ERA Consulting and BioMelbourne Network presents
Cell and Gene Therapies: Preparing for International Clinical Development
About the event:
This workshop will focus on how cell and gene therapies (advanced therapy medicinal products, “ATMPs”) should be prepared for clinical development to meet the requirements of regulatory authorities in Australia, the EU and US; however, the main focus of the workshop will be on clinical development in the EU and US.
We will provide attendees with a regulatory scientific approach for successful translation of ATMPs into the clinic. The content will include an overview of the applicable regulatory pathways and essential elements to address prior to application to perform clinical trials. This will include practical advice on ‘dos and don’ts’ for product design and manufacturing platform selection. Attention to these factors is important in order to optimise product safety, avoid regulatory difficulties, and facilitate and expedite further development towards market authorisation. Some mistakes made at the beginning may be very costly to correct later in development, hence appropriate planning to avoid associated obstacles is critical for the credibility of programs with potential investors.
Factors in the design of cell and gene therapies that impact acceptability to regulatory authorities
Considerations in selection of the manufacturing platform
Essential product testing before entry into clinical trials
Pre-clinical studies that are relevant to the safety of cell and gene therapies
The value of regulatory strategies in the early development of cell and gene therapies
Who should attend?
Industry related professionals
Doctoral students and Post-doctoral scientists
Date: Tuesday, 23 October 2018 Location: Karstens, 123 Queen Street, Melbourne Registration: 1:45pm Time: 2:00pm – 5:00pm, followed by networking
Dr Dianne Jackson-Matthews; Chief Scientific Officer, ERA Consulting Group/Director of Regulatory Affairs (Australia)
Dr Dianne Jackson-Matthews, BSc, PhD, RAC
Chief Scientific Officer, ERA Consulting Group/Director of Regulatory Affairs (Australia)
Dianne has over 25 years of experience in pharmaceutical product development, spanning the areas of drugs, biotech/biologics/biosimilars and cell/gene therapies in the US, Europe and Australia. She has experience in development of regulatory and technical strategies, conducts regulatory agency interactions worldwide, prepares regulatory documentation and submissions, and performs regulatory and technical due diligence assessments supporting funding and licensing opportunities for the investment community and the industry. Prior to joining ERA in 2001 as the Director of the Washington DC office, Dianne was the Director of Regulatory Affairs at a biotech company in New Jersey, where she gained extensive experience with biotechnology products over a 12 year period, covering GMP production, GLP and bioanalytical testing, and regulatory submissions and approvals. She also has 6 years’ experience with in vitro diagnostic device development in the US. Dianne has held an Adjunct Associate Professor position at the University of Queensland, Australia, since 2010.
Dr Tim Farries; Director of Regulatory Affairs – Cell and Gene Therapy, ERA Consulting (UK)
Dr Tim Farries, PhD
Director of Regulatory Affairs – Cell and Gene Therapy, ERA Consulting (UK)
Tim Farries is an expert in the development of Advanced Therapy Medicinal Products (ATMPs) with over 16 years’ commercial experience spanning employment in biotech and big pharma companies. Since 2013, Tim has been ERA’s “Director of Regulatory Affairs – Gene and Cell Therapies” in ERA’s London office where he is responsible for managing a team of consultants focussed on CMC regulatory and development matters for complex biological therapeutics. This team supports a wide range of products throughout the regulatory process and notably was pivotal for the first marketing authorisation ever achieved in the EU for a product containing stem cells. Tim was previously responsible for managing regulatory, development and manufacturing aspects of the gene therapy development programme of Ark Therapeutics Ltd., including liaising with EMA, FDA and other national regulatory authorities, and compiling CMC, non-clinical and environmental risk assessment documentation for marketing authorisation applications. He has also held roles in the management of advanced biotechnology programmes at Gendaq Limited (acquired by Sangamo Biosciences) and Novartis Pharma, and holds a PhD from Cambridge University.
Dr Kilian Kelly; Vice President, Product Development – Cynata Therapeutics Ltd
Kilian Kelly has approximately 15 years’ experience in the biopharmaceutical industry, including over eight years developing stem cell-based therapies. He holds a Masters in Pharmacy and a PhD in Pharmaceutical Sciences. He has previously held a variety of regulatory affairs and clinical development positions with companies including Biota Pharmaceuticals, Mesoblast, Amgen and AstraZeneca.
Kilian is currently Vice President, Product Development at Cynata Therapeutics, an Australian stem cell and regenerative medicine company developing therapies based on its proprietary Cymerus™ stem cell technology platform, which utilises induced pluripotent stem cells (iPSCs) to produce MSCs through a proprietary process that is independent of donor limitations providing an “off-the-shelf” stem cell platform for therapeutic product manufacture. A Phase 1 clinical trial of the Company’s first product in graft versus host disease completed recruitment in May 2018, with very promising initial results.