B25. How to make sense of RNA-based therapeutics

Tracks
Prescription Medicines and Devices Regulation
Thursday, June 13, 2024
4:30 PM - 5:30 PM
C2.5+C2.6

Chair & Speakers

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Annegret Vaggelas
Senior Manager
Cencora PharmaLex

Chair: How to make sense of RNA-based therapeutics

Biography

Dr. Annegret Vaggelas is working as Senior Consultant/Manager at Cencora Pharmalex, Australia. She has more than 8 years of experience in the development, approval and life cycle management of biopharmaceuticals such as mRNA vaccines, gene and cell therapies, tissue-engineered products, oncolytic viruses, monoclonal antibodies, biosimilars, but also first-in class small molecules. She provides scientific as well as regulatory and strategic support with regards to the regulatory requirements applicable to biopharmaceuticals and the global administrative processes required by agencies such as EMA and FDA. Dr Vaggelas is a vet by training and holds a PhD in Microbiology.
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Dr Tiina Palomaki
Director, Principal consultant
Cencora PharmaLex GmbH

How to make sense of RNA-based therapeutics

Biography

Dr Tiina Palomäki holds a PhD in genetics. She has been working as a Director, Principal consultant at Cencora Pharmalex, Munich Germany since 2022, and she is specialized in scientific and strategic consulting for cell and gene therapies as well as biotechnological products. Prior to joining Cencora Pharmalex Dr Tiina Palomäki worked as a senior researcher at the Finnish Medicines Agency, the National Competent Authority in Finland, where she was responsible for preclinical aspects of advanced therapy medicinal products and biotechnological products 2006-2022. She has hold positions at the EMA (European Medicines Agency) Committee for advanced therapies (CAT), the Cell-based product working party, and the Gene therapy working party. Prior to joining the Finnish medicines agency, she worked 13 years in academic research in the field of stem cells, molecular and cellular biology. She graduated from the University of Helsinki 1993, and made her PhD and a post doc in the Dept of Biosciences in the University of Helsinki.
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Mohit Khera
Acting Director and Medical Officer, Clinical Evaluation section, Prescription Medicines Authorisations Branch
Department of Health and Aged Care (TGA)

How to make sense of RNA-based therapeutics

Biography

Dr Mohit Khera is an Assistant Director (Clinical) in Prescription Medicines Authorisation Branch, TGA. Dr Khera trained in Clinical Rehabilitation medicine in the NHS, UK and has a Certificate of Completion of Specialist Training in Pharmaceutical medicine, acquired-Joint Committee on Higher Medical Training, Royal College of Physicians and GMC, UK. He is a Fellow of Faculty of Pharmaceutical Medicine, Royal College of Physician RCP, UK. Dr Khera has been an Investigator for Phase 1 and Phase 2 studies at the St. George’s Hospital Medical School, London and Global Phase 4 studies. Dr Khera has been an academia researcher at Menzies Research Institute Tasmania, Hobart and Monash University, Melbourne. Dr Khera has been in Pharmaceutical industry Medical Affairs lead roles in the UK and Australia. Dr Khera has been a Medicines Australia and ABPI (UK) final signatory for medico-marketing programmes.
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