He closed his presentation by stating that combination products have had to be innovative in the areas of new products, new processes, and regulations, evident by the first De Novo combination product.


Ciby Abraham, PhD
Senior Director and Group Manager, Project and Product Leadership
Christine M. V. Moore, PhD
Executive Director, Quality Systems & Compliance
Organon LLC
Peter G. Millili, PhD
Senior Director, Manufacturing Science and Technology
Bristol-Myers Squibb
Melanie Eacho, PhD
Chief, Cellular Therapy Branch, Division of Cell and Gene Therapies
Tami J. Frederick
Senior Director, Corporate Quality Systems & Cultural Excellence
Christian Woelbeling
Executive Industry Advisor
Djamila Harouaka, PhD
Sr. Scientific Advisor
Bryan C. Castle, PhD
Associate Vice President - Synthetic Molecule Design & Development
Eli LIlly & Company
Nina S. Cauchon, PhD
Director Regulatory Affairs - CMC
Amgen Inc.
Raphael Sanches Pereira
Health Regulation and Surveillance Specialist
Jayda Siggers, PhD
Senior Scientific Evaluator
Health Canada
Eli Zavialov, PhD
Senior Director
Hugo Hamel, MSc, MBA
Manager, Biotherapeutic Quality Division
Health Canada
Connie Langer
Director, CMC - Global Regulatory
Richard R. Panton
Principal Engineer
Roche Genentech
Thomas F. O'Connor, PhD
Deputy Director, Office of Pharmaceutical Quality
Jessica L. Hale, PharmD
Associate Director-US & Global Regulatory Affairs
Merck & Co Inc
Valerie E. Jensen, CAPT (Ret.), RPh
Associate Director, Drug Shortage Staff
Megan E. McMahon
Senior Director and Team Leader, Global CMC
Steven Hertz, MBA, PE
Consumer Safety Officer, Office of Pharmaceutical Quality