Finny Liu is the APAC Regional Regulatory Policy Lead, Product Development Regulatory, at Roche based in Singapore, responsible for leading regional Regulatory Policy activities, developing and executing a regional policy roadmap and associated Roche positions to drive global regulatory convergence in APAC. Previously, she was the Head of APAC International Operations at Roche located in Singapore responsible for Asia Pacific regional management of life-cycle submissions for Roche products to ensure right first-time submissions to Health Authorities during Aug. 2013 to June 2016.

James is in charge of identifying the educational needs for the various stakeholders involved in regulatory affairs in the Asia Pacific region, and establishing education roadmaps, priorities and deliverables. In this role, he actively conducts discussions with regulatory affairs professionals across Asia Pacific, and develops training workshops to enhance regulatory competencies, He is involved in regional and global initiatives for regulatory systems strengthening. James draws his experiences as a regulator in Singapore’s Health Sciences Authority, hospital pharmacist, and his PhD on benefit-risk decisions and innovation in regulatory affairs.

Audrey is the Head of Business Development at Clinical Research Malaysia (CRM). She has over 10 years of experience in the clinical research field, with cross-functional roles in marketing, project management, stakeholder management, corporate communication, and medical writing. At CRM, she is responsible for growing industry-sponsored research in the country. Her role includes strategizing and executing the organization’s business plan, working closely with stakeholders and industry players to create a thriving clinical research ecosystem, and contributing to national policies, frameworks and guidelines to catalyze clinical trials in the country.

Helene Sou is a Director in Global Regulatory Policy and Innovation in Takeda. She is focused on the Growth and Emerging Markets region and is based in Singapore. In the early part of her career, Helene worked as an EU Regulatory Consultant at Voisin Consulting Life Sciences in Paris, France before expanding her focus to International Regulatory Affairs in Boston, USA. Then, in Shire Human Genetic Therapies, Helene held several regional RA positions in Asia-Pacific. In Takeda, Helene was a Global Regulatory Lead for plasma-derived therapies, then acted as the Regulatory Liaison for the Emerging Markets. Since 2023, Helene joined the Program Committee DIA Singapore Annual Meeting.

•Founder of Asia Regulatory Professionals Association (ARPA) with more than 7000 members •Author of Medical Regulatory Affairs Handbook (3rd Edition now) •Adjunct Professor/Lecturer in Chinese University of Hong Kong, National University of Singapore and Tohoku University Japan •CEO of RNAscence (a Biotech startup spin off from Nanyang Technological University and National Skin Center Singapore) •More than 26 years experience in Pharma and MedTech sector

With 20 years’ experience in regulatory affairs and strategy, Sannie's initial career was with the Singapore Agency for 10+ years. She represented Singapore in the WHO prequalification program, the ASEAN Pharmaceutical Products Working Group, and the Australia-Canada-Singapore-Switzerland (ACSS) Consortium for work-sharing initiatives. In 2014, she accepted a role with Roche as Asia Pacific (AP) Regulatory Policy Lead. There, she expedited patients’ access by tracking KPIs of regulators’ convergence in APEC, and co-championing the APEC biotherapeutics work areas on behalf of the BIO coalition. Sannie continues to drive an efficient and sustainable regulatory environment that is powered by digital transformation.

Dr. Senthil Sockalingam is Head of IQVIA Biotech in Japan-Asia Pacific as well as Chief Medical Officer (CMO) for IQVIA Asia Pacific based in Singapore. Senthil is a physician by training, acquiring a MBBS degree from the University of Malaya and practicing in Malaysia prior to joining the industry. In his current role, he leads IQVIA’s specialized clinical development services for the Biotech sector across Japan-Asia Pacific. In addition, he is overall responsible for the safety and ethics of IQVIA clinical development projects in the Asia Pacific region. Prior to joining IQVIA, Senthil led clinical development and medical affairs for several pharmaceutical companies in the region.

Thean Soo Lo is a Regulatory Affairs Management Consultant specializing in the design and development of a robust, efficient, forward looking regulatory department within the organization to provide optimal support to the business, through optimal and expeditious product registration and product license maintenance within the organization. Thean Soo Lo is a pharmacist by training, with a B. Pharmacy (Hons) degree, and a MSc degree on comparative analytical methodology and pharmacokinetics of drugs in biological fluids. Prior to his current role, Thean Soo Lo had prior experience as the AP Lead for regulatory policy & intelligence, and AP Regulatory Affairs Head in Janssen Pharmaceuticals, J&J.

