Achieving regulatory milestones & meeting commercial goals
Sponsored by: Novotech
- Product Development
Date: 18 December
Time: 4PM London / 8AM PST/ 11AM EST
The importance of a streamlined & focused global program strategy
Determining your product development strategy can seem daunting and complex. There are varying regulatory pathways to navigate, regulatory and compliance standards to achieve, milestones to map, commercial budgets to be mindful of and time ticking away.
Crystallising and simplifying your product development strategy into a step-wise plan can help remove the overwhelming nature of propelling your program forward and meeting milestones. Doing this with quality, cost and time efficiencies in mind is what we call intelligent development!
This webinar is one to watch regardless of your pipeline indication, stage of development or whether you have a local or global strategy in mind or in fruition. We will define and explain the key questions you need to be asking, the important considerations, where your focus needs to be and give you the tools to tackle the decision-making steps to reach those corporate goals.
Principal Consultant, Novotech
Tracey is a Principal Consultant with over 30 years’ experience in preclinical drug development, having worked as a Toxicology Study Director for 10 years and a Project Co-ordinator for over 10 years, responsible for the designing, implementing and interpretation of the toxicology packages required for a variety of clinical indications. Tracey has particular expertise in inhaled products developed while working in a large international pharmaceutical company. Tracey is a member of the British Toxicology Society (BTS) and the US Society of Toxicology (SOT) as well as being a US (DABT), UK/EU Registered Toxicologist.
Dr Hiram Chipperfield,
Principal Consultant, Novotech
Hiram is a Principal Consultant with over 10 years of regulatory affairs experience. He has a scientific background with a PhD in cell biology followed by academic and commercial post-doctoral research. Prior to joining Novotech, Hiram held roles in a regulatory affairs consulting firm and a global diagnostics company. With experience in products from diagnostics to cell therapies, he has managed projects ranging from preclinical development, first-in-human clinical trials, product registration, through to post-market reimbursement applications.
Robert Shepherd, PhD,
Research & Development Director, Dimerix Bioscience
Dr Shepherd is a professional drug developer with experience managing and leading multidisciplinary pharmaceutical development teams in projects from lead identification to product registration. At Dimerix Bioscience, Robert is a member of the executive team and leads the renal and respiratory portfolio of clinical-stage assets as well as being responsible for the identification and development of new programs. Previously, Robert has worked with Medicines Development for Global Health and Monash University, holds a PhD in molecular cell biology and immunology, and is currently enrolled in a Global Executive MBA program.
Connect with Robert on LinkedIn
Key Learning Objectives
- What does the bench to market process look like on a macro level
- The power of a drug development plan
- The value of a gap analysis
- The role of BioDesk as a virtual product development team
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