Brooke Higgins (Invited) (Branch Chief, CDER Office of Compliance / Office of Manufacturing Quality at US FDA)

Brooke Higgins (Invited)

Branch Chief, CDER Office of Compliance / Office of Manufacturing Quality at US FDA

Brooke K. Higgins is the Branch Chief CDER Office of Compliance / Office of Manufacturing Quality at US FDA. In this role, Ms. Higgins oversees the review of domestic and international pharmaceutical cases and handling of associated regulatory actions. Ms. Higgins has also served as an expert witness on CGMP violations in federal court. Prior to joining CDER in 2014, she spent 12 years with the Office of Regulatory Affairs, first as an Investigator and later as a Pre-Approval Manager, both for the Baltimore District. While working as the Pre-Approval Manager, Ms. Higgins continued performing drug manufacturing inspections, both domestically and internationally, became a member of the Pharmaceutical Inspectorate in 2009, and was a Level II drug certification auditor. Ms. Higgins received a M.S. in Food Science, focusing on food microbiology, and a B.S. in Biology from Virginia Tech.

Hue Kwon (Member, RAQAB at Parenteral Drug Association)

Hue Kwon

Member, RAQAB at Parenteral Drug Association

Dr. Hue Kwon served leads a global quality team providing GxP quality and compliance oversight for the end -to-end drug development and lifecycle.

Hue was the former Vice President and Quality Team Leader at Samsung Bioepis, and prior to joining Samsung Bioepis, she was the Head of Business Management and Head of Quality and Compliance in Roche, as a member of a senior management team and leading international GxP capability building and interaction with foreign regulatory agencies to influence in the decision making and building consensus.

She also served as a senior advisor consultant in regulatory strategies for multiple organizations and global matrix environment and for digital health strategy, global IT and global operational alignment project in drug development.

Until December 2010, she served at US FDA for about 9 years on the development of regulatory guidance, emerging regulatory strategy and review and data integrity inspections.

Peter Qiu (External Advocacy Lead, APAC at Roche Genentech)

Peter Qiu

External Advocacy Lead, APAC at Roche Genentech

Dr. Peter Qiu is the External Advocacy Lead for Asia Pacific at Roche Genentech with over 13 years of experience working with the US FDA. He was the Division Director in the Division of Biotechnology Manufacturing, Office of Pharmaceutical Manufacturing Assessment, CDER. He led the assessment of manufacturing processes, facilities, and microbiological control for CDER’s Biologics License Application review and inspection program.

Dr. Qiu has extensive knowledge in microbial controls and sterility assurance assessment as well as in pre-license and pre-approval inspections for biotech products.

Dr. Qiu graduated from the University of Southern California with a Ph.D. in Biological Sciences.

Won Min Kim (Assistant Manager, Bio-Process Team at Green Cross)

Won Min Kim

Assistant Manager, Bio-Process Team at Green Cross

Won Min Kim is the Leader for GC Biopharma’s Drug Product 2 team, manufacturing department which specified for Visual inspection (AVI, MVI) process and packaging process.

In his current role, he is responsible for establishing and maintaining AVI & MVI data such as AVI validation & MVI Qualification. He is also responsible for Vial packaging machine (1 Multi-packaging line & 1 Single Packaging Line). He set up new vial auto inspection machine from Koerber and entire manual inspection procedure and executed entire whole Validation not only initial validation but also regular validation or additional validation after change control.

He joined the company in 2022 as an experenced AVI engineer from Celltrion Pharm, in charge of maintaining the hardware and software of the company’s equipment. In Celltrion Pharm, he was mainly responsible for establishing & maintaining Syringe Auto inspection machine. He was also responsible for establishing & executing validation for part washer & auto-clave & Laminar flow hood.

Hannah Lee (Johnson & Johnson)

Hannah Lee

Johnson & Johnson

Hannah Lee is the site process owner of data integrity at a manufacturing site, J&J Innovative Medicine since 2023. Experienced in document and training management systems for 3 years. Supported supplier qualification and internal audits for a while. Spent 4 years at a GMP consulting firm and 1.5 years in cosmetics, OTC and quasi-drugs quality at Kenvue (formally J&J Consumer Health).

Emily Cheah (Senior Managing Director of Charles River Laboratories)

Emily Cheah

Senior Managing Director of Charles River Laboratories

A pharmacist by training, Emily is currently Senior Managing Director of Charles River Laboratories Singapore (Microbial Solutions) and APAC Technical Operations Lead. Emily oversees the APAC laboratory operations, as well as site operations including R&D / Centre of Excellence, and market development operations. She oversees technical programme roll outs in APAC and is involved in the evaluation and implementation of new technology & services within the Microbial Solutions division and serves on various committees within the company.