Vicky offers more than 17 years of leadership and management experience including the operational oversight of multi-therapeutic, global Phase I-III trials as well as early clinical development operational strategy. She is currently overseeing and managing multi-compound portfolios across multiple therapeutic areas at global level. She is responsible and accountable for the operational delivery for APAC Biotech Business Unit for the studies conducted regionally and globally. She also drives the Cross-Business Service Units collaborations at programs / accounts level cross the regions.

Martin Lim, based in Singapore, is a managing consultant at NNIT, a Copenhagen-based Life Sciences IT consulting firm and has over 20 years of experience in healthcare software product management, clinical research site management and co-founding a digital clinical research start-up. Martin is passionate about digitalizing and building capacity/capability for clinical research in ASEAN. Martin holds an BS in Biology from UC Irvine, MS in Physiology from Georgetown University and an MBA from UCLA.

Mr. Jin is currently Head, Regulatory Competency Center Asia Pacific, Middle East and Africa (APMA) at Sandoz Asia Pacific Pharmaceutical Pte. Ltd. He is responsible for all regulatory related activities in Asia Pacific, Middle East and Africa (APMA). Mr. Jin has been working in regulatory affairs field in pharmaceutical industry for more than 20 years. He has extensive expertise in regulatory affairs and in the drug development in the region. Prior to joining Sandoz, he worked in Abbott, AbbVie, Takeda, Parexel and GE Healthcare. Mr. Jin is trained as a pharmacist with business degree.

Dr Yeo Jing Ping has more than 25 years of experience in Clinical Research in the Pharmaceutical and CRO industries. She was previously the Vice President and Head of Asia Pacific in Cytel, responsible for leading the growth of Cytel. Prior to Cytel, she was the Research Director, leading the compliance and IRB matters, ensuring all research at the institutions/hospitals were conducted according to legislative requirements, ethical principles and standards. She was previously the Corporate Vice President for PAREXEL International CRO, leading the global biopharmaceutical unit in project delivery and for providing strategic consultancy to the biopharma companies.

Kum Cheun (KC) is Head of Asia Pacific Regulatory & Development Policy for Novartis, leads in the development of regulatory and development policy, and regulatory intelligence for Asia Pacific. He is Co-Chair of Singapore Association of Pharmaceutical Industries (SAPI) Regulatory Affairs Committee, Chair of EFPIA ASEAN Regulatory Network, ASEAN Pharmaceutical Research Industry Association (APRIA) and active member of EFPIA International Regulatory Expert Group (IREG), EFPIA regional regulatory networks (India, Korea-Taiwan), DIA Steering Committee of Singapore, DIA Asia Labelling Community member, ISPE Asia Pacific Focus Group, Steering Committee of APAC, member of APAC RA-EWG, member of APACRM and CoRE Duke-NUS Visiting Expert.

Fengyun (Vicky) Han, the Senior Director, Head of Asia Pacific Regulatory Policy, Global Regulatory Affairs, Johnson & Johnson Vicky has more than 25 years regulatory experience in pharmaceutical industry mainly in GSK ang J&J with various roles in China, Belgium, UK, and Singapore, encompassing a wide range of products, including chemical and biological products, vaccines, biosimilars, and generics. In recent year, she has been involving in many policy areas discussion such as MRCT & ICH E17, RWE, Digital/AL/ML, Cell & Gene Therapy, Orphan Drug, Regulatory Reliance etc.Vicky is the Chair of EFPIA Japan Network, and Vice-Chair of EFPIA China Network.

Professor John CW Lim is founding Executive Director of the Duke-NUS Centre of Regulatory Excellence (CoRE), inaugural Chairman of the Consortium for Clinical Research & Innovation Singapore, Senior Advisor at Singapore’s Ministry of Health (MOH), and Policy Core Lead at the SingHealth Duke-NUS Global Health Institute. Formerly Chief Executive Officer of Singapore’s Health Sciences Authority and Deputy Director of Medical Services in MOH, Professor Lim has also held other senior positions in Singapore’s Health and Education ministries.

