2023 Annual Report - D.K. Kim International Center for Regulatory Science, USC Mann School

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Contents 3 4 5 6 6 7 7 8 9 10

Foreword A Message from the Director Advisory Committee Cluster Activities Regulatory Innovation Laboratory Connections Capacity Building Consulting 2023 by the Numbers 2023 Highlights

Kim Center Staff

Affiliated Faculty

Lawrence Liberti, PhD, BPharm, RAC Director liberti@usc.edu

Susan Bain, DRSc Terry David Church, DRSc Chiaoyun (Benson) Kuo, PhD Nancy Pire-Smerkanich, DRSc

Eunjoo Pacifici, PharmD, PhD Associate Director epacific@usc.edu

Affiliated Staff Karen Manrique, MS Araksi L. Terteryan, MPH Gordon D. Wimpress

Apurva Uniyal, MA, MS Regulatory Innovation Research Scientist uniyal@usc.edu Deborah Schroyer Program Specialist schroyer@usc.edu

About the Kim Center The D.K. Kim International Center for Regulatory Science, part of the USC Mann School of Pharmacy and Pharmaceutical Sciences, is an academic and research institution focused on educating individuals with a scientific background in international regulatory science. The center aims to meet the growing demand for professionals equipped to navigate global regulatory processes. Through transformative education and research, it seeks to contribute to a healthier and safer world by emphasizing the crucial role of regulatory science in shaping global health outcomes. The center engages in open and accessible initiatives tailored to foster collaboration among our faculty and external institutions.

Foreword As we launch the inaugural Annual Report for the D.K. Kim International Center for Regulatory Science, I want to extend my appreciation to Dr. Frances Richmond for her exceptional leadership.

Over her 45-year career, Dr. Richmond has made enduring contributions to academia, research, and therapeutic advancement. Recognizing her remarkable legacy, I am delighted to announce Dr. Richmond’s new title as Professor Emeritus of Regulatory and Quality Sciences, a fitting tribute to her profound influence on our program and the broader academic community.

Eunjoo Pacifici PharmD, PhD Chair and Associate Professor, Department of Regulatory and Quality Sciences Associate Director, D.K. Kim International Center for Regulatory Science

As we bid farewell to one remarkable leader, we are pleased to introduce another. Dr. Larry Liberti, the new Director of the Kim Center and Associate Professor of Regulatory and Quality Sciences, brings a wealth of experience from both academia and industry, with a focus on international regulatory policies. Having previously led the Centre for Innovation in Regulatory Science (CIRS) in London, Dr. Liberti’s distinguished career includes collaborative projects with regulatory authorities worldwide, underscoring his deep understanding of global regulatory frameworks. His appointment as director will expand our Center’s international footprint and enhance student engagement in regulatory policies on a global scale.

We extend our appreciation to Dr. Richmond for her exemplary leadership and offer a warm welcome to Dr. Liberti as the newest member of our Regulatory Science family. Together, we look forward to a future marked by continued growth, innovation, and collaboration.

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A Message from the Director When I entered the pharmaceutical industry in 1978, much like today, the regulatory department served as the hub of the company’s wheel. The regulatory department saw the “big picture,” linking and guiding preclinical and clinical development with manufacturing and ultimately, the global regulatory strategies to ensure medicine availability. While regulators and regulatory departments continue to play their critical roles, what sets today apart is our formal recognition of the importance of the science that for decades has guided these collaborative activities – the emergence of the field of regulatory science.

Lawrence Liberti PhD, BPharm, RAC Director, D.K. Kim International Center for Regulatory Science Associate Professor, Department of Regulatory and Quality Sciences

It is now a given that having a robust medicine and device regulatory system is the basis for equitable, quality healthcare.

The World Health Organization has observed that effective regulatory systems are an essential component of health system strengthening and contribute to better public health outcomes, that regulators are an essential part of the health workforce, and that inefficient regulatory systems themselves can be a barrier to access to safe, effective, and quality medical products.

