Sinan has worked in the EU regulatory system for more than a decade. At the EMA, he has served as a member of the Committee for Medicinal Products for Human Use (CHMP), the Committee for Advanced Therapies (CAT), and the Scientific Advice Working Party (SAWP), and as a member and chair of CHMP’s Oncology Working Party (ONCWP). He also served as chief medical officer at the Danish Medicines Agency. He was responsible for the scientific evaluation of new cancer products, extension of indications, and national scientific advice. His experience covers oncology, hematology, rare diseases, advanced therapies, small molecules, monoclonal antibodies, and other protein-based products.

Cecil has amassed over 30 years of experience in regulatory affairs and clinical development, with a focus on biological medicines for the past 25 years. His expertise lies in monoclonals and biosimilars, spanning various therapeutic areas including oncology, inflammatory disease, diabetes, growth factors, multiple sclerosis, neurology, antivirals, blood products, and vaccines. Since joining Parexel in 2001, he has been instrumental in clinical development, regulatory submissions, biosimilars, orphan drugs, and training. He crafts efficient and effective clinical development plans, collaborating with pharmacologists, statisticians, therapeutic experts and conducting feasibility analyses.

Christiane has over 12 years of regulatory agency experience in biological medicines, specializing CMC development plans and regulatory strategies for the EU and FDA. Her experience is vast, spanning all types of regulatory submissions and agency interactions as well as advising on strategic considerations for product development. Her expertise lies in cell and gene therapies, viral vectors, RNA products, and novel vaccines, including vectored vaccines. As an ex-regulator, she served as a senior quality assessor and manager at the MHRA and was a member of the Committee for Advanced Therapies (CAT) at the EMA.

Miles Liu is the Vice President of Business Development at Parexel International. With extensive experience in the pharmaceutical and biotechnology sectors, Miles is dedicated to driving innovative solutions and strategic growth for Parexel.