Daehyun Baek is a researcher at the Ministry of Food and Drug Safety. Daehyun has more than 20 years of research and review experience at the MFDS. In particular, before joining the Cell and Gene Therapy Products Division in 2022, he was in charge of reviewing monoclonal antibody therapeutics and recombinant hormone drugs in the Recombinant Protein Products Division. Before taking charge of review work, Daehyun had conducted research on the development of an in vitro toxicity test using stem cells. Daehyun received his PhD in veterinary medicine from Seoul National University.

Penny Chia is the OneRoche Lead at Roche Diagnostics Asia Pacific since 2021. She has been with the organization for the past 8 years. In her current role as the OneRoche Lead, she collaborates closely with the key stakeholders across the Diagnostics and Pharmaceutical divisions of Roche to lead the co-creation of overarching joint healthcare approaches. With the patient journeys in various disease areas as the foundation, she works with teams across their organization to identify challenges and market needs across areas such as testing, therapeutics, digital healthcare solutions and data interpretation to improve end to end patient experiences and outcomes.

Ahmed Elhusseiny has worked in the pharmaceutical industry for nearly 20 years, working across Europe, North America and Asia. He has a strong track record of developing and implementing comprehensive strategies for innovative health therapies. Prior to joining Roche in 2013, he was at Novartis for 10 years, where he led various business units, including Ophthalmology and Primary Care. Before becoming Area Head for Asia Pacific, Ahmed was the Head of Integrated Strategies for Pharma International 7. In this role, he led a regional transformation towards new ways of working and processes, improving decision-making across teams and enhancing the patient and customer experience.

A/Prof Danny Soon is CEO at the Consortium for Clinical Research and Innovation, Singapore (CRIS) and concurrent Executive Director at the Singapore Clinical Research Institute (SCRI). Danny is also the Interim Executive Director for Advanced Cell Therapy and Research Institute, Singapore (ACTRIS). Danny has had a long experience in drug development, having worked at Eli Lilly and Company for 15 years, where he headed up the Lilly-NUS Centre for Clinical Pharmacology (LNUS). As the inaugural CEO of CRIS, Danny has the responsibility of bringing together five research programmes and platforms under the auspices of CRIS, promulgating synergies and strategies, building corporate functions to service the entire entity.

Daniel Oscar Baskoro holds a Bachelor's degree in Computer Science from Gadjah Mada University and a Master of Science in Technology Management, Columbia University, New York. Oscar has also received professional education at theMassachusetts Institute of Technology (MIT), Cambridge. Oscar has received various international awards in the field of technological innovation such as Champion Winner from ITU, Switzerland, Innovation Global Winner in London from the World Bank, Great Youth RI, and other awards. In 2020 Oscar was awarded the 1st Winner of the Public Policy Dean Challenge in New York.

Rena Dharmawan is a surgeon-innovator, entrepreneur, educator, and former biomedical engineer, obsessed with creating value and driving positive change in healthcare, particularly in the training of our next-generation clinician-innovators. Key highlights of career include co-inventing two medical patents (Instalief™ & SwabBot™), being one of the founding members of Asia’s top home-care operator: Jaga-Me, and earning recognition as one of the “Leaders of Tomorrow” for healthcare in the Tatler Gen.T 2022 list. She is assistant dean and professor for clinical innovation and ecosystem development at the Duke-NUS Medical School, where she initiated a healthcare innovation programme that aims to become a venture-building incubator.

Serena Foo is Director in Janssen Pharmaceuticals Johnson and Johnson Asia Pacific Regulatory Affairs as well as the Southeast Regulatory Affairs Head, based in Singapore. Serena is a pharmacist by training, with a BSc (Pharmacy)(Hons) and a Masters in Health Economics & Pharmacoeconomics. Serena has more than 20 years of diverse work experience including pharmaceutical manufacturing, regional quality assurance, local and regional regulatory affairs. In Janssen, Serena has gained extensive regulatory affairs expertise within the oncology therapeutic area. She currently leads the Asia Pacific regulatory strategy for CAR-T cell therapy.