Therefore, it is through the practical application of regulatory science that the D.K. Kim International Center for Regulatory Science contributes to this goal of regulatory system strengthening.

The Kim Center brings a unique blend of academic research, practical experience, and global reach. Building on the legacy of the Kim Center’s founder, Dr. Frances Richmond, we are well-positioned to continue the mission to apply regulatory science to regulatory and health solutions around the world. The Kim Center’s activities are organized into four “clusters,” described in detail in this Annual Report. Each cluster is designed to optimize our approach to researching, implementing, and communicating how regulatory science informs best practices for regulators and developers alike. The Kim Center provides state-of-the-art educational opportunities and creative, research-based global solutions to catalyze the development and regulation of novel therapeutics and devices.

I am honored to lead the Kim Center as we build on the deep relationships forged with regulators, academics and developers around the globe.

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Advisory Committee The Kim Center benefits from the insights and support of a panel of advisors composed of senior experts from academia, pharmaceutical companies, and government regulatory agencies.

Our Mission To apply regulatory science to regulatory and health solutions globally

Lawrence Liberti Director, D.K. Kim International Center Virginia (Ginny) Acha Associate Vice President, Global Regulatory Policy, Merck Mario Alanis Advisor, Latin American Regulatory Policy Virginia (Ginny) Beakes-Read Head, Global Regulatory Policy and Intelligence, The Janssen Pharmaceutical Companies of Johnson & Johnson Marieke DeBruin Scientific Director, Utrecht Collaborating Centre for Pharmaceutical Policy and Regulation, Utrecht University Ken Getz Executive Director and Research Professor, Tufts Center for the Study of Drug Development (CSDD) Camilla Horta Gomes Regulatory Policy Lead, Latin America, Roche Pharma Melissa Hunt Director, Health Canada Star Khoza Associate Professor, University of the Western Cape Eui-Kyung Lee Professor, SungKyunKwan University (SKKU)

Michelle Limoli Associate Director for International Affairs, U.S. Food and Drug Administration (FDA) Brian O’Rourke Advisor, O’Rourke Healthcare Consulting Inc. John Skerritt Professor, University of Melbourne, Australia, formerly Therapeutic Goods Administration (TGA) Patricia Tagliari Associate Director, Brazilian Health Regulatory Agency (ANVISA) Steffen Thirstrup Chief Medical Officer, European Medicines Agency (EMA) Kim Trautman Advisor, Medical Device Regulation and Policy Stuart Walker Founder, Center for Innovation in Regulatory Science (CIRS)

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Activity Clusters In order to optimize the use of our resources and to work towards the goal of informing regulatory best practices, the Kim Center’s activities are organized into four “clusters.”

Each is designed to optimize our approaches to researching, implementing and communicating how regulatory science informs best practices for regulators and developers alike.

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3 Regulatory Innovation Laboratory

Capacity Building

2 Connections

4 Consulting

Cluster Activities

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Regulatory Innovation Laboratory

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The Regulatory Innovation Laboratory cluster at the Kim Center is the nucleus of innovative research, utilizing data science and collaboration with USC graduate students, faculty, and Library/ Information Services to drive advances in regulatory science. The Laboratory identifies and anticipates trends, providing crucial insights that directly influence the goals of the Capacity Building and Connections Clusters.

Doctoral Dissertations Student Capstones Regulatory Science Research Team (SC CTSI) FRPath ® Projects Regulatory Science Fellowships

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Connections

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This cluster highlights the imperative for research at the Kim Center to go beyond internal boundaries, contributing to the global regulatory knowledge system, strengthening regulatory systems, and showcasing the Center’s work. The overarching goal is to widely disseminate insights, making them accessible to the global regulatory community thereby fostering additional research and collaborations.

Cluster activities include peer-reviewed publications, posters and lectures, local forums, and academic relationships.

Capacity Building The Kim Center, building on the research from the Regulatory Innovation Laboratory, provides practical programs such as training, symposia, and regulatory system strengthening initiatives.

