Date: Wednesday 2 April 2025
Time: 18:00 - 20:00 GMT
Event Format: In-person event
This evening will centre around a highly interactive panel discussion on Quality, Manufacturing, Regulatory, Clinical Development and Patient Engagement to accelerate new medicines to the clinic. It will be of particular interest to TOPRA members who are interested in early drug development, global factors affecting drug development and those interested in learning more about advanced therapies and rare diseases. It is ideal for current and emerging leaders in the regulatory affairs profession, especially in academia, start-ups, SME companies and R&D pharma.
Key Topics expected to be included in this session:
• Innovator hot topics across drug development domains: Quality, Chemistry Manufacturing and Controls. (CMC), Regulatory, Clinical Development and Patient engagement
• Development pathways for new medicines with a spotlight on Advanced Therapy Medicinal Products (ATMPs) and challenges encountered by innovators.
• Early development challenges for innovators.
• How organisations should interact with regulators to gain successful outcomes for therapies in rare diseases in US, EU and UK.
• Patient engagement and recruitment for trials in rare diseases.
Learning objectives when attending this session:
• Greater understanding of the hot topics facing innovators in today’s environment.
• Understand regulatory challenges developing therapies in rare diseases.
• Appreciate key challenges for cutting-edge therapies like ATMPs which include manufacturing and controls, cost, accessibility and other ethical considerations.
• Understand common regulatory challenges facing SME companies and how they may differ to established biotechnology and pharmaceutical firms.
• Know where to find suitable supportive resources.
Chair: Dr Tim Hardman
Tim Hardman is the Managing Director of Niche Science & Technology Ltd., a 30+ person bespoke services CRO based in the UK, which he founded in 1998. With over 40 years of experience in clinical research, Dr Hardman is highly regarded for his expertise in translational science, clinical pharmacology, and the strategic design and implementation of clinical studies.
Panellists:
Mr Ian Pardo, RareGenix Quality Lead
Ian is a highly experienced EU/UK Pharmaceutical Qualified Person (QP) with two decades of expertise in pharmaceutical manufacture and quality. His distinguished career spans the development, manufacturing, and certification of a broad range of medicinal products, including vaccines, cell and gene therapies, , monoclonal antibodies and traditional small molecules. Ian is known for his leadership in quality improvement and remediation.
Dr Dima Al-Hadithi, RareGenix CMC Lead
Dima has more than 20 years of expertise specialising in CMC strategy and product development for medicines & drug-device combinations across multiple therapeutic areas, including rare diseases. As a former Senior Pharmaceutical Assessor at the UK Medicines & Healthcare products Regulatory Agency (MHRA), Dima provided scientific advice to developers and assessed UK/EU MAAs. Dima has led CMC development for advanced therapies with expertise spanning CDMO selection, product development, analytical strategy, GMP compliance and regulatory planning.
Dr Christine Grew, RareGenix Regulatory Lead
Christine has more than 20 years of leading successful regulatory outcomes working for Top 10 pharma, contract manufacturers, research organisations and drug development consultancies. Christine is a fractional chief regulatory officer for a start-up and was awarded TOPRA fellowship in 2024 for her distinguished contribution to regulatory affairs. Christine has worked across a broad range of therapeutic areas from early development through to registration procedures, to post licensing activities and is a co-Chair of TOPRA’s Clinical Trial Special Interest Network (SPIN).
Dr Dmitry Zamoryakhin, RareGenix R&D Medical Lead
Dmitry has more than 20 years of expertise in global drug development, with a specialisation in rare diseases, oncology and precision medicine. His experience spans the entire life cycle of pharmaceutical innovation, including early discovery, preclinical research and all phases of clinical development right the way through to regulatory approval. Dmitry has led programs utilizing diverse therapeutic modalities, such as lentiviral vectors, mRNA platforms, CAR-T therapies, antibody-drug conjugates (ADCs), and drug-device combinations.
Mr Keith Berelowitz, RareGenix Patient Engagement Lead
Keith has dedicated over 20 years to the field of clinical research, specialising in patient engagement and retention. Keith supports biotechnology companies acting as a strategic advisor and board member and in his previous leadership role, led effective patient recruitment strategies as Director of Operations/Commercial Director. Keith is the Chair of the Fulham Research Ethics Committee and also the founder of patientRx Ltd.
Pricing:
Type
TOPRA Member: Free
Non Member: £45