Complex Medicines: Science, Regulation, and Accelerating Development
Event Date: May 13, 2019
Deadline to Submit Abstracts and Fellowships: April 15, 2019
The rise of bio- and nano-technologies has accelerated the development of complex medicines, and at the same time it has revealed new hurdles in regulatory science and accelerating patient access to new therapies. Complex medicines include biologics (e.g. vaccines, gene therapies, recombinant proteins) and non-biological complex drug products (e.g. glatiramoids, iron-carbohydrate complexes, polymeric micelles, complex ocular emulsions, and liposomes). Their diverse nature poses challenges for the development of regulatory guidelines. While complexity is not new in medicines, our technical capacity to measure and analyze data has increased. This requires a determination of which measurements are relevant to demonstrate therapeutic efficacy and safety. Further, many obstacles remain in regulatory harmonization across global authorities, given their different approaches and legal frameworks.
To advance research and build consensus, it is necessary to engage together key stakeholders from academia, regulatory bodies, industry, and drug manufacturing. The Non Biological Complex Drugs Working Group and the New York Academy of Sciences will present the conference Complex Medicines: Science, Regulation, and Accelerating Development to stimulate this discussion. This convening is a follow up to the 2016 event, Equivalence of Complex Drug Products: Scientific and Regulatory Challenges. The conference will identify the best scientific approaches for complex medicines development and regulation, will outline outstanding challenges in the assessment of equivalence, and will discuss how to improve timely patient access for new medicines and building a sustainable healthcare system. The end goal is to facilitate the translation of scientific findings into advancements in medicine for the benefit of patients.
To register for this event, please visit the main website at: https://www.nyas.org/events/2019/complex-medicines-science-regulation-and-accelerating-development/