It emphasizes the practical application of data derived from the Laboratory and conducts international outreach programs, with a focus on supporting regulators in low- and middle-income countries through capacity-building initiatives.

Cluster activities include agency outreach, USCAsia Pacific Economic Cooperation (APEC) training, and Southern California Clinical and Translational Science Institute (CTSI).

Academic Relationships Regulatory Interactions

Asia Taiwan

National Taiwan University Student Exchange and Collaborative Training

Asia

Taipei Medical University Embedded Graduate Program

National Cheng Kung University Embedded Graduate Program

South Korea

Sungkyunkwan University Student Exchange and Collaborative Training

Taiwan FDA DRSc Asia Course

Africa

Ewha Womans University Student Exchange and Collaborative Training

Yonsei University Student Exchange and Collaborative Training

South African Regulatory Authority Training Support

APEC Embedded Graduate Program

Pharmaceuticals and Medical Devices Agency DRSc Asia Course

South America

Brazilian Health Regulatory Agency (Anvisa) Training Support

Pan American Health Organization Regulatory System Strengthening

Japan

China

Other Organizations

China Pharmaceutical University Student Exchange and Collaborative Training

Shenyang Pharmaceutical University Student Exchange and Collaborative Training

Hiroshima University Collaborative GMP Training

South America Colombia

Universidad del Atlántico Academic and Cultural Interchange

Americas Rise for Health Educational Support

Regulatory Affairs Professionals Society Collaborative Research

Bill & Melinda Gates Foundation Regulatory System Strengthening

Abiquifia Academic Link

Centre for Innovation in Regulatory Science Collaborative Resarch

Brazil

Universidad del Magdalena Academic and Cultural Interchange

FIOCRUZ Collaborative Educational Programs

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4 Consulting The Kim Center offers tailored learning experiences for students and fellows through the Translational Regulatory Consulting Center.

Students engage in industry-sponsored real-world projects via the Department of Regulatory and Quality Science’s TeamBased Regulatory and Quality Solutions program.

Additionally, the Center addresses the complex requirements of medicine and device regulators via the Regulator’s Solution Center.

Consulting Cluster Continuum From Ideation to Regulation Translational Regulatory Consulting Center

Team-Based Regulatory and Quality Solutions

Regulator’s Solution Center

Supporting academic investigators and small innovative initiatives

Tackling real-world cooperative projects sponsored by the industry

Addressing the research needs of medicine and device regulators

• Students enrolled in a master’s, PharmD or DRSc program

• Interdisciplinary team of students

• Students enrolled in a master’s, PharmD or DRSc program

• Regulatory support: ° Investigational new drug for drugs and biologics ° Study protocols ° Medical device premarket notification ° Medical device quality System ° 510 k Submissions ° Orphan drug designation ° Repurposed drugs • Faculty with new grants

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• Regulatory strategy for product licensure • Clinical research and commercialization strategies • Market launch strategy • Competitive analysis andreimbursement strategy • Quality system gap analysis validation master plans and protocols

• Tailored solutions to address: ° Capacity building ° Regulatory system assessment and strengthening ° Process optimization ° Related research themes ° Training program to integrate scientific advice into development ° Educational support ° Collaborative research

2023

BY THE Numbers In 2023 the Kim Center continued its mission through its local and global activities.

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Conferences

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Regulatory Solution Center Consultations

