SEA’s Only End-to-End Therapeutic Biologics Platform

Dr. Mohd Azlan Bin Zaharudin is the Director of the Malaysian Vaccine Project Office (MVPO) under the Ministry of Science, Technology, and Innovation (MOSTI). In this role, he oversees the coordination and implementation of strategies related to Malaysia's National Vaccine Development Roadmap (NVDR). His responsibilities include leading efforts in vaccine ecosystem development and facilitating collaborations to advance vaccine innovation in Malaysia.

Prior to his role at MVPO, Dr. Mohd Azlan was part of the Strategic Technology and S&T Application Division of MOSTI, where he focused on the biotechnology sector. His work in this division provided him with valuable insights and experience that he now applies to his current position.

Shanti Marlina Sibuea is the Acting Director of the Directorate of Production of Drug, Narcotic, Psychotropic and Precursor Control at the Indonesian FDA (Badan POM). With over 15 years of experience as a GMP inspector, she has led and participated in numerous international inspections across China, India, South Korea, Japan, and Puerto Rico. Her expertise spans regulatory systems, quality management, and oversight of biological products and advanced therapies. She serves as a PIC/S assessor and actively contributes to global regulatory convergence, including international regulatory assessments and expert circles on ATMPs. She holds a PhD from Monash University, focusing on stem cell and regenerative medicine, and supports national and regional capacity building in regulatory science.

Dr. Badarulhisam is currently the Chief Scientific Officer at Pharmaniaga Berhad. He is responsible to spearhead product development and regulatory strategies for the company, inclusive of product ideation, development, trial, registration and product life cycle management. Among others, he is currently leading the team for various biopharma and vaccine development program, either through in house development or through technology transfer from several international strategic partners.

Dr Badarulhisam qualified as a Biochemical Engineer. He received his PhD from the Johns Hopkins University, USA and MSc and Advanced Diploma from the University College of London, UK.  His area of expertise is in the fields of Biochemical Engineering and Biotechnology.  Dr. Badarulhisam developed his early career as a lecturer at the Department of Bioprocess Engineering, University Technology of Malaysia and he is still active academically. He has served as a Professor (adjunct) at Chemical Engineering Department, University Putra Malaysia and he is also a member for the Board of Academic Advisory, School of Pharmacy, Universiti Kebangsaan Malaysia and a few other universities. He has served as an industrial advisor to several Bioprocess Engineering Programs in major universities in Malaysia and co supervises Masters and PhD students in various aspects of Biopharmaceutical Plant Design, Biologics Drug Development and Process Optimizations.

Butet Manurung is a pharmacist and Master of Public Health. She is as seasoned professional with over 24 years of experience in Quality and Manufacturing within Pharmaceutical, Biopharmaceutical, Cell Therapy, and Cosmetic industries.  Butet has a strong background in regulatory compliance, consulting, and operations, with proven leadership in driving continuous improvement and operational excellence.

Meenu Batolar is the Asia Pacific Lead for Global Regulatory Affairs at CEPI, where she drives regulatory collaboration and preparedness strategies for future epidemics and pandemics. With leadership experience across Takeda Vaccines, Sanofi Pasteur, Biogen Idec, Baxter, and UCB, she has built deep expertise in Regulatory Affairs, Pharmacovigilance, Compliance, and Government Affairs across the Asia Pacific region. Meenu played a pivotal role in securing the first licensure of Inactivated Polio Vaccines (IPV) in India and advancing dengue vaccine registrations across Asia. An AIIMS New Delhi pharmacology graduate, she is recognized for pioneering regulatory innovations, fostering public health partnerships, and championing vaccine access. Beyond work, she enjoys storytelling, travel, fitness, yoga, and Reiki.

Dr Vinod Bura is a physician and global health expert with deep specialization in vaccines, disease control, and public-health programmes focused on strengthening health systems and preventing infectious diseases worldwide.

He brings over 30 years of experience across the Government of India, the World Health Organization, and UNICEF, where he has led and supported work on immunization programmes, vaccine policy, and infectious-disease surveillance.

