The goals of clinical development have shifted from achieving registration and approval by regulatory bodies, to getting reimbursed- and having market access. Experience shows that real innovation comes from differentiation at an earlier stage. New mechanisms of action can help doing that, but ensuring a constant delivery of new data during the lifecycle of a drug is the way to succeed.
There are more and more means to achieve that goal and using the best method to fill each identified gap is essential. The advent of biosimilars also added pressure on the development molecular entities- requiring synergies across R&D departments early in the lifecycle. Personalized medicine is also a trend that complexifies development, and ask for more than randomized clinical trials that do not reflect clinical practice.
Using examples, we will be examining how to articulate a development strategy from Phase 2 to phase 4, highlighting the importance of synergies of Clinical Operations, Medical Affairs, Health Outcomes and Pharmacoeconomics in bringing to market innovative medicines.
Christian J. Agboton currently serves as Senior Global Brand Medical Director at Takeda based in Zurich, Switzerland.
He previously served as Medical Director of Biosimilars Immunology / inflammation at Sandoz and Hospira/Pfizer.
Christian also worked at GSK vaccines, Merck Serono and UCB Pharma in Clinical and Medical Affairs roles.
Channeling innovation to deliver evidence while keeping quality and timelines has always been at the heart of his approach to data generation.
Christian is member of the Royal Faculty of Pharmaceutical Medicine.