Dr Michael Ho is the Head of Innovation and Strategy at NHIC, where he oversees the Medical Technology and Bio Technology portfolio. He has over 10 years of experience working with early stage MedTech innovations, guiding many innovations from conceptualisation stage through to commercialisation. He is an active member in several evaluation committees, and had spearheaded multiple programs that accelerate HealthTech innovations.

Dr Srinivasan is currently the Regulatory Policy Lead for APAC based in Roche Pharma Singapore. At Roche he drives regulatory convergence initiatives with a focus on CMC topics and ensures the implementation of reliance pathways across the region. Srini spent 16 years with the Health Sciences Authority (HSA), Singapore where he headed the Advanced Therapy Products Branch, responsible for policy and legislation and implementation of the regulation of cell, tissue, and gene therapy products (CTGTP) that came into force in March 2021. Srini also holds an adjunct assistant professor position at Duke–NUS CoRE

Yu currently holds the position of Associate Director, Regulatory CMC APAC at MSD. He is part of the Technical Advocacy and Policy group for APAC, advocating for topics including reliance and agility, PACMP and ICH Q12. He is a member of the IFPMA ICH M4Q(R2) EWG representing Singapore through SAPI. Yu holds a master’s degree in Pharmaceutical Sciences from Université de Montréal and a bachelor’s degree in Pharmacology from Université de Sherbrooke in Canada.

Prof Damian O’Connell heads EDDC as Chief Executive Officer (CEO). He also holds additional positions including Adjunct Professor at the University College Cork, Ireland, Member of the Advisory Board SingHealth Investigational Medicine Unit in Singapore, and a board member of the INFANT research centre in Ireland. In addition, he is a member of several medical societies. These include the British Pharmacological Society, the Drug Safety Executive Council (DSEC), the American Society for Clinical Pharmacology and Therapeutics, the American College of Clinical Pharmacology, the American Society of Pharmacometrics, the Irish Association of Pharmacologists, the Irish Cardiac Society, and the British Hypertension Society.

Hueybee Pey is a member of Parexel team since 2012. She has 20 years of experience in the industry and 12 years in CRO. Manager of Project Leadership teams in SEA. 20 years progressive experience in the CRO/pharmaceutical/ Institutional industry with roles in clinical research quality control, business compliance and research development. Management and operational oversight of multi-therapeutic, global Phase I-III drug/biologic trials, and early-phase studies across APAC, EU and US. Therapeutic areas experience include Oncology; Infectious Diseases; Neurology, Dermatology, Cardiovascular Disease/ Cardiology, Dermatology, and Respiratory Disease.

Manfred is currently with the IQVIA APAC Cell and Gene Therapy (CAGT) Center of Excellence as a Cell and Gene Therapy Strategy Director, working with a cross functional team globally, to provide end to end expertise and services in supporting clinical development activities of Cell and Gene Therapy, i.e., development of regulatory and clinical strategies, CAGT site network, CAGT clinical trial solutions (including logistics, patient recruitment and retention strategies), et cetera. Prior to this role, Manfred led the Clinical R&D business development activities in South East Asia, and provided coverage for Australia as well as South Korea, serving clients across various therapeutic areas and drug modalities.

Isabel is a Regional Dossier Publisher focusing on publishing submissions in various formats, including eCTD, and providing technical consultation for AP countries who have implemented eCTD or actively planning towards eCTD implementation. Isabel holds a bachelor’s degree in Pharmacy from National University of Singapore.

Dr. Maria Ruriko Umano-Urbiztondo currently holds the position of regional manager for the Philippines at the Department of International Trials, National Center for Global Health and Medicine, Japan. She joined the center in 2020 and has since been actively coordinating the center’s research collaborations and networking with key teaching-training hospitals in the Philippines. She is highly involved in enabling multi-national research through ARISE, a network of Academic Research Organization in Asia established by NCGM.Dr. Umano obtained her Medical Degree from the West Visayas State University. She is a certified American Medical Technologist and a licensed pathologist in the Philippines.