Translational Regulatory Center Consultations

FIFTEEN Global Touchpoints

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Selected Presentations Translational Science 2023, Association for Clinical and Translational Science (ACTS), Washington, D.C. – April 18-20, 2023 Baltazar S, Pacifici E. “Examining the Landscape of Clinical Trials Targeting Alcohol or Opioid Use Among Homeless Individuals” Crovetto A, Church T. “Hindering Generic Antiretroviral Treatment Competition for Human Immunodeficiency Virus: Anti-Competitive Agreements and HIV Disease Management Concerns in Los Angeles Sample” Davies C, Terteryan R, Church T. “A Mixed Methods Review of Endpoint Measures Utilized in Adult ADHD Medication Clinical Trial Design” Lee J, Church T. “Transgender Inclusion: Language of Recruitment in PrEP Clinical Trials” Riggs G, Church T. “Disposable Electronic Nicotine Delivery Systems (ENDS) and Underage Nicotine Addiction: A Survey of College Students (2020 – 2023)” Wu W, Pacifici E. “An Investigation on the Activity of Repurposing Already Marketed Drugs for New Indications from 2015 to 2021” USC Institute for Addiction Science (IAS) Early Career Addiction Science Showcase, Los Angeles – April 25, 2023 Riggs G, Church T. “Disposable Electronic Nicotine Delivery Systems (ENDS) and Underage Nicotine Addiction: A Survey of College Students” Drug Information Association (DIA) Global Annual Meeting 2023, Boston – June 25-29, 2023 Kim J, Pire-Smerkanich N. “Analysis of Quality of Life Patient- Reported Outcomes in Clinical Trials for Parkinson’s Disease from 2010-2021” Liberti L et al. “Maximizing the Impact of Regional Regulatory Initiatives: An Analysis of Process Characteristics from the FRPath® Database” 2023 Asia-Pacific Economic Cooperation (APEC) Good Registration Management Center of Excellence Workshop, Taiwan – September 7-9, 2023 Liberti L. “The Regulatory Competency Framework as a Tool for Lifelong Learning; The Elements of Quality Regulatory Decision Making” Regulatory Affairs Professionals Society (RAPS) Convergence, Canada – October 3, 2023 Bain S. “Career Development Session for Students” Third IFA/ABIQUIFI Seminar (São Paulo, Brazil) – December 5, 2023 Liberti L. “Academic Relationships that Support Pharmaceutical Excellence: The Role of Centers of Excellence” Sixth Biennial Scientific Conference on Medical Products Regulation in Africa, Egypt – December 5-7, 2023

Kim Center Hosted Events

FOUR Publications

Ncube B. “Maximizing the Impact of Regional Regulatory Initiatives in Africa: An Analysis of Process Characteristics of Pathways in the FRPath® Database” Liberti L. et al. “Identifying Opportunities to Align Regulatory Reliance Pathways Across the African Continent: Applying the Novel ARCH (Assessing Reliance for Collaborative Harmonization) Archetype”

Selected Publications Adams, I., Cuff, P. A., & Liberti, L. (2023). A Mixed Methods Study to Explore Relevant Metrics for a Results Framework Measuring the Public Health Impact of Reliance-Based Pathways. Therapeutic innovation & regulatory science, 57(6), 1260–1268.

Church, T. D., Burkhardt, A. M., Phan, T., & Davies, D. L. (2023). Pharmacy undergraduate programs: Development of an adaptive curriculum for student success. Heliyon, 9(2), e13437.

Jiang, S., Liberti, L., & Lebo, D. (2023). Direct-to-Consumer Genetic Testing: A Comprehensive Review. Therapeutic innovation & regulatory science, 57(6), 1190–1198.

Kim, S. T., Pressman, P., Clemens, R., Moore, A., Hamilton, R., & Hayes, A. W. (2023). The absence of genotoxicity of Aloe vera beverages: A review of the literature. Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 174, 113628.

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D.K. Kim International Center for Regulatory Science

Building Bridges | The USC-APEC Center of Excellence and Kim Center Organized and Hosted the “Harmonizing Medical Device Regulation” Workshop on October 1213, 2023.

The workshop featured in-person sessions live- streamed to online attendees. Representatives from 17 institutions and 13 economies attended, with key contributors including Malaysia, South Korea, Chile, and the U.S.

Trailblazing Together || Dr. Susan Bain and Dr. Lawrence Liberti Lead the Student Career Development Session at Regulatory Affairs Professional Society (RAPS) Convergence Conference 2023.

