Advancing Biologics from the Lab to the Clinic event will provide essential perspectives from both industry, regulatory and scientific perspectives in terms of what are the factors preventing biologics from progressing further in development and the vital elements of a successful early stage strategy for biologic studies. Attendees will achieve an advanced understanding of how to incorporate the specific biologic requirements into the strategic & operational planning for an early phase clinical trial that provides the best opportunity to save time, reduce risk, reduce costs and maximise product value. Escalating biologic drug R&D costs combined with a decline in the output of new molecular entities making it to the market has resulted in many pharma and biotech companies re-evaluating their traditional approaches. Clinical development for biologics is widely acknowledged as being potentially more expensive and risky than small molecule development. The clinical development program should focus on not only on the normal questions of safety and efficacy, but also cover the biologic activity of the product in humans: immunogenicity, optimum dosage levels, potential biomarkers to measure effects. To have the highest chance for success it also needs to factor in both the products characterization and preclinical programs. The unique properties of these highly distinct products must be considered to minimize risks, aid later product development and demonstrate product value at an early stage. Why attend?
Meet experts directly involved in biologic trial design and implementation
Learn about the specific regulatory guidance and level of proof required to satisfy the governing bodies.
Understand the perspectives of all stakeholder involved, i.e. regulators, sponsors, CROs, SMOs, central labs and experienced biologic investigators.
Come to benchmark, share experience and help to develop a best-practice approach to biologic clinical development.
Build stronger relationships upon a better understanding of the challenges faced by each group, who are all vital to the planning and implementation of the study.
Experienced executives from Pharma and Biotechs involved in Biologic development
VPs, Professors, Senior Directors and Managers
Early phase clinical development
PK & PD
Drug safety & biomarkers
https://www.nextlevelpharma.com/events/view/advanced_biologics_from_the_lab_to_the_clinic About NextLevel Pharma
NextLevel Pharma is a leading, global strategic business information and opportunity provider for the international life sciences industry. NextLevel Pharma brings the life sciences industry closer together and organise intelligent conferences and events for industry, personalised meetings for individual companies, as well as tailored partnering services. For more information, please visit www.nextlevelpharma.com.