Dr Shui-Yen Soh is the Head and Senior Consultant from the Paediatric Haematology/Oncology Service of KK Women’s and Children’s Hospital (KKH) in Singapore. Dr Soh graduated from the Faculty of Medicine, National University of Singapore (NUS). She received her Paediatric Medicine training in Singapore and also completed 1 year of Paediatric Oncology clinical fellowship at the Hospital of Sick Children in Toronto, Canada. Her academic interests are in paediatric brain and solid tumours, as well as in cellular and immunotherapies in cancer. She is currently the lead investigator and co-investigator respectively, of two investigator-initiated CAR T clinical trials in Singapore.

With 17 years of leadership and management experience in global CRO, John is presently the Head of PMO at Tigermed overseeing clinical process & quality management, professional training & development, and innovative clinical system. Prior to Tigermed, he has extensive project management experience leading Phase I to IV MRCT studies in wide therapeutic indication for regional biotech and global pharmaceutical companies.

Felicity completed a PhD in natural product synthesis at the ANU and then took up a role at Singapore’s Institute of Chemical and Engineering Sciences. Felicity then joined the TGA as a Pharmaceutical Chemist and has experience with new generic medicines and variations. Felicity has broad knowledge of the regulation of prescription medicines and has led teams responsible for: case management, confidence building with other regulators, external evaluator procurement, Industry Working Groups, AusPARs, expert advisory committees, FOI, media and ministerial responses and business reforms. She has recruited a team which builds on the achievements of the past five years and reaffirms Australia’s support for regional regulators.

Siti Hidayah binti Kasbon presently holds the position of Senior Principal Assistant Director at the National Pharmaceutical Regulatory Agency's (NPRA), Centre of Product and Cosmetic Evaluation. She has 14 years’ experience in reviewing and evaluating dossiers related to New Drug Products since she joined the New Drug Product Section, NPRA in 2009. She formerly worked as an evaluator in the Generic Section. Mainly, her duties revolve around regulation and registration of pharmaceutical products. She is involved in many policy amendments and guideline revisions that are used by the industry and stakeholders nationwide. Her expertise is on the post-approval changes or variations.

Joyce is presently working at AbbVie leading a clinical team to oversight clinical studies in Intercontinental region since 2021. She has participated and led global initiatives within AbbVie in Change Management. Joyce has worked in the pharmaceutical industry since 2001, including positions of increasing responsibilities at Bayer, Boehringher-Ingelheim and Allergan. She has passion in study start up, patient recruitment, data quality and has amassed experience in various therapeutic areas including Aesthetics, Endocrinology, Immunology, Neuroscience, Oncology, Ophthalmology and Respiratory.

Dr Karen Loft is a chemist by training, obtaining a PhD in Organic Chemistry at the University of Melbourne. Prior to joining the TGA, she spent a number of years in medicinal chemistry research. Karen has over 10 years’ experience at the TGA in the areas of pharmaceutical chemistry evaluation (new registrations and variations), including products manufactured using advanced processes, as well as Risk Management Plan assessment. Karen now works in the Regulatory Strengthening Program, providing technical assistance to countries across Southeast Asia and the Pacific.

Dr. Krishna Reddy Nallamalla is the President, ACCESS Health International, ASIA. He is building InOrder, the Health Systems Institute with a purpose ‘to strengthen systems to secure health’. He is the Program Lead for ‘Global Learning Collaborative for Health Systems Resilience (GLC4HSR)’ and ‘Digital Health for Universal Health Care’. ACCESS Health undertakes research to inform health policy, offers courses in building human resource capacity in health insurance management, health information management and health leadership and management, provides advisory & technical support to national and state governments and private sector stakeholders.

Dr Rama is the Director, Medical Devices Branch, Health Sciences Authority (HSA). She oversees the pre-market registration and the post-market controls for medical devices in Singapore. She also oversees the device development consultation that aims to support safe innovation in medical technologies locally. She has been working in the area of Medical Device Regulations for over 10 years now. She received her PhD from the School of Medicine in NUS in 2006. She holds the Professional certification for Regulatory Affairs on Global regulations from the Regulatory Affairs Professional Society (RAPS). She currently represents Singapore as a member of the Management Committee of the International Medical Device Regulators Forum (IMDRF).