Representing the Department of Regulatory and Quality Sciences and the Kim Center respectively, Drs. Bain and Liberti shared regulatory science education opportunities and career insights with 35 students and professionals at the 2023 RAPS Conference in Montreal, Canada.

Looking Ahead | Strategic Plans for 2024 Unveiled at the December 2023 Regulatory Harmonization Steering Committee Meeting (RHSC) Committee on Trade and Investment (CTI) in Oakland, California.

The committee discussed the potential relocation of the RHSC under the Sub-Committee on Standards and Conformance (SCSC) within the Committee on Trade and Investment (CTI) and making the CTI the oversight body for the RHSC. Apurva Uniyal delivered a presentation at the Medical Device Priority Work Area Steering Committee Preparatory Meeting, and Dr. Liberti presented on the goals and activities of the Kim Center.

Contributing Internationally | Dr. Liberti Shares Insights on Regulatory Science’s Role in Pharmaceutical Innovation in Sao Paolo and Rio de Janeiro, Brazil.

Dr. Liberti spoke at ABIQUIFI about the Kim Center’s approach to practical research in regulatory science and its innovative role in regulatory optimization through his presentation, “How Can Academia Foster GovernmentIndustry Relations for Pharmaceutical Innovation.”

He also visited Oswaldo Cruz Foundation (FIOCRUZ), a leading global public health and science institution in Brazil, to explore educational and research partnerships in regulatory science.

HIGHLIGHTS Elevating Expertise | Dr. Liberti and Dr. Mario Alanis co-moderated the November 2023 episode of the FRPanorama Regulatory Webinar Series.

The webinar episode, “Three Best Practices for the Effective and Efficient Use of Reliance Pathways,” featured specialists from the U.S. National Academy of Sciences, the International Federation of Pharmaceutical Manufacturers Association (IFPMA) and the United States Pharmacopeial Convention (USP).

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Empowering Global Progress | The Kim Center Continues its Dedication to Advancing Regulatory Science and International Collaboration Globally.

Collaborative engagements within Asia-Pacific Economic Cooperation (APEC) drive global exchanges in regulatory science. The Kim Center actively participates in various initiatives within APEC. In September 2023, Dr. Liberti took part in multiple training sessions during the APEC Good Registration Management Workshop in Taipei, Taiwan.

Enhancing Regulatory Capacity through Innovation and Collaboration | The Kim Center Remains Committed to Progress in Healthcare.

The Kim Center’s efforts in improving regulatory capacity are anchored in the provision of agency support, guided by innovative research and data.

In August 2023, the Kim Center welcomed regulatory reviewers from the South African Health Products Regulatory Authority (SAHPRA) to the new USC Capital Campus in Washington, DC. Drs. Liberti, Eunjoo Pacifici, Susan Bain and Mary Ellen Cosenza orchestrated presentations and discussions on topics encompassing fundamental aspects of drug development, translational safety considerations and the latest updates on the regulatory status of in vitro diagnostics and biologics.

Shaping Tomorrow’s Regulatory Landscape | The Kim Center Pioneers the ARCH Archetype for Harmonized Regulatory Reliance at SCoMRA VI in Africa.

The Kim Center’s presence at the 6th Biennial Scientific Conference on Medical Products Regulation in Africa (SCoMRA VI) included a poster, “Identifying Opportunities to Align Regulatory Reliance Pathways Across the African Continent using the ARCH (Assessing Reliance for Collaborative Harmonization) Archetype.”

This approach illustrated regulatory pathway similarities among countries. FRPath® Project collaborator Bakani Ncube provided novel insights into regulatory best practices through an oral presentation, “Maximizing the Impact of Regional Regulatory Initiatives in Africa.”

The work of the Kim Center is made possible by the continued support of the D.K. Kim Foundation.

1540 Alcazar Street Los Angeles, CA 90089 Website | https://mann.usc.edu/departments/regulatory-quality-science-department/dk-kim-center/ © 2024 The D.K. Kim International Center for Regulatory Science

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