Advancing CGT Trial Ecosystems in the Asia-Pacific Region

Frederick Derosier, Vice President, Therapeutic Strategy, Clinical Lead for Enterprise Cell and Gene Therapy, Fortrea

Frederick Derosier provides medical/scientific executive leadership for rare diseases and advanced therapeutics (cell, gene and RNA) at Fortrea. He joined Fortrea (Covance Inc.) in mid-2017 after pursuing 10 years of private practice (Board Certified Internal Medicine). He has 22 years of pharmaceutical/biotech clinical development experience, primarily focused in neurosciences and rare diseases.

Frederick has drug development experience across a variety of platforms, including small molecules, combination products, antibodies, neurotoxins, antisense oligonucleotides and gene therapy, and has employed a variety of delivery modalities. He has broad clinical development experience from Phase I – IV through life-cycle management. This experience encompasses clinical development planning and strategy, pediatric investigational plans (PIP) and registries and clinical strategy and oversight across program regulatory documents for the US FDA, European Medicines Agency (EMA) and Japanese Regulatory Agency (PMDA).

Dong Yang, Head of Regulatory, Fortrea China

Dong Yang is the Head of Regulatory Affairs at Fortrea China and has over 17 years of professional experience in drug development to support IND/NDA-enabling projects and regulatory affairs.

As a board-certified Regulatory Affairs Professional (RAC global), Dong leads the regulatory relevant activities and provides strategic regulatory input for internal and external customers, including performing gap analysis and working with clients and regulatory agencies in the organization and preparation of clinical development plans, agency interactions/consultation and KOL engagements, IND and NDA applications, HGRAC submissions and CIQ applications.

Dr. Jennifer Hollands, Government and Academic Liaison, Cell Therapies (Subsidiary of Peter MacCallum Cancer Centre)

Dr Jennifer Hollands is Cell Therapies’ Government and Academic Liaison and is responsible for all collaborations with Australian agencies, medical research institutes and researchers. Jennifer has over 15 years’ experience in regenerative medicine research as a stem cell biologist, with a major focus on the development of cell replacement therapies for neurodegenerative diseases.

Within Cell Therapies Pty Ltd, an advanced cell and gene-based therapies CDMO located in Peter MacCallum Cancer Centre, Jennifer’s role is to support the translation of pre-clinical research to early-phase clinical trials. Notably, Peter Mac is one of the leading institutions in cancer immunotherapy research, located in Australia’s premier Biomedical Precinct in Parkville, Melbourne.

Eytan Abraham, VP, Business Head of Cell, Gene and Nucleic Acids Franchises, Resilience

Eytan Abraham is an experienced scientist and business leader with expertise in basic and applied biological and cell therapy R&D as well as in management, technology, and commercialization. He has an interdisciplinary background which consists of biological research, biomedical engineering, commercialization, management, and bio manufacturing, inspires passion towards being an instrumental team player in bringing novel life-saving therapies from bench-to-bedside.

Ritu Singla, Project Manager, Fortrea

Ritu Singla is a pharmaceutical professional with over 15 years of experience in research and project management. She has experience in the full drug discovery cycle from concept stage to Phase I-III clinical trial to launch of products in therapeutic areas of hematology and oncology (including immunotherapy across multiple geographies). In her current role and her previous roles at different pharmaceutical companies such as Cell Therapies, Sienna Cancer Diagnostics, Starpharma and CSL, she has demonstrated a history of successful delivery of tangible outcomes, building global teams, managing high-profile client relationships, negotiating deals and effective strategy implementation and key stakeholder management in complex, multi-disciplinary environments. She holds a PhD and MBA from the University of Melbourne.