She received her Ph.D. (Pharm. Technology) from the National University of Singapore and her EMBA from INSEAD.

Emily is one of the founding members of the PDA Singapore Chapter and has served as a Board Member in various capacities since its inception in 2013. Emily is the current President of PDA Singapore Chapter.

Juhong Liu (President at GlobalSubmissions Consulting, LLC)

Juhong Liu

President at GlobalSubmissions Consulting, LLC

Dr. Juhong Liu received his Ph.D. in Biochemistry and Molecular Biology in 1995 and trained as a cancer biologist at the US National Cancer Institute. He joined the US FDA, Office of Biotechnology Products (OBP) in 2008. Serving as CMC reviewer, Team Leader, and Review Chief, he managed CMC reviews of over 50 licensed biologics and over 300 biologics under IND. In 2018, Dr. Liu funded GlobalSubmissions Consulting firm. He focused on helping biotechnology companies to bring their products to global market. He successfully advanced Evive biotechnology’s Ryzneuta to obtain FDA, EMA, and NMPA approval in 2023.

Ditte Kivsmose Kaldor (Quality Director, PS Aseptic Manufacturing QA of Novo Nordisk)

Ditte Kivsmose Kaldor

Quality Director, PS Aseptic Manufacturing QA of Novo Nordisk

As a leader in Novo Nordisk, I am passionate about collaboration towards good solutions for employees and for the business. We ensure that people who rely on our products can feel safe – by making decisions based on regulatory requirements, business needs and patient safety. We work for a future where the lives of people with chronic diseases are not limited by their condition.

With over 20 years of experience in the industry, I have a broad understanding of the requirements for production of aseptic drug product and active pharmaceutical ingredients, produced in a controlled and classified area. I have experience from different roles in production, quality assurance (QA) and manufacturing science and technology (MSAT). My background is environmental and analytical chemistry.

Michael de la Torre (CEO of Redica Systems)

Michael de la Torre

CEO of Redica Systems

Michael, the founder and CEO of Redica Systems, is a data analyst at heart. Michael is leading
the way in applying advanced analytics and AI to regulatory and vendor intelligence. He began
his career at McKinsey & Company, and has held executive roles in Product Management,
Marketing, and Business Development. Michael received his Bachelors in International Finance
from Texas A&M University and his MBA from University of Chicago Booth School of Business.

Niraj Mehta (Executive Director and Global Quality Lead, Strategic Programs and Regulatory Intelligence of MSD)

Niraj Mehta

Executive Director and Global Quality Lead, Strategic Programs and Regulatory Intelligence of MSD
Taehoon Kim (Johnson & Johnson)

Taehoon Kim

Johnson & Johnson

Taehoon has been with Johnson & Johnson Innovative Medicine and excels in aseptic manufacturing process. As a manufacturing process specialist in operations, he participates in aseptic operations as a filling operator, played a key role in newly establishing the RABs setup/intervention procedure, and contributes to the site's sterility assurance team to achieve a high level of contamination control.

Haneul Jie (Johnson & Johnson)

Haneul Jie

Johnson & Johnson

Haneul is the subject matter expert of Lab Equipment Lifecycle Management including Analytical Instrument Qualification at J&J Innovative Medicine. In addition to the execution of qualification and CSV of lab instruments, she has led multiple cross-functional projects with focuses on introducing new technologies and digitalization solutions to the QC laboratory, contributing to achieving the highest level of data integrity and risk control.

Jaehee Kim (Johnson & Johnson)

Jaehee Kim

Johnson & Johnson

Jaehee has been with Johnson & Johnson Innovative Medicine and has expertise in aseptic process simulation. As an engineer in Manufacturing Science and Technology, she led initial validation of aseptic process, participated in risk assessment of the filling process, and contributed to the development of technical solutions to achieve a higher level of controls in aseptic processing as part of mitigation efforts to obtain FDA approval.

Enrico Barichello (Product Manager at Stevanato Group)

Enrico Barichello

Product Manager at Stevanato Group

With a background in Industrial Engineering and a Master’s in Management at the University of Padua, Enrico Barichello acquired broad-spectrum skills in technical concepts and complex processes. He joined Stevanato Group in 2017 as a Product Management Specialist for syringe platform. He defined and coordinated all the activities required to bring the products to market, bridging gaps between different company functions and aligning the involved teams. From January 2021, he is the product owner, responsible for the roadmap and execution of the new innovative platform SG Alba®.