Clare has been working in clinical operations and project management for 20 years. In her most recent role as the Director of Global Clinical Operations at Tessa Therapeutics, a Singapore-based, privately owned, clinical stage cell & gene therapy company. Clare had vast experience including management of global cell therapy studies, focusing on EBVSTs and CAR-T treatments in oncology disease across US, APAC, and EU. She worked closely with the CRO partners, strategically partnered sites, and other collaborators to run these studies together. Clare in the past has led the Asia Pacific Early Clinical Development team at LabCorp to run Early Phase Immuno-Oncology, Rare Diseases, and Epidemiology studies.

Piyanan is a Professional Level Pharmacist working with the Thai FDA. She has completed a BSc in Pharmaceutical Science from Thailand, MSc in Pharmaceutical Biotechnology, and Ph.D. in Chemical Engineering from the UK. Her main duties with the Thai FDA are approval of ATMPs & biological products and developing guidelines for the regulation of ATMPs & biological products. Her expertise in CTD assessment for investigational new drug applications and for marketing authorization is CMC or Quality part. She is a focal point and reviewer for the joint assessment of biological products, working together with the regulators from ASEAN countries.

Dr. Milind Sabnis, Head Healthcare Practice for Asia Pacific, has 15+ years of healthcare strategy consulting experience engaging top global clients in the US, the UK and Asia Pacific. His specializations include Market Entry Strategy, Mergers & Acquisitions, Marketing, Business Planning, National Roadmaps. He has advised top pharmaceutical/biotech, Medical device & Technology companies, Hospital/healthcare services groups, National Governments, and Investment Groups. He has been interviewed by various media, including BBC, CNBC, CNA. He holds an MBA from the University of Cambridge, UK; an MD and an MBBS from University of Mumbai.

Ms. Nidhi Swarup M.Sc. Operations Research, M.Sc. Finance and Graduate Certificate in Professional Counselling. She has facilitated the formation of Support Groups in Thailand, Malaysia, Philippines, and India despite being diagnosed with multiple chronic conditions.An inspirational speaker at global conferences, Nidhi shares her journey from ‘illness to wellness’.

Dr Dorothy Toh is the Assistant Group Director (Medicinal Products Pre-market Cluster) and Covering Director (Advanced Therapy Products Branch) at HPRG, HSA. Her responsibilities include ensuring that clinical trials and health products are approved in accordance with regulatory requirements. Being a strong advocate for public health and safety, she promotes the safe use of health products and initiated the use of data analytics for safety monitoring. During the COVID-19 pandemic, she co-led the development of biologics testing capability and won the Public Service Transformation Dare to Do Team Award. She also represents HSA as a regulatory member on ICH.

Kristiina Puusaari is an eSubmission coordinator at the European Medicines Agency (EMA) working on Programme and Project Management for electronic submission systems and projects, such as eCTD, EMA eSubmission Gateway, electronic Application Form (eAF), Common Repository, PSUR Repository and the Single Submission Portal. Kristiina is the business domain expert for the EMA eSubmission systems as well as the Chair of the eSubmission Change Management Board. Kristiina also represents EMA in the ICH M8 IGW/EGW.

Dr. Min Wun earned his M.B.,B.S degree from University of Medicine. He began his professional career as an assistant physician at Yangon General Hospital in 2001. Then he pursued his Master in Pharmacology at the University of Medicine. After that, Dr. Min joined Department of Medical Research in 2006, where he first served as a Researcher in the Pharmacology Research Division and then Pharmaceutical Toxicology Research Division, National Poison Control Centre. Dr. Min underwent training on Pharmacovigilance at the Ramathibodi Poison Center as a WHO fellow. In 2017, he had the honor of joining the FDA and today is serving as Director of the FDA (Yangon Branch).

Jia-Ying Chuang, also known as Leon has been working for 12 years at Taiwan FDA (TFDA), His focus is on import licenses and Taiwan's ECTD business. At TFDA, he ensures safe and quality pharmaceutical products, prioritizing compliance. His major contribution has been in ECTD implementation.

Lim Boon Kian graduated from the National University of Singapore and began her career in HSA as a project manager handling full dossier applications. She has taken on different job functions in the branch and is now leading the regulatory support team in product registration, post-approval variations and product life-cycle management.

Rakesh Neelam is a highly accomplished and dedicated regulatory professional certified by RAPS, with 10 years of experience in Regulatory eCTD submission management, Rakesh is currently working as a Regulatory Submission Specialist at MSD Pharmaceuticals.