This session will focus on the attractiveness of developing and obtaining marketing approval of pharmaceutical products in Japan from regulatory and industry perspectives, aiming to get rid of old-fashioned ideas and views about Japan.
Learning Objectives
Discuss outdated misconceptions and “urban legends” about Japan when considering Research and Development (R&D) on new medicines in Japan; Examine the attractiveness of performing R&D in Japan, both from regulatory and industrial perspectives: attractive market, flexibility/predictability, designation for each product characters; Analyze the Roles and Prospects of the PMDA’s Overseas Offices.
Director, Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Daisuke Koga is the Director of the Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. He started his career in 1996 at the Ministry of Health and Welfare of Japan. He worked in the Ministry on drugs, medical devices, food... Read More →
Division Director, Division of Planning and Management, Office of International, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
2024-present Division Director, Division of Planning and Management, Office of International Strategy and Planning, PMDA 2019-2024 Deputy Review Director, Office of Cellular and Tissue-based Products, PMDA 2015-2019 Senior Reviewer, Office of pharmacovigilance II, PMDA 2013-2015 Section... Read More →
Executive Vice President Data Business, CMIC Co., Ltd, Japan
Eri Sekine is Executive Vice President of CMIC Co., Ltd. and in charge of Data Business which includes CDM, Biostatistics, Statistical Analysis, Pharmacovigilance, Outsourcing, Quality Management and Dx Strategy. Eri Sekine has over 30 years' experience in various functions in clinical... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT 147ABWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
In this forum, leaders from ANVISA will provide an update on regulatory priorities for Brazil, and inform about local trends, regulatory convergence, and collaboration initiatives. The discussion will also invite questions of general interest from the audience.
Learning Objectives
Describe ANVISA’s regulatory initiatives and strategic priorities; Discuss regulatory convergence of Brazilian regulations for medicines and medical devices to international guidelines and standards; Identify trends and opportunities for engagement with the Brazilian regulator
Pharmacist. At Anvisa, serving as General Manager of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs, and Advanced Therapy Products.
Bachelor's degree in Pharmaceutical Sciences with Clinical and Industrial qualification. Master's degree in Health Science. Professional experience as a pharmacist at the Ministry of Health in Brazil. Since 2014, working as a CMC reviewer at the National Health Surveillance Agency... Read More →
Advisor to the International Affairs Office at the Brazilian Health Regulatory Agency (Anvisa). Specialist in Health Regulation and Constitutional Law, with extensive experience in health regulation and enforcement, as well as in bilateral and multilateral negotiations, international... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT 145ABWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Turnover in the clinical research industry hovers at 27%. Given the high stress, high turnover nature of the industry, the need for stress reduction tools is critical. In this session you will learn techniques to implement for yourself and teams.
Learning Objectives
Identify a simple way to immediately reduce stress in less than 2 minutes; Practice a technique to increase energy, clarity and decision making; Complete a guided non-sleep deep rest practice to calm, soothe and restore.
Founder, CEO, Clinical Research Pro, United States
Jess Thompson brings over 15 years of clinical research experience across labs, sites, CROs, and pharma. She founded Clinical Research Pro to empower professionals through education, development, and career growth. Under her leadership, Clinical Research Pro fosters a supportive community... Read More →
Executive Vice President, SOGLIA, SOGLIA - Entrada Ventures Group, United States
Leanne is the EVP at Soglia. As a Patient Experience Organization, or PXO, we are driven to reimagine the way patients interact with pharmaceutical companies throughout their treatment journey. With over 25 years of experience in clinical research and coaching, Leanne brings a unique... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT 206Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
This session will review the 2024 revision of the Declaration of Helsinki, one of the foundational codes of clinical research ethics, and the rationale and practical implications of the changes made in the current version.
Learning Objectives
Discuss the history of the Declaration of Helsinki and its relevance and importance for the healthcare industry; Recognize the changes made in the 2024 version and how they will impact the conduct of biopharma clinical trials; Discuss multi-stakeholder efforts that are working towards operationalizing ethical principles in the DOH and where more collaboration and alignment is needed.
Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States
Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →
Director, Global Bioethics and Technology Ethics Lead, Takeda, United States
I am a Bioethicist by training with more than 20 years’ experience in industry across various global roles in Research and Development and Pre-competitive Industry Collaborations. I have a passion for evolving and implementing ethical frameworks to address emerging tensions at the... Read More →
Director, Office of Clinical Policy, FDA, United States
Ann Meeker-O’Connell is the Director of FDA’s Office of Clinical Policy in the Office of the Commissioner. In this role, she leads an organization that develops and implements cross-cutting policy related to clinical development and research ethics. Ms. Meeker-O’Connell has... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT 204ABCWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Tufts CSDD and DIA collaborated on a research study with a working group of 16 biopharmaceutical companies and CROs examining the current use of artificial intelligence (AI) and machine learning (ML) to support clinical research.
Learning Objectives
Describe the level of adoption of artificial intelligence (AI) and machine learning (ML) across biopharmaceutical companies and contract research organizations and the top activities where AI/ML is being implemented and utilized; Discuss the impact of AI/ ML on time savings, investment, and deployment of organizational resources.
Chair
Mary Jo Lamberti, PhD, MA
Speaker
Panelist Mukul Virmani, Esq, MS
Use Case Examples within Clinical Development Emily Carter, MBA
Director, Data Science & Analytics, AbbVie, United States
Emily leads the Data Science & Analytics Trial Execution teams in R&D at AbbVie. Her teams’ focus is on enhancing the efficiency and quality of end-to-end trial execution through comprehensive data analysis and insights across RBQM, Feasibility & RWD, Medical & Safety, Trial Diversity... Read More →
Director of Sponsored Research, Research Associate Professor, Tufts Center for the Study of Drug Development, United States
Mary Jo Lamberti is on the faculty at Tufts University and is Director of Sponsored Research at Tufts Center for the Study of Drug Development (CSDD). She is a global expert on benchmarking drug development operating practices. Her research focuses on a variety of areas including... Read More →
Luciana Petcu is a Senior Manager in Takeda’s Emerging Priorities & Innovation (EP&I) team within the R&D Global Development organization. She leads cross-functional initiatives that drive innovation, operational excellence, and cultural transformation in clinical trial operations... Read More →
Director, Clinical Data Science, AI Research Center, Gilead, United States
Strategic and visionary leader with over a decade of experience driving innovation in clinical data science, AI/ML analytics, and operational excellence within global pharmaceutical and CRO settings. Demonstrated expertise in managing high-performing teams, delivering transformational... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT 207BWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Representatives from pediatric cluster health authorities will describe the common deficiencies they see in global pediatric development programs and describe best practices and what to expect for those companies that seek a common commentary.
Learning Objectives
Describe common deficiencies in global pediatric development plans; Explain the process for obtaining a common commentary; Recognize topics that are discussed at monthly pediatric cluster calls.
Director, Office of Pediatric Therapeutics, FDA, United States
Dr. Dionna J. Green is Director of the US Food and Drug Administration Office of Pediatric Therapeutics, a congressionally mandated office whose mission is to assure access for children to innovative, safe, and effective medical products. She leads an organization responsible for... Read More →
Chief Medical Adviser, Australia Health Products Regulation Group, Australia
Professor Langham is the Chief Medical Adviser of the Therapeutic Goods Administration, the therapeutic goods regulator in Australia. A nephrologist by training, Prof Langham has spent much of their career as a clinician researcher, in translational studies and drug development.
Scientific Officer, Paediatric Medicines Office, European Medicines Agency, Netherlands
Franca Ligas serves as a Scientific Officer at the Paediatric Medicines Office of the European Medicines Agency (EMA), overseeing Paediatric Investigation Plans, particularly in oncology. Since 2021, she has led the Paediatric cluster from the EMA's side. Franca holds a medical degree... Read More →
Director, Regulatory Affairs (Global Regulatory Lead, Oncology Early Development, AbbVie, United States
Melodi J. McNeil, R.Ph., M.S. Ms. McNeil is currently a Director in AbbVie’s Rockville, Maryland Regulatory Policy and Intelligence office. She identifies, assesses, and comments on proposed regulatory policies, and ensures appropriate AbbVie personnel are aware of emerging and... Read More →
Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as... Read More →
Head of Translational Sciences Office, European Medicines Agency, Netherlands
Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. Throughout her career, she has worked in multinational and multicultural environments... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT 209ABCWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
In this forum, speakers from the National Medical Products Administration (NMPA) , academia and industry will present the progress in drug regulation, review China's biopharma innovation in the past decade, and discuss accelerating innovative drug approvals in China. Attendees will have an opportunity to discuss the issues related to drug development with NMPA officials, clinical researcher and industry executive.
