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Dr. Lucas Chan
Chief Scientific Officer at Cellvec SingaporeDr. Lucas Chan is the Chief Scientific Officer of CellVec in Singapore, a CDMO dedicated to the development and manufacture of viral vectors for human gene therapy. Lucas received his PhD at Imperial College London and was a Senior Investigator and Head of Manufacture for Advanced Therapies at King’s Health Partners in London, where he led the translational development of IMPs for the clinic and established UK’s first GMP viral vector core. He is an elected Fellow of the Royal Society of Biology and an advisory member to Singapore’s Ministry of Health on cell and gene therapy regulations.
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Emily Cheah
President at PDA Singapore ChapterA registered pharmacist, Dr. Emily Cheah is currently the Managing Director of Charles River Laboratories Singapore (Microbial Solutions). Emily oversees strategic technical operations and market development in Singapore, Malaysia, and Indonesia; and is involved in the implementation of new technology/services at the Singapore site. She also conducts numerous training for the Industry. She received her Ph.D. (Pharm. Technology) from the National University of Singapore and EMBA from INSEAD.
Emily is President of the PDA Singapore Chapter and is an active volunteer with the Chapter since its inception in 2014.
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Justine Mann
President Elect at PDA Australia ChapterJustine is partner and senior consultant with CBE (Centre for Biopharmaceutical Excellence) consulting firm. As a senior leader with extensive technical and management experience in Quality and Manufacturing in the Pharmaceutical, Biotechnology and Medical Device industries Justine has worked on assignments in USA, Europe and Asia over a career of 20+ years.
Formally a Senior Director of Quality Operations for ANZ and India at Hospira Corp. Pty Ltd and Pfizer Corp. Ltd, Justine has had responsibility for providing technical, operational and strategic leadership to ensure site compliance in accordance with US FDA, EU-TGA-PIC/s regulations and local and international standards. Combining a Microbiology background with an MBA specialising in business management and leadership, Justine works with clients to provide strategic and compliant solutions.
Justine is a registered auditor for the Australian Pesticides and Veterinary Manufacturing Authority (APVMA) and in this role, conducts GMP licensing audits on behalf of the Australian government. Further Justine is a board member and President-elect of the Parenteral Drug Association (PDA), Australian chapter.
Gerry McKiernan
Director of Quality at Cell Therapies Pty. Ltd. Melbourne AustraliaGerry has 20 years’ experience in various Quality roles in R&D and cGMP manufacturing in Europe, Asia and Australia and holds the accountability for the Quality Management System to deliver complex cell and gene therapy products to patients on behalf of Cell Therapies Pty Ltd.
Gerry’s career has included biotechnology, pharmaceutical and medical device industries, where he was overseeing quality systems for product development, clinical trials, validation and contract manufacturing. He has led large Quality Management System implementation projects for cell therapy manufacturing in China and Japan and was the project lead for the commercial manufacturing license approvals for Cell Therapies Pty Ltd for Australian and Asian markets.
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Andiyanto Sutandar
President Elect at PDA Singapore ChapterAndiyanto is a Manager in NNIT Singapore. Andi leads NNIT Singapore's Manufacturing Science and Technology service unit. He has broad and in-depth experience in technology transfer, NPI, risk management, deviation and NC management, supply chain management, manufacturing workflow optimization and project management in the pharmaceutical industry. Additionally, Andi has expertise in infection control risk management and design & management of high containment facilities for infectious diseases research.
Andi has been a volunteer with PDA Singapore Chapter since 2015 and has previously served as Secretary of PDA Singapore Chapter board. He holds a PhD in Mechanical & Production Engineering from Nanyang Technological University.
Andi is the current President-Elect of PDA Singapore Chapter.
Dr Zlatibor Velickovic
Facility Director of Cell & Tissue Therapies WADr. Zlatibor Velickovic is the Facility Director of Cell & Tissue Therapies Western Australia (CTTWA), Royal Perth Hospital. Zlatibor obtained his BSc degree in Molecular biology and Physiology at the University of Belgrade and his PhD in Immunogenetics at the University of Otago. He commenced his scientific career in Australia at the Australian Red Cross Blood Service (ARCBS) in Sydney. He gained extensive GMP knowledge and experience during his years at ARCBS, where he was able to obtain and maintain TGA accreditation successfully. Using his GMP expertise, he helped set up and validate the newly built GMP facility at the Royal Prince Alfred Hospital, where he managed productions activities for cell and gene therapy projects and clinical trials for ten years. In his current role at CTTWA, Zlatibor directs FACT, TGA and NATA accredited GMP facility for manufacturing of licensed cell therapy products and manages in-house and industry-sponsored cell, gene and tissue therapy clinical trials. Alongside this, Zlatibor is a Research Fellow at the Faculty of Medicine and Health at the University of Sydney and the International Society for Cell & Gene Therapy (ISCT) Regional Vice-President Elect, Australia & New Zealand.
Dr Ramandeep Kaur Virk
Senior Regulatory Specialist at HSA SingaporeDr Virk received her degrees of MBBS and MD (Microbiology) from the Maharishi Dayanand University, Rohtak, India. After moving to Singapore, she obtained her PhD degree from the National University of Singapore (NUS). During her 10 years of research, her work focused on understanding the molecular epidemiology and genetic evolution of human influenza viruses. Dr Virk is currently a Senior Regulatory Specialist (Clinical), Advanced Therapy Products Branch (ATPB) at the Health Sciences Authority (HSA), Singapore. She is also a member of the S12 network under the Access Consortium’s International Council for Harmonization (ICH) Working Group.