This one-hour webinar will focus on strategic considerations for the molecule, including a brief review of the dynamic research landscape of oncology drug development, patient recruitment and product development aspects.
- What is on the horizon in oncology drug development
- Clinical development strategy and tactics
- Clinical design and consideration:
- Early V Late Phase
- Regulatory considerations
- Clinical aspects – cure or control
- Patient centricity – practical considerations
- Trial design – early phase 3+3, Rolling 6 and other designs
- Protocol development – clear unambiguous protocols, sense checking with KOL’s and subject matter experts. The importance of understanding how to ‘operationalize’ the protocol with thorough feasibility
- Proof of concept – how do you confirm for MAA?
Shankar Balaratnam, MBBS, MSc, MRCS, MFPM, Associate Medical Director, Simbec-Orion Group
Shankar Balaratnam has been the Associate Medical Director of Orion Clinical Services since October 2016. He has over 10 years of clinical experience in pharmaceutical medicine, covering clinical development, medical affairs and pharmacovigilance and is a Specialist in Pharmaceutical Medicine, Faculty of Medicine, Royal College of Physicians, London.
His previous experience includes acting as a Medical Assessor, Pharmacovigilance and Risk Management Group for MHRA. He has also held senior medical roles in oncology for Celgene, GSK and Roche, covering the UK and Republic of Ireland.
He has a keen interest in oncology and has acted as Medical Monitor for numerous research-related projects, including clinical trials and compassionate use programs. He is responsible for input into development strategies, medical monitoring, and oversees pharmacovigilance for challenging studies in oncology therapeutic areas.
Claire Barton, MA, MB, BChir, MRCP, PhD, FFPM, Orion Clinical Oncology Advisory Board Member
Claire Barton is a pharmaceutical physician who originally trained as a medical oncologist and completed a PhD before joining the pharmaceutical industry in 1995. She worked in oncology clinical development at Wellcome, Eli Lilly and Roche before starting her own advisory company (Barton Oncology Ltd) in 2004. Claire has worked on a range of oncology products (including monoclonal antibodies, targeted therapies, conventional cytotoxic agents, hormonal therapies, growth factors, supportive care products, gene and cellular therapies) and malignancies, and has experience of global regulatory submissions (for trastuzumab, rituximab, bevacizumab, pertuzumab and obinutuzumab), assessing oncology in-licensing opportunities, requests for funding to charitable bodies, and of advising companies on their oncology portfolio and strategy. Recent early clinical development projects include a CAR T-cell therapy, an IgE monoclonal antibody, a tribody, a novel immunomodulatory agent, a targeted agent, and a vaccine. Claire is also a Specialty Advisor for pharmaceutical physicians undertaking higher medical training in Pharmaceutical Medicine, and is an appraiser for the Faculty of Pharmaceutical Medicine.
Chirag Patel, Director of Regulatory Affairs & Technical Writing, Simbec-Orion Group
Chirag has ten years Regulatory Affairs experience both within Clinical Research Organisations (CROs) and Pharmaceutical industry. He has in-depth experience of managing submissions for multi-country studies across Phases I, II & III and provides expert knowledge of local national requirements for the EU and Latin America. He has managed the preparation of a Marketing Authorisation Application (MAA) via decentralised procedure and filed US IND Applications
Who Should Attend?
C-level and senior professionals from Biotechnology companies involved in Oncology research and drug development
Orion Clinical is the full-service clinical development division of Simbec-Orion Group.
Founded 20 years ago as a full service CRO we have expanded, through consistent delivery of studies in complex areas. Our operations are based in the United Kingdom, France, USA, Germany and Italy. We have operational staff across mainland Europe (Western, Eastern & Central) and throughout North America.
With over 20 years of experience in the delivery and conduct of oncology clinical trials, including rare & orphan and paediatric studies, we use our skills elegantly to design, execute and deliver our clients’ clinical development needs.