Learning Objectives
Describe the latest information on the National Medical Products Administration’s activities in drug regulation; Describe the trend in biopharma innovation in the past decade; Discuss the strategies for accelerating innovative drug development and approval in China.
Chair
Ling Su, PhD
Speaker
Brief Introduction from the NMPA Feng Zhu
The Progress of China's Drug Review and Approval Reform Jianwu Zhang, PhD
Accelerating the Development and Approval of Innovative Drugs in China: Industry's Perspective Wei Zhang
The Past Decade of China's Biopharma Innovation Xiaoyuan Chen, PhD
Researcher Chen Xiaoyuan graduated with a bachelor's degree in clinical medicine in 1996 and a master's degree in clinical pharmacology in 2002. In 2010, he received a doctorate in pharmacology from Shanghai Jiaotong University. In 2002, he joined the drug evaluation center of the... Read More →
Research Fellow, Shenyang Pharmaceutical University, Yeehong Business School, China
Dr. Ling Su is a Research Fellow in Shengyang Pharmaceutical University Yeehong Business School and a Venture Partner in Lilly Asia Ventures (LAV). He has 30 years of experience in drug regulatory and development. He had worked in various R&D management positions in the pharma industry... Read More →
This session outlines an approach to developing technical experts into global leaders by breaking the "expert trap" and aligning talent development with organizational growth strategy.
Learning Objectives
Identify strategies for breaking the "expert trap" and enhancing career growth for technical talent; Recognize how to align talent development with organizational growth through strategic initiatives; Identify methods to cultivate a diverse leadership pipeline in life sciences.
Science Exchange, CEO and Co-Founder, United States
Elizabeth Iorns, Ph.D., is the CEO and co-founder of Science Exchange. Science Exchange accelerates scientific discovery by enabling instant connections to the world’s best R&D facilities through a marketplace of pre-qualified and pre-contracted scientific service providers. Science... Read More →
Corporate Strategy, Astellas Pharma, United States
Amber Meriwether is a global leader with 20+ years in healthcare, driving initiatives that accelerate innovation and deliver measurable impact. As Director of Corporate Strategy at Astellas Pharma, she leads cross-functional teams to develop strategic capabilities and deliver key... Read More →
Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States
Michael Torok, Ph.D. is the Global Head of Quality Assurance Programs at Genentech/Roche. He is energized and driven by the mission of positioning Quality to be an accelerant in developing new therapeutics, rather than a guardrail or "policemen". To enable this shift, cross-functional... Read More →
The ability to find, access, understand, and apply healthcare-related information (health literacy) plays a large role in global health outcomes. This session reviews health literacy and strategies to increase health literacy in a digital age.
Learning Objectives
Discuss the basics of health literacy and how they relate to health outcomes; Explain ways to apply new strategies for communicating healthcare information to a broad audience with a range of health literacy levels; Utilize digital tools to achieve strategic goals around healthcare information dissemination.
Founder and Principal, Apath Nexus Consulting, United States
Founder of Apath Nexus, Lindsay provides strategic regulatory guidance and intelligence to support innovation and compliance with FDA and select international frameworks. He has worked with pharmaceutical and biotechnology companies, patient groups, and trade associations to align... Read More →
Associate Director, Development Unit Lead, Patient Centricity and Engagement, Biogen, Inc., United States
Anna Osinski is an Associate Director, Development Unit Lead in Biogen’s Patient Centricity and Engagement team. Anna has more than 17 years of experience in clinical trial recruitment and currently oversees patient engagement strategy for trials in Movement Disorders, MS & Immunology... Read More →
Principal Medical Writer and Consultant, Whitsell Innovations, Inc., United States
Chantelle holds a PhD in Medical and Molecular Genetics from Oregon Health & Science University and completed postdoctoral training at the University of North Carolina (UNC) at Chapel Hill prior to transitioning into a medical writer role at Whitsell Innovations, Inc. (WI), where... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT 151AWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Regulatory decisions are often a widely discussed topic, but have you considered how a breadth of experience in the career journeys of regulators positively influences decision making within regulatory bodies? Join us to hear from our panel about the impact of their varied career paths in the critical work that they do. This is your opportunity to hear directly from regulators from the UK, Canada & Brazil about what they do, how they got there and what they have experienced and learnt along the way!
Learning Objectives
Recognize how breadth of experience within regulators supports medicines development for patients and society; Identify how skills developed in one sector (e.g., industry, academia, healthcare) can contribute to the skills needed in another (e.g., regulators).
Chair
Paula Walker, MA
Speaker
Panelist Marcelo Moreira, MS
ANVISA Career Pathway: Impact to Medicines Development Bianca Zimon, LLM
MHRA Career Pathway: Impact to Medicines Development Mandy Kaur Budwal-Jagait, MSc
Head of GCP, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Mandy Budwal-Jagait is the Head of GCP and Lead Senior GCP inspector with the MHRA. She joined the Agency in April 2014 as a GCP Inspector and became GPvP Operations Manager in 2020, responsible for the Pharmacovigilance Inspection programme. In 2022, Mandy became the Head of GCP... Read More →
Global Head of Risk Based Quality Management, Roche Products Ltd., United Kingdom
Paula is the Global Head of RBQM at Roche, having started with the company with a Quality Policy focus. Formerly Head of Compliance (GCP/PV/GLP) at the MHRA and Acting Head of Inspectorate, having started in 2009 as a GCP Inspector; spending 13.5 years at the Regulator. Paula has... Read More →
Advisor to the International Affairs Office at the Brazilian Health Regulatory Agency (Anvisa). Specialist in Health Regulation and Constitutional Law, with extensive experience in health regulation and enforcement, as well as in bilateral and multilateral negotiations, international... Read More →
Pharmacist. At Anvisa, serving as General Manager of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs, and Advanced Therapy Products.
Tuesday June 17, 2025 4:00pm - 5:00pm EDT 206Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
This session will present two contrasting approaches to workforce development which address the challenges in attracting and retaining the ideal talent. First, what can pharma learn from other industries who have developed a remote, agile and on-demand talent base responsive to changing needs. Second a case study in meeting the challenge of extraordinary growth in product pipeline and expansion by implementing an integrated, multi-faceted, workforce development ecosystem in collaboration with academic institutions and other manufacturing companies that also builds and sustains the local economy.
Learning Objectives
Discuss how to maximize agility and attract the best talent to get the critical work of drug development and manufacturing done; Identify novel approaches to developing and retaining a skilled workforce capable of meeting the needs of a highly regulated industry; Recognize how the organization can achieve unprecedented agility by embracing the Future of Work tools and methodologies.
Chair
Denyse Baker, RAC
Speaker
Far Beyond Remote Work: NASA, The Ford Motor Company, and The New World of Work - Opportunities for Pharma Sheila Mahoney Jewels, MBA
Transforming Talent: Leveraging Partnerships for Biopharma Success Dedric Day
Assoc. Vice President Global Quality Compliance, Eli Lilly and Company, United States
Denyse Baker is Associate Vice President of Global Quality Compliance with Lilly. She has more than 35 years of experience in the pharmaceutical industry including leadership roles with AstraZeneca, US FDA and PDA. Denyse’s expertise includes policy development, external engagement... Read More →
Senior Director- Strategic Talent Partnerships, Eli Lilly and Company, United States
Dedric Day has worked at Eli Lilly and Company for 22 years since graduating with a bachelor’s degree in chemical engineering from Rose-Hulman Institute of Technology. He has held leadership roles in engineering, operations, and technical services/manufacturing sciences in manufacturing... Read More →
Drug Development Multi-Functionalist, LifeSciHub , United States
Life sciences R&D Ecosystem Expert, Independent Small Business and Workforce Advocate, Software Platform Developer and Investor. Focus areas include: Regulatory and Clinical Operations, Strategic Patient Engagement, CMC, Real World Evidence, Pharmacovigilance, and Biometrics, Medical... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT 201Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