Gabriel Gori (Invited) (Chair, Science Advisory Board at Parenteral Drug Association)

Gabriel Gori (Invited)

Chair, Science Advisory Board at Parenteral Drug Association

Gabriele Gori has been in the sterile Pharmaceutical/Vaccine/Medical Device business since 1994 – in different local and global roles in multinational companies, including, Bausch & Lomb, Chiron, Novartis, GlaxoSmithKline, Thermo Fisher Scientific, Zambon and Biogen. His experience covers R&D, Engineering, Validation, Quality Control, Quality Assurance, GXP Compliance and Auditing, Quality Operations and includes senior roles e.g. Global Head of Quality for Zambon and Biogen, and the leading of teams of more than 500 associates located in multiple countries across the globe. Currently Gabriele is providing support to the Pharma and Medical Device industry as a consultant. Sterility Assurance and GMP Compliance expert, Gabriele is currently the Chair of the Science Advisory Board (SAB) of the Parenteral Drug Association (PDA): invited speaker in international conferences and workshops on topics dealing with Aseptic Processing, Quality Systems and GMP Compliance, he also provided training to inspectors of European National Health Authorities. He has been further supporting the Industry concerning the review and commenting of the revised EU GMP Annex 1 by co-chairing a dedicated PDA Subject Matter Expert team. Gabriele holds a bachelor in Chemistry (University of Florence – Italy) and a master in Quality Management (University of Pisa/Consorzio Qualital – Italy).

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Alan Hoffmeister

Senior Global Scientific Portfolio Specialist at Charles River Laboratories

Alan Hoffmeister is the Senior Global Scientific Portfolio Specialist for Charles River, Microbial Solutions Division, specialising in the Bacterial Endotoxins Test. Alan’s experience with the Bacterial Endotoxins Test (BET) dates to 1988, since when he has been actively involved in all aspects of the assay. Alan has directed workshops and training courses and lectured internationally on a variety of BET topics including, amongst others, LAL Methodologies, Product Validations, Interference Matrices, Data Integrity and BET Regulatory Affairs. He has also contributed to the development of BET protocols, technical guides and fact sheets internally as well as for clients and industry organisations.

James Agalloco (Invited) (President at Agalloco & Associates)

James Agalloco (Invited)

President at Agalloco & Associates

James Agalloco is President of Agalloco & Associates, a technical service firm to the pharmaceutical and biotechnology industry. Since the formation of Agalloco & Associates in 1991, Jim has assisted more than 200 health care firms in a wide range of validation, automation, and compliance areas. Jim has 50+ years of industry experience and has worked in organic synthesis, pharmaceutical formulation, pharmaceutical production, project and process engineering, validation, and process automation during his career at Merck, Pfizer, Squibb, and Bristol-Myers Squibb. He received his BS in Chemical Engineering from Pratt Institute in 1968 and his MS, also in Chemical Engineering from Polytechnic Institute of New York in 1979. He received his MBA in Pharmaceutical Studies from Fairleigh Dickinson University in 1983. He is a past President of the Parenteral Drug Association and served as an Officer or Director from 1982 to 1993. He was a member of USP’s Microbiology Expert Committee from 2005-2022. Jim serves on the scientific advisory boards of MEDInstill and Eniware. He is a frequent author and lecturer on the subjects of sterilization, aseptic processing, and process validation.

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Kir Henrici (Invited)

The Henrici Group
Steve Langille (Senior Microbiology Consultant at Valsource)

Steve Langille

Senior Microbiology Consultant at Valsource

Dr. Stephen Langille is a Senior Microbiology Consultant at ValSource, Inc. He specializes in microbiological and particulate matter contamination control of drug, device, and biological products. He holds a BS degree in Biology from the University of Massachusetts and a PhDin Microbiology from the University of Maryland. Prior to joining ValSource in 2019, he spent 19 years with the FDA as a Microbiology Reviewer, Branch Chief, and Director of the Division of Microbiology Assessment in the Center for Drug Evaluation and Research. He currently serves as a member of the United States Pharmacopoeia’s Visual Inspection Expert Panel and serves on several PDA task forces related to microbiological product quality.

Sebastian Scheler (Managing Director of Innerspace GmbH)

Sebastian Scheler

Managing Director of Innerspace GmbH

Sebastian is passionate about pushing the boundaries of advanced risk assessment technologies and Virtual Reality (VR) to unlock new possibilities for managing risks in highly critical environments. He spearheads a dynamic team of visionary professionals, driving the development of high-end Virtual Reality simulators and advanced risk assessment methodologies. The core focus of his professional work lies in Frame-by-Frame Risk Profiling—an innovative, automated approach to risk assessment. This cutting-edge technology facilitates process improvement, process automation, autogenerated SOPs, and immersive training curricula, empowering organizations to achieve unparalleled levels of efficiency, compliance and safety in drug manufacturing. With a profound background in psychology, he has always been captivated by the intersection of human behavior and technology. His passion for Virtual Reality has culminated in pioneering VR simulator methodologies that push the boundaries of experiential learning, training, and behavior measurement systems.