Dr Bura has extensive expertise in strategic programme planning, implementation, and technical guidance for large-scale public-health initiatives. He also received postgraduate training in epidemiology from the London School of Hygiene & Tropical Medicine.

Indriana Permatasari is a Project Head with more than 19 years of experience in clinical research and drug development, covering Phase 1–4 clinical trials in local, regional, and global settings. She has extensive expertise in project management, clinical operations, regulatory compliance, risk management, and stakeholder engagement. Throughout her career at International Vaccine Institute and IQVIA, she has successfully led multidisciplinary teams, managed global clinical trial portfolios across multiple countries, and supported regulatory inspections and sponsor audits. With a strong background in vaccines, oncology, nutrition, and infectious diseases, she is recognized for her leadership, adaptability, problem-solving abilities, and commitment to delivering high-quality project outcomes.

Zainab Sadat is a senior healthcare executive with over two decades of global leadership experience across pharmaceuticals, vaccines, and diagnostics. As General Manager for Southeast Asia and India at Sanofi, she spearheads strategic growth initiatives across diverse and rapidly evolving markets. Prior to Sanofi, Zainab held executive roles at Abbott and GSK. She is recognized as a transformative leader, known for her expertise in P&L management, digital transformation, successful product launches and passion for people development. Her leadership focuses on advancing healthcare access and driving innovation across emerging markets, impacting millions of lives throughout the Asia-Pacific region

Dr. Sushant Sahastrabuddhe (MD, MPH, MBA) is the Associate Director General for the Innovation, Initiatives and Enterprise Development unit at the International Vaccine Institute in Seoul, South Korea. Sushant is working at IVI since 15 years and has led multiple vaccine development programs involving typhoid conjugate, Chikungunya, and COVID-19 vaccines. Sushant is a medical graduate from India with Masters in Public Health from Johns Hopkins Bloomberg School of Public Health, Baltimore, USA and an MBA from the Indiana University, USA. Before joining IVI, Sushant worked with National AIDS Research Institute (NARI) under the umbrella of Indian Council of Medical Research (ICMR) and International AIDS Vaccine Initiative (IAVI).

Sushant has over 40 manuscripts and 2 book chapters and is affiliated with Yonsei University, Seoul, South Korea as Adjunct Professor in the College of Medicine; Research Fellow, at CIRI – Centre International de Recherche en Infectiologie, Team GIMAP, Université Jean Monnet, Université Claude Bernard Lyon 1, France and Visting Professor, Department of Infectious Disease Epidemiology and Dynamics, Institute of Tropical Medicine, Nagasaki University, Japan. Sushant has been awarded with Honorary citizenship from Seoul Metropolitan Government for his contributions to global public health in 2021.

A biopharmaceutical professional specializing in mRNA platform development, with strong expertise in downstream processing, manufacturing, and bioprocess development. He has contributed to the advancement of self-amplifying mRNA (saRNA) vaccine platforms at Gennova Biopharmaceuticals, focusing on process development. At Kashiv BioSciences, he played a key role in developing multiple COVID-19 vaccine variants and other vaccine candidates, with an emphasis on purification strategies and process characterization. He brings proven experience in enhancing process robustness through critical parameter evaluation and scalable bioprocessing approaches. Passionate about advancing innovative, regulatory-compliant nucleic acid and peptide-based therapeutics, while bridging technical expertise with strategic business insights in bioprocess manufacturing.

Mr. Vipul Doshi has been in pharmaceutical Industry from more than four decades with diverse leadership and operational expertise across development, manufacturing, R&D, GXP quality assurance (QA) and manufacturing operations (parenterals, solid dosage forms, biotechnology, transdermal, biologics and vaccines).

He has been leading the Quality and Regulatory affairs function in the Pharmaceutical Companies of high credentials. Throughout his career he has been providing passionate global leadership and pioneered in guiding the companies to meet the Global Regulatory, Quality Standards and Compliance requirements.

He has been a Great Contributor in developing and implementing Quality attributes and Culture of Excellence based upon a set of core values and ethical practices, which integrate and improve business operations and enhance the compliance within the Organization.

Dr. Deepak Mukherjee’s career is defined by a 360-degree view of healthcare. While a Medical Doctor by training, his professional journey bridges clinical practice, academia, and leadership within the global pharmaceutical sector. He has spent years analyzing and operating within the distinct healthcare ecosystems of India, Malaysia, Singapore, and Indonesia. Having lent his expertise to industry giants like Boehringer Ingelheim, Novartis, and Novo Nordisk, Dr. Mukherjee now leads as the Country Medical Director for Roche, Indonesia. He is recognized for his versatile leadership, steering high-performing teams not only in Medical Affairs but also in Clinical Trials, Regulatory, and Quality.

Indra Rudiansyah is the Project Lead for the mRNA Vaccine Programme at Bio Farma, Indonesia, working with WHO, the Medicine Patent Pool (MPP) and CEPI to build national and regional mRNA manufacturing capabilities and strengthen outbreak preparedness.

He holds a D.Phil. in Clinical Medicine from the University of Oxford, where he specialised in malaria vaccine development and contributed to the clinical advancement of the ChAdOx1 nCoV-19 vaccine during the COVID-19 pandemic. He has also supported the COVAX Facility on vaccine policy and product monitoring.

In addition, Indra is a Research Assistant at Impact Global Health for the G-FINDER project, tracking investments in EIDs, neglected diseases and SRH.

His Ph.D. program concentrates on the mechanism of how exosomes facilitate Flaviviridae vector-borne diseases transmission from arthropods to host.  As the pioneer of this novel theory, he published on several top journals (PNAS, EMI, PLoS Pathg, EMBO etc.). As an ORISE postdoc fellow worked at the FDA, he became an expert on live attenuated rubella vector vaccine expressing antigens of HIV, RSV and Malaria. After back to China, he worked as the TA head & CSO assistant at CNBG-Virogin, was responsible for POC stage research of mRNA vaccine for infectious disease. Now he is working as CEO scientific assistant at Abogen Biosciences, responsible for scientific collaboration and discussion.

Neni Nurainy, Ph.D., joined Bio Farma in 1997. She currently serves as the Head of the Translational Development of Life Science Products Division at PT Bio Farma, Indonesia. She graduated from the Pharmacy Department at the Bandung Institute of Technology in 1996, and later completed her postgraduate studies, earning a Ph.D. in Biomedical Science from the University of Indonesia in 2005. Driven by her interest in vaccine development, she pursued a Postdoctoral Research Fellowship at the Department of Microbiology and Immunology at the University of Melbourne in 2009.

Dr. Nurainy’s extensive experience in vaccinology includes the development of the Haemophilus influenzae type b conjugate, Hepatitis B, and COVID-19 vaccines. Her current research and development work focuses on a new TB vaccine, mRNA and viral vector technology, adjuvants, delivery systems, and therapeutic proteins. Additionally, she serves as the co-lead for the CEPI Vaccine Manufacturing Facility Network at Bio Farma. She has authored and co-authored numerous peer-reviewed articles published in reputable international journals and holds several national patents in the field of Hep B recombinant protein.

As the Director of the Mahidol Vivax Research Unit (MVRU) at the Faculty of Tropical Medicine, Mahidol University, I lead a research team of > 30 staff including junior scientists, postdoctoral fellows and graduate students.  We are one of a few research groups that consistently work on the P. vivax parasite, which cannot be continuously cultured in laboratory.  I have established the first field-based membrane feeding assay for evaluation of transmission blocking immunity against P. vivax.  This method has been used to evaluate vaccine candidates and naturally acquired immunity in endemic populations. Our capacity to conduct research on P. vivax biology has contributed to the progress on P. vivax transmission blocking vaccine.  The first P. vivax human challenge study in Thailand has been established by my team in collaboration with Oxford University.  This study will increase our capacity to evaluate the new vaccine candidates and drugs against all stages of P. vivax.  To better understand the immune response against malaria infection is important for better vaccine